各种实验设计方法在元胡止痛分散片处方优化中的应用研究

Study on Application of Experiment Design Methods in Optimizing Preparation of Yuanhuzhitong Dispersible Tablet

目的:探讨3种实验设计方法在元胡止痛分散片处方优化中的优势。方法:以崩解时间为评价指标,分别采用混料设计、中心组合设计、正交设计对元胡止痛分散片处方中药粉、填充剂、崩解剂的配比进行优化。结果:经处方优化的分散片均符合制剂要求,且3种实验方法各有优点,但混料设计更为适宜处方配比的优化。结论:混料设计不仅可以减少分散片工艺处方优化的试验次数,而且其结果直观、可靠,值得在中药研究中推广应用。

Objective：To investigate the advantages of three kinds of experiment design methods in optimizing the preparation of dispersible tablet. Method： The disintegration time was chosen as the evaluation index of dispersible tablet. The optimal formulation of Yuanhuzhitong Dispersible Table including the extract powder, fillers and disintegrants were established by the mixture design, the central composite design and orthogonal design. Results： The dispersible tablet optimized by the three experiment design methods met the requirements of dispersible tablet. The three experiment design methods have their owner＇s advantages,but the mixture design is more suitable for optimizing the formulation than other experiment design methods. Conclusion： The mixture design can decrease the times of experiment in optimizing formulation of dispersible tablet, and the result is intuitive and reliable. The mixure design deserves promotion in the research of traditional Chinese medicine.