生色底物法测定肝素钠的效价

Determination of the potency of heparin sodium by chromogenic substrate method

目的:基于生色底物法采用紫外可见光法和酶标仪法测定肝素钠的效价,以建立适当的检测方法。方法:采用两种方法对3批肝素钠注射液和3批肝素钠原料药进行效价测定,对获得的数据进行分析。结果:紫外可见光法有更优的重现性和准确性,其平均相对标准偏差和可信限率均小于酶标仪法;酶标仪法的检测用时明显少于紫外可见光法法,实验操作也更加便捷。结论:两种测定方法均可获得符合生物统计学要求的可靠、有效的数据。

Objective:To determine the potency of heparin sodium by UV-visible light method(UV-VIS) and microplate reader method(ELIASA) based on chromogenic substrate method so as to establish a suitable determination method.Methods:The potency heparin sodium from 3 batches of injection and 3 batches of active pharmaceutical ingredient(API) was determined by two approaches and their results were analyzed.Results:The UV-VIS had better reproducibility and accuracy,and its average relative standard deviation and confidence limit rate were smaller than those of the ELIASA.However,the detection time of the ELIASA was significantly less than that of the UV-VIS,and its experimental operation was also more convenient.Conclusion:Both assays can yield reliable and valid data meeting biostatistics requirement.