芪贞慢咽宁颗粒的质量标准研究  

Quality Standard for Qizhenmanyanning Granules

作　　者：赵静[1] 何倩灵[1] 谭琴[1] 姚仲青[1] 

机构地区：[1]扬子江药业集团有限公司中药研究院,江苏泰州225321

出　　处：《现代中药研究与实践》2016年第5期58-62,共5页Research and Practice on Chinese Medicines

摘　　要：目的建立芪贞慢咽宁颗粒的质量标准。方法采用薄层色谱法对制剂中的黄芪、女贞子进行鉴别，采用高效液相色谱法测定毛蕊异黄酮葡萄糖苷、特女贞苷、木蝴蝶苷B的含量。用C18柱（4．6mm×250mm，5μm）。毛蕊异黄酮葡萄糖苷：流动相为乙腈-0．1％甲酸（16：84），检测波长260nin。特女贞苷：流动相为乙腈-水（18：82），检测波长224nm。木蝴蝶苷B：流动相为甲醇-0．1％磷酸（38：62），检测波长276nm。结果黄芪、女贞子的薄层色谱特征斑点分离清晰，阴性无干扰。毛蕊异黄酮葡萄糖苷、特女贞苷、木蝴蝶苷B分别在0．0534-1．0671μg，0．193～3．865μg，0．0646—1．292μg线性关系良好，回收率分别为99．22％、97．50％、101．17％，RSD分别为O．99％、1．65％、1．10％。结论该方法操作简便、准确可靠、专属性强，可用于芪贞慢咽宁颗粒的质量控制。Objective To establish the quality standard for Qizhenmanyanning granules. Methods Radix Astragali, Fructus Ligustri Lucidi were identified by thin layer chromatography.Calycosin glucoside, specnuezhenide, oroxin B were determined simultaneously by high performance liquid chromarography. C18 （ 4.6mm×250mm,5μm ） column was used as the chromarographic column. Calycosin glucoside：the mobile phase was acetonitfile-0.1% formic acid solution （16 ： 84） with detection wavelength at 260 nm.Specnuezhenide： the mobile phase was acetonitrile-water （18 ： 82） with detection wavelength at 224 nm. Oroxin B： the mobile phase was methanol-0.1% phosphoric acid （38 ： 62） with detection wavelength at 276 nm. Results TLC spots were clear and well-separated without interference from negative control. The linear range of calycosin glucoside, specnuezhenide, oroxin B were 0.053 4 - 1.067 1 μg, 0.193 - 3.865 μg, 0.064 6 - 1.292μg. The average recovery were 99.22%, 97.50%, 101.17% with RSD 0.99%, 1.65%, 1.10%. Conclusion The methods were simple, accurate and reproducible for the quantification of Qizhenmanyanning granules.

关 键 词：芪贞慢咽宁颗粒 质量标准 薄层鉴别 高效液相色谱 

分 类 号：R927.1[医药卫生—药学]