水性包衣制备银杏总内酯缓释微丸及其质量评价

Preparation of Delayed Release Pellets Containing Ginkgolides by Aqueous Coating Technique and Quality Evaluation of the Pellets

目的制备银杏总内酯(主含银杏内酯GA,GB,GC)缓释微丸并对其进行质量评价。方法采用乙基纤维素的水性分散体对微丸进行流化床包衣,并对影响药物释放的因素,如包衣液的组成、制备工艺因素、释放度测定方法等进行考察。对所制备的银杏总内酯缓释微丸进行质量评价。结果所制备的微丸具有较理想的释放及较好的圆整度、流动性、稳定性等,不同成分体外释放度拟合的释药方程不同。结论采用流化床水性包衣技术制备缓释微丸,具有快速、高效、质量可控的特点,可适合产业化生产。

OBJECTIVE To prepare the controlled release pellets containing the ginkgolides （main components of GA, GB and GC） and evaluate their quality. METHODS Aqueous coating technique was used to prepare the pellets with fluidized bed, ethylcellulose aqueous dispersion as film materials. The factors influenced the pellet release were studied, including the coating dispersion, preparation method and assay method of release. RESULTS The prepared pellets had ideal control release and Characteristics. The different formulations were described by in vitro release equations. CONCLUSION The aqueous coating method had the advantages of rapidness, high efficiency, controllable quality, and could be used in industrialized manufacture.