The invention relates to an
isosorbide mononitrate sustained-release pellet, and an
isosorbide mononitrate quick-release and sustained-release pellet
capsule adopting it. The sustained-release film of the sustained-release pellet adopts Eurdragit RS 30D as a film forming material, the core of the sustained-release pellet contains high-expansibility
sodium carboxymethyl starch and a pharmaceutically-acceptable
excipient commonly used for sustained-release
pellets, and optimally, the
excipient is
microcrystalline cellulose, wherein the weight percentage of
sodium carboxymethyl starch in the core of the sustained-release pellet is 5-20%. The sustained-release film of the sustained-release pellet includes the Eurdragit RS 30D, a
plasticizer triethyl citrate and an anti-adherent talcum
powder, the optimal ratio of the Eurdragit RS 30D to
triethyl citrate to the talcum
powder is 30:3:4, and the optimal
coating weight gain is 19-38%. The core will obviously expand after absorbing water because of the containment of
sodium carboxymethyl starch highly expanding after contacting with water, so the sustained-release film is stretched, the thickness of the film is thinned, the apertures of water-pervious micro-pores are increased, the permeability is good, and the permeability decrease caused by film
ageing is compensated, thereby the middle and later stage release speed is basically constant, the last stage residue is small, and a stable release performance is always maintained prior to the
expiration date.