The present invention provides a sustained-release
capsule of
urapidil, comprising sustained-release micropellets and a hollow
gelatin capsule shell; the sustained-release micropellets comprise a blank core, a
drug-loading layer and a sustained-release layer, and an
isolation layer is further provided between the
drug-loading layer and the sustained-release layer; the
drug-loading layer comprises
urapidil API and a binder; the
isolation layer is hydroxypropyl methylcellulose and / or
hydroxypropyl cellulose; the sustained-release layer comprises a sustained-release material, an enteric material and a pore-forming agent. The
urapidil sustained-release
capsule of the present invention has a stable API
crystal form, the prepared product has good stability, and the
dissolution is stable during the accelerated test process, thus solving the problems of API
crystal form transformation and low drug loading efficiency during the drug loading process of the drug-loading layer, as well as the problem of rapid
dissolution during the
stability test of the sustained-release capsule. The present invention also provides a method for preparing urapidil sustained-release capsules, which improves the stability of the preparation by adding an
isolation layer and screening a suitable sustained-release layer prescription, thereby ensuring the safety and effectiveness of the drug.