摘 要：目的 制备雷公藤红素缓释滴丸，考察药物的分散状态和体外释放度，优化制备工艺。方法 以聚乙二醇4000（PEG 4000）和单硬脂酸甘油酯为载体材料，采用固体分散体方法制备雷公藤红素缓释滴丸，以圆整度和质量差异为评价指标，采 用正交试验考察滴丸成型的影响因素。结果 选择缓释滴丸处方组成为雷公藤红素、单硬脂酸甘油酯和PEG 4000 的质量比 为1∶3∶7，药料温度80 ℃，滴速20 滴/min，滴距5 cm，冷凝液温度15 ℃。缓释滴丸中药物以非晶形存在，该缓释滴丸 12 h 的最大累积释放率可达91.2%。结论 所制得的雷公藤红素缓释滴丸具有良好的缓释效果。

Abstract: Objective To prepare the tripterine sustained-release dropping pills, investigate its dissolution in vitro and determine the preparation technology. Methods The tripterine sustained-release dropping pills were prepared by solid dispersions method with PEG 4000 and glycerol monostearate as carrier materials. Orthogonal design was conducted to explore the influencing factors of sustained-release dropping pills by evaluating the indexes of roundness and weight difference. Results The ideal condition of preparing tripterine sustained-release dropping pills: the ratio of tripterine, glycerol monostearate and PEG 4000 was 1:3:7; the temperature of drug mixture was 75 ℃; dropping speed was 20 d/min; dropping distance was 5 cm and the condensate temperature was 15 ℃. Tripterine existed in carriers as amorphous state. The cumulative release amount of tripterine was 91.2% at 12 h. Conclusion The prepared tripterine sustained-release dropping pills had a good sustained-release effect.

基金项目：江苏省中医药领军人才专项（2006 贾晓斌）；江苏省高等学校大学生创新训练计划项目（011042004000）