不同厂家小儿咳喘灵颗粒微生物限度检查与分析

目的:根据山东省药品监督管理局药品质量风险监测的方案，对16家生产小儿咳喘灵颗粒的厂家抽取48批次进行微生物限度检查，为进一步提升该药品的质量提供参考。方法:按照《中国药典》2020年版四部1105、1106,分别采用常规法、增加稀释液或培养基体积进行微生物方法适用性试验及微生物限度检查。结果:16个厂家中8个厂家的需氧菌总数采用常规法，5个厂家的需氧菌总数采用增加稀释液法，其余3个厂家的需氧菌总数采用增加培养基体积法；霉菌和酵母菌总数、大肠埃希菌均可采用常规法进行检查。结论:不同厂家生产的小儿咳喘灵颗粒质量存在一定的差异，在进行微生物检查时需先进行方法适用性试验，用适合本产品的方法进行微生物限度检查，以保证用药安全。

Result Analysis for Microbial Limit Test of Xiaoerkechuanling granules from different pharmaceutical Factories

Objective: According to the plan of drug quality risk monitoring of Shandong Provincial Drug Administration, 48 batches of xiaoerkechuanling granules were selected from 16 factories for microbial limit inspection, to provide reference for further improving the quality of the drug. Methods: Applicability test and microbial limit test were conducted according to Chinese Pharmacopoeia 2020 edition Volume 4 1105 and 1106. Results: Conventional method was used for the total number of aerobic bacteria in 8 of the 16 factories, the total number of aerobic bacteria in 5 factories was increased by diluent method, in the other 3 manufacturers, the total number of aerobic bacteria was increased by medium volume method; The total number of mould, yeast and Escherichia coli can be examined by conventional method. Conclusion: There are some differences in the quality of xiaoerkechuanling granules produced by different factories, the suitability test of the method should be carried out before microbiological examination, to ensure the safety of drug use, conduct microbiological limit check in a method suitable for this product.