阿柔比星A聚乳酸毫微粒冻干针剂的研制及体外药物释放规律的研究

Preparation of lyophlized aclarubicin A poly-lactide nanoparticle for injection and the study on the drug releasing mechanism

研究阿柔比星 A聚乳酸毫微粒 (ACRB- A- PL A- NP)冻干针剂的制备 ,并对其体外释药进行考察。根据低共熔点测定结果 ,以及外观、色泽、再分散性等质量参数为指标 ,制备出 ACRB- A- PL A- NP冻干针剂 ,采用动态透析法研究其体外释放规律。结果 ,制得的 ACRB- A- PL A- NP冻干针剂色泽均匀 ,再分散性良好。其体外释药可用 3种方式表达。提示 ACRB- A- PL A-

The preparation of lyophlized aclarubicin A poly- lactide nanoparticle for injection and the drug releasing mechanism in vitro were studied.The lyophlization conditions such as the eutetic point,the color and the cake forming as well as the reconstitution properties were determined;and the drug releasing mechanism in vitro was conducted by dynamic dialysis experimental process.Results showed that the lyophlized producthad a good appearance and easily reconstituted in the injection media;while the in vitro drug releasing mechanism could be expressed in the combined three formulas of fit,and manifested itself a significant characteristic of sustained release properties.