通心舒滴丸成型工艺研究

目的　通过试验选择通心舒滴丸最佳的成型工艺。方法　以滴丸的溶散时间、丸重差异变异系数及外观质量作为综合评定指标,对药物清膏与基质的比例、基质配比(PEG4 0 0 0与PEG6 0 0 0的比例)、滴速、药液温度以正交试验法实验,优选出滴丸最佳成型工艺。结果　以清膏∶基质 =1∶2 5,PEG4 0 0 0∶PFG6 0 0 0 =1∶1,滴速为 4 5滴·min-1,药液温度为 85℃进行滴制,为最佳成型工艺。结论　本试验筛选出滴丸的最佳成型工艺,滴丸外观性状好、溶散度较好,丸重差异小,符合滴丸剂的质量标准。

Research of Tongxinshu Drop pills formulation process

Objective Selected the best formulation process of Tongxishu Drop pills.Methods Proportion of drug extract and base,matching of base(the proportion of PEG400 and PEG6000),drip rate,temperature of drug dissolution were determined by cross test on dissolution time,weight coefficient of variation and appearance.Results The best formulation process was extract:base=1∶2.5,PEG4000∶PEG6000=1∶1, drip rate 45 drops.min -1,drug dissolution temperature is 80℃.Conclusion Tongxishu Drop pills made in this process has good appearance and dissolution rate, with low weight coefficient of variation.This process is suitable for quality control.