目的 完善六味地黄丸的质量控制方法。方法 采用薄层色谱法对六味地黄丸中酒萸肉所含马钱苷和莫诺苷进行鉴别;用高效液相色谱法同时测定六味地黄丸中莫诺苷、马钱苷和丹皮酚的含量,色谱柱为Phenomenex Gemini 110 C18 (4.6 mm×250 mm, 5 μm);流动相为乙腈(A)-0.3%磷酸水溶液(B)梯度洗脱。流速为1.0 mL·min-1;莫诺苷和马钱苷检测波长为240 nm,丹皮酚检测波长为274 nm;柱温为40 ℃。结果 薄层色谱斑点清晰;莫诺苷、马钱苷和丹皮酚进样量分别在0.021~1.039、0.020~1.017、0.046~2.288 μg 内与峰面积呈良好线性关系,平均回收率分别为97.97%、100.99%和100.82%,RSD分别为2.3%、1.4%、1.6%。结论 提高后的质量标准分析方法简便、快速、准确,能更全面有效控制六味地黄丸的质量。
Abstract
OBJECTIVE To improve the quality control method of Liuwei Dihuang Pills.METHODS Morroniside and loganin from processed Fructus Corni were identified by TLC. Morrniside, loganin and paeonol in Liuwei Dihuang Pills were determined by HPLC. The determination was performed on a Phenomenex Gemini 110 C18 column (4.6 mm×250 mm, 5 μm) maintained at 40 ℃ with gradient elution of acetonitrile (A) and 0.3% phosphoric acid aqueous solution (B) at a flow rate of 1 mL·min-1. The detective wavelength was set at 240 nm for morroniside and loganin and 274 nm for paeonol. RESULTS The TLC spots were clear. Morrniside, loganin and paeonol showed good linear relationship in the range of 0.020 78-1.039, 0.020 34-1.017, and 0.045 76-2.288 μg, respectively. The average recoveries (n=9) were 99.97%-100.99% with RSDs less than 2.3%. CONCLUSION The method is simple, rapid, accurate and can be used to control the quality of Liuwei Dihuang Pill more effectively.
关键词
六味地黄丸 /
薄层色谱 /
含量测定 /
莫诺苷 /
马钱苷 /
丹皮酚
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Key words
Liuwei Dihuang Pill /
TLC /
HPLC /
morroniside /
loganin /
paeonol
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中图分类号:
R284
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参考文献
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脚注
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基金
国家药品标准提高暨2015版药典科研项目;北京市科学技术委员会课题资助项目(Z111100074911002)
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