基于特征图谱和量值传递关系评价荆芥配方颗粒的关键生产工艺

Evaluation of key production processes of Schizonepetae Herba formula granules based on characteristic chromatogram and quantitative transfer relationship

基于特征图谱和量值传递关系相结合的新模式,对荆芥配方颗粒的关键生产工艺进行评价。通过对配方颗粒各生产环节的中间体进行研究,分析指标成分胡薄荷酮在各环节的损失,建立特征图谱评价模式,评价荆芥配方颗粒制备工艺设计的合理性。10批荆芥标准汤剂中胡薄荷酮为0.067%~0.124%(平均值的70%~130%),转移率为44.58%~93.97%,经工艺改进制备的颗粒中胡薄荷酮质量分数为0.093%,胡薄荷酮总转移率为68.38%,符合标准汤剂参数范围。该文强调了中药配方颗粒研究过程的整体性,为长期以来以含量测定为主要评价指标的传统中药质量控制提供了新思路。

The aim of this paper was to evaluate the key production processes of Schizonepetae Herba formula granules based on the new model of combining characteristic chromatogram with quantitative transfer relationship.The rationality of production process design was evaluated by studying the intermediates in different processes of formula granules,analyzing the loss of index component pulegone in each step,and establishing the characteristic chromatogram.The content of pulegone in 10 batches of standard decoction ranged between 0.067%and 0.124%(70%-130%of the average value),and the transfer rate of pulegone was 44.58%-93.97%.After the improvement of the production process,the content of pulegone in Schizonepetae Herba formula granules was 0.093%,and the transfer rate of pulegone was 68.38%,which was consistent with the parameters range of standard decoction.This study emphasized the integrality of the research process of traditional Chinese medicine(TCM)formula granules,and provided a new idea for the quality control of TCM with content determination as the main evaluation index for a long time.