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目的:建立两种规格硝酸益康唑栓的微生物限度检查方法。方法:分别采用平皿法、培养基稀释法、薄膜过滤法、中和-稀释-薄膜过滤法进行微生物限度检查方法学验证试验。结果:建立了两种规格硝酸益康唑栓的微生物限度检查方法。结论:采用薄膜过滤法及添加乳化剂十四烷酸异丙酯可有效消除该药物的抑菌作用,该方法适用于两种规格栓剂的微生物限度检查。
OBJECTIVE: To establish a microbial limit test method for two kinds of standard econazole nitrate suppositories. Methods: Microbial limit test methodological validation test was carried out by using plate method, medium dilution method, membrane filtration method and neutralization-dilution-membrane filtration method, respectively. Results: Two established limits of microbial limit test of econazole nitrate suppository were established. Conclusion: The antibacterial effect of this drug can be effectively eliminated by the membrane filtration method and the addition of emulsifier isopropyl myristate. This method is suitable for the microbial limit test of two kinds of suppositories.