丹栀逍遥胶囊质量标准研究  

Study on quality standard of Danzhi XiaoYao capsules

作　　者：陈东鸿[1] 陈航[1] 邹义栩[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2013年第2期41-44,共4页Strait Pharmaceutical Journal

摘　　要：目的建立丹栀逍遥胶囊的质控标准。方法用TLC法对丹栀逍遥胶囊中的当归、白术、牡丹皮、甘草进行鉴别;用HPLC法对丹栀逍遥胶囊中栀子苷、芍药苷的含量进行测定。采用C18(SYNCRONIS AQ 250mm×4.6mm,5μm)色谱柱,流动相为乙腈-水(15:85),检测波长为238nm,流速:1.0mL.min-1。结果当归、白术、牡丹皮、甘草的薄层色谱鉴别效果好、专属性强,分离度高,且阴性样品无干扰;栀子苷在0.117～0.780μg范围内线性关系良好,R2=0.9996,平均回收率97.63%,RSD=0.93%(n=6)。结论本文建立的方法不仅操作简便、结果准确、重现性好,而且能够对丹栀逍遥胶囊进行定性和定量质控,符合中成药的质控要求。OBjECTIVE To establish the guality standard of DanZhi XiaoYao capsules. METHODS The thin-layer chromatography （TLC） was used for the identification of Angelic, Atractylodes, tree peony bark and licorice;high performance liquid chromatography （HPLC） was used to determine the content of geniposide on C18 （250ram ×4.6mm,5μm） SYNCRONIS column. The mobile phase was consisted of acetonitrile-water（ 15 ： 85 ）. The flow rate was 1.0mL . min^-1. The detection wavelength was at 238nm. RESULTS TLC results of Angelic, Atrac- tylodes ,tree peony bark and licorice was good,and there was no interference in negative control;the calibration curve of geniposide was linear in the range of 0. 117 - 0. 780μg, R2 = 0. 9996, the average recovery rate was 97.63 %, RSD =0. 93% （n =6）. CONCLUSION TLC method shows clear and specific spots,and can be used for the identificatin of DanZhi XiaoYao capsules;HPLC method is simple, rapid, precise with good reproducibility, and can be used to control the quality of DanZhi XiaoYao capsules.

关 键 词：丹栀逍遥胶囊 质控标准 栀子苷 HPLC 

分 类 号：R927.2[医药卫生—药学]