Adenafil sustained-release pellet as well as preparation method and application thereof

Abstract

The invention relates to an aldenafil sustained-release pellet as well as a preparation method and application thereof. The aldenafil sustained-release pellet sequentially comprises the following components in percentage by mass: 60-85% of a drug-containing pellet core, 0.5-3% of an isolating layer, 2-8% of an acidic coating layer and 5-30% of a sustained-release coating layer from inside to outside, the medicine-containing pill core comprises the aldenafil and / or pharmaceutically acceptable salt or ester thereof, a diluent and an adhesive; the isolating layer comprises a film coating material; the acidic coating layer comprises an organic acid and an acidic polymer; the organic acid accounts for 0.5%-5% of the mass of the aldenafil sustained-release pellet; the sustained-release coating layer comprises a sustained-release material. The aldenafil sustained-release pellet can provide an acidic microenvironment in time, meanwhile, the acidic buffering capacity of the microenvironment is improved, the aldenafil sustained-release pellet can be dissolved out in different dissolution media within 12-24 h without pH dependence, the aldenafil sustained-release pellet can be completely dissolved out in an alkaline intestinal environment, absorption of a sustained-release preparation is not affected, and the aldenafil sustained-release pellet has high bioavailability.

Images