头孢拉定胶囊的处方工艺及质量研究

Study on Preparation Technology and Quality of Cefradine Capsules

文章研究头孢拉定胶囊的处方工艺,并对其质量进行考察。根据头孢拉定胶囊参比制剂的处方剖析结果,选择合适辅料,筛选头孢拉定胶囊处方工艺,开发质量方法,并进行稳定性考察。质量与参比制剂相当,在四种溶出介质中15 min的累积溶出度≥85%。本实验研制的头孢拉定胶囊适合工业化生产,产品质量稳定。

In this paper,the formulation and quality of cefradine capsules were studied.According to the prescription analysis results of reference preparation of cefradine capsules,the appropriate excipients were selected,the formulation process of cefradine capsules was screened,the quality method was developed,and the stability was investigated.The quality of the preparation was similar to that of the reference preparation,and the cumulative dissolution in four dissolution media was more than 85%in 15 min.The cefradine capsules developed in this experiment are suitable for industrial production and the product quality is stable.