医药导报2024，Vol.43Issue(3)：431-435,5.DOI:10.3870/j.issn.1004-0781.2024.03.018
安菲博肽生物活性测定
Bioactive Determination of Anfibatide
戴向荣 1梁杰 1蒋涛 1李刚 1许雷鸣2
作者信息
- 1. 兆科药业(合肥)有限公司,合肥 230088
- 2. 安徽省食品药品检验研究院,合肥 230051
- 折叠
摘要
Abstract
Objective To screen and establish a method for determining the biological activity of anfibatide.Meth-ods Three methods of light transmittance aggregometry(LTA),whole blood electrical impedance aggregometry,and continuous platelet count method were compared and studied.And the constant platelet counting method was chosen and verified to detect the biological activity of anfibatide.Results The RSD values of anfibatide biological activity detected by LTA,whole blood electri-cal impedance aggregometry,and continuous platelet count method were 10.3%,14.0%,and 3.6%,respectively.RSD of repeat-ability of 6 parallel test articles was 11.0%.The RSD of intermediate precision of 12 test articles for different personnel was 9.8%,and the inhibition rate of anfibatide was linear in the range of 0.3-0.5 U.The correlation coefficient was more than 0.990.The ac-tivity of three batches of anfibatide was determined,and the inhibition rate was 49.9%～53.6%.Conclusion The continuous platelet count method for determining anfibatide activity was established and verified,which can be used for quality control for an-fibatide activity since the precision and detection limit of the method met the requirement for activity assay of biological products.关键词
安菲博肽/光学比浊法/全血电阻法/连续血小板计数法/生物活性Key words
Anfibatide/Light transmittance aggregometry/Whole blood electrical impedance aggregometry/Continuous platelet count method/Biological activity分类
医药卫生引用本文复制引用
戴向荣,梁杰,蒋涛,李刚,许雷鸣..安菲博肽生物活性测定[J].医药导报,2024,43(3):431-435,5.
