雷公藤红素缓释滴丸的研究  

Study on Tripterin Sustained-release Dropping Pills

作　　者：夏海建[1,2] 张振海[2] 贾晓斌[1,2] 

机构地区：[1]南京中医药大学附属中西医结合医院,江苏南京210028 [2]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,江苏南京210028

出　　处：《中草药》2013年第7期834-838,共5页Chinese Traditional and Herbal Drugs

基　　金：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)

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(PEG4000)和单硬脂酸甘油酯(GM)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。结果经过优化缓释滴丸处方以雷公藤红素、GM和PEG4000按质量比1∶3∶7组成,药料温度80℃,滴速20滴/min,滴距5cm,冷凝液温度15℃。缓释滴丸中药物以非晶形存在,该缓释滴丸12h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。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 cartier 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.

关 键 词：雷公藤红素 固体分散体 缓释滴丸 体外释放度 圆整度 制备工艺 

分 类 号：R283.6[医药卫生—中药学]