消渴康颗粒质量标准研究

目的提高消渴康颗粒的质量标准。方法南五味子鉴别以石油醚(30~60℃)-甲酸乙酯-甲酸(15∶5∶1)为展开剂,在GF254薄层板上展开,254nm下检视;山茱萸鉴别采用硅胶G薄层板,乙酸乙酯-乙醇-冰醋酸(50∶10∶1)为展开剂,50g·L~(-1)香草醛硫酸溶液显色;芒果苷含量测定采用Kromasil C18色谱柱,乙腈-2 mL·L-1冰醋酸溶液(18∶82)为流动相,检测波长258nm,柱温35℃。结果薄层鉴别斑点清晰,阴性对照无干扰;芒果苷在0.021 82~0.218 2μg范围内线性关系良好,回归方程:Y=1 112 484X+1.972 433(r=0.999 9),样品回收率为98.7%,RSD为1.1%。结论该方法简单准确,可用于控制该制剂的质量。

Study on the quality standard of Xiaokekang Granules

Objective To improve the quality standard of Xiaokekang Granules .Methods Kadsura was indentified by using silica gel GF254 plate and petroleum ether(30 60 ℃)-ethyl formate-formic acid (15∶5∶1) upper layer as a developing solvent system . The fluorescence spots were examined at 254 nm .Cornusofficinalis was identified by using silica gel G plate with ethyl acetate-ethanol-acetic acid (50∶10∶1) as the developer and 50 g?L -1 vanillin sulfuric acid solution as the coloration reagent .HPLC sep-aration was carried out on a Kromasil C18 column for determining mangiferin ,using acetonitrile-2 mL?L -1 acetic acid (18∶82) as an eluent .Detection was performed with spectrophotometric detection (258 nm) at 35 °C .Results The TLC spots were clear and no interference was found in the negative reference .For mangiferin ,a good linear relationship between the peak area and sample volume was found in the ranges of 0 .021 82-0 .218 2 μg .The regression equation was Y=1 112 484X+1 .972 433(r=0 .999 9) . The recovery was 98 .7% ,and the relative standard deviation was 1 .1% .Conclusion The method is simple and accurate ,and it can be used for the quality control of the preparation .