HPLC法同时测定生脉注射液中9种成分  

Simultaneous determination of nine compositions in Shengmai Injection by HPLC

作　　者：王进[1] 张平[2] 唐海涛[2] 刘汉清[1] 刘霖[1] 唐云[1] 

机构地区：[1]南京中医药大学,江苏南京210046 [2]江苏苏中药业集团股份有限公司,江苏姜堰225500

出　　处：《中成药》2013年第3期508-512,共5页Chinese Traditional Patent Medicine

基　　金：江苏省重点科研成果产业化项目(BA2011124)

摘　　要：目的建立生脉注射液(红参、麦冬、五味子)9种成分(8种皂苷和1种木脂素)同时测定的方法。方法HPLC法的色谱条件为Waters symmetry shieldTM RP18(4.6 mm×250 mm,5μm)色谱柱,symmetryshieldTM RP18预柱,以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,体积流量1.0 mL/min,检测波长203 nm,柱温30℃。结果 9种成分(Rg1、Re、Rf、Rb1、Rc、Rb2、Rb3、Rd、五味子醇甲)具有良好的分离度,各成分的质量浓度和相应的峰面积之间呈现良好的线性关系(r≥0.999 1),精密度、重复性及加样回收率的RSD均小于3.61%。结论该方法简便易行,且能同时测定生脉注射液中9种成分,可作为本品多成分内控质量的测定方法。AIM To develop an HPLC method for simultaneously determining nine compositions（eight ginsenosides and a lignan） in Shengmai Injection（Ginseng Radix et Rhizoma rubra,Ophiopogonis Radix,Schisandrae chinensis Fructus）.METHODS HPLC chromatographic conditions of Shengmai Injection were Waters symmetry shieldTMRP18（4.6 mm × 250 mm,5 μm） as the analytical column and symmetry shieldTM RP18 as a pre-column.The mobile phase consisted of acetonitrile-water（containing 0.1% phosphoric acid） in gradient elution mode with the flow rate of 1.0 mL / min.The detection wavelength was set at 203 nm and the column temperature was maintained at 30 ℃.RESULTS The relationship between the concentrations and the peak areas of nine compositions（ginsengnoside Rg1,Re,Rf,Rb1,Rc,Rb2,Rb3,Rd,schizandrin） was linear respectively（r≥0.999 1）.The RSDs of precision,reproduciability and recovery were all less than 3.61%.CONCLUSION The simple and feasible method can be used to determine simultaneously nine compositions in Shengmai Injection and applied to its inner quality control.

关 键 词：生脉注射液 HPLC 多成分定量测定 8种皂苷成分 五味子醇甲 

分 类 号：R927.2[医药卫生—药学]