慢肾康颗粒HPLC指纹图谱及含量测定研究  

Study on Establishment of HPLC Fingerprint and Content Determination of Manshenkang Granules(慢肾康颗粒)

作　　者：肖满 龚年春 李旻熹 李鹏辉 彭艳梅[2,3] 杨永玉 向大雄[4,5] 唐裕宬 李泳江[4] 黄思 XIAO Man;GONG Nianchun;LI Minxi;LI Penghui;PENG Yanmei;YANG Yongyu;XIANG Daxiong;TANG Yucheng;LI Yongjiang;HUANG Si(Hunan University of Chinese Medicine,Changsha Hunan 410208,China;Hunan Academy of Chinese Medicine,Changsha Hunan 410013,China;Research and Development Platform of Hunan Furong Laboratory for Key Technologies of TCM Preparations,Changsha Hunan 410013,China;Department of Pharmacy,The Second Xiangya Hospital of Central South University,Changsha Hunan 410011,China;Hunan Provincial Engineering Research Central of Translational Medical and Innovative Drug,Changsha Hunan 41001l,China)

机构地区：[1]湖南中医药大学,湖南长沙410208 [2]湖南省中医药研究院,湖南长沙410013 [3]湖南省芙蓉实验室中药制剂关键技术研发平台,湖南长沙410013 [4]中南大学湘雅二医院药学部,湖南长沙410011 [5]湖南省转化医学与创新药物工程技术研究中心,湖南长沙410011

出　　处：《中医药导报》2024年第4期61-66,共6页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：长沙市科技重大专项(kh2103006)。

摘　　要：目的:建立慢肾康颗粒高效液相色谱(HPLC)指纹图谱,并测定其有效成分丹酚酸B含量,为慢肾康颗粒的综合质量控制提供参考。方法:采用HPLC法,Welch Ulimate Plus C_(18)色谱柱(4.6 mm×250 mm,5μm),以乙腈-0.1%磷酸溶液为流动相,梯度洗脱,流速1.0 mL/min,检测波长260 nm、280 nm,柱温30℃,建立慢肾康颗粒指纹图谱,并在最佳条件下对丹酚酸B进行含量测定。结果:建立的慢肾康颗粒HPLC指纹图谱共标定12个色谱峰,通过对照品和对照药材比对,分别指认了5种化学成分和5味中药的特征峰;丹酚酸B在33.93~203.58μg/mL范围内呈良好的线性关系(r=0.999 7),稳定性、重复性试验的RSD值均小于3.0%,平均加样回收率为103.30%,RSD值为1.35%。结论:本研究建立的HPLC指纹图谱及含量测定方法准确,重复性和稳定性好,可以为慢肾康颗粒质量控制提供参考。Objective:To establish the high performance liquid chromatograph(HPLC)fingerprints for Manshenkang Granules(慢肾康颗粒),and to determine the contents of salvianolic acid B,then to provide a reference for the quality control of Manshenkang Granules.Methods:HPLC was used to establish the fingerprint of Manshenkang Granules.The separation was performed on a 30℃ Welch Ulimate Plus C_(18) column(4.6mmx 250 mm,5μm)by using a gradient elution with acetonitrile-0.1%phosphoric acid aqueous solution.The flow rate was 1.0 mL/min and the detection wavelength was set as 260 nm and 280 nm.The content of salvianolic acid B was also determined under optimal conditions.Results:There were 12 chromatographic peaks calibrated in the HPLC fingerprints of Manshenkang Granules.And the characteristic peaks of 5 chemical components and 5 medicinal materials were identified by the comparison of reference substance and reference medicinal materials.Salvianolic acid B showed a good linear relationship in the range of 33.93 to 203.58μg/mL(r=0.9997).The RSD of stability and repeatability tests were both less than 3.0%,and the average recovery rate was 103.30%with the RSD of 1.35%.Conclusion:The HPLC fingerprint and content determination method estab-lished in this study is accurate,repeatable and stable,which can provide a reference for the quality control of Manshenkang granules.

关 键 词：慢肾康颗粒 高效液相色谱 指纹图谱 含量测定 丹酚酸B 

分 类 号：R284.1[医药卫生—中药学]