目的 制備雷公藤紅素緩釋滴丸，考察藥物的分散狀態(tài)和體外釋放度，優(yōu)化制備工藝。方法 以聚乙二醇4000（PEG 4000）和單硬脂酸甘油酯（GM）為載體材料，采用固體分散體方法制備雷公藤紅素緩釋滴丸，以圓整度和質(zhì)量差異為評價指標，采用正交試驗考察滴丸成型的影響因素。結(jié)果 經(jīng)過優(yōu)化緩釋滴丸處方以雷公藤紅素、GM和PEG 4000按質(zhì)量比1∶3∶7組成，藥料溫度80 ℃，滴速20滴/min，滴距5 cm，冷凝液溫度15 ℃。緩釋滴丸中藥物以非晶形存在，該緩釋滴丸12 h的最大累積釋放率可達91.2%。結(jié)論 所制得的雷公藤紅素緩釋滴丸具有良好的緩釋效果。

Objective To prepare the Tripterin Sustained-release Dropping Pills (TSRDPs), investigate the disperse state and in vitro release, and optimize the preparation technology. Methods The TSRDPs were prepared by solid dispersion method with PEG 4000 and glycerol monostearate (GM) as carrier materials. Orthogonal design was conducted to explore the influencing factors of the preparation technology by evaluating the indexes of roundness and weight difference. Results The ideal condition of TSRDPs: the ratio of tripterin-GM-PEG 4000 was 1∶3∶7; the temperature of drug mixture was 80 ℃; dropping speed was 20 d/min; dropping distance was 5 cm; and the condensate temperature was 15 ℃. Tripterin existed as amorphous state in carriers. The maximum cumulative release amount of tripterin was 91.2% at 12 h. Conclusion The prepared TSRDPs have a good sustained-release effect.

江蘇省中醫(yī)藥領(lǐng)軍人才專項（2006賈曉斌）；江蘇省高等學(xué)校大學(xué)生創(chuàng)新訓(xùn)練計劃項目（011042004000）