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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 the forming process of seven-drop pills. Methods: Based on the single factor test and orthogonal test, drug-matrix, drip distance Effect of feed temperature and drip rate on forming technology of Qigui dropping pills. Results: The optimum forming process was polyethylene glycol 4000, drug - matrix (1: 2), temperature 85 ℃, dropping rate 45 drops / min, dripping distance 9 cm, cooling column length 110 cm, Liquid paraffin, condensing agent temperature 12 ℃; Pill weight difference <10%, dissolution time limit 5.02 min. Conclusion: The preferred molding process is stable and feasible. The preparation rate of prepared sesame seed pills is high, which meets the quality requirements of drip pills.