基于Box-Behnken设计优化复方葛根黄酮泡腾片的制备工艺研究

Study on the Preparation Process of Compound Pueraria lobata Flavonoids Effervescent Tablets Based on Box-Behnken Design

主要在目前葛根黄酮的提取纯化技术基础上,通过大孔树脂纯化葛根总黄酮,经试验得到纯化后的总黄酮浓度比纯化前高17.6%。以葛根黄酮为原料,通过正交试验和响应面Box-Behnken设计优化出复方葛根黄酮泡腾片的制备工艺。试验得到其最佳填充剂类型及质量比为乳糖10%、甘露醇10%,泡腾片的最佳主体配方为:黄酮粉添加量10.43%,辅料添加量74.39%,甜味剂添加量0.56%。按该工艺条件制备的复方葛根黄酮泡腾片可压性好、崩解迅速、溶液澄清、口感适宜,符合相关规定和药典标准,可作为生产指导工艺配方。

The study based on the extraction and purification technology of Pueraria lobata flavonoids, the total flavonoids of Pueraria lobata were purified by macroporous resin. The total flavonoids were 17.6% higher than those before purification. Then, the preparation technology of compound Pueraria lobata flavonoids effervescent tablets was optimized by orthogonal test and response surface method of Box-Behnken design. The best filler type and quality ratio of 10% lactose and 10% mannitol, the optimum formula for flavonoids effervescent tablets was 10.43% flavonoids powder, the amount of excipient 74.39%, the amount of sweetener 0.56%. According to the condition of the preparation of compound Pueraria lobataflavonoids effervescent tablets, it had good pressure, disintegration quickly, clear solution, taste appropriate, in line with relevant regulations and pharmacopoeia standards, and could be used as a production guide process recipe.