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HPLC法同时测定乙肝益气解郁颗粒中的11种成分

Simultaneous determination of eleven constituents in Yigan Yiqi Jieyu Granulesby HPLC
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摘要 目的 建立HPLC法同时测定乙肝益气解郁颗粒中柴胡皂苷a、柚皮苷、芍药苷、毛蕊异黄酮苷、丹参酮IIA、桂皮醛、五味子醇甲、紫丁香苷、盐酸小檗碱、大黄酚和橙皮苷的含量,并采用主成分分析(PCA)法对其质量进行综合评价。方法 采用HPLC法,色谱柱为Caprisil C18-AQ(250 mm×4.6 mm,5.0μm);流动相为0.1%磷酸水溶液-乙腈,梯度洗脱,体积流量0.8mL/min;柱温45℃。最后将定量结果与PCA法相结合对不同批次药物进行科学的质量评价分析。结果 乙肝益气解郁颗粒中柴胡皂苷a、柚皮苷、芍药苷、毛蕊异黄酮苷、丹参酮IIA、桂皮醛、五味子醇甲、紫丁香苷、盐酸小檗碱、大黄酚和橙皮苷11种成分分别在1.6~80.0、14~700、10~500、1.6~80.0、1.6~80.0、2.4~120.0、1.2~60.0、1.2~60.0、8.0~400.0、2.0~100.0、2.0~100.0μg/m L线性关系良好;平均加样回收率分别为98.3%、99.2%、98.8%、99.3%、101.9%、97.5%、99.8%、101.7%、101.1%、102.5%、100.9%,RSD均<2.0%;16批样品中11种有效成分的质量分数分别为0.233~0.322、3.007~3.142、2.201~2.273、0.320~0.355、0.317~0.399、0.451~0.523、0.265~0.297、0.209~0.226、1.848~1.873、0.380~0.425、0.615~0.647mg/g。结论 实验建立的方法简便准确、重复性好,可用于乙肝益气解郁颗粒的质量控制,为乙肝益气解郁颗粒后续质量提高提供参考。 Objective To establish HPLC method for the simultaneous determination of saikosaponin a,naringin,paeoniflorin,calycosin-7-glucoside,tanshinone IIA,cinnamaldehyde,schisandrin,syringin,berberine hydrochloride,chrysophanol and hesperidin in Yigan Yiqi Jieyu Granules(YYJG),and conduct a quality assessment using principal component analysis.Methods The chromatographic separation was achieved on an Caprisil AQ-C18(150 mm×4.6 mm,5.0μm)column with mobile phase consisted of 0.1%phosphate-acetonitrile for gradient elution,at the flow rate of 0.8 mL/min;The column temperature was 45℃.The results of the content were then combined with the principal component analysis to achieve the scientific assessment of the different batches of drugs.Results The content of saikosaponina,naringin,paeoniflorin,calycosin-7-glucoside,tanshinone IIA,cinnamaldehyde,schisandrin,syringin,berberine hydrochloride,chrysophanol and hesperidin in YYJG had good linear relationship in the ranges of 1.6—80.0,14—700,10—500,1.6—80.0,1.6—80.0,2.4—120.0,1.2—60.0,1.2—60.0,8.0—400.0,2.0—100.0,and 2.0—100.0μg/mL,respectively;The average sample recovery rate range were 98.3%,99.2%,98.8%,99.3%,101.9%,97.5%,99.8%,101.7%,101.1%,102.5%,and 100.9%(RSD<2.0%);The content of 11 active ingredients in 16 batches of samples respectively were 0.233—0.322,3.007—3.142,2.201—2.273,0.320—0.355,0.317—0.399,0.451—0.523,0.265—0.297,0.209—0.226,1.848—1.873,0.380—0.425,and 0.615—0.647 mg/g,respectively.Conclusion The established method is simple,accurate and reproducible,and can provide the reference for the quality control of YYJG.
作者 李妍 王丽 李雅 LI Yan;WANG Li;LI Ya(Tianjin Third Central Hospital,Tianjin300170,China;Tianjin Unversity of Traditional Chinese Medicine,Tianjin301617,China;Yunnan Unversity of Traditional Chinese Medicine,Kunming650500,China)
出处 《中草药》 CAS CSCD 北大核心 2019年第18期4346-4351,共6页 Chinese Traditional and Herbal Drugs
关键词 乙肝益气解郁颗粒 柴胡皂苷A 柚皮苷 芍药苷 毛蕊异黄酮苷 丹参酮IIA 桂皮醛 五味子醇甲 紫丁香苷 盐酸小檗碱 大黄酚 橙皮苷 HPLC 主成分分析 Yigan Yiqi Jieyu Granules saikosaponin a naringin paeoniflorin calycosin-7-glucoside tanshinone IIA cinnamaldehyde schisandrin syringin berberine hydrochloride chrysophanol hesperidin HPLC principal component analysis
作者简介 李妍,女,本科,研究方向为临床药学与药物分析。Tel:13820734739 E-mail:13820734739@139.com
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