王婷婷,朴晋华,张蕻,高华.注射用糜蛋白酶中组胺类物质检查方法学研究[J].中国药品标准,2018,19(6):448-452 |
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 |
投稿时间:2018-10-19 修订日期:2018-11-06 |
DOI: |
中文关键词: 注射用糜蛋白酶 组胺类物质检查 豚鼠 离体回肠 |
英文关键词: Chymotrypsin for Injection histamine test guinea pigs isolated ileum |
基金项目:] 国家药典会国家药品标准提高研究课题,952;山西省实验动物科研专项,2009k05。 |
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中文摘要: |
【摘要】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70%;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:该方法准确与猫法相当、重复性好,可作为降压物质检查法的替代方法。 |
英文摘要: |
Objective:A method of histamine test in Chymotrypsin for injection was established. Methords: The histamine in Chymotrypsin for Injection was tested by method of histamine test,and compared with depressor substance test .Results: The recovery was 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 sensitivity and specificity of depressor substance test were 100% and 68%, respectively. The within-laboratory reproducibility of this method was 82%、75%、83%、81% in four laboratories |
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