眼疲宁合剂微生物限度检查法的建立与验证

目的 探索建立眼疲宁合剂有效可控的微生物限度检查方法。方法 选取不同阳性菌种进行方法学试验，并对本制剂进行培养基稀释法及薄膜过滤法两种方法比较研究。结果 确立用枯草芽孢杆菌、金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌及黑曲霉作为阳性菌种进行方法学试验；确立需氧菌检查采取薄膜过滤法、霉菌酵母菌检查采取培养基稀释法，并验证了控制菌大肠埃希菌计数实验用培养基的量。结论 确立了眼疲宁合剂的微生物学检查方法及质量标准，可有效控制制剂的卫生学质量。

Establishment and validation of microbial limit test method of Yanpining Liquid Preparations

Objective The formulation has complex composition and the strong antibacterial activity, so its quite essential to establish the microbial limit test for Yanpining Liquid Preparations through the experiments. Methods we select different positive strains tested methodology and microbial limit tests were validated. comparative studies have been carried out between culture medium dilution method and membrane filtration. Results Experiments verified by Bacillus subtilis, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger as positive strains tested methodology and results show that the former method could be used for mold and yeast counting test; the latter could be used for total aerobic bacteria counting of the preparations; The amount of culture medium for Escherichia coli count experiment was verified. Conclusion Microbial limit tests has the good reference value and the confirmed experimental results could effectively control the hygiene quality of forYanpining Liquid Preparations.