抗菌消炎胶囊微生物限度检查法的建立及方法学验证

目的建立抗菌消炎胶囊微生物限度检查的方法并验证。方法按中国药典2010年版,用大肠埃希菌、枯草芽胞杆菌、金黄色葡萄球菌、黑曲霉和白色念珠菌对抗菌消炎胶囊进行微生物限度检查方法学验证试验。细菌的计数方法为低速离心-培养基稀释联用法;霉菌、酵母菌计数方法为培养基稀释法;控制菌检查采用常规法检验。结果抗菌消炎胶囊对细菌中的金黄色葡萄球菌、枯草芽孢杆菌有很强的抑制作用,对大肠埃希菌、白色念珠菌有一定的抑制作用。结论该方法用于抗菌消炎胶囊的质量控制有效、可行。

Establishment and Validation of Microbial Limit Method for Kangjunxiaoyan Capsules

OBJECTIVE To establish and validate the microbial limit test for Kangjunxiaoyan capsules. METHODS The microbial limit test for Kangjunxiaoyan capsules was validated using Escherichia coli, Bacillu subtilis, Staphylococcus aureus, Aspergillus niger and Candida albicans according to Chinese Pharmacopoeia 2010. Low speed centrifuge and medium dilution method were used with count of bacterium. Culture medium diluting method was used with counts mold and yeasts. Pathogenic bacteria could be tested when general method were used. RESULTS Kangjunxiaoyan capsules had very strong inhibition on Staphylococcus aureus and Bacillus subtilis, they could make certain inhibition effect on Escherichia coli and Candida albicans. CONCLUSION The method is feasible, effective and can be used for quality control of Kangjunxiaoyan capsules.