目的 采用Pierce^TM Quantitative Colorimetric peptide assay试剂盒（试剂盒法）和福林酚法分别测定鹿瓜多肽注射液中多肽，对两种测定方法的优劣进行比较。方法 考察试剂盒法的检测限、线性关系、准确度和精密度试验以及福林酚法的线性关系、准确度和精密度试验，采用试剂盒法和福林酚法分别测定鹿瓜多肽注射液中多肽，并对两种方法的测定结果进行配对t检验比较两种方法的优劣。结果 试剂盒法和福林酚法的方法学参数均符合要求，统计结果显示两种方法测得结果之间没有显著差异，同时发现，试剂盒法比福林酚法操作简单、快捷。结论 试剂盒法可以用于鹿瓜多肽注射液中多肽的测定，比福林酚法操作简单、耗时少、通量大，特别适合大批量样品的快速测定。

Objective To determine the polypeptides in Cervus and Cucumis Polypeptide Injection by the Pierce^TM Quantitative Colorimetric peptide assay kits (kits method) and foline-phenol method, and compare the advantages and disadvantages of the two methods. Methods The limit of detection, linearity, accuracy, and precision of the kits method and the linearity, accuracy, and precision of the foline-phenol method were studied, then the polypeptides contents of Cervus and Cucumis Polypeptide Injection were used to determine by two methods. The results of the two methods were tested by paired t-test and the advantages and disadvantages of the two methods were compared. Results The kits method and the foline-phenol method were both complied with the requirements. The statistics results showed that there were no significant difference between two methods. The kits method was simple and fast than the foline-phenol method. Conclusion The kits method is also suitable for the determination of the polypeptide contents of Cervus and Cucumis Polypeptide Injection and it is more simple, time-saving, and high flux than the foline-phenol method, and especially suitable for rapid determination of large quantities of samples.

R286.02

2019年国家药品抽检中央补助地方经费项目（153）；天津市市场监督管理委员会科技计划项目（2020-W26）