水杨酸钠制备工艺改进的研究

Study on Improvement of Preparation Process of Sodium Saligylate

为了保证产品质量,控制成本,对水杨酸钠的制备工艺进行研究。通过改变两种原料药水杨酸、碳酸氢钠的级别及投料比,根据检验结果判断是否符合规定。经过改进,按照药用级水杨酸∶水∶药用级碳酸氢钠∶保险粉∶EDTA=100∶100∶60.75∶0.05∶0.05进行实验,水杨酸钠工艺改进后产品质量明显提高,结果符合《中华人民共和国卫生部颁药品标准》规定。该工艺成本低,产品质量可靠。

The process of preparation of sodium salicylate,mass analysis of products were studied to identify the possible causes of the impact on product quality and process to make improvements to ensure product quality while controlling costs. To analyze the original trials,its main raw material was industrial- class,content was lower than the same level of medicinal materials. All the inspection items were not qualified which was not suitable for sure reactant ratio. Therefore,the experiment was first considered to change level of two API and identify the most suitable reactant ratio,then to change level of a kind of API alonly. According to the test results,deciding whether was compliance with.Thus the most suitable scheme of production enterprise was selected. By the improvement,according to the medicinal grade salicylic acid∶water∶medicinal grade sodium bicarbonate∶insurance powder∶EDTA = 100∶100∶60. 75∶0. 05∶0. 05 to conduct the experiment. The all results were in line with Ministry of Health of the People＇s Republic of China promulgated the Drug Standards（ The first book of chemicals and preparations）. Process improvement of salicylic acidsodium showed product quality was improved significantly,conforming standard provisions. At the same time,the cost of production was controlled in an acceptable level.