一次性储液袋冻存腮腺炎病毒原液的浸出物研究  

Study on extracts of disposable storage bag for frozen mumps virus stock solution

作　　者：陈晓望 杨文震 周锋 张芹 汪张建 李贞妮 闻捷 许晚 沈谊清 Chen Xiaowang;Yang Wenzhen;Zhou Feng;Zhang Qin;Wang Zhangjian;Li Zhenni;Wen Jie;Xu Wan;Shen Yiqing(Vaccine Room 2,Shanghai Institute of Biological Products Co.,Ltd.,Shanghai 201403,China;Shanghai Institute of Biological Products Co.,Ltd.,Shanghai 201403,China)

机构地区：[1]上海生物制品研究所有限责任公司疫苗二室,上海201403 [2]上海生物制品研究所有限责任公司,上海201403

出　　处：《国际生物制品学杂志》2024年第5期281-284,共4页International Journal of Biologicals

基　　金：国家科技重大专项(2018ZX09738003-005)。

摘　　要：目的通过考察与腮腺炎病毒原液直接接触的一次性储液袋在冻存情况下的浸出物水平,评估使用一次性储液袋冻存腮腺炎病毒原液的安全性。方法将使用一次性储液袋和标准肖特瓶盛装的腮腺炎病毒模拟料液放置于-60℃以下冰箱保存,分别于0、6、12、15个月各取出3份样品,以提取物研究中检出的丙酮、叔丁醇和异丙醇作为靶标物质进行浸出物检测及安全剂量分析。结果丙酮、叔丁醇和异丙醇在保存周期中均于15个月时出现检出最高峰,浸出物含量分别达到415.02、275.82和936.92μg/L,且各检测时间节点一次性储液袋浸出物含量均低于允许日接触量或安全评估阈值。结论使用一次性储液袋冻存的腮腺炎病毒模拟料液的浸出物含量未超出安全范围,安全性风险小。Objective To investigate the leaching level of extracts in disposable liquid storage bags directly in contact with mumps virus stock solution under cryopreservation,in order to evaluate the safety of mumps virus stock solution cryopreservation in disposable storage bags.Methods The mumps virus simulant liquid stored in disposable liquid storage bags and standard schott bottles was kept in-60℃freezer.Three samples were taken out at 0,6,12 and 15 months,respectively.Extract detection and safety dose analysis were conducted using acetone,tert-butanol and isopropanol detected in the extraction experiment as target substances.Results The highest detection peaks of acetone,tert-butanol and isopropanol were detected at 15 months,and the extracts concentrations reached 415.02,275.82 and 936.92μg/L,respectively.The extracts concentrations in disposable storage bags at each detection time point were lower than the allowable daily exposure or safety assessment threshold.Conclusion The extract content of mumps virus simulated liquid in disposable liquid storage bag under cryopreservation does not exceed the safety range,and the safety risk is small.

关 键 词：腮腺炎疫苗 腮腺炎病毒原液 一次性储液袋 浸出物 

分 类 号：R392-33[医药卫生—免疫学] R512.1[医药卫生—基础医学]