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目的:建立肾炎Ⅱ号颗粒的质量标准。方法:采用显微镜对石韦进行显微特征性鉴别;采用TLC法对主要成分地黄、茜草、小蓟等进行定性鉴别;采用HPLC法测定西洋参中人参皂苷的含量,色谱柱:WONDER CRACT ODS-2(150 mm×46mm,5μm),流动相:乙腈-0.1%磷酸溶液(28∶72),流速:1.1 ml·min~(-1),检测波长:203 nm,柱温:40℃,进样量:10μl。结果:薄层色谱斑点清晰,在与对照药材或对照品色谱相应的位置上,显相同颜色的荧光主斑点,阴性样品无干扰;西洋参中人参皂苷的线性浓度38.9~194.5μg·ml~(-1)(r=0.999 3),平均回收率为98.3%,RSD为1.9%(n=6)。结论:本方法操作简便,专属性高、重复性好,可作为肾炎Ⅱ号颗粒的质量控制方法。
Objective: To establish the quality standard of nephritis granules. METHODS: The microscopic identification of Shiwei was carried out by microscopy. The main constituents of Rehmanniae, Rubia cordifolia and Artemisia annua were identified by TLC. The content of ginsenosides in Panax quinquefolius was determined by HPLC. The chromatographic column was WONDER CRACT ODS-2 (150 mm × 46 mm, 5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid solution (28:72), the flow rate was 1.1 ml · min -1, the detection wavelength was 203 nm, Amount: 10 μl. Results: The TLC spots were clear. No significant difference was observed in the fluorescence spots and the negative samples of the same color at the corresponding position of the reference drug or reference substance. The linear concentration of ginsenosides in American ginseng was 38.9-194.5 μg · ml ~ (-1) 1) (r = 0.999 3). The average recovery was 98.3% and the RSD was 1.9% (n = 6). Conclusion: The method is simple and convenient, high specificity, good repeatability, and can be used as quality control method of nephritis granules.