毛细管电泳法测定重组人乳头瘤病毒原液的纯度

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50 μm×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 papillomavirus 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-voltage: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 16L1 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.

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