复方鸦胆子油脂质体的制备工艺研究study on prescription and .pdf

中药制剂工程与技术 年 第第1414卷卷 第第35期期 复方鸦胆子油脂质体的制备工艺研究 涂颖秋 ，蒋杉杉，李玉清，黄绳武 （浙江中医药大学，浙江杭州310053） 摘要 目的：研究复方鸦胆子油脂质体的处方筛选及制备工艺。方法：采用气相 色谱 法测定脂质体 包封率。以脂质体 包 封率为主要指标 ，对制备工艺 中可能影响脂质体性质的工艺参数和处方因素进行单 因素考察和正交设计 ，优化制备 工 艺。用不同冻干保护剂进行冷冻干燥 ，以筛选合适的保护剂。测定 Zeta 电位、粒径大小及分布。结果：采用乙醇注入 法制 备复方鸦胆子油脂质体 ；最佳制备工艺为磷脂浓度为 1.5%，磷脂胆 固醇质量 比为 5∶1，油水两相体积 比为 1∶10，甘露醇∶ 蔗糖∶磷脂质量比为 1∶1∶1，水相介质为蒸馏水，温度为 50 ℃，搅拌速度为 30 rpm 。最佳处方制备的平均 包封率为 91.9% ， Zeta 电位为-32.1 mV ，平均粒径为 170.3 nm。结论：该 实验制备的复方鸦胆子油脂质体具有 包分率高、稳定性好、表 面带 负电等特点 ，为进一步研究复方鸦胆子油脂质体奠定 了基础。 关键词 鸦胆子油；蟾酥 ；复方脂质体 ；制备工艺 中图分类号：R285.5 文献标识码：Ａ 文章编号：1671-0258（2013）05-0025-05 Study on Prescription and Preparation of Compound Oleum Fructus Bruceae Liposomes Tu Yingqiu，Jiang Shanshan ，Li Yuqing ，Huang Shengwu （Zhejiang Chinese Medical University ，Hangzhou Zhejiang 310053） Abstract Objective ：To optimize the prescription and preparation of compound oleum fructus bruceae liposomes. Methods ： The encapsulation efficiency of liposomes was examined by Gas Chromatography. Orthogonal design was adopted and encap － sulation efficiency of liposomes was taken as index in observation. Formulation and preparation factors which may influence properties of liposomes were studied. Result ：Compound oleum fructus bruceae liposomes was prepared by ethanol injection method. The optimum preparation conditions were as follows ：the concentration of the soybean lecithin was 1.5% ，ratio of lecithin to cholesterol was 5∶1，volume ratio of water-oil was 10∶1，the best proportion for mannitol ，sucrose，lecithin was 1∶1∶1， the aqueous phase was distilled water ，the temperature was 50 ℃，and the stirring speed was 30 rpm. The average encapsula－ tion efficiency was 91.9%. The Zeta potential of the liposomes was -32.1 mV and the average size was 170.3 nm. Conclu－ sion ：The formulation and preparat