降脂合剂的质量标准研究  

Quality Standard of Jiangzhi Mixture

作　　者：黄和军 杨军辉[1] 陈国宝[1] 蒋赢 俞宾 柳佳[1] 李书霖[2] HUANG Hejun;YANG Junhui;CHEN Guobao;JIANG Ying;YU Bin;LIU Jia;LI Shulin(Jiangyin Affiliated Hospital of Nanjing University of Chinese Medicine,Jiangyin 214400,China;The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine,Harbin 150001,China)

机构地区：[1]南京中医药大学江阴附属医院,江苏江阴214400 [2]黑龙江中医药大学附属第二医院,黑龙江哈尔滨150001

出　　处：《中医药学报》2019年第6期78-82,共5页Acta Chinese Medicine and Pharmacology

摘　　要：目的:建立降脂合剂的内控质量标准。方法:采用薄层色谱(TLC)法对制剂中枸杞、泽泻、石菖蒲和决明子开展定性鉴别。采用高效液相色谱(HPLC)法测定降脂合剂中丹酚酸B含量,色谱柱:Sepax C18赛芬液相色谱柱(4.6 mm×250 mm,5μm),流动相为0.1%甲酸溶液-乙腈,程序洗脱,流速定为1 mL·min^-1,检测波长定为289 nm,柱温定为30℃。结果:薄层色谱(TLC)法可以特异性地鉴别制剂中的泽泻、枸杞子、石菖蒲、决明子。丹酚酸B在12.84~410.8μg·mL^-1以内线性关系良好(r=0.9999),回收率为103.93%(RSD=1.94%,n=6),其精密度、稳定性及可重复性都合乎含量测定的要求。结论:这种分析方法操作过程比较简单,结果正确可靠,可作为于降脂合剂的质量控制的有效检测方法。Objective:To establish an internal quality control standard for Jiangzhi Mixture.Methods:The identification of Alismatis Rhizoma,Lycii Fructus,Acori Tatarinowii Rhizoma and Cassiae Semen was carried out by TLC.The content of salvianolic acid B was determined by HPLC.The analytical column was the Sepax C18(4.6 mm×250 mm,5μm),the mobile phase was acetonitrile-0.1%formic acid solution with gradient elution at a flow rate of 1mL/min,the testing conditions were determined under detection wavelength in 289nm and the column temperature of 30℃.Results:TLC method could specifically identify Alisma,Scorpion,Shichangpu and Cassia.In the range of 12.84~410.8μg·mL^-1,Salvianolic acid B showed good linear correlations(r=0.9999).The recycling rate was 103.93%(RSD=1.94%,n=6).Its precision,stability and repeatability meet the requirement of content determination.Conclusion:The analysis method is simple and accurate,which can be used effectively for the quality control of Jiangzhi Mixture.

关 键 词：降脂合剂 质量标准 薄层色谱 高效液相色谱 

分 类 号：R286.0[医药卫生—中药学]