我院欧盟进口与国产无菌制剂说明书中药品开启或配制后使用期限的对比与分析  

Comparative Analysis of In-use Period after First Opening or Reconstitution of European Union Imported Sterile Products and Domestic Sterile Products in Our Hospital

作　　者：钱佩佩 曹凯 兰丙欣 Qian Peipei;Cao Kai;Lan Bingxin(Department of Pharmacy,Xuchang Central Hospital,Henan Xuchang 461000,China)

机构地区：[1]许昌市中心医院药学部,河南许昌461000

出　　处：《中国药师》2018年第10期1828-1830,共3页China Pharmacist

基　　金：许昌市科技计划项目(软科学研究)(编号:20160713199)

摘　　要：目的:为完善我国无菌制剂说明书中开启或配制后使用期限信息提供参考和建议。方法:调查我院在用无菌制剂的说明书,筛选出使用前需经配制的无菌制剂以及多剂量包装无菌制剂,并对其中欧盟进口无菌制剂和国产无菌制剂说明书中开启或配制后使用期限进行对比分析。结果:我院国产无菌制剂说明书中使用期限信息标注率为32. 25%,低于其他进口无菌制剂的55. 56%,远低于欧盟进口无菌制剂的93. 55%。结论:我国药品稳定性研究技术指导原则中关于无菌制剂开启或配制后使用期限方面的内容提出较晚,且缺少具体的技术方案。建议我国药品行政管理及其技术支持部门进一步完善相关指导原则,并指导药品研发和生产企业积极开展药品使用期间的稳定性研究,逐渐完善药品说明书中使用期间稳定性的相关信息。Objective： To provide reference and suggestions for improving the in-use period information of sterile products after first opening or reconstitution in China. Methods： The package inserts of sterile products in our hospital were investigated. The sterile products needed to be reconstituted before use and with multiple-dose package were selected. The in-use period information of European imported sterile products and domestic sterile products were comparatively analyzed. Results： The presentation rate of in-use period in the package inserts of domestic sterile products was 32. 25%,which was less than 55. 56% of the other imported sterile products,and significantly less than 93. 55% of European imported sterile products. Conclusion： The relevant content of in-use period of sterile products after first opening or reconstitution is supplemented relatively late in China＇s stability testing guidance for drug substances and products,moreover,the specific technical proposals are absent. It is suggested that the drug administrative department and its technical supportive agencies should improve the relevant guidance and guide pharmaceutical research enterprises and manufacturing enterprises to carry out in-use stability studies,furthermore,gradually improve the relevant in-use period information in package inserts.

关 键 词：无菌制剂 临用新配制剂 多剂量包装 欧盟进口 国产 使用期限 

分 类 号：R951[医药卫生—药学]