氟苯尼考PEG6000固体分散体的制备与表征

以聚乙二醇6000(PEG6000)为载体,采用熔融法和溶剂熔融法制备氟苯尼考(florfenico1,FF)固体分散体,用红外光谱法、显微观察法、差示热分析法和溶出速率法验证固体分散体,比较FF、FF和PEG6000的物理混合物、氟苯尼考PEG6000固体分散体的溶解度,用分光光度法测定固体分散体中FF的含量.结果表明,氟苯尼考、混合物、固体分散体的差示热曲线、红外光谱和溶出速率差异很大,固体分散体的溶解度为1.118mg/mL,氟苯尼考的平均回收率为100.5%,相对标准差1.0%,FF对照品溶液浓度为50.0～350.0μg/mL时,吸光度(y)与浓度(x)线性关系良好,回归方程为y=0.0027x+0.0073,r=0.9998.氟苯尼考PEG6000固体分散体制备方法简单,质量可控,可以显著提高药物的溶解度.

Preparation and characterization of florfenicol-polyethyleneglycol 6000 solid dispersions

The florfenicol(FF) - Polyethyleneglycol 6000 (PEG6000) solid dispersions (SDs) were prepared by melting and solvent-melting method with PEG6000 as carriers. The SDs were validated by infrared spectroscopy, microscopy, differential thermal analysis and dissolution rate. The solubilities of FF, mixture and SDs were measured. The spectrophotometer method was developed to determine the concent of FF. It was found that the spectra of infraed spectroscopy, differential thermal analysis of the SDs were remarkably different from that of FF and physical mixture. Solubility of FF was 1.118 mg/mL for the formation of SDs. The average recoveries of FF were 100.5% and relative standard deviation was less than 1.0%. The calibration curve was linear with an correlation coefficient r = 0.999 8 in range of 50.0~350.0 µg/mL. The method was simple in preparation, validation and determination the FF/PEG6000 SDs. Solubility of FF was enhanced remarkably for the formation of SDs.