自体树突状细胞注射液制备和初步稳定性试验  

Autologous Dendritic Injection preparation process and different formulation prescriptions on the stability

作　　者：刘俊云 邹沛华 邓海英 王东凯[1] LIU Junyun;ZOU Peihua;DENG Haiying;WANG Dongkai(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;HRYZ Biotech Company,Guangzhou 510663,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]恒瑞源正生物科技有限公司,广东广州510663

出　　处：《中国药剂学杂志（网络版）》2024年第2期31-39,共9页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的通过进行鲜活的自体树突状细胞(Dentritic Cells,DC)注射液的制备、质量检测、制剂处方筛选和初步稳定性试验,确定DC注射液的制备流程、制剂处方和有效期。方法首先,制备DC注射液并进行质量检测,通过观察DC在含不同浓度人血白蛋白的0.9%氯化钠注射液中的细胞存活率,选择合适的DC注射液处方;然后,分别在(5±3)℃、(25±1)℃或(37±1)℃保存,进行初步稳定性试验,确定DC注射液的有效期。结果显示DC在含0.25%人血白蛋白的氯化钠注射液的制剂处方中,在(5±3)℃贮存至6小时,DC注射液的细胞存活率>90%,其它各项质量检测指标均符合规定;在(25±1)℃或(37±1)℃贮存时,树突状细胞的稳定性分别维持3小时和1小时。结论该制备流程制备的DC注射液各项指标均符合质量标准的规定,鲜活的DC注射液在含有0.25%人血白蛋白的氯化钠注射液中,(5±3)℃贮存的有效期为6小时。Objective:To evaluate the effects of different formulation prescriptions on the stability of dendritic cells in order to define an appropriate formulation prescription of fresh dendritic cell infusion and to determine its expiration date.Methods:Human dendritic cells were suspended in 0.9%Sodium Chloride(NaCl)injections alone or in 0.9%NaCl injections containing 0.125%~0.50%human albumin to generate dendritic cell injections.The cell injections were stored at(5±3)℃,(25±1)℃,or(37±1)℃,and the stability of injections was evaluated by measuring the cell survival rate at different time points.Results:Compared with 0.9%NaCl infusion alone,0.9%NaCl injections with 0.125%~0.50%human albumin significantly increased the survival rate of dendritic cells and effectively prevented cell aggregation after 4 h storage at(5±3)℃.The 0.9%NaCl infusion with 0.25%human albumin was selected as the formulation prescription of fresh dendritic cell infusion.The stability of dendritic cell injections was further evaluated at different temperatures.The results showed that the cell survival rate of fresh dendritic cell injections was over 90%after 6 h storage at(5±3)℃.When dendritic cell infusion were stored at(25±1)℃or(37±1)℃,the stability of dendritic cells were maintained for 3 h and 1 h,respectively.Conclusion:All indexes of DC injection prepared by this preparation process meet the requirements of quality standards.The validity period of fresh DC injection stored in NaCl injection containing 0.25%human blood albumin at(5±3)℃is 6 hours.

关 键 词：自体免疫细胞治疗产品 树突状细胞 制备工艺 制剂处方 稳定性试验 

分 类 号：R94[医药卫生—药剂学]