牡荆油滴丸成型工艺研究

Study on preparation process of Mujing Oil Dripping Pills

目的研究牡荆油滴丸最佳成型工艺。方法采用正交试验设计,以丸重变异、溶解时限、外观质量等为考察指标,研究基质类型、药物与基质配比、药液温度、冷凝剂温度、滴速等因素对滴丸成型工艺的影响,优化成型工艺。结果最佳成型工艺为基质由聚乙二醇6000与聚乙二醇4000混合组成(配比8∶1),药物与基质的配比为1∶7,药液温度为75℃,冷凝液温度为8～10℃,滴速为50滴·min-1。结论该滴丸成型工艺重现性好,工艺简单、可行,适宜工业化生产。

Objective To establish the optimized preparation process of Muting Oil Dripping Pills. Methods The orthogo- hal design was adopted with weight variation of pills, dissolution time limit and appearance quality as index. The preparation process was optimized through study on the influence of ratio of drug and matrix, drug fluid temperature, condensation temperature and dripping rate. Results The optimum preparation process was as follows ： the ratio of PEG 6000 and PEG 4000 was 8 ： 1, the ratio of drug fluid and substance was 1： 7,the temperature of drug fluid was 75 ℃ and the condensation temperature was 8 - 10 ℃, the rate of dripping was 50 drops · min ^-1. Conclusion The process was reproducible, practical and easy to operate, and it was suitable for industrial production.