HK1084868B - Composition comprising panax ginseng and paullinia cupana extracts - Google Patents

Description

Composition containing extracts of ginseng and Sapindus mukurossi

Background

1. Field of the invention

The present invention relates to a method for improving cognitive skills in a human by administering a composition comprising:

(1) an effective amount of an extract of the plant ginseng (Panax ginseng); and

(2) an effective amount of an extract of the plant Sapindus amazonii (Paulllinia cupana).

2. Background of the invention

Ginseng (Panax ginseng c.a. meyer) root contains some triterpene glycosides called ginsenosides (or ginsenosides), which are believed to contribute to the improved adaptability and physical behavior of ginseng extract properties. It is used to treat anemia, diabetes, insomnia, neurasthenia, gastritis, abnormal blood pressure, dyspepsia, hypertension, and fatigue.

French patent application RF2712191 claims and discloses a composition having anti-fatigue activity towards weight loss which comprises an extract of ginseng roots and an extract of Guarana (Guarana) seeds.

French patent application FR2710267 discloses an oral composition for the treatment of male impotence consisting of guanodeoxycholic acid, ginseng extract, sapporo babassu (Muira puama) extract, yohimbine (gohimbine) hydrochloride, guarana extract, Nux vomica (Nux vomiea) extract, ternax (Pamiana) extract, niacinamide, nicotinic acid, tocopheryl acetate, diamminohydramine hydrochloride (clenbuterol Hydzochloride) and excipients.

It is a first object of the present invention to provide a method for improving memory speed and memory quality in normal, healthy subjects, a method for preventing a decrease in memory speed with a decrease in cognitive function in humans and a method for inhibiting cognitive fatigue.

It is another object of the present invention to provide a method for improving memory speed and a method for preventing memory speed from being decreased by taking a preparation containing herbal ingredients, wherein the medication and/or dietary supplement is manufactured according to a controllable method for preserving the therapeutic quality of the herbal ingredients.

It is still another object of the present invention to provide a method for improving memory rate and a method for preventing memory rate deterioration, which comprises herbal ingredients and minimizes or does not have side effects, thus being safe for internal consumption.

Summary of the invention

Surprisingly, it has been found that the cognitive skills of a person can be improved by administering a composition comprising

(1) An effective amount of a plant ginseng extract; and

(2) an effective amount of the plant Sapindus amazonii extract.

Another aspect of the invention is the use of a composition comprising

(1) An effective amount of a plant ginseng extract; and

(2) an effective amount of the plant Sapindus amazonii extract.

In addition, the invention relates to a pharmaceutical composition or dietary supplement consisting essentially of

(1) An effective amount of a plant ginseng extract;

(2) an effective amount of the plant Sapindus amazonii extract;

(3) one or more vitamins;

(4) one or more minerals and/or trace elements; and

(5) optionally a carrier and/or an adjuvant.

The invention also relates to a dietary supplement comprising the following composition:

a) vitamin preparation

b) Minerals and optionally trace elements

c) Caffeine obtained from guarana.

Furthermore, the invention relates to a dietary supplement comprising vitamins, minerals, trace elements and caffeine in the form of guarana extract.

Detailed description of the invention

The two components (1) and (2) are optionally formulated together or together with the components (3), (4) and (5) to form a formulation. For example, the formulation comprises an extract of dried ginseng root or other plant ingredients, optionally pulverized, and dried extract of Paullinia cupana seed, or other plant ingredients, optionally ground. The formulations may be presented as tablets, coated tablets, chewable tablets, powders in capsules, soft-shelled capsules, syrups, solutions or suspensions, for example aqueous, alcoholic or mixtures thereof, dragees, gels, injections or other suitable means known to the skilled person. Oral administration forms are preferred.

The term "human" or "a person in need thereof" or "patient" as used in this context relates to a healthy woman or man who is to improve cognitive skills. Typically these are adults or elderly people between 18-80 years, preferably 20-65 years, with an average age of 42.5 years.

The term "effective amount" as used in the present invention means an amount sufficient to improve cognitive ability when ingredients (1) and (2) and optionally (3) and (4) are taken together in a single dosage form. In general, the combination of components (1) and (2) can exhibit synergistic effects, meaning that the effect on cognitive skills is higher than the purely additive effects expected for components (1) and (2) alone and/or components (1), (2), (3) and (4) alone.

The term "plant" is to be understood as meaning both the plant itself and parts of the plant which comprise the active ingredient. Such as the leaves, stems, seeds, fruits or roots described above. Preferably, the plant or plant part is dried. Optionally, they are cut into pieces, ground or pulverized.

The term "extract" refers to a plant or plant part extracted with a suitable solvent such as water, ethanol, butanol, acetone, mixtures thereof, ethers, oils, or any other suitable solvent known in the art for extracting plants. If pharmacologically acceptable, these extracts may be used, or the solvent of the resulting solution may be removed and the residue may be used as such, or after further processing, for example after redissolution or after resuspension in a pharmacologically suitable solvent.

The terms "major active ingredient" and major active substance, mean all active ingredients which primarily determine the pharmacological effect. The preparation preferably contains at least 75%, more preferably 90%, of all the components of the plant concerned, which determine the pharmacological effect.

The term "improvement of cognitive skills" refers to an improvement of all situations where a person is considered to have acquired intellectual behavior, including quality of memory, accuracy and speed, learning ability, short and long term memory, attention, alertness and reduction of fatigue due to high workload and/or a required intellectual behavior necessity.

The term "pharmaceutical composition" refers to a composition that is suitable for prescription and OTC medications and is available from doctors, chemical stores or drug stores.

The term "dietary supplement" refers to a composition that supplements regular ingested food with additional nutrients to improve quality of life and can be freely purchased not only at a pharmacy but also from a food store or supermarket without a prescription.

Preferably, ginseng extract is used, which contains, together with other substances, ginsenosides and polysaccharides, preferably at least 3%, more preferably 3.5-5.0%, especially 3.6-4.4% of ginsenosides, under the trade name G115The standard ginseng extract of (1) is most preferred and is commercially available from Pharmaton S.A., CH-6934 Bioggio, Switzerland.

Usually guarana extract is prepared from seeds of Sapindus amazonii. The plant belongs to Sapindaceae, and is a woody vine plant cultivated in the central Amazon region. The most important components of pimpinella pavonica are caffeine, tannin and saponin, and polysaccharides, disaccharides, fats and resins.

The seeds are carefully dried and ground into small pieces, preferably 0.1-5.0mm, especially 0.5-1.5 mm. To achieve the desired caffeine content, the extraction is carried out with an aqueous ethanol solution at elevated temperature, preferably in the range of 60-80 deg.C, for a period of at least 6 hours to 10 hours. The preferred method is complete diafiltration using aqueous ethanol in the presence of a weak base. Preferably, the ethanol is evaporated under vacuum and the extracted semi-dry residue is dried under vacuum. The resulting dry extract is preferably ground and sieved.

Preferably, a dried extract of Sapindus amazonii with a caffeine content of up to 12% is used.

In a preferred embodiment of the invention, the weight ratio of ginseng extract to guarana extract is from 1: 10 to 10: 1, preferably from 1: 5 to 2: 1, especially from 1: 3 to 1: 1, most preferably about 1: 1.9.

Preferably, the present invention relates to a method wherein said composition further comprises

(3) One or more vitamins; and

(4) one or more minerals and/or trace elements.

In particular

Wherein said one or more vitamins (3) are selected from provitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D3, D, 1-alpha-tocopheryl acetate (vitamin E), folic acid, biotin (vitamin H) and vitamin PP; and/or

Wherein the one or more minerals and/or trace elements (4) are selected from copper, calcium, iron, zinc, selenium, phosphorus and magnesium.

Preferably, the pharmaceutical composition or dietary supplement of the present invention comprises essentially of

(1)20-100mg of plant ginseng extract;

(2)50-100mg of Sapindus amazonii extract;

(3)0.001-120mg of one or more, preferably two to 12, in particular 5-11 vitamins;

(4)0.01-400mg of one or more, preferably two-10, especially 4-7 minerals and/or trace elements; and

(5) optionally a carrier and/or an adjuvant.

The best pharmaceutical composition or dietary supplement mainly comprises

30-50mg, especially about 40mg of standard Ginseng radix extract G115

60-90mg, especially about 75mg, of Sapindus amazoni extract containing up to 12% by weight caffeine

1000-

1.0-2.0mg, especially about 1.4mg of vitamin B1

1.0-2.0mg, especially about 1.6mg of vitamin B2

1.0-3.0mg, especially about 2.0mg of vitamin B6

0.5-2.0. mu.g, especially about 1.0. mu.g of vitamin B12

10-100mg, especially about 60mg of vitamin C

50-300IU, especially about 160IU of vitamin D3

10-20mg, in particular about 15mg, of d, 1-alpha-tocopheryl acetate (vitamin E)

100-300. mu.g, especially about 200. mu.g, of folic acid

100-200. mu.g, in particular about 150. mu.g of biotin

10-30mg, especially about 18mg of vitamin PP

0.1-1.0mg, especially about 0.5mg, of copper

0-150mg, especially 0 or about 120mg, of calcium

1-10mg, especially about 5mg, of iron

1-10mg, in particular about 5mg, of zinc

0 to 150mg, in particular 0 or about 90mg, of phosphorus

10-150 μ g, especially about 30 μ g of selenium

5-100mg, especially 10-70mg, of magnesium

And optionally a carrier and/or adjuvant.

Preferred are pharmaceutical compositions or dietary supplements in soft shell capsules or tablets.

A preselected amount of the composition of the present invention comprising ginseng extract (1), guarana extract (2), vitamin(s) (3) and mineral(s) (4) is preferably encapsulated in a soft gelatin comprising bovine, porcine, vegetable and succinylated gelatin shells. Optionally, the soft gelatin shell is substantially transparent to enhance the aesthetic quality of the capsule. Typically the soft gelatin shell comprises the following main ingredients as well as optional ingredients.

Gelatin is the main component of the soft gelatin shell of the present invention. The gelatin raw material for manufacturing the soft capsule is obtained by partially hydrolyzing a collagen raw material such as skin of an animal, white connective tissue or bone. Gelatin materials can be divided into type a gelatin, which is obtained from acid-treated pigskin and has an isoelectric point between pH 7 and pH 9, and type B gelatin; whereas type B gelatin, obtained from alkali-treated bone and animal (bovine) skin, has an isoelectric point between pH 4.7 and pH 5.2. Mixtures of type a gelatin and type B gelatin may be used to obtain a composition having the viscosity and bloom strength characteristics necessary to make a capsule. Gelatin suitable for capsule manufacture is available from Sigma chemical company, st. For general descriptions of gelatin and gelatin-based capsules, see Pharmaceutical Sciences of Remingtons, 16 th edition, Mack publishing company, Easton, Pa, (1980), pages 1245 and 1576-1582; and U.S. patent 4935243 issued to Borkan et al, 1990, 6/19; both of these references are incorporated by reference in their entirety.

The soft gelatin shell of the capsules of the present invention, as initially prepared, comprises from about 20% to about 60% gelatin, preferably from about 25% to about 50% gelatin, and most preferably from about 40% to about 50% gelatin. Gelatin may be of type a and type B, or a mixture thereof having a bloom number (bloom numbers) of from about 60 to about 300.

The plasticizer is another component of the soft gelatin shell of the present invention. To produce a soft gelatin shell, one or more plasticizers may be incorporated. The soft gelatin thus obtained has the flexibility characteristics necessary for use as a capsule. Plasticizers useful in the present invention include glycerin, sorbitan, sorbitol or similar low molecular weight polyols and mixtures thereof.

The shell of the present invention, when initially prepared, generally contains from about 10% to about 35% plasticizer, preferably from about 10% to about 25% plasticizer, and most preferably from about 10% to about 20% plasticizer. The preferred plasticizer for use in the present invention is glycerin.

The soft gelatin shell of the present invention may also comprise water. While not being limited by theory, it is believed that the water helps the soft gelatin shell to rapidly dissolve or break upon contact with gastrointestinal fluids encountered in the human body.

The shell of the present invention, when initially prepared, generally comprises from about 15% to about 50% water, more preferably from about 25% to about 40% water, and most preferably from about 30% to about 40% water.

Other optional ingredients that can be incorporated into the soft gelatin shell include coloring agents including colored coatings, flavoring agents, preservatives, antioxidants, fragrances, and other aesthetically pleasing ingredients.

The composition of the present invention can be packaged in any conventional soft gelatin shell containing the composition at essentially suitable intervals, and the soft gelatin shell of the present invention can be prepared by combining the appropriate amounts of gelatin, water, plasticizer, and optional ingredients in a suitable container, and shaking and stirring while heating to about 65 ℃ until a homogeneous solution is obtained. The soft gelatin shell formulation is used to encapsulate a predetermined amount of the composition using standard encapsulation methods to produce a monomeric, sealed soft gelatin capsule. The gelatin capsule is formed into a predetermined shape and size for easy swallowing. The soft gelatin capsules of the present invention are sized for easy swallowing and typically contain from about 100mg to about 2000mg of the active composition. Soft gelatin capsules and encapsulation methods are described in p.k.wilkinson et al, "Softgels: manufacturing considerings ", Drugs and Pharmaceutical Sciences, 41(Specialized drug delivery Systems) p.tyle, editors (Marcel Dekker, inc., New York, 1990) pp.409-449; horns et al, "Capsules, Soft", Encyclopedia of pharmaceutical technology, volume.2, j.swarbrick and j.c. boylan, eds (Marcel Dekker, inc., new york, 1990) pp.269-284; patel et al, "Advances in software formulation technology", Manufacturing chemistry, vol.60, No.7, pp26-28(July 1989); patel et al, "Softgel Technology", Manufacturing Chemist, vol.60, No.8, pp47-49(August 1989); jimers on, "Soft gel (Soft gel Capsule) Update", Drug Development and Industrial Pharmacy (Interphex' 86 Conference), Vol.12, No.8&9, pp1133-1144 (1986); and w.r.ebert, "Soft Elastic Gelatin Capsules: AUnique Dosage Form ", Pharmaceutical Technology, Vol.1, No.5, PP44-50 (1977); these documents are incorporated herein by reference in their entirety. The resulting soft gelatin capsules are soluble in water and gastrointestinal fluids. Upon swallowing the capsule, the gelatin shell rapidly dissolves or ruptures in the gastrointestinal tract, thereby introducing the pharmaceutically active ingredient from the liquid core into the physiological system.

The tablets of the invention generally contain at least one pharmaceutically or dietetically acceptable excipient commonly used in solid dosage form formulation technology.

Suitable excipients that may be incorporated include lubricants, such as magnesium stearate and stearic acid; disintegrants, such as cellulose derivatives; starch; binders such as modified starch, polyvinylpyrrolidone and cellulose derivatives; glidant, such as colloidal silica; compression aids, such as cellulose derivatives; as well as preservatives, suspending agents, wetting agents, flavoring agents, bulking agents, binding agents, coloring agents, and sweetening agents in a form suitable therefor.

Suitably, when the composition is present as a tablet, the composition may further comprise a film coating, for example Hydroxypropylmethylcellulose (HPMC). Suitable film coatings are transparent film coatings, although opaque film coatings may also be used, for example, as obtained when using film coating materials incorporating opacifying agents or pigments such as titanium dioxide, lakes, or dyes. Advantageously, it has been found that coating with an opaque film coating minimizes tablet discoloration that can occur upon long term storage. Discoloration can also be avoided by incorporating a coloring agent into the tablet core. Suitable tablets may also be film coated, for example, as desired for aesthetic purposes and/or to aid in swallowing.

The extract is first mixed with the excipients of the core and then compressed on a suitable tablet press.

The compression force necessary to produce a tablet with the appropriate resistance to breakage and therefore the necessary disintegration time depends on the shape and size of the perforation tool used. The preferred compressive force is in the range of 2-20 kN. High compression forces can lead to delayed release of the active substances (1) to (4) of the tablet. Low compression forces can produce mechanically unstable tablets. The tablet core can be in different forms; the preferred patterns are bi-planar or bi-convex and oval or elliptical.

The coating solution may be prepared by mixing a film-forming agent with a coloring material and a plasticizer in water. The film-coating solution is applied to the core using a suitable coating pan.

Preferably the tablet has an oval shape to facilitate swallowing. In the case of a coated tablet containing 115mg of the combined extracts (1) and (2), the oval tablet is about 10-20mm long and about 5-10mm wide.

In another preferred embodiment of the invention, the composition contains vitamins, minerals, trace elements and caffeine in the form of guarana extract. Caffeine in guarana extract can restore human body and nerve behaviors. This is milder than caffeine typically obtained from coffee or tea.

Preferably, the dietary supplement of the invention contains in one package the necessary doses of the various active ingredients taken daily, in particular 0.05-1.00 grams of caffeine.

More preferably, the dietary supplement of the present invention comprises at least the following 5 ingredients:

calcium phosphate, sodium lauryl sulfate, calcium hydrogen phosphate, magnesium oxide, potassium chloride, vitamin C, polyvinylpyrrolidone, nicotinamide, iron (II) fumarate, vitamin E, zinc oxide, manganese sulfate, calcium pantothenate, stearic acid (stearinic acid), magnesium stearate, silicon dioxide, copper sulfate, vitamin B6, vitamin B2, lactose, vitamin B1, β -carotene (carotine), vitamin a, chromium, sodium, folic acid, biotin, potassium iodide, sodium selenate, vitamin K1, vitamin D3, vitamin B12, vitamin B3, and vitamin B5; and/or

At least one of the following components:

microalgae (microalgae), ginseng, ginko (ginkgo), anise (anise), artichoke (artichoke), valerian (valerian), eucalyptus (eucalyptus), fennel (fennel), bot hip, hops (hops), Saint John's plant (Saint-John's-wort), chamomile, cava cava, garlic, passionflower (passionflower), peppermint, tagatose (taiga root), hawthorn, ginger, alfalfa (alfalfa), wheatgrass, parvica (pawpaw), silica, royal jelly, gentian root, yeast, wormwood (wormwood) or processed products of these plants in a carding, grinding, powdering, pressing, fermentation and/or extraction, and seeds, leaves or stems thereof.

Additive effects can be achieved by adding one or more extracts of herbs, such as ginkgo or ginseng. For example, the addition of microscopic algae can provide supplemental amounts of iodine to the body. The addition of Ginkgo biloba can improve neurobehavioral and increase stress tolerance.

In order to allow the medication to be taken when it is really needed, products comprising 2-6 tablets or capsules are prepared, collected in 7 x 12cm packages made of synthetic material. By this packaging, the vitamin caffeine and mineral composition can be easily carried in a handbag.

To determine the synergistic effect of the drugs and/or dietary supplements of the present invention, a computerized version of the modified SerialSevens test was used. The original Serial seven tests (m.hayman, arch.neuron.Psychiatry 17: 125-: 279-291(1985)]. In the new computerized version of the current study, participants were provided with a numerical value by which they were instructed to successively reduce to 7, entering their three digit response into the numerical pad of the keyboard.

The participants in the first group were given placebo, the second group a composition containing ginseng extract (1) and vitamins, the third group a composition containing guarana extract (3) and vitamins, and the fourth group a composition containing both ginseng and guarana extracts (1) and (2) and vitamins.

The test period was 2 minutes. A standard instruction screen reports that the participant uses the return key to calculate the return 7 from a given value as quickly and accurately as possible to enter each response value. Participants may also be instructed to, if they are wrong, subtract from the new wrong number. The starting numbers between 800 and 900 are arbitrarily generated and appear on the screen only until the first response is generated, after which the entered numbers are indicated by asterisks. Work was scored as a total number of deductions. The number of false answers may also be recorded. In the case of errors, subsequent responses are scored as positive as possible, provided they are correct for the new number.

Tests clearly show that the composition of the invention improves the correct deduction value and reduces the errors caused by the participants.

Furthermore, the efficacy of the compositions of the invention was tested in the following studies:

(A) for comparison of quality of life (QoL) parameters in subjects receiving the compositions of the invention, according to Drugs Exptl Clin Res 1996; 22(6): 323-329 the method described was performed in a double-blind, placebo-controlled, randomized, parallel group trial.

The increase observed in the group receiving the composition of the invention was statistically significantly better than that seen in the conventional multivitamin group. The negative impact of the composition was the lowest in both groups. Significant increases in both body weight and diastolic blood pressure were observed in the group treated with the conventional multivitamin formulation, but none of the groups treated with the composition of the present invention was much more effective in improving quality of life in the population experiencing high physical and neural activity stress than the conventional multivitamin formulation alone.

(B) To examine the impact of dietary supplements on quality of life (QoL) related health in a non-clinical population of 313 healthy adults. This study was conducted in accordance with a paper published in Usher et al, Brit J health Psychol 5, 173-.

The composition of the invention is shown to be more significant in improving physical strain, behavioral strain, cognitive strain and whole strain.

(C) According to Current Theapeutic Research 1994; 55(1): 32-42 to a composition comprising standardized ginseng G115Effect of quality of life of the composition with placebo essential substances an additional double-blind comparison was performed.

The improvement in subjects with the composition of the invention and placebo was sufficient, but was more evident from baseline in the group receiving the composition of the invention. According to the Visual analog Scales scores, subjects receiving the compositions of the present invention had more significant improvements in overall score, alertness, relaxation, and appetite.

In order to improve cognitive skills, the daily dose of the capsule or tablet should correspond to 50-200mg, preferably 70-160mg, especially 90-130mg of the combined extracts (1) and (2). The total amount of extract per day can be divided into 1-3 capsules or tablets, preferably in a single dosage form. The daily dose should be taken once, preferably in the morning.

The first successful improvement in cognitive skills can be found immediately after taking the composition of the invention. However, in 6 weeks of continuous use, impressive and continuous improvement in cognitive skills can be expected. The optimization effect may be maintained or enhanced over long term use.

The procedures as examples for preparing the compositions of the present invention will be described in detail below. The examples follow merely as a detailed illustration and do not limit the subject matter of the invention, to which in addition extracts of herbs can be added.

Example 1

Method for producing guarana extract preparation

Herbal formulation, standard guarana extract (code PC102), was prepared by the following method:

1. source plants: amazon Sapindus H.B.et Kunth

2. The parts used were: dried seed

3. Extracting solvent: ethanol (95-96% v/v): deionized water (50: 50) (v/v)

4. Ratio of herbs to standardized extract: limit 3-7: 1

5. The components of the medicinal herb preparation are as follows: 80-90% of natural extract

20-10% maltodextrin MD01

6. Standard batch size: 360kg

The production steps are as follows:

1. dried Sapindus amazoni H.B.et Kunth was coarsely ground (10mm) on a grinder to obtain about 0.5-1.5mm sized pieces. Transferring pulverized guarana seed to percolator, extracting with 50% ethanol, and alkalifying with sodium carbonate. Under the same conditions, the extraction procedure was repeated to deplete the herbs. Usually 5 extractions are required, each lasting 3 hours. Diafiltration was considered complete when the dry residue of the last percolate was < 0.5%.

2. The percolate obtained is partially concentrated at a temperature below 50 ℃ and under vacuum.

3. Hydrochloric acid is added until the pH reaches 5.5-6.5.

4. Standing at 2-5 deg.C for 8 hr, and centrifuging the mixture.

5. The mixture was concentrated under vacuum at a temperature below 50 ℃ until a soft extract of about 70% dry residue was obtained.

6. Drying the soft extract at a temperature below 70 deg.C under vacuum.

7. The total alkaloid content of the ground dry extract was determined and maltodextrin MD01 was added to obtain the desired titer.

8. The product is ground by a centrifugal mill, mixed and sieved.

Example 2

Soft capsule

Soft gelatin capsules were prepared containing the following active ingredients:

formula amount of active ingredients

Herbal ginseng standard extract 40mg

Sapindus amazonii extract PC 10275 mg

Provitamin A1110 IU (vitamin A Activity)

Vitamin B11.4 mg

Vitamin B21.6 mg

Vitamin B62.0mg

Vitamin B121.0 μ g

Vitamin C60 mg

Vitamin D3160 IU

14.9mg of d, l-alpha-tocopheryl acetate (vitamin E)

Folic acid 200 ug

Biotin 150. mu.g

Vitamin PP 18mg

Mineral and trace element copper 0.5mg

Iron 5mg

5mg of zinc

Selenium 30 mug

Magnesium 10mg

The ingredients are mixed and encapsulated into gelatin, water and plasticizer to form a soft gelatin capsule.

Example 3

Tablet formulation

Formula amount of active ingredients

Standardized extract of medicinal herbs and Ginseng radix 40mg

Paullinia cupana extract PC 10275 mg

Provitamin A1110 IU (vitamin A Activity)

Vitamin B11.4mg

Vitamin B21.6mg

Vitamin B62.0mg

Vitamin B121.0 μ g

Vitamin C60 mg

Vitamin D3160 IU

14.9mg of d, l-alpha-tocopheryl acetate (vitamin E)

Folic acid 200 ug

Biotin 150. mu.g

Vitamin PP 18mg

Mineral and trace element copper 0.5mg

120mg of calcium

Iron 5mg

5mg of zinc

Phosphorus 93mg

Selenium 30 mug

Magnesium 62.5mg

The ingredients are mixed with excipients and compressed into tablets.

Example 4

Active ingredient formula amount [% ]

Standardized extract of herb ginseng 15

Sapindus amazonii extract PC 10235

Microalgae 15

Vitamins, minerals and trace elements 35

Example 5

Active ingredient formula amount [% ]

Radix Adenophorae Trachelioidis Sapindus extract PC 10255

Microalgae 15

Vitamins, minerals and trace elements 30

Claims (6)

1. A dietary supplement comprising the following composition:

a) vitamin preparation

b) Minerals and optionally trace elements

c) Caffeine obtained from guarana.

2. The dietary supplement of claim 1, comprising in a package the dosage required for daily intake.

3. The dietary supplement of claim 1 or 2, comprising 0.05-1.00 grams of caffeine.

4. The dietary supplement of any one of claims 1-3, comprising at least 5 of the following ingredients:

calcium phosphate, sodium dodecyl sulfate, calcium hydrogen phosphate, magnesium oxide, potassium chloride, vitamin C, polyvinylpyrrolidone, nicotinamide, iron (II) fumarate, vitamin E, zinc oxide, manganese sulfate, calcium pantothenate, stearic acid, magnesium stearate, silicon dioxide, copper sulfate, vitamin B6, vitamin B2, lactose, vitamin B1, beta-carotene, vitamin A, chromium, sodium, folic acid, biotin, potassium iodide, sodium selenate, vitamin K1, vitamin D3, vitamin B12, vitamin B3, and vitamin B5.

5. The dietary supplement of any one of claims 1-4, comprising at least one of the following ingredients:

microalgae, ginseng, ginkgo biloba, anise, fennel, garlic, hawthorn, ginger, royal jelly, yeast or processed products of said plants by combing, crushing, powdering, pressing, fermenting and/or extracting, and seeds, leaves or stems thereof.

6. The dietary supplement of any one of claims 1-5, formulated as a soft shell capsule or tablet.