茴香橘核丸的微生物计数及控制菌检查方法的建立  

Establishment of microbial counting and control bacteria examination method for Huixiang Juhe pills

作　　者：殷丽 侯晓玲 李瑶 朱顺娟 侯建忠 YIN Li;HOU Xiaoling;LI Yao;ZHU Shunjuan;HOU Jianzhong(Jiuquan Second People’s Hospital,Jiuquan Gansu 735000,China;Jiuquan Institute for Drug Control,Jiuquan Gansu 735000,China)

机构地区：[1]甘肃省酒泉市第二人民医院,甘肃酒泉735000 [2]甘肃省酒泉市药品检验检测中心,甘肃酒泉735000

出　　处：《中兽医医药杂志》2023年第6期73-77,共5页Journal of Traditional Chinese Veterinary Medicine

基　　金：甘肃省药品监督管理局科研项目(2022GSMPA0081);甘肃省酒泉市科技计划项目(2023CA1014)。

摘　　要：建立茴香橘核丸的微生物检查方法,探究茴香橘核丸的微生物计数及控制菌检查方法的适用性。按照《中华人民共和国药典》2020年版四部通则1105、1106和1107相关要求,对来自2个不同生产厂家的6批次茴香橘核丸进行需氧菌、霉菌和酵母菌计数及控制菌的适用性试验,对其微生物限度检查的方法学进行验证。结果显示,可采用平皿法(1∶10)进行霉菌和酵母菌总数计数,采用增加培养基体积法(1∶500)进行需氧菌总数计数,回收率均大于0.5;采用常规法检查控制菌大肠埃希菌、耐胆盐革兰氏阴性菌及沙门菌,出现典型菌落且生化试验结果准确可靠。此验证方法合理,符合回收率要求,可用于茴香橘核丸的微生物检查。To establish a microbiological examination method for Huixiang Juhe pills,and explore the applicability of microbial counting and control methods for it.According to the relevant requirements of General Principles 1105,1106,and 1107 of the 2020 edition of the Chinese Pharmacopoeia,aerobic bacteria,mold,and yeast counts were conducted on 6 batches of Huixiang Juhe pills from 2 different manufacturers,and the applicability of controlled bacteria was tested.The methodology for microbial limit examination was validated.The total number of molds and yeast could be detected using the plate method(1∶10),while aerobic bacteria could be detected using the increase in medium volume method(1∶500),with recovery rates greater than 0.5;conventional methods were used to control Escherichia coli,bile salt tolerant Gram negative bacteria and Salmonella,which showed good colony growth and accurate and reliable biochemical test results.This validation method can meet the requirements for recovery rate,and can be used for microbiological examination of Huixiang Juhe pills.

关 键 词：茴香橘核丸 微生物限度检查 抑菌性 方法适用性 

分 类 号：S853.7[农业科学—临床兽医学]