高冠平胶囊的质量标准提升研究  

Study on the improvement of quality standard for Gaoguanping Capsules

作　　者：赵利娟 李夕 李晔 任建平 李晓杰 程绪钊 刘小卫 王蓓 张俏 ZHAO Lijuan;LI Xi;LI Ye;REN Jianping;LI Xiaojie;CHENG Xuzhao;LIU Xiaowei;WANG Bei;ZHANG Qiao(Shaanxi Institute of Traditional Chinese Medicine(Shaanxi Medical Information Center),Xianyang 712000,China;Shaanxi Pharmaceutical Holding Pharmaceutical Research Institute Co.,Ltd,Xi’an 710075,China;Shaanxi Union Research Center of University and Enterprise,Separation and Preparation Technology of Traditional Chinese Medicine,Xi’an 710075,China;Shaanxi Key Laboratory for Chinese Medicine and Natural Medicine Research and Development,Xi’an 710075,China;Shanhaidan Hospital,Xi’an 710004,China)

机构地区：[1]陕西中药研究所(陕西医药信息中心),咸阳712000 [2]陕西医药控股医药研究院有限公司,西安710075 [3]陕西省“四主体一联合”中药提取分离与制剂工艺工程技术研究中心,西安710075 [4]陕西省中药及天然药物研发重点实验室,西安710075 [5]山海丹医院,西安710004

出　　处：《西北药学杂志》2025年第1期83-89,共7页Northwest Pharmaceutical Journal

基　　金：咸阳市重点研发计划项目(编号:2021ZDYF-SF-0011);陕西中药行业全产业链检验检测平台项目(编号:2021PT-040)。

摘　　要：目的 提升高冠平胶囊的质量标准,确保临床应用的安全性和有效性。方法 采用薄层色谱法(thin layer chromatography,TLC)鉴别高冠平胶囊中的葛根素和丹参酮ⅡA;采用高效液相色谱法(high performance liquid chromatography,HPLC)测定羟基红花黄色素A、葛根素和3’-甲氧基葛根素的含量。结果 高冠平胶囊中的葛根素和丹参酮ⅡA的TLC特征斑点清晰可见,分离效果好,且阴性样品无干扰。HPLC测定结果显示,羟基红花黄色素A、葛根素、3’-甲氧基葛根素分离度良好,质量浓度分别在相应范围内(1.63~32.61、5.94~118.79、4.90~97.90μg·mL^(-1))均与其峰面积线性关系良好(r≥0.999 8);平均加样回收率为98.85%~100.38%,相对标准偏差(relative standard deviation,RSD)均小于1.5%。结论 建立的高冠平胶囊TLC定性鉴别和HPLC定量测定方法简便、准确,专属性和重复性好,可用于提升高冠平胶囊的质量标准,加强其质量控制。Objective To improve the quality standard of Gaoguanping Capsules to ensure the safety and effectiveness in clinical application.Methods Puerarin and tanshinoneⅡA in Gaoguanping Capsules were identified by thin-layer chromatography(TLC).The content of hydroxysafflor yellow A,puerarin and 3’-methoxy puerarin in Gaoguanping Capsules was determined by high-performance liquid chromatography(HPLC).Results The TLC characteristic spots of puerarin and tanshinoneⅡA in Gaoguanping Capsules were clear,with good separation effect and without interference.The HPLC method showed excellent chromatographic separation of hydroxysafflor yellow A,puerarin and 3’-methoxy puerarin,and within the corresponding concentrations ranges(1.63~32.61,5.94~118.79,4.90~97.90µg·mL^(-1)),all of components showed a good linear relationship with their peak areas(r≥0.9998).The average recovery rates were in the ranges of 98.85%~100.38%,and the relative standard deviation(RSD)was less than 1.5%.Conclusion The established TLC qualitative identification and HPLC quantitative methods for Gaoguanping Capsules are simple,accurate,specific and reproducible,which can be used to improve the quality standard of Gaoguanping Capsules and strengthen the quality control of the capsules.

关 键 词：高冠平胶囊 薄层色谱法 高效液相色谱法 葛根素 丹参酮ⅡA 羟基红花黄色素A 3’-甲氧基葛根素 

分 类 号：R927[医药卫生—药学]