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目的探讨抗结核固定剂量复合剂的微生物限度检查方法的建立。方法按照《中国药典》2010年版附录XⅢC进行验证实验。结果抗结核固定剂量复合剂对金黄色葡萄球菌、枯草芽胞杆菌、大肠埃希菌有一定的抑制作用。结论抗结核固定剂量复合剂对细菌的计数方法应为离心沉淀法-薄膜过滤法,常规法进行霉菌(酵母菌)计数检验,薄膜过滤法进行控制菌检验。
OBJECTIVE To investigate the establishment of microbial limit test methods for anti-tuberculosis fixed-dose combination. Methods According to the “Chinese Pharmacopoeia” 2010 edition Appendix X Ⅲ C to verify the experiment. Results The anti-tuberculosis fixed-dose combination has a certain inhibitory effect on Staphylococcus aureus, Bacillus subtilis and Escherichia coli. Conclusion The counting method of anti-tuberculosis fixed-dose combination agents for bacteria should be centrifugal sedimentation method - membrane filtration method, conventional method for mold (yeast) count test, membrane filtration method for control bacteria test.