Combined polyvitamin composition and method for its preparing

FIELD: medicine.

SUBSTANCE: invention relates to polyvitamin composition comprising complex of vitamins A, B1, B2, B6, B12, C, E, nicotinamide and calcium pantothenate and, optionally, folic acid, biotin, chlorocalciferol, phytomenadione and sorbitol, lactose, lubricating agent, taste and/or odor corrector as special supplements, and, optionally, microcrystalline cellulose and/or aerosil, and to a method for its preparing. The composition shows the enhanced stability.

EFFECT: improved and valuable properties of composition.

19 cl, 1 tbl, 4 ex

 

The invention relates to medicine, specifically to a combined multivitamin preparations.

Among the factors of particular importance for maintaining the health, performance and longevity of a person, the most important role belongs to the vitamins. Vitamins are an important and indispensable components of food. At the same time, the results of multiple surveys of different populations clearly indicate very insufficient consumption of vitamins a significant part of the population of Russia. The generalization of the obtained data allows to conclude that the identified deficiency is in the nature of a combined failure, i.e. is polyhypovitaminosis.

Vitamins almost not synthesized in the body, and people should get them. The ability to store vitamins for the future, the body is missing, therefore, is of great importance regular supply of their body, in the full set and the number corresponding to the physiological needs of the human body. Inadequate intake of vitamins causes significant damage to health: reduces physical and mental performance, resistance to various diseases, enhances the negative effects on the body of adverse environmental conditions, harmful production factors, neuro-emotional e.g. the supply and stress, increases the number of cases of occupational injuries, increases the body's sensitivity to radiation, reduces the duration of active working life. Breaking metabolism, weakening the body, vitamin deficiency aggravates during any illness that prevents their successful treatment, reduces the effectiveness of preventive and therapeutic measures, complicates the outcome of surgical interventions, postoperative process.

One way to solve the problem of lack of vitamins is the use of multivitamin preparations, which determines the relevance of the development of ready-made forms of such drugs.

Known multivitamin composition, which contains vitamins a, E, and carotene (RF patent No. 2137471, 1999). The composition contains only fat-soluble vitamins and is in the form of a solution of these vitamins in natural fat. However, the latter is barely acceptable as a carrier for a multivitamin that also contains water-soluble vitamins.

In the patent of Russian Federation № 2156087, 2000, describes the components, including vitamins A, B1B2B6B12C, D, E, K, nicotinic acid and nicotinamide, calcium Pantothenate, calcium pangamat, folic acid, trace elements - lithium, potassium, magnesium, iron, zinc, copper, manganese, Nickel, boron, cobalt, molybdenum, vanadium, fluorine, iodine and the other is biologically active compounds - glycine, adenosine triphosphate, glutamic acid and Mexidol. The composition is performed in aqueous solution, which is not always convenient for application. In addition, in the process of storage is the stratification of the oil and aqueous phase, which significantly reduces the shelf life and makes the use of the composition as a semi.

Known multivitamin composition containing as active principle a combination of vitamins A, B1B2In6, C, D, nicotinamide, calcium Pantothenate and as auxiliary substances talc or powdered skimmed milk, or discouny phosphate of magnesium, preferably the latter (U.S. patent No. 2519487, 1950). However, these auxiliary substances, the composition can be performed only in the form of capsules.

Tablet preparation according to the patent of Russian Federation № 2190391, 2002, includes a core containing a source of calcium, iron, copper, magnesium, zinc, manganese, cobalt (in the form of corresponding salts, vitamins a, b1B6B12, E, P, Riboflavin-mononucleotide, calcium Pantothenate, nicotinamide, folic acid, lipoic acid, auxiliary ingredients - citric acid, low molecular weight polyvinylpyrrolidone, sugar, calcium stearate, starch, talc, and a shell of magnesium basic carbonate, wheat flour, sugar, beeswax, dioxide is Ethan, methylcellulose, talc, gelatin.

A method of obtaining a known drug is the following: I granulate obtained from calcium phosphate, vitamins C, B1In6, P, add a mixture of cyanocobalamin with powdered sugar, a mixture of folic acid with starch, then granulate II calcium Pantothenate, lipoic acid, vitamin E and nicotinamide, Riboflavin-mononucleotide, calcium phosphate and granular III, obtained from iron (II) sulfuric acid 7-water, magnesium phosphate-disubstituted acid, cobalt (II) sulfuric acid 7-water, manganese (II) sulfuric acid 5-water, copper sulfate, zinc sulfuric acid 7-water, citric acid and polyvinylpyrrolidone, mixed, enter vitamin a in the circulation optivault calcium stearate, talc, starch, pressed tablets, followed by the application shell method extension.

Present trace elements perform mainly restorative function, so well-known structure is proposed as an additive to food to compensate for vitamin and mineral deficiencies. However, in order for the product could be widely applied, it should have less contraindications, can be both safe and effective. On this basis, the introduction of an excessively large number of different minerals is not always justified, and in a number of the cases is contraindicated.

In the patent of Russian Federation № 2206318, 2003, described the complex water and fat-soluble vitamins, including as the active agent a combination of vitamins A, B1In2B6B12C , E, nicotinamide, calcium Pantothenate, routine and folic acid taken in a pharmacologically permitted quantities, and as auxiliary substances - sugar (sand, grit and powder), vegetable oil, starch syrup, essential oil, flour, wax, sunflower oil, and talc. Known analogue is obtained by multistage drazhirovanija by wetting each layer of a vitamin or a mixture of vitamins, dusted with powdered sugar, sprinkling sugar syrup with the addition of molasses, starch and subsequent rolling of powdered sugar, calibration on the screens, coating tablets protective sugar layer and glencove the surface of the bean wax-fat composition. The use of the above method improves the stability of the drug during storage. However, the complexity of the multistage known way of getting of pills leads to a significant loss of ingredients and requires more labor, and the quality of the ingredients is not possible to obtain a stable tablet formulation of multivitamin preparation. In the decomposition of the concentration of active ingredients is significantly reduced and sootvetstvenno which sharply decreases the activity of the drug, and the decay products can cause allergic side effects. In addition, the use of ingredients such as flour and starch syrup impose additional difficulties in the standardization process of receipt and compliance of the finished form of normative documents, in particular on microbiological purity.

The objective of the invention is the selection of the optimal combination of auxiliary substances for the combined multivitamin composition in the form of a solid dosage form which is stable for a sufficiently long period (at least 2 years), satisfies the requirements of normative documents on quality and does not have side effects.

To accomplish the tasks proposed multivitamin composition comprising the active principle and targeted supplements in which the active principle is a combination of vitamins A, B1B2In6B12C , E, nicotinamide, calcium Pantothenate, and as the target additive composition contains sorbitol, milk sugar, grease and corrigent taste and/or odor in the following ratio of ingredients, 1 mg vitamin C:

Vitamin C 1 mg,

Vitamin a - 3,7-92 IU (international units)

Vitamin B1- 0,01-0,09 mg,

Vitamin B2- 0,01-0,06 mg,

Vitamin b6- 0,01-0,07 mg,

12- 0,00001-0.0008 mg,

Vitamin E - 0.14 to 0.7 mg,

Nicotinamide - 0,12-0,4 mg,

Calcium Pantothenate - 0.04 to 0.26 mg,

Milk sugar is 0.5 - 10 mg,

Sorbitol - 0.5 to 19.5 mg,

Grease - 0.04 to 1.5 mg,

Corrigent taste and/or smell of 0.01 to 1.6 mg

The proposed ratio of ingredients is best found experimentally.

As active principle according to the invention apply complex of vitamins A, B1B2B6In12C , E, nicotinamide and calcium Pantothenate. Included in the drug vitamins exclusively necessary for the regulation and normalization of the fundamental metabolic processes in the body. Vitamin a (retinol acetate), interacting with different opsins, participates in the formation of visual pigments; ensures the integrity of epithelial tissues, regulates bone growth. Vitamin E (tocopherol acetate) possesses antioxidant properties, protects unsaturated fatty acids in membranes from the effects of lipoperoxidation, participates in the formation of intercellular substance of connective tissue, smooth muscles of blood vessels, the digestive tract. Vitamin B1as a coenzyme involved in carbohydrate metabolism, the functioning of the nervous system, is a necessary factor for the transmission of nerve impulses. Vitamin b2(Riboflavin - the most important catalyst for processes of cellular respiration and visual perception. Vitamin b6(pyridoxine hydrochloride) as a coenzyme involved in the metabolism of amino acids and proteins in the synthesis of neurotransmitters. Calcium Pantothenate, sometimes called vitamin b5plays an important role in the acetylation and oxidation of carbohydrates and fats as an integral part of coenzyme A. Nicotinamide (vitamin PP) is involved in the processes of tissue respiration, lipid and carbohydrate metabolism. Vitamin C (ascorbic acid) provides the synthesis of collagen, is involved in the metabolism of folic acid and iron plays an important role in the synthesis of steroid hormones and catecholamines. Vitamin b12(canoco-balamin) involved in the synthesis of nucleotides involved in the formation of red blood cells and nerve cells membranes, necessary for growth of the organism.

Inclusion according to the invention in the multivitamin complex lactose, sorbitol, lubricants and corrigenda taste and/or odor in the stated quantities allows to obtain the following technical result of the claimed combined multivitamin composition is stable for a sufficiently long period and has a shelf life of more than 2 years, meets the requirements of normative documents on quality and not have side effects.

The preferred content of the milk sugar in the inventive composition is 1.6-5.4 mg/1 mg of vitamin C, more preferably 2,2-4,9 mg/1 mg of vitamin C.

The preferred content of sorbitol in the new song is 1.9-17,0/1 mg of vitamin C, more preferably 2,6-15.3 mg/1 mg of vitamin C.

As the lubricant, the new composition may contain stearic acid, salt of stearic acid, hydrogenated vegetable oil, castor, cottonseed oil or other substances commonly used in the pharmaceutical industry as a lubricant, preferably a salt of stearic acid, in particular magnesium stearate.

Examples of corrigenda taste and/or odor are sweetener and/or flavoring with the corresponding aroma of fruits, lemon, orange, banana or similar. As a sweetener, you can use aspartame, sodium saccharinate, sodium cyclamate, preferably aspartame.

A study was conducted Toxicological actions of the proposed structure. The experiment was carried out on the nonlinear rats male. The composition was administered intragastrically at doses of 50.0 (therapeutic) and 500.0 mg/kg once a day for 2 weeks. According to the results of the experiment in laboratory animals revealed no irritating effect on the mucous membrane of the gastro-intestinal tract and su is the natural enemy impact on integral performance (weight gain, feed consumption, water and the General behavior of animals). The drug does not cause structural abnormalities in organs and tissues. Experimental data show no significant differences from peripheral blood, lipid and carbohydrate in the liver, as well as the functions of the urinary, cardiovascular and nervous systems during a two-week effects in the studied doses compared with the control group. Thus, it was experimentally confirmed the absence of side effects in the new structure.

Advanced b complex vitamins may include cholecalciferol and/or Biotin, and/or fitomenadion, and/or folic acid. Preferably cholecalciferol or last with folic acid and fitomenadion. In another preferred embodiment, the inventive composition further includes folic acid and Biotin.

Appropriate number of additional active ingredients amount per 1 mg of vitamin C:

Cholecalciferol - 1,2-6,4 ME,

Biotin - 0,6-1,5 mcg,

Fitomenadion - 0,12-0,4 µg,

Folic acid - 1-7 mcg

As an auxiliary component in the composition may further comprise microcrystalline cellulose, including modified, and/or Aerosil. The optimal amount of microcrystalline cellulose is 0.5-1.5 mg per 1 mg of vitamin C and optimal the number of Aerosil - 0.05 to 1 mg per 1 mg of vitamin C.

New multivitamin composition is in the form of solid dosage forms, preferably in the form of tablets, such as chewable tablets, that provides maximum adaptability subsequent packaging and precision dosing of the active substance.

The way to get a new composition involves mixing active and auxiliary ingredients and, if necessary, subsequent tableting the mixture. To improve the homogeneity of the dosing is possible to preliminarily obtain a mixture of active ingredients with the entire amount or part of milk sugar. The use of the claimed quantitative and qualitative composition of ingredients allows to exclude from the process flowsheet stage wet granulation and drying, which significantly simplifies the manufacture of the dosage form, reduces losses. Mix ingredients in specified proportions also provides satisfactory strength tablet compression (more than 14 kgs) and abrasion - above 99.5%.

The invention is illustrated by the following examples (see Table):

Example 1. Pre-prepare a mixture of vitamin C, taken in an amount of 5 g, vitamin a - 57 mg (or 33,32 ME on 1 mg of vitamin C), vitamin B1in the form of thiamine Mononitrate - 0.11 g (0,022 - hereinafter relative amount, mg is and 1 mg of vitamin C), vitamin b20.1 g (0.02 mg), vitamin b60.16 g (0,032 mg), vitamin b12- 0.15 mg (0,00003 mg), vitamin E - 1,05 g (0.21 mg), calcium Pantothenate - 0.3 g (0.06 mg) and nicotinamide - 1 g (0.2 mg) from 17.5 g of milk sugar (3.5 mg) and add to it 71,7 g of sorbitol (14,34 mg), 0.5 g of aspartame, 1 g of banana flavoring and 1.5 g of magnesium stearate (0.3 mg) and stirred in a homogenizer-mixer to obtain a homogeneous mass. The mixture tabletirujut on a tablet press and get chewable tablets with an average weight of 1.0 g that satisfy the requirements of the pharmaceutical agent. Deviations in the weight of individual tablets from the average weight is 20 out of 20 is not more than 5%. Microbiological purity meets the requirements of Gosfarmakapei XI edition, issue 2, s, and changes # 2, category 3A. Strength tablets compression is 22.4 kgf, abrasion - 99,8%. The shelf life of the composition over 30 months.

Example 2 carried out analogously to example 1 with the difference that the composition additionally include cholecalciferol and Aerosil, as the lubricant used stearic acid, Corrigendum taste and/or smell is only aspartame and to obtain preliminary mixture with vitamins load only half of the total number of milk sugar.

Example 3 carried out analogously to example 1 with the difference that the composition include updat the additional folic acid and Biotin, as well as a modified microcrystalline cellulose marks Avicel CE-15, containing guar gum, and Aerosil, as corrigenda taste and/or odour, use the apricot flavoring mixture and sodium saccharinate

Example 4 perform similarly to the previous example, with the difference that the composition additionally include folic acid, cholecalciferol, fitomenadion, microcrystalline cellulose, and Corrigendum taste and/or smell is the only flavor sweet orange.

Obtained in examples 2-4 tablets meet the requirements of the pharmaceutical agent and have a shelf life of more than 24 months.

Table
IngredientsContents, 1 mg vitamin C
Examples
1234
Vitamin C mg1111
Vitamin A, ME33,3292,03,733,32
Vitamin B1mg0,0220,090,010,022
Vitamin b2mg0,020,060,010,02
Calcium Pantothenate mg0,060,260,050,04
Vitamin B6mgto 0.0320,070,01to 0.032
Vitamin b12, mcg0,030,80,010,03
Vitamin E, mg0,210,30,70,14
Vitamin PP, mg0,20,40,120,2
Cholecalciferol, ME-6,4-1,2
Biotin, mcg--1,5-
Fitomenadion, mcg---0,4
Folic acid, mcg--1,07,0
Milk sugar3,510,00,56,82
Sorbitol14,347,519,50,5
Grease0,30,041,50,7
Corrigent taste and/or odor0,30,21,60,01
Microcrystalline cellulose--1,50,5
Aerosil.-0,051,0

1. Multivitamin composition in the form of separate dosage units comprising the active principle and targeted supplements in which the active principle is a combination of vitamins A, B1In2In6In12C , E, nicotinamide, calcium Pantothenate and as the target additive composition contains sorbitol, milk sugar, grease and corrigent taste and/or odor in the following ratio of ingredients, in mg per 1 mg of vitamin C:

Vitamin C1
Vitamin a3,7-92 IU (international units of action)
Vitamin B10,01-0,09
Vitamin b20,01-0,06
Vitamin b60,01-0,07
Vitamin b120,00001-0,0008
Vitamin E0,14-0,7
Nicotinamide0,12-0,4
Calcium Pantothenate0,04-0,26
Milk sugar0,5-10
Sorbitolfrom 0.5 to 19.5
Lubricating ve is esto 0,04-1,5
Corrigent taste and/or odor0,01-1,6

2. The composition according to claim 1, which contains as the lubricant magnesium stearate.

3. The composition according to claim 1, which contains as corrigenda taste and/or smell of sweetener and/or flavoring.

4. The composition according to claim 3, which contains as a sweetener aspartame.

5. The composition according to claim 1, which contains the milk sugar in the amount of 1.6-5.4 mg per 1 mg of vitamin C.

6. The composition according to claim 5, which contains the milk sugar in the amount of 2,2-4,9 mg per 1 mg of vitamin C.

7. The composition according to claim 1, which contains sorbitol in the amount of 1,9-of 17.0 mg per 1 mg of vitamin C.

8. The composition according to claim 7, which contains sorbitol in the amount of 2.6-15.3 mg per 1 mg of vitamin C.

9. The composition according to claim 1, which further comprises as the active ingredient cholecalciferol in the amount of 1,2-6,4 ME on 1 mg of vitamin C.

10. The composition according to claim 1, which further comprises as the active ingredient cholecalciferol in the amount of 1,2-6,4 ME on 1 mg of vitamin C, folic acid number 1-7 μg per 1 mg of vitamin C and fitomenadion in the amount of 0.12 to 0.4 μg per 1 mg of vitamin C.

11. The composition according to claim 1, which further comprises as the active ingredient folic acid in the amount of 1-7 μg per 1 mg of vitamin C and Biotin in the amount of 0.6 to 1.5 μg per 1 mg of vitamin C.

12. The composition according to claim 1, to the which additionally contains microcrystalline cellulose and/or Aerosil.

13. The composition according to item 12, which contains microcrystalline cellulose in an amount of 0.5-1.5 mg per 1 mg of vitamin C.

14. The composition according to item 13, which contains as microcrystalline cellulose microcrystalline cellulose, modified the guar resin.

15. The composition according to item 12, which contains Aerosil in the amount of 0.05-1 μg per 1 mg of vitamin C.

16. The composition according to any one of claims 1 to 15, which is made in the form of tablets.

17. The composition according to item 16, which is made in the form of chewable tablets.

18. A method of obtaining a multivitamin composition described in claims 1 to 17, which comprises mixing the active ingredients and special additives and, if necessary, subsequent tableting the mixture.

19. The way of getting p, which previously get the mixture of active ingredients with the entire amount or part of milk sugar, and then to this mixture add the remaining ingredients.



 

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FIELD: sterilization agents and facilities in medicine.

SUBSTANCE: sterilization method comprises first-step treatment of an object with 0.05-0.3% (based on active component) solution of biocide agents based on clatrate of quaternary ammonium compound with urea and second-step treatment with solution containing 2.5-3.5% hydrogen peroxide. Kit contains (i) concentrate of biocide agent based on clatrate of quaternary ammonium compound with urea and (ii) peroxide compound.

EFFECT: allowed quick achievement of sterility of objects and suppressed final stage of washing objects in sterile water or other liquid to remove the rest of biocides.

13 cl, 1 tbl

FIELD: medicine, neurology, pediatrics.

SUBSTANCE: method involves administration of aminolone in the dose 0.25-0.5 g, 2-3 times per a day for 6-8 months, cerebrolysine in the dose 1.0-1.2 ml by intramuscular route, course 15-20 injections, mydocalm in the dose 50-75 mg, 2 times per a day for 1-1.5 month, vitamin B12 in the dose 150-300 mcg, course 15-20 injections wherein injections of vitamin B12 and cerebrolysine are alternated in each other day; in 1.5 month after onset of this treatment prefizone in the dose 1 ml by intramuscular route is administrated every day, course 15-20 injections, pyrogenal in the dose 100-200 MTD is administrated by course 15-20 injections and curative physical culture is carried out with heat procedure in sauna (dry bath) for 3 months, and after termination of medicinal therapy hyppotherapy is carried out for 3-5 months for each other day. Method allows straightening the kyphoscoliotic carriage and to improve joins mobility due to increase of the motions volume in them. Invention can be used in treatment of spastic diplegia in infantile cerebral paralysis.

EFFECT: improved treatment method.

3 ex

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