国产皮内注射用卡介苗的稳定性研究

摘要

Objective To observe the stability of the domestic BCG vaccine for intradermal injection (BCG).Methods Each testing item was performed on 26 batches of BCG produced between 2007 and 2018 by Shanghai Institute of Biological Products Co.Ltd.(SIBP),according to the registration specification approved by China Food and Drug Administration and the requirement of the Chinese pharmacopoeia.The thermostability test was performed on Month 0.The identity,appearance,weight variation,osmolarity (products produced after December 2015),residual moisture content,bacterial purity and potency tests as well as test for the absence of virulent mycobacterium were performed on Month 0 and Month 24.The test for number of culturable particles was performed on Month 0,Month 12 and Month 24.At the same time,the accelerated stability test and long term stability test were performed on 3 batches each of vaccines produced in the new and old facilities,with emphasis on the residual moisture content test and the test for number of culturable particle.Results The testing results of BCG met the registration specification and the requirement of the Chinese pharmacopoeia.The products produced in the new facility is similar to those produced in the old facility.Residual moisture contents of all vaccine were not higher than 3.0％.The numbers of culturable particles were all in the range of 1.0 × 106-8.0 × 106 colony-forming unit/mg.Conclusion The BCG produced by SIBP is safe,effective,stable and consistent.%目的 观察国产皮内注射用卡介苗(卡介苗)的稳定性.方法 取26批上海生物制品研究所有限责任公司(上海公司)2007-2018年生产的卡介苗,按照国家食品药品监督管理总局批准的卡介苗注册标准和中国药典的要求进行各项检定:在0个月进行热稳定性试验,在0和24个月进行鉴别试验,外观、装量差异、渗透压摩尔浓度(2015年12月以后的制品)、水分、纯菌检查,效力测定,无有毒分枝杆菌试验.在0、12、24个月进行活菌数测定.同时对新、老车间生产的各3批疫苗进行加速稳定性与长期稳定性试验,重点考察水分和活菌数.结果 卡介苗在有效期内各项指标检定结果 均符合注册标准和中国药典要求.新、老车间生产的疫苗质量相似.疫苗水分都不高于3.0％.活菌计数均在1.0×106～8.0×106菌落形成单位/mg.结论 上海公司生产的卡介苗安全、有效、稳定、均一.