两性霉素B阴道泡腾片微生物限度检查方法探讨

Discussion on Microbial Limit Test Method for Amphotericin B Vaginal Effervescent Tablets

目的:探讨并建立两性霉素B阴道泡腾片微生物限度检查方法。方法:采用薄膜过滤-培养基稀释法,用6株阳性试验菌验证其抑菌性是否消除。结果:所建方法回收率≥70.0%,并且3株阳性试验菌检出率为100%。结论:采用本文探讨的方法消除该药品的抑菌作用是有效的,该法适用于两性霉素B阴道泡腾片的微生物限度检查。

Objective： To discuss and construct a microbial limit test method of Amphotericin B Vaginal Effervescent Tablets. Method：Adopting membrane filtration and culture medium dilution methods to test whether the bacteriostatic effect was eliminated using six positive test strains. Result： The recovery rate was greater than 70% and the positive rate of three positive test strains was 100% o Conclusion： It is effective that using the method discussed in this paper to eliminate the hacteriostatic action , it can be used as microbial limit test for Amphotericin B Vaginal Effervescent Tablets.