蛭丹化瘀组方制剂的质量研究  

Quality Study of Zhidan Huayu Preparation

作　　者：刘怡[1] 李任[1] 王丽丽[1] 沈素[1] 

机构地区：[1]首都医科大学附属北京友谊医院,北京100050

出　　处：《中国药业》2016年第15期24-27,共4页China Pharmaceuticals

基　　金：北京市科学技术委员会"十病十药"研发项目;项目编号:Z141100002214019

摘　　要：目的建立同时测定中药制剂蛭丹化瘀组方中芍药苷、阿魏酸、丹皮酚和芒柄花素含量的反相高效液相色谱（RP—HPLC）法，并探讨口服液、配方颗粒和浸膏剂的质量差异。方法色谱柱采用Kromasil 100—5 C18柱（150mm×4．6mm，5μm）；流动相为乙腈（A）-0．1％甲酸水溶液（B），梯度洗脱；上述4种活性成分检测波长分别为230，320，274，248nm；流速1．5mL／min。结果芍药苷在进样量为0．5～5．0μg范围内与峰面积线性关系良好（n=5）；阿魏酸、丹皮酚和芒柄花素在进样量为0．04～0．4μg范围内与峰面积线性关系良好（n=5）；各成分加样回收率分别为98．92％，96．47％，98．93％，102．48％（RSD=1．54，1．15，1．42，1．97，n：6）；3种蛭丹化瘀组方制剂中各有效成分含量不同。结论该法可用于蛭丹化瘀组方制剂的质量控制，不同工艺可能导致制剂中有效成分含量的差异。Objective To establish an RP- HPLC method for the simultaneous content determination of paeoniflorin, ferulic acid, paeonol and formononetin in Zhidan Huayu Prescription, and to investigate the quality differences among oral liquid, particle formulation and ex- tract of Zhidan Huayu Prescription. Methods The Kromasil 100-5 C18 column was used. Gradient elution was developed. The detection wavelength was at 230, 320, 274 and 248 nm for the above 4 components. The flow rate was 1.5 mL/min. Results The method was specific, accurate and sensitive for the content determination of the 4 components. The content of these components were different in oral solution, concrete and compatible granule. Conclusion The RP- HPLC method can be used for quality control of Zhidan Huayu Prescription. Different preparation process may affect the quality the effective component in the prescription.

关 键 词：蛭丹化瘀方 芍药苷 阿魏酸 芒柄花素 丹皮酚 含量测定 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学] R286[医药卫生—中医学]