板蓝根颗粒和感冒清热颗粒微生物限度试验方法的适用性研究  

Study on the applicability of microbial limit test methods for Banlangen granule and Ganmao Qingre granule

作　　者：刘立 Liu Li(Beijing Tongrentang Health Pharmaceutical Co Ltd,Beijing102600)

机构地区：[1]北京同仁堂健康药业股份有限公司,北京102600

出　　处：《天津药学》2024年第1期11-13,共3页Tianjin Pharmacy

摘　　要：目的:试验板蓝根颗粒和感冒清热颗粒微生物限度检查法的适用性。方法:根据《中国药典》2020版微生物限度试验方法进行试验,从平皿法、稀释法、薄膜过滤法中选出适用于板蓝根颗粒和感冒清热颗粒的方法,并粗略判断两种药品的抑菌能力。结果:感冒清热颗粒需氧菌总数、霉菌和酵母菌总数回收率均高于0.5,符合方法适用性试验要求;板蓝根颗粒采用平皿法回收率(除黑曲霉外)均低于0.5,采用稀释法和薄膜过滤法均可以满足回收率在0.5~2范围内的要求,符合方法适用性试验要求。结论:本研究表明,板蓝根颗粒和感冒清热颗粒微生物限度检验时,感冒清热颗粒可采用平皿法,板蓝根颗粒可采用稀释法和薄膜过滤法进行试验,板蓝根颗粒和感冒清热颗粒的控制菌检查均可以选择常规法进行。Objective:To test the applicability of the microbial limit test methods for Banlangen granule and Ganmao Qingre granule.Methods:According to the four microbial limit test methods in the 2020 edition of the《Chinese Pharmacopoeia》,the suitable methods for Banlangen granule and Ganmao Qingre granule were selected from the plate method,dilution method,and membrane filtration method,and the antibacterial ability of the two drugs was roughly judged.Results:The recovery rate of aerobic bacterial count,mold count,and yeast count in Ganmao Qingre granule was higher than 0.5,which met the requirements of the method applicability test.The recovery rate of Banlangen granule using the plate method(except for Aspergillus niger)was lower than 0.5.The dilution and membrane filtration methods can meet the requirements of a recovery rate within the range of 0.5~2,which met the requirements of the method applicability test.Conclusion:This study indicates that when testing the microbial limit of Banlangen granule and Ganmaoqingre granule,the Ganmaoqingre granule can be tested using the plate method,the Banlangen granule can be tested using the dilution and membrane filtration method,and the control bacteria can be tested using the routine method of Escherichia coli.

关 键 词：板蓝根颗粒 感冒清热颗粒 微生物限度 《中国药典》2020版 

分 类 号：R927.1[医药卫生—药学]