CN105267751A - Drug for treating malignant pleural effusion with Qi and Yin deficiency - Google Patents

Abstract

The invention provides a drug for treating malignant pleural effusion with Qi and Yin deficiency, comprising materials: Radix Codonopsis, Radix Acanthopanacis Semticosi, Radix Scrophulariae, Semen Plantaginis, Semen Lepidii, Herba Ephedrae, Ramulus Cinnamomi, Radix et Rhizoma Rhei, Cortex Mori, Rhizoma Dioscoreae, Herba Orchidis Latifoliae, Radix Morinaceae, Radix Araliae, Radix Asparagi, Flos lonicerae, Herba Cymbopogonis, Herba seu Radix Asteris Ageratozdis, and pollen typhae. An effective means to treat malignant pleural effusion is given using the drug with chemotherapy through pleural perfusions, thus recurrence rate of pleural effusion of lung cancer is decreased and curative effect is improved, toxic and side effects of chemotherapy can also be relieved and the curative effect can also be enhanced, by using traditional Chinese medicine, and meanwhile, life quality of a patient is improved and clinical symptoms are relieved, both the entirety and locality of the patient are cared and the purpose of strengthening body resistance and eliminating evil is achieved.

Description

Drugs for the treatment of malignant pleural effusion of Qi and Yin deficiency type

technical field

The invention relates to the technical field of traditional Chinese medicine, in particular to a medicine for treating malignant pleural effusion of Qi and Yin deficiency type.

Background technique

Malignant pleural effusion refers to pleural effusion caused by malignant tumor involving the pleura or primary pleural tumor. It is one of the common complications of malignant tumors in the late stage, and the incidence rate accounts for about 25% of pleural effusions. Malignant tumors that cause malignant pleural effusions include lung cancer, breast cancer, and lymphoma. Clinically, it can cause symptoms such as chest pain and dyspnea, and even respiratory failure, which seriously affects the quality of life of patients and shortens the survival time of patients. Some studies have shown that the survival time is generally less than 6 months. The rapid growth of malignant pleural effusion can cause compressive atelectasis and restrictive ventilatory dysfunction, mediastinal shift and decreased return of cardiac blood, thereby affecting the respiratory and circulatory function and seriously threatening the life of the patient.

In the treatment of malignant pleural effusion, the treatment method of western medicine is as follows: when the amount of pleural effusion is not much and the patient's symptoms of wheezing and chest pain are not serious, systemic chemotherapy is the main anti-tumor; when the pleural effusion has reached a moderate or even large amount, the patient is short of breath When symptoms are prominent and seriously affect normal physiological functions, intrapleural fluid drainage should be used as soon as possible. The pleural effusion should be drained through closed drainage with chest tube or thoracentesis to quickly relieve shortness of breath and other emergencies. Chemotherapy drugs, sclerosing agents, or biologics are injected to promote pleural adhesions. The outstanding advantage of this method is that it can relieve symptoms quickly, but it will inevitably cause a large amount of protein loss in some patients due to pumping pleural effusion, and the symptoms will aggravate; some patients have fever and severe vomiting after intrathoracic injection of drugs.

Although the treatment of traditional Chinese medicine can't relieve the symptoms immediately, but in the slow stage of the disease's development, it can give full play to its treatment characteristics of overall regulation. It analyzes the pleural effusion on the basis of syndrome differentiation, and through the method of combining disease differentiation and dialectics, it can make the patient Symptoms gradually improved, pleural effusion subsided.

Chinese medicine believes that malignant pleural effusion belongs to the category of "hanging drink". Phlegm turbidity accumulates and becomes drink, body fluid is not distributed, evil flow in the chest and hypochondrium, block the triple burner, and water and drink accumulate to form pleural effusion. Its nature of disease is deficiency in origin and excess in superficiality, and the pathogenesis is mainly qi deficiency and phlegm dampness.

After understanding the etiology, pathogenesis and classification of syndrome types of suspended drink, the present invention draws up traditional Chinese medicine treatment prescriptions through syndrome differentiation, which is very meaningful for the treatment of malignant pleural effusion. With reference to "Oncology of Traditional Chinese Medicine" (Zhou Daihan), malignant pleural effusion is divided into lung-heat and phlegm-stasis type, qi-yin deficiency type, yin-deficiency phlegm-heat type, and qi-yin deficiency type. A new drug is proposed for malignant pleural effusion of two-deficiency type.

Qi and Yin Deficiency Syndrome Malignant Pleural Effusion is caused by deficiency of Qi in the lungs, spleen, and kidneys. In the body, a suspension drink is formed. Patients with malignant tumor pleural effusion are prone to cough, less sputum, thin sputum or blood in sputum, low coughing sound, shortness of breath, fatigue, pale complexion, bad wind, spontaneous sweating or night sweats, dry mouth . From the analysis point of view, if qi deficiency loses its function of consolidating yin fluid, there will be bad wind, spontaneous sweating or night sweats, and qi deficiency can also cause it to lose its function of consolidating blood, resulting in bloody phlegm. Deficiency of lung qi and deficiency of qi can cause cough. If there is deficiency of spleen qi, the spleen is the source of phlegm, and the amount of phlegm will be small and the texture of phlegm will be thin; if the body has insufficient yin fluid, symptoms of dry mouth will appear. Therefore, in the treatment, it is based on the principles of invigorating the kidney and strengthening the spleen, nourishing qi and nourishing yin, warming water and drinking, and the present invention proposes on this treatment principle.

Contents of the invention

The technical problem to be solved by the present invention is to provide a medicine for treating malignant pleural effusion of deficiency of both qi and yin, and combined with pleural infusion chemotherapy is an effective means for treating malignant pleural effusion, thereby reducing the recurrence rate of lung cancer pleural effusion and improving the curative effect , and traditional Chinese medicine can be used to reduce the toxic and side effects of chemotherapy, consolidate the curative effect, improve the quality of life of patients and relieve clinical symptoms at the same time, taking into account the whole and part of the patient, so as to achieve the purpose of strengthening the body and eliminating pathogenic factors.

In order to solve the above-mentioned technical problems, the present invention provides a medicine for treating malignant pleural effusion of Qi and Yin deficiency type, and its raw materials include Codonopsis pilosula, Acanthopanax, Scrophulariaceae, Semen Plantaginis, Semen Tingli, Ephedra, Guizhi, Rhubarb, Morus Alba, Chinese Yam, Red Door Orchid, Curculigo, Duhuo, Asparagus, Honeysuckle, Rutaceae, Mountain White Chrysanthemum, and Puhuang.

Wherein, the weights of the raw materials in the drug are respectively Codonopsis 55g～65g, Acanthopanax 30g～40g, Scrophulariaceae 10g～20g, Plantago 20g～30g, Tinglizi 15g～25g, Ephedra 10g～20g, Guizhi 10g-20g, rhubarb 15g-25g, mulberry bark 10g-20g, yam 20g-30g, red door orchid 10g-20g, white curculigo 25g-35g, grass 10g-20g, asparagus 20g-30g, honeysuckle 10g-20g, 10g-20g of rue, 15g-25g of chrysanthemum and 20g-30g of Puhuang.

Wherein, the weights of the raw materials in the drug are respectively Codonopsis 58g～62g, Acanthopanax 33g～37g, Scrophulariaceae 13g～17g, Plantago 23g～27g, Tinglizi 18g～22g, Ephedra 13g～17g, Guizhi 13g-17g, rhubarb 18g-22g, mulberry bark 13g-17g, yam 23g-27g, red door orchid 13g-17g, curculigo 28g-32g, grass 13g-17g, asparagus 23g-27g, honeysuckle 13g~17g, rue 13g~17g, mountain white chrysanthemum 18g~22g and Puhuang 23g~27g.

Wherein, the weight of each crude drug in the medicine is respectively Codonopsis 60g, Acanthopanax 35g, Scrophulariaceae 15g, Semen Plantaginis 25g, Semen Tinglizi 20g, Ephedra 15g, Guizhi 15g, Rhubarb 20g, Cortex Mori 15g, 25g Chinese yam, 15g red door orchid, 30g white curculinum, 15g duhuo, 25g asparagus, 15g honeysuckle, 15g rue herb, 20g mountain white chrysanthemum and 25g Puhuang.

Wherein, the medicine provided by the invention is an oral dosage form.

Wherein, the medicine is prepared into tablets, capsules, oral liquids, granules, powders, decocting liquids, pills and the like.

Wherein, the medicine is prepared into granules.

The present invention also provides the preparation method of above-mentioned medicine, it comprises:

The first step is to weigh Codonopsis pilosula, Acanthopanax, Scrophulariaceae, Plantago, rhubarb, Chinese yam, red door orchid, curculi, grass lovage and asparagus, and mix them together with alcohol concentration of 70%~ 80% ethanol solution is heated and refluxed for 2 extractions, and the time for each extraction is 1 to 2 hours. The weight ratio of the ethanol solution and the Chinese medicinal materials mixed together in this step is 5 to 8: 1, and the extract is collected and filtered. Concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.02 to 1.06 at 60°C, and put it on a macroporous adsorption resin column. The weight of the macroporous adsorption resin is 1 to 3 times the weight of the Chinese medicinal materials mixed together in this step. The ethanol solution with a concentration of 50% to 80% is eluted, and the volume of the eluent is 5 to 20 times the volume of the macroporous adsorption resin column. clear ointment;

In the second step, other bulk drug components are weighed by the above weight, mixed together, extracted twice with water, firstly add 12 times the weight of water relative to the weight of the Chinese medicinal materials mixed together in this step, decoct for 2 hours, For the second time, add 8 times the weight of water relative to the weight of the Chinese medicinal materials mixed together in this step, and decoct for 1 hour; combine the decoction liquid, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.15 at 55°C ;

The third step is to mix the clear cream obtained in the first step and the second step together, and after the mixture and dextrin are mixed uniformly in a ratio of 3:1 by weight, they are dried under reduced pressure at 75°C and pulverized to obtain the intermediate drug powder. Get the intermediate medicinal powder and add equal weight of starch: mannitol=2: 3 mixed auxiliary materials and mix evenly to obtain the mixed medicinal powder, then add 0.3% protein sugar relative to the mixed medicinal powder quality, 1.0% citric acid, and use 12-14% Water-based granules, dried at 60°C, divided into packages, 8g per bag.

Beneficial effects of the present invention:

The invention provides a medicine for treating malignant pleural effusion of deficiency of both qi and yin, and combined with pleural infusion chemotherapy is an effective means for treating malignant pleural effusion, thereby reducing the recurrence rate of lung cancer pleural effusion, improving curative effect, and reducing chemotherapy by traditional Chinese medicine. To eliminate toxic and side effects, consolidate the curative effect, improve the quality of life of patients and relieve clinical symptoms at the same time, take into account the whole and part of the patient, and achieve the purpose of strengthening the body and eliminating pathogenic factors.

detailed description

In traditional Chinese medicine literature, malignant pleural effusion belongs to the categories of "lung accumulation", "addiction to drinking", "breathing cardia", "lung congestion", "breath accumulation", "addiction to knot", "hanging drink" and other categories in traditional Chinese medicine. The ancients' understanding of "lung accumulation" was described in "Plain Questions · Strange Diseases": "The disease is full of Qi under the threat, and the upper is reversed. The name of the disease is Qi accumulation. It may as well be used for food." "Su Wen Six Yuan Zheng Ji Da Lun Pian" said, "Where the Taiyin comes, it is separated by accumulated drink." ((Suwen·Zhizhenyaodalunpian) said: "Dampness and obscenity... People's diseases accumulate drink...". "Scholar Notes on the Origin and Symptoms of Various Diseases · Obsession with Throat" pointed out: "This is due to drinking water gathering and not dispersing, and then due to eating and drinking...or abdominal distension, or wheezing, shortness of breath, so the cloud becomes obsessed." "Theory of the Causes of Diseases · Phlegm and Drinking Symptoms" stated: " This is due to drinking a lot of water, and the water vapor stops gathering between the two flanks. When the cold air fights, it will agglomerate and form lumps, which is called drinking. The strings under the flanks rise together, and when pressed, there is a sound of water." These descriptions are consistent with malignant thoracic cavity The symptoms of effusion are similar. "Jinbian Yaolue Phlegm, Drinking, Cough and Syndrome and Treatment": "After drinking, the water flows under the flanks, and coughing and saliva cause pain, which is called hanging drink."

Lung cancer is caused by internal deficiency of righteous qi and imbalance of viscera, which leads to evil poison taking the opportunity to enter. , phlegm and qi intertwine, addiction obstructs collaterals, and with the passing of time, it becomes lung accumulation. Malignant pleural effusion is mostly caused by lung failure to regulate water channels, spleen failure to transport and transform, kidney failure to clear and secrete turbidity, qi movement is not smooth, water, dampness, evil poison coagulates, flows in the chest and flanks, blocks the triple burner, and accumulates water and drink . "San Ji Zong Lu" says: "Three energizers, the end of qi transformation, and the road of water and valley. The qi channels are even, and the three energizers are adjusted, then the water can flow into the meridians, turn into blood, and irrigate the whole body. The qi is astringent, the veins are unfavorable, the water and drink are stagnant, and they gather into phlegm drink." The location and symptoms of the disease are consistent with hanging drink. As for the malignant pleural effusion of lung cancer, the basic pathogenesis is lung qi deficiency, evil toxins take advantage of the opportunity to enter, the evil stagnates in the lungs, the lungs fail to ventilate and descend, the movement of qi is not smooth, stagnation of qi and phlegm coagulation, blockage of veins, and then abnormal circulation of water and liquid , clear and turbid are mixed, phlegm and turbidity accumulate, body fluid is not distributed, evil flow in the chest and hypochondrium, block the triple burner, water accumulation accumulates to form pleural effusion.

Qi and Yin Deficiency Syndrome Malignant Pleural Effusion is caused by deficiency of Qi in the lungs, spleen, and kidneys. In the body, a suspension drink is formed. Patients with malignant tumor pleural effusion are prone to cough, less sputum, thin sputum or blood in sputum, low coughing sound, shortness of breath, fatigue, pale complexion, bad wind, spontaneous sweating or night sweats, dry mouth . From the analysis point of view, if qi deficiency loses its function of consolidating yin fluid, there will be bad wind, spontaneous sweating or night sweats, and qi deficiency can also cause it to lose its function of consolidating blood, resulting in bloody phlegm. Deficiency of lung qi and deficiency of qi can cause cough. If there is deficiency of spleen qi, the spleen is the source of phlegm, and the amount of phlegm will be small and the texture of phlegm will be thin; if the body has insufficient yin fluid, symptoms of dry mouth will appear. Therefore, in the treatment, the principles of tonifying the kidney and spleen, nourishing qi and nourishing yin, and warming water are the principles.

The invention provides a medicine for treating malignant pleural effusion of deficiency of both qi and yin. White bark, yam, red door orchid, curculinum, lovage, asparagus, honeysuckle, rue, chrysanthemum and cattail.

Further preferably, the drug is prepared only from the above raw materials.

The diseases targeted by the present invention are usually in the late stage of tumors, therefore, how to alleviate the symptoms of patients, improve the quality of life of patients with tumors, and prolong the life of patients is the main purpose of treatment. Among the prescriptions involved in the present invention, Tinglizi, raw ephedra, cassia twig, rhubarb, Morus alba to relieve lung and water, and warm water to improve pleural effusion are the monarch drug group, Codonopsis, Acanthopanax, Chinese yam , Red Gate Orchid, White Curculigo, Grass Duhuo nourishes the kidney and strengthens the spleen, Asparagus nourishes qi and nourishes yin, so it is a ministerial drug, adding Scrophulariaceae, honeysuckle, rue grass, mountain white chrysanthemum, Puhuang and other drugs to clear away heat and detoxify, dissipate Blood stasis disappears stagnation, to treat tumor, plays adjuvant role in the present invention, and the traditional Chinese medical science thinks to give evil with a way out, " open ghost door, clean mansion ", so ephedra opens upper source, plantago seed opens lower source, and water drinks from Urine and let out, so it is used as medicine.

Codonopsis: sweet in taste, flat in nature, enters the lung and spleen meridian, has the effect of invigorating qi and spleen, nourishing blood and promoting body fluid, mainly used for symptoms such as fatigue, shortness of breath, cough and spontaneous sweating caused by spleen and lung qi deficiency or qi and blood deficiency. Good at invigorating the spleen and nourishing the stomach, regulating the middle burner, and nourishing the blood. It is flat in nature, invigorating the spleen and transporting it but not dry; the taste is yin but not damp, which can improve the body's immune status, improve disease resistance, and promote digestion and absorption. Improve metabolism and promote intestinal absorption of nutrients.

Acanthopanax: the roots, rhizomes or stems and leaves of Acanthopanax acanthopanax of Araliaceae: spicy, bitter, slightly sweet, warm in nature, enters the spleen, kidney, and heart meridian, has the functions of nourishing qi and invigorating the spleen, nourishing the kidney and calming the nerves. The effect of expelling wind and dampness is used for wind-cold-damp arthralgia, waist and knee pain, flaccidity of muscles and bones, slow movement, physical weakness, bruises, fractures, edema, beriberi, yin damp itching and other syndromes.

Scrophulariaceae: sweet, bitter, sweet, slightly cold in nature, returns to the lung, stomach, and kidney channels, has the effects of clearing away heat and cooling blood, purging fire and detoxification, and nourishing yin. , crimson tongue, spots, bone steaming and labor cough, fatigue and fatigue, constipation due to Tianjin injury, dim eyesight, sore throat, scrofula, phlegm nucleus, carbuncle and sore virus.

Semen Plantaginis: sweet in taste, cold in nature, enters the liver, kidney, small intestine, lung, and bladder meridian, has heat-clearing and diuretic effects, eliminates phlegm, relieves cough, and improves eyesight. It is mainly used for coughing and spitting when wind-heat invades the lung; Redness, swelling and pain; syndromes such as damp-heat accumulating in the lower burner, dysuria caused by heat-stamped bladder, and damp-heat jaundice.

Tinglizi: pungent, bitter, cold in nature, enters the lung, heart, liver, stomach, and bladder meridian, has the effects of purging lung and lowering qi, eliminating phlegm and relieving asthma, diuresis and swelling, venting evil, and mainly treating phlegm and saliva obstructing the lung Breathing, coughing and phlegm; lung abscess; edema; hydrothorax and abdomen; dysuria; chronic cor pulmonale; asthma and swelling of heart failure; scrofula and tuberculosis. .

Ephedra: pungent in taste, slightly bitter, warm in nature, enters the lung and bladder meridians, has the effects of sweating and dispelling cold, clearing the lungs and relieving asthma, diuresis and detumescence, used for exogenous wind-cold, aversion to cold and fever, head and body pain, nasal congestion, no Sweat, floating and tight pulse, etc. are evidences.

Guizhi: Latin name cinnamomiramulus, dry twigs of Lauraceae plant cinnamon: pungent, sweet, warm in nature, returning to the heart, lung, and bladder meridian, has the functions of sweating and relieving muscles, warming the meridians, helping yang to transform qi, dispelling cold and relieving pain, Cinnamomum twig is the dry twig of cinnamon of the family Lauraceae, which warms the meridians and unblocks the limbs. It is used for exogenous wind-cold symptoms, regardless of sweating or no sweating. It is also used for rheumatic arthralgia, stomach cold abdominal pain, amenorrhea, and dysmenorrhea. , rheumatic arthralgia, cold pain in the shoulders, arms, and limbs, etc., phlegm retention syndrome and bladder water storage, heart and spleen yang deficiency, water dampness internal stagnation, fullness of the chest and flanks, cough and dizziness and other syndromes of phlegm retention.

Rhubarb: Bitter in taste, cold in nature, returns to stomach meridian, large intestine meridian, liver meridian, spleen meridian, has the effects of clearing heat and detoxifying, killing insects and relieving itching, astringent, detumescence and hemostasis. ; jaundice; gonorrhea; edema and full abdomen; difficulty urinating; red eyes; sore throat; sore mouth and tongue; stomach heat and vomiting; vomiting blood; hemoptysis; epistaxis; blood in the stool; hematuria; blood accumulation; Accumulation of abdominal mass; bruises; pyretic poisonous carbuncles; erysipelas; scalds and other syndromes.

Mori Cortex: Latin name MoriCortex, sweet in taste, cold in nature, enters the lung meridian, has the effect of purging lungs and relieving asthma, diuresis and reducing swelling, used for cough and asthma due to lung heat, edema of the face, dysuria and other diseases.

Yam: Latin name dioscoreaerhizoma, sweet in taste and flat in nature, enters the lung, spleen and stomach meridian, has the functions of nourishing the spleen and stomach, nourishing the lung and strengthening the kidney, nourishing yin and promoting body fluid, and mainly treats weak spleen and stomach, poor appetite and poor spleen transportation. , nausea and diarrhea and other evidence.

Red door orchid: It is the whole plant of the orchid family Red door orchid. It is sweet in taste and flat in nature. It has the effects of strengthening the heart, nourishing the kidney, promoting body fluid, quenching thirst, and strengthening the spleen and stomach. Diet, deficiency of Yin fluid, irregular menstruation, etc.

Curculigo chinensis: the root of Apostichopus japonicus, a plant of the genus Dipsacus in the family Dipsacaceae, sweet in taste, slightly bitter, and warm in nature. Spleen deficiency indigestion, kidney deficiency impotence, vaginal discharge, uterine prolapse, bruises, fractures and other syndromes.

Cao Duhuo: It is the root of Yunnan Longan Longan, a plant of Araliaceae. It tastes bitter, pungent, and slightly warm in nature. Indications for anemofrigid cold, cough, spleen deficiency and edema, malnutrition in children, chest and hypochondrium pain, swelling and pain from falls, rheumatism pain, lumbago, bone fracture, irregular menstruation, traumatic bleeding and other syndromes.

Asparagus: sweet, bitter, cold in nature, returns to the lungs and kidneys, has the effect of nourishing yin and moistening dryness, clearing the lungs and promoting body fluid, mainly treating dry-heat cough, cough due to yin deficiency, hyperactivity of fire due to yin deficiency, nocturnal emission due to weak kidney essence, premature ejaculation And throat swelling and pain caused by asthenic fire and upper inflammation, febrile disease, fluid and wound thirst, internal heat, quenching thirst, intestinal dryness and constipation.

Honeysuckle: Latin name loniceraejaponicaeflos, sweet in taste, cold in nature, enters the heart, lung, stomach, and large intestine meridians, has the effect of clearing away heat and detoxification, and can cool blood and stop dysentery. It is mainly used for exogenous wind-heat, febrile disease with strong heat toxin, or when the heat evil is still on the upper burnt at the beginning of febrile disease and has not descended; heat toxin diarrhea, blood in stool; summer heat syndrome

Rutaceae: pungent, slightly bitter, warm in nature, has the functions of relieving exterior syndrome; promoting dampness; relieving cough and relieving asthma.

Mountain white chrysanthemum: bitter, pungent, cool in nature, has the effect of clearing away heat and detoxification, eliminating phlegm and cooling blood, mainly treating cold and fever, tonsillitis, bronchitis, hepatitis, enteritis, hot stranguria, carbuncle, swollen furuncle, snake bites and other syndromes .

Puhuang: sweet in taste, flat in nature, enters the liver and pericardium meridians, has the effects of stopping bleeding, removing blood stasis, and treating stranguria. For hematemesis, epistaxis, hemoptysis, metrorrhagia, traumatic bleeding, amenorrhea dysmenorrhea, epigastric pain, tumbling pain, bloody stranguria and puckery pain.

The weights of the raw materials in the medicine are respectively 55g-65g of Codonopsis, 30g-40g of Acanthopanax, 10g-20g of Scrophulariaceae, 20g-30g of Plantago, 15g-25g of Tinglizi, 10g-20g of Ephedra, 10g-20g of Guizhi 10g～20g, rhubarb 15g～25g, mulberry bark 10g～20g, Chinese yam 20g～30g, red door orchid 10g～20g, white curculigo 25g～35g, duhuo 10g～20g, asparagus 20g～30g, honeysuckle 10g～ 20g, rue 10g-20g, mountain white chrysanthemum 15g-25g and cattail 20g-30g.

The weights of the raw materials in the medicine are respectively Codonopsis 58g～62g, Acanthopanax 33g～37g, Scrophulariaceae 13g～17g, Plantago 23g～27g, Tinglizi 18g～22g, Ephedra 13g～17g, Guizhi 13g～17g, rhubarb 18g～22g, mulberry bark 13g～17g, yam 23g～27g, red door orchid 13g～17g, white curculigo 28g～32g, grass 13g～17g, asparagus 23g～27g, honeysuckle 13g～ 17g, rue 13g-17g, mountain white chrysanthemum 18g-22g and cattail 23g-27g.

The weight of each crude drug in the medicine is respectively Codonopsis 60g, Acanthopanax 35g, Scrophulariaceae 15g, Semen Plantaginis 25g, Semen Tinglizi 20g, Ephedra 15g, Guizhi 15g, Rhubarb 20g, Cortex Mori 15g, Chinese yam 25g , 15g of red door orchid, 30g of white curcuma, 15g of duhuo, 25g of asparagus, 15g of honeysuckle, 15g of rue, 20g of mountain white chrysanthemum and 25g of cattail.

The medicine provided by the present invention is an oral dosage form, which can be prepared into various commonly used dosage forms by adding conventional auxiliary materials as required, such as tablets, capsules, oral liquids, granules, powders, decoctions, pills, etc., preferably prepared into granules.

The present invention also provides a drug granule for treating malignant pleural effusion of Qi and Yin deficiency type, which is prepared by adding conventional auxiliary materials to the above-mentioned traditional Chinese medicine.

The present invention also provides a preparation method for the above-mentioned pharmaceutical granules, which includes:

The first step is to weigh Codonopsis pilosula, Acanthopanax, Scrophulariaceae, Plantago, rhubarb, Chinese yam, red door orchid, curculi, grass lovage and asparagus, and mix them together with alcohol concentration of 70%~ 80% ethanol solution is heated and refluxed for 2 extractions, and the time for each extraction is 1 to 2 hours. The weight ratio of the ethanol solution and the Chinese medicinal materials mixed together in this step is 5 to 8: 1, and the extract is collected and filtered. Concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.02 to 1.06 at 60°C, and put it on a macroporous adsorption resin column. The weight of the macroporous adsorption resin is 1 to 3 times the weight of the Chinese medicinal materials mixed together in this step. The ethanol solution with a concentration of 50% to 80% is eluted, and the volume of the eluent is 5 to 20 times the volume of the macroporous adsorption resin column. clear ointment;

In the second step, other bulk drug components are weighed by the above weight, mixed together, extracted twice with water, firstly add 12 times the weight of water relative to the weight of the Chinese medicinal materials mixed together in this step, decoct for 2 hours, For the second time, add 8 times the weight of water relative to the weight of the Chinese medicinal materials mixed together in this step, and decoct for 1 hour; combine the decoction liquid, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.15 at 55°C ;

The third step is to mix the clear cream obtained in the first step and the second step together, and after the mixture and dextrin are mixed uniformly in a ratio of 3:1 by weight, they are dried under reduced pressure at 75°C and pulverized to obtain the intermediate drug powder. Get the intermediate medicinal powder and add equal weight of starch: mannitol=2: 3 mixed auxiliary materials and mix evenly to obtain the mixed medicinal powder, then add 0.3% protein sugar relative to the mixed medicinal powder quality, 1.0% citric acid, and use 12-14% Water-based granules, dried at 60°C, divided into packages, 8g per bag.

The following examples are used to describe the implementation of the present invention in detail, so as to fully understand and implement the process of how to apply technical means to solve technical problems and achieve technical effects in the present invention.

Embodiment 1 Granule 1

Weigh 60g of Codonopsis, 35g of Acanthopanax, 15g of Scrophulariaceae, 25g of Plantago, 20g of Rhubarb, 25g of Chinese Yam, 15g of Red Gateland, 30g of Curculigo, 15g of Duhuo and 25g of Asparagus, and mix them with 2kg alcohol concentration Heating and refluxing 80% ethanol solution for 2 extractions, each extraction time is 2 hours, collecting the extract, filtering, concentrating the filtrate under reduced pressure to a concentrated solution with a relative density of 1.06 at 60°C, and putting it on a macroporous adsorption resin column , the weight 500g of macroporous adsorption resin, be 50%, 60% and 80% ethanol solution eluting with alcohol concentration, the volume of each described eluent is 5 times of macroporous adsorption resin column volume, collects elution Liquid, concentrated into a clear paste with a relative density of 1.15 at 55°C, weighed 20g of Tinglizi, 15g of Ephedra, 15g of Guizhi, 15g of Morus alba, 15g of honeysuckle, 15g of rue, 20g of chrysanthemum and 25g of Puhuang, mixed Together, extract twice with water, first add 1.6kg of water to decoct for 2 hours, add 1.2kg of water for the second time, decoct for 1 hour; combine the decoctions, filter, and concentrate the filtrate to 55°C For clear ointment with a relative density of 1.15, mix the above-obtained clear ointment together, mix the mixture and dextrin evenly in a ratio of 3:1 by weight, dry under reduced pressure at 75°C, and pulverize to obtain the intermediate drug powder. Add starch of equal weight to the body medicine powder: mannitol = 2: 3 mixed excipients and mix evenly to obtain the mixed medicine powder, then add 0.3% protein sugar relative to the quality of the mixed medicine powder, 1.0% citric acid, and prepare with 12-14% water Granules, dried at 60°C, packed separately, 8g per bag.

Toxicology testing

Codonopsis, Acanthopanax, Scrophulariaceae, Plantago, Tinglizi, Ephedra, Guizhi, Rhubarb, Morus alba, Yam, Red Door Orchid, Curculigo, Grass Duhuo, Asparagus, Honeysuckle, Rue Herb, Mountain The compatibility of white chrysanthemum and Puhuang accords with the theory of traditional Chinese medicine, and there is no fear of each other or opposite medicinal materials. According to the results of literature search, no toxic reaction was found in the acute toxicity test of each medicinal material, and no mutagenic or teratogenic effects were found in the chronic toxicity test, indicating that All traditional Chinese medicines are non-toxic, and the consumption of each traditional Chinese medicinal material in the present invention is within the scope of the therapeutic dosage prescribed by the state. The acute oral toxicity test of the present invention shows that: the acute oral MTD of female and male mice is greater than 32g/kgBW, which is non-toxic; the mouse bone marrow polychromatic erythrocyte micronucleus test is negative; the mouse sperm abnormality test is negative Result; Emes test is a negative result; 30 days feeding test is judged according to the evaluation standard of 30 days feeding test in Ministry of Public Health " Health Food Inspection and Evaluation Technical Specification " (2003 edition): in the tested dose range, this medicine has no effect on rats. Weekly body weight, weekly food intake, weekly food utilization rate, weight gain, total food intake, total food utilization rate, blood routine indicators, biochemical indicators, wet weight of major organs and organ/body ratio, after statistical analysis, There were no significant differences; no significant histopathological changes related to the tested animals were found in the histopathological examination.

Embodiment 2 Granules 2

Weigh 58g of Codonopsis, 33g of Acanthopanax, 13g of Scrophulariaceae, 23g of Plantago, 18g of Rhubarb, 23g of Chinese Yam, 13g of Red Door Orchid, 28g of Curculigo chinensis, 13g of Duhuo and 23g of Asparagus, and mix them together with 2kg alcohol concentration Heating and refluxing 80% ethanol solution for 2 extractions, each extraction time is 2 hours, collecting the extract, filtering, concentrating the filtrate under reduced pressure to a concentrated solution with a relative density of 1.06 at 60°C, and putting it on a macroporous adsorption resin column , the weight 500g of macroporous adsorption resin, be 50%, 60% and 80% ethanol solution eluting with alcohol concentration, the volume of each described eluent is 5 times of macroporous adsorption resin column volume, collects elution liquid, concentrated into a clear paste with a relative density of 1.15 at 55°C, weighed Tinglizi 18g, Ephedra 13g, Guizhi 13g, Morus alba 13g, Honeysuckle 13g, Rue 13g, Lime chrysanthemum 18g and Puhuang 23g, mixed Together, extract twice with water, first add 1.6kg of water to decoct for 2 hours, add 1.2kg of water for the second time, decoct for 1 hour; combine the decoctions, filter, and concentrate the filtrate to 55°C For clear ointment with a relative density of 1.15, mix the above-obtained clear ointment together, mix the mixture and dextrin evenly in a ratio of 3:1 by weight, dry under reduced pressure at 75°C, and pulverize to obtain the intermediate drug powder. Add starch of equal weight to the body medicine powder: mannitol = 2: 3 mixed excipients and mix evenly to obtain the mixed medicine powder, then add 0.3% protein sugar relative to the quality of the mixed medicine powder, 1.0% citric acid, and prepare with 12-14% water Granules, dried at 60°C, packed separately, 8g per bag.

Embodiment 3 Granules 3

Weigh 62g of Codonopsis, 37g of Acanthopanax, 17g of Scrophulariaceae, 27g of Plantago, 22g of Rhubarb, 27g of Chinese Yam, 17g of Red Gate Orchid, 32g of White Curculigo, 17g of Duhuo and 27g of Asparagus, and mix them together with 2kg alcohol concentration Heating and refluxing 80% ethanol solution for 2 extractions, each extraction time is 2 hours, collecting the extract, filtering, concentrating the filtrate under reduced pressure to a concentrated solution with a relative density of 1.06 at 60°C, and putting it on a macroporous adsorption resin column , the weight 500g of macroporous adsorption resin, be 50%, 60% and 80% ethanol solution eluting with alcohol concentration, the volume of each described eluent is 5 times of macroporous adsorption resin column volume, collects elution liquid, concentrated into a clear paste with a relative density of 1.15 at 55°C, weighed Tinglizi 22g, Ephedra 17g, Guizhi 17g, Morus Alba 17g, Honeysuckle 17g, Rutaceae 17g, Mountain White Chrysanthemum 22g and Puhuang 27g, mixed Together, extract twice with water, first add 1.6kg of water to decoct for 2 hours, add 1.2kg of water for the second time, decoct for 1 hour; combine the decoctions, filter, and concentrate the filtrate to 55°C For clear ointment with a relative density of 1.15, mix the above-obtained clear ointment together, mix the mixture and dextrin evenly in a ratio of 3:1 by weight, dry under reduced pressure at 75°C, and pulverize to obtain the intermediate drug powder. Add starch of equal weight to the body medicine powder: mannitol = 2: 3 mixed excipients and mix evenly to obtain the mixed medicine powder, then add 0.3% protein sugar relative to the quality of the mixed medicine powder, 1.0% citric acid, and prepare with 12-14% water Granules, dried at 60°C, packed separately, 8g per bag.

Embodiment 4 animal experiments

Animals: 100 Wistar rats, half male and half male, were purchased from the Experimental Animal Center of the Affiliated Hospital of Qingdao University School of Medicine, with a body weight of (220±20) g.

Tumor strain: Ehrlich ascites tumor (EAC) cell line.

Reagent: CYFRA21-1 fragment ELISA detection kit, purchased from RB Company, USA. The granules prepared in Example 1. Lierfan (mannan peptide for injection), produced by Jilin Province Yixin Pharmaceutical Co., Ltd.

Grouping and modeling: 100 rats were randomly divided into 5 groups including blank control group, model group, traditional Chinese medicine group, Lierfan group, and Chinese medicine Jialierfan group, with 20 rats in each group. The modeling method was as follows: the Ehrlich ascites cancer cell line was passaged once a week, a small amount of ascites was extracted from Wistar rats bearing tumors for 7 days, and the concentration of tumor cells was counted to 5×10 ⁸ /mL with a cell counting board. After rats were anesthetized by intraperitoneal injection of 1.5 mg/kg 25% urethane, 0.3 mL of the above tumor cell suspension was injected into the right back chest cavity. In the blank control group, 0.3 mL of normal saline was injected into the chest cavity in the same way.

Method of administration

From the next day after modeling, the blank control group and the model group were administered with 3 mL of normal saline, once a day, for 7 days; g/(kg·d) intragastrically, once a day, for 7 consecutive days; the Lierfan group and the traditional Chinese medicine Jialierfan group were given Lierfan diluted with normal saline 1:1, at 1 mg/(kg·d) , intraperitoneal injection, once every other day, and the treatment time was 7 days.

Specimen collection and testing

On the 8th day after modeling, blood from the rat liver portal vein was collected and centrifuged to determine the content of CYFRA21-1 in serum and pleural fluid by enzyme-linked immunosorbent assay (ELISA). The pleural effusion and pleural tissue were collected, and the morphological changes of the pleural tissue and pleural effusion were observed under a light microscope.

Statistical analysis

The statistical software SPSS (edition 17.0) was used for statistical analysis, and the data were (mean ± standard deviation) indicates that the measurement data is analyzed by one-way analysis of variance, and the difference between groups is tested by t test. P<0.05 means significant difference, and P<0.01 means very significant difference.

result

Pleural effusion sediment smear: under the microscope, a large number of cancer cells can be seen in the model group gathered into clusters with irregular shapes; the number of cancer cells in the Lierfan group and the traditional Chinese medicine group was significantly less than that of the model group, and there were less clusters. The cancer cells in the traditional Chinese medicine Jialierfan group were scattered, and there were very few clusters.

Pleural tissue: HE staining blank control group showed no thickening of the pleura, no infiltration of tumor cells, evenly stained nuclei, and no accumulation of dense staining. In the model group, the pleura was obviously thickened and severely damaged, with lymphocyte infiltration, a small amount of mesothelial cells, and a large number of cancer cell nuclei enlarged and densely stained, and some of them appeared in clusters. Each treatment group was less severe than the model group.

Serum CYFRA21-1 content, the results are shown in Table 1.

Table 1 Comparison of serum CYFRA21-1 content in each group of rats (ng/mL)

group no Serum CYFRA21-1 Blank control group 20 0.903±0.100 ^* model group 20 3.792±0.629 Chinese medicine group 20 1.932±0.618 ^a* Lierfan Group 20 2.165±0.623 ^a* Traditional Chinese Medicine Jialierfan Group 20 1.359±0.602 ^*

Note: Compared with the model group, ^* P<0.05; compared with the traditional Chinese medicine Jialierfan group, ^a P<0.05.

The serum CYFRA21-1 content of the model group was significantly higher than that of the blank control group (P<0.05); Significantly lower than that of Lierfan group and Chinese medicine group (P<0.05); the level of Chinese medicine group and Lierfan group was similar (P>0.05).

Embodiment 5 clinical data

Source of cases: From January 2012 to September 2013, the outpatients of the Affiliated Hospital of Qingdao University School of Medicine mainly had advanced lung cancer complicated with pleural effusion syndrome, and the patients who met the inclusion criteria were divided into treatment groups ( Pleural perfusion chemotherapy plus traditional Chinese medicine group) and the control group (pleural cavity perfusion chemotherapy alone group), the short-term curative effect and long-term curative effect, toxic and side effects of the two groups were analyzed.

Chinese and Western medicine diagnostic criteria

(1) Chest X-rays in all cases showed: moderate to massive pleural effusion, all of which were diagnosed as lung cancer by histocytology or pathology;

(2) Determination of pleural fluid volume:

A small amount of effusion: Chest X-ray shows that the effusion is limited to the posterior costal septal angle (it is difficult to find when the pleural effusion is very small, and when the fluid volume exceeds 300ml, the costal septal angle can be seen to become blunt on the standing posteroanterior view);

Moderate amount of effusion: Chest radiograph shows that the upper edge of the effusion is above the level of the front end of the fourth rib, below the level of the front end of the second rib, and above the level of the inner edge of the second anterior rib as a large amount, and between the two is a moderate amount;

Massive effusion: Chest radiograph shows that the upper edge of the effusion reaches above the front of the second rib.

(3) In line with the clinical manifestations of lung cancer pleural effusion, such as dyspnea, chest pain, cough and other symptoms;

(4) Health status (Karflofsky standard) ≥ 50 points, expected survival time > 3.5 months;

(5) Those who have been ruled out of infection by laboratory or imaging examination.

Diagnostic criteria of TCM syndromes: formulated with reference to "Oncology of Traditional Chinese Medicine" (Zhou Daihan), who belong to lung cancer with pleural effusion and deficiency of both Qi and Yin: cough with little phlegm, low coughing sound, blood in sputum, mental fatigue, lack of appetite and shortness of breath Qi, dry mouth, not much drink, tongue texture, thin coating, thready or rapid pulse.

inclusion criteria

(1) Patients with histopathologically or cytologically confirmed lung cancer and pleural effusion who were hospitalized in the Affiliated Hospital of Qingdao University School of Medicine from May 2009 to February 2010; and the pleural effusion was above the moderate level by B-ultrasound examination;

(2) According to the patient's main syndrome and pulse condition of the tongue coating, the syndrome type belongs to deficiency of both Qi and Yin;

(3) aged 40 to 80 years old;

(4) Using traditional Chinese medicine as the main treatment method: Western medicine radiotherapy, patients who have not undergone surgery, radiotherapy, intervention, biological therapy and other methods after stopping chemotherapy for more than 2 months;

(5) The survival time is greater than or equal to 3 months;

(6) The Karnofsky score is 50 or above, and the quality of life score is 31 or above;

(7) Those who gave informed consent.

Criteria for excluding cases:

(1) Patients who do not meet the diagnostic criteria for the above diseases;

(2) Combined with other malignant tumors that need to be treated at the same time;

(3) Patients who failed to complete the study process during the observation process;

(4) The researchers think that it is not suitable to conduct this clinical trial;

(5) Patients with severe heart, brain, kidney or hematopoietic system diseases and mental illness;

(6) Poor compliance and refusal to cooperate;

(7) Exclude patients with pleural effusion caused by other medical diseases (such as tuberculosis, heart failure, liver cirrhosis, nephrotic syndrome, etc.);

(8) Women younger than 40 years old (excluding 40 years old) or older than 80 years old (not including 80 years old), pregnant or breastfeeding.

Case culling and dropout:

(1) Those who cannot adhere to treatment;

(2) Those who did not follow the treatment plan;

(3) Subjects with serious adverse events/adverse reactions;

(4) Patients with other serious concurrent diseases or disease progression during the course of treatment;

(5) The investigator believes that continuing the experiment may cause harm to the subject.

Research methods

In the clinical research, 136 patients were simply randomly divided into a treatment group and a control group, 68 cases in each group.

Control group: closed thoracic drainage under local anesthesia with 2% lidocaine, drained the pleural effusion as much as possible (general drainage for 3 to 5 days), and injected 20ml of normal saline plus 80mg of nedaplatin to close the tube after confirmed by B-ultrasound or chest X-ray. Advise the patient to continuously rotate the body position to facilitate full contact between the liquid medicine and the pleura, routinely use furosemide 20mg and ondansetron 8mg intravenously for diuresis and prevent vomiting. Use for 1 day, observe for 4 days, 1 week is a course of treatment, apply 2 courses of treatment depending on the situation of pleural effusion, and observe for 4 weeks. If the pleural effusion grows rapidly in the early stage of treatment, the pleural effusion can be simply extracted in the middle of the 2 courses of treatment instead of pleural injection. Drugs, continued conventional treatment such as symptomatic support, no systemic radiotherapy and chemotherapy.

The treatment group: Nedaplatin perfused into the pleural cavity and the granules prepared in Example 1 were taken with water, 1 dose per day, 2 times a day, for 2 weeks.

Clinical observation indicators, curative effect standards and safety testing

Clinical Observation Index

(1) Treatment of pleural effusion: review chest radiographs before and after treatment, and record pleural effusion volume

(2) Quality of life: According to the quality of life standard and Karnofsky score of tumor patients, observe whether the conditions such as cough, expectoration, chest tightness, shortness of breath, and edema are improved.

(3) Toxicity evaluation standard: according to WHO anticancer drug toxicity evaluation standard, chemotherapy toxicity is graded according to WHO standard, divided into grade 0-IV.

Efficacy standard references were formulated as follows:

(1) Complete remission (CR): The pleural effusion is completely absorbed, the symptoms disappear, and no pleural effusion is found in the X-ray examination, and it lasts for more than 4 weeks;

(2) Partial remission (PR): Significant reduction of pleural effusion, relief of symptoms, clinical and X-ray examination of pleural effusion reduced by more than 1/2, and maintained for more than 4 weeks;

(3) Ineffective (NC): After treatment, the pleural effusion still continues to grow, or the pleural effusion does not decrease significantly, and the symptoms do not improve, or continue to aggravate;

(4) Deterioration (PD): increased pleural effusion, no improvement or aggravation of symptoms.

The effective rate is calculated as CR+PR, and the quality of life standard is carried out by Karnofsky scoring standard. After treatment, when the increase or decrease is greater than 10 points compared with before treatment, it is considered to be improved or decreased, and if the change before and after treatment is less than 10 points, it is considered to be stable.

Security testing

Including blood routine (WBC, HGB), liver function (ALT), renal function (CR), examination (before and after comparison, abnormal liver and kidney function not caused by complications caused by the disease).

result

The distribution of Karnofsky scores between the two groups was compared, and the results are shown in Table 2.

Table 2 Comparison of Karnofsky scores before and after treatment in the two groups

group Number of cases Score before treatment Score after treatment control group 68 60.206±4.113 65.023±3.991 therapy group 68 58.939±3.068 76.082±2.938

Before treatment, there was no statistically significant difference in Karnofsky scores between the two groups, P>0.05. After treatment, the Karnofsky scores of patients taking the medicine provided by the invention were significantly improved, P<0.05.

The quality of life scores of the two groups of patients before and after treatment were compared, and the results are shown in Table 3.

Table 3 Comparison of the quality of life scores of the two groups of patients before and after treatment

group Number of cases Quality of life score before treatment Quality of life score after treatment control group 68 37.933±3.609 41.017±3.996 therapy group 68 38.211±3.561 46.082±3.208

Before treatment, there was no significant difference in the quality of life scores between the two groups, P>0.05, and after treatment, the quality of life scores in the treatment group were significantly improved, P<0.05.

Table 4 shows the comparison of blood routine white blood cell examinations between the two groups of patients.

Table 4 Comparison of white blood cell examination before and after treatment in the two groups of patients (×10 ⁹ /L)

group Number of cases WBC before treatment White blood cells after treatment control group 68 6.935±1.306 7.739±1.206 therapy group 68 7.028±1.173 7.832±1.180

Before treatment, there was no significant difference in white blood cells between the two groups, P>0.05. After treatment, there was no significant change in white blood cells in the treatment group and the control group, and both treatments had no side effects of bone marrow suppression.

The blood routine hemoglobin examinations of the two groups of patients before and after treatment were compared, and the results are shown in Table 5.

Table 5 Comparison of blood routine hemoglobin examination between the two groups of patients (g/L)

group Number of cases Hemoglobin before treatment Hemoglobin after treatment control group 68 98.237±4.029 103.663±8.709 therapy group 68 97.919±4.576 113.631±9.693

Before treatment, there was no significant difference in hemoglobin between the two groups of patients, P>0.05. After treatment, both groups of patients could improve the anemia of the patients, and the improvement effect of the traditional Chinese medicine provided by the invention was better than that of the control group, P<0.05.

The liver function (ALT) comparison between the two groups before and after treatment, the results are shown in Table 6.

Table 6 Comparison of liver function (ALT) before and after treatment in two groups of patients (U/L)

group Number of cases ALT before treatment ALT after treatment control group 68 25.387±3.616 27.035±2.618 therapy group 68 25.961±3.081 26.997±2.501

Before treatment, there was no significant difference in liver function ALT between the two groups, P>0.05, and there was no significant effect on the liver function of the two groups after treatment.

The renal function (Cr) of the two groups of patients before and after treatment was compared, and the results are shown in Table 7.

Table 7 Comparison of renal function (Cr) between the two groups of patients before and after treatment (umol/L)

group Number of cases Cr before treatment Cr after treatment control group 68 62.990±5.306 64.119±7.351 therapy group 68 61.382±5.013 63.660±6.982

There was no significant difference in renal function Cr between the two groups before treatment, P>0.05, and there was no significant effect on the renal function of the two groups after treatment.

The total effective rate was compared between the two groups after treatment, and the results are shown in Table 8.

Table 8 compares the total effective rate of the two groups after treatment

group Number of cases CR PR NC PD total effective rate therapy group 68 43 twenty one 4 0 94.12% control group 68 16 27 17 8 63.24%

Adverse reactions: There were no related serious adverse reactions and suspensions during the experiment, and invalid cases of clinical trials were withdrawn.

All of the above-mentioned primary implementations of this intellectual property rights are not intended to limit other forms of implementations of this new product and/or new method. Those skilled in the art will, with this important information, modify the above to achieve a similar implementation. However, all modifications or alterations to the new product based on the present invention belong to reserved rights.

The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention to other forms. Any skilled person who is familiar with this profession may use the technical content disclosed above to change or modify the equivalent of equivalent changes. Example. However, any simple modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still belong to the protection scope of the technical solution of the present invention.

Claims (8)

1. A medicine for the treatment of both qi and yin deficiency type malignant pleural effusion, characterized in that: crude drug comprises Codonopsis pilosula, Acanthopanax, Scrophulariaceae, Semen Plantaginis, Semen Tingli, Ephedra, Cinnamon Twig, Rhubarb, Morus alba, Chinese yam, red door orchid, curculinum, lovage, asparagus, honeysuckle, rue, chrysanthemum and cattail. 2. The medicine according to claim 1, characterized in that: the weight of each raw material medicine is 55g-65g of Codonopsis, 30g-40g of Acanthopanax, 10g-20g of Scrophulariaceae, 20g-30g of Plantago, Tinglizi 15g～25g, ephedra 10g～20g, cassia twig 10g～20g, rhubarb 15g～25g, mulberry bark 10g～20g, yam 20g～30g, red door orchid 10g～20g, white curculinum 25g～35g, grass lovage 10g～ 20g, asparagus 20g-30g, honeysuckle 10g-20g, rue herb 10g-20g, mountain white chrysanthemum 15g-25g and cattail 20g-30g. 3. The medicine according to claim 1 or 2, characterized in that: the weight of each raw material drug is 58g-62g of Codonopsis, 33g-37g of Acanthopanax, 13g-17g of Scrophulariaceae, 23g-27g of Plantago, 18g～22g of Lizizi, 13g～17g of ephedra, 13g～17g of cassia twig, 18g～22g of rhubarb, 13g～17g of mulberry bark, 23g～27g of Chinese yam, 13g～17g of red door orchid, 28g～32g of white curculinum, and Duhuo 13g~17g, asparagus 23g~27g, honeysuckle 13g~17g, rue herb 13g~17g, mountain white chrysanthemum 18g~22g and Puhuang 23g~27g. 4. The medicine as claimed in claims 1 to 3, characterized in that: the weights of the raw materials are Codonopsis 60g, Acanthopanax 35g, Scrophulariaceae 15g, Plantago 25g, Tinglizi 20g, Ephedra 15g, Gui Branches 15g, rhubarb 20g, mulberry bark 15g, yam 25g, red door orchid 15g, curculinum 30g, chrysanthemum 15g, asparagus 25g, honeysuckle 15g, rue 15g, mountain white chrysanthemum 20g and cattail 25g. 5. The medicament according to claims 1 to 4, characterized in that: the medicament is an oral dosage form. 6. The medicine according to claims 1 to 5, characterized in that: said medicine is prepared into tablets, capsules, oral liquids, granules, powders, decoctions, pills and the like. 7. The medicine according to claims 1 to 6, characterized in that: said medicine is prepared as granules. 8. The preparation method of the medicine described in claims 1 to 7, characterized in that, comprising: The first step is to weigh Codonopsis pilosula, Acanthopanax, Scrophulariaceae, Plantago, rhubarb, Chinese yam, red door orchid, curculi, grass lovage and asparagus, and mix them together with alcohol concentration of 70%~ 80% ethanol solution is heated and refluxed for 2 extractions, and the time for each extraction is 1 to 2 hours. The weight ratio of the ethanol solution and the Chinese medicinal materials mixed together in this step is 5 to 8: 1, and the extract is collected and filtered. Concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.02 to 1.06 at 60°C, and put it on a macroporous adsorption resin column. The weight of the macroporous adsorption resin is 1 to 3 times the weight of the Chinese medicinal materials mixed together in this step. The ethanol solution with a concentration of 50% to 80% is eluted, and the volume of the eluent is 5 to 20 times the volume of the macroporous adsorption resin column. clear ointment; In the second step, other bulk drug components are weighed by the above weight, mixed together, extracted twice with water, firstly add 12 times the weight of water relative to the weight of the Chinese medicinal materials mixed together in this step, decoct for 2 hours, For the second time, add 8 times the weight of water relative to the weight of the Chinese medicinal materials mixed together in this step, and decoct for 1 hour; combine the decoction liquid, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.15 at 55°C ; The third step is to mix the clear cream obtained in the first step and the second step together, and after the mixture and dextrin are mixed uniformly in a ratio of 3:1 by weight, they are dried under reduced pressure at 75°C and pulverized to obtain the intermediate drug powder. Get the intermediate medicinal powder and add equal weight of starch: mannitol=2: 3 mixed auxiliary materials and mix evenly to obtain the mixed medicinal powder, then add 0.3% protein sugar relative to the mixed medicinal powder quality, 1.0% citric acid, and use 12-14% Water-based granules, dried at 60°C, divided into packages, 8g per bag.