六味地黄软胶囊质量标准的研究  

Quality Standard for liuweidihuang Soft Capsules

作　　者：胡丹[1] 曹红[1] 陈玉敏[1] 水彩红[1] 单婷婷[1] 张贵英[1] HU Dan CAO Hong CHEN Yu-min SHUI Cai- hong SHAN Ting-ting ZHANG Gui-ying(Institute for Drug and Instrument Control, Health Dept, GLD of PLA, Beijing 100166, China)

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100166

出　　处：《解放军药学学报》2016年第4期345-347,350,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：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 a standard for quality control of Liuweidihuang soft capsules. Methods TLC was used for the identification of cornus. The content of morroniside,loganin and paeonol was determined by HPLC. The mobile phase consisted of acetonitrile-0. 3% phosphate acid solution in a gradient elution mode. The detection wavelength was set at 240 nm for morroniside and loganin and 274 nm for paeonol. Results Cornus could be detected by TLC. Morroniside,loganin and paeonol were well separated under the chromatographic condition. The average recovery was 97. 29%（ RSD = 2. 30%） for morroniside,97. 58%（ RSD = 1. 25%） for loganin and 99. 67%（ RSD = 0. 79%） for paeonol. Conclusion This method is simple,accurate and reproducible for quality control of the preparation.

关 键 词：六味地黄软胶囊 质量标准 莫诺苷 马钱苷 丹皮酚 

分 类 号：R927.1[医药卫生—药学]