含有金银花的两种中药制剂微生物限度检查方法的建立  

Establishment of microbial limit test method for traditional Chinese medicine preparation containing Flos Lonicerae

作　　者：侯晓玲 李瑶 郭华荣 向雪娇 陈卫英 HOU Xiaoling;LI Yao;GUO Huarong;XIANG Xuejiao;CHEN Weiying(Jiuquan Municipal Center for Drug Inspection and Testing,Jiuquan Gansu 735000,China;Jiuquan Hospital of Traditional Chinese Medicine,Jiuquan Gansu 735000,China)

机构地区：[1]甘肃省酒泉市药品检验检测中心,甘肃酒泉735000 [2]甘肃省酒泉市中医院,甘肃酒泉735000

出　　处：《中兽医医药杂志》2022年第4期66-69,共4页Journal of Traditional Chinese Veterinary Medicine

基　　金：甘肃省酒泉市科技计划项目(2060402应用技术研究与开发)。

摘　　要：建立含有金银花的2种中药制剂的微生物限度检查方法。按照《中国药典》2020年版(四部)通则非无菌产品微生物限度检查微生物计数法与控制检查法、标准的规定,分别采用常规平皿法、培养基稀释法及薄膜过滤法对含金银花的鼻炎糖浆和退热口服液2种中药制剂的微生物限度与控制菌进行检查及方法学验证研究。结果显示,鼻炎糖浆、退热口服液均有抑菌作用。采用常规平皿法和培养基稀释法测定需氧菌总数,回收率低,不符合回收率要求;采用薄膜过滤法加菌回收率显著高于常规平皿法与培养基稀释法,符合回收率要求。采用常规法进行霉菌和酵母菌总数及大肠埃希菌检查,均符合回收率要求。结果提示,所建立的方法符合《中国药典》2020年版四部通则的相关规定,可用于这2种中药制剂的微生物限度检查。To establish a microbial limit test method for two kinds of traditional Chinese medicine preparations containing Flos Lonicerae.According to the Chinese Pharmacopoeia(2020 edition),the microbial limit and the control bacteria in rhinitis syrup and antipyretic oral liquid were examined,and the methodology was validated by using plate method,medium dilution method and membrane filtration method.The recovery rate of aerobic bacteria was lower by using conventional platemethod and medium dilution method,which did not meet the requirement of recovery rate.The recovery rate of aerobic bacteria by membrane filtration method was significantly higher than that by using conventional plate method and medium dilution method,which met the recovery requirements.The results of mold,yeast and E.coli examination met the recovery rate requirements by using conventional methods.The microbial identification method was in accordance with the relevant provisions of the 2020 edition of Chinese Pharmacopoeia.

关 键 词：金银花 中药制剂 鼻炎糖浆 退热口服液 微生物限度检查方法 

分 类 号：S853.7[农业科学—临床兽医学]