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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。
OBJECTIVE: To analyze the quality and problems of the live attenuated vaccine of trivalent oral poliovirus (TOPV) before and after the implementation of the national batch and to evaluate the quality of TOPV. Methods Data and laboratory tests were used to analyze the TOPV test results from 2002 to 2004 for statistical and quality trend analysis. The TOPV results from 1997 to 2004 were also compared. Results A total of 320 batches of TOPV batch records digest were reviewed, of which 85 batches of laboratory tests, the results meet the regulations. After the “China Biological Products Regulations” (2000 version) and the implementation of the national batch of the implementation, TOPV quality has been significantly improved. Conclusion The TOPV quality in China has been stable in recent years. The implementation of national batch issuance has played a normative and supervisory role in the production and management of TOPV and promoted the improvement of vaccine quality, but there are still some problems.