正交设计法优选参附滴丸最佳成型工艺

Study on the preparation technology of Shenfu Dripping Pills by orthogonal test

目的:建立参附滴丸的成型工艺。方法:以滴丸的混合、沉降、成形、丸重差异变异系数等为评价指标,探讨了不同基质、冷凝剂、药物基质比、滴管口径、药液温度、滴速、滴距和冷凝液温度对滴丸成型性的影响,采用正交试验法优选了最佳成型工艺。结果:聚乙二醇-4000,冷却剂为二甲硅油,药物基质比1∶2.5,药液温度80℃,滴管口径为2mm/3mm,滴速30滴/min,滴距8cm,冷却温度5-10℃时,参附滴丸成型质量最好,拟做成每丸约32.364mg。结论:该工艺适用于滴丸实验室试验和工业化生产。

Objective： To optimize a preparation technology of Shenfu Dripping Pills. Methods： Indicators for the evaluation of mixed status, subsidence, forming conditions, RSD, et al. The impact of the pill form ability such as the different kinds of primary substance, refrigerant, liquid temperature, drip speed, drip distance, refrigerant temperature, using L9（3）^4 orthogonal to design the best molding process. Results： The best quality pills forming the conditions of using polyglycol-4000, liquid temperature of 80 degrees, drip system speed of 30 drops per minute, drip distance of 8 cm, condensing temperature of 5-10 degrees. Conclusion： This preparation method is suitable for both the lab oratory test and the industrial production for Shenfu Dropping Pills.