薄膜分散法制备SN-38脂质体及质量评价  

Preparation of SN-38 Liposomes by Membrane Forming Method and It Quality Evaluation

作　　者：银晓晶 王淑君[2] 叶田田[2] YIN Xiao-jing;WANG Shu-jun;YE Tian-tian(Department of Pharmacy,Cancer Hospital of China Medical University,Liaoning Cancer Hospital and Institute,Shenyang Liaoning 110042,China;School of Pharmacy,Shenyang Pharmaceutical University,Shenyang Liaoning 110016,China)

机构地区：[1]中国医科大学肿瘤医院辽宁省肿瘤医院药学部,辽宁沈阳110042 [2]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《当代化工》2023年第4期872-877,共6页Contemporary Chemical Industry

摘　　要：为了制备7-乙基-10-羟基喜树碱(SN-38)脂质体并进行相关制剂学评价,采用薄膜分散法制备SN-38脂质体,以包封率为评价指标,用高效液相色谱法进行测定,通过单因素实验考察优化SN-38脂质体的制备工艺并进行质量评价。结果表明:制备工艺中,磷脂浓度3%,药脂比为1∶20,胆固醇与磷脂比为1∶6,水化温度为50℃,包封率平均值为92.0%,选择质量分数为10%的甘露醇为冻干保护剂,制备SN-38脂质体的冻干品;质量评价方面,SN-38脂质体的外观澄清带有蓝色乳光,平均粒径为147 nm。选用载体成膜法制备SN-38脂质体的工艺操作简便、合理可行。In order to prepare 7-ethyl-10-hydroxy-camptothecin(SN-38)liposomes and to evaluate related preparations,SN-38 liposomes were prepared by carrier membrane forming method.Using the encapsulation rate as evaluation index,the preparation process of SN-38 liposomes was investigated and the quality was evaluated by single factor experiment.The results showed that,in the preparation process,the concentration of phospholipid was 3%,the ratio of drug to lipid was 1∶30,the ratio of cholesterol to phospholipid was 1∶6,the hydration temperature was 50℃,the average encapsulation rate was 92.0%,and 10%mannitol was selected as the lyophilized protector to prepare the freeze-dried SN-38 liposomes.In terms of quality evaluation,the appearance of SN-38 liposomes was clear with blue opalescent,and the average particle size was 147 nm.The preparation process of SN-38 liposomes by carrier film forming is simple,reasonable and feasible.

关 键 词：SN-38 薄膜分散法 脂质体 制备工艺 质量评价 

分 类 号：R283.6[医药卫生—中药学]