非洛地平缓释片的研制及其体外释放研究-制药工程专业论文.docxVIP

上海交通大学硕士学位论文II 上海交通大学硕士学位论文 II STUDY ON I N VI TRO DRUG RELEASE AND PREPARATI ON OF FELODI PI NE SUSTAI NED RELEASE TABLET ABSTRACT Felodipine belongs to the second-generation of dihydropyridine calcium ions channel blocker which was originally developed by AstraZeneca pharmaceutical company. It inhibits calcium ions of small artery smooth muscle from flowing into cells and decreases peripheral blood vessel pressure to cure hypertension, without direct action to heart muscle contractility and heart conduction. It can not cause postural hypopiesia. There are some differences on release rate, treatment effect, action duration and adverse effects among different felodipine sustained release tablets. Using matrix based tablet fabrication technology, felodipine sustained release tablets (SR tablet) were prepared. The influences of matrix material kinds, viscosity, quantity, and fillers, as well as process techniques, were also studied. The SR tablets were evaluated by investigating the similarity of their drug release rates in 4 kinds of release media. 3 kinds of HPMC, sodium alginate, Compritol 888 ATO and xanthogenate, were used as matrix materials, and wet granulation applied. When the wetting agent was 80% alcohol aqueous solution, the 上海交通大学硕士学位论文III 上海交通大学硕士学位论文 III granulation time was 40 sec, and the hardness was between 50~70N, the SR tablets were prepared, which has a similar drug release profile with Plendil?. The similarity factors (f2) were all exceed 50. At the same time, the quality evaluation and stability study of the tablets were also performed, the sustained release tablets kept stable after 6 months accelerated test and 12 months long-term test. KEY WORDS: felodipine, sustained release tablet, HPMC, release rate, f2 function 上海交通大学 学位论文原创性声明 本人郑革声明:所呈交的学位论文，是本人在导师的拥导下， 独丘进行研究，了 f乍所取得的成果。除文中己经注明引用的内容外，4-\ 论文不包含任何其他个人戎集体已经发表或撰写过的作品成果 e 对本 文的研究做出豆要贡献的个人和集体，均已在文中以明确方式标明。 本人完全意识到本声明的法律结果由本人承担。 学位论文作者签名 :t飞h j ， 日期: 2 010 年门月 12.. Fl 上海交通