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A kind of preparation method of penehyclidine hydrochloride injection

A technology for penehyclidine hydrochloride and injection, which can be applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., and can solve the problems of rising pH value, poor stability, and decreasing content, etc. problem, to achieve the effect of stable content, easy product quality and improved stability

Active Publication Date: 2017-02-08
JINZHOU AHON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention aims to solve the problem that the existing penehyclidine hydrochloride injection has poor stability in the commercially available ampoules and vials without any treatment, and the pH value rises and the content drops after long-term storage for 8 months, and provides A novel preparation method of penehyclidine hydrochloride injection, especially a method of pre-processing penehyclidine hydrochloride injection before potting

Method used

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  • A kind of preparation method of penehyclidine hydrochloride injection
  • A kind of preparation method of penehyclidine hydrochloride injection
  • A kind of preparation method of penehyclidine hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0337] Example 1 (acidified ampoule)

[0338] Prescription: Penhyclidine Hydrochloride 20g

[0339] Add water for injection to 20000ml

[0340] (Specification: 1ml: 1mg, 1ml per bottle)

[0341] Preparation Process:

[0342] Fill the ampoule of the inner packaging material with 0.1mol / L hydrochloric acid solution (prepared with water for injection, temperature 75°C), soak for 1 hour, then spin dry, wash with purified water and water for injection, then sterilize and dry at high temperature for later use;

[0343] Weigh 20.0 g of penehyclidine hydrochloride, add 16000 ml of water for injection to dissolve, add water for injection to make up the full amount, measure pH=5.78, content=100.1%. The medicinal solution is filtered through a 0.22 μm filter membrane and filled into the aforementioned spare ampoules. The samples obtained by potting were sterilized at 121° C. for 12 minutes. The sample of embodiment 3 is obtained after passing the inspection.

Embodiment 2

[0344] Embodiment 2 (the vial of acidification treatment)

[0345] Prescription: Penhyclidine Hydrochloride 10g

[0346] Add water for injection to 20000ml

[0347] (Specification: 1ml: 0.5mg, 1ml per bottle)

[0348] Preparation Process:

[0349] Fill the inner packaging vial with 0.1mol / L hydrochloric acid solution (prepared with water for injection, the temperature is about 75°C), soak it for 1 hour, then dry it, wash it with purified water and water for injection, and then sterilize and dry it at high temperature for later use;

Embodiment 3

[0352] As mentioned above, with the same principle and steps, when the concentration of the hydrochloric acid solution is 0.2 mol / L or 0.5 mol / L, the object of the present invention can also be achieved.

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Abstract

The invention discloses a novel method for preparing a penehyclidine hydrochloride injection and belongs to the field of medical drugs. The preparation process of the injection comprises the following steps: (1) performing acid treatment on an inner package in advance, washing with pure water and water for injection, performing high-temperature sterilization and drying for later use; (2) weighing penehyclidine hydrochloride according to the prescription amount, adding a proper amount of water for injection for dissolving, regulating the pH of the liquid medicine to be 4.6-4.8 by using a pH regulator, adding the water for injection to the total amount, and uniformly stirring; (3) measuring the pH value and the content, filtering and encapsulating the water in the spare inner package after the water is qualified, and sterilizing at a high temperature to obtain the injection. The penehyclidine hydrochloride injection product prepared by the process method is stable in pH and content, and the product quality is easily guaranteed; meanwhile, the long-term animal toxicity test and pharmacodynamic test prove that the final product is safe and effective.

Description

technical field [0001] The invention relates to a preparation method of an injection liquid, in particular to a novel preparation method of a selective anticholinergic drug penhyclidine hydrochloride injection, belonging to the field of medical drugs. Background technique [0002] Penehyclidine hydrochloride injection is a new type of selective anticholinergic drug, which can bind to M and N choline receptors and selectively act on M 1 , M 3 , N 1 , N 2 receptor, to M 2 The receptor has no effect, and has the advantages that anticholinergic drugs such as atropine and scopolamine do not have, such as strong anticholinergic effect, long duration of action, protection of heart rate two-way regulation mechanism, improvement of microcirculation, and low toxicity and side effects. It has shown broad application prospects: treatment of organophosphorus pesticide poisoning, drug use before anesthesia, application in respiratory diseases, anti-shock, protective effect on cerebral...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/439A61K47/02A61K47/12A61P9/00A61P9/06A61P11/00A61P1/00A61P39/02
Inventor 黄绍渊张浩金红娣刘新春朱登军
Owner JINZHOU AHON PHARM CO LTD
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