摘要
目的根据《中国药典》2020年版的规定,建立安乐阴洗剂的微生物限度检验方法。方法采用常规法、稀释法、中和法、薄膜过滤法和中和-薄膜过滤法对安乐阴洗剂进行方法适用性试验,通过比较各试验菌的回收率,选择该品适合的微生物计数和控制菌检查法。结果稀释剂中添加4%聚山梨酯80和0.5%大豆卵磷脂可有效消除样品的抑菌性,并能增加供试样品的溶解性。需氧菌总数计数可采用1∶10供试液按平皿法(1 ml/皿)进行计数;霉菌和酵母菌总数计数可采用1∶10供试液10 ml按薄膜过滤法进行计数(冲洗量300 ml/膜);控制菌金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌和梭菌可采用1∶10供试液10 ml依相应检查法检查。结论本研究所建立的安乐阴洗剂微生物限度检查法科学、合理,对药品的监管检验具有借鉴意义。
Objective To establish a microbial limit test method for Anleyin lotion following the regulations in the 2020 edition of the Pharmacopoeia of the People’s Republic of China.Methods Routine method,dilution method,neutralization method,membrane filtration method,and neutralization-membrane filtration method were used to conduct method suitability tests on Anleyin lotion.By comparing the recovery rates of various test bacteria,suitable microbial counting and control bacterial test methods for the product were selected.Results Adding 4%polysorbate 80 and 0.5%soybean lecithin to the diluent could effectively eliminate the antibacterial activity of the sample and increase the solubility of the test sample.The total number of aerobic bacteria could be counted using a 1∶10 test solution with the plate method(1 ml/plate).The total number of molds and yeast could be counted using a 1∶10 test solution of 10 ml with the membrane filtration method(flushing amount of 300 ml/membrane).The control bacteria Staphylococcus aureus,Pseudomonas aeruginosa,Candida albicans,and Clostridium could be tested using a 1∶10 test solution of 10 ml according to the corresponding test methods.Conclusion The microbial limit test method for Anleyin lotion established in this study is scientific and reasonable and has reference significance for drug supervision and inspection.
作者
郑域茹
朱铮
郑挺
高丹玲
廖燕萍
ZHENG Yuru;ZHU Zheng;ZHENG Ting;GAO Danling;LIAO Yanping(Fujian Institute for Food and Drug Quality Control,Fujian,Fuzhou 350001,China)
出处
《中国医药科学》
2023年第23期77-81,共5页
China Medicine And Pharmacy
基金
福建省漳州市自然科学基金资助项目(ZZ2016J24)。
关键词
微生物限度
安乐阴洗剂
抑菌性
中和法
薄膜过滤法
Microbial limit
Anleyin lotion
Antibacterial activity
Neutralization method
Membrane filtration method
