注射用促肝细胞生长素的质量考察

Study on the quality of hepatocyte hrowth-promotting factors for injection

目的研究注射用促肝细胞生长素的质量。方法测定水分、游离氨基酸、稳定剂、赋形剂含量 ,并考察制剂外观。结果与正常组比较 ,萎缩组游离氨基酸含量显著增加 (P <0 .0 1 ) ,褐变组稳定剂含量显著减少 (P <0 .0 1 ) ,水分含量增加 (P <0 .0 5)。结论在现有工艺条件下 ,注射用促肝细胞生长素外观质量与游离氨基酸、稳定剂、水分有关 。

PurposeTo study the quality of hepatocyte growth promotting factors for injection(HGF).MethodsThe contents of moisture, free amino acid (FAA),sodium chloride , excipient and stabilizer were determined, and the preparation exterior was investigated.ResultsCompared with the normal group, FAA was increased significantly in the shrinkage group( P < 0.01 ), while stabilizer was decreased significantly( P < 0.01 ),and moisture was increased ( P <0.05) in the browning group. ConclusionThe contents of FAA, stabilizer and moisture showed the relationship with the exterior quality of HGF under the present processing condition. Quality could be guaranteed by controlling these parameters.