复方磺胺多辛片的工艺研究

Process of compound sulfadoxin tablets

为优选复方磺胺多辛片处方和制备工艺,通过对产品工艺处方和制备方法的预试验,拟订初步工艺,以复方磺胺多辛片中磺胺多辛和乙胺嘧啶溶出度、硬度、脆碎度为主要考察指标,采用正交试验方法优选辅料配方和生产工艺。优选出的处方和制备方法适合大生产,磺胺多辛和乙胺嘧啶溶出度及其它质量指标完全符合USP27要求。

To optimize the preparing process of compound sulfadoxintablets,the initial process was drawn up after the preliminary test with the formula,and the preparative method.Orthogonal test was taken to optimize the compounding of the adjuvant and the process,by investigating the dissolution rate,degree of hardness and friability of the sulfadoxin and pyrimethamine of the compound sulfadoxin tablets.The optimized formula and the preparative method are suitable for large-scale production.The dissolution rate and t...