心通滴丸成型工艺研究

Study on Shaping Operation of Xintong Dropping Pills

目的:确定心通滴丸的成型工艺。方法:以滴丸的外观质量为评价标准,对基质与冷凝液的选择、滴速、滴距采用单因素平行实验法;以滴丸的溶散时限、外观质量及丸重差异为考察指标,对提取物与基质的用量配比、滴制温度、冷凝剂温度采用正交试验法,优选出最佳滴制条件。结果:最佳工艺为PEG6000-PEG4000=1∶1作为基质,药物与基质比为1∶2,二甲基硅油作为冷却剂,药液温度80℃,以每分钟5～6滴的速度,滴入10℃左右的冷却剂中,滴距为5～8cm,滴丸外观质量最好。结论:通过上述试验确定的成型工艺合理,所制滴丸符合药典规定。

Objective：To ascertain the preparation techniques of Xintong dropping pills.Method：Using parallel experimentation for the choice of matrix and refrigerant,dropping distance and speed with the appearance quality of drop pills as the evaluation quota.Using orthogonal experimentation for the choice of the ratio of extractum to base material,temperature of drug and refrigerant with the dissolve scattered limit,appearance quality and weight difference as the evaluation quota to decide the best dropping condition.Results：The optimized parameters for the forming technology were as follows：PEG4000：PEG6000（1∶ 1） was used as base material with the ratio of extractum to base material at 1∶ 2,dimethyl silicon oil is refrigerant,the temperature of the drug at 80℃.Drug is dropped into the refrigerant of 10℃ by 6 to 7 dropping per minute.The dropping distance was 5～8cm.Conclusion：The Xintong dropping pills has ideal quick-release,which give references to develop a new preparation of Xintong.