注射用酚磺乙胺制备工艺研究

目的：制备优良的注射用酚磺乙胺。方法：采用正交设计试验对处方工艺进行研究,通过对甘露醇的量,活性炭用量和抗氧剂三因素的考察,以酚磺乙胺含量作为考察指标,按照确定的处方工艺中试三批样品,并将样品进行影响因素考察。结果：最佳甘露醇的量,活性炭的加入量和抗氧剂分别为10%,0.05%,0.02%亚硫酸氢钠,在光照和高温条件下考察10 d,各项指标均符合质量标准规定。结论：按该方法制备的注射用酚磺乙胺,完全符合质量标准。

Preparation Process of Etamsylate for Injection

Objective： To prepare etamsylate for injection with high quality. Method： The formula and preparation process were investigated. The amounts of mannitol, activated carbon and antioxidant were optimized by an orthogonal design. According to the opti- mized formula and preparation process, three batches of pilot-scale products were prepared, and then the stress testing was conducted. Result： The optimal amount of mannitol, activated carbon and sodium bisulfite was 10% , 0.05% and 0.02% , respectively. During the testing 10 days, all indices were accordant with the relative quality standards. Conclusion： The products prepared by the optimized method are completely accordant with the quality standard of etamsylate for injection.