盐酸帕罗西汀薄膜衣片微生物限度检查法方法验证

摘要

Objective: To develop a method for the microbial limit test of paroxetine hydrochloride film-coated tablets. Methods; Validation experiment was conducted according to the test methods for microbial limits in appendix of "Chinese Pharmacopoeia 2010 (2nd section)". Results; The number of bacteria and control bacteria were quantified using membrane filtration method, and the molds and yeasts were measured using direct inoculation method. The recovery rates were greater than 70% . Conclusion; This method is applicable in microbial limit test for paroxetine hydrochloride film-coated tablets.%目的:建立盐酸帕罗西汀薄膜衣片微生物限度检查法方法.方法:按《中华人民共和国药典》2010年版(二部)附录微生物限度检查法进行方法学验证试验.结果:通过试验确定盐酸帕罗西汀薄膜衣片细菌数和控制菌均采用薄膜过滤法,霉菌和酵母菌数采用直接接种法,回收率均高于70％.结论:此方法可用于盐酸帕罗西汀薄膜衣片微生物限度检查.