干扰素脂质体的质量控制研究  

Quality Control of Interferon Liposome

作　　者：李云富[1] 张水华 李久立 杨虹 易艳蓉 王妍 

机构地区：[1]上海交通大学生命科学技术学院,上海200030 [2]深圳海王英特龙生物技术股份有限公司研发部,深圳518054

出　　处：《中国生物制品学杂志》2006年第6期603-606,共4页Chinese Journal of Biologicals

摘　　要：目的 建立稳定的干扰素脂质体质控体系。方法 采用电子显微镜、粒度分析仪、气相色谱仪以及酶标仪等仪器和检测手段，对干扰素脂质体的形态、粒径、包封率、有机物的残留量以及稳定性等进行分析。结果 干扰素脂质体透射电镜下观察为圆形，直径50～350nm，粒径呈正态分布，平均粒径为200-210nm，跨距为0．80～1．10，包封率达到90％以上。有机物残留量低于《中国药典》二部（2005版）规定的标准。在2～8℃下保存6个月，渗漏率不高于20％，而总活性基本不变。结论 该干扰素脂质体的质控体系的检测项目比较全面，检测结果稳定，可用于产品的质量控制。Objective To develop a stable quality control system of interferon liposome. Methods Analyze the morphology, particle size,envelope rate, residual organism content and stability by using electron microscope, size distribution analyzer, gas phase chromatography and EIA reader. Results Interferon liposome was in a form of round particles in diameters of 50-350 nm under trans-mission electron microscope. Analysis by size distribution analyzer showed normal distribution of size of interferon liposome,in a mean diameter of 200-210 nm. The span of particles was 0. 80-1.10, and their envelope rate reached more than 90%. The residual organism content was less than the standard described in Chinese Pharmacopoeia. After storage at 2-8℃ for 6 months ,the leakage rate of liposome was not more than 20% ,and the total activity of interferon showed no significant change. Conclusion The developed quality control system of interferon liposome was stable and practical.

关 键 词：干扰素 脂质体 质量控制 

分 类 号：R943[医药卫生—药剂学]