天舒滴丸的成型工艺研究

Study on Formation Technology of Tianshu Dropping Pill

目的确立天舒滴丸的最佳成型工艺。方法以滴丸的硬度、圆整度和耐冻耐热性等为评价指标,探讨了基质的选择,冷却剂的选择,药物与基质的配比;采用正交试验,以滴制温度、冷却剂温度、滴速和滴距为考察因素,以丸重变异系数和综合外观质量为评价指标,优选最佳成型工艺。结果天舒滴丸最佳成型工艺为以聚乙二醇6000为基质,二甲基硅油为冷却剂,浸膏与基质的比例为1：3,药液滴制温度为75℃;优选的滴制条件为滴距8cm,滴速40~50滴·min-1,冷却剂温度为5℃~15℃。结论本法确定的天舒滴丸制备工艺稳定可行,适用于工业化生产。

Objective To establish the optimum formation technology for Tianshu dropping pill. Methods We studied the choice of substrate, the cooling agent, the proportion of drug to substrate with the hardness, roundness and resistance to freezing and heat of Tianshu dropping pill as indexes. Wc selected four factors as the dropping and cooling agent temperature, dropping speed and dropping distance to optimize the preparation process by the orthogonal test with the pill weight variation and appearance quality as indexes. Results The optimum technique was as follows： the substrate was PEG6000,the cooling agent was simethicone, the ratio of drug to substrate was 1：3, the temperature of dropping solution was 75℃, the dropping distance was 8cm, the droping speed was 40-50 drops per minute ,the cooling temperature was 5 ℃-15℃. Conclusion The method optimized was steady and suitable for the industrial production for Tianshu dropping pill.