中国医药科学2025，Vol.15Issue(5)：41-44,4.DOI:10.20116/j.issn2095-0616.2025.05.10
泊沙康唑肠溶片微生物限度检查方法适用性研究
Research on the applicability of microbial limit test method for posaconazole enteric-coated tablets
摘要
Abstract
Objective To establish a validated method to detect the microbial limit test method for posaconazole enteric-coated tablets.Methods According to the relevant requirements of People's Republic of China Pharmacopoeia(2020 edition),Part Ⅳ,1105 and 1106,considering the possible impacts of this drug on microbial growth,2 methods were proposed.Method 1 was to take 1∶10 samples for test solution by conventional method and directly inoculate tryptone soybean agar(TSA).Method 2 was to use membrane filtration method,in which the antibacterial activity was removed by washing and filtering polyvinylidene fluoride(PVDF)membrane,and the membrane was attached to a flat plate to check the total number of aerobic bacteria,molds and yeasts.However,Escherichia coli would be tested by inoculating 1∶10 test solution into 100 ml TSA liquid culture medium by conventional method.Results Posaconazole had a strong inhibitory effect on Candida albicans and aspergillus niger,but it had no obvious inhibitory effect on Pseudomonas aeruginosa,Staphylococcus aureus and bacillus subtilis.Simultaneously,it had no obvious effect on Escherichia coli.Conclusion The total number of aerobic bacteria is checked,and the total number of molds and yeasts is counted by membrane filtration method.The washing solution is physiological saline with pH 3.8,and the filtration membrane is PVDF filtration membrane.Escherichia coli is detected by the conventional method specified in People's Republic of China Pharmacopoeia(2020 edition,PartⅣ).The results of this experiment provide an idea of microbial limit test for posaconazole enteric-coated tablets.关键词
泊沙康唑/微生物限度/方法学验证/薄膜过滤Key words
Posaconazole/Microbial limit/Methodological verification/Membrane filtration分类
医药卫生引用本文复制引用
郑露,周剑,陈洁..泊沙康唑肠溶片微生物限度检查方法适用性研究[J].中国医药科学,2025,15(5):41-44,4.基金项目
重庆市教育委员会科学技术研究计划项目(KJQN202302803). （KJQN202302803）
