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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 ginkgolide (containing ginkgolide GA, GB, GC) sustained release pellets and evaluate its quality. Methods The aqueous dispersions of ethylcellulose were used to coat the pellets in fluidized bed. Factors affecting the drug release, such as the composition of the coating liquid, preparation process factors and the determination of release degree, were investigated. The prepared ginkgo lactone sustained-release pellets were evaluated for quality. Results The prepared pellets had better release and better roundness, fluidity, stability and so on. The release equations of different components in vitro were different. Conclusion The preparation of sustained-release pellets by fluidized bed water-based coating technology has the characteristics of rapid, high efficiency and quality control, which is suitable for industrial production.