【摘要】 制备烯丙孕素缓释片，对其进行质量评价并建立含量测定方法。以烯丙孕素缓释片的亲水凝胶骨架种类，用量以及片芯厚度作为考察因素，以缓释片的释放度为考察指标，对烯丙孕素缓释片的处方工艺进行单因素筛选和中心组合设计响应面法优化并进行质量评价，建立体外释药模型及建立烯丙孕素缓释片的高效液相色谱检测方法。烯丙孕素缓释片的最佳处方为：烯丙孕素2%,羟丙基-β-环糊精70%,硬酯酸镁0.5%,微晶纤维素19.1%,卡波姆B 8.4%,片厚3.8 mm。体外释药符合Higuchi模型，烯丙孕素在10～80 mg/L之间呈现良好线性关系R~2=0.999 98。优化所得烯丙孕素缓释片工艺稳定，具有显著缓释效果。所建立高效液相色谱法准确可靠，可用于检测缓释片中烯丙孕素含量。更多还原

【Abstract】 This study aims to prepare altrenogest extended-release tablets,evaluate their quality and establish a content determination method.The hydrophilic gel skeleton type,dosage and core thickness of altrenogest extended-release tablets were used as the investigating factors,and the release degree of the tablets was used as the investigating index,the prescription process of altrenogest extended-release tablets was optimized by one-factor screening and central combinatorial design response surface method,and quality evaluation was carried out,the in vitro release model was established,and a high-performance liquid chromatography(HPLC) assay method was set up for the determination of altrenogest extended-release tablets.The results showed that the optimal prescription of altrenogest extended-release tablets was 2% as the main drug,70% as the solubilizer,0.5% as the lubricant,19.1 % as the filler,8.4% as the hydrophilic gel skeleton material,and the thickness of the tablets was 3.8 mm.The in vitro drug release conformed to the Higuchi model,and the altrenogest showed a good linear relationship with the R~2=0.999 98 in the range of 10—80 mg/L.The optimized process for the extended-release tablets was stable and had a good quality.The extended-release tablets were stable and had significant slow-release effect.The HPLC method is accurate and reliable and can be used for the determination of altrenogest in extended-release tablets.更多还原