硫酸长春新碱脂质体的质量评价研究  

Quality evaluation of Vincristine Sulphate Liposomes

作　　者：张雪冰[1,2] 李文静[1] 王杏林[2] 杨志强[2] 吴溪[1,2] 

机构地区：[1]天津中医药大学,天津300193 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300193

出　　处：《现代药物与临床》2015年第6期658-662,共5页Drugs & Clinic

基　　金：国家重大新药创制项目(2014ZX09507005-001)

摘　　要：目的评价硫酸长春新碱脂质体的质量。方法采用p H梯度法制备硫酸长春新碱脂质体。透射电镜观察脂质体的外观形态,阳离子交换树脂柱法测定包封率,并考察其p H值、粒径、Zeta电位、稳定性及体外释放规律。结果形态学观察结果显示,脂质体均匀圆整度良好。硫酸长春新碱脂质体粒径为120 nm左右,Zeta电位约为10 m V,包封率均在90%以上。光照、4℃、18℃、25℃条件下,脂质体各项指标无显著变化。40℃条件下,包封率明显降低。结论本法准确,操作简便,可用于硫酸长春新碱脂质体的质量评价。Objective To evaluate the quality of Vincristine Sulphate Liposome.Methods Vincristine sulphate was encapsulated in the liposomes using the pH gradient-dependent remote loading technique. The morphological examination of liposomes was observed with transmission electron microscopy. The encapsulation efficiency was determined by cation exchange resin column. Their pH value, particle size, Zeta potential, stability, andin vitrodeliveryof vincristine sulphate were investigated.Results The morphology of Vincristine Sulphate Liposome showed that liposomes were uniformity, good roundness. The particle size of the liposomes was about 120 nm, the Zeta potential was about 10 mV, and the encapsulation efficiency was above 90%. Vincristine sulphate liposomes did not occur significant changes under the light condition and at 4℃, 18℃, and 25℃ conditions. At 40℃, the encapsulation efficiency decreased.Conclusion The method is accurate and simple to evaluate the quality of Vincristine Sulphate Liposomes.

关 键 词：硫酸长春新碱脂质体 硫酸长春新碱 质量评价 稳定性 

分 类 号：R927.2[医药卫生—药学] R944