Methodology Validation of Microbial Limit Test of Bupi Qiangli Ointment  

补脾强力膏微生物限度检查方法学检测研究（英文）

作　　者：李江萍[1] 杨亮[1] 蒋玲[1] 

机构地区：[1]贵阳中医学院第二属医院,贵州贵阳550001

出　　处：《Agricultural Science & Technology》2017年第2期365-367,共3页农业科学与技术（英文版）

基　　金：Supported by Traditional Chinese Medicine and Ethnic Minority Medicine Technology Research Subject of Guizhou Administrative Bureau(QZYY2013-70,QZYY-2014-026);Joint Application of Basic Research Fund of Science and Technology Department o Yunnan Province-Guiyang University of Chinese Medicine(QKHLHZ[2014]7323)~~

摘　　要：[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting in sample recovery test. [Result] The medium dilution method （1：10 test solution, 0.5 ml/plate） could effectively eliminate the inhibition effect of the Bupi Qiangli Ointment, and the recovery of Staphylococcus aureus was greater than 70% in the 3 batches of samples; and the conventional method exhibited the recoveries of E. coil, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in the 3 batches of samples. [Conclusion] Due to Bupi Qiangli Ointment has strongly antibacterial effect on Staphylococcus au- reus, the medium dilution method was used for bacterial counting, and the conventional method was used for mold and yeast counting; and the conventional method was used for controlled bacterium examination of E. coll.[目的]建立医院制剂补脾强力膏的微生物限度检查方法。[方法]按照《中华人民共和国药典》2010年版(一部)采用常规法、培养基稀释法对补脾强力膏的细菌、霉菌及酵母菌计数测定进行加样回收率试验。[结果]采用培养基稀释法(1:10供试液,0.5 ml/皿)能使三个批号样品对金黄色葡萄球菌的加样回收率均大于70%;常规法能使3个批号样品对大肠埃希菌、枯草芽孢杆菌、白色念珠菌及黑曲霉的加样回收率均大于70%,控制菌中大肠埃希菌按照药典常规法可检出。经验证补脾强力膏的细菌计数方法为培养基稀释法(1:10供试液,0.5ml/皿);霉菌及酵母菌的计数方法为常规法;控制菌大肠埃希菌的检查法为常规法。[结论]该复方制剂对金黄色葡萄球菌的抑菌作用较强,符合药理研究结果。

关 键 词：Bupi Qiangli Ointment Microbial limit tests Method validation Medium dilution method 

分 类 号：R286.0[医药卫生—中药学]