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目的:优选复方血塞通滴丸的成型工艺。方法:以丸重变异系数和外观质量作为评价指标,对药物的加入方式、滴速、滴距采用单因素考察,对药物与基质的比例、两种水溶性基质的比例及药液温度的确定用正交试验法,优选出最佳滴制条件。结果:以聚乙二醇4000(PEG-4000)与聚乙二醇6000(PEG-6000)为基质,甲基硅油:液状石蜡(2:1)混合为冷凝液,90℃药液以20d·min~(-1)滴速、2cm滴距滴入冷凝液中,滴丸成型率最高。结论:本试验优选出的滴丸成型工艺条件制成的滴丸,成品得率高,符合《中国药典》中滴丸剂的质量标准。
Objective: To optimize the forming process of compound Xuesaitong dropping pills. Methods: Taking the coefficient of variation of the weight of the pellet and the appearance quality as the evaluation index, the way of adding the drug, drip rate and dripping distance were investigated by single factor, the ratio of the drug to the matrix, the ratio of the two water-soluble matrix and the temperature of the liquid Orthogonal test method, preferably the best drop conditions. Results: Polyethylene glycol 4000 (PEG-4000) and polyethylene glycol 6000 (PEG-6000) were used as matrix, methyl silicone oil: liquid paraffin (2: 1) min ~ (-1) drip rate, 2cm drip distance drip into the condensate, dropping pill forming the highest rate. Conclusion: The drop pills prepared by the dropping pill molding process conditions optimized in this experiment have high yields of finished products and meet the quality standards of pills in the Chinese Pharmacopoeia.