精蛋白胰岛素注射液无菌检查方法的建立

Establishment of the Sterility Test Method for Protamine Insulin Injection

关键词:  精蛋白  精蛋白胰岛素注射液  肝素钠  无菌检查  薄膜过滤  方法适用性试验

Key words:  protamine  protamine insulin injection  heparin sodium  sterility test  membrane filtration  suitability of the test method

摘要:

目的 建立精蛋白胰岛素注射液的无菌检查方法。方法 根据中国药典2015年版四部通则1101无菌检查法进行方法适用性试验，对药典收载的精蛋白胰岛素注射液无菌检查方法进行优化，使用无微生物毒性的肝素钠溶液中和胰岛素注射液中的精蛋白，使精蛋白胰岛素注射液由白色混悬液变为澄清透明液体，便于薄膜过滤法处理。结果 使用薄膜过滤法，无菌检查方法适用性试验中6株阳性对照菌均可正常生长。结论 建立了可行的精蛋白胰岛素注射液的无菌检查方法，为下一版中国药典修订已收载的精蛋白胰岛素注射液无菌检查方法提供了实验依据。

Abstract:

OBJECTIVE To establish a method for sterility test of insulin protamine injection. METHODS The method suitability test was performed according to the sterility test method in General Chapter 1101 of Chinese Pharmacopoeia 2015 Volume IV. And optimized the sterility test method of protamine insulin injection included in the Pharmacopoeia. The protamine insulin injection was neutralized with heparin sodium solution without microbial toxicity, so that the protamine insulin injection changed from white suspension to clear and transparent liquid, which was convenient for membrane filtration method. RESULTS Using membrane filtration method, all six positive control test strains could grow normally in the suitability test of sterility test method. CONCLUSION A feasible sterility test method for protamine insulin injection is established, which provides an experimental basis for the revision of the sterility test method for protamine insulin injection included in the next edition of Pharmacopoeia.