质量提取法对注射用头孢他啶包装系统的密封完整性研究  

Container Closure Integrity of Packaging System of Ceftazidime for Injection by Mass Extraction Method

作　　者：郭燕燕 张莞英 邱怡婷 任锟 王晓兰 江燕 蒲小聪 GUO Yan-yan;ZHANG Wan-ying;QIU Yi-ting;REN Kun;WANG Xiao-lan;JIANG Yan;PU Xiao-cong(Sichuan Institute for Drug Control,Chengdu 611731,China)

机构地区：[1]四川省药品检验研究院,成都611731

出　　处：《包装工程》2023年第21期273-278,共6页Packaging Engineering

基　　金：四川省科技厅重点研发项目(2021YFG0089)。

摘　　要：目的建立一套完整的质量提取方法,对注射用头孢他啶(规格为15 mL,1.0 g)的包装系统的密封完整性进行研究。方法通过对阴性对照样品、阴性样品以及阳性样品进行测试,进而优化试验参数,完成系统适用性、检出限以及质量提取法的方法学确认,并对在加速条件下存放的0月、3月、6月的6批样品进行测试。加速条件:温度为(40±2)℃,相对湿度为(75±5)%。结果该方法的检测限为2μm,检测灵敏便捷,本品的密封完整性符合要求。结论质量提取方法可用于顶空无菌包装系统的注射用头孢他啶的密封性研究。The work aims to establish a complete set of mass extraction method to study the container closure integrity of the packaging system of ceftazidime for injection(specification:15 mL;1.0 g).The experimental parameters were optimized by testing the negative control samples,negative samples and positive samples to complete system suitability confirmation,detection limit confirmation and methodological confirmation of mass extraction method,and test the 6 batches of samples after storage at acceleration conditions(temperature:40℃±2℃ and relative humidity 75%±5%)for 0,3 and 6 months.This method had a detection limit of 2μm,which was sensitive and convenient and the container enclosure integrity of the product complied with the requirements.The mass extraction method can be used to study the container closure integrity of ceftazidime for injection in the headspace aseptic packaging system.

关 键 词：质量提取法 注射用头孢他啶 密封完整性 顶空无菌包装系统 

分 类 号：TB487[一般工业技术—包装工程]