摘要
目的基于特征图谱整体性表征中药组分群的优势,研究玳玳黄酮滴丸药效组分群的体外溶出行为,评价组分群的同步释药情况。方法建立HPLC特征图谱法及特征活性成分测定法,并采用转篮法评价玳玳黄酮滴丸组分群在4种不同p H值溶出介质(p H 1.2的盐酸溶液、p H 4.5的醋酸-醋酸钠缓冲液、p H 6.8的磷酸盐缓冲液和蒸馏水)中的溶出度及释药特性,分别运用单指数方程模型、威布尔方程模型、对数分布方程模型拟合溶出曲线。结果玳玳黄酮滴丸特征图谱中的9个共有峰成分溶出曲线的相似因子(f2)均大于50,且特征药效成分新橙皮苷及柚皮苷溶出曲线的f2为94.86,表明玳玳黄酮滴丸组分群具有相似的溶出曲线及同步释药特性,特征图谱的9个共有峰活性成分组分群较符合威布尔方程模型的溶出机制。结论所建立的基于特征图谱评价中药有效部位制备的玳玳黄酮滴丸组分群的溶出及同步释药特性的方法可行,为提高其内在质量评价奠定了实验基础。
Objective Based on the advantages of representation of herb components group Clustering by characteristic spectrum integrity, to study the in vitro dissolution behavior of Daidai Flavones Dropping Pills （DFDP）, and to evaluate the synchronization release situation of group clustering. Methods Rotating basket method and HPLC characteristic spectrum were employed to evaluate the group clustering dissolution and the release characteristics of DFDP in different dissolution media （pH 1.2 hydrochloric acid solution, pH 4.5 acetic acid-sodium acetate buffer, pH 6.8 phosphate buffer, and distilled water）. The single exponential, logarithmic distribution and Weibull equation model were applied to fit the dissolution curves. Results The similarity factor （A） of the dissolution curves of nine common peak components in characteristic spectrum of DFDP was over 50; In addition the 3~ of neohesperidin and naringin was 94.86, which indicated that the group clustering of DFDP had similar dissolution curves and synchronization release characteristics. Meanwhile the dissolution mechanism of group clustering of nine common peak activity composition was following the Weibull equation model. Conclusion The established method is simple, rapid, and stable, which provides an experimental basic for in vitro analysis and quality evaluation of DFDE
出处
《中草药》
CAS
CSCD
北大核心
2015年第3期353-358,共6页
Chinese Traditional and Herbal Drugs
基金
福建省发展和改革委员会产业技术开发项目(闽发改高技[2011]1598号)
福建省自然科学基金项目(2012J01386)
福建省科技计划项目(2010Y2004)
关键词
玳玳黄酮滴丸
HPLC特征图谱
溶出度
同步释药
相似因子
威布尔方程模型
新橙皮苷
柚皮苷
Daidai Flavones Dropping Pills
HPLC characteristic spectrum
dissolution
synchronization release
similarity factor
Weibull equation model
neohesperidin
naringin
