复方乳酸钠注射液2号质量标准提高研究  

Quality Control of Compound Sodium Lactate Injection No.2

作　　者：邓朝晖[1] 胡文军[1] 李爱红[1] 

机构地区：[1]中国人民解放军广州军区联勤部药品仪器检验所,广东广州510500

出　　处：《中国药业》2015年第17期57-59,共3页China Pharmaceuticals

基　　金：军队医疗机构制剂标准提高科研专项课题;项目编号:13ZJZ25

摘　　要：目的：提高复方乳酸钠注射液2号的质量控制标准。方法修订复方乳酸钠注射液2号中乳酸钠含量测定方法，建立测定氯化钾含量的原子吸收分光光度法，通过计算方法测定氯化钠的含量。结果乳酸钠质量浓度线性范围为0.0311～0.7765 g/mL，氯化钾为0.1353～4.059μg/mL，氯化钠为0.928～5.568 g/L。乳酸钠的回收率为99.81％，RSD 为0.48％（ n＝9）；氯化钾的回收率为100.01％，RSD为0.96％（ n＝9）；氯化钠的回收率为98.78％，RSD为0.31％（ n＝9）。结论经方法学验证，复方乳酸钠注射液2号中乳酸钠、氯化钾、氯化钠的含量测定方法可行。Objective To imProve the the quality control standard of ComPound Sodium Lactate Injection No. 2. Methods The content determination method of sodium lactate was amended. A method of Atomic AbsorPtion SPectroPhotometry （ AAS ） for determination Potas-sium chloride was established. The content of sodium chloride was obtained by calculation. Results Sodium lactate showed excellent linearity at the range of 0. 031 1~0. 776 5 g/mL,0. 135 3~4. 059 μg/mL,0. 928~5. 568 g/L. The average recoveries were 99. 81%（ RSD=0. 48%,n=9 ） ,100. 01% （ RSD=0. 96%,n=9 ） ,98. 78% （ RSD=0. 31%,n=9 ） resPectively. Conclusion According to the result of method verification,sodium lactate,Potassium chloride and sodium chloride of ComPound Sodium Lactate Injection No. 2 could be assayed.

关 键 词：复方乳酸钠注射液2号 乳酸钠 氯化钠 氯化钾 

分 类 号：R927.11[医药卫生—药学] R977.7