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Preparation and in vitro release of Mesalamine Delayed-release Tablets
Author(s): 
Pages: 452-457
Year: Issue:  7
Journal: Qilu Pharmaceutical Affairs

Keyword:  美沙拉嗪缓释片肠溶包衣体外释放;
Abstract: 目的 制备美沙拉嗪肠溶缓释片,考察其体外释放.方法 以体外释放相似因子(f2)为主要评价指标,通过单因素处方筛选和正交试验设计得到最优处方,重现3批,比较自制美沙拉嗪肠溶缓释片与参比制剂的体外释放行为.结果 片芯中羧甲基纤维素钠(CMC 7HXF PH)用量为45 mg,羧甲淀粉钠(CMSNa)用量为35 mg;肠溶包衣层中Eudragit L100和Eudragit S100以2:3的比例联用,包衣增重为6%.自制肠溶缓释片与参比制剂的相似因子f2值均大于50.结论 自制美沙拉嗪肠溶缓释片与参比制剂体外释放相似,处方工艺稳定可重现,可用于美沙拉嗪肠溶缓释片的制备.
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