不同厂家小儿咳喘灵颗粒微生物限度检查与分析  

Microbial limit test and analysis of pediatric kechuanling granules from different manufacturers

作　　者：刘博 任仲丽 李瑞英 LIU Bo;REN Zhongli;LI Ruiying(Heze Institute for Food and Drug Control,Heze 274000,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274000

出　　处：《中国药品标准》2023年第1期32-38,共7页Drug Standards of China

基　　金：山东省药品监督管理局药品质量风险监测项目(局函[2021]118号,第5号)。

摘　　要：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。Objective:According to the drug quality risk monitoring program of the Shandong Provincial Drug Administration,48 batches of 16 manufacturers producing pediatric kechuanling granules were selected for microbial limit test,which provided a reference for further improving the quality of the drug.Methods:According to the Chinese Pharmacopoeia 2020 VolⅣ1105 and 1106,the conventional method was used to increase the volume of dilution or medium to carry out the microbial method suitability test and microbial limit check.Results:Among the 16 manufacturers,the total number of aerobic bacteria of 8 manufacturers was used by the conventional method,the total number of aerobic bacteria of 5 manufacturers was increased by dilution method,and the total number of aerobic bacteria of the remaining 3 manufacturers was increased by the volume of culture medium.The total number of molds and yeasts,as well as Escherichia coli,can be checked by routine methods.Conclusion:There are certain differences in the quality of pediatric kechuanling granules produced by different manufacturers,and the method suitability test needs to be carried out first when conducting microbiological examination,and the microbial limit test is carried out with a method suitable for this product to ensure the safety of medication.

关 键 词：小儿咳喘灵颗粒 常规法 增加稀释液法 增加培养基体积法 适用性试验 结果分析 

分 类 号：R921.2[医药卫生—药学]