五种复方制剂微生物限度检查法方法验证

Validation of Microbial Limit Test Method of 5 Kinds of Chinese Patent Medicines

目的:建立五种复方制剂的微生物限度检查方法。方法:采用中国药典2010年版一部附录微生物限度检查法项下方法进行方法验萄球菌有一定的抑制作用,但可通过培养基稀释法消除。结论:胎安合剂、碳酸氢钠溶液、水合氯醛灌肠液可按常规法进行微生物限度检查,茵黄合剂按培养基稀释法进行微生物限度检查。各品种控制菌检查均可用常规法。

Objective:To study the antimicrobial effect of 5kinds of Chinese patent medicines and to establish microbial limit test method for them.Methods:Common method and culture medium dilution method were used to do the recovery test in order to establish and validate the method.Result:Yinhuang oral liquid showed an antimicrobial effect on Staphylococcus aureus to some extent but the effect can be eliminated by culture medium dilution method.Other 4kinds did not show an antimicrobial effect.Conclusion:The common method can be used for the microbial limit test of Taian oral liquid,sodium bicarbonate solution,chloral hydrate clyster and tannin ointment.Dilution method can be used for the microbial limit test of Yinhuang oral liquid.