Process for preparing penehyclidine hydrochloride injection

Abstract

The invention discloses a process for preparing a penehyclidine hydrochloride injection and belongs to the field of medicines. The specific preparation process of the injection is as follows: (1) treating inner packaging materials with acid in advance, then washing the inner packaging materials with purified water and water for injection and then pasteurizing and drying the inner packaging materials for standby application; (2) weighing penehyclidine hydrochloride based on the prescription dose, adding a defined amount of water for injection to dissolve penehyclidine hydrochloride, then adding water for injection to reach the total amount and stirring the liquid medicine uniformly; and (3) measuring the pH value and the content, filtering the liquid medicine after the pH value and the content are qualified, filling and sealing the filtrate in the inner packaging materials for standby application and carrying out pasteurization, thus obtaining the penehyclidine hydrochloride injection. The process has the following beneficial effects: not only can the pH value and content of the penehyclidine hydrochloride injection product obtained by the process be more stable, but also the product quality is more easily ensured; and meanwhile, the final product is proved to be safe and effective by animal long-term toxicity tests and pharmacodynamics tests.

Description

technical field [0001] The invention relates to a preparation method of a medicinal liquid for injection, in particular to a preparation process of a selective anticholinergic drug penhyclidine hydrochloride injection, and belongs to the field of medical drugs. Background technique 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 cereb...

AI Technical Summary

Problems solved by technology

The present invention aims to solve the problem that the existing penehyclidine hydrochloride injection has poor stability in commercially available ampoules and vials without any treatment, and the pH value increases and the content decreases after long-term storage for 8 months. A new preparation process for penehyclidine hydrochloride injection, especially a method for pre-processing penehyclidine hydrochloride injection before potting

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