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目的:建立苯磺酸氨氯地平滴丸的最佳成型工艺。方法:以滴丸的混合、沉降、成形、溶散时限、丸重变异系数等为评价指标,探讨不同基质、药物与基质比例、冷凝剂种类、药液温度、滴速、滴距和冷却液温度对滴丸成型性的影响,采用正交试验法优选最佳成型工艺。结果:以聚乙二醇-6000为基质,甲基硅油为冷却液,药液温度80℃,滴速45～50滴/min,滴距8cm,冷却温度10～12℃时,苯磺酸氨氯地平滴丸成型质量最好。结论:本实验筛选出的滴丸成型工艺条件制成的滴丸符合药典规定。
Objective: To establish the best forming process of amlodipine besylate dropping pills. Methods: The effects of different matrix, drug and matrix ratio, types of condensate, liquid temperature, drip rate, dripping distance and cooling liquid were investigated with droplet mixing, sedimentation, forming, dissolution time limit, The influence of temperature on the moldability of dropping pills, orthogonal test was used to optimize the best forming process. Results: Using polyethylene glycol-6000 as matrix and methyl silicone oil as cooling solution, the temperature of solution was 80 ℃, the dropping speed was 45 ~ 50 drops / min, the dropping distance was 8cm and the cooling temperature was 10 ~ 12 ℃. Chlorpheniramine pills forming the best quality. Conclusion: The drop pills prepared by this experiment were prepared according to the regulations of Pharmacopoeia.