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(cè)定鹿瓜多肽注射液中多肽，對(duì)兩種測(cè)定方法的優(yōu)劣進(jìn)行比較。方法 考察試劑盒法的檢測(cè)限、線性關(guān)系、準(zhǔn)確度和精密度試驗(yàn)以及福林酚法的線性關(guān)系、準(zhǔn)確度和精密度試驗(yàn)，采用試劑盒法和福林酚法分別測(cè)定鹿瓜多肽注射液中多肽，并對(duì)兩種方法的測(cè)定結(jié)果進(jìn)行配對(duì)t檢驗(yàn)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(xué)參數(shù)均符合要求，統(tǒng)計(jì)結(jié)果顯示兩種方法測(cè)得結(jié)果之間沒(méi)有顯著差異，同時(shí)發(fā)現(xiàn)，試劑盒法比福林酚法操作簡(jiǎn)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(cè)定，比福林酚法操作簡(jiǎn)單、耗時(shí)少、通量大，特別適合大批量樣品的快速測(cè)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(guó)家藥品抽檢中央補(bǔ)助地方經(jīng)費(fèi)項(xiàng)目（153）；天津市市場(chǎng)監(jiān)督管理委員會(huì)科技計(jì)劃項(xiàng)目（2020-W26）