摘要
目的 建立一种准确性高,简便快速的方法,对人血白蛋白中间品的辛酸钠含量进行质量控制;方法 通过采用气相法和乙醚萃取法,分析比较T公司20批制品.结果 乙醚萃取法与气相法相比,回收率均在97% ~101%的范围内,相对误差小于2%,萃取法与气相法差异无统计学意义(P>0.05).结论 此法简便快速,结果可靠,可应用于中间产品辛酸钠含量的测定.
Objective To establish an accurate and rapid lnethod to detect sodiuln caprylate during the process of hu- man seruln albumin(HSA). Methods 20 salnples of company T was analyzed with ether extraction and gas ehrolnatogra- phy( GC). Results The lnean recovery ranged from 97% to 101% and RSD was less than 2%. Conclusion The results showed that this lnethod was rapid, convenient and accurate,which could lneet the quality control during the production of HSA.
出处
《药学研究》
CAS
2014年第2期85-86,共2页
Journal of Pharmaceutical Research
关键词
辛酸钠含量
乙醚萃取法
气相法
Sodium caprylate assay
Ether extraction
Gas chromatography