盐酸多奈哌齐口崩片的处方优选及稳定性研究

目的:优选盐酸多奈哌齐口崩片处方并考察其稳定性。方法:采用正交试验确定最佳处方,并与普通薄膜衣片进行体外溶出度比较。在不同条件下留样进行稳定性研究。结果:筛选后最佳处方为崩解剂用量10%、填充剂用量20%、泡腾剂用量5%,所制制剂崩解迅速,几乎在30s内崩解完全,并能通过内径为710μm的筛,其溶出速度快于普通片剂,稳定性均合格。结论:所得口崩片质量稳定,有效期定为2y。

Optimation Prescription of Donepezil Hydrochloride Oral Disintegrating Tablets and Its Stability

OBJECTIVE: To prepare donepezil hydrochloride oral disintegrating tablet and to study its stability.METHO_DS:The formula was optimized by orthogonal experimental,and the dissolution of the oral-disintegrating tablets was compared with that of common film coating tablets.The stability test was performed on samples that were taken under different condition.RESULTS:The optimized formula was the following:the dose ratios of disintegrating agent, loading agent and effervescent effervescent were 10%,20% and 5%,respectively.The prepared tablets disintegrated rapidly and were completely disintegrated within 30s, which could pass through the mesh (with diameter at 710 μm),with dissolution faster than the common tablets and stability all up to the standard.CONCLUSION:The prepared oral-disintegrating tablets were stable in quality with validity duration of 2 years.