注射用七叶皂苷钠无菌检查方法适用性研究  

Applicability Research on Sterility Test Method for Sodium Aescinate for Injection

作　　者：唐澜 杨爽 TANG Lan;YANG Shuang(Guizhou Institute for Food and Drug Control,Guiyang 550001,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550001

出　　处：《化工管理》2024年第17期145-149,共5页Chemical Engineering Management

摘　　要：文章探索并改进注射用七叶皂苷钠的无菌检查方法。通过运用薄膜过滤法,从多个方面进行了深入研究,包括检验过程中使用的稀释液与冲洗液的对比、薄膜过滤器冲洗泵速的对比,以及不同取样方式的比较。经过实验和分析,将七叶皂苷钠注射液的无菌检查方法优化统一为:采用单筒过滤法,冲洗方法确定为每膜冲洗100 mL 0.1%无菌蛋白胨水溶液,控制溶解泵速为50 r/min,同时确保冲洗泵速不大于150 r/min。此方法可为注射用七叶皂苷钠的无菌检查提供有效的参考依据。The paper explores and improves the sterility test method for sodium aescinate for injection using the membrane f iltration method.Through comprehensive research on multiple aspects,including comparisons of diluents and rinsing solutions used during testing,comparisons of flushing pump speeds for membrane f ilters,and different sampling methods,the sterility test method for sodium aescinate injection has been optimized and unif ied.The optimized method involves using a single-cylinder f iltration method,flushing each membrane with 100 mL of 0.1%sterile peptone aqueous solution,controlling the dissolution pump speed at 50 r/min,and ensuring that the rinsing pump speed does not exceed 150 r/min.This method provides an effective reference for the sterility testing of sodium aescinate for injection.

关 键 词：注射用七叶皂苷钠 化学药品检验 薄膜过滤法 无菌检查法 

分 类 号：R927.11[医药卫生—药学]