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.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.