生物制品用原辅料微生物限度检测方法的验证

目的建立生物制品用原辅料(乳糖、葡萄糖、明胶、淀粉、胰酶、纯化水)微生物限度检查法,并进行验证。方法分别采用平皿法及薄膜过滤法检测上述6种原辅料的微生物限度,并按设立的验证试验方法,在供试品中加入5种标准菌,测定标准菌的回收率。结果大肠埃希菌、金黄葡萄球菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种标准菌在上述6种原辅料供试品溶液中的平均回收率均大于80%,符合《中国药典》二部(2005版)中要求大于70%的合格标准。结论平皿法适用于检测乳糖、葡萄糖、明胶、淀粉、胰酶等原辅料的微生物限度,薄膜过滤法适用于检测纯化水的微生物限度。

Verification of Method for Microbial Limit Test on Raw and Subsidiary Materials of Biologics

Objective To develop and verify a method for microbial limit test on raw and subsidiary materials of biologics. Methods The microbial limits of 6 kinds of raw and subsidiary materials of biologics, i.e. lactose, glucose, gel, starch, trypsin and purified water, were tested by Petri dish culture and membrane filtration methods separately, and the developed methods were verified by adding standard microorganisms with known counts into the test sample and determining their recovery rates. Results All the recovery rates of standard Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Candida albicans and Aspergillus niger in the test samples of 6 kinds of raw and subsidiary materials were more than 80%, which met the requirements (more than 70%)in Chinese Pharmacopoeia (Volume Ⅱ, 2005 edition). Conclusion The developed Petri dish culture method was suitable for microbial limit test on lactose, glucose, gel, starch and trypsin, and membrane filtration method for that on purified water.