罗红霉素胶囊微生物限度检查法的验证

Roxithromycin Capsules microbial limit test method

为了验证罗红霉素胶囊微生物限度检查法,参照《中国药典》2005年版二部附录XIJ微生物限度检查法进行试验。结果表明,供试品对各试验菌的回收率均高于70%,稀释剂对5种试验菌的回收率均高于70%,且控制菌检查具有专属性,说明采用离心-薄膜过滤法检查罗红霉素胶囊微生物限度方法可行。

In order to verify the limits of Roxithromycin Capsules microbial method, in the light of ＂Chinese Pharmacopoeia＂ in 2005 version of Appendix 2 re,microbial limit test. The results showed that all test materials to the recovery rate of bacteria were higher than 70% thinner to test five kinds of bacteria were higher than the recovery rate of 70 percent, and the control of bacteria with specific inspection. Note the use of centrifugal - membrane filtration method to check the limits of microbial capsules Roxithromycin method is feasible.