摘要
目的建立检测β-丙内酯(BPL)含量的气相色谱法,并分析其水解情况。方法用气相色谱法检测BPL的含量,确定线性范围及定量限,验证该方法的重复性及专属性,并分析37℃条件下BPL的水解趋势。结果气相色谱法检测BPL含量的线性范围为8.9～566.9ppm,定量限为8.9ppm,重复性和专属性均良好。37℃条件下水解120min,BPL含量下降至初始浓度的19%。结论建立了检测BPL含量的气相色谱法,该方法准确可靠,可用于病毒疫苗生产过程中BPL含量的检测,为病毒灭活工艺验证提供了依据。
Objective To develop a gas chromatography for determination ofβ-propiolactone（BPL）content and analyze the hydrolysis of BPL.Methods Gas chromatography was used for determination of BPL content,then evaluated for linear range and detection limit,and verified for reproducibility and specificity.The tendency of BPL hydrolysis at 37℃was analyzed.Results The developed gas chromatography for BPL showed a linear range of 8.9～566.9 ppm,a detection limit of 8.9 ppm,and high reproducibility and specificity.After hydrolysis at 37℃for 120 min,the BPL content decreased to the 19%of original one.Conclusion A gas chromatography for determination of BPL content was developed,which was accurate,reliable and might be used for determination of BPL content during production of viral vaccines.It provided a basis for verification of virus inactivation procedure.
出处
《中国生物制品学杂志》
CAS
CSCD
2010年第3期323-324,332,共3页
Chinese Journal of Biologicals
关键词
β-丙内酯
气相色谱法
水解
β-propiolactone（BPL） Gas chromatography Hydrolysis
