头孢曲松钠生产工艺与色级的关系

Relations of Ceftriaxone Sodium Production Process and Color-level

头孢曲松钠属于第三代半合成头孢菌素类抗生素,在抗生素药物中占有非常重要的地位。质量是企业的生命,保证质量是企业神圣的职责,目前头孢曲松钠生产工艺比较完善,生产出的头孢曲松钠含量较高,收率好,符合药典要求,相关物质也符合标准,只是色级不稳定,时间长了色级有升高的趋势,无法满足用户需求,而且退货不但影响企业声誉,还给企业增加了成本,为从根本上解决这个问题,重新设计工艺参数,通过改变工艺条件,正交设计,优化试验,得到了一个工艺稳定的路线,基本解决了这个问题。

The ceftriaxone sodium is the third- generation semi -synthetic cephalosporin antibiotics, it have a very important position in the area of the antibiotics. The quality is the life of the factory , and the quality assure is the enterprise sacred duty. The production process of the ceftriaxone sodium is a little perfect at present. The yield is content our standard , and the impurity and the content are according to the pharmacopoeia standard. But the color is instability. The color - level is rising along with the storage time, and this item is not content our requirement. The production is untreaded is not only affect the company＇ s reputation, but also increase the cost of production. To solve this problem, we re - design the production process according to orthogonal design and process optimizing. Then we have the steady process at last and have solved the problem basically.