The solution of dalargin for injection

 

(57) Abstract:

The invention relates to pharmaceutical industry and relates to the preparation of dalargin for injection, used as a medicine in the acute gastric ulcer and duodenal ulcer, acute pancreatitis and pancreonecrosis. The invention lies in the fact that the proposed isotonic 0.1% solution of dalargin for injection contains dalargin, sodium chloride and water for injection. The invention provides stability properties during manufacturing and storage for at least 3 years. 1 PL.

The invention relates to medicine and for the preparation dalargin, used as a medicine in the acute gastric ulcer and duodenal ulcer, acute pancreatitis and pancreonecrosis.

Dalargin - synthetic compound consisting of residues 6 amino acids (Hexapeptide), tyrosyl-D-alanyl-i.e. phenylalanyl-leucyl-arginine diacetate (C35H51N9O8×2H3COOH), is a white amorphous powder, readily soluble in water.

However, dalargin, like other peptides in aqueous solutions exposed to the chemical mechanisms the P>

To ensure stability and constant concentration of dalargin storage poured into ampoules and lyophilizers. Immediately before use the contents of the capsules dissolve and prepare a solution for injection.

The closest in technical essence and the achieved result is dalargin for intravenous and intramuscular injection in the form of dried powder or porous mass in ampoules of 0.001 g (1 mg) immediately before use prepare a solution for injection (M. D. Mashkovsky. Medicinal product. 14th edition. M: the New time. 2000, S. 166-167).

However, the production of dried dalargin is a costly process. In addition, there is a need for preparation of a solution of dalargin just before the introduction is preferably carried out in aseptic conditions, which complicates the work of medical personnel.

The objective of the invention is to provide liquid dosage forms of 0.1% solution of dalargin for intravenous and intramuscular injection, in which dalargin sustainable (stable) storage and has a physiological tolerance to injections, as well as simplifying the production leskovo solution of sodium chloride, which as a stabilizer and preservative provides resistance (stability) of dalargin during storage, and also eliminates the process of dissolution of the drug before the introduction, which facilitates its application in medical practice. In addition, by eliminating the stage of freeze drying simplifies the technological process of production of the dosage form of dalargin, reduced energy costs and ultimately reduces the cost of the drug.

0.1% solution of dalargin contains these components in the following ratio of 1 ml:

The substance of dalargin, mg 0,85-1,15

Sodium chloride, mg of 8.7 and 9.3

Water for injection to 1 ml

0.1% solution of dalargin for injection is prepared as follows.

To prepare 100 l of a solution of dalargin take 102 g of the substance of dalargin, 900 g of sodium chloride and water for injection to 100 HP

In the reactor pour 95 liters of hot water for injection, mix and cool. Then open the valve on the feed to the reactor sterile nitrogen and bubbled water for injection with nitrogen for 5 minutes.

The weighted components of sodium chloride and substance of dalargin sequentially loaded into the reactor when the Torah to 100 l, adjust pH and stirred until the final dissolution. After dissolution spend sterilizing filtration of the resulting solution and in aseptic conditions gradually poured into ampoules under nitrogen.

Received 0.1% solution of dalargin is a clear, colorless liquid. The drug is a sterile, apyrogenic, non-toxic, has a pH 6,0-7,0. Obtained in this way 0.1% solution of dalargin was stored for 4 years at room temperature.

Comparative tests for retention of 0.1% solution of dalargin and freeze-dried forms of dalargin production unitary enterprise “plant showed that a 0.1% solution of dalargin stable during storage and qualitative indicators (including quantitative content of dalargin, toxicity and progenote) is not different from lyophilized form of dalargin (table). Consequently, the received 0.1% solution of dalargin can be stored for at least 3 years (as freeze-dried form of dalargin).

Examples of the composition of the injection of 0.1% solution of dalargin for injection.

Example 1.

Composition: the Substance of dalargin 86 g of sodium chloride 930 g of water for injection to 100 L. the resulting solution with a content of dalargin 0,86 is 5,8.

Example 2.

Composition: the Substance of dalargin 102 g of sodium chloride 900 g water for injection to 100 l of the resulting solution with a content of dalargin of 1.02 mg/ml, sodium chloride (9.1 mg/ml, pH of 6.1. After 3 years the solution contained of dalargin 1.0 mg/ml of sodium chloride 9 mg/ml, pH of 6.2.

Example 3.

Composition: the Substance of dalargin 115 g of sodium chloride 870 g of water for injection to 100 L. the resulting solution with a content of dalargin of 1.13 mg/ml, sodium chloride solution of 8.3 mg/ml, pH 6.6. After 3 years the solution contained of dalargin of 1.12 mg/ml, sodium chloride solution of 8.3 mg/ml, pH 6.8.

The dalargin solution for injection, containing the substance of dalargin, characterized in that it additionally contains water for injection and sodium chloride, giving stability and isotonicity solution, in the following ratio of components 1 ml:

The substance of dalargin, mg 0,85-1,15

Sodium chloride, mg of 8.7 and 9.3

Water for injection Up to 1 ml



 

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