| 摘要 |
<p>The invention provides a controlled-release pharmaceutical formulation for oral administration comprising 4-amino-6, 7-dimethoxy -2-(5-methanesulfonamido -1, 2, 3, 4-tetrahydroisoquinol-2-yl) -5-(2-pyridyl)quinazoline, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable adjuvant, diluent or carrier; characterized in that the formulation is adapted to release at least 50% by weight of the 4-amino-6, 7-dimethoxy-2 -(5-methanesulfonamido -1, 2, 3, 4-tetrahydroisoquinol- 2-yl)-5 -(2-pyridyl) -quinazoline, or the pharmaceutically acceptable salt thereof, after 6 hours in Apparatus 1 described in the United States Pharmacopoeia 24 (2000), pp 1941-1943, having 1 litre vessels, baskets of 40 mesh (0.4 mm apertures), a rotation speed of 100 rpm, and a dissolution medium consisting of 900 ml of 0.01 M hydrochloric acid containing 0.7% w/v sodium chloride at 37 degree C. Formulations according to the invention are suitable for the treatment of BPH.</p> |
