毛细管电泳用于测定人绒促性素的解离亚基及其质量控制

发布时间：2018-04-14 21:02

本文选题：人绒促性素 + 毛细管电泳　；参考：《药学学报》2017年03期

【摘要】：人绒促性素(hCG)是用于治疗不孕症等的常用药物。其由α亚基和β亚基组成,研究发现hCG在生产及储存过程中均可能产生亚基的解离,从而影响其活性。本文旨在建立hCG解离亚基的测定方法,通过考察样品制备缓冲体系、样品制备温度、分离电压、毛细管温度等,建立了毛细管电泳(CE-SDS)定量测定hCG解离亚基的方法。方法验证结果表明,α亚基和β亚基含量具有良好的灵敏度、线性、准确度和精密度,优于传统的凝胶电泳SDS-PAGE。本文所开发的方法适用于不同来源的hCG,并可应用于指导工艺开发及稳定性研究。因此,该方法应作为hCG生物制品的重要质控方法。
[Abstract]:HCGs are commonly used in the treatment of infertility.It is composed of 伪 subunit and 尾 subunit. It is found that the dissociation of subunit may occur during production and storage of hCG, thus affecting its activity.The aim of this paper is to establish a method for the determination of dissociated subunits of hCG. A method for quantitative determination of dissociated subunits of hCG by capillary electrophoresis (CE SDS) has been established by investigating the sample preparation buffer system, sample preparation temperature, separation voltage, capillary temperature, etc.The results showed that the content of 伪 subunit and 尾 subunit had good sensitivity, linearity, accuracy and precision, and was superior to the traditional gel electrophoresis SDS-PAGE.The method developed in this paper is suitable for hCGs from different sources and can be used to guide process development and stability study.Therefore, this method should be used as an important quality control method for hCG biological products.
【作者单位】：珠海市丽珠单抗生物技术有限公司;
【基金】：国家发展和改革委员会资助专项:丽珠医药集团股份有限公司国家级企业技术中心创新能力建设(抗体药物实验室)(发改投资[2013]535号、粤发改高技术[2013]243号、珠发改产业[2013]70号)
【分类号】：R927

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