盐酸伐地那非口崩片的制备与质量评价

Preparation and Quality Evaluation of Vardenafil Hydrochloride Orally Disintegrating Tablets

目的制备盐酸伐地那非口崩片并对其质量进行评价。方法选用盐酸伐地那非为主药,交联聚维酮(PVPP)为崩解剂,采用粉末直接压片法制备口崩片;以PVPP、薄荷脑、复配掩味剂SGxj用量为考察因素,以崩解时间、苦距为考察指标,设计响应面优化实验筛选处方;采用电子舌评价口崩片的口感,并与口尝实验进行比较,同时以外观、崩解时间、含量、含量均匀度等指标进行质量评价。结果优选处方为PVPP 13.26%,薄荷脑0.43%,复配掩味剂SGxj1.26%;电子舌评价结果与口尝实验结果一致;所制得的口崩片的各项指标均符合规定,崩解时间为(22.34±0.34)s。结论该制剂的制备方法简单,质量可控。

Objective To prepare vardenafil hydrochloride orally disintegrating tablets and evaluate their quality.Methods The tablets were prepared by direct power compression method, using crosslinking povidone（ PVPP） as disintegrants. The preparation method was optimized by response surface test using amount of PVPP,menthol and taste-masking agents as factors with disintegrating time and distance of bitterness as index. The results of taste of orally disintegrating tablets were determined by electronic tongue,comparing to the results of taste tests. At the same time,the properties of the tablets were evaluated using appearance,content uniformity,disintegrating time,et al. as index. Results The optimal formula was as follows： PVPP 13. 26%,menthol 0. 43%,taste-masking agent SGxj 1. 26%. The results on evaluation of electronic tongue were consistent with the results of taste tests. The quality of the prepared tablets was in line with standard. The disintegrating time was（ 22. 34 ± 0. 34） s. Conclusion The preparation technology of orally disintegrating tablets is simple,and controllable in quality.