[关键词]
[摘要]
目的 探索人脐带间充质干细胞复方电解质注射液制剂稳定性。方法 人脐带间充质干细胞(密度5×105/mL)分别与复方电解质注射液及0.9%氯化钠注射液(分别设加/不加2%人血白蛋白组)制备制剂,通过观察24 h内不同时间节点凋亡变化趋势优选出制剂方案;探讨该制剂的光照稳定性、热循环稳定性、加速稳定性以及长期稳定性。结果 复方电解质注射液制剂较0.9%氯化钠注射液制剂细胞凋亡水平低;2%白蛋白添加能够有效降低细胞凋亡水平。光照对复方电解质注射液添加2%白蛋白细胞制剂无严重影响;温度波动能导致细胞存活率快速下降;高温对细胞制剂状态有较大影响,导致絮状物大量出现,细胞存活率快速下降;在低温条件下,该制剂能长时间保持细胞存活率。结论 复方电解质注射液添加2%白蛋白是一种优良的人脐带间充质干细胞制剂方法。
[Key word]
[Abstract]
Objective To explore a preparation method of human umbilical cord mesenchymal stem cells and its stability in Multiple Electrolytes Injection. Methods Observed the apoptosis levels of human umbilical cord mesenchymal stem cells (5×105/mL) in Sodium Chloride Injection and Multiple Electrolytes Injection (2% human serum albumin was added or not). The best preparation was further studied, which included light stability, thermal cycle stability, accelerated stability and long-term stability. Results The apoptosis level of Multiple Electrolytes Injection preparation was lower than that of 0.9% sodium chloride injection, and 2% albumin could effectively reduce the apoptosis level. The results showed that light had no serious effect on the cell preparation supplemented with 2% albumin; the fluctuation of temperature could lead to the rapid decrease of cell survival rate; the high temperature had a great influence on the state of cell preparation, which led to the rapid decline of cell survival rate; under the condition of low temperature, the preparation could maintain the cell survival rate for a long time. Conclusion Multiple Electrolytes Injection is a good preparation method for stem cell.
[中图分类号]
R329
[基金项目]
国家重点研发计划“干细胞及转化研究”重点专项(2019YFA0112100);天津市科技计划项目(17ZXXYSY00020)