|
|||||
|
|
| 不同生产厂家注射用头孢哌酮钠含量测定的近红外定量模型的建立 | |
| 引用本文： | 逄焕欢,冯艳春,胡昌勤,相秉仁.不同生产厂家注射用头孢哌酮钠含量测定的近红外定量模型的建立[J].光谱学与光谱分析,2006,26(12):2214-2218. |
| 作者姓名： | 逄焕欢 冯艳春 胡昌勤 相秉仁 |
| 作者单位： | 1. 中国药品生物制品检定所,北京,100050;吉林省药品检验所,吉林,长春,130062 2. 中国药品生物制品检定所,北京,100050;中国医学科学院中国协和医科大学医药生物技术研究所,北京,100050 3. 中国药品生物制品检定所,北京,100050 4. 中国药科大学,江苏,南京,210009 |
| 摘 要： | 采用近红外漫反射光谱法和偏最小二乘回归算法建立了2种测样方式对不同厂家注射用头孢哌酮钠中头孢哌酮的含量进行快速测定的定量分析模型.对9个厂家的19批注射用头孢哌酮钠样品及其降解物中头孢哌酮的含量进行了预测,积分球模型的交叉验证均方根误差(RMSECV)和预测均方根误差(RMSEP)分别为0.636和2.01,光纤模型的交叉验证均方根误差(RMSECV)和预测均方根误差(RMSEP)分别为0.857和3.71.根据ICH指导原则,从专属性、线性、重现性、稳定性、准确性等几个方面对两模型的方法进行了验证,进而说明光纤测样方式建立的模型专属性和适用性均良好,完全可以对不同生产厂家的同一品种的药品进行快速的初步定量分析,适用于药品检验车的快速无损检测. |
| 关 键 词： | 近红外漫反射光谱 定量分析 方法验证 快速检测 头孢哌酮 |
| 文章编号： | 1000-0593（2006）12-2214-05 |
| 收稿时间： | 2005-10-17 |
| 修稿时间： | 2006-01-16 |
Construction of Universal Quantitative Models for Determination of Cefoperazone Sodium for Injection from Different Manufacturers Using Near Infrared Reflectance Spectroscopy |
|
| PANG Huan-huan,FENG Yan-chun,HU Chang-qin,XIANG Bing-ren.Construction of Universal Quantitative Models for Determination of Cefoperazone Sodium for Injection from Different Manufacturers Using Near Infrared Reflectance Spectroscopy[J].Spectroscopy and Spectral Analysis,2006,26(12):2214-2218. | |
| Authors: | PANG Huan-huan FENG Yan-chun HU Chang-qin XIANG Bing-ren |
| Institution: | 1.. National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China ;2. Jilin Institute of Drug Control, Changchun 130062, China ;3. China Pharmaceutical University, Nanjing 210009, China; 4. Institute of Medicinal Biotechnology, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China |
| Abstract: | Universal quantitative models using NIR reflectance spectroscopy in two different kinds of sampling mode were developed for the analysis of cefoperazone sodium for injection from different manufacturers in China.The quantitative models were established using partial least squares(PLS).Nineteen batches of cefoperazone sodium for injection samples from 9 different manufacturers were predicted by the quantitative models.The root mean square errors of cross validation(RMSECV) and the root mean square errors of prediction(RMSEP) of the model in integrating sphere sampling mode were 0.99 and 0.98,respectively.The values of RMSECV and RMSEP of the model in fibre sampling mode were 1.12 and 1.17,respectively.Based on the ICH guidelines and characteristics of NIR spectra,the quantitative models were then evaluated in terms of specificity,linearity,accuracy,and precision.The authors' study has shown that it is feasible to build a universal quantitative model in fibre sampling mode for quick analysis of pharmaceutical products from different manufacturers.As a result of its good specificity and applicability,the model could be used for quick,non-destructive prescreening of counterfeit and substandard drugs in the mobile vehicle. |
| Keywords: | NIR reflectance spectroscopy Quantitation Validative analysis Quick inspection Cefoperazone |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |