目的 优化汉防己甲素滴丸的制备工艺，并考察其溶出速率。方法 首先以基质配比、基质与药物配比、滴制温度、滴速、滴距、冷凝温度作为考察因素，使用Plackett-Burman实验设计筛选出对汉防己甲素滴丸的成型率影响较为显著的关键因素；再以汉防己甲素滴丸成型率、滴丸质量差异作为评价指标，通过Box-Behnken效应面法优化其制备工艺参数；并通过转篮法比较了汉防己甲素滴丸与片剂的体外溶出速率。结果 Plackett-Burman实验设计分析表明，基质配比、滴制温度、冷凝温度对汉防己甲素滴丸的成型率影响较为显著；经Box-Behnken效应面法优化得到汉防己甲素滴丸的最佳制备工艺参数为基质配比为2.6：1、滴制温度为82.4℃、冷凝温度7.5℃，制备的汉防己甲素滴丸成型率高、圆整度好、重量稳定、药物溶出速率较快。结论 通过实验设计法优化制备的汉防己甲素滴丸质量符合要求，可以进一步放大研究。

Objective To optimize the preparation process of tetrandrine dropping pills (TDP) and investigate the in vitro dissolution rate. Methods Plackett-Burman experimental design was used to screen the critical factors in the preparation process of TDP from the ratio of matrix, ratio of matrix to drug, dropping temperature, dropping rate, dropping distance, and condensate temperature. The forming rate and weight variation of TDP were used as the evaluation index, the parameters in the preparation process of TDP were optimized by using the Box-Behnken response surface method. Moreover, the in vitro dissolution rate of TDP was compared with tetrandrine tablets by rotating basket method. Results The Plackett-Burman experimental design results showed that the ratio of matrix, dropping temperature and condensate temperature had a significant effect on the forming rate of TDP. The optimum preparation parameters by Box-Behnken response surface method were as follows:the ratio of matrix was 2.6:1, dropping temperature was 82.4℃ and condensation temperature was 7.5℃ with high forming rate, good roundness, stable weight, and fast drug dissolution rate of TDP. Conclusion The quality of TDP by experimental design method can meet the requirements and can be further amplified.

陕西省科技厅项目（2015SF203）；陕西省中药制药重点学科资助项目（1008）