摘要
目的对有特殊抑菌作用的品种联苯苄唑乳膏建立适合的微生物限度检查方法。方法改进《中国药典》2005年版微生物限度检查法规定的具有抑菌成分药物的薄膜过滤法。结果以1%的无菌聚山梨酯80的pH7.0无菌氯化钠-蛋白质缓冲液作冲洗液,采用本方法,可消除基质干扰,作为本品的微生物限度检查方法。结论本方法操作简单.快速,结果准确度高。
Objective To establish suitable microbial limit test method for Bifonazole cream that has special bacteriostasie effect. Methods The method was determined by improving membrane filtration method of Chinese Pharmacopeia (ChP) 2005. Results The matrix interference could be eliminated by using 1% sterile polysorbate 80 with sterile NaCl- protein ( pH 7.0) as rinsing fluids. Conclusion The method can be used for microbial limit test of Bifonazole cream.
出处
《今日药学》
CAS
2010年第3期14-16,共3页
Pharmacy Today
基金
广东省药品检验所科技创新基金项目(编号:SN20071118)