注射用糜蛋白酶中组胺类物质检查方法学研究

Study on histamine test in chymotrypsin for injection

目的:建立注射用糜蛋白酶中组胺类物质检查方法。方法:采用组胺检查法对注射用糜蛋白酶中组胺类物质进行限度检查方法学研究,并与现行猫法进行比较研究。结果:加标回收率86%～117%;豚鼠法方法特异性(真阴性率) 100%,灵敏度(真阳性率) 70%,猫法方法特异性100%,灵敏度68%;四个实验室室内重复性分别为82%、75%、83%、81%;实验室间重复性为92. 9%～96. 4%.结论:该法准确度与猫法相当、重复性好,可作为降压物质检查法的替代方法。

Objective:To establish a method of histamine test in Chymotrypsin for injection.Methods:The histamine in Chymotrypsin for Injection was tested by the method of histamine test,and compared with depres- sor substance test.Results:The spiked recoveries were from 86% to 117%.The sensitivity of histamine test, which described the probability of correctly classifying positive samples,was 70% and specificity,which described the probability of correctly classifying negative samples,was 100%.The specificity and sensitivity of depressor substance test were 100% and 68% respectively.The within-laboratory reproducibilities of this method in four laboratories were 82%,75%,83%,81% respectively,and the inter-laboratory reproducibilities were 92.9%-96.4%.Conclusion:The established method of histamine test in Chymotrypsin for Injection has the high sensitivity and good reproducibility,and it can substitute the method of depressor sub- stance test.