浅论甲钴胺片处方优选.doc

浅论甲钴***片处方优选浅论甲钴***片处方优选日期: 07月 10日摘要:甲钴***片;处方;正交设试验计;溶出度【摘要目的筛选甲钴***片的最佳处方组成。方法以辅料中的微晶纤维素( MCC )、十二烷基硫酸钠( SDS-Na )、羧甲淀粉钠( CMS-Na )、微粉硅胶( SiliciiDoxydum )作为考察因素,每个因素取三个水平, 用 L9( 34) 正交表布置试验, 以甲钴***片的溶出度为主要考察指标, 以片重差异作为参考指标,进行正交试验[ 1] 。结果辅料中影响甲钴***片溶出度的主要因素是十二烷基硫酸钠, 最佳处方组成为微晶纤维素( PH101 ) 35g ,十二烷基硫酸钠 ,羧***淀粉钠 , 微粉硅胶 。结论采用该处方及工艺制得的甲钴***片溶出度较高, 而且产品质量稳定,制备工艺简单可行,适合工业化大生产。【甲钴***片;处方;正交设试验计;溶出度 Study on formulation and preparation technique of mecobalamin tablets 【 Abstract Objective To select the optimum formulation technique of mecobalamin tablets. Methods The L9( 34) orthogonal table and four factors ( dissolution as main factor , weight difference as reference factor ) were used to select the best formulation by taking MCC ( HP101 )、 SDS-Na 、 CMS-Na and silicii doxydum as the four factors , and three levels were adopted for each factors. Results The experimental resultes indicated SDS-Na was the chief factor of influencing dissolution of macobalamin tablets. The optimum formulation posed of MCC ( HP101 ) 35g , SDS-Na , CMS-Na and silicii doxydum . Conclusion The optimum formulation and preparing technique are reliable. Becasue the quatily of macobalamin tablets accords with China pharmacopoeia standard. The preparing technique are simple and feasible , it is suitable for industrialized production. 【 Key words macobalamin tablet; formulation; orthogonal experiment de