降脂胶囊质量标准研究  

Quality standard of Jiangzhi Jiaonang(降脂胶嚢)

作　　者：曾芳俐 张磊 冯华 ZENG Fangli;ZHANG Lei;FENG Hua(Inspection Centre,Guizhou Provincial Medical Products Administration,Zunyi,Guizhou,550081,China;Pharmaceutical and Cosmetic Inspection Department,Zunyi Product Quality Inspection and Testing Institute,Zunyi,Guizhou,563000,China)

机构地区：[1]贵州省药品监督管理局检查中心,贵州遵义550081 [2]遵义市产品质量检验检测院药品化妆品检验部,贵州遵义563000

出　　处：《甘肃中医药大学学报》2021年第5期23-26,共4页Journal of Gansu University of Chinese Medicine

基　　金：贵州省科技计划项目(黔科合平台人才[2018]5744号);遵义市创新人才团队培养项目(遵市科合[2016]7号)。

摘　　要：目的初步建立降脂胶囊的质量标准。方法采用薄层色谱(TLC)法对降脂胶囊中的何首乌和银杏叶进行定性鉴别;采用高效液相色谱(HPLC)法对降脂胶囊中的2,3,5,4,-四羟基二苯乙烯-2-O-β-D葡萄糖苷进行含量测定,色谱柱为Welch ultimate XB-C18(4.6 mm×250.0 mm,5μm),流动相为甲醇-水(30∶70),等梯度洗脱,流速1.0 m L/min,检测波长320 nm,柱温35℃,进样量10μL。结果 TLC斑点清晰,分离效果好。含量测定中2,3,5,4,-四羟基二苯乙烯-2-O-β-D葡萄糖苷的回归方程为Y=393 249X-40 465,r=0.9999,表明其在190.72~1716.48μg范围内线性关系良好;平均加样回收率为99.80%,RSD为0.07%。结论该法简单、快速、可行,重复性好,可为降脂胶囊的质量控制提供参考。Objective To preliminary establish quality standard of Jiangzhi Jiaonang( 降脂胶囊) . Methods The qualitative identification of Polygoni multiflori radix and Ginkgo folium in Jiangzhi Jiaonang were established by thin layer chromatography( TLC);The content of 2,3,5,4,-tetrahydroxystilbene-2-O-β-D-glucoside in Jiangzhi Jiaonang was determined by high performance liquid chromatography( HPLC) method. The chromatographic column was Welch ultimate XB-C18( 4.6 mm×250.0 mm,5 μm),and a mixture of methyl alcohol and water( 30 ∶ 70) as the mobile phase with isocratic elution at the flow rate of 1.0 m L/min,detection wavelength of 320 nm,column temperature at 35 ℃,and injection volume of 10 μL. Results The TLC method had clear spots and good resolution effect. In the content determination,the regression equation of 2,3,5,4,-tetrahydroxystilbene-2-O-β-D-glucoside was Y = 393 249 X-40 465,r = 0.9999,which showed a good linear relationship in the range of 190.72 to 1716.48μg;the average recovery was 99.80%,RSD was 0.07%.Conclusion This method is simple,rapid,feasible and reproducible,which can provide a reference for the quality control of Jiangzhi Jiaonang.

关 键 词：降脂胶囊 何首乌 银杏叶 2 3 5 4 -四羟基二苯乙烯-2-O-β-D葡萄糖苷 薄层色谱 高效液相色谱 含量测定 

分 类 号：R284.2[医药卫生—中药学]