消毒型医用超声耦合剂无菌检查方法研究  

Research on Sterility Test Method of Disinfection Type Medical Ultrasound Coupling Agent

作　　者：吴文婷 丁琦 何世耀 孟杨 康艳 张芸 WU Wen-ting;DING Qi;HE Shi-yao;MENG Yang;KANG Yan;ZHANG Yun(Jiangxi Center of Medical Device Testing,Jiangxi Nanchang 330029;Nanchang Key Laboratory for Quality Evaluation of Medical Devices,Jiangxi Nanchang 330029)

机构地区：[1]江西省医疗器械检测中心,江西南昌330029 [2]南昌市医疗器械质量评价重点实验室,江西南昌330029

出　　处：《中国医疗器械信息》2024年第21期41-43,57,共4页China Medical Device Information

基　　金：江西省药品监督管理局科研项目(项目名称:内生真菌介导高活性纳米银可控制备及合成机制研究,项目编号:2022JS12)。

摘　　要：目的:筛选消毒型医用超声耦合剂的无菌检查方法,并验证方法的可行性和有效性。方法:以消毒型医用超声耦合剂为研究对象,参照2020年版《中华人民共和国药典(四部)》通则1101无菌检查法,分别采用“直接接种”和“对样品进行适当的前处理后,再进行薄膜过滤”这两种方法进行无菌检查方法适用性试验,以确定该产品适宜的无菌检查方法。结果:该产品经适当的前处理后,再进行薄膜过滤,这样进行无菌检查方法适用性试验,样品对照组和菌液对照组的各试验菌均生长良好。按直接接种法对该产品进行无菌检查方法适用性试验,菌液对照组的各试验菌均生长良好,而样品对照组的个别试验菌存在不生长的情况。结论:本研究所采用的前处理方法结合薄膜过滤法适用于消毒型医用超声耦合剂的无菌检查。Objective:To select sterility test method of the disinfection-type medical ultrasound coupling agent and verify the feasibility and effectiveness of the method.Methods:According to the 2020 edition of the Chinese Pharmacopoeia(Part IV)General Rule 1101 sterility test method,the disinfection-type medical ultrasound coupling agent was taken as the research object,the suitability test of sterility test method was conducted separately using the“direct inoculation”and“membrane filtration after appropriate pretreatment of samples”to determine the suitable sterilization test method for the product.Results:“membrane filtration after appropriate pretreatment of the product”was used for the suitability test of the sterility test method,these test bacteria in the sample control group and the bacterial suspension control group all grew well.In the suitability test of the sterility test method using the direct inoculation method,these test bacteria in the bacterial suspension control group grew well,while some test bacteria in the sample control group did not grow.Conclusion:The pretreatment method combined with the membrane filtration method in this study is suitable for the sterility test of disinfection type medical ultrasound coupling agent.

关 键 词：消毒型医用超声耦合剂 无菌检查 方法验证 

分 类 号：R115[医药卫生—公共卫生与预防医学]