破伤风类毒素原液质量分析方法的研究

发布时间：2018-03-28 13:51

本文选题：破伤风类毒素　切入点：电泳　出处：《中国医药生物技术》2016年04期

【摘要】：目的建立对破伤风类毒素原液进行质量分析的分子排阻色谱方法和聚丙烯酰胺凝胶电泳方法。方法分别建立分子排阻色谱方法和聚丙烯酰胺凝胶电泳方法对破伤风类毒素原液单体和聚体含量进行分析,并对两种方法的关键影响因素及两种方法检测结果进行评价分析。结果以含1%异丙醇的p H 7.0,0.2 mol/L磷酸盐缓冲液为流动相,选取TSK-GEL G3000SWxl色谱柱,可以对破伤风类毒素单体、二聚体和多聚体分离,经配套软件分析得到其三个组分的相对含量;选用实验室自配的10%浓度的分离胶对破伤风类毒素原液进行电泳后经Image Lab软件分析可以对破伤风类毒素原液的单体和聚体进行纯度分析,两种方法检测结果具有可比性。结论建立的两种检测破伤风类毒素原液单体和聚体含量的方法能够对所含单体、二聚体和多聚体进行分离和定量,两种方法相辅相成,可以对生产的破伤风类毒素原液批间一致性进行监控和用于不同目的的破伤风类毒素质量情况进行监督。
[Abstract]:Objective to establish molecular exclusion chromatography method and polyacrylamide gel electrophoresis method for quality analysis of tetanus toxoid. The contents of monomer and polymer in the solution of wind toxoid were analyzed. The key influencing factors of the two methods and the detection results of the two methods were evaluated and analyzed. Results the tetanus toxoid monomer could be determined by TSK-GEL G3000SWxl column with the mobile phase of pH 7.0N 0.2 mol/L phosphate buffer containing 1% isopropanol. The relative contents of the three components were obtained by software analysis. After electrophoresis of tetanus toxoid with 10% concentration in laboratory, the purity of monomer and polymer of tetanus toxoid could be analyzed by Image Lab software. Conclusion the two methods can separate and quantify the monomers, dimers and polymers contained in tetanus toxoid, and the two methods complement each other. The consistency of tetanus toxoid can be monitored and the quality of tetanus toxoid used for different purposes can be monitored.
【作者单位】：北京天坛生物制品股份有限公司;中国食品药品检定研究院;
【分类号】：R392-33

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