补脾强力膏微生物限度检查方法学检测研究

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.coli,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 aureus,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.coil.%[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.