七归滴丸成型工艺考察

Optimization of Molding Technology of Qigui Dropping Pills

目的:优选七归滴丸的成型工艺。方法:以滴丸的溶散时限、丸重变异系数、外观评分(圆整度、硬度、色泽)的综合评分为指标,在单因素试验基础上,通过正交试验考察药物-基质、滴距、料温、滴速对七归滴丸成型工艺的影响。结果:最佳成型工艺为以聚乙二醇4000为基质,药物-基质(1∶2),料温85℃,滴速45滴/min,滴距9 cm,冷却柱长110 cm,冷凝剂为液状石蜡,冷凝剂温度12℃;丸重差异<10%,溶散时限5.02 min。结论:优选的成型工艺稳定可行,制备的七归滴丸成型率高,符合滴丸制剂的质量要求。

Objective：To optimize molding technology of Qigui dropping pills.Method：Taking dissolution time of dropping pills,pill weight coefficient of variation,appearance score （roundness,hardness,color） as a comprehensive assessment index,based on single factor tests,orthogonal test was adopted to optimize molding technology by taking proportion of drug extract-matrix,dropping distance,material temperature and dropping speed as factors.Result：The best molding technology of Qigui dropping pills was as following：with polyethylene glycol 4000 as matrix,proportion of drug extract-matrix 1 ∶ 2,material temperature 85 ℃,dropping speed of 45 d ·min-1 dropping distance of 9 cm,with atolin as coolant,cooling column length of 110 cm coolant temperature at 12 ℃; dissolution time was 5.02 min,pill weight difference was less than 10％.Conclusion：This optimized molding technology is stable and feasible.These prepared Qigui dropping pills have high molding rate to meet quality requirements of dropping pills.