平衡液质量控制及处方改进

Study on Quality Control and Formulation Improvement of Balanced Salt Solution

目的 :探讨控制平衡液质量稳定的方法。方法 :对半成品、成品中的离子含量检验结果进行分析 ,找出离子含量变化规律。结果 :灭菌后 ,成品中Cl-、Ca2 +、HCO3-含量与半成品中比较 ,分别下降1 %以下、1 5 %～2 1 %和9 0 %～13 5 %。结论 :将半成品中Cl-、Ca2 +、HCO3-的含量控制在99 %～104 %、100 %～106 %和108 %～114 %之间 ,所得灭菌后成品中离子成分含量及pH值适宜 ,质量稳定。

OBJECTIVE:To study the method to control the quality stability of balanced salt solution.METHODS:The detecting results of the contents of electrolyte ions in semi-finished product and end product were analysed to find out their changing regulation.RESULTS:After sterilization,the contents of Cl-,Ca2+and HCO-3 in end product decreased by<1%,1.5%～2.1%and 9.0%～13.5%respectively comparing those in semi-finished product.CONCLUSION:If the contents of Cl-,Ca2+and HCO-3 are controlled in the ranges of 99%～104%,100%～106%and 108%～114%of end product,the contents and pH value of sterilized end product will be appropriate and the quality stable.