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目的研究重组人血管内皮抑制素(endostar)冻干粉针剂的制备和质量控制。方法以4%甘露醇、2%蔗糖、30mm乙酸钠为辅料,将endostar制备成冻干粉针剂。分别采用聚丙烯酰胺凝胶电泳法(SDS-PAGE)和高效液相法(HPLC)分析冻干粉的纯度,使用人脐带静脉内皮细胞(HUVEC)分析冻干粉的活性,其他检测项目按照《中国药典》进行。结果 Endostar冻干粉的纯度大于99%,生物学活性每支含量2.4×105U,等电点主区带在8.8～9.8之间,冻干粉用胰蛋白酶消化后,肽图与理化对照品一致。结论按照此工艺制备的endostar冻干粉针剂各项指标均符合《中国药典》要求。
Objective To study the preparation and quality control of recombinant human endostar lyophilized powder injection. Methods 4% mannitol, 2% sucrose, 30mm sodium acetate as excipients, the endostar was prepared as lyophilized powder. The purity of lyophilized powder was analyzed by polyacrylamide gel electrophoresis (SDS-PAGE) and high performance liquid chromatography (HPLC), respectively. The activity of freeze-dried powder was analyzed by human umbilical vein endothelial cells (HUVEC) Chinese Pharmacopoeia “. Results The purity of Endostar freeze-dried powder was more than 99%, the content of each activity was 2.4 × 105U, and the isoelectric point was between 8.8 ~ 9.8. After lyophilized powder was digested with trypsin, . Conclusion The endostar freeze-dried powder prepared according to this procedure all meet the requirements of ”Chinese Pharmacopoeia".