CN113144048A

CN113144048A - A topical Chinese medicinal patch for treating gouty joint pain and preparation method thereof

Info

Publication number: CN113144048A
Application number: CN202110482823.2A
Authority: CN
Inventors: 邱洪斌; 郑佳新; 苏瑾; 宋朝宇
Original assignee: Jiamusi University
Current assignee: Jiamusi University
Priority date: 2021-04-30
Filing date: 2021-04-30
Publication date: 2021-07-23
Also published as: JP2022171531A; JP7362140B2

Abstract

本发明公开一种治疗痛风性关节肿痛的中药外用贴剂及其制备方法，属于中药领域。包括背衬材料、药物、基质和防粘层，其中药物包括黄柏30‑35份，秦艽20‑25份，肿节风30‑35份，苍术20‑25份，威灵仙30‑35份，大黄20‑25份，大青叶20‑25份，天花粉15‑20份，冰片5‑7.5份。原料超微粉碎成细粉，与基质混合均匀，再用涂布机涂于背衬材料上，表面覆盖防粘层，即得治疗痛风性关节肿痛的中药外用贴剂。该贴剂直接贴于患处，作用缓和持久，消肿止痛效果显著，可有效预防或缓解痛风引起的关节肿痛及改善痛风形成的结节，使用方便、患者顺应性好，无刺激，适合多次用药。The invention discloses a traditional Chinese medicine external patch for treating gouty joint swelling and pain and a preparation method thereof, belonging to the field of traditional Chinese medicine. It includes a backing material, a drug, a matrix and an anti-adhesive layer, wherein the drug includes 30-35 parts of Cork, 20-25 parts of Qinjie, 30-35 parts of Zangjiefeng, 20-25 parts of Atractylodes, and 30-35 parts of Wei Lingxian, 20-25 parts of rhubarb, 20-25 parts of Daqingye, 15-20 parts of trichosanthin, and 5-7.5 parts of borneol. The raw materials are superfinely pulverized into fine powder, mixed evenly with the matrix, and then coated on the backing material by a coating machine, and the surface is covered with an anti-adhesive layer to obtain a traditional Chinese medicine external patch for treating gouty joint swelling and pain. The patch is directly attached to the affected area, has a mild and lasting effect, and has obvious effects of reducing swelling and pain. It can effectively prevent or relieve joint swelling and pain caused by gout and improve the nodules formed by gout. It is easy to use, has good patient compliance, and is non-irritating. time medication.

Description

A topical Chinese medicinal patch for treating gouty joint pain and preparation method thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine external patch for treating gouty joint swelling and pain and a preparation method thereof.

Background

Gout (gout) refers to a metabolic disease closely related to hyperuricemia and urate deposition. Hyperuricemia is a metabolic abnormality syndrome caused by purine metabolic disorder. Acute Gouty Arthritis (AGA) is caused by deposition of urate due to increased blood uric acid in the body, which in turn causes local tissue disease damage and inflammatory reactions, often involving the kidneys causing chronic interstitial nephritis and kidney stone formation. The acute gouty arthritis is higher in incidence rate in men than in women, is mostly caused by joints of lower limbs, is manifested by red, swelling, heat and pain of the joints and surrounding tissues, is aggravated at night, has intolerable pain and is easy to repeatedly attack, causes inconvenient movement of patients, and is accompanied by symptoms of headache, fever, increase of white blood cells and the like. In recent years, as the living standard of people is improved and the living style is changed, purine and protein intake is increased due to high-fat and high-protein diet, and the gout incidence rate in China and the world is on the rise and is continuously in the trend of youth. The '2017 Chinese gout status report white paper' indicates that more than 800 thousands of gout patients in China have AGA which is a common clinical manifestation of gout.

The record of gout in traditional Chinese medicine is the recognition of joint diseases at the earliest time, and the traditional Chinese medicine clinical diagnosis is classified into the categories of arthralgia, gout, calendar and the like according to joint symptoms and causes when gout occurs. It is thought that "gout" is caused by the retention of phlegm-dampness in meridians and joints due to congenital weakness plus infection by exogenous pathogenic factors. According to literature and examination, the ancient doctors' knowledge of gout is mostly limited to the pathological changes of joints, namely acute gouty arthritis. With the development of modern diagnosis technology, modern Chinese medicine diagnosis gives new knowledge and introduction to hyperuricemia based on traditional Chinese medicine theory and modern medical theory, the theory that hyperuricemia belongs to 'blood turbidity' and 'turbid blood stasis arthralgia' is provided, and abnormal hemorheology, circulatory disturbance and the like can be called as blood turbidity.

The existing gout disease prevention and treatment medicines commonly used in clinic mainly comprise chemical medicines, and respectively aim to reduce the level of hematuria acid, diminish inflammation and relieve pain, such as colchicine, glucocorticoid and the like, have definite and quick effects, can relieve clinical symptoms in an acute stage, but have different degrees of safety risks, such as gastrointestinal tract reaction, gastrointestinal bleeding, liver and kidney function damage, substance metabolism disorder and the like, and are easy to cause repeated symptoms after medicine withdrawal.

Disclosure of Invention

Aiming at the technical problems, the invention provides a traditional Chinese medicine external patch for treating gouty joint swelling and pain and a preparation method thereof. The traditional Chinese medicine is externally applied without oral gastrointestinal administration, so that the first-pass effect and gastrointestinal adverse reaction are avoided, the traditional Chinese medicine directly acts on an affected part, the safety is high, the operation is simple, and the compliance of a patient is good.

In order to achieve the technical purpose, the invention provides the following technical scheme:

a traditional Chinese medicine external patch for treating gouty joint pain comprises: backing material, medicament, matrix and anti-adhesive layer;

the medicine comprises the following raw materials in parts by weight:

30-35 parts of phellodendron, 20-25 parts of gentiana macrophylla, 30-35 parts of glabrous sarcandra herb, 20-25 parts of rhizoma atractylodis, 30-35 parts of radix clematidis, 20-25 parts of rheum officinale, 20-25 parts of folium isatidis, 15-20 parts of trichosanthes root and 5-7.5 parts of borneol.

Further, the borneol can be replaced by any one of azone, eucalyptus oil, oleic acid and menthol.

Further, the backing material may be selected from non-woven fabric or nylon cloth.

Further, the matrix accounts for 85-92% by mass percent, and the medicine accounts for 8-15% by mass percent.

The invention also provides a preparation method of the traditional Chinese medicine external patch for treating gouty joint swelling and pain, which is characterized by comprising the following steps of:

pulverizing the raw materials, mixing with matrix at rotation speed of 180-.

Further, the raw materials are crushed into 100-120-mesh fine powder.

Further, the preparation method of the matrix comprises the following steps: soaking the skeleton material in water, heating to dissolve after swelling, adding humectant, and mixing at 50-55 deg.C for 1 hr to obtain matrix.

Further, the framework material is formed by mixing gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate and sodium carboxymethylcellulose; the humectant is formed by mixing glycerol and polyethylene glycol 400; the mass ratio of the framework material to the humectant is (11-12): (5-8).

Further, the gelatin may be any one of agar and gum arabic powder.

Still further, the carbomer may be selected from any of the formats 934, 940 and 941.

Furthermore, the polyvinylpyrrolidone can also be selected from polyvinyl alcohol.

Furthermore, the sodium polyacrylate can also be polyacrylic acid or polyethylene glycol.

Further, the sodium carboxymethyl cellulose may be any one of carboxymethyl cellulose, sodium methyl cellulose, and cellulose derivatives.

Further, the humectant may be any one selected from azone, eucalyptus oil, oleic acid and menthol.

Further, the mass ratio of the gelatin to the carbomer to the polyvinylpyrrolidone to the sodium polyacrylate to the sodium carboxymethylcellulose to the glycerol to the polyethylene glycol 400 is (3-5) to (6-8) to (10-12) to (0.7-0.9) to (7-9) to (9-11).

Further, the mass ratio of the gelatin to the carbomer to the polyvinylpyrrolidone to the sodium polyacrylate to the sodium carboxymethylcellulose to the glycerol to the polyethylene glycol 400 is 4:7:7:11:0.8:8: 10.

The amount of the matrix component used in the present invention after replacement may be adjusted to achieve the same viscosity as the above ratio.

The traditional Chinese medicine composition adopted by the invention is referred to Chinese pharmacopoeia (2020 edition):

cortex Phellodendri is dried bark of cortex Phellodendri of Rutaceae. [ PROPERTIES, WESTERN AND GUIJING ] is bitter and cold. [ FUNCTIONS AND INDICATIONS ] can clear away heat, eliminate dampness, purge fire, remove dampness, remove toxicity and treat sore. Can be used for treating dysentery due to steaming heat, jaundice, dark urine, tinea pedis, atrophy 36484, bone steaming, overstrain, pyocutaneous disease, toxic swelling, eczema, and eczema.

The radix Gentianae Marcrophyllae is dried root of radix Gentianae Marcrophyllae, radix Gentianae Marcrophyllae or radix Gentianae Marcrophyllae of Gentianaceae. [ PROPERTIES AND WEIGHT GUIJING ] is pungent, bitter and mild. It enters stomach, liver and gallbladder meridians. [ FUNCTIONS AND INDICATIONS ] can dispel wind-damp, clear away damp-heat, relieve arthralgia, and relieve deficiency-heat. Can be used for treating rheumatalgia, apoplexy, hemiplegia, spasm of tendons and vessels, soreness of bone joints, jaundice due to damp-heat pathogen, hectic fever due to yin-deficiency, and infantile malnutrition with fever.

Herba Pileae Scriptae is dry whole plant of Chloranthaceae. [ PROPERTIES AND WEIGHT-RESERVING GEN ] is bitter, pungent and mild. [ FUNCTIONS AND INDICATIONS ] can clear heat and cool blood, promote blood circulation and remove ecchymoses, dispel wind and dredge collaterals. Can be used for treating blood heat, speckle, and rash, rheumatalgia, and traumatic injury.

Rhizoma Atractylodis is dried rhizome of Atractylodes lancea or Atractylodes chinensis of Ranunculaceae. [ PROPERTIES AND WEIGHT GUIDING GEN ] is pungent, bitter and warm. It enters spleen and stomach, liver and meridians. [ FUNCTIONS AND INDICATIONS ] can eliminate dampness, invigorate the spleen, expel wind and remove cold, and improve eyesight. Can be used for treating damp obstruction of middle warmer, abdominal distention, diarrhea, edema, tinea pedis atrophy 36484m, rheumatalgia, wind-cold type common cold, night blindness, dim eyesight, and astringency.

The radix Clematidis is dried root and rhizome of Clematis chinensis Osbeck, Clematis Filamentosa or Clematis chinensis Osbeck of Ranunculaceae. [ PROPERTIES AND WEIGHT GUIDING GEN ] is pungent, salty and warm. It enters bladder meridian. [ FUNCTIONS AND INDICATIONS ] can dispel wind-damp and dredge meridians. Can be used for treating rheumatalgia, numbness of limbs, spasm of channels, and difficulty in flexion and extension.

The radix et rhizoma Rhei is dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. Ex Balf. or Rheum officinale Baill. of Polygonaceae. [ PROPERTIES, WESTERN AND GUIJING ] is bitter and cold. It enters spleen, stomach, large intestine, liver and pericardium meridians. [ FUNCTIONS AND INDICATIONS ] can purge and attack, clear heat and purge fire, remove heat from the blood and toxic materials, remove blood stasis and dysmenorrhea, and promote diuresis to alleviate jaundice. Can be used for treating constipation due to excessive heat accumulation, hematemesis, epistaxis, conjunctival congestion, pharyngeal swelling, carbuncle, furuncle, traumatic injury, jaundice, and dark urine; it can be used for external treatment of burn and scald. Folium Isatidis is dried leaf of Isatis indigotica fort of Brassicaceae. [ PROPERTIES, WESTERN AND GUIJING ] is bitter and cold. It enters heart and stomach meridians. [ FUNCTIONS AND INDICATIONS ] can clear away heat and toxic materials, cool blood and remove ecchymoses. Can be used for treating epidemic febrile disease, hyperpyrexia, coma, speckle, eruption, mumps, pharyngitis, erysipelas, and carbuncle.

Trichosanthis radix is dry root of Trichosanthes kirilowii Maxim or Trichosanthes rosthornii Maxim of Cucurbitaceae. [ PROPERTIES AND WESTERN CHANNELS ] is sweet, slightly bitter and slightly cold. It enters lung and stomach meridians. [ FUNCTIONS AND INDICATIONS ] can clear away heat, purge fire, promote the production of body fluid, quench thirst, relieve swelling and expel pus. Can be used for treating fever polydipsia, lung heat dry cough, internal heat diabetes, and pyocutaneous disease poisoning. The medicinal mechanism of the invention is as follows:

yuan, Zhuzhenheng (Danxi Xin Lao gout sixty three)' recorded in Yuan: the traditional Chinese medicine composition is characterized by comprising radix clematidis, cortex phellodendri, radix gentianae macrophyllae, radix angelicae sinensis, radix trichosanthis, radix sophorae flavescentis, radix angelicae sinensis, cortex phellodendri, radix angelicae sinensis, radix trichosanthis, radix sophorae chinensis, radix scutellariae, radix angelicae sinensis, radix scutellariae, rhizoma atractylodis, radix angelicae sinensis, radix scutellariae, radix sophorae chinensis, radix sophorae flavescentis, radix sophorae chinensis, radix trichosanthis, radix sophorae flavescentis, radix sophorae sinensis, radix sophorae flavescentis, radix sophorae, radix ophiopogonis, radix sophorae flavescentis, radix sophorae, radix ophiopogonis, radix sophorae, radix ophiopogonis, radix sophorae, radix ophiopogonis, radix scutellariae, rhizoma atractylodis, radix scutellariae, rhizoma atractylodis, radix scutellariae.

Compared with the prior art, the invention has the beneficial effects that:

the patch is directly pasted on an affected part when used, has mild and lasting effect and obvious effects of relieving swelling and pain, can effectively prevent or relieve joint swelling and pain caused by gout and improve nodules formed by gout, is convenient to use, has good patient compliance, has no stimulation, and is suitable for being taken for multiple times. And the defect of poor palatability of oral medicines is avoided. Meanwhile, due to the proper consistency of the matrix, the skin surface can feel cool when being applied to the skin, the symptoms of local redness, swelling, heat and pain can be relieved, and the added transdermal enhancer can accelerate the drug penetration to achieve the purpose of quick acting. In the preparation process of the matrix, the proportion of each component, the heating temperature, the stirring speed, the mixing time and the defoaming degree can all influence the consistency and the drug release performance of the matrix, and all influencing factors are required to be matched with each other, so that the product with corresponding efficacy is finally prepared.

Detailed Description

Reference will now be made in detail to various exemplary embodiments of the invention, the detailed description should not be construed as limiting the invention but as a more detailed description of certain aspects, features and embodiments of the invention.

It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. Further, for numerical ranges in this disclosure, it is understood that each intervening value, between the upper and lower limit of that range, is also specifically disclosed. Every smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in a stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference herein for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.

It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the present disclosure without departing from the scope or spirit of the disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification. The specification and examples are exemplary only.

As used herein, the terms "comprising," "including," "having," "containing," and the like are open-ended terms that mean including, but not limited to.

The traditional Chinese medicine external patch for treating gouty joint swelling and pain prepared by the invention is 10 multiplied by 8cm per patch²The backing material contains 18.0 + -0.5 g of drug and matrix.

The heat resistance, the excipient performance, the content uniformity and the like of the prepared sample meet the standard requirements according to the 0122 emplastrum of the general rule of the four parts of Chinese pharmacopoeia (2020 edition), and irritation experiments and allergy experiments show that the sample has no irritation and sensitization to skin.

Example 1

(1) Selecting raw materials:

33 parts of phellodendron, 23 parts of gentiana macrophylla, 32 parts of glabrous sarcandra herb, 22 parts of rhizoma atractylodis, 32 parts of clematis root, 22 parts of rhubarb, 23 parts of folium isatidis, 18 parts of trichosanthes root and 6 parts of borneol.

(2) Respectively crushing the weighed raw materials, sieving the crushed raw materials with a 110-mesh sieve, and mixing the crushed raw materials to obtain medicine fine powder;

(3) preparing a matrix according to the weight percentage: gelatin: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethylcellulose: glycerol: polyethylene glycol 400: 4:7:7:11:0.8:8: 10.

(4) The preparation method of the matrix comprises the following steps: soaking gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate and sodium carboxymethylcellulose in water, swelling, heating to dissolve, adding glycerol and polyethylene glycol 400, and mixing at 53 deg.C for 1 hr to obtain matrix;

(5) mixing the fine powder with matrix at rotation speed of 190r/min for 36min, defoaming, coating on non-woven fabric, cutting, oven drying at 50 deg.C for 2 hr, and covering with anti-adhesion layer to obtain the final product.

The matrix accounts for 88 percent, and the medicine accounts for 12 percent.

Example 2

(1) Selecting raw materials:

35 parts of phellodendron, 25 parts of gentiana macrophylla, 30 parts of glabrous sarcandra herb, 20 parts of rhizoma atractylodis, 35 parts of clematis root, 25 parts of rhubarb, 20 parts of folium isatidis, 15 parts of trichosanthes root and 5 parts of borneol.

(2) Respectively crushing the weighed raw materials, sieving with a 120-mesh sieve, and mixing to obtain fine medicine powder;

(3) preparing a matrix according to the weight percentage: gelatin: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethylcellulose: glycerol: polyethylene glycol 400: 4:6:7:10:0.8:7: 11.

(4) The preparation method of the matrix comprises the following steps: soaking gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate and sodium carboxymethylcellulose in water, swelling, heating to dissolve, adding glycerol and polyethylene glycol 400, and mixing at 50 deg.C for 1 hr to obtain matrix;

(5) mixing the fine powder with matrix at rotation speed of 180r/min for 42min, defoaming, coating on non-woven fabric, cutting, oven drying at 50 deg.C for 2 hr, and covering with anti-adhesion layer to obtain the final product.

The matrix accounts for 85 percent, and the medicine accounts for 15 percent.

Example 3

(1) Selecting raw materials:

30 parts of phellodendron, 20 parts of gentiana macrophylla, 35 parts of glabrous sarcandra herb, 25 parts of rhizoma atractylodis, 30 parts of clematis root, 20 parts of rhubarb, 25 parts of folium isatidis, 20 parts of trichosanthes root and 7.5 parts of borneol.

(2) Respectively crushing the weighed raw materials, sieving with a 100-mesh sieve, and mixing to obtain fine medicine powder;

(3) preparing a matrix according to the weight percentage: gelatin: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethylcellulose: glycerol: polyethylene glycol 400: 3:7: 11:0.8:9: 10.

(4) The preparation method of the matrix comprises the following steps: soaking gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate and sodium carboxymethylcellulose in water, swelling, heating to dissolve, adding glycerol and polyethylene glycol 400, and mixing at 55 deg.C for 1 hr to obtain matrix;

(5) mixing the fine powder with matrix at rotation speed of 190r/min for 36min, defoaming, coating on nylon cloth, cutting into pieces, oven drying at 50 deg.C for 2 hr, and covering with anti-adhesion layer to obtain the final product.

The matrix accounts for 92% of the total weight of the composition, and the medicine accounts for 8%.

Example 4

(1) Selecting raw materials:

33 parts of phellodendron, 21 parts of gentiana macrophylla, 30 parts of glabrous sarcandra herb, 24 parts of rhizoma atractylodis, 34 parts of clematis root, 21 parts of rhubarb, 22 parts of folium isatidis, 19 parts of trichosanthes root and 5.5 parts of eucalyptus oil.

(3) preparing a matrix according to the weight percentage: agar: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethylcellulose: propylene glycol-5: 6:7:10:0.8: 17.

(4) The preparation method of the matrix comprises the following steps: soaking gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate and sodium carboxymethylcellulose in water, swelling, heating to dissolve, adding propylene glycol, and mixing at 53 deg.C for 1 hr to obtain matrix;

The matrix accounts for 90 percent, and the medicine accounts for 10 percent.

Comparative example 1

The difference from example 1 is that the raw material was pulverized and sieved through a 80 mesh sieve.

Comparative example 2

The difference from example 1 is that the fine drug powder and the base are mixed at a rotation speed of 100 r/min.

Comparative example 3

The difference from example 1 is that the mixing time of the drug fine powder and the base is 20 min.

Comparative example 4

The difference from example 1 is that the matrix ratio is 95% and the drug is 5%.

Comparative example 6

The difference from example 1 is that the ratio of the matrix is 80% and the drug is 20%.

The prepared traditional Chinese medicine external patch has overlarge viscosity, and poor application effect and body feeling.

Comparative example 7

The difference from example 1 is that the heating temperature in step (4) is 72 ℃.

The heating time is too long, so that the viscosity of the matrix material is changed, and the effect of the prepared traditional Chinese medicine external patch is weakened.

Firstly, clinical curative effect observation:

the effect of the patch of the present invention (examples 1 to 4) and the patch of the control group (comparative examples 1 to 7) and the patch of the traditional Chinese medicine for external use (control group) for treating gouty joint pain sold in the pharmacy were observed and verified on the treatment effect of gouty joint pain.

1100 gouty arthritis patients were selected and randomly divided into 11 groups of 100 patients each. There was no statistical difference in age, sex, course of disease, and level of joint pain for each group (p > 0.05).

The treatment method comprises the following steps:

the patch is directly applied to the joint, 1 day, and 12 days is a treatment course.

And (3) judging standard:

1. and (3) healing: the pain of the joints disappears or basically disappears, the joint movement returns to normal, and the joint swelling phenomenon does not exist;

2. the method has the following advantages: the joint pain is improved, the joint movement is slightly limited, and the slight joint swelling phenomenon can be accompanied;

3. and (4) invalidation: joint pain is not obviously improved or even aggravated, joint movement is limited, operation is strong, and severe joint swelling can be caused.

And (3) test results:

the statistical results of the clinical efficacy of each test group after 12 days of treatment are shown in table 1 below.

TABLE 1 statistical table of clinical efficacy of each test group

	Recovery method	Is effective	Invalidation	High efficiency
					Example 1	99	0	1	99％
Example 2	98	1	1	99％
					Example 3	96	2	2	98％
Example 4	96	1	3	97％
					Comparative example 1	88	3	9	91％
Comparative example 2	86	0	14	86％
					Comparative example 3	79	9	12	88％
Comparative example 4	81	6	13	87％
					Comparative example 5	72	9	19	81％
Comparative example 6	64	13	23	77％
					Comparative example 7	61	16	23	77％
Control group	58	10	32	68％

The patients have routine treatment before and after treatment, and have no abnormality in liver and kidney function and electrocardio. The gout treated by the patch prepared by the invention is not subjected to late revisitation, and joint swelling and nodules caused by gout do not appear.

As can be seen from Table 1, after 12 days of treatment, the patients who used the patch of the present invention were substantially cured, while the effective rates of comparative examples 1 to 7 of the patch which was not prepared according to the preparation method of the present invention were substantially 90% or less, indicating that the patch of the present invention for treating gouty joint pain was more effective after the treatment according to the specific preparation method of the present invention. The treatment effect of the patch sold in a pharmacy after 12 days is obviously poor.

Secondly, ibuprofen is generally given to patients with gouty arthritis for treatment in the present clinic, and in order to verify the effect of the patch prepared by the invention, the following verification is carried out:

70 patients with acute gouty arthritis (all male) were selected and randomized into control (ibuprofen alone) and treatment (the patch prepared in example 1 was used in conjunction with ibuprofen) groups of 35. The treatment time is 12 days, and laboratory indexes (erythrocyte sedimentation rate (ESR), blood Uric Acid (UA), C-reactive protein (CRP)) before and after treatment of the patient, traditional Chinese medicine symptom evaluation, joint swelling, activity degree and other evaluations, pain reaction of the patient and adverse reaction conditions are observed.

The results show that:

1) after treatment, the ESR, UA and CRP levels of the patients in the two groups are lower than those before treatment (P < 0.05), and the difference between the groups has no statistical significance.

2) Compared with traditional Chinese medicine symptom evaluation, the treatment group is lower than the control group (P < 0.05).

3) Joint swelling and mobility evaluation, and the difference between groups has no statistical significance.

4) The time for complete relief of joint pain is shorter in the treatment group than in the control group (P < 0.05).

5) The blood, urine and feces before and after treatment of the two groups of patients are conventional, and the liver and kidney function and the electrocardio function are not abnormal.

The clinical treatment results show that when the ibuprofen is combined to treat acute gouty arthritis, the clinical symptoms of patients can be obviously improved, the course of disease is shortened, the traditional Chinese medicine external patch prepared by the invention has a good treatment effect on gouty joint swelling and pain, and if the oral administration of a medicine is not needed, the patch can be selected to have a treatment effect; or the composition is used together with oral medicines, so that the course of disease is shortened, the pain is reduced, and the selection range of patients is enlarged.

Case (2):

wangzhi, female age 45, gouty joint pain of 3 years, limb joint pain, inconvenient movement and great pain. After the patch is used for 6 days, the swelling disappears, the pain is relieved, and after the patch is used for 6 days, the patch is recovered to be normal and the patient is cured clinically.

Li Zeng, male, 38 years old, acute gout for 1 year, and has no significant effect when taking Chinese and Western medicines. When the patch is used for 1 patch every day, the pain is relieved after 3 days, the symptoms are obviously improved after the patch is continuously used for 9 days, the pain basically disappears, and the symptoms disappear after the patch is continuously used for one month.

Qianzhi, a man aged 58 years old, suffered from osteoarthritis for 5 years, had swelling and pain in joints of limbs, and was unable to walk. The pain disappears after the patch is used for 12 days, and the pain moves freely after 1 treatment course.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included therein.

Claims

1. a Chinese medicine external patch for the treatment of gouty joint swelling and pain is characterized in that, comprising: backing material, medicine, matrix and anti-adherent layer;

Among them, in parts by mass, the medicine includes the following raw materials:

30-35 parts of Cork, 20-25 parts of Qinjie, 30-35 parts of tumefaciens, 20-25 parts of Atractylodes, 30-35 parts of Wei Lingxian, 20-25 parts of rhubarb, 20-25 parts of Daqingye, 15 parts of small pollen -20 servings, borneol 5-7.5 servings.

2. the traditional Chinese medicine external patch for the treatment of gouty joint swelling and pain according to claim 1, is characterized in that, described borneol can be replaced with any one in azone, eucalyptus oil, oleic acid and menthol.

3 . The external Chinese medicine patch for treating gouty joint swelling and pain according to claim 1 , wherein the backing material can be selected from non-woven fabrics or nylon cloths. 4 .

4 . The external Chinese medicine patch for treating gouty joint swelling and pain according to claim 1 , wherein, by mass percentage, the matrix is 85-92%, and the drug is 8-15%. 5 .

5. a preparation method of the Chinese medicine external patch for the treatment of gouty joint swelling and pain according to any one of claims 1-4, is characterized in that, comprises the following steps:

After pulverizing each raw material, mix it with the matrix for 30-42min at a rotational speed of 180-200r/min, defoaming, then coat it on the backing material, dry it at 50°C for 2h, and cover the surface with a release layer, that is, There is a traditional Chinese medicine external patch for the treatment of gouty joint swelling and pain.

6. The preparation method according to claim 5, wherein the raw material is pulverized into 100-120 mesh fine powder.

7. preparation method according to claim 5, is characterized in that, the preparation method of described matrix is: add skeleton material to be soaked in water, after appearing swelling phenomenon, be heated to dissolve, add humectant again, at 50-55 ℃ Mix for 1h to obtain the matrix.

8. preparation method according to claim 7, is characterized in that, described skeleton material is gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate and sodium carboxymethyl cellulose mixed; Described moisturizing agent is Glycerol and polyethylene glycol 400 are mixed; the mass ratio of the skeleton material to the moisturizing agent is (11-12): (5-8).

9. preparation method according to claim 8 is characterized in that, described gelatin, carbomer, polyvinyl pyrrolidone, sodium polyacrylate, sodium carboxymethyl cellulose, glycerol and polyethylene glycol 400 mass ratio are ( 3-5):(6-8):(6-8):(10-12):(0.7-0.9):(7-9):(9-11).

10. preparation method according to claim 8 is characterized in that, described gelatin, carbomer, polyvinyl pyrrolidone, sodium polyacrylate, sodium carboxymethyl cellulose, glycerol and polyethylene glycol 400 mass ratio are 4 :7:7:11:0.8:8:10.