经典名方苓桂术甘汤制剂提取工艺研究

Study on preparation extraction process of Linggui Zhugan Decoction

确定苓桂术甘汤固态制剂适宜的提取液制备工艺。分别采用传统工艺(工艺一)、传统工艺提取液蒸馏分离挥发油后合并挥发油和蒸馏后的剩余液(工艺二)、现代二次回流工艺(工艺三)和提取挥发油后再按传统工艺煎煮并合并提取液和挥发油(工艺四)制备4种提取液;以工艺一提取液的特征图谱、甘草苷、甘草酸铵、桂皮醛和肉桂酸4种指标性成分含量和出膏量为基准,比较工艺一与工艺二、三、四提取液物质基准的异同。工艺二和工艺四与工艺一提取液的特征图谱相似度均大于0.97,4种指标性成分和出膏量均无统计学差异;工艺三与工艺一特征图谱相似度为0.91,21个峰中13个峰绝对峰面积显著增加,4种指标性成分中3种指标性成分含量和出膏量与显著增加,7个峰的相对峰面积显著增加。该研究结果为工艺二和工艺四所得提取液的物质基准与传统工艺提取液能保持一致,因此为适宜的提取工艺。

To verify the appropriate preparation process of extracts for the solid substance benchmark of Linggui Zhugan Decoction. The extracts were prepared by different preparation processes, namely the traditional process(process 1), the extract combined with volatile oil separated from traditional process extract liquid(process 2), the modern secondary reflux extraction process(process 3) and the process that volatile oil was extracted first, then prepared according to the traditional process, and combined with extract(process 4);based on the characteristic spectrum, index components of cinnamaldehyde, glycyrrhizin, ammonium glycyrrhizinate, cinnamic acid, and the dry extract rate of process 1, the differences and similarities of four extracts were compared. The results showed that the similarity of the characteristic spectrum of process 2, process 4 and process 1 were all greater than 0.97, while there was no significant difference for the content of 4 quality control components and dry extract rate;the similarity of the characteristic spectrum of process 3 and process 1 was 0.91, the absolute peak area of 13 out of 21 peaks and the relative peak area of 7 peaks increased significantly, and the content of 3 out of 4 quality control components and dry extract rate also significantly increased. In conclusion, the material standards of extracts by the process 2 and 4 are consistent with that of the traditional process, so the two processes are suitable.