双唑泰阴道泡腾片微生物限度检查方法学验证

目的建立双唑泰阴道泡腾片微生物限度检查的验证方法。方法根据2005年版《中国药典（二部）》附录ⅪJ微生物限度检查法,对双唑泰阴道泡腾片的微生物限度检查进行方法学验证。结果平皿法可检查该制剂的霉菌、酵母菌数,薄膜过滤法可检查该制剂的细菌、控制菌数。结论薄膜过滤法能有效去除双唑泰阴道泡腾片中的杀菌成分,使污染的微生物得以生长,故能较好地对细菌和控制菌进行检测。

Methodology Validation Study of Microbial Limit Examination of Metronidazole,Clotrimazole and Chlorhexodine Acetate Vagina Effervescence Tablet

Objective To establish a method of microbial limit examination of metronidazole, clotrimazole and chlorhexodine acetate vagina effervescence tablet. Methods According to the method in the Appendix ⅪJ of Chinese Pharmacopoeia （2005 edition）, the method of microbial limit examination of metronidazole, clotrimazole and chlorhexodine acetate vagina effervescence tablet was validated. Results The method of plane utensil was used to check up the number of mold and yeast of the sample, and the comembrane filtration was used to examine the bacteria and control bacteria of the sample. Conclusion The method of membrane filtration can be good for getting rid of the component of sterilization and keeping the microbe in the sample being living. It is a more feasible method to microbial limit examination of the sample and examination of the bacterial number or control bacteria.