目的 研究葛根素注射劑的雜質(zhì)譜，并對雜質(zhì)進(jìn)行結(jié)構(gòu)鑒定。方法 建立高效液相梯度洗脫法，分析11個廠家共12批次葛根素注射劑雜質(zhì)譜，利用半制備高效液相對注射劑中的雜質(zhì)進(jìn)行分離并結(jié)合核磁技術(shù)進(jìn)行雜質(zhì)結(jié)構(gòu)確認(rèn)。結(jié)果 不同生產(chǎn)廠家及批次的葛根素注射劑雜質(zhì)種類及含量差別明顯，共分離并鑒定了注射劑中的5個雜質(zhì)，分別為3'-羥基葛根素、3'-甲氧基葛根素、染料木素-8-葡萄糖苷、新葛根素B、新葛根素A，均為葛根素異構(gòu)體或其衍生物。結(jié)論 采用此方法檢出的雜質(zhì)峰數(shù)目較現(xiàn)行方法多，且精密度高、重復(fù)性好。通過對葛根素注射劑雜質(zhì)譜的研究，可以有目的地控制部分雜質(zhì)，為質(zhì)量控制研究提供參考。

Objective To study the impurity profiling of Puerarin Injections and identify its chemical structures.Methods Twelve batches of Puerarin Injections from eleven manufactures were detected by establishing HPLC gradient analysis. High preparative performance liquid chromatography and NMR technique were used to isolate and identify the impurities.Results There were obvious differences in the numbers and content of impurities among the Puerarin Injections from different manufacturers. Five impurities were totally isolated from puerarin raw material and identified to be isomers or derivatives of puerarin, named 3'-hydoxypuerarin, 3'-methoxypuerarin, genistin-8-C-glucoside, neopuerarin B and neopuerarin A.Conclusion The method by which more peaks could be detected is accurate and reliable. Furthermore, the study on the impurity profiles of Puerarin Injections provides reference for the quality control of Puerarin Injection, according to this, several impurities can be controlled.