山楂精降脂胶囊的质量标准研究  

Research on Quality Standard of Shanzhajing Jiangzhi Capsule

作　　者：朱才庆[1] 李艳[1] 吴迪[1] 何南生[1] 曾宪仪[1] 余华[1] 

机构地区：[1]江西省药物研究所,江西南昌330029

出　　处：《时珍国医国药》2008年第11期2760-2762,共3页Lishizhen Medicine and Materia Medica Research

摘　　要：目的以山楂对照药材和熊果酸作为对照品，分别建立薄层色谱（TLC）鉴别和高效液相色谱（HPLC）法控制山楂精降脂胶囊的质量。方法TLC鉴别用甲苯-醋酸乙酯-甲酸（20：4：0．5）为展开剂；HPLC法采用Alltima C18色谱柱（5μm，4．6mm×250mn），用乙腈-甲醇-水-乙酸铵（70：16：14：0．5）为流动相，检测波长220nm；柱温25℃；流速1．0ml／min。结果TLC鉴别图谱斑点清晰，阴性无干扰；熊果酸含量1．7968～17．9680μg范围内呈良好线性关系，得回归方程Y=44820X＋5725．5，r=0．9999，平均加样回收率及RSD分别为101．17％和1．02％。结论以熊果酸为对照品，采用TLC法和HPLC法控制山楂精降脂胶囊质量的方法简便快速、准确可靠、重复性好，专属性强。Objective To establish the method for the quality control of Shanzhajing Jiangzhi capsule by HPLC so as to determine the content of ursolic acid and TLC with Fructus Crataegi as reference substance respectively. Methods Methylbenzene - ethyl ac- etate - formic acid（20： 4： 0.5） was used as developer for TLC and Alhima C18 column（5 μm,4.6 mm ×250 mm） was adopted with acetonitrile - methanol - H2O - ammonium acetate （70： 16 ： 14 ： 0.5 ） as mobile phase , the detection wavelength was 220nm, the column temperature was 25℃, and the mobile phase speed was 1.0 ml per min for HPLC. Results The picture of TLC was clear and negative control had no interference. The calibration curve was linear at a range of 1. 7968 to 17. 9780 μg for ursolic acid content and the linear equation was Y=44 820X ＋5 725.5（r =0. 999 9）. The average recovery ratio was 101.17% and the relative standard deviation was 1.02%. Conclusion TLC and HPLC methods are convenient,fast, accurate, repeatable and special, and can be used to control Shanzhajing Jiangzhi capsule.

关 键 词：山楂精降脂胶囊 薄层鉴别 高效液相色谱 熊果酸 

分 类 号：R284.2[医药卫生—中药学]