替硝唑栓微生物限度检查方法学研究

Methodological study on microbial limit test of tinidazole suppositories

目的对替硝唑栓的微生物限度检查方法进行研究。方法按照《中华人民共和国药典》2010年版附录的要求进行方法学验证,细菌计数采用低速离心-薄膜过滤法,真菌及酵母菌计数采用薄膜过滤法,控制菌检查采用薄膜过滤法与低速离心-薄膜过滤法。结果细菌、真菌及酵母菌的回收率均>70.0%,控制菌检查中,各阳性试验菌均检出,阴性对照无菌生长。结论薄膜过滤法与低速离心-薄膜过滤法可消除替硝唑栓的抑菌作用,适用于该制剂的微生物限度检查。

Objective To study the method of microbial limit test of tinidazole suppositories. Methods According to the appendix of Chinese Pharmacopoeia （2010 edition）, methodology validation was taken in the test. Low-speed centrifugal-membrane filtration method was applied for bacteria counting, and membrane filtration method was used for fungus and saccharomycetes counting. Both the above methods were used in control bacteria check. Results The recovery rates of bacteria, fungus, and saccharomycetes were all〉70.0%. The results of control bacteria check showed that all positive test bacteria were detected, and no negative control bacteria occurred. Conclusion Both of membrane filtration method and low-speed centrifugal-membrane filtration method can eliminate the bacteriostasis of tinidazole suppositories, and they are applicable to the microbial limit test of tinidazole suppositories.