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目的建立六味地黄软胶囊的质量标准。方法采用TLC法对山茱萸药材进行鉴别;采用HPLC法同时测定莫诺苷、马钱苷与丹皮酚3种成分的含量。流动相为乙腈-0.3%磷酸水梯度洗脱,检测波长:240 nm(莫诺苷和马钱苷)、274 nm(丹皮酚)。结果山茱萸的TLC鉴别方法简单可行;莫诺苷、马钱苷和丹皮酚与其他色谱峰得到良好的分离,平均回收率分别为97.29%、97.58%和99.67%;RSD分别为2.30%、1.25%和0.79%。结论该方法简便、准确,重复性好,可用于控制该制剂质量。
Objective To establish the quality standard of Liuwei Dihuang soft capsule. Methods TLC method was used to identify Cornus officinalis. The contents of morroniside, loganin and paeonol were determined simultaneously by HPLC. The mobile phase consisted of gradient elution with acetonitrile-0.3% phosphoric acid. The detection wavelength was 240 nm (morroniside and loganin) and 274 nm (paeonol). Results TLC identification of dogwood was simple and feasible. The average recoveries of morroniside, loganin and paeonol were 97.29%, 97.58% and 99.67%, respectively. The RSDs were 2.30%, 1.25 % And 0.79%. Conclusion The method is simple, accurate, reproducible and can be used to control the quality of the preparation.