Prostacor solution for making injections

FIELD: medicine.

SUBSTANCE: solution has extract produced from cattle prostate and a carbohydrate.

EFFECT: no toxic effects; storage stability.

2 cl, 1 tbl

 

The invention relates to medicine and related drug, used as a drug in the treatment of acute and chronic prostatitis.

The main active ingredient of the drug is an extract from the prostate bulls and steers, the age of sexual maturity, are exempt from androgenic and estrogenic hormones and proteins (RU, patent 2089204, C1 And 61 To 35/48, 35/55). Extract, representing a solution of the regulatory peptides, and other peptides in aqueous solutions exposed to the mechanisms of chemical and physical decomposition, so when stored under normal conditions the concentration decreases sharply.

Known liquid drug Reveron ("ROBAPHARM L.T.D." Switzerland), containing an extract from the prostate gland, which is added m-Cresol, ensuring the stability of the content of regulatory peptides in the product during storage (Medmaravis "Drugs", Vilnius, 1994, Vol.2, p.143). However, m-Cresol has toxic properties, so patients with the introduction of Everone sometimes anaphylactic shock, allergic reactions, urticaria or eczema. In such cases, the drug is contraindicated, so he currently excluded from the range of medicines permitted for medical use.

The closest in composition and the achieved result is that the drug is: "Prostatilen" ("Belmedpreparaty" Belarus, "Biopharma" Ukraine)in which to ensure the stability of the content of regulatory peptides during storage of the drug in the extract from the prostate gland adds cryoprotector (glycine), and then poured into ampoules and lyophilizer (reference Vidal. Astra Pharm Service. Meters, the - 1997-p. B-486). The product is a lyophilized powder for preparation of injection solution. Immediately before use, dissolve themselves and prepare a solution for injection.

However, the production of a lyophilized drug is a costly process. In addition, there is a need for preparation of a solution of the drug directly to the introduction, which complicates the work of medical personnel in aseptic conditions.

The objective of the invention is to provide a liquid non-toxic drug dosage form for intramuscular injection, sustainable (stable) during storage.

The problem is solved by the introduction part of the preparation of carbohydrate (e.g., mannitol, maltose etc,), which as a preservative and stabilizer provides stability (the stability of) the liquid preparation when stored.

The exception process of freeze drying eliminates the need for dissolution of the drug before the introduction, allows to simplify the production technology lekarstvennayaforma, to reduce energy and labor costs and ultimately reduce the cost of the drug. In addition, the product does not contain toxic components such as m-Cresol.

Liquid dosage form of the drug contains 1 ml of 4 to 6 mg of regulatory peptides and from 30 to 60 mg of carbohydrate.

The solution protecor for injection is prepared as follows.

To prepare 100 l of a solution for intramuscular take 100 l of an extract from the prostate gland of cattle (containing 1 ml of 4 to 6 mg of regulatory peptides) and from 3.0 to 6.0 kg of carbohydrate.

In a reactor with a capacity of 100 l 90 pour l extract of prostate cancer include a stirrer and with constant stirring download small portions weighted carbohydrate. Not disabling the mixer, open the valve on the supply of sterile nitrogen into the reactor and verbatimout for 30 minutes Then bring the volume of solution in the reactor extract up to 100 l, adjust pH, mix and verbatimout nitrogen until complete dissolution of the carbohydrate. After dissolution spend sterilizing filtration of the resulting solution, under aseptic conditions gradually poured into ampoules and sealed.

The resulting solution for intramuscular injection is a clear yellowish liquid. The drug is a sterile, apyrogenic, non-toxic, has a pH of 5.6-6,. The resulting solution for injection was stored for 3 years at room temperature.

Comparative tests for retention of liquid dosage forms of the drug and lyophilized production unitary enterprise "plant" (table) showed that the solution is stable when stored and qualitative indicators (including quantitative content of regulatory peptides, the reaction of the alkaline phosphatase, inhibited by cysteine, toxicity, progenote) is not different from lyophilized Prostatilen. Accordingly, the liquid dosage form of the drug can be stored at least 2 years.

Examples of the composition of the solution for intramuscular injection

Example 1.

Ingredients: Extract of the prostate gland, containing 5.2 mg/ml of regulatory peptides up to 100 l and maltose 6 kg of the resulting solution with a content of regulatory peptides 5.2 mg/ml maltose 60 mg/ml and a pH of 5.7. After 3 years the solution contained 5.1 mg/ml of regulatory peptides, 60 ml/mg of maltose and pH of 5.8.

Example 2.

Ingredients: Extract of the prostate containing 5.5 mg/ml of regulatory peptides up to 100 l and mannitol 3 kg of the resulting solution with a content of regulatory peptides of 5.5 mg/ml, mannitol, 30 mg/ml and pH of 5.8. After 3 years the solution contained 5.4 mg/ml of regulatory peptides, 30 ml/mg of mannitol and pH 6.0.

Example 3.

Composition: the Former is ract of the prostate, containing 5.4 mg/ml of regulatory peptides up to 100 l and maltose 4 kg of the resulting solution with a content of regulatory peptides of 5.4 mg/ml maltose 40 mg/ml and pH 6.0. After 3 years the solution contained 5.3 mg/ml of regulatory peptides, 40 ml/mg of maltose and a pH of 6.2.

Table 1

Comparison of quality of Prostatilen lyophilized powder for preparation of injection solution 5 mg and 0.5% solution of Prostacare for injection in the preparation and after 3 years of storage.
The quality indicatorsProstatilen lyophilized powder for preparation of injection solution 5 mg0.5% solution of Prostacare for injection
When cookingAfter 3 yearsWhen cookingAfter 3 years
1. AppearanceDried porous mass compacted in tablet white with a yellowish sheen colorDried porous mass compacted in tablet white with a yellowish sheen colorTransparent yellowish liquid with a weak peculiar smellTransparent yellowish liquid with a weak peculiar smell
2. TransparencyOl is dissolved transparent When dissolved transparentTransparentTransparent
3. ColorWhen dissolved harder standard 5BWhen dissolved harder standard 5BHarder standard 3bHarder standard 3b
4. pH6,06,16,06,2
5. ProgenoteNephrogenicNephrogenicNephrogenicNephrogenic
6. ToxicityNon-toxicNon-toxicNon-toxicNon-toxic
7. SterilitySterileSterileSterileSterile
8. Reactivation of alkaline phosphatase, inhibited by cistena27%26%27%26%
9. Total nitrogen13,8%13,8%0,1%0,1%
10. ProteinNoNoNoNo
11. Heavy metalsNot more than 0.005%Not more than 0.005%Not more than 0.005%Not more than 0.005%
12. Glycine18 mg/ml18 mg/mlNoNo
13. m-CresolNoNoNoNo
14. MaltoseNoNo40 mg/ml40 mg/ml
15. Regulatory peptides5.4 mg/ml5.3 mg/ml5.4 mg/ml5.3 mg/ml

1. Solution for injection, containing an extract from the prostate gland of cattle and stabilizer, carbohydrate in the following ratio of components 1 ml:

The carbohydrate mg30-60
Extract from the prostate gland, major
cattle containing from 4 to 6 mg/ml
regulatory peptidesTo 1 ml

2. The solution according to claim 1, characterized in that the carbohydrate it contains mannitol or maltose.



 

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