关键词: 注射用促肝细胞生长素, 降压物质检查, 组胺类物质检查

Abstract: Objective To study the feasibility of histamine-like substance test in hepatocyte growth-promoting factors for injection safety. Method Histamine-like substance and depressor substance in three batches of hepatocyte growth-promoting factors was test according to the test method in the appendix of Chinese Pharmacopoeia (edition 2015) and the result of the tests were compared. Result The test result of histamine-like substance test in all three batches of hepatocyte growth-promoting factors were consistent with the test result of depressor substance test and met the requirement of Chinese Pharmacopoeia. While positive result were observed in depressor substance test, but negative result observed in histamine-like substance test. Conclusion Hepatocyte growth-promoting factors for injection may cause drop of blood pressure without histamine-like substance, and in vivo experiments cannot be extrapolate simply by the result of in vitro experiments.

Key words: Hepatocyte growth-promoting factors for injection, depressor substance test, histamine-like substance test