注射用促肝细胞生长素中组胺类物质检查和降压物质检查的比较研究

目的 探讨注射用促肝细胞生长素安全性检查中，以组胺类物质检查法替代降压物质检查法的可能性。方法 按照《中国药典》2015年版中降压物质检查和组胺类物质检查方法的规定，分别对3批注射用促肝细胞生长素进行降压物质检查和组胺类物质检查，比较两种检查方法结果的异同。结果 1.根据药典相关判定标准，3批注射用促肝细胞生长素降压物质检查和组胺类物质检查结果一致，均符合规定。2. 降压物质检查中3批注射用促肝细胞生长素均引起猫血压明显下降，结果呈阳性；3批供试品均未引起豚鼠离体回肠收缩，结果呈阴性。结论 注射用促肝细胞生长素在组胺类物质含量符合要求时也可能引起动物血压明显下降，体外实验结果不能简单扩推至体内实验。

Comparison of Test Method for Histamine-like Substance and Depressor Substance in Hepatocyte Growth-promoting Factors for Injection

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.