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.
Applicability Research on Sterility Test Method for Sodium Aescinate for Injection
The paper explores and improves the sterility test method for sodium aescinate for injection using the membrane filtration method.Through comprehensive research on multiple aspects,including comparisons of diluents and rinsing solutions used during testing,comparisons of flushing pump speeds for membrane filters,and different sampling methods,the sterility test method for sodium aescinate injection has been optimized and unified.The optimized method involves using a single-cylinder filtration 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.
sodium aescinate for injectionchemical drug testingmembrane filtration methodsterility test method
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