复方乳酸钠注射液中乳酸钠含量测定方法的比较研究

目的：建立一种重现性好,操作相对简单的乳酸钠含量测定方法。方法：以离子交换法（药典法）作对照,进行氧化还原法,中和法和紫外分光光度法的回收率比较研究。结果：氧化还原法和中和法与离子交换法无显著性差异（P〉0.05）,紫外分光光度法与离子交换法有显著性差异（P〈0.05）。结论：药典法结果准确、重现性好,但操作繁琐;中和法操作简单快速,但终点不易观察;紫外分光光度法简便易行,但偏差较大。改进后的氧化还原法操作简便,结果准确可靠,重现性好,适合医院制剂的分析要求,是乳酸钠含量测定比较理想的方法。

Comparison of measure methods of sodium lactate in compound sodium lactate injection

Objective:To establish an easy method with good reproducibility to determine the content of sodium lactate in the compound sodium lactate injection.Methods: The recovery rates of the improved redox process method,neutralization method and UV method were tested,and compared with the ion-exchange resin method which was recommended by Chinese Pharmacopeia and used as control.Results: No significant difference was found between the improved redox process and ion-exchange resin methods.There existed significant difference between the UV and the control methods(P<0.05).Conclusion: The redox method recorded in Chinese Pharmacopeia is accurate,with good reproducibility,but too complex for manipulation.The neutralization method is simple and rapid,but difficult to observe the end-point.The UV method is also simple to manipulate,but with great deviation.The improved redox process method is simple,rapid and accurate,with good reproducibility,which is ideal for determining the content of sodium lactate in the compound sodium lactate injection in hospital.