拉曼光谱法快速测定氨茶碱注射剂中无水茶碱和乙二胺的含量  

Rapid quantitative determination of theophylline anhydrous and ethylenediamine in aminophylline injection by Raman spectroscopy

作　　者：李珺婵[1,2] 沈捷雯 张予敏[4] 陈桂良[1] 乐健[1,5,6] 

机构地区：[1]上海市食品药品检验所,上海201203 [2]东华大学计算机科学与技术学院,上海200051 [3]上海市黄浦区中西医结合医院中医内科,上海200010 [4]上海市食品药品监督管理局稽查处,上海200010 [5]药物制剂国家工程研究中心,上海200437 [6]复旦大学药学院药剂学教研室,上海201203

出　　处：《中国临床药学杂志》2014年第3期141-145,共5页Chinese Journal of Clinical Pharmacy

基　　金：上海市食品药品监督管理局十二五规划子课题(编号2011JY1-5)

摘　　要：目的建立一种运用拉曼光谱技术快速测定氨茶碱注射剂中无水茶碱和乙二胺的方法。方法采用拉曼光谱技术对3种规格的氨茶碱注射剂直接测定,分别以CLS、PLS和PCR定量模型对数据进行分析,并将无水茶碱和乙二胺的定量结果与法定方法的结果进行比较。结果 CLS定量模型测定氨茶碱注射剂中2种成分的结果较PLS和PCR定量模型法理想,其无水茶碱的回收率为98.4%,乙二胺的回收率为105.9%。其样品测定结果与法定方法测定结果基本一致。其中无水茶碱测定结果的准确度为(99.7±0.9)%,乙二胺的准确度为(96.5±5.5)%。结论本方法操作简便、快速无损,可成为注射剂快速检测的分析方法。AIM To develop a method for the rapid determination of theophylline anhydrous and ethylenediamine in aminophylline injection using Raman spectroscopy. METHODS The Raman spectra of aminophylline injections were analyzed with the help of chemometric models including classical least squares （CLS）, partial least squares （PLS） and principal component regression （PCR）. RESULTS To compare the quantification ability of three models, the calcula- tion results indicated that the CLS method was more efficient than the other two methods. The declared values with the recovery were 98.4% for theophylline anhydrous and 105.9% for ethylenediamine respectively by the CLS method. Concentrations found from the Raman data analysis agreed with the results from the conventional eompendial titration method, and the values with the accuracy were （99.7 ±0.9）% for theophylline anhydrous and （96.5 ±5.5）% for ethylenedi- amine respectively. CONCLUSION The proposed procedure can be a convenient, fast and nondestructive alternative to the compendia/ quantitative determination of aminophylline injection.

关 键 词：拉曼光谱 快速检测 氨茶碱注射剂 无水茶碱 乙二胺 含量测定 

分 类 号：R927.2[医药卫生—药学] O657.37[理学—分析化学]