摘要
目的筛选并建立安菲博肽生物学活性测定方法。方法通过对比光学比浊法、电阻法、连续血小板计数法,确定以连续血小板计数法检测安菲博肽生物活性,并对检测方法进行验证。结果以光学比浊法、电阻法、连续血小板计数法检测安菲博肽生物活性的RSD分别为10.3%、14.0%和3.6%;6份平行供试品的重复性RSD为11.0%;不同人员12份供试品的中间精密度RSD为9.8%;安菲博肽在0.3~0.5 U范围内,抑制率呈线性关系,相关系数>0.990,测定3批安菲博肽的活性,抑制率49.9%~53.6%,活性良好。结论所建立的连续血小板计数法检测安菲博肽生物活性,操作简便,专属性、准确度和精密度符合生物制品活性测定的要求,可用于安菲博肽活性的质量控制。
Objective To screen and establish a method for determining the biological activity of anfibatide.Methods 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 electrical impedance aggregometry,and continuous platelet count method were 10.3%,14.0%,and 3.6%,respectively.RSD of repeatability 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 activity 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 anfibatide activity since the precision and detection limit of the method met the requirement for activity assay of biological products.
作者
戴向荣
梁杰
蒋涛
李刚
许雷鸣
DAI Xiangrong;LIANG Jie;JIANG Tao;LI Gang;XU Leiming(Zhaoke Pharmaceutical(Hefei)Ltd.,Hefei 230088,China;Anhui Institutes for Food and Drug Control,Hefei 230051,China)
出处
《医药导报》
CAS
北大核心
2024年第3期431-435,共5页
Herald of Medicine
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
Anfibatide
Light transmittance aggregometry
Whole blood electrical impedance aggregometry
Continuous platelet count method
Biological activity
