Abstract: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 (Part Ⅳ) 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.
李翔 黎春彤 王晶 段斯庭 张晓娟 马建丽▲. 医院耳鼻制剂微生物限度检验方法的建立[J]. 中国医药导报, 2018, 15(34): 23-26.
LI Xiang LI Chuntong WANG Jing DUAN Siting ZHANG Xiaojuan MA Jianli▲. Establishment of microbial limit test for hospital ear and nose preparations. 中国医药导报, 2018, 15(34): 23-26.