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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: To characterize the advantages of traditional Chinese medicine (TCM) component population based on the characteristic map, to study the in vitro dissolution behavior of the group of medicated components of ToDai flavone dropping pills and to evaluate the simultaneous release of drug components. Methods HPLC profiling method and characteristic active ingredient determination method were established. The composition of toadstool flavone dropping pills in four different p H dissolution media (hydrochloric acid solution of p H 1.2, acetic acid - acetic acid of p H 4.5 Sodium buffer, p H 6.8 phosphate buffer, and distilled water). The single-exponential model, Weibull model and log-log model were used to fit the dissolution curves. Results The similarities (f2) of dissolution curve of nine common peak components in the Daitai flavone dropping pills characteristic map were both greater than 50, and the f2 of the elution curve of the characteristic neem hesperidin and naringin was 94.86, indicating that Daidai tobi Flavone dripping pill group has similar dissolution curve and synchronous drug release characteristics. The 9 common peak active component groups of the characteristic spectrum are more consistent with the dissolution mechanism of Weibull equation model. Conclusion The elution and synchronous drug release characteristics of Toi Dandruff Dropping Pill group based on the atlas of the characteristic maps established by the traditional Chinese medicine preparation are feasible. The experimental basis for improving the internal quality evaluation is established.