口服脊髓灰质炎减毒活疫苗糖丸质量评价

目的分析实施国家批签发前后三价口服脊髓灰质炎减毒活疫苗糖丸(TOPV)的质量及存在问题,评价TOPV的质量。方法通过资料审查和实验室检定,对2002~2004年TOPV检定结果作统计和质量趋势分析。同时将1997~2004年检定的TOPV结果进行了比较。结果共对320批TOPV批记录摘要进行资料审查,其中85批进行实验室检定,结果符合规定。在《中国生物制品规程》(2000年版)及国家批签发实施后,TOPV质量有了明显提高。结论近年来中国TOPV质量稳定。实施国家批签发对TOPV的生产和管理起到规范及监督作用,促进了疫苗质量的提高,但尚存在一些问题。

Quality Evaluation of Oral Live Attenuated Polio Vaccine

Objective Analyzing the quality condition and problems of trivalent Oral Polio Vaccine dragee(TOPV)(after implemented National Lot Release,and evaluating the quality of TOPV.Methods By reviewing the lots summary protocol and testing of TOPV produced from 2002-2004,the results were statistically calculated and the trend of vaccine quality was analyzed.Testing data of vaccine from 1997 to 2004 were also compared.Results Total 320 lots summary protocol were reviewed,and samples of 85 lots were tested.The results conformed to the established standards.The quality of TOPV has been improved obviously since the implementation of the new requirements and National Lot Release.Conclusion The quality of TOPV has been improved in recent years.The implementation of National Lot Release can stipulate and supervise the production and management of the vaccine,it has improved the quality of thevaccine,but some problems still exist.