目的 采用Pierce^TM Quantitative Colorimetric peptide assay試劑盒（試劑盒法）和福林酚法分別測定鹿瓜多肽注射液中多肽，對兩種測定方法的優(yōu)劣進行比較。方法 考察試劑盒法的檢測限、線性關(guān)系、準確度和精密度試驗以及福林酚法的線性關(guān)系、準確度和精密度試驗，采用試劑盒法和福林酚法分別測定鹿瓜多肽注射液中多肽，并對兩種方法的測定結(jié)果進行配對t檢驗比較兩種方法的優(yōu)劣。結(jié)果 試劑盒法和福林酚法的方法學參數(shù)均符合要求，統(tǒng)計結(jié)果顯示兩種方法測得結(jié)果之間沒有顯著差異，同時發(fā)現(xiàn)，試劑盒法比福林酚法操作簡單、快捷。結(jié)論 試劑盒法可以用于鹿瓜多肽注射液中多肽的測定，比福林酚法操作簡單、耗時少、通量大，特別適合大批量樣品的快速測定。

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年國家藥品抽檢中央補助地方經(jīng)費項目（153）；天津市市場監(jiān)督管理委員會科技計劃項目（2020-W26）