Multivitamin preparation with mineral additives and method thereof

 

(57) Abstract:

The invention relates to chemical-pharmaceutical industry, namely the creation of a multivitamin preparation with mineral additives. The product includes a core containing retinol acetate, tocopherol acetate, thiamine hydrochloride, Riboflavin mononucleotide, pyridoxine hydrochloride, ascorbic acid, folic acid, nicotinamide, rutin, calcium Pantothenate, cyanocobalamin, lipoic acid, iron (II) sulfate, copper sulfate, calcium phosphate, cobalt (II) sulphate, manganese sulphate, zinc sulphate, magnesium phosphate, citric acid, HPP low molecular weight, sugar, calcium stearate, talc, potato starch, shell containing magnesium basic carbonate, wheat flour, sugar, beeswax, titanium dioxide, methylcellulose, talc, gelatine. The proposed method of producing tablets multivitamin preparation with mineral additives is as follows: I granulate obtained from calcium phosphate, ascorbic acid, thiamine chloride, pyridoxine hydrochloride, routine, add a mixture of cyanocobalamin with powdered sugar, a mixture of folic acid with starch, then granulate II calcium Pantothenate, lipoa the scientists of iron (II) sulfate 7-water, magnesium phosphate (disubstituted), cobalt (II) sulfate 7-water, manganese (II) sulfate 5-water, copper sulfate, zinc sulfate 7-water, citric acid and polyvinylpyrrolidone, mixed, injected retinol acetate in microspheres, optivault calcium stearate, talc, starch, pressed tablets, followed by the application shell method extension. The proposed structure has a greater effectiveness. The method provides better bioavailability of the drug received. 2 c.p. f-crystals.

The invention relates to chemical-pharmaceutical industry, namely the creation of a multivitamin preparation.

Currently known for a very wide range of vitamin preparations.

Actively participating in biochemical processes, the vitamins in combination have a strong and diverse biological effects than separately. In some cases, vitamins reinforce their physiological effects. These and other peculiarities of the action of vitamins serve as the basis for their combined application. Known number of pre-mixed preparations that contain different vitamins and minerals. Many of them are megacomp the viola, manganese, molybdenum, selenium, chromium.

Thus, in (1) disclosed the preparation is intended for use in special diet containing

vitamin a - 1500-13500 ME,

beta-carotene - 5000-45000 ME,

vitamin B1 - 10-300 mg,

vitamin B6 - 50-450 mg,

vitamin B12 - 30-270 mcg,

Niacin - 20-180 mg,

Niacinamide is between 100 and 900 mg

vitamin C - 200 mg,

magnesium - 50-450 mg,

zinc - 10-90 mg

This drug helps to improve the processes of cellular metabolism.

Known imported vitamin complex drugs, for example Vitrum (2), having the following composition per tablet:

retinol acetate (vitamin a) - ME,

-tocopherol acetate - 30 ME,

ascorbic acid 60 mg,

folic acid - 400 mg,

thiamine chloride 1.5 mg,

Riboflavin is 1.7 mg,

nicotinamide 20 mg,

pyridoxine hydrochloride 2 mg

cyanocobalamin - 6 mcg,

vitamin D - 400 ME,

Biotin is 30 mcg,

calcium Pantothenate 10 mg,

calcium phosphate dibasic - 162 mg,

potassium iodide - 150 mg

fumarata iron 18 mg,

magnesium oxide 100 mg,

copper oxide 2 mg

zinc oxide 15 mg,

potassium chloride 40 mg,

manganese sulfate 2.5 mg

is icela sulfate 5 mcg,

tin chloride 10 mg,

sodium metasilicate - 10 mcg,

sodium metavanadate 10 ug.

The way to obtain the drug are not disclosed. The above composition is the closest analogue to the proposed multivitamin preparation. However, the disadvantage of imported drugs is their high cost. The high price of the drug caused by the necessity to buy medication overseas and includes excessive overhead costs associated with transportation, customs clearance, registration. Given the use of long-term preventive and Wellness courses, this disadvantage is significant.

In addition to the product could be widely applied in the preventive purposes, the normalization condition of the body in various pathological conditions, it should have less contraindications, can be effective and safe. And from this point of view, the introduction of a very large number of different minerals is not always justified, and in some cases is contraindicated.

When developing ways to obtain tablets multivitamin preparations, as a rule, takes into account their compatibility. Most often in the prior art of opisyvayuschaya multi-layer solid dosage drugs vitamins from a number of masses, containing active substances, which are subjected to a co-extruded and then molded received coextruding multilayer material, if necessary, put a shell (EN 98110461/14 AND, 20.05.2000). However, this method does not provide sufficient bioavailability incoming active substances.

The technical task of the present invention is to expand the range of domestic vitamin preparations necessary for the prevention of beriberi, optimal in a complex of vitamins and mineral elements, as well as the development of the method of obtaining such drugs with optimal bioavailability.

The problem is solved by the creation of the drug, intended to compensate for vitamin and mineral deficiencies in different pathological conditions: for faster recovery after injuries, surgeries, infectious diseases, to improve tolerance to prolonged physical exercise.

The proposed structure includes

Component - Content, wt.% per pill

tablet-core

Retinol acetate (vitamin a) - 0,144-0,176

-Tocopherol acetate (vitamin E) - 1,333-1,147

Thiamine hydrochloride (vitamin B1) - 0,117 ascorbic (vitamin C) - 5,7165-6,6435

Folic acid (vitamin B6) - 0,017-0,023

Nicotinamide (vitamin PP) - 0,801-0,979

Rutin (vitamin P) - 2,7565-3,2035

Calcium Pantothenate (vitamin B3) - mean HDI of 0.531-0,649

Cyanocobalamin (vitamin b 12) - 0,0085-0,015

The lipoic acid - 0,225-0,275

Iron(II) sulfate 7-water - 2,59-3,01

Copper sulfate 5-water - 0,297-0,363

Calcium phosphate - 23,142-25,578

Cobalt(II) sulfate 7-water - 0,051-0,069

Manganese(II) sulfate 5-water - 1,3223-1,1377

Zinc sulfate 7-water - 0,891-1,089

Magnesium phosphate disubstituted - 12,5-13,86

Citric acid - 1,8777-2,1823

The low-molecular polyvinylpyrrolidone - 0,36-0,44

Sugar - 0,396-0,484

Calcium stearate - 0,576-0,7040

Talc - 1,1747-1,3653

Potato starch - 1,8592-2,1608

shell

Magnesium carbonate basic - 8,9262-10,3738

Wheat flour 6,8265-7,9335

Sugar - 18,3825-20,3175

Beeswax - 0,034-0,046

Titanium dioxide - 0,3060-0,374

Methylcellulose - 0,189-0,231

Talc - 0,0255-0,0345

Gelatin - 0,034-0,046

The introduction of the vitamins provides a normalization of the various biochemical processes in the body. The constituent minerals are sources of iron, copper, calcium, cobalt, manganese, zinc and magnesium, to the role in adaptation of the organism, metabolism and studies currently most often a shortage of content, especially under pathological conditions.

To provide the necessary technological properties, dosing accuracy, strength, raspadaemosti tablets in the composition have a number of auxiliary substances, which have a loosening, binders, wetting, anti-friction action. Introduction citric acid and polyvinylpyrrolidone helped to increase the activity of the composition. Although these substances are used in the manufacture of tablets, their choice is not obvious to the expert. Thus, each of the many components has its own form of particles, certain physico-chemical properties, etc., that significantly affect the process of tabletting (flowability, compressibility), and in addition, each interacts in some way with the other components, and in this case to provide the necessary bioavailability each of them requires an optimal set of auxiliary substances. Of great importance is the quantitative content of the components. The price of the drug is small compared with the imported drugs by means of production Omer composition of multivitamin preparation with mineral additives

Component - Content, wt.% per pill

tablet-core

Retinol acetate (vitamin a) - 0,16

-Tocopherol acetate (vitamin E) - 1,24

Thiamine hydrochloride (vitamin b 1) - 0,13

Riboflavin mononucleotide - 0,16

Pyridoxine hydrochloride (vitamin B6) - 0,59

Ascorbic acid (vitamin C) - 6,18

Folic acid (vitamin B6) - 0.02

Nicotinamide (vitamin PP) - 0,89

Rutin (vitamin P) - 2,98

Calcium Pantothenate (vitamn B3) - 0,59

Cyanocobalamin (vitamin b 12) - 0,01

The lipoic acid - 0,25

Iron(II) sulfate 7-water - 2,8

Copper sulfate 5-water - 0,33

Calcium phosphate - 24,36

Cobalt(II) sulfate 7-water - 0,06

Manganese(II) sulfate 5-water - 1,23

Zinc sulfate 7-water - 0,99

Magnesium phosphate disubstituted - 13,2

Citric acid - 2,03

The low-molecular polyvinylpyrrolidone - 0,4

Sugar - 0,44

Calcium stearate - 0,64

Talc - 1,27

Potato starch is 2.01

shell

Magnesium carbonate basic - 9,65

Wheat flour 7,38

Sugar - 19,35

Beeswax - 0.04

Titanium dioxide - 0,34

Methylcellulose - 0,21

Talc - 0,03

Gelatin - 0.04

Example 2

An example of obtaining panulat vitamins (including compatibility of vitamins) and one granular micronutrients. The proposed method of producing includes the following stages:

1. Raw material preparation: sifting, heat treatment of flour, cooking granulating agent - 5-s % starch paste.

2. Cooking I granulate containing calcium phosphate, ascorbic acid, thiamine hydrochloride, pyridoxine hydrochloride, rutin. The process is conducted in the dryer-granulator SG-30M. He is the hydration of these substances granulating agent, followed by wet granulation, drying and dry granulation. The process temperature is 455oC.

3. Preparation of granulate II containing calcium Pantothenate, lipoic acid, nicotinamide, Riboflavin mononucleotide, a-tocopherol acetate, calcium phosphate.

The process is conducted using the dryer-granulator SG-30M. He is the hydration of the above substances granulating agent, then hold wet granulation, drying, dry granulation. Process temperature - 47,52,5oC.

4. Preparation of granulate III. Iron(II) sulfate 7-water, cobalt(II) sulfate 7-water, magnesium phosphate disubstituted, manganese sulfate 5-water, copper sulfate 5-water, zinc sulfate 7-water vivatrat in the air, drying avodat wet granulation, dried at a temperature 4010oC for 4-6 hours, conduct a dry granulation and pass on the tabletting operation.

5. Preparation of tablet mass. In the mixer load I granulate the mixture of cyanocobalamin with powdered sugar, a mixture of folic acid with starch granules II, granulate III, mix, introducing vitamin a in the circulation optivault calcium stearate, talc, starch and sent for tableting.

6. Tableting. Tableting is performed on a rotary press with a diameter of 12 mm punches with a deep field. Filling mix 2 kg carried out periodically every 5-8 minutes. The resulting tablet cores are laid on trays low layer and allow to stand at room temperature for stress relaxation inside the tablet, resulting from high pressure during pressing. Get biconvex tablets average weight 0,575%(0,570,028) ,

7. Coating of tablets-shell nuclei by the method of expansion. Primer spend a sugar syrup with the addition of methylcellulose, sprinkle with a mixture of flour and magnesium carbonate basic. Then perform layering using the suspension containing sugar, methylcellulose, magnesium carboys titanium, wax, talcum. Polishing carry beeswax, then tablets optivault talc. The obtained tablets are sent to the stage of packing.

Sources of information

1. WO 95/29668 Al, 01.11.95.

2. Register of medicines of Russia, encyclopedia of drugs, M., 2001, S. 194.

3. EN 98110461/14 AND, 20.05.2000.

1. Tablets multivitamin preparations with mineral additives containing core, including retinol acetate, tocopherol acetate, thiamine hydrochloride, pyridoxine hydrochloride, ascorbic acid, folic acid, nicotinamide, calcium Pantothenate, cyanocobalamin, sources of calcium, iron, copper, magnesium, zinc, manganese, and a shell, wherein the core further comprises rutin, lipoic acid, Riboflavin-mononucleotide, citric acid, low molecular weight polyvinylpyrrolidone, sugar, calcium stearate, starch, talc, cobalt (II) sulfate 7-water, as a source of copper includes copper sulfate 5-water, as a source of iron - iron (II) sulfate 7-water, as a source of calcium - calcium phosphate as a source of zinc is zinc sulfate 7-water, as a source of manganese as manganese (II) sulfate 5-water, as istochnoye, sugar, beeswax, titanium dioxide, methylcellulose, talc and gelatin, in the following ratio, wt. % per tablet:

tablet-core:

Retinol acetate (vitamin a) - 0,144-0,176

-Tocopherol acetate (vitamin E) - 1,333-1,147

The thiamine hydrochloride (vitamin B1) - 0,117-0,143

Riboflavin mononucleotide - 0,144-0,176

Pyridoxine hydrochloride (vitamin B6) - mean HDI of 0.531-0,649

Ascorbic acid (vitamin C) - 5,7165-6,6435

Folic acid (vitamin B6) - 0,017-0,023

Nicotinamide (vitamin PP) - 0,801-0,979

Rutin (vitamin P) - 2,7565-3,2035

Calcium Pantothenate (vitamin B3) - mean HDI of 0.531-0,649

Cyanocobalamin (vitamin B12) - 0,0085-0,015

The lipoic acid - 0,225-0,275

Iron (II) sulfate 7-water - 2,59-3,01

Copper sulfate 5-water - 0,297-0,363

Calcium phosphate - 23,142-25,578

Cobalt (II) sulfate 7-water - 0,051-0,069

Manganese (II) sulfate 5-water - 1,3223-1,1377

Zinc sulfate 7-water - 0,891-1,089

Magnesium phosphate disubstituted - 12,5-13,86

Citric acid - 1,8777-2,1823

Polivinilpirrolidon low-molecular - 0,36-0,44

Sugar - 0,396-0,484

Calcium stearate - 0,576-0,7040

Talc - 1,1747-1,3653

Potato starch - 1,8592-2,1608

shell

Magnesium carbonate basic - 8,9262-10,3738

Multicellular - 0,189-0,231

Talc - 0,0255-0,0345

Gelatin - 0,034-0,046

2. The method of obtaining tablets multivitamin preparation with mineral additives, characterized in that the granulate I obtained from calcium phosphate, ascorbic acid, thiamine chloride, pyridoxine hydrochloride, routine method of wet granulation using as a granulating agent, starch paste, followed by dry granulation, add a mixture of cyanocobalamin with powdered sugar, a mixture of folic acid with starch, then granulate II, obtained from calcium Pantothenate, lipoic acid, nicotinamide, Riboflavin-mononucleotide, a-tocopherol acetate, calcium phosphate by the method of wet granulation using as a granulating agent, starch paste, followed by dry granulation, the granulate III, obtained from iron (II) sulfate 7-water, magnesium phosphate disubstituted, cobalt (II) sulfate 7-water, manganese (II) sulfate 5-water, copper sulfate 5-water, zinc sulfate 7-water, citric acid and polyvinylpyrrolidone, mixed, injected retinol acetate in microspheres, optivault calcium stearate, talc, starch, pressed tablets after the other, methylcellulose, talc, gelatin.

 

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