盐酸莫西沙星片微生物限度检查方法讨论

The discussion of the microbial limit test method used for moxifl oxacin hydrochloride tablets

目的 解析盐酸莫西沙星片微生物限度检查方法,对影响方法的关键因素进行探讨,为进一步的方法优化提供思路。方法 汇总比较部分盐酸莫西沙星片药品标准中收载微生物限度检查方法;探讨镁离子与稀释剂/冲洗液、培养基的相容性及影响测试菌株生长的条件;优化检测方法,讨论稀释剂/冲洗液不影响测试菌株生长的最佳条件,并验证优化方法对4个企业产品检测的有效性。结果 各标准收载的微生物限度方法在执行中可能存在结果重现性差的问题;在优化方法中,推荐镁离子使用浓度0.1 mol/L,不超过0.2 mol/L,并细化配制、添加流程,保证体系的稳定性。利用优化方法检测4个企业产品,测试菌株可得到满意的回收,满足药典标准要求。结论 盐酸莫西沙星片微生物限度检查方法影响因素较多,如镁离子的合理用量与配制、表面活性剂或增溶剂的合理配制、滤膜材质、培养基等具体试验环节,建议细化日常标准操作规程(SOP),保证检验方法稳定,检验结果可靠。

Objective To analyze the microbial limit test method of moxifloxacin hydrochloride tablets and discuss several key factors affecting the method, so that further method optimization could be provided. Methods Microbial limit test methods for moxifloxacin hydrochloride tablets in different pharmaceutical criteria were summarized and compared. The compatibility of magnesium ion in diluent/rinse solution or in medium and the magnesium condition affecting test organisms were discussed. The microbial limit test method was optimized and the optimal diluent/rinse solution conditions which can not affect the growth of tested strains was discussed. The method effectiveness from the recovery of test bacteria in four enterprises’ products was verified. Results There may be poor reproducibility of the microbial limit test methods for moxifloxacin hydrochloride tablets in different pharmaceutical criteria. It is recommended to use the magnesium ion concentration of 0.1 mol/L, not more than 0.2 mol/L in the optimization method. The preparation and ion addition process are also detailed to ensure the stability of the system. With the optimized method, the tested strains can be recovered satisfactorily in four enterprises’ products, and the products meet the requirements of pharmacopoeia standards. Conclusion The microbial limit test method of moxifloxacin hydrochloride tablets could be affected by many specific factors, such as reasonable use and preparation of magnesium ions/surfactants or solubilizer, membrane material, and culture medium. Refinements of the microbial limit test method of moxifloxacin hydrochloride tablets in standard operating procedures(SOP) are suggested, so that the stability of test methods and the reliability of test results could be guaranteed.