复方盐酸表柔比星聚乳酸-羟基乙酸共聚物纳米粒的制备及含量测定  

Preparation and quality control of compound epirubicin hydrochloride-loaded polymeric nanoparticlesof L-lactic-co-glycolic acid

作　　者：纪建松[1] 傅红兴[3] 宋晶晶[2] 李慧[3] 朱雁林[3] 

机构地区：[1]东南大学临床医学博士后流动站,南京210096 [2]丽水市中心医院放射科,南京210096 [3]温州医学院药学院,南京210096

出　　处：《中华医学杂志》2011年第47期3371-3373,共3页National Medical Journal of China

基　　金：卫生部科研基金（WKJ2009-2-035）;江苏省博士后科研基金（20100712）

摘　　要：目的制备复方盐酸表柔比星聚乳酸一羟基乙酸共聚物（PLGA）纳米粒，并对其含量进行测定。方法采用乳化-溶剂挥发法制备复方盐酸表柔比星纳米粒，添加适量乳糖后采用冷冻干燥法制备得到复方盐酸表柔比星纳米粒冻干粉，通过反相高效液相法测定盐酸表柔比星和钆喷酸双葡甲胺的含量和释放度。结果制备得到复方盐酸表柔比星PLGA纳米粒，初步建立了可同时测定两种药物成分的高效液相含量测定方法，复方制剂中盐酸表柔比星和钆喷酸双葡甲胺的含量分别为100．6％±1．6％、99．1％±1．9％，且两种成分均能在9d内释放完全。结论本方法制备复方盐酸表柔比星PLGA纳米粒简便可行，所拟定的含量测定方法可行。Objective To prepare compound epirubicin hydrochloride-loaded polymeric nanopartieles of L-laetic-co-glycolic acid and establish their quality control. Methods The emulsion-solvent evaporation method was employed to prepare and freeze-dry the compound epirubicin hydrochloride-loaded polymeric nanoparticles of L-laetic-co-glycolic acid after the addition of lactose. The contents and cumulative release of epirubicin hydrochloride and dimeglumine gadopentetate were detected simultaneously by RP- HPLC （reverse phase-high performance liquid chromatography ）. Results The above nanoparticles were prepared and the quality standards for simultaneously determining the contents of epirubicin hydrochloride and dimeglumine gadopentetate established primarily. The contents of epirubiein hydrochloride and dimeglumine gadopentetate in compound preparation were 100.6% ±1.6% and 99. 1%±1.9% respectively. And two compositions could be completely released within 9 days. Conclusion The preparation method of nanoparticles is simple and their quality control feasible.

关 键 词：表柔比星 葡甲胺 复方 

分 类 号：R927[医药卫生—药学] R94