Immunomodulatory agent in form of film-coated tablet containing sodium nucleinate

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and pharmacy, namely film-coated tablets containing sodium nucleinate. Sodium nucleinate represents sodium salt of nucleic acid and refers to immunoregulatory agents.

EFFECT: prepared agent is storage-stable and complies with the Pharmacopoeia requirements.

3 ex, 1 tbl

 

The invention relates to medicine and the pharmaceutical industry and relates to immunomodulatory drugs Sodium nukleinat.

Sodium nukleinat - drug mass immune disorders, affecting virtually all elements of the immune system and metabolicheskie processes. Targets for action nucleinate sodium in the body, first of all, are the cellular and humoral factors of the immune system.

The effect of sodium nucleinate is manifested in the induction of leukocyte reactions, stimulation of bone marrow, intracellular metabolism and nucleic acid metabolism, stimulation of T - and b-system and phagocytic immune system, especially when immunodeficiencies, antitoxic resistance of the organism and reduce toxic immunosuppressive properties of cytostatics (cyclopian), antibiotics, hormones and cardiac glycosides; tissue regeneration dystrophy and ulcerative defects, including trophic ulcers of the extremities, ulcer disease ulcer and 12 duodenal ulcer, ulcerative colitis and other processes, in which are recorded the defects of the immune system; prevent or reduce the intensity of allergic reactions.

Sodium nukleinat used in the treatment of as an immunomodulating funds: in cases involving development the m immunodeficiency syndrome (diseases of the upper respiratory tract and various pneumonia, tuberculosis, rheumatic fever, ulcerative processes of the gastroduodenal region, herpetic keratitis, kidney and liver, mental disorders, and others); leukopenia and agranulocytosis, lymphocytopenia, in violation of phosphorus metabolism (phosphaturia, rickets and other); if dystrophy and ulcerative processes, including tapetoretinal retinal dystrophy; periodontal disease; with intense physical activity (athletes) and work in extreme conditions; to improve the activity netcommunity vaccines and vaccination of people with immune deficiency; prevention of postoperative bacterial complications and improve wound healing; for treating and preventing bacterial and professional intoxications; for the recovery of immune status in elderly and senile age.

Low molecular weight RNA and its sodium salt (sodium nukleinat) are natural medicines, they come in all foods of plant and animal origin and oral is easily absorbed by the body.

Known immunomodulatory agent sodium nukleinat representing the sodium salt of the nucleic acid obtained by hydrolysis of yeast with further purification (RF patent No. 2244008). The drug is available in powder form for oral administration in vials of 0.5 g and tablets covered about is accoi, 250 mg Prescribed dose: children of 0.005 to 0.3 g per day for adults, 1-2 g per reception 3-4 [1-3].

Tablet form in comparison with powder for oral administration is more convenient to use, but the sugar coating sheath has a number of disadvantages, in particular, lack of stability and the need for strict adherence storage (significant influence of such factors as temperature, humidity, light). Drageeing boilers have low rates of heat and mass transfer, therefore, when using aqueous solutions (suspensions) the process of applying sugar shell slow, which reduces the performance of the device.

The present invention is to develop more convenient to use and are stable during storage of a tablet form of sodium nucleinate.

To achieve the objectives of the proposed drug in the form of tablets, film coated liner.

Film wrapper has several advantages compared to sugar shell:

- film membrane is more stable to high temperatures, microbial contamination than sugar shell;

- film membranes more supple;

tablets, film coated liner have smaller weight and size, it is easier ingested;

- coating in the fluidized bed installations and Kotero POS is s due to the high ratio of effective thermal conductivity and heat transfer from the coolant to cover the pills significantly accelerate the process of coating, reduce energy and labor costs.

The technical solution of the present invention is that the core tablets containing sodium nukleinat, potato starch, polyvinylpyrrolidone, calcium stearate in the following ratio of ingredients, wt.%:

sodium nukleinat70÷95,
polyvinylpyrrolidone5÷15,
calcium stearate or magnesium stearate0,2÷1,0,
potato starch or milk sugarrest

coated, comprising hypromellose, titanium dioxide, vaseline oil, Polysorbate in the following ratio, wt.%:

Polysorbate5÷20,
titanium dioxide10÷40,
vaseline oil0÷15,
the hypromellose30÷50,
sugar milk0÷50.

The coating Obolo the Ki conduct film-forming suspension in a solvent mixture of ethyl alcohol and methylene chloride (1:1) or a solvent mixture of water - ethyl alcohol (1:3).

The invention is illustrated by the following examples.

Example 1. Powder sodium nucleinate (287 g) moistened with a solution of 34 g of polyvinylpyrrolidone in 400 ml of ethyl alcohol. The wetted mass is stirred, dried to a moisture content of 10.0%. The dried mass granuliruth. The granulate optivault the calcium stearate (2.5 g), potato starch (6.5 g), tabletirujut. After tabletting get 300 g of the core tablets. 300 g of the core tablets in the installation type Wurster put 410,8 g of a suspension containing 4.5 g of hydroxypropylmethylcellulose, 1.0 g of sugar of milk, 4.5 g of titanium dioxide, 1.1 g of tween 80 (Polysorbate), 0.7 g of paraffin oil, 300 g of ethyl alcohol, 100 g of water.

Example 2. Powder sodium nucleinate (250 g) moistened with a solution of 17 g of polyvinylpyrrolidone in 150 ml of ethyl alcohol and 50 ml of water. The wetted mass is stirred, dried to a moisture content of 12.0%. The dried mass granuliruth. The granulate optivault the calcium stearate (1.5 g), potato starch (28.5 g), tabletirujut. After tabletting obtain 270 g of the core tablets. 270 g of the core tablets in couture put a suspension containing 4.0 g of hydroxypropylmethylcellulose, 3.0 g of sugar of milk, 1.6 g of titanium dioxide, 0.5 g of tween 80 (Polysorbate), 27 g of water.

Example 3. Powder sodium nucleinate (300 g) moistened with a solution of 30 g of polyvinylpyrrolidone in 150 ml of water. Uvlag the built mass is stirred, dried to moisture content of 13.0%. The dried mass granuliruth. The granulate optivault the calcium stearate (1.8 g), potato starch (5 g), tabletirujut. After tabletting get 300 g of the core tablets. 300 g of the core tablets in the installation type Wurster put 450 g of a suspension containing 4.5 g of hydroxypropylmethylcellulose, 3.2 g of titanium dioxide and 2.0 g of tween 80 (Polysorbate), 0.3 g of paraffin oil in a mixture of methylene chloride - ethyl alcohol in a 1:1 ratio.

Received the drug meets the requirements of the Pharmacopoeia, stable during storage and has a shelf life of 2 years (see table 1).

Sources of information

1. Mashkovsky PPM Medicines. Ed. 15. LLC "New Wave", 2005, s.

2. Register of medicines, CLIVAR, CD.

3. Search the Internet.

4. Database inventions of Rospatent.

5. RF patent №2244008.

Immunomodulatory agent in the form of tablets, coated film-coated, containing sodium nukleinat, characterized in that the core contains nukleinat sodium, starch, polyvinylpyrrolidone, calcium stearate in the following ratio, wt.%:

sodium nukleinat70÷95
polyvinylpyrrolidon is n 5÷15
calcium stearate or magnesium stearate0,2÷1,0
potato starch or milk sugarthe rest,

the shell contains hypromellose, titanium dioxide, vaseline oil, milk sugar, Polysorbate in a solvent mixture of ethyl alcohol and methylene chloride (1:1) or a solvent mixture of water - ethanol (1:3) in the following ratio, wt.%:
Polysorbate5÷20
titanium dioxide10÷40
vaseline oil0÷15
the hypromellose30÷50
sugar milk0÷50



 

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