摘要
纯化水是制药生产过程中非常重要且大量使用的工艺用水,对药品安全至关重要。本试验采用国际认可和通用的纯化水处理工艺“反渗透”体系作为模型,对处理工艺中必须加入的几种化学溶液,即次氯酸钠(NaClO)溶液、亚硫酸氢钠(NaHSO)溶液、氢氧化钠(NaOH)溶液的浓度进行计算,用科学的观点阐述以上几种化学溶液的加注原因,并基于余氯和pH值的测定结果以定量分析的方法确定配制浓度与加注量,用以指导纯化水的工艺工程操作。
Purified water is very important and widely used in pharmaceutical production as process water,which is crucial for the drug safety.The internationally recognized and generally accepted purified water treatment process,"reverse osmosis" system,was adopted as the model,and the concentrations of several chemical solutions were calculated,such as sodium hypochlorite(NaClO) solution,sodium bisulfite(NaHSO) solution and sodium hydroxide(NaOH) solution,which must be added in the treatment process to ensure the quality of purified water for pharmaceutical use.From a scientific point of view,the reasons for adding of above chemical solutions were explained,and the concentrations and adding amounts were determined based on the determination results of free chlorine residual and pH values by quantitative analysis method,for guiding the operation procedure of purified water generation.
作者
王海
申峰
WANG Hai;SHEN Feng(Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650106)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2022年第7期1043-1048,共6页
Chinese Journal of Pharmaceuticals
关键词
制药用水
反渗透法
纯化水
次氯酸钠溶液
亚硫酸氢钠溶液
氢氧化钠溶液
余氯
pH值
pharmaceutical water
reverse osmosis method
purified water
sodium hypochlorite solution
sodium bisulfite solution
sodium hydroxide solution
free chlorine residual
pH value