HPLC波长切换法同时测定排毒养颜胶囊中10种成分  

Simultaneous determination of 10 components in Paidu Yangyan Capsules by HPLC wavelength change method

作　　者：李静 张青 肖春霞 蒲旭峰 LI Jing;ZHANG Qing;XIAO Chun-xia;PU Xu-feng(College of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611130,China;Chengdu Institute for Food and Drug Control,Chengdu 610000,China)

机构地区：[1]成都中医药大学药学院,四川成都611130 [2]成都市食品药品检验研究院,四川成都610000

出　　处：《中草药》2018年第20期4824-4830,共7页Chinese Traditional and Herbal Drugs

基　　金：<中国药典>2020年版标准提高项目(479)

摘　　要：目的利用HPLC法同时测定排毒养颜胶囊中番泻苷A、番泻苷B、松果菊苷、毛蕊花糖苷、橙皮苷、芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚的含量,结合化学模式识别评价不同批次排毒养颜胶囊的质量差异。方法结合变波长检测器,建立同时测定15批次排毒养颜胶囊中10种成分含量的HPLC法,并对含量测定结果进行主成分分析(PCA)和聚类分析,综合评价市售排毒养颜胶囊质量的差异性。结果排毒养颜胶囊中番泻苷A、番泻苷B、松果菊苷、毛蕊花糖苷、橙皮苷、芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚10种成分分别在0.167 4～2.093 0、0.093 5～1.177 0、0.075 9～0.948 6、0.049 9～0.623 7、0.109 0～1.363 0、0.033 5～0.418 4、0.079 7～0.996 1、0.013 9～0.174 3、0.025 2～0.315 6、0.012 3～0.061 4μg/m L线性关系良好;平均加样回收率分别为99.84%、99.15%、99.34%、99.81%、100.6%、99.36%、99.86%、100.1%、100.1%、99.76%,RSD均<2.0%;检测限为0.64～2.18 ng/m L;定量限为3.19～9.55 ng/m L;15批样品中10种有效成分的含量分别为0.712 7～1.118 0、0.403 9～0.522 0、0.236 4～0.320 3、0.671 1～1.183 0、0.058 0～0.146 7、0.108 7～0.259 2、0.014 7～0.050 1、0.517 3～0.582 8、0.275 4～0.305 1、0.162 1～0.185 3 mg/粒,各批次样品存在一定差异,主要是不同大黄投料造成。结论实验建立的方法简便准确、重复性好,可用于排毒养颜胶囊的质量控制,提示厂家在制剂生产过程中要加强对大黄药材的质量控制,为排毒养颜胶囊后续质量提高提供参考。Objective The contents of sennoside A,sennoside B,echinacoside,verbascoside,hesperidin,aloe-emodin,rhein,emodin,chrysophanol,and rheochrysidin in Paidu Yangyan Capsules（PYC） were determined by HPLC.The quality of different batches of psoralen were evaluated by chemical pattern recognition.Methods HPLC was established for the simultaneous determination of 10 components in 15 batches of PYC with variable wavelength detector,and the results were analyzed by principal component analysis and cluster analysis to comprehensively evaluate the difference in quality of PYC which is available in the market.Results The contents of sennoside A,sennoside B,echinacoside,verbascoside,hesperidin,aloe-emodin,rhein,emodin,chrysophanol,and rheochrysidin in PYC had good linear relationship in the ranges of 0.167 4-2.093 0,0.093 5-1.177 0,0.075 9-0.948 6,0.049 9-0.623 7,0.109 0-1.363 0,0.033 5-0.418 4,0.079 7-0.996 1,0.013 9-0.174 3,0.025 2-0.315 6,and 0.012 3-0.061 4 μg/m L,the average sample recovery rate range were 99.84%,99.15%,99.34%,99.81%,100.6%,99.36%,99.86%,100.1%,100.1%,and 99.76%（RSD 2.0%）,the detection limits were 0.64-2.18 ng/m L,quantitative limits were 3.19-9.55 ng/m L,the content of 10 active ingredients in 15 batches of samples respectively were 0.712 7-1.118 0,0.403 9-0.522 0,0.236 4-0.320 3,0.671 1-1.183 0,0.0580-0.1467,0.108 7-0.2592,0.0147-0.0501,0.5173-0.5828,0.2754-0.3051,and 0.1621-0.1853 mg/grain and there were some differences among the samples in different batches,mainly due to different rhubarb dosages.Conclusion The established method is simple,accurate and reproducible,and can be used to control the quality of PYC.It is suggested that the quality control of Rhei Radix et Rhizoma should be strengthened in the process of preparation production for providing a reference of PYC follow-up quality improvement.

关 键 词：HPLC 排毒养颜胶囊 含量测定 主成分分析 一致性评价 番泻苷A 番泻苷B 松果菊苷 毛蕊花糖苷 橙皮苷 芦荟大黄素 大黄酸 大黄素 大黄酚 大黄素甲醚 

分 类 号：R286.02[医药卫生—中药学]