基于指纹图谱和多成分定量评价地榆槐角丸质量

目的：建立地榆槐角丸HPLC指纹图谱，测定其中7个有效成分含量。方法：采用HPLC法，以甲醇（A）-0.05%磷酸水溶液（B）为流动相梯度洗脱，流速为1.0 mL·min^-1，检测波长278 nm，柱温35℃，进样量10 μL，通过相似度评价对14批地榆槐角丸指纹图谱进行质量评价，并对其中的7个指标成分进行定量分析。结果：在指纹图谱研究中，标定了20个共有峰，通过与对照品比较指认其中7个共有峰分别为没食子酸、芍药苷、柚皮苷、芦丁、槐角苷、黄芩苷和升麻素苷，14批地榆槐角丸与对照图谱的相似度均在0.90以上。结论：所建立的地榆槐角丸指纹图谱和含量测定分析方法可用于地榆槐角丸的质量控制。

Objective: To establish the HPLC fingerprints of Diyu Huaijiao pills and determine the contents of seven compounds. Methods: HPLC analysis was performed with methanol(A)-0.05% phosphoric acid aqueous solution(B)as the mobile phase at a flow rate of 1.0 mL·min^-1. The detection wavelength was 278 nm and column temperature was 35℃. The injection volume was 10 μL. Similarity evaluation was used to evaluate the fingerprints of 14 batches of Diyu Huaijiao pills and seven markers were quantified. Results: The common mode of the fingerprint showed 20 common peaks,7 of which were identified by comparison with the reference substances. They were gallic acid,paeoniflorin,naringin,rutin,sophoricoside,baicalin and prim-O-glucosylcimifugin. The similarities of 14 batches of samples were above 0.90. Conclusion: The established method can be used for the quality control of Diyu Huaijiao pills.

[1] 中华人民共和国药典2015年版.一部[S].2015:821 ChP 2015.VolⅠ[S].2015:821
[2] 卢静华.RP-HPLC法同时测定地榆槐角丸中芍药苷、橙皮苷和黄芩苷[J].中成药,2013,35(9):1929 LU JH.Simultaneous determination of paeoniflorin,hesperidine and baicalin in Diyu Huaijiao pills by RP-HPLC[J].Chin Tradit Pat Med,2013,35(9):1929
[3] 孟珺,王立军.HPLC同时测定槐角丸中槐角苷、黄芩苷和柚皮苷含量[J].中药材,2011,34(4):638 MENG J,WANG LJ.Simultaneous determination of sophoricoside,baicalin and naringin in Huaijiao pills by HPLC[J].J Chin Med Mater,2011,34(4):638
[4] 靳怡然,田婷婷,贺璠,等.液相色谱-串联质谱法同时测定地榆槐角丸中9种化学成分[J].河北医科大学学报,2015,36(7):745 JIN YR,TIAN TT,HE F,et al.Simultaneous determination of nine constituents in Di-Yu-Huai-Jiao pill by LC-MS/MS[J].J Hebei Med Univ,2015,36(7):745
[5] 魏晓亮,王冬梅,张瑜,等.RP-HPLC同时测定槐角丸中4种有效成分的含量[J].中国药学杂志,2011,46(7):549 WEI XL,WANG DM,ZHANG Y,et al.Simultaneous determination of four components in Huaijiao pills by RP-HPLC[J].Chin Pharm J,2011,46(7):549
[6] 黎春彤,段斯庭,李翔,等.HPLC法同时测定化瘀祛斑胶囊中芍药苷、黄芩苷和黄芩素的含量[J].中国药师,2018,21(7):1287 LI CT,DUAN ST,LI X,et al.Determination of paeoniflorin,baicalin and baicalein in Huayuquban capsules by HPLC[J].China Pharm,2018,21(7):1287
[7] 李强,朱晓红,王强,等.三黄颗粒HPLC指纹图谱与化学模式识别分析[J].解放军药学学报,2015,31(3):194 LI Q,ZHU XH,WANG Q,et al.HPLC fingerprint and chemical pattern recognization of Sanhuang granules[J].Pharm J Chin PLA,2015,31(3):194
[8] 李莉娜,杨淑婷,杨健,等.生芪消渴胶囊UPLC指纹图谱建立及6种成分含量测定[J].中国新药杂志,2018,27(18):2196 LI LN,YANG ST,YANG J,et al.Establishment of UPLC fingerprint and determination of six components of Shengqi Xiaoke capsules[J].Chin J New Drugs,2018,27(18):2196
[9] 周志,谢耀轩,黄文婷,等.双黄连颗粒高效液相指纹图谱和特征色谱峰归属研究[J].中医学报,2018,33(9):1721 ZHOU Z,XIE YX,HUANG WT,et al.Attribution study on fingerprint and characteristic chromatographic peak of Shuanghuanglian granules by high performance liquid chromatography[J].Acta Chin Med,2018,33(9):1721
[10] 杨静,罗廷顺.清火栀麦片HPLC指纹图谱的建立和3种成分含量测定[J].中国药师,2017,20(4):673,679 YANG J,LUO TS.Establishment of the HPLC fingerprint of Qinghuo Zhimai tablets and determination of three constituents[J].China Pharm,2017,20(4):673,679
[11] 曹瑞竹.木香顺气丸HPLC特征指纹图谱研究及多成分含量测定[J].药物分析杂志,2017,37(6):1127 CAO RZ.Fingerprint and multi-components determination of Muxiang Shunqi pills by HPLC[J].Chin J Pharm Anal,2017,37(6):1127
[12] 康帅,张炜,郑健,等.淫羊藿黄酮苷类成分的指纹图谱与含量测定研究[J].中国药品标准,2018,19(5):359 KANG S,ZHANG W,ZHENG J,et al.Investigation of fingerprint and assay of flavonoid glycosides in Epmedii Folium[J].Drug Stand China,2018,19(5):359
[13] 高燕,吕凌,王亮,等.银黄颗粒HPLC指纹图谱与模式识别分析[J].中华中医药杂志,2017,32(9):4238 GAO Y,LV L,WANG L,et al.Analysis of HPLC fingerprint and pattern recognition of Yinhuang granules[J].Chin J Tradit Chin Med,2017,32(9):4238