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目的:建立舒乐胶囊的质量标准。方法:采用显微镜对玄参、柴胡进行显微特征性鉴别;采用TLC法对主要成分浙贝母、穿心莲、拳参等进行定性鉴别;采用HPLC法测定丹参中有效成分丹酚酸B的含量。色谱柱:phenomenex synergi 4 hydroRP 80A(250 mm×4.6 mm),流动相:乙腈-甲醇-甲酸-水(10∶30∶59∶1),流速:1.0 ml·min-1,检测波长:286 nm,柱温:20℃,进样量:10μl。结果:显微鉴别具有特征性;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;丹参中丹酚酸B在10.001~100.007μg·ml~(-1)浓度范围内线性关系良好(r=1.000 0),平均回收率为99.3%,RSD为1.8%(n=6)。结论:本方法操作简便,专属性高、重复性好,可作为舒乐胶囊的质量控制方法。
Objective: To establish the quality standard of Shule capsule. Methods: Microscopic identification of Scrophulariaceae and Radix Bupleurum was carried out by microscope. The main constituents Fritillaria nivalis, Andrographis paniculata were identified by TLC. The HPLC method was used to determine the content of Salvianolic acid B . Column: phenomenex synergi 4 hydroRP 80A (250 mm × 4.6 mm), mobile phase: acetonitrile-methanol-formic acid-water , Column temperature: 20 ℃, injection volume: 10μl. Results: The microscopic identification was distinctive; the TLC spots were clear; the main spots of fluorescence of the same color and the negative samples showed no interference in the position corresponding to the chromatogram of the reference drug or reference substance; the concentration of salvianolic acid B in Danshen was between 10.001 ~ The linear range was 100.007μg · ml -1 (r = 1.000 0). The average recovery was 99.3% and the RSD was 1.8% (n = 6). Conclusion: The method is simple, high specificity, good reproducibility, and can be used as a quality control method for Shule capsules.