RU2071779C1 - Method of preparing pantocrin for injection - Google Patents

Abstract

FIELD: pharmacy. SUBSTANCE: method involves filtration of pantocrin concentrate on Buchner funnel charged with solid, narrow-porous, slowly filtering paper for thin deposits, addition of acidin (4-9 vol.%) to the obtained filtrate, dilution of mixture with distilled water (1:100), treatment of solution with activated carbon for 30 min followed by filtration. Then under aseptic conditions sterilizing filtration and preparation ampoule were carried out. Storage time for pantocrin for injection is prolonged up to 5 years at the retained biological activity of pantocrin. EFFECT: improved method of preparing, prolonged storage. 3 tbl

Description

 The invention relates to the pharmaceutical industry and can be used to obtain an injection of pantocrine, used as a therapeutic agent.

 Known methods for producing pantocrine for injection [1, 2] in accordance with which the pantocrine concentrate is previously kept in the cold, the precipitate is filtered off, diluted with water, a stabilizer is introduced into the resulting solution, then it is treated with activated carbon, filtered and ampouled under aseptic conditions.

 The basis of the claimed invention is the task of creating a technology for producing an injection solution of pantocrine, which allows to obtain a technical result, expressed in reducing the time of the process and simplifying it, in extending the shelf life of the preparation obtained by the claimed technology.

 The problem is solved in that when implementing the method for producing an injection solution of pantocrine, which includes filtering the pantocrine concentrate, diluting it with distilled water, introducing acidin, treating it with activated carbon for 30 minutes, followed by sterilizing filtration and ampulling, according to the invention, acidin at a concentration of 4: 9 volume percent is introduced before dilution of the concentrate with distilled water.

 The advantage of the proposed method is that, thanks to the introduction of acidin in pantocrine concentrate before diluting it with distilled water, the process time is reduced by eliminating the stage of pantocrin incubation for 7-10 days, the shelf life of pantocrine is increased to 5 years.

 We provide information confirming the possibility of implementing the proposed method.

Example 1
The pantocrine concentrate (Khabarovsk HFZ) is filtered off on a Buchner funnel filled with dense, narrow-porous, slowly filtering paper for fine precipitates, acidine (4 volume) is added to the filtrate, the resulting mixture is diluted with distilled water (1: 100 ratio), then 6.0 g are added activated carbon (0.2% of the solution volume). Stirred for 30 minutes and filtered.

 Further operations are carried out under aseptic conditions. Sterile filtration of the solution is carried out on Millipor disk filters with layer-by-layer stacking of filters with a pore diameter of 0.2 μm (outlet), 0.45 μm and a Millipor prefilter. The sterile solution from the filter is directly fed into 1.0 ml sterile ampoules. From the capillaries of the ampoules, the remainder of the solution is removed under vacuum and sealed. Received pantocrine for injection, series 30187.

Example 2
The pantocrine concentrate (Khabarovsk HFZ) is filtered off on a Buchner funnel filled with dense, narrow-porous, slowly filtering paper for fine precipitates, acidine (7 vol) is added to the filtrate, the resulting mixture is diluted with distilled water (1: 100 ratio), then 6.0 g are added activated carbon (0.2% of the solution volume). Stirred for 30 minutes and filtered.

 Further operations are carried out under aseptic conditions. Sterile filtration of the solution is carried out on Millipor disk filters with layer-by-layer stacking of filters with a pore diameter of 0.2 μm (outlet), 0.45 μm and a Millipor prefilter. The sterile solution from the filter is directly fed into sterile ampoules with a capacity of 1 ml. From the capillaries of the ampoules, the remainder of the solution is removed under vacuum and sealed. Received pantocrine for injection, series 10187.

Example 3
The pantocrine concentrate (Khabarovsk HFZ) is filtered off on a Buchner funnel filled with dense, narrow-porous, slowly filtering paper for fine precipitates, ampoules (9 vol.) Are added to the filtrate, the resulting mixture is diluted with distilled water (1: 100 ratio), then 6.0 g are added. activated carbon (0.2% of the solution volume). Stirred for 30 minutes and filtered.

 Further operations are carried out under aseptic conditions. Sterile filtration of the solution is carried out on Millipor disk filters with layer-by-layer stacking of filters with a pore diameter of 0.2 μm (outlet), 0.45 μm and a Millipor prefilter. The sterile solution from the filter is directly fed into 1.0 ml sterile ampoules. From the capillaries of the ampoules, the remainder of the solution is removed under vacuum and sealed. Received pantocrine for injection, 20187 series.

 The data shown in tables 1, 2, 3, confirm the advantages of the claimed technology for pantocrine for injection compared with the known, expressed in reducing the time of the process (1 day instead of 8-11), increasing the shelf life of the drug (5 or more years instead of 3 ) with guaranteed preservation of the biological activity of the drug.

 Currently, the Pharmacopoeia Committee of the Russian Federation is considering pharmacopoeial articles on pantocrine concentrate and pantocrine for injection (instead of VFS 42-1784-83), which will be produced using the claimed technology.

Claims (1)

 The method of obtaining pantocrine for injection by grinding antlers, extraction with the release of concentrate, dilution with distilled water, the introduction of a stabilizer with activated carbon, adjusting the pH of the solution to 3.5 - 5.0, filtration followed by sterilizing filtration with the ampoule of the target product, characterized in that the concentrate before dilution with distilled water is filtered, and then enter the acidin in a concentration of 4 to 9 about.

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