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

作　　者：郑露 周剑 陈洁 ZHENG Lu;ZHOU Jian;CHEN Jie(Chongqing Medical and Pharmaceutical College,Chongqing 401331,China;Chongqing Institute for Food and Drug Control,National Medical Products Administration,Key Laboratory of Quality Monitoring of Narcotic Psychotropic Drugs,Chongqing 401121,China)

机构地区：[1]重庆医药高等专科学校,重庆401331 [2]重庆市食品药品检验检测研究院,国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆401121

出　　处：《中国医药科学》2025年第5期41-44,共4页China Medicine And Pharmacy

基　　金：重庆市教育委员会科学技术研究计划项目(KJQN202302803)。

摘　　要：目的建立1种经过验证的检测泊沙康唑肠溶片中微生物限度的方法。方法根据《中华人民共和国药典》2020年版四部通则1105、1106相关要求,考虑到这种药物对微生物生长可能产生的影响,拟采用两种方法。方法一:常规法取1∶10样品供试液直接接种胰酪大豆胨琼脂;方法二:薄膜过滤法,用聚偏氟乙烯(PVDF)膜薄膜冲洗过滤的方式去除抑菌性,将薄膜贴于平板,用来检查需氧菌总数、霉菌和酵母菌总数;而大肠埃希菌则会采用常规法,取1∶10供试液接种至100 ml胰酪大豆胨液体培养基中进行检查。结果泊沙康唑对白色念珠菌和黑曲霉有很强的抑制生长作用,但对铜绿假单胞菌、金黄色葡萄球菌和枯草芽孢杆菌的生长抑制并不明显;对大肠埃希菌也没有明显影响。结论需氧菌总数检查及霉菌和酵母菌总数计数用薄膜过滤法,冲洗液选择pH 3.8的生理盐水,滤膜选用PVDF滤膜;采用《中华人民共和国药典》2020年版四部规定的常规法检测大肠埃希菌。本实验结果为泊沙康唑肠溶片提供了微生物限度检查方法的思路。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),PartⅣ,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 

分 类 号：R9752[医药卫生—药品]