抗结核固定剂量复合剂微生物限度检查方法的建立和验证

Establishment and Validation of Microbial Limit Method for Anti-tuberculosis Fixed Dose Combinations

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 set up a method for microbial limit of Rifampin and Isoniazid Tablets.Methods Validation of microbial limit tests according to Chinese Pharmacopoeia edition 2010.Results FDCs has very strong inhibiting effect on Staphylococcus aureus,Bacillus subtilis and Candida albicans.Conclusion Low speed centrifuge-filtration methods were used with take count of bacterium;General methods were used with take count of mold and yeasts of FDCs.Pathogenic bacteria can be tested when filtration methods were used.