医院耳鼻制剂微生物限度检验方法的建立  

Establishment of microbial limit test for hospital ear and nose preparations

作　　者：李翔[1] 黎春彤 王晶[1] 段斯庭 张晓娟[1] 马建丽[1] LI Xiang;LI Chuntong;WANG Jing;DUAN Siting;ZHANG Xiaojuan;MA Jianli(Department of Pharmacology and Pharmacy, the Fourth Medical Center, Chinese PLA General Hospital, Beijing 100048, China)

机构地区：[1]解放军总医院第四医学中心药剂药理科,北京100048

出　　处：《中国医药导报》2018年第34期23-26,共4页China Medical Herald

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ26)

摘　　要：目的建立3种医院滴鼻液滴耳液的微生物限度检验方法。方法按照2015版《中华人民共和国药典》(四部)微生物限度检查法的规定,采用平皿法对3种医院耳鼻制剂的微生物限度检验方法进行适用性试验。结果本研究建立的检查方法对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉五种验证菌株的回收率均在0.5～1.5,控制菌(大肠埃希菌、铜绿假单胞菌、金黄色葡萄球菌)可检出,阴性对照组未检出控制菌。结论采用平皿法对硼酸滴耳液、复方呋喃西林滴鼻液和复方薄荷脑滴鼻液进行微生物限度检查,操作简单、快速,结果准确、可靠,可以客观地反映药物中微生物的污染状况,能较好的控制3种医院耳鼻制剂的质量。Objective To establish the method of microbial limit test for 3 kinds of hospital ear and nose preparations.Methods According to the provisions of the 2015 edition of the Pharmacopoeia of the People′s Republic of China(PartⅣ)microbiological limit inspection method,the applicability test was carried out on the microbial limit test method of the three kinds of hospital nasal drop and ear drops by using the plate method.Results The method established in this study has a recovery rate of 0.5-1.5 for five kinds of proven bacterial strains of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger.Control bacteria(Escherichia coli,Pseudomonas aeruginosa,Staphylococcus aureus)could be detected,but control bacteria were not detected in negative control group.Conclusion The microbial limit test of boric acid ear drops,compound furacilin nasal drops and compound menthol nasal drops was carried out by plate method.The operation was simple,rapid,the results were accurate and reliable.It could objectively reflect the contamination of microorganisms in drugs and better control the quality of three kinds of hospital ear and nose preparations.

关 键 词：硼酸滴耳液 复方呋喃西林滴鼻液 复方薄荷脑滴鼻液 微生物限度检查 方法适用性试验 

分 类 号：R286[医药卫生—中药学]