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目的建立头孢克肟胶囊微生物限度检查法。方法以含3%聚山梨酯80和0.3%蛋黄卵磷脂的pH7.0无菌氯化钠-蛋白胨缓冲液作为稀释液配制供试品储备液,离心沉淀后加入十四烷酸异丙酯,充分振摇,以500r/min离心3min,使水油完全分离,弃去油层,将水层混匀,作为1∶10的供试液,最终以1∶100的稀释液为最低稀释级,采用薄膜过滤法进行细菌计数;采用培养基稀释法进行霉菌和酵母菌计数;采用薄膜过滤法进行大肠埃希菌检查。结果该方法能有效消除头孢克肟的残留,确保实验质量。结论本法操作简便,可用于头孢克肟胶囊的微生物限度检查。
Objective To establish a limit test for cefixime microbes. Methods To prepare the stock solution of the test solution with pH7.0 sterile sodium chloride-peptone buffer containing 3% polysorbate 80 and 0.3% egg yolk lecithin, centrifuge and precipitate, add isopropyl myristate, Shake thoroughly and centrifuge at 500r / min for 3min to completely separate the water and oil, discard the oil layer, mix the water layer, as 1:10 for the test solution, the final dilution of 1: 100 as the lowest dilution level, using Bacterial count by membrane filtration method; Counting of molds and yeasts by culture medium dilution method; Escherichia coli examination by membrane filtration method. Results The method can effectively eliminate cefixime residues, to ensure the quality of the experiment. Conclusion This method is easy to operate and can be used for microbial limit test of cefixime capsules.