含热不稳定成分的中药临方浓缩水丸制备工艺选择研究

Preparation process selection of presonalized traditional Chinese medicine concentrated watered pills containing heat-unstable components

在临方浓缩水丸制备过程中,处方水煎液需要经过受热浓缩与辅料或者饮片细粉混合制备软材。而部分中药成分受热易分解或转化,因此,为了减少处方中热不稳定活性成分的损失,优选中药临方浓缩水丸的制备工艺,该研究以苓桂术甘方、小承气方、散偏方、小儿七星方、逍遥方5个含有热不稳定成分中药的复方为模型处方,基于研究团队前期建立的2种临方浓缩水丸制备技术,分别制备全浸膏浓缩水丸以及零辅料浓缩水丸,进行特征图谱表征,并与全方水煎液特征图谱进行对比。结果表明5个模型处方的零辅料浓缩水丸的特征图谱与全方水煎液接近,其特征峰的数量及峰面积均高于全浸膏浓缩水丸,且部分峰的峰面积高于全方水煎液。提示当处方中含有热不稳定成分的中药时,优先选择“药辅合一”的工艺制备零辅料临方浓缩水丸,以便更大程度地保留热不稳定成分,为后续中药临方丸剂的合理开发和应用提供依据。

In the process of preparing presonalized concentrated watered pills,the decoction needs to be concentrated by heat and mixed with medicinal slices or powder to prepare a wet mass.However,some of the traditional Chinese medicine(TCM)components are easily decomposed or transformed by heat.In order to optimize the preparation process of presonalized TCM concentrated watered pills and reduce the loss of heat-unstable components in prescriptions,this study uses five compound TCM prescriptions containing heat-unstable components as model prescriptions,namely the Linggui Zhugan Formula,Xiaochengqi Formula,Sanpian Formula,Xiaoer Qixing Formula,and Xiaoyao Formula.Based on the two kinds of preparation process of presonalized concentrated watered pills previously established by our research group,whole extract concentrated watered pills and concentrated watered pills without excipients are prepared,respectively.Characteristic maps are measured and compared with those of the corresponding decoction.The results show that the characteristic maps of the concentrated watered pills without excipients of the five model prescriptions are very close to those of the decoction,and the number of characteristic peaks and peak areas are higher than those of whole extract concentrated watered pills.In addition,the peak area of some peaks is higher than that of the corresponding decoction.Thus,it is recommended to select the preparation process of prescription-based concentrated watered pills without excipients based on the"unification of medicines and excipients"to preserve those heat-unstable components more effectively when the prescription contains a heat-unstable component of TCM.This study provides a basis for the subsequent reasonable development and application of presonalized TCM pills.