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[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。
[Objective] To establish a method of microbial limit test of BuXiao Powerful Ointment in hospital preparation. [Method] According to “The People’s Republic of China Pharmacopoeia” 2010 edition (a) by conventional method, medium dilution method for the spleen power paste bacteria, mold and yeast count determination of the recovery rate test. [Result] The sample dilutions (1:10 for test solution, 0.5 ml / dish) of three batches of samples could all increase the recovery rate of Staphylococcus aureus by more than 70%. The conventional method can make three batch samples The recoveries of Escherichia coli, Bacillus subtilis, Candida albicans and Aspergillus niger were all more than 70%, and the Escherichia coli in the control bacteria could be detected according to the routine pharmacopoeia. The proven bacterial count method for strengthening the spleen strong broth medium dilution method (1:10 for the test solution, 0.5ml / dish); count method of mold and yeast for the conventional method; control bacteria Escherichia coli test method Regular method. [Conclusion] The antibacterial activity of the compound preparation against Staphylococcus aureus is strong, which accords with the results of pharmacological research.