3种医院外用制剂微生物限度检查方法的建立

Establishment of Microbial Limit Test Method for 3 Kinds of Hospital External Use Preparations

目的建立尿素软膏、维生素E乳膏、复方苯甲酸软膏3种医院外用制剂的微生物限度检查方法。方法根据2015年版《中国药典(四部)》通则1105,1106,1107项下方法进行试验,分别对样品进行5种试验菌回收率试验及控制菌检查方法验证。结果在适宜的供试品配制条件下,需氧菌总数检查,尿素软膏采用常规法,维生素E乳膏采用培养基稀释法,复方苯甲酸软膏采用中和法和培养基稀释法联用;霉菌及酵母菌总数检查,尿素软膏、维生素E乳膏可采用常规法,复方苯甲酸软膏可采用中和法和培养基稀释法联用;金黄色葡萄球菌、铜绿假单胞菌检查,尿素软膏、维生素E乳膏采用常规法,复方苯甲酸软膏采用中和法和培养基稀释法联用。结论该方法适用于3种医院制剂的微生物限度检查。

Objective To establish a microbial limit test method for Urea Ointment,Vitamin E Cream and Compound Benzoic Acid Ointment.Methods The experiment was conducted according to items 1105,1106 and 1107 of the four general principles of the 2015 edition of Chinese Pharmacopoeia.Five kinds of test bacteria recovery rate tests and control bacteria inspection methods were carried out on the samples respectively.Results Under suitable preparation conditions,the total number of aerobic bacteria was checked,and Urea Ointment was checked by conventional method,Vitamin E Cream was diluted by culture medium,Compound Benzoic Acid Ointment was checked by neutralization method and culture medium dilution method.For total number of mold and yeast,Urea Ointment and Vitamin E Cream could be tested by conventional method,Compound Benzoic Acid Ointment could be tested by combination of neutralization method and culture medium dilution method.For examination of staphylococcus aureus and pseudomonas aeruginosa,Urea Ointment and Vitamin E Cream were examined by routine method,Compound Benzoic Acid Ointment was examined by neutralization method and culture medium dilution method.Conclusion This method is suitable to be used in the microbial limit test for the 3 kinds of hospital preparations.