雷贝拉唑钠冻干粉针的研制  

Preparation of Rabeprazole Sodium Freeze-dried Injection

作　　者：郭绍梅[1] 

机构地区：[1]莱州市人民医院,山东莱州261400

出　　处：《食品与药品》2013年第3期196-198,共3页Food and Drug

摘　　要：目的制备雷贝拉唑钠冻干粉针。方法选用单因素筛选冻干粉针的支架种类,采用高效液相色谱法测定主药的含量。结果选用右旋糖酐40作为支架剂,氢氧化钠调节pH,雷贝拉唑钠含量测定表明雷贝拉唑钠进样量在47.87～71.81μg/mL范围内与吸收峰面积呈良好的线性关系(r=0.9999)。平均回收率为100.77%,RSD=0.78%(n=9)。结论制备工艺合理,质量检测方法简便、准确、重现性良好。Objective To investigate the preparation technology of rabeprazole sodium freeze-dried injection. Methods The supporting agents were screened with single-factor experiments. The content of freeze-dried injection was determined by HPLC method. Results Dextran-40 was selected as supporting agent, with NaOH as pH regulator. There was good linearity of rabeprazole sodium in the concentration range of 47.87-71.81 μg/mL （r=0.9999）. The average recovery was 100.77 %, with RSD of 0.78 % （n=9） . Conclusion The preparation technology is appropriate, and the quality control method is simple, accurate and repeatable.

关 键 词：雷贝拉唑钠 冻干粉针 高效液相色谱法 含量测定 

分 类 号：R975[医药卫生—药品]