Preparation and Release Determination of Compound Isosorbide Mononitrate Sustained-release Capsules / 中国药师

ABSTRACT

Objective:To prepare compound isosorbide mononitrate sustained-release capsules and study the drug release. Meth-odsIsosorbide mononitrate pellets were prepared by the fluidized bed coating technology. The influencing factors in the preparation process were examined and the major factors were optimized by single factor experiments. The drug release was determined by HPLC. The best formula was screened by optimizing aspirin coating solution. Results:The compound isosorbide mononitrate sustained-release capsules were prepared by the best formula. Both the two drugs could achieve promising release, and in vitro release behavior of isosor-bide mononitrate was fitted Higuchi equation,which was similar to that of the imported preparations. The release of aspirin in acidic and alkaline media was in coincidence with the release requirements. Conclusion:The formula is reasonable and the preparation process is stable with promising sustained release property.