海藻酸钠在盐酸二甲双胍缓释片中的应用  

Application of sodium alginate in Metformin Hydrochloride Sustained-release Tablets

作　　者：王福洲 王中华 郝冠华 

机构地区：[1]寿光富康制药有限公司,山东寿光262700

出　　处：《药学研究》2016年第11期653-656,共4页Journal of Pharmaceutical Research

摘　　要：目的采用海藻酸钠作为缓释材料制备盐酸二甲双胍缓释片。方法通过自制样品与原研药进行体外溶出曲线及稳定性的对比,考察海藻酸钠作为缓释材料在盐酸二甲双胍缓释片中的缓释效果。结果试验处方制得的盐酸二甲双胍缓释片与原研药对比几条关键p H溶出介质体外溶出曲线,相似因子(f2)达到70以上;试验处方制得的盐酸二甲双胍缓释片有关物质基本无增加;试验处方制得的盐酸二甲双胍缓释片片重约850 mg,原研药约1 000 mg。结论采用海藻酸钠作为缓释材料制备的盐酸二甲双胍缓释片与原研药的体外释放相似度高;处方、工艺稳定可行,质量可控。Objective To prepare Mefformin Hydrochloride Sustained- release Tablets with sodium alginate assustained-release materials.Methods To compare the dissolution profile and stability between domestic and the brand drugwith sodium alginate as sustained-release material in Metformin Hydrochloride Sustained-release Tablets.Results Similar-ity factors （f2） of several critical pH dissolution medium between domestic and the brand drug was more than 70, and therelated substances of domestic are no significant increase, the average tablet weight of domestic was 850 rag,while the branddrug was 1 000 mg.Conclusion With sodium alginate as sustained-release materials, Metformin Hydrochloride Sustained-release Tablets had the same dissolution profile as the brand drug.The formulation and process of Metformin HydrochlorideSustained-release Tablets with sodium alginate as sustained-release materials were reasonable and practicable, its processwas stable and the quality was controlled.

关 键 词：海藻酸钠 缓释材料 体外溶出曲线 稳定性 

分 类 号：TQ460.4[化学工程—制药化工]