摘要
采用流化床包衣法,分别用苏丽丝和尤特奇为包衣材料,制备了2种释药速率的磷酸卡维地洛缓释微丸。考察了2种微丸在不同混合比例下灌装得到的胶囊在pH 6.8磷酸盐缓冲液(含0.05%Tween-80)中的释放行为,并评价其与原研制剂(Coreg CR)的释放行为相似性。结果表明,在4种介质(pH 1.2盐酸、pH 4.5磷酸盐缓冲液、含0.05%Tween-80的pH 6.8磷酸盐缓冲液和水)中,将2种微丸照各自主成分各占胶囊标示量50%比例混合后灌装得到的自制胶囊与原研制剂释放曲线的相似因子(f_2)大于50。
Two kinds of carvedilol phosphate sustained-release pellets with different release rates were prepared by fluidized bed coating technology with Surelease and Eudragit as the coating material, respectively. The release behaviors of the capsules containing two kinds of sustained-release pellets in different mixed ratios were investigated in pH 6.8 phosphate buffer containing 0.05 % Tween-80. The release similarity between the self-made capsules and reference listed drug, Coreg CR, was investigated. The results showed that when the mixed ratio of the Surelease-coated pellets to the Eudragit-coated pellets was 50 ：50, the calculated similarity factor （f2） values were all above 50 in pH 1.2 hydrochloric acid, pH 4.5 phosphate buffer, pH 6.8 phosphate buffer containing 0.05 % Tween-80 and water, which indicated that the release behaviors of the self-made capsules and Coreg CR were similar.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2017年第2期204-207,共4页
Chinese Journal of Pharmaceuticals
基金
江苏省药物研究所有限公司提供资助
关键词
磷酸卡维地洛
缓释胶囊
缓释丸
释放度相似性
carvedilol phosphate
sustained-release capsule
sustained-release pellet
release similarity
