4-氨基水杨酸钠口服结肠定位包衣片的溶出曲线测定  

Determination of Dissolution Curve of 4-Amino Salicylate Sodium Oral Colon-Specific Coated Tablets

作　　者：徐冀文[1] 王红爱[1] 李曼[1] 

机构地区：[1]广东省第二人民医院药学部,广东广州510317

出　　处：《中国药业》2013年第21期25-26,共2页China Pharmaceuticals

摘　　要：目的 建立4-氨基水杨酸钠口服结肠定位包衣片溶出曲线的测定方法.方法 采用浆法、转速为100 r/min,介质体积为900 mL,测定溶出曲线,以Kromasil C18柱（250 mm x4.6 mm,5 μm）为色谱柱,流动相为甲醇-水（35∶65）,检测波长为254 nm,流速为1 mL/min,柱温为30℃,进样量为20 μL.结果 4-氨基水杨酸钠进样量在2.778 ～ 27.78 μg（r=0.999 8）范围内与峰面积呈良好线性关系,回收率均符合要求.结论 所用方法简便、准确、专属性强、回收率高,可用于该制剂的质量控制.Objective To establish a determination method for the dissolution curve of 4-Amino Salicylate Sodium Oral Colon-Specific Coated Tablets.Methods The stirring paddle method was adopted with the rotating speed of 100 r/min and the medium volume of 900 mL.High performance liquid chromatography（HPLC） was performed on the C18 column with methanol-water （35：65） as the mobile phase at a flow rate of 1 mL/min.The detection wavelength was at 254 nm.The column temperature was 30 ℃ and the sample size was 20 μL.Results The linear range of 4-amino salicylate sodium was 2.778-27.78 μg（r =0.999 8）.The recovery rate met the requirement.Conclusion The used method is simple and accurate with strong specificity and high recovery rate and can be used for the quality control of this preparation.

关 键 词：4-氨基水杨酸钠口服结肠定位包衣片 高效液相色谱法 溶出曲线 

分 类 号：R927.1[医药卫生—药学] R975