卡介菌不同代次制备的疫苗质量分析  

Analysis of qualities of vaccines prepared with BCG strains of various passages

作　　者：程鹏飞[1] 刘朝阳[1] 景辉[1] 张亦超[1] 陈艳红[1] 马相虎[1] 

机构地区：[1]上海生物制品研究所有限责任公司质量检定室,上海200052

出　　处：《中国生物制品学杂志》2013年第11期1529-1532,1539,共5页Chinese Journal of Biologicals

摘　　要：目的分析由卡介菌上海D2株工作种子批连续传代至不同代次的菌种制备的疫苗的质量差异。方法选取自工作种子批(11-007)传代至6、9、12代的单批培养物制备的皮内注射用卡介苗,采用多重PCR法鉴定特异性缺失区RD1;对原液的单位产能、半成品的沉降率、成品的效力及热稳定性进行测定,并对结果进行统计学分析。结果6、9、12代菌种培养物制备的卡介苗成品缺失RD1区,具有卡介菌特征;各代次制备的疫苗单位产能、沉降率、动物效力、热稳定性检测结果差异均无统计学意义(P>0.05),且疫苗动物效力、热稳定性检测结果均符合《中国药典》三部(2010)版及国家药监局批准的企业注册标准。结论工作种子批连续传代至不同代次的卡介菌制备的皮内注射用卡介苗均缺失RD1区,具有卡介菌的特征,关键质量指标安全、有效、一致。Objective To analyze the qualities of vaccines prepared with working seeds of BCG Chinese D2 strain of var-ious passages. Methods BCG vaccine for intradermal injection, prepared from a single harvest derived from the working seeds （11-007） subcuhured to passages 6, 9 and 12, were determined for region of deletion （RD） 1 by multiplex PC R. The harvest rate of bulk, sedimentation rate of final bulk, as well as potency and heat stability of final product were de-termined, and the results were analyzed statistically. Results The RDls were in lack in final products of BCG vaccine prepared from the working seeds of passages 6, 9 and 12, indicating characteristics of BCG strain. No significant differ- ences were observed in harvest rates of bulks, sedimentation rates of final bulks as well as potencies and heat stabilities of final products prepared with working seeds of various passages （P 〉 0. 05）, while the potencies and heat stabilities met the requirements in Chinese Pharmacopoeia （Volume Ⅲ, 2010 edition） and the requirements for license approved by the SFDA. Conclusion BCG vaccine for intradermal injection prepared with working seeds subcultured to various passages were of characteristics of BCG strain, of which the RDls were in lack, while the main quality indicators safe, effective, and consistent.

关 键 词：卡介苗 质量控制 传代 一致性 稳定性 

分 类 号：R378.911[医药卫生—病原生物学] R392-33[医药卫生—基础医学]