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多西紫杉醇脂质体制备工艺及处方优化研究
引用本文:黄红兵,刘韬,徐月红,林子超,钟锦堂,刘庆,郑蓥蓥,阮惠诗.多西紫杉醇脂质体制备工艺及处方优化研究[J].中国药学杂志,2007,42(24):1872-1876.
作者姓名:黄红兵  刘韬  徐月红  林子超  钟锦堂  刘庆  郑蓥蓥  阮惠诗
作者单位:1. 华南肿瘤学国家重点实验室,中山大学肿瘤医院药剂科,广州,510060
2. 中山大学药学院,广州,510080
摘    要: 目的优化制备多西紫杉醇脂质体的工艺和处方。方法采用正交设计法,以磷脂和胆固醇的比例、药物与脂类比例和高压匀质次数为主要考察因素,以包封率、粒径分布及稳定性为综合考察指标,优化多西紫杉醇脂质体的制备工艺和处方。结果最佳处方和工艺条件为:药物∶(磷脂+胆固醇)为1∶20;磷脂∶胆固醇为6∶1,水合介质为磷酸盐缓冲液(pH=7.4),制备浓度为0.5 g·L-1,采用薄膜-超声分散工艺制备,高压乳匀次数为6次。按该工艺制备3批含药脂质体,包封率最高可达(84.4±1.6)%,平均粒径为(147.1±41.1)nm,Zeta电位为(+2.25±0.2)mV;在室温条件下放置14 d和在4℃下放置180d,各项指标变化不显著;体外释放实验显示,含药脂质体具有明显缓释特性。结论按优化处方和工艺制得的多西紫杉醇脂质体的包封率较高,粒径大小可符合靶向制剂要求,且质量稳定。

关 键 词:多西紫杉醇  脂质体  正交设计
文章编号:1001-2494(2007)24-1872-05
收稿时间:2006-10-11
修稿时间:2006年10月11

Study on Optimization of Preparation and Formulation of Docetaxel-Containing Liposomes
HUANG Hong-bing,LIU Tao,XU Yue-hong,LIN Zi-chao,ZHONG Jin-tang,LIU Qing,ZHENG Ying-ying,RUAN Hui-shi.Study on Optimization of Preparation and Formulation of Docetaxel-Containing Liposomes[J].Chinese Pharmaceutical Journal,2007,42(24):1872-1876.
Authors:HUANG Hong-bing  LIU Tao  XU Yue-hong  LIN Zi-chao  ZHONG Jin-tang  LIU Qing  ZHENG Ying-ying  RUAN Hui-shi
Institution:1. State Key Laboratory of Oncology in South China,Tumor Hospital Affiliated to Sun Yat-Sen University,Guangzhou 510060,China;2.School of Pharmaceutical Sciences,Sun Yat-sen University,Guangzhou 510080,China
Abstract:OBJECTIVE To optimize the preparation and formulation of docetaxel-containing liposomes.METHODS Orthogonal design was adopted to screen the preparation and formulation of docetaxel-containing liposomes on the basis of the comprehensive score of the encapsulation efficiency,particle size and stability of liposomes.RESULTS The ideal combination of preparation and formulation were as follows: docetaxel-(lecithin+cholesterol)=1∶20;lecithin-cholesterol=6∶1.The formulation was prepared by thin-film ultrasonic dispersion technique using specified volume of PBS as hydrating medium.The concentration of liposome solution was 0.5 g·L-1.The average encapsulation efficiency of the optimized liposome was(84.4±1.6)%,the average particle size was(147.1±41.1)nm and the Zeta potential was(+2.25±0.2)mV.The docetaxel liposome was quite stable after being stored in refrigerator for 6 months.The sustained release was obtained in vitro.CONCLUSION The thin-film ultrasonic method and the optimized preparation can be used to prepare docetaxel liposome successfully.
Keywords:docetaxel  liposome  orthogonal design
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