3种医院制剂的微生物限度方法验证  

Validation of Microbial Limit Methods for Three Hospital Preparations

作　　者：王一帆 夏伟 贺娟 李春 陈婷 Wang Yifan;Xia Wei;He Juan;Li Chun;Chen Ting(School of Pharmacy,Kunming Medical University,Kunming 650000,China;Pharmacy Department of the 920th Hospital of the PLA Joint Logistics Support Force,Kunming 650000,China;Department of Pharmacy,Fantastic Ethnic Medicine College,Guizhou Medical University,Guiyang 550000,China)

机构地区：[1]昆明医科大学药学院,云南昆明650000 [2]中国人民解放军联勤保障部队第九二〇医院药剂科,云南昆明650000 [3]贵州医科大学神奇民族医药学院药学系,贵州贵阳550000

出　　处：《云南化工》2022年第12期56-58,61,共4页Yunnan Chemical Technology

摘　　要：按照《中华人民共和国药典》2020版四部通则1105、1106和1107的指导原则,采用常规法对10%鱼肝油软膏、复方薄荷脑滴鼻剂和10%氯化钾溶液的微生物限度方法进行了验证。结果表明,在用微生物计数法测定微生物的限度中,金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、铜绿假单胞菌和黑曲霉中的回收比值在0.5~2.0之间;而在控制菌的检查中,10%鱼肝油软膏试验组能检出金黄色葡萄球菌和铜绿假单胞菌的反应特性;复方薄荷脑滴鼻剂试验组能检出金黄色葡萄球菌、铜绿假单胞菌和大肠埃希菌的反应特性;10%氯化钾溶液能检出大肠埃希菌的反应特性。该微生物限度方法适用于3种医院制剂的微生物限度检查。According to the guiding principles of General Rules 1105,1106 and 1107 of the fourth part of the Chinese Pharmacopoeia(2020 edition),the microbial limit method of 10%cod liver oil ointment,compound menthol nasal drops and 10%potassium chloride solution was verified by conventional method.The results showed that the recovery ratio of Staphylococcus aureus,Bacillus subtilis,Candida albicans,Pseudomonas aeruginosa and Aspergillus niger in the microbial limit determined by microbial counting method was between 0.5 and 2.0.In the examination of control bacteria,the reaction characteristics of Staphylococcus aureus and Pseudomonas aeruginosa could be detected in the 10%cod liver oil ointment test group.In the compound menthol nasal drops test group,Staphylococcus aureus,Pseudomonas aeruginosa and Escherichia coli could be detected.The 10%potassium chloride solution can detect the reaction characteristics of Escherichia coli,so it can be concluded that the microbial limit method is applicable to the microbial limit test of three hospital preparations.

关 键 词：医院制剂 微生物限度 软膏 滴鼻剂 口服制剂 

分 类 号：R194[医药卫生—卫生事业管理]