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目的建立重组天门冬酰胺酶Ⅱ纯化过程质量监控的方法。方法用高效毛细管区带电泳法监 测 Ｌ－天门冬酰胺酶的纯化过程。经优化的电泳条件为：４５ｃｍｘ５０ｕｍ ｉ．ｄ．石英毛细管（有效长度为 ３７．５ｃｍ），检测波 长 ２１４ｎｍ，分离电压 １２ｋＶ，压差迸样 １０ｓ，恒温 １３℃，分离介质为 ｐＨ７．０的 ８０ｍｍｏｌ／Ｌ磷酸钠缓冲液。实测了 ６批样品 的纯度，用于各纯化步骤的质量监控。结果该方法简单、快速，尤其适合于重组蛋白的质量控制。结论毛细管 区带电泳法（ＣＺＥ），可以用于对Ｌ－天门冬酰胺酶的纯化过程的质量监控，还可用于半成品和成品的质量控制。
Objective To establish a method for quality monitoring of recombinant asparaginase II purification process. Methods The purification of L-asparaginase was monitored by high performance capillary zone electrophoresis. The optimized electrophoresis conditions are: 45cmx50um i. d. Quartz capillary (effective length 37.5cm), detection wavelength 214nm, separation voltage 12kV, differential pressure sample 10s, constant temperature 13°C, separation medium pH7.0 80mmol/L sodium phosphate buffer. The purity of the 6 batches of samples was measured for quality monitoring of each purification step. Results The method is simple and rapid, especially suitable for quality control of recombinant proteins. Conclusions Capillary zone electrophoresis (CZE) can be used for quality monitoring of the purification process of L-asparaginase and can also be used for quality control of semi-finished and finished products.