重组人血小板生成素参考品的研制

Establishment of Reference for Recombinant Thromobopoietin

目的 制备重组人血小板生成素参考品，为ｒｈＴＰＯ的体外生物学活性测定提供相对标准。方法 采用ＴＰＯ依赖细胞株进行ｒｈＴＰＯ体外生物学活性测定。结果 效价测定９次。ＳＤ＝０．１５７９．ＣＶ＝１４．１％，平均效价 为ｌ１０００Ｕ／支，其他项目均达到国家标准品要求。参考品置－２５℃保存６个月后稳定性良好。结论 作为参考品可 用于ｒｈＴＰＯ体外生物学活性控制。

Objective To establish the reference for rhTPO and provide a relative standard for the in vitro bioassay of rhTPO. Methods The in vitro biological activity of rhTPO was detected by using TPO-de-pendent cell strains. Results The biological activity was detected for 9 times. The result showed that the SD, CV and mean potency of the reference were 0. 1579,14.1 % and 11000U/ampoule respectively. All the other items meet the requirements for national standard.The reference was stable after being stored at-25℃ for 6 months. Conclusion The reference for rhTPO can be used for the control of the in vitro bioassay of rhTPO.