摘要
目的:建立毛细管电泳法测定重组人乳头瘤病毒原液的纯度。方法:采用50μm×57 cm(有效长度50 cm)无涂层毛细管。进样时方法设置为:进样5 kV,20 s;分离电压为15 kV,维持30 min,两端加压138 kPa;温度:25℃;检测波长:220 nm。结果:毛细管电泳法测定重组人乳头瘤病毒(HPV)16型、18型原液主峰分离度分别为2.4和3.0,HPV 16L1和HPV 18L1原液在浓度为0.125~0.750 mg.mL-1时线性关系良好(HPV 16L1,r=0.9836;HPV 18L1,r=0.9931)。HPV 16L1和HPV 18L1原液的精密度和稳定性试验的RSD均<2.0%。结论:本文建立的方法可用于重组人乳头瘤病毒原液的纯度检测。
Objective:To establish a CE -SDS method to evaluate the purity of the recombinant human papilloma- virus bulk. Methods: The determination was performed under the following conditions : bare - fused silica capillary of 50 μm × 75 cm ( 50 cm of effective length) ; sample injection method : injection voltage :5 kV, 20 s ; separate - volt- age : 15 kV ; time :30 min ; column pressure : 138 kPa; temperature :25 ℃ ; detecting wavelength :220 nm. Results: The resolutions of HPV 16 and HPV 18 bulk by CE - SDS were 2.4 and 3.0. The linear concentration of HPV 16L! and HPV 18L1 ranged from 0. 125 to 0. 750 mg· mL^-1 ( HPV 16L1 ,r =0. 9836 ;HPV 18L1 ,r =0. 9931 ). The RSDs in precision and stability tests were both below 2.0%. Conclusion:The method established in this paper can be used to determine the purity of HPV bulk.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第12期2118-2121,共4页
Chinese Journal of Pharmaceutical Analysis
基金
上海人才发展资金资助项目(2011017)