胃病康颗粒质量标准提高  

Improved Quality Standard for Weibinkang Granules by TLC Coupled with RP-HPLC Gradient Elution

作　　者：王玲洁[1] 宋宗辉 陈相旭 徐文强 甘萍[1] 于波涛[1] WANG Ling-jie;SONG Zong-hui;CHEN Xiang-xu;XU Wen-qiang;GAN Ping;YU Bo-tao(General Hospital of Chengdu Military Command,Chengdu 610083,China;Southwest Jiaotong University,Chengdu 610031,China;North Sichuan Medical College,Nanchong 637007,China)

机构地区：[1]成都军区总医院药剂科,四川成都610083 [2]西南交通大学,四川成都610031 [3]川北医学院,四川南充637007

出　　处：《解放军药学学报》2018年第4期309-312,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项课题;No.14ZJZ17-2;四川省卫生厅面上项目;No.16PJ02

摘　　要：目的提高胃病康颗粒的质量标准。方法采用TLC法对处方中的元胡、甘草、柴胡定性鉴别,RP-HPLC法同时测定胃病康颗粒中4种指标成分(芍药苷、芦丁、桂皮醛、丹参酮ⅡA)的含量,色谱柱为Agilent HC-C18(4.6mm×250mm,5μm),流动相为乙腈-0.1%磷酸溶液,梯度洗脱,流速:1ml·min^(-1),柱温:35℃;选择二极管阵列检测器,提取258nm波长处色谱图,进样量:10μl。结果 TLC中各斑点清晰,分离度好,专属性强。芍药苷、芦丁、桂皮醛、丹参酮ⅡA的线性范围分别为7.38~236μg·ml^(-1)(r=0.9999)、6.13~210μg·ml^(-1)(r=0.9998)、2.97~95μg·ml^(-1)(r=0.9999)、1.24~84.3μg·ml^(-1)(r=0.9999),线性关系均良好,平均回收率均大于99%,RSD均小于3%。结论建立的质量标准控制方法,准确灵敏,重复性好,专属性强,易于操作,为胃病康颗粒的质量标准提高提供依据。Objective To improve the quality standard for Weibingkanggranules.Methods TLC was used to identify chief components in the preparation,including CorydalisturtschaninoviiBess,Glycyrrhiza uralensis Fisch and Bupleurum chinense.The contents of four indicative components（Paeoniflorin,Rutinum,Cinnamaldehyde and TanshinoneⅡA）in Weibingkanggranules were determined simultaneously by RP-HPLC.The conditions of chromatography were Agilent HC-C18（4.6 mm×250 mm,5μm）.The mobile phase consisted of acetonitrile and 0.1% phosphoric acid by gradient elution.The flow rate was 1 ml·min-1 and the column temperature was 35 ℃.Quantitation was completed by an aphotodiode array detector at the detection wavelength of 258 nm.The sample quantity was 10 μl.Results Paeoniflorin,Rutinum,Cinnamaldehyde and TanshinoneⅡAshowed good linear relationships within the ranges of 7.38-236μg·ml-1（r =0.9999）,7.19-230μg·ml-1（r =0.9998）,6.13-210μg·ml-1（r =0.9999）,2.97-95μg·ml-1（r =0.9999）,respectively.All the average recoveries were over 99% with RSDs less than 3%.Conclusion The established method is specific,accurate,sensitive,reproducible,which can be used for quality control of Weibingkang granules.

关 键 词：胃病康颗粒 质量标准 TLC RP-HPLC 

分 类 号：R927.2[医药卫生—药学]