CONTROLLED RELEASE PHARMACEUTICAL COMPOSITION CONTAINING THIAZIDES AND ANGIOTENSIN-II-RECEPTOR BLOCKERS

摘要

A pharmaceutical composition comprising a thiazide compound and an angiotensin-II-receptor blocker is provided to maximize the pharmacological and clinical antihypertensive effects and complication preventive effects of drugs and reduce the side effects of the drugs. A controlled release oral pharmaceutical composition comprises a thiazide compound or a pharmaceutically acceptable salt thereof and an angiotensin-II-receptor blocker or a pharmaceutically acceptable salt thereof as active ingredient, wherein after the oral administration of the composition, the thiazide compound or pharmaceutically acceptable salt thereof is immediately released, and angiotensin-II-receptor blocker or pharmaceutically acceptable salt thereof is released in an intended lag time delayed manner. A method for preparing the composition comprises the steps of: (a) mixing or granulating an angiotensin-II-receptor blocker with pharmaceutically acceptable additives to obtain a mixture or granules, optionally compressing the granules or mixture into a tablet using a tabletting machine and coating the tablet with a coating solution to obtain a delayed-release tablet; (b) obtaining particles or granules from a mixture of a thiazide compound with pharmaceutically acceptable additives to obtain a mixture, optionally dissolving or suspending the particles or granules with a film coating agent to obtain a coating solution, thereby obtaining an immediate release formulation; and (c) mixing the particles, granules or coating solution, obtained from the steps(a) and (b), with pharmaceutically acceptable excipients, and tabletting, coating or filling the mixture, thereby obtaining a desired composition. Further, the 5 to 100 mg of thiazide compound is comprised in the composition.