硫酸长春新碱脂质体的质量评价研究-天津中草药杂志社.PDFVIP

·658 · 现代药物与临床 Drugs Clinic 第 30 卷 第 6 期 2015 年 6 月 硫酸长春新碱脂质体的质量评价研究 1, 2 1 2* 2 1, 2 张雪冰 ，李文静 ，王杏林 ，杨志强 ，吴 溪 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 摘 要：目的 评价硫酸长春新碱脂质体的质量。方法 采用 pH 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 pH 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 mV，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。 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 中图分类号： R927.2 ；R944 文献标志码：A 文章编号：1674 - 5515(2015)06 - 0658 - 05 DOI:10.7501/j.issn.1674-5515.2015.06.011 Quality evaluation of Vincristine Sulphate Liposomes 1, 2 1 2 2 1, 2 ZHANG Xue-bing , LI Wen-jing , WANG Xing-lin , YANG Zhi-qiang , WU Xi 1. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 2. Tianjin Institute of Pharmaceutical Research, State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin 300193, China Abstract: 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, and in vitro delivery of 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 occ