注射用促肝细胞生长素辅料的研究

寻找一种注射用促肝细胞生长素（ＨＧＦ）适用的辅料。方法：以三批不同批次的ＨＧＦ原料液为实验对象，分别通过 Ｆｏｌｉｎ－酚和~３Ｈ－ＴｄＲ掺入法研究了三种辅料： ３％右旋糖酐， ８％甘露醇， ２％右旋糖酐＋ ８％甘露醇对ＨＧＦ多肽含量及活性的影响。结果：８％甘露醇作为辅料时使ＨＧＦ多肽含量测定显著增高，而右旋糖酐则不影响测定结果。三种辅料对ＨＧＦ活性均无显著影响。结论：最终选用３％右旋糖酐作为ＨＧＦ的辅料。

Studies on the Excipient of Hepatocyte Growth-promoting Factor for Injection

Purpose: To find an apposite stabilizer and excipient for hepatocyte growth-promoting factor (HGF). Methods: 3% dextran, 8% mannitol and 2% dextran plus 8% mannitol were selected as the stabilizer and excipient of HGF respectively. And the influence caused by them was studied on assay of the content of polypeptide in HGF by Lowry method and on assay of the activity of HGF by 3~ H-TdR method. Results: 8 % mannitol made a significantly and remarkably higher content of polypeptide, wherease 3% dextran had little influence. And the stabilizer and excipient had no significantly remarkable influence on the activity of HGF. Conclusion: Finally, 3% dextran was determined as the optimal stabilizer and excipient by comparing.