他克莫司降压物质检查法的研究

Study on the test method of depressor substance of tacrolimus

目的:建立他克莫司降压物质检查方法,提高其临床用药安全。方法:通过对他克莫司与组胺对照品引起麻醉猫血压下降程度比较研究,确定他克莫司降压物质检查法的限值。结果:降压物质检查项限值定为0. 5 mg·kg^(-1),按此限值检查,三批样品降压作用均不大于对照品的降压作用的一半。结论:建立的他克莫司降压物质检查法方法可行。

Objective:To establish the depressor substance test method of tacrolimus and improve the safety of drug clinical use.Methods :The limit of the depressor substance test of tacrolimus was determined by the comparative study on tacrolimus and histamine causing the decrease of blood pressure of anesthetic cats.Results:The limit of depressor substance test was defined as 0.5mg·kg^-1.As per this limit test,the hypotensive effect of three batches of samples was not more than half of that of the control substance.Conclusion:The established test method of the depressor substance of tacrolimus is feasible.