伊维康咀嚼片的处方筛选及制备工艺的优化

Formula Screening and Optimization of Technology Processing in Yiweikang Chewable Tablets

目的研制伊维康咀嚼片,并筛选和优化伊维康咀嚼片的最佳处方和制备工艺。方法采用湿法制粒法研制伊维康咀嚼片,通过单因素考察实验,选择合适的填充剂、矫味剂、抗黏剂;通过对咀嚼片的外观、口感、风味、硬度等地考察筛选处方,并通过正交设计实验确定最优处方。结果采用正交表L_9(3~4)得到9种试验的咀嚼片,确定最佳方案:20%枸杞子提取物粉末、7%葫芦巴提取物粉末、5%败酱草提取物粉末、10%甘露醇、49.5%微晶纤维素(MCC)、0.5%阿斯帕坦、3%滑石粉、2%薄荷香精、1%柠檬香精、1%桔子香精、0.5%甜橙香精、0.5%硬脂酸镁、以75%的乙醇溶液为黏合剂。结论通过处方筛选和工艺优化可制得口感好、表面光滑美观、色泽均匀、硬度适中、服用方便、工艺简单的伊维康咀嚼片。

Objective To develop the Yiweikang chewable tablets, and to optimize the formulation and preparation technology of Yiweikang chewable. Methods Yiweikang chewable tablets were prepared by the wet granule method. The type of filler, taste-masking agent and adhesive-resist agent were screened by single factor experiment. The tablet formulation was optimized by the orthogonal design and using appearance, taste and flavor, hardness as the index. Results The optimized formulation from orthogonal design of L9 （ 34 ） was as follows： 20% fructus lycii extract powder, 7% fenugreek extract powder, 5% sauce herb extract powder, 10% mannitol and 49.5% microcrystalline cellulose, 0.5% aspen Tampa, 3% talcum powder, 2% mint essence, 1% lemon essence, 1% orange essence,0.5% sweet orange essence,0.5% magnesium stearate, with 75% ethanol solution as binder. Conclusion The optimized formulation and process can provide tablets with good taste, smooth surface, uniform colour and lustre and moderate hardness. The tablets are convenient for oral administration and its production process is simple.