【摘要】 目的探讨消除拉丝封口导致灭菌注射用水pH值升高的解决方案。方法考察不同封口工艺对灭菌注射用水的影响,根据《中国药典》(2010版)二部的规定对灭菌注射用水pH值进行测定。结果采用拉丝封口联合预热火处理可消除拉丝封口导致的灭菌注射用水pH值升高。结论拉丝封口联合预热火处理制备灭菌注射用水简单可行,质量可靠。更多还原

【Abstract】 Objective To discuss the solution on eliminating the rising pH value of sterile water for injection caused by wiredrawing seal.Methods The effect of different seal processes on the pH value of sterile water for injection were investigated.The pH value of sterile water for injection was detected according to the Part Two in the Chinese Pharmacopoeia(2010 version).Results The rising pH value of sterile water for injection caused by wiredrawing seal could be eliminated by the process of the combination of wiredrawing seal together with preheating flame.Conclusion The established technique is simple and feasible with controllable quality for manufacturing sterile water for injection by the combination of wiredrawing seal together with preheating flame.更多还原