【摘要】 目的查找造成灭菌注射用水pH升高的原因,寻求可能的解决方法。方法在灭菌注射用水生产过程中,分别在不同阶段取样,或以不同的工艺条件和不同生产厂家的安瓿来考察,并根据《中国药典》(2005年版)二部的规定对灭菌注射用水的pH值进行检测。结果高压灭菌时的高温使安瓿玻璃中的弱碱性成分分解释放到注射用水中是造成灭菌注射用水pH升高的主要原因。结论将安瓿经过注水后再煮沸的预处理方法能较好的解决灭菌注射用水的pH值升高问题。更多还原

【Abstract】 OBJECTIVE The reason for the rising pH value of sterile water for injection was investigated and the capable solving method was found.METHODS In the production process,the pH value of sterile water for injection was detected according to Chinese Pharmacopoeia(2005 version).The different sampling points,production conditions and the ampoule from the different producers effecting on the pH value of sterile water for injection were investigated.RESULTS Autoclaving made the weak alkaline components of ampoule entered into the sterile water for injection,which caused the pH value raised primarily.CONCLUSION When ampoule was filled with water and boiled,problem of pH value raised could be solved.更多还原