卡波姆抑菌凝胶剂微生物限度检查方法的建立

目的:建立含抑菌成分的卡波姆凝胶剂微生物限度检查方法。方法: 在pH 6.8的磷酸盐缓冲溶液中,加入硫酸锰,使凝胶中的卡波姆形成沉淀,从而达到破胶的目的,再采用薄膜过滤法去除其抑菌作用,取1:10供试液 1 mL,加入0.9%无菌氯化钠溶液50 mL,过滤,用500 mL pH 7.0无菌氯化钠-蛋白胨缓冲溶液冲洗滤膜,每次50 mL,边冲洗边振摇,泵速为160 r·min^-1。结果: 此方法既可消除卡波姆的干扰,使薄膜过滤正常进行,又几乎不会影响到样品中的微生物,并且计数试验中5种试验菌的回收率均大于85%,控制菌的验证结果也为阳性,符合中国药典2010年版的基本要求。结论: 该方法准确、可靠,对含抑菌成分的卡波姆凝胶剂的微生物限度检查具有借鉴作用。

Objective: To establish a method of microbial limit test for carbomer gel which contains antibacterial components. Methods: In pH 6.8 phosphate buffer solution,manganese sulfate was added to precipitate carbomer in the gel for gel breaking,then the membrane-filter method was adopted to inhibit the residual antimicrobial activity.The test solution(1:10)1 mL was taken and added with 50 mL 0.9% sterile NaCl solution for filtration.The filter membrane was washed 10 times with 500 mL pH 7.0 sterile NaCl-peptone buffer solution,50 mL for each time by flushing and shaking at a pump speed of 160 r·min^-1. Results: This method not only eliminated the interference of carbomer to ensure the membrane-filter operate normally but also had little effect on microbes in the carbomer gel sample.The recoveries for 5 test strains were all over 85% in the count test,and the validation test of control bacteria was positive,which met the basic requirement of Chinese Pharmacopoeia(version 2010). Conclusion: The method is accurate and reliable,and can provide reference for microbial limit tests of carbomer gels which contain antibacterial components.

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