多效蒸馏器制备注射用水的质量控制研究

目的 为制备高质量的注射用水提供技术保障。方法 选取蒸气压力、进料水质量、进料水流量、冷却水流量4个可能影响多效水质量的因素，按2000年版《中国药典》注射用水项下各项规定对不同运行条件下制得的注射用水进行检测和质量评定。结果 影响多效蒸馏器产水质量的因素，按重要性大小依次为进料水质量、蒸气质量、进料水流量、冷却水流量。进料水质量是制备合格注射用水的前提，可通过监测电导率进行水质控制。结论 在规定的技术参数下运行，多效蒸馏器制备的注射用水质量稳定、可靠。

Study on Quality Control of Water for Injection by Multi- effect Still

Objective To find out the factors influencing the quality of water by multi-effect still and to assure that high quality water for injection can be attained. Methods The four probable factors influencing the quality of water for injection by multi- effect still were investigated. According to the Chinese Pharmacopoeia,to analyze and evaluate the quality of water for injection under the different quality of steam,quality of purified water,flow rate of purified water and flow rate of cooling water, Results Of four factors,the qualities of purified water and steam were the most important,then the flow rate of purified water and flow rate of cooling water. Monitoring the conductivity can control the quality of purified water and water for injection. Conclusion Under the specified operation parameters,the quality of water by multi- effect still is steady,reliable.