海藻酸钠在盐酸二甲双胍缓释片中的应用

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 pH 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1000 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。

Application of sodium alginate in Metformin Hydrochloride Sustained-release Tablets

Objective To prepare Metformin Hydrochloride Sustained - release Tablets with sodium alginate as sustained-release materials.Methods To compare the dissolution profile and stability between domestic and the brand drug with 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 the related substances of domestic are no significant increase,the average tablet weight of domestic was 850 mg,while the brand drug 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 Hydrochloride Sustained-release Tablets with sodium alginate as sustained-release materials were reasonable and practicable,its process was stable and the quality was controlled.