兔血浆-APTT法测定水蛭抗凝血活性的剂量-效应曲线考察和测定方法确定研究  

Study on dose-response curve of rabbit plasma-APTT method for determination of anticoagulant activity of leeches

作　　者：肖斯婷 胡宇驰 郭玉东 许华玉[2] 杨文良 李波[3] XIAO Si-ting;HU Yu-chi;GUO Yu-dong;XU Hua-yu;YANG Wen-liang;LI Bo(Beijing Institute for Drug Control,NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drug,Beijing Key Laboratory of Analysis and Evaluation on Chinese,Beijing 102206,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]北京市药品检验研究院、国家药品监督管理局创新药物安全研究与评价重点实验室、中药成分分析与生物评价北京市重点实验室,北京102206 [2]国家药典委员会,北京100061 [3]中国食品药品检定研究院,北京102629

出　　处：《中国药理学通报》2023年第1期170-177,共8页Chinese Pharmacological Bulletin

基　　金：国家药典委员会药品标准提高研究(No2016453)。

摘　　要：目的进行兔血浆-APTT法测定水蛭抗凝血活性的统计模型选择研究。方法制备水蛭浸提液,测定不同剂量浸提液加入兔血浆后的APTT值,进行剂量-效应曲线考察,统计分析后选择符合要求的最佳生物检定方法模型,并进行样品的预测定。结果在低于30 g·L^(-1)的剂量下,水蛭的浓度与APTT值的对数呈现直线关系,符合斜率比法测定的统计模型的要求,采用3剂量法进行3批蚂蟥和4批医蛭的预测定表明方法可行,且蚂蟥和日本医蛭应分别采用不同对照药材进行测定。结论斜率比法是适宜的量化测定水蛭抗凝血活性的生物检定方法。Aim To study the selection of statistical model for the determination of anticoagulant activity of leeches by rabbit plasma-APTT.Methods Leech extract was prepared,APTT value of different doses of leech extract was measured after adding rabbit plasma,dose-effect curve was investigated,and the best biological assay model was selected after statistical analysis,and the sample was predicted.Results When the dose was lower than 30 g·L^(-1),the logarithm of leech concentration and APTT value showed a linear relationship,which was in line with the requirements of the statistical model determined by slope ratio method.The method was feasible to predict 3 batches of leech and 4 batches of medical leech by using 3-dose method,and different control materials should be used for determination of leech and Japanese medical leech.Conclusions Slope ratio method is a suitable method for quantitative determination of anticoagulant activity of leeches.

关 键 词：水蛭 抗凝血活性 测定方法 APTT法 剂量-效应曲线 斜率比法 

分 类 号：R-332[医药卫生] R282.74R446.11R917R973.2