连三叶触变凝胶剂微生物限度检查的方法学验证

Methodology Validation of Microbial Limit Test for Lian Sanye Thixotropic Gel

目的建立连三叶触变凝胶剂微生物限度的检查方法。方法采用稀释法、中和剂法及薄膜过滤法联用计数需氧菌、霉菌、酵母菌,并进行控制菌的检查。结果金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉微生物计数方法回收率在0.5~2之间;控制菌检查法验证试验符合规定;连三叶触变凝胶剂卫生学符合《中国药典》(2015年版)中"非无菌不含药材原粉的中药制剂的微生物限度标准"项下"阴道、尿道给药制剂"的要求。结论所建立的方法准确、可靠、重现性好,适用于连三叶触变凝胶剂的微生物限度检查。

Objective To establish microbial limit test method for Lian sanye thixotropic gel. Methods Dilutionmethod, neutralizer method combined with membrane filtration were used for microbial limit test of aerobicbacteria,mold and yeast;and the control bacteria were examined. Results The recovery rates of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans,Aspergillus niger were 0.5-2;the controlbacteria test was in conformity with the standard of Pharmacopoeia. Lian sanye thixotropic gel tested conformed to themicrobial limit standard of non-aseptic drugs in the Chinese Pharmacopoeia(The fourth part of the 2015 Edition).Conclusion The method is accurate,reliable and reproducible,and suitable for the microbial limit test of Lian sanye thixotropic gel.