硫酸长春新碱脂质体含量测定及3种包封率测定方法的比较  

Content Determination of Vincristine Sulphate Liposomes and Comparison of 3 Methods for Entrapment Efficiency

作　　者：陈颖翀[1] 李翔[1,2] 张婧[3] 刘微[1] 罗晓健[1] 孟拓[4] 

机构地区：[1]江西中医药大学/中药固体制剂制造技术国家工程研究中心,南昌330006 [2]江西本草天工科技有限责任公司,南昌330006 [3]江西中医药大学/现代中药制剂教育部重点实验室,南昌330004 [4]中国药科大学药学院,南京210009

出　　处：《中国药房》2014年第37期3504-3507,共4页China Pharmacy

基　　金：江西省青年科学基金资助项目(No.20122BAB215018;20132BAB215022);江西省科技支撑计划资助项目(No.20123BBG70181);江西省卫生厅中医药科研计划资助项目(No.2012A157);江西省教育厅青年科学基金资助项目(No.GJJ12536)

摘　　要：目的：建立测定硫酸长春新碱脂质体含量的方法，并对其3种包封率测定方法进行比较。方法：采用高效液相色谱法测定药物含量，色谱柱为Agilent C18，流动相为4．5％二乙胺水溶液（pH7．0）．甲醇（1：7，V/V），流速为1．0ml／min，检测波长为297nm；分别采用超速离心法、超滤法、微柱离心法分离游离药物并测定包封率。结果：硫酸长春新碱检测质量浓度线性范围为1-160μg／ml（r=0．9999），平均回收率为（97．8±1．1）％；3种方法测定包封率的方法回收率均符合方法学要求（回收率均≥96．54％），测得样品的包封率分别为96．54％、96．84％、95．29％。结论：本品含量测定方法准确；包封率测定方法中以超滤法操作更简单且快速。建立的含量和包封率测定方法可用于该制剂的质量控制。OBJECTIVE： To establish the method for the content determination of vincristine sulphate （VS） liposomes, and to compare 3 methods for entrapment efficiency. METHODS： HPLC method was adopted. The determination was performed on Agilent C18 column with mobile phase consisted of 4.5% diethylamine solution （pH 7.0）-methanol （1：7, V/V） at the flow rate of 1.0 ml/min. The detection wavelength was set at 297 nm. The entrapment efficiency was determined by ultracentrifugation, ultrafiltration and microcolumn centrifugation method, respectively. RESULTS： The linear range of VS were 1-160 μg/ml （r=0.999 9） with an average recovery of （97.8 ± 1.1）%. Method recoveries of 3 methods for entrapment efficiency were in line with the methodology requirements （recoveries≥96.54%）, entrapment efficiency were 96.54%, 96.84%, 95.29%. CONCLUSIONS： The method for content determination is accurate; ultracentrifugation method is more simple and rapid among 3 methods. Established methods for content determination and entrapment efficiency can be used for quality control of the preparation.

关 键 词：硫酸长春新碱脂质体 含量测定 包封率 

分 类 号：R927.2[医药卫生—药学]