文档介绍：阿齐沙坦胃漂浮缓释片的制备及体外释放研究
(作者:___________单位: ___________邮编: ___________)
【摘要】目的采用湿法制粒制备阿齐沙坦胃漂浮缓释片,并对其进行释放度评价。方法以释放度为考察指标,采用单因素试验考察处方中HPMC的规格及用量、碳酸氢钠的用量及低取代羟丙基纤维素的用量。对所制片剂进行影响因素( 高温、强光、高湿) 考察。结果最佳处方HPMCK100M的用量110mg/片、碳酸氢钠的用量200 mg/片及低取代羟丙基纤维素的用量100 mg/片。%,。影响因素试验中片剂的稳定性均较好。结论各考察指标均符合规定,该处方工艺可靠。
【关键词】阿齐沙坦胃漂浮缓释片制备体外释放
【ABSTRACT】 OBJECTIVE Azilsartan Floating Sustained Release Tablets were prepared by granulation method, and the in vitro release was The formulation of Azilsartan Floating Sustained Tablets was optimized by One-factor experimental design using the in vitro release as the main evaluation amount of HPMCK100M, sodium bicarbonate and low-substituted hydroxypropyl cellulose were used as factors. The influencing factors(high temperature, high light, and high moisture)were investigated as well. RESULTS The optimized formulation of Azilsartan Floating Sustained Tablets was as follows: HPMCK100M 110mg/tablet, sodium bicarbonate 200 mg/tablet, and L-HPC 100 mg/tablet. The drug release was %, and floating time was . In the influencing factor test, the tablets were stable. CONCLUSION Each index of the prescription of Azilsartan Floating Sustained Release Tablets meet technology is stable and reliab1e.
【Key Words】 Azilsartan Floating Sustained Release Tablets Preparation In vitro release
阿齐沙坦是新一代选择性A