硫辛酸注射液与木糖醇和果糖注射液的配伍稳定性考察  

Compatible stability of thioctic aciol injection(ALA) in xylitol injection and fructose injection

作　　者：甘惠贞[1] 林淑瑜[1] 潘丹婷[1] 杨昌云[1] 

机构地区：[1]解放军第180医院药学科,福建泉州362000

出　　处：《实用药物与临床》2014年第11期1449-1453,共5页Practical Pharmacy and Clinical Remedies

基　　金：南京军区医学科技创新课题项目(10MA085)

摘　　要：目的探讨硫辛酸注射液的高效液相色谱法检测条件以及在木糖醇和果糖注射液中的稳定性，为临床提供参考。方法将600mg硫辛酸注射液与250mL的木糖醇注射液及果糖注射液配伍，测定溶液的pH值、硫辛酸的含量，定时观察溶液的颜色及澄明度。结果本实验所建立的色谱备件对硫辛酸注射液的检测专属性好，硫辛酸在0．06～2．0mg／mL浓度范围内，线性关系良好（r=0．9997）。硫辛酸注射液与木糖醇配伍后，在避光条件下硫辛酸含量、溶液的pH值、澄清度均无明显的变化，24h内稳定性好。而与果糖注射液配伍后溶液的颜色澄清度有明显的变化，且硫辛酸降解快，4h后的含量为89．89％，配伍稳定性不好。结论硫辛酸注射液可以与木糖醇注射液配伍，不宜与果糖注射液配伍。Objective To investigate a appropriate chromatography method for ALA and the stability of ALA in xylitol injection and fructose injection. Methods 600 mg ALA was added into 250 mL xylitol injection and fructose injection respectively at room temperature and dark conditions, pH value and visual appearance of the admixture were observed at immediate 1,2,4,6,8,12,24 h after ALA adding to the solvent. ALA concentrations were determined by the method of HPLC. Results The chromatography method established in this study was specific, ALA showed a good linear relationship within the range of 0. 06 - 2. 0 mg/mL （ r = 0. 999 7 ）. The admixture showed clear and achromatic color in 24 h after adding into the 0. 9% NS ,5% xylitol injection, and the pH value and ALA content showed no great change, pH value, colour, visual appearance of the admixture changed apparently after ALA adding into fructose injec- tion, and the degradation was rapid, the content of ALA was 89. 89% after 4 h. Conclusion ALA can be mixed with xylitol injection in clinical practice,but cannot be mixed with fructose injection.

关 键 词：硫辛酸注射液 配伍 稳定性 HPLC 

分 类 号：R969.2[医药卫生—药理学]