腹膜透析液(乳酸盐)中葡萄糖和乳酸钠的含量测定方法改进  

Improved Method of Simultaneous Determination of Glucose and Sodium Lactate in Peritoneal Dialysis Solution(Lactate)

作　　者：梁伟娜 江雪欣 Liang Weina Jiang Xuexin(Yantai Center for Food and Drug Control and Test, Yantai 264000, Chin)

机构地区：[1]烟台市食品药品检验检测中心,烟台264000

出　　处：《中国药事》2016年第11期1107-1111,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:建立HPLC法同时测定腹膜透析液(乳酸盐)中葡萄糖和乳酸钠的含量。方法:采用Carbomix H-NP 10:8%(7.8 mm×300 mm,10μm)色谱柱,流动相为水,流速0.5 m L·min-1,柱温55℃,示差折光检测器检测池温度为55℃。并将测得结果与国家标准中收载的碘量法(葡萄糖)与HPLC法(乳酸钠)进行比较。结果:葡萄糖和乳酸钠浓度分别在2.0918~7.3214 mg·m L^(-1)(r=0.9999)、0.7954~2.7825 mg·m L-1(r=0.9999)呈良好的线性关系,平均回收率分别为99.0%(n=9)、98.6%(n=9)。本法测得结果与国家标准中的碘量法与HPLC法的结果基本一致。结论:本方法简便、快速、准确,可用于腹膜透析液(乳酸盐)的质量控制。Objective： To establish an HPLC method to simultaneously determine the contents of glucose and sodium lactate in peritoneal dialysis solution（lactate）. Methods： The analysis was performed on a Carbomix H-NP 10：8% column（7.8 mm×300 mm, 10 μm） with gradient elution of water at a flow rate of 0.5 m L · min-1. The temperatures of column and the differential detector were both set at 55 ℃. And the measured results were compared with the results from lodimetry（glucose）and HPLC（sodium lactate） of the national standard（WS） method. Results： The linear ranges were 2.0918-7.3214 mg·m L-1（r = 0.9999） for glucose and 0.7954-2.7825 mg·m L-1（r = 0.9999） for sodium lactate, respectively. The average recoveries of glucose and sodium lactate were 99.0%（n = 9） and 98.6%（n = 9）, respectively. The determination results of this method were consistent with those of lodimetry and HPLC methods. Conclusion： The method was simple, rapid and accurate, which is suitable for quality control of peritoneal dialysis solution（lactate）.

关 键 词：腹膜透析液(乳酸盐) 葡萄糖 乳酸钠 高效液相色谱法 方法比较 标准改进 

分 类 号：R917[医药卫生—药物分析学] R927.2[医药卫生—药学]