Box-Benhnken试验设计优化湖北海棠总黄酮口崩片的制备工艺

Optimization of the Preparation Process of Orally Disintegrating Tablets of Total Flavonoids Tablets of Malus hupehensis(Pamp.)Rehd.by Box-Benhnken Test Design

目的优化湖北海棠总黄酮口崩片的制备工艺。方法以片剂的崩解时限、硬度、片重差异为评价指标,采用单因素实验确定压片方法、MCC∶乳糖的比例、崩解剂的种类及用量、润滑剂的种类、主药药量;采用Box-Benhnken试验设计,响应面分析法优化湖北海棠口崩片的最优制备工艺。结果确定最优制备工艺:湖北海棠总黄酮提取物35%、乳糖∶MCC(1∶1)37%、交联聚维酮(PVPP)12%、甘露醇15%、硬脂酸镁1%,采用全粉末压片制备。制备的片剂片重差异符合要求,平均硬度在73.8 N左右,崩解时限在24 s左右。结论湖北海棠总黄酮口崩片制备工艺可行,操作简便,能够满足工业化大生产的要求。

Objective To optimize the preparation method of total flavonoids extract orally disintegrating tablet of Malus hupehensis(Pamp.)Rehd.Methods The disintegration time,hardness and weight difference of tablets are used as evaluation indexes to screen the tableting method,the ratio of lactose to MCC,the type and amount of disintegrant,the type of lubricant and the dosage of main drug by single factor method.Box-Benhnken is used to determine the optimal preparation of oral disintegrating tablet of the total flavonoids in Malus hupehensis(Pamp.)Rehd.Results Determine the optimal preparation is 35%of total flavonoids extract from Malus hupehensis(Pamp.)Rehd.,37%of lactose∶MCC=1∶1,12%of Polyvinyl polypyrrolidone(PVPP),15%of mannitol,1%of magnesium stearate.Using full powder tableting.The weight difference of the prepared tablets meets the requirements,the average hardness is about 73.8 N,and the disintegration time is about 24 s.Conclusion The preparation process of orally disintegrating tablets of total flavonoids in Malus hupehensis(Pamp.)Rehd.is feasible and easy to operate,which can meet the requirements of large-scale industrial production.