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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 explore the advantages of three experimental design methods in the prescription optimization of Yuanhu Zhitong Dispersible Tablets. Methods: With the disintegration time as the evaluation index, the compounding design, center combination design and orthogonal design were respectively used to optimize the formulation of traditional Chinese medicine powder, filler and disintegrant. Results: The optimized dispersible tablets were in accordance with the requirements of the preparation, and the three experimental methods have their own advantages, but the mixture design is more suitable for the optimization of prescription ratio. Conclusion: Mixture design not only can reduce the number of trials of dispersible tablets, but also the results are intuitive and reliable, so it is worth to popularize and apply it in the research of traditional Chinese medicine.