痤疮散微生物限度检查方法的适用性试验研究

Applicability Test of Microbial Limit Test for Cuochuang Powder

目的研究痤疮散的微生物限度检查方法。方法按2015年版《中国药典(四部)》通则1105,1106,1107进行方法的建立和验证。结果该产品对需氧菌中的金黄色葡萄球菌有较强的抑制作用,对枯草芽孢菌、白色念珠菌有一定的抑制作用,故需氧菌计数采用薄膜过滤法(1:20稀释级)、霉菌和酵母菌计数采用平皿法(1:20稀释级)进行检测,回收率均达50%~200%。控制菌中的金黄色葡萄球菌可采用稀释法(500 mL)进行检测,铜绿假单胞菌可采用常规法进行检测。结论该方法可用于痤疮散的微生物限度检查。

Objective To study the method of microbial limit test for Cuochuang Powder.Methods Applicability test of microbial limit test was established and verified according to General rule 1105,1106 and 1107 of Chinese Pharmacopoeia（ 2015 Edition,Volume Ⅳ）.Results This product had strong antibacterial activity against Staphylococcus aureus,had a certain inhibitory effect on Candida albicans and Bacillus subtilis.The total number of aerobic bacteria was measured by membrane filtration and washing（ 1：20 dilution grade）,the total number of molds and yeasts were measured by culture medium dilution method（ 1：20 dilution grade）,and the recovery rate was in the range of 50%-200%.Staphylococcus aureus in the control bacteria was detected by dilution method（ 500 mL）,Pseudomonas aeruginosa was detected by the routine method.Conclusion This method is reliable and feasible,which can be used in microbial limit test of Cuochuang Powder.