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目的研究肿节风滴丸的最佳成型工艺条件。方法通过对肿节风滴丸制备过程的考察,以丸质量变异系数和溶散时限为考察指标,药物与基质质量比、PEG 4000与PEG 6000质量比、药物与水质量比为考察因素,采用L9(34)正交试验设计对肿节风滴丸的制备工艺进行优选,并考察了影响滴丸成型的其他因素。结果滴丸最佳成型工艺条件为药物-PEG 4000-PEG 6000-水(1∶1.7∶0.3∶0.3),熔融温度80℃,滴制温度85℃,冷却剂为甲基硅油,冷却剂温度1～5℃。结论通过实验确定的成型工艺条件制备的肿节风滴丸表面光滑,大小一致,工艺方法简便可行,各质量指标均符合《中国药典》2010年版规定。
Objective To study the best forming process conditions of Fengjiefeng drop pills. Methods Through the study of the preparation process of QDJI pills, taking the coefficient of variation of the quality of the pills and the dissolution time as the index of investigation, the ratio of the drug to the matrix, the mass ratio of PEG 4000 to PEG 6000 and the ratio of the drug to the water as the investigation factors, L9 (34) Orthogonal design of the experimental design of the preparation of QDD drip pills preferred, and investigated the impact of dropping pills forming other factors. Results The optimum forming conditions for the dropping pills were as follows: drug-PEG 4000-PEG 6000-water (1: 1.7: 0.3: 0.3), melting temperature of 80 ℃, dropping temperature of 85 ℃, coolant temperature of methyl silicone oil, ~ 5 ℃. Conclusion The experimental results show that the swollen drops pills prepared by the molding process conditions are smooth and uniform in size, and the process is simple and feasible. The quality indicators are in accordance with the 2010 edition of Chinese Pharmacopoeia.