拉曼光谱法快速筛查盐酸哌替啶注射液  

Non-Invasive Determination of Pethidine hydrochloride injection by Raman Spectroscopy

作　　者：赵瑜[1] 马讯[1] 沈雨婷 南楠[1] 曹丽梅[1] 尹利辉[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药学杂志》2016年第11期925-929,共5页Chinese Pharmaceutical Journal

基　　金：中国食品药品检定研究院中青年发展研究基金资助项目(2015C03)

摘　　要：目的 为了实现便携式拉曼光谱仪用于药品现场执法检测,本实验对盐酸哌替啶注射液的无损检测方法开展研究。方法 使用拉曼光谱法结合化学计量学的方法建立定性和定量模型：其中,使用CLS算法拟合消除安瓿瓶的干扰,相关系数法建立定性模型;PLS算法建立定量模型。另外,考察了所建模型在不同便携式拉曼光谱仪上的传递。结果 4个批次19个样品对模型进行验证,定性结果与参考结果一致;定量结果相对HPLC的相对偏差在5%以内,同时,考察了同一批次不同样品Raman法的准确性和重复性,均值相对偏差、RSD值均在1%以内,说明本方法相对于HPLC准确性重复性好。通过控制仪器关键指标控制仪器台间差,51个样品3台仪器定量结果均落在90%~110%之内,其中96%落在95%~105%之内。结论 拉曼光谱法可用于盐酸哌替啶注射液的现场无损检测。OBJECTIVE To explore the determination of pethidine hydrochloride injection by using Raman spectroscopy to realize in-site non-invasive inspection. METHODS CLS algorithm was used to eliminate the interference of the ampoule, correlation coeffi- cient was used for identification, and PLS algorithm was used to establish the quantitative model. Moreover, the transfer performance of the models was investigated when used on different portable Raman instruments. RESULTS Nineteen samples of four different bat- ches were used to verify the method. The results showed a good coincidence with reference results on both identification and quantifica- tion, and the relative deviation from HPLC method was within 5%. Meanwhile, the Raman method showed good accuracy and repeat- ability with relative deviation of mean and RSD value within 1% for samples from the same batch. The differences between instruments were controlled by the key index, and quantitative analysis results of 51 samples measured on three instruments all fell in the range of 90% to 110% , among which 96% fell in a more narrow range of 95% to 105%. CONCLUSION The Raman method established in this study could be used for the in-situ non-invasive determination of pethidine hydrochloride injection.

关 键 词：拉曼光谱法 无损检测 定性 定量 台间差 

分 类 号：R927[医药卫生—药学]