川苏救心滴丸成型工艺研究

Research of forming technology for Chuansu Jiuxin dropping pills

目的考察川苏救心滴丸的成型工艺。方法采用滴制法制备滴丸,以重量差异、溶散时限和外观性状为评价指标,以PEG4000与PEG6000配比、药物与基质配比、料液温度和滴速为影响因素,分别采用单因素试验和正交试验设计优选川苏救心滴丸的最佳成型工艺。结果以PEG4000-PEG6000（4∶1）为基质,以5~15℃的二甲基硅油-100为冷却剂,川苏救心滴丸的最优成型工艺为：药物与基质的比例为1∶3,料液温度为90℃,滴速为35滴/min,滴距为4 cm。结论所优选的成型工艺合理可行,稳定性好,可为川苏救心滴丸的工业化生产提供参考。

Objective To research the forming technology of Chuansu Jiuxin dropping pills.Methods The pills were prepared by dropping method.The forming technology of the pills was optimized by single factor test and orthogonal experiment by using the amount of PEG4000 to PEG6000, ratio of drug-matrix ,dropping temperature and speed as factors and with pill weight RSD,the time limit of collapse and appearance quality of the pills as evaluation indexes.Results Using PEG 4000 and PEG 6000 as matrix with the ratio of 4：1 and dimethyl silicone oil（100 mPa＆#183; s）as refrigerant at 5~15℃,the optimized parameters for the forming technology were as follows：the ratio of herbal extract to matrix was 1：3,the dropping temperature was at 90 ℃ and the dropping speed was 35 drops per minute,dropping from 4 cm.Conclusion The optimized technology is sample and feasible,and can provide a reference for industrial production of Chuansu Jiuxin dropping pills.