近红外光谱法快速分析硫普罗宁注射液的含量  

Development of a Near IR Method for Rapid Determination of tiopronin for Injection

作　　者：卢京光 王立云 李新荣 丛江 

机构地区：[1]青岛市药品检验所,山东青岛266071

出　　处：《中国药学杂志》2012年第16期1328-1332,共5页Chinese Pharmaceutical Journal

摘　　要：目的建立测定硫普罗宁注射液含量的近红外光谱(NIR)快速分析方法。方法收集国内7家企业生产的45批硫普罗宁注射液样品,利用高效液相色谱法测定其含量值作为参考值,用光纤探头配合1 mm光程测样配件采集光谱,用偏最小二乘法建立了其近红外透反射定量分析模型。结果所建模型具有较好的预测能力,验证集样品的近红外光谱预测值与真实值间的相关性为99.0%,平均预测偏差为1.30%,预测均方差(RMSEP)为0.982%。结论该法快速、简便,满足药品现场快速检查的需要。OBJECTIVE To establish a near infrared spectroscopy method for the determination of the concentration of tiopronin for injection. METHODS By using optical fiber probes and 1 mm sampling accessories, the near infrared transmission reflectance spectra of tiopronin for injection from seven pharmaceutical factories were obtained. The partial least square method was applied to es- tablish the model with HPLC as the reference method. RESULTS The model had a good prediction performance. The value of the correlation coefficient （ r2 ） was 99. 0% , the mean difference of prediction for test sets was 1.30%, and the root mean square error of prediction （RMSEP） was 0. 982%. CONCLUSION NIR is a rapid, reliable and powerful method for the quantitation of tiopronin for injection, and can be applied to rapid drug determination on the spot and stability study.

关 键 词：近红外光谱法 快速分析 硫普罗宁 定量 

分 类 号：R917[医药卫生—药物分析学]