葛根素注射剂杂质研究

目的 研究葛根素注射剂的杂质谱，并对杂质进行结构鉴定。方法 建立高效液相梯度洗脱法，分析11个厂家共12批次葛根素注射剂杂质谱，利用半制备高效液相对注射剂中的杂质进行分离并结合核磁技术进行杂质结构确认。结果 不同生产厂家及批次的葛根素注射剂杂质种类及含量差别明显，共分离并鉴定了注射剂中的5个杂质，分别为3''-羟基葛根素、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，均为葛根素异构体或其衍生物。结论 采用此方法检出的杂质峰数目较现行方法多，且精密度高、重复性好。通过对葛根素注射剂杂质谱的研究，可以有目的地控制部分杂质，为质量控制研究提供参考。

Study on impurities of Puerarin Injection

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.