黄体酮注射液无菌检查方法的改进及验证

摘要

目的：对黄体酮注射液无菌检查方法进行改进并验证。方法按《中国药典》2010年版二部无菌检查法的有关要求，采用封闭式薄膜过滤器过滤，最后用大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌、黑曲霉对所采用的方法进行验证。结果黄体酮注射液采用封闭式薄膜过滤器进行无菌检查，所用的各验证菌均生长良好。结论改进后的方法重现性好，稳定、可靠，可作为黄体酮注射液的无菌检查方法。%Objective A method study to improve the method for sterility test of progesterone injection. Methods According to the sterility test in Chinese Pharmacopoeia(2010 edition, VolumeⅡ), iflter with the enclosed membrane iflter, and using the Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Clostridium Sporogenes, Candida albicans, Aspergillus niger to verifying the method that is uesed. Result Adopt the enclosed membrane iflter to do the sterility test of progesterone injection, and all the veriifcation bacteria grow well. Conclusion This improved method is stabilization, credibility, reproducible and suitable for the sterility text of progesterone injection.