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目的建立通脉胶囊的微生物限度检查方法。方法参照《中国药典》2010版,采用5种阳性对照菌回收率试验测定其是否含抑菌成分。结果该品种对金黄色葡萄球菌和枯草芽孢杆菌有抑菌活性,采用培养基稀释方法进行细菌测定,霉菌和酵母菌数采用常规法进行测定及控制菌的检查。结论用该方法进行微生物限度检查可以客观地反映药物中微生物的污染状况,可用于该制剂微生物控制。
Objective To establish a microbial limit test of Tongmai capsule. Methods Reference “Chinese Pharmacopoeia” 2010 edition, using five kinds of positive control bacteria recovery test to determine whether it contains antibacterial components. The results of the species of Staphylococcus aureus and Bacillus subtilis antibacterial activity, the use of medium dilution method for bacterial determination, the number of molds and yeasts by conventional methods for the determination and control of bacteria. Conclusion The method of microbial limit test can objectively reflect the contamination status of the microorganism in the medicine and can be used for the microbial control of the preparation.