用固体分散法提高磺胺嘧啶片溶出速度的研究

PREPARATION AND IN VITRO EVALUATION OF SULFADIAZINE SOLID DISPERSIONS

为了提高磺胺嘧啶（SD）在水中的溶解度、溶出速度，加速其在体内的崩解、溶出、吸收过程，达到速效、高效的目的，以PEG－6000、尿素等材料为载体，采取溶剂熔融法，制备SD的固体分散体，分别测定了固体分散体与原料药的溶解度以及固体分散体片剂与普通片剂的溶出度和溶出速率，固体分散体片剂的溶出度均达到99．0％以上，而普通片剂的最大熔出度为26％，方差分析固体分散体片剂组与普通片剂组具有极显著差异（P＜0．01），固体分散体能显著提高血的溶解度和溶出速度。

To improve the dissolution of sulfadiazine (SD), Sulfadiazine solid dispersions were prepared using solvent - melting methods with PEG - 6000 and urea as carriers. In vitro dissolution characteristics were studied in simulated gastric juice. In PEG - 6000 - SD solid dispersion, stilfadiazine existed as fine crystal. In vitro dissolution results showed that higher carriers - SD ratio led to faster drug dissolution.PEG -6000 was potent in impiming the solubility and dissolution of SD and had the potential for prachcal use.