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目的:筛选固体分散体技术制备水飞蓟素-丹参素复方滴丸的最佳工艺条件。方法:采用聚乙二醇4000,聚乙二醇6000和Poloxamer 188为固体分散体载体材料,熔融法制备复方水飞蓟素-丹参素滴丸。以丸重差异、圆整度、溶出度为指标,采用单因素试验考察滴速、冷却剂与冷却温度等因素对滴丸成型的影响;通过正交试验优选基质组成、药物与基质配比、药液温度、滴距等制备工艺条件。结果:最佳制备工艺条件为基质组成PEG 4000-PEG 6000-Poloxamer 188为5∶5∶1,药物与基质配比1∶2,滴制时药液温度90℃,滴距5 cm,滴速40滴/min,二甲基硅油为冷却剂,冷却温度(10～15)℃。结论:优选的复方水飞蓟素-丹参素滴丸制备工艺合理可行,对主药有良好的增溶效果。
OBJECTIVE: To screen the best preparation conditions of silymarin-Danshensu compound dropping pills by solid dispersion technology. Methods: Polyethylene glycol 4000, polyethylene glycol 6000 and Poloxamer 188 were used as solid dispersion carrier materials. The compound silymarin-Danshensu drops were prepared by melt method. The effects of drip rate, coolant temperature and cooling temperature on dropping pill were investigated by single factor test based on the difference in pill weight, roundness and dissolution rate. The orthogonal experiment was conducted to optimize the composition of matrix, the ratio of drug to matrix, Liquid temperature, drip distance and other preparation process conditions. Results: The optimum preparation conditions were as follows: the PEG 4000-PEG 6000-Poloxamer 188 was 5: 5:1, the ratio of drug to matrix was 1: 2, the temperature of the solution was 90 ℃, the dripping distance was 5 cm, 40 drops / min, simethicone as a coolant, cooling temperature (10 ~ 15) ℃. Conclusion: The preparation process of the compound silymarin-Danshensu dropping pills is reasonable and feasible, and has a good solubilization effect on the main drug.