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目的:对姜黄素缓释滴丸的处方和工艺进行研究,并考察其体外释放度。方法:以释放度为评价指标,采用正交设计实验优化处方。以滴丸成形性为评价指标,优化滴丸的制备工艺。结果:最佳处方为:硬脂酸70 mg,单硬脂酸甘油酯25 mg,聚乙二醇-12-羟基硬脂酸酯6 mg。释药行为符合Higuchi方程,具有明显的缓释特征。最佳工艺为:冷凝液粘度100 mm2/s,料液温度80℃,冷却温度30~0℃,滴速(21±2)滴/min。结论:姜黄素缓释滴丸具有良好的体外缓释效果,可进一步进行体内释药行为考察。
Objective: To study the prescription and technology of curcumin sustained-release dropping pills and investigate its in vitro release. Methods: Taking the release degree as the evaluation index, orthogonal design experiment was used to optimize the prescription. Taking dropping pill formability as evaluation index, the preparation process of dropping pills was optimized. Results: The best prescription was stearic acid 70 mg, glycerol monostearate 25 mg and polyethylene glycol 12-hydroxystearate 6 mg. Release behavior consistent with Higuchi equation, with a sustained release characteristics. The optimum process is: condensate viscosity 100 mm2 / s, feed temperature 80 ℃, cooling temperature 30 ~ 0 ℃, dropping speed (21 ± 2) drops / min. CONCLUSION: Curcumin sustained-release dropping pills have a good in vitro sustained-release effect and can be further investigated in vivo.