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

目的 制备复方盐酸表柔比星聚乳酸-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.

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

Objective To prepare compound epirubicin hydrochloride-loaded polymeric nanoparticles of L-lactic-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-lactic-co-glycolic acid after the addition of lactose.The contents and cumulative release of epirubicin hydrochloride and dimeglumine gadopentetate were detected simultaneously by RPHPLC (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 epirubicin 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.