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作 者:杨正红 王莘泉 YANG Zheng-hong;WANG Xin-quan(Insearch Technology Development Beijing Ltd.,Beijing 100096,China)
机构地区:[1]仪思奇(北京)科技发展有限公司,北京100096
出 处:《药物分析杂志》2023年第6期991-998,共8页Chinese Journal of Pharmaceutical Analysis
摘 要:目的:探讨脂质体zeta(ζ)-电位不稳定性的根源。方法:以DT-1202超声法粒度和ζ-电位分析仪对原浓体系脂质体的ζ-电位及其微观电学参数进行了研究。由于ζ-电位与表面电荷(密度)有线性关系,且脂质体的稳定化机制主要靠亲水溶胶的离子化层,并非依靠静电斥力,建议脂质体的稳定性测定应该以表面电荷为评价参数,并且直接测量原有浓度的胶体体系,同时扣除本底连续相的影响。结果:发现ζ-电位的不稳定性与脂质体的配方有关,即脂质体的ζ-电位受其环境影响,但是胶体的表面电荷却是相对稳定的。结论:胶体振动电流(CVI)电声法是脂质体配方开发和质量控制的理想工具。Objective:To investigate the instability source of the zeta(ζ)-potential of liposomes.Methods:The ζ-potential and its related micro electrical parameters of liposomes in the raw concentrated system were studied by DT-1202 ultrasonic particle size and electroacoustic ζ-potential analyzer.Because there was a linear relationship between the ζ-potential and the surface charge(density),and the stabilization mechanism of liposomes mainly depends on the ionization layer of the hydrophilic sol but not on the electrostatic repulsion,it was suggested that the stability of liposomes should be measured with the surface charge as the evaluation parameter,and the original concentrated colloidal system should be measured directly with deducting the effect of the background from the continuous phase.Results:It was found that the instability was related to the formulation of liposomes.The ζ-potential of liposomes was affected by the environment,but the surface charge of colloids was relatively stable.Conclusion:It is shown that colloidal vibrational current(CVI)electroacoustic method is an ideal tool for the formulation development and quality control of liposomes.
关 键 词:脂质体 电声法 ZETA电位 表面电荷 分散稳定性 胶体振动电流法
分 类 号:R917[医药卫生—药物分析学]
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