甲硝唑氯己定洗剂微生物限度检查法方法适用性试验

Suitability Tests of Microbiological Examination of Metronidazole and Chlorhexidine Lotion

目的:对甲硝唑氯己定洗剂进行微生物限度检查法适用性试验的研究。方法:按照《中国药典》2015年版四部附录通则1105、1106、1107的要求,需氧菌总数取1:20的供试液采用薄膜过滤法,稀释剂用量为100ml,冲洗液用量为800ml;霉菌和酵母菌总数取1:10的供试液采用薄膜过滤法,稀释剂用量为100ml,冲洗液用量为300ml;控制菌金黄色葡萄球菌检查采用薄膜过滤法分两膜过滤,稀释剂用量为100ml,冲洗液用量为每膜900ml,培养基用量为100ml,铜绿假单胞菌和白色念珠菌检查均采用薄膜过滤法,稀释剂用量均为100ml,冲洗液用量均为300ml,培养基用量均为100ml。结论:建立了甲硝唑氯己定洗剂的微生物限度检查法,采用薄膜过滤法消除药物本身的抑菌作用,方法准确、可靠、重现性好。

Objective: To study the suitability tests of microbiological examination of Metronidazole and Chlorhexidine Lotion.Method: According to the General Notices 1105,1106 and 1107 of the Pharmacopoeia of People’s Republic of China(volume Ⅳ,Edition 2015),the method adopted for TAMC of the product is membrane filtration with a 1 in 20 dilution of the sample,100 ml diluent and 800 ml rinsing diluent;the method for TYMC is also membrane filtration with a 1 in 10 dilution of the sample,100 ml diluent and 300 ml rinsing diluent;the method for Staphylococcus aureus is membrane filtration with 100 ml diluent filtrating through 2 membranes simutaneously and 900 ml rinsing diluent per membranes;the method for Pseudomonas aeruginosa and Candida albicans are membrane filtration with 100 ml diluent,300 ml rinsing diluent and 100 ml culture media.Conclusion: The microbiological examination method of Metronidazole and Chlorhexidine Lotion is established by adopting membrane filtration to neutralize the antimicrobial activity of the product,which is proved to be accurate,reliable and repeatable.