目的　建立用电位滴定法测定生物制品中氯化钠含量的方法并进行初步应用。方法　以氯化钠基准物质为对照，根据硝酸银滴定液滴定电位测定样品中氯化钠含量并验证方法。分别用不同方法测定同一样品并比较。结果　在6~15 mg/ml范围内，氯化钠浓度与消耗的硝酸银滴定液体积呈良好的线性关系，回归方程的决定系数为0.999 9；脑膜炎球菌多糖疫苗培养基、破伤风抗毒素原液、b型流感嗜血杆菌结合疫苗、疫苗用氢氧化铝佐剂中氯化钠平均回收率分别为100.0%、99.8%、100.2%、100.3%，表明电位滴定法具有良好的准确度；同批次供试品6次测定结果的相对标准偏差最大为0.7%，表明电位滴定法具有很好的重复性；将供试品在稀释后分别放置5和30 min后再检测，对结果无明显影响，表明该方法具有良好的耐用性；对电位滴定法和中国药典2020年版采用的福尔哈德法所得结果进行统计学分析，从t检验结果可知，2种方法测定结果差异无统计学意义（t值在-2.12~2.50，P>0.05）。结论　建立了用电位滴定法测定生物制品中氯化钠含量的方法，该方法线性范围良好、重复性好、定量准确，适用于生物制品中氯化钠含量的检测。

Objective　To develop and apply a potentiometric titration method for determination of sodium chloride content in biological products. Methods　With sodium chloride primary standard as control, the content of sodium chloride in sample was determined by potentiometric titration with silver nitrate titrant.The same samples were determined and compared by different methods. Results　The concentration of sodium chloride in the range of 6-15 mg/ml showed a good linear relationship with the volume of silver nitrate titrant consumed. The coefficient of determination for the regression equation was 0.999 9. The average recovery rates of sodium chloride in meningococcal polysaccharide vaccine culture medium, tetanus antitoxin stock solution, Haemophilus influenzae type b conjugate ,aluminum hydroxide adjuvant for vaccine were 100.0%, 99.8%, 100.2% and 100.3%,respectively, which showed that the potentiometric titration method had good accuracy. The maximum relative standard deviation of the six determinations of the same batch of samples was 0.7%, indicating that the method had good repeatability. The test samples were placed for 5 and 30 min, respectively, after dilution and then tested, which had no obvious effect on the results, indicating that the method had good durability. Statistical analysis of the results obtained by potentiometric titration method and the Volhard method adopted in Chinese pharmacopoeia 2020 edition showed that there was no statistically significant difference between the results of the two methods (t values were -2.12—2.50，P>0.05). Conclusions　The method of potentiometric titration for the determination of sodium chloride content in biological products is established. The method has good linear range, good repeatability and accurate quantification, and is suitable for the determination of sodium chloride content in biological products.