三十烷醇滴丸的制备工艺研究

Study on preparation process of 1-Triacontanol Dropping Pills

目的研究三十烷醇滴丸的最佳制备工艺条件。方法以PEG4000和PEG6000为辅料、液体石蜡和植物油为冷凝液制备三十烷醇滴丸。采用单因素考察法确定冷凝液配比、基质质量比,采用L_9(3~4)正交试验法考察药液温度、冷凝液温度、滴距、滴速对制备工艺的影响,确定最佳工艺。结果三十烷醇滴丸的最佳制备工艺条件为:PEG4000:PEG6000=1:4;药液:基质=1:10;滴距3 cm,温度80~85℃,滴速30滴/min,冷凝温度10~15℃。该工艺制备的滴丸外观圆整度良好,硬度较好,色泽均一。结论本法筛选的三十烷醇滴丸制备工艺可行,符合2010版《中国药典》中滴丸剂的质量规定。

Objective To determine the optimum preparation process of 1-Triacontanol Dropping Pills.Methods 1-Tri- acontanol Dropping Pills were prepared by PEG 4000 and PEG 6000 as exeipient,proportional fluid wax and vegetable oil were used as condensate.Single factor test was used to screen the mass ratio of matrix and condensate.The L9 （34） or- thogonal test was used to screen the drug-soup temperature,condensate temperature,dropping distance,dropping speed and to decide the best preparation process.Results m （PEG4000）：m （PEG6000） = 1：4,m （API）：m（matrix） = 1：10,the tempera- ture of drug was 80-85℃,the dripping speed was 30 drops per minute,the condensate temperature was 10-15℃,the dropping distance was 3 em were the optimum preparation technology of 1-Triacontanol Dropping Pills.The preparation of the Drop Pills had a good roundness,a good hardness and a uniform color.Conclusion This method is feasible for the preparation of 1-Triacontanol Drop Pills,which is in accordance with the quality of the Dropping Pills in Pharmacopoeia of the People＇s Republic of China （2010 edition）.