中国医药科学2023，Vol.13Issue(23)：77-81,5.DOI:10.20116/j.issn2095-0616.2023.23.18
安乐阴洗剂微生物限度检查方法学的研究
Study on the methodology of microbial limit test for Anleyin lotion
摘要
Abstract
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.关键词
微生物限度/安乐阴洗剂/抑菌性/中和法/薄膜过滤法Key words
Microbial limit/Anleyin lotion/Antibacterial activity/Neutralization method/Membrane filtration method分类
医药卫生引用本文复制引用
郑域茹,朱铮,郑挺,高丹玲,廖燕萍..安乐阴洗剂微生物限度检查方法学的研究[J].中国医药科学,2023,13(23):77-81,5.基金项目
福建省漳州市自然科学基金资助项目(ZZ2016J24). （ZZ2016J24）
