The invention relates to a
quetiapine fumarate film-controlled slow-release pellet
capsule. A slow-release film of the
quetiapine fumarate film-controlled slow-release pellet utilizes Eurdragit RL 30D as a film-formation material. A pellet core of the
quetiapine fumarate film-controlled slow-release pellet contains low-substituted
hydroxypropyl cellulose having high expansibility, and also contains a pharmaceutically-acceptable common
excipient for the slow-release pellet, wherein preferably, the
excipient comprises
microcrystalline cellulose, and the pellet core comprises 10 to 40wt% of the low-substituted
hydroxypropyl cellulose. The slow-release film comprises Eurdragit RL 30D,
triethyl citrate as a
plasticizer and talcum
powder as an antiplastering aid, wherein preferably, a ratio of Eurdragit RS 30D to
triethyl citrate to talcum
powder is 30: 3: 4 and a film
weight increasing ratio is in a range of 19 to 35%. The
quetiapine fumarate film-controlled slow-release pellet comprises the pellet core containing low-substituted
hydroxypropyl cellulose having high water expansibility and thus after absorbing water, the
quetiapine fumarate film-controlled slow-release pellet expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the
quetiapine fumarate film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.