摘要
目的通过分析我国人血白蛋白制品在执行国家批签发制度前后的质量和问题，评价国内人血白蛋白制品目前的质量状况。方法采用资料审查和试验室检测，对2002-2008年人血白蛋白的部分关键项目的结果作质量趋势分析。结果6年中我所对人血白蛋白888批记录摘要进行了资料审查，其中831批做试验室检测，平均合格率98．6％。结论目前国内人血白蛋白制品质量总体稳定，国家批签发制度的实施促进了该制品的生产和检定愈加规范，但也存在一些问题有待解决。
Objective To evaluate the current quality of domestic human albumin preparations , by quality trend analysis and comparison of the preparations before and after implementation of lot release. Methods By the information review and laboratory testing, from 2002 to 2008, the results of the quality for some of the key projects of human albumin preparations were carried on trend analysis. Results From 2002 to 2008, 888 lots of the preparations were submitted to our institute and all the manufacturing protocol summarys were reviewed, among 831 lots were tested according to lot release procedures, the average eligibility rates are 98. 60%. Conclusions The quality of current domestic human albumin preparations is generall satisfied, lot release system has promoted the quality of products and standardized production and quality regulation. But there are still some problems needed to be solved.
出处
《中国药事》
CAS
2009年第8期796-798,共3页
Chinese Pharmaceutical Affairs
关键词
人血白蛋白
国家批签发制度
质量评价
human albumin preparations
lot release system
quality evaluation
