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抗癌灵缓释滴丸包衣工艺及体外释放度研究
Study on the coating technology and dissolution test in vitro of Kang’ailing sustained-release dropping pills
【摘要】 目的:对抗癌灵缓释滴丸的包衣工艺进行研究,并考察其体外释放度。方法:以释放度为评价指标,采用正交试验优选包衣工艺。结果:最佳包衣处方为:缓释层乙基纤维素水分散体(Surelease)与羟丙甲纤维素(HPMC)比例为15∶6,缓释层聚合物增重百分数为4%,肠溶层FS30D增重百分数为20%。释药行为符合Higuchi方程,具有明显的缓释特征。结论:该包衣工艺简单实用,所制备的滴丸具有良好的缓释效果,符合中国药典要求。
【Abstract】 OBJECTIVE To study the coating technology of Kang’ailing sustained-release dropping pills and investigate their release property in vitro.METHODS The coating technology was optimized by orthogonal test with the drug release in vitro.RESULTS The optimization of technique was that the ratio of surelease:HPMC was(15∶6),the sustained-release layer polymer was 4% higher by weight and the enteric coated layer was 20% higher by weight.The release behavior of the sustained-release dropping pills was coincident with Higuchi equation well and the character of sustained-release was significant.CONCLUSION The sustained-release dropping pills have a good property of sustained-release in vitro by the optimized coating technology that was simple and economic and their release behaviors meet the standard of Chinese Pharmacopoeia.
【Key words】 Kang’ailing sustained-release dropping pills; the coating technology; dissolution test in vitro;
- 【文献出处】 中国医院药学杂志 ,Chinese Journal of Hospital Pharmacy , 编辑部邮箱 ,2012年16期
- 【分类号】R283
- 【下载频次】99