Substance lipovitan beta carotene liposomal vitamin complex and a method for its manufacture

 

(57) Abstract:

The invention relates to medicine, namely to the pharmaceutical industry, to create vitamin complex and method of its production. The invention lies in the fact that the proposed substance containing beta-carotene, alpha-tocopherol acetate, ascorbic acid, phosphatides or phospholipids, and vitamin complex, involving a specified substance. Vitamin complex is a preformed shape. Proposed also a method of obtaining vitamin complex. The invention provides for an expansion of the range of domestic vitamin preparations necessary for the prevention of beriberi. 3 S. and 4 C.p. f-crystals.

The invention relates to the field of pharmaceutical industry, namely the creation of a vitamin complex and method of its production.

Known tablets multivitamin complexes, for example, tablets "Hasnain", containing ascorbic acid, nicotinic acid, thiamine bromide or thiamine bromide and glucose tablets "Pangeksavit" containing retinol acetate or retinol palmitate, thiamine bromide or thiamine hydrochloride, Riboflavin hydrochloride, ascorbic acid /see M the of tablet dosage forms, including vitamin complexes, providing a mixture of active ingredients with physiologically acceptable components, manufacture of engines and drawing on his film coating /see Technology of medicinal forms, M, Medicine, 1994, so 2, page 134-221/.

The technical task of the present invention is the creation of a substance called "Lipovitan beta, Carotene liposomal and vitamins in pill form that will allow us to expand the range of domestic vitamin complexes that are necessary for the prevention of beriberi.

To solve this problem is proposed substance containing beta-carotene, alpha-tocopherol acetate, ascorbic acid and phosphatides or phospholipids in a ratio, mg/g:

Beta-carotene - 10-90

Alpha-tocopherol acetate - 10-90

Ascorbic acid - 5-45

Phospholipids or phosphatides - 20-180

Vitamin complex is a preformed shape. It includes the core and the shell. The core contains the substance and additionally magnesium carbonate, potato starch, calcium stearinovokisly in the following ratio of components in g per 1 tablet weight 0,25 - 0,35:

Beta-carotene - 0,0017-0,015

Alpha-t is likely - 0,04-0,12

Potato starch - 0,005-0,05

The core also contains the antioxidant butylacetamide in the number 0,000034,

The shell contains a low-molecular polyvinylpyrrolidone, tween-80, titanium dioxide, tropeolin Oh, dye and methylcellulose in the following ratio of components in g per 1 tablet weighing 0.25-0.35 g:

The low-molecular polyvinylpyrrolidone - 0,004-0,008

Tween-80 - 0,0010-0,0025

Titanium dioxide - 0,0008-0,0017

Tropeolin ABOUT - IS 0.0002 TO 0.0004

Dye - 0,00007-0,00015

Methylcellulose - 0,003-0,005

To obtain vitamin complex first prepare the core. While beta-carotene, alpha-tocopherol acetate, phospholipids or phosphatides, ascorbic acid and chloroform mix. To the obtained powder add sorbent, re-mix 4,5-5,5 h at a pressure of 0.1 ATM at a temperature of 40-50oC. the powder is mixed with magnesium carbonate and starch. The resulting mass optivault calcium stearinovokisly and pressed. Further to the core of the applied film-forming composition comprising a primer slurry containing methylcellulose, titanium dioxide, and microcrystalline cellulose. Then put colored suspension containing methylcellulose, titanium dioxide, on butylacetamide. As the sorbent in the preparation of vitamin complex use sorbitol, and/or sugar and/or salt cookbook, and/or xylitol food, and/or mannitol and/or lactose.

Specific example 1:

One tablet of vitamin complex mass of 0.30 0.05 g contains:

Lipovitan beta carotene liposomal - substance for the production of tablets - 0.17 g

it consists of:

Beta-carotene - 0,005 grams

Alpha-tocopherol acetate - 0,005 grams

Ascorbic acid, 0.0025 g

Phosphatide concentrates soy or sunflower or phospholipids from sunflower seeds - 0,010 g

Sorbent - Rest

Excipients (to obtain core tablets weighing 0,30 0,05 g):

Magnesium carbonate is From 0.04 to 0.12 g

Potato starch From 0,005 to 0,05 g

Calcium stearinovokisly From 0.001 to 0.004 g

Excipients to obtain a shell tablet weight (0,30 0,05 g):

The low-molecular polyvinylpyrrolidone medical - From 0.0004 to 0.0008 grams

Tween-80 - between 0.0010 to 0.0025 g

Titanium dioxide is From 0.0002 to 0.0004 g

Acid red - 0,00007-0.00015 grams

Methylcellulose - 0,003-0,005 grams

Tropeolin ABOUT - IS 0.0002 TO 0.0004

Example 2

The consumption of raw materials to produce 1 kg of tablets:

Lipovic From 31 to 46 g

Calcium stearinovokisly - From 7.7 to 11.5 grams

For making vitamin complex at first, prepare the dry preparation of sorbent:

As the sorbent used:

- sorbitol,

- powdered sugar,

- salt cookbook,

- xylitol food,

- mannitol,

- the milk sugar (lactose)

or a mixture of the above sorbents.

Weighted estimated number of sorbent distribute a layer of 0.2-0.3 cm and dried at a temperature of 50-60oC for 5 hours the residual humidity of the dry sorbent should not exceed 4-6%.

The dry sorbent is crushed to obtain particles with a size of 5-20 μm.

Then prepare lipovitan beta carotene liposomal.

Estimated number of beta-carotene, phospholipids or phosphatides, ascorbic acid and chloroform load and mix the components for 30 minutes

Next, add the calculated amount of sorbent and stirred at a negative pressure of 0.1 ATM at a temperature of 455oC.

The mixing process continued for 5 hours

Prior to pelletizing lipovitan beta carotene liposomal, magnesium carbonate and starch is sifted through a sieve with a diameter of lipovitan beta, carotene liposomal mixed with magnesium carbonate and dried starch. The resulting mixture was passed through a sieve with the hole diameter of 0.75 mm, the Mass is thoroughly mixed and optivault calcium stearinovokisly.

Core tablets lipovitan beta carotene liposomal pressed in a tablet press with a biconcave punches with a diameter of 9.0 or 10.0 mm Average weight of kernel (0,28 0,03) , In the pressing process quality control of tablets: the surface and the edges of the tablets should be smooth, without chips.

Film-forming composition for coating cores of tablets prepared on the basis of a 2% aqueous solution of methylcellulose. Methylcellulose pour hot water, cooled, stirred, filtered, add tween-80, mix. Part of the solution is kept for applying gloss on tablets.

Of the remaining solution are two composition: primer and painted suspension.

In the preparation priming suspension in a solution of methylcellulose is added to the crushed titanium dioxide and microcrystalline cellulose.

To obtain colored suspension in a solution of methylcellulose is added to the crushed titanium dioxide, dissolve polyvinyl prigotovleniya compounds are thoroughly mixed and filtered through a nylon sieve N 46.

Application of polymer film coating on the core tablets lipovitan beta carotene liposomal carried out in a fluidized bed apparatus. In the apparatus loads the kernel tablets and consistently applied primer, then painted suspension. At the end of the process to make the tablets of glitter applied film of the transparent original solution of methylcellulose. Throughout the process control temperature (55 to 70oC). After application of all film-forming composition of the tablets are dried and discharged from the apparatus.

Vitamin complex having the composition and obtained by the proposed method, called "Lipovitan beta, Carotene liposomal".

He serves as a biologically active food Supplement for the prevention of beriberi.

"Lipovitan beta, Carotene liposomal use 1-2 tablets 1-3 times a day for 30 days.

1. Substance, including beta-carotene, alpha-tocopherol acetate, ascorbic acid and phospholipids or phosphatides in the following ratio of ingredients, mg/l:

Beta-carotene - 10 - 90

Alpha-tocopherol acetate - 10 - 90

Ascorbic acid - 5 - 45

Phospholipids or phosphatides - 20-benovoy acid and phospholipids or phosphatides, characterized by the fact that it is a tablet formulation containing core coated, and the nucleus contains the substance and additionally magnesium carbonate, potato starch, calcium stearic in the following ratio of components, g per 1 tablet weight 0,25 - 0,35:

Beta-carotene - 0,0017 - 0,015

Alpha-tocopherol - 0,0017 - 0,015

Ascorbic acid - 0,0008 - 0,0075

Phospholipids or phosphatides - 0,003 - 0,030

Magnesium carbonate - 0,04 - 0,12

Potato starch - 0,005 - 0,05

Calcium stearic acid - 0,001 - 0,004

and the shell contains a low-molecular polyvinylpyrrolidone, tween-80, titanium dioxide, tropeolin 0, dye and methylcellulose in the following ratio of ingredients, grams per 1 tablet weight 0,25 - 0,35:

The low-molecular polyvinylpyrrolidone to 0.0004 - 0,0008

Tween-80 - 0,0010 - 0,0025

Titanium dioxide - 0,0008 - 0,0017

Tropeolin 0 - is 0.0002 to 0.0004

Dye - 0,00007 - 0,00015

Methylcellulose - 0,003 - 0,005

3. Vitamin complex on p. 2, characterized in that it further comprises butiloksianizol in the number 0,000034,

4. Vitamin complex under item 2 or 3, characterized in that it contains phosphatides sunflower seeds or soy phospholipids or PADCO etiologichesky acceptable fillers, manufacture of engines and drawing on his film coating, characterized in that in the manufacture of the core beta-carotene, alpha-tocopherol acetate, phospholipids or phosphatides, ascorbic acid and chloroform is stirred, to the obtained powder add the sorbent and again stirred for 4.5 - 5.5 hours, a pressure of 0.1 ATM at a temperature of 40 - 50oWith, then the powder is mixed with magnesium carbonate and starch, the resulting mass optivault calcium stearinovokisly and pressed, then the kernel is applied film-forming composition comprising methylcellulose, titanium dioxide, microcrystalline cellulose, polyvinylpyrrolidone, tween-80 and dye.

6. The method according to p. 5, characterized in that in the manufacture of cores further added butylacetamide.

7. The method according to p. 5 or 6, characterized in that the sorbent use sorbitol, and/or sugar and/or salt cookbook, and/or xylitol food, and/or mannitol and/or lactose.

 

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