依巴斯汀口服溶液的制备及质量控制  

Preparation and quality control of ebastine oral solution

作　　者：谢丽晓[1] 吴明钗[1] 胡瑞颖[1] 叶可人[1] 林洁[1] 金丽敏[1] 陈晓孩[1] 

机构地区：[1]温州医学院附属第三医院,瑞安325200

出　　处：《海峡药学》2010年第4期53-54,共2页Strait Pharmaceutical Journal

摘　　要：目的制备依巴斯汀口服溶液并建立其质量控制方法。方法以依巴斯汀为主药,β-环糊精为辅料制备口服溶液。采用高效液相色谱法测定依巴斯汀的含量。结果依巴斯汀在10～100mg·mL-1范围内线性关系良好(r=0.9998),平均回收率为98.99%(RSD=1.06%,n=3)。结论该口服溶液制备简单且质量可控。OBJECTIVE To prepare ebastine oral solution and establish a method tor its quality control. METHODS Ebastine and β-cyclodetrin were used as main compositions. The content of ebastine was determined by HPLC spectrophotometry. RESULTS The linear range of ebastine was 10-100 mg·L^-1（r = 0. 9998）, and the average recovery was 98.99 % （ RSD = 1.06 %, n = 3）. CONCLUSION The preparation of ebastine oral solution is simple, and the quality can be controlled.

关 键 词：依巴斯汀 口服溶液 制备 质量控制 

分 类 号：TQ460.6[化学工程—制药化工] R927.11[医药卫生—药学]