[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 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 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.