醋酸氟氢可的松片的研制

Preparation of Fludrocortisone Acetate Tablets

采用粉末直接压片法,通过处方筛选、工艺优化及体外药物释放特征研究,进行醋酸氟氢可的松片的研制。以纤维素-乳糖复合辅料作为稀释剂、硬脂酸镁作为润滑剂,进行混合压片,测定自制制剂的溶出曲线,采用f2相似因子法评价自制制剂和参比制剂的体外释放曲线。硬脂酸镁最佳用量为0.5%、片剂最佳硬度为60~80N,在优化条件下,自制制剂和参比制剂体外释放试验f2相似因子均大于50。醋酸氟氢可的松片的自研制剂工艺更加简单,并和参比制剂在体外药物释放特征一致。

To prepare fludrocortisone acetate tablets by direct powder compression method,through formulation selection,process optimization and in vitro drug release characteristics.The cellulose-lactose complex excipient was used as diluent,and magnesium stearate was used as lubricant.The release curves of the self-made preparation were determined,f2 similarity factor method was used to evaluate the in vitro release curves of self-made and reference preparations.The optimal dosage of magnesium stearate was 0.5%,and the optimal hardness of the tablet was 60~80 N.Under the optimal conditions,the f2 similarity factors of self-made preparation and reference preparation in vitro release test were greater than 50.The self-developed process of fludrocortisone acetate tablets is simpler,and the drug release characteristics in vitro are consistent with those of reference preparations.