制药用水质量标准及制备系统技术的探讨

Discussion of Quality Standard for Pharmaceutical Water and Preparation in the System Technology

制药用水是药品生产过程中应用最广泛的物料和溶剂,对药品质量至关重要。目前,各国药典对制药用水的质量均做了严格规定;但由于各企业所采用的制水系统技术不同,其所产纯化水和注射用水的质量也参差不齐,严重影响药品质量。本文综述了中国、美国、欧盟和日本等国家和组织的药典中关于纯化水和注射用水的质量标准及其变革,对比了各药典中纯化水和注射用水的质量指标差异,如细菌内毒素、电导率、总有机碳和微生物限度等。探讨比较了热压式蒸馏和多效蒸馏注射用水制备技术以及双级反渗透和反渗透加电去离子纯化水制备技术、制药用水储存及分配系统设计技术。

Pharmaceutical water is the material and solvent used most widely in the process of drug production, which is of great importance to drug quality. At present, pharmacopoeia of each country has strict regulations on the quality of pharmaceutical water. However, in view of the different water system technologies adopted by enterprises, the qualities of purified water and water injection are uneven, which seriously affect the quality of drugs. In this article, the quality indexes of purified water and injection water in different pharmacopoeias are compared, such as bacterial endotoxin, electrical conductivity, total organic carbon and microbial limitation. The preparations of water for injection with the thermocompression type distillation and multi-effect distillation, preparations of deionized purified water by the double stage reverse osmosis and the combined mode of reverse osmosis and electrodeionization, as well as pharmaceutical water storage and distribution system design technology are discussed.