蒲地蓝消炎片微生物限度检查方法的验证

Validation of methods in microbial limit tests for Pudilan Xiaoyan Tablets

目的:建立蒲地蓝消炎片微生物限度检查的方法。方法:参照《中国药典》2005版,采用5种阳性对照菌回收率试验测定其是否含抑菌成分。结果:按供试品制备方法,各试验菌样品中的回收率均大于70%。结论:采用培养基稀释法可消除药品的抑菌作用,可有效地检出污染的微生物,使测定结果准确,药品质量安全有效,可用于该药品的微生物限度检查。

Objective： To establish a method of microbial limit tests for Pudilan Xiaoyan Tablets. Methods： According to China Pharmacopoeia edition 2005, 5 positive control trains were carried out to determine the recovery rate of antimicrobial effect. Results： According to the results, the recovery rates of sample were over 70%. Conclusion： Pudilan Xiaoyan Tablets preparations can eliminate the bacteriostatic action with accurate result and reach the objective, and it can be used in the microbial limit tests.