5种近红外光谱仪采集药品光谱的一致性检验

目的: 研究5种近红外光谱仪测定相同样品所得光谱的相似程度。 方法: 使用5种不同厂家不同型号的近红外光谱仪在相同的采样条件下,分别采集由8个品种71批次药品组成的样品集的近红外光谱,采用近红外光谱一致性检验方法对获得的光谱进行数据处理,统计分析后考查测得的光谱的相似程度。 结果: 共采集近红外光谱2100张,一致性检验方法数据显示本文中5种近红外光谱仪测定相同样品所得光谱具有显著差异。 结论: 一致性检验方法对本文中5种仪器采集得到的近红外光谱之间的差异非常敏感,造成CI值的数值和范围都很大,用于比较不同仪器测得的药品光谱的相似程度过于严格,不能清晰的反映不同仪器测得的药品光谱的相似程度,考虑探索其他适用性更好的方法。

Objective: To study the similarity of spectra collected by 5 different near-infrared (NIR) spectrometers. Methods: Based on the same sample set of 71 batches of 8 kinds of drugs,5 different NIR spectrometers from different manufactures were used to collect spectra of the sample set under the same condition.The NIR spectroscopic conformity test was employed to conduct data process on the obtained spectra and the similarity of these spectra was investigated after statistical analysis. Results: A total of 2100 NIR spectra were collected.The data of conformity tests showed the spectra collected by the 5 NIR spectrometers in this article were significantly different. Conclusion: NIR spectroscopic conformity test is extremely sensitive to the differences between the spectra collected by the 5 NIR spectrometers in this article,resulting in relatively high value results and wide ranges of CI value.In this case,therefore,the NIR conformity test cannot appropriately reflect the similarity between the drug spectra by different spectrometers as it could be too strict to apply this test to compare the similarity.Other methods with better applicability will be explored.

1 NIE Li-xing(聂黎行),WANG Gang-li(王钢力),LI Zhi-meng(李志猛),et al.Application of near infrared spectroscopy in quality control of excipients of traditional Chinese medicine(近红外光谱法在中药辅料质量控制中的应用).Chin J Chin Mat Med(中国中药杂志),2009,34(17):2185
2 LEI De-qing(雷德卿),HU Chang-qin(胡昌勤),FENG Yan-chun(冯艳春),et al.Feasibility of the extended application of near infrared universal quantitative models(扩展近红外通用性定量模型应用范围的可行性研究).Acta Pharm Sin(药学学报),2010,45(11):1421
3 LU Wan-zhen(陆婉珍).Modern Near Infrared Spectroscopy Analytical Technology(现代近红外光谱分析技术).2nd Ed(第二版).Beijing(北京):China Petrochemical Press(中国石化出版社),2006.92
4 YAN Yan-lu(严衍禄).The Basic and Application of the NIR Spectrum(近红外光谱分析基础与应用).Beijing(北京):China Light Industry Press(中国轻工业出版社),2005.82
5 ChP(中国药典).2010.Vol II(二部):Appendix(附录) XIX K
6 FDA.USA,Guidance for Industry:Analytical Procedures and Methods Validation.2000:9
7 USP 35.2012.S1 1119:714
8 EP 7.0.2010.61
9 BP 2012.Appendix II A:155
10 JP 16.2011.G1:2141
11 ZHANG Xue-bo(张学博),YIN Li-hui(尹利辉).Study of near-infrared spectroscopic conformity test for rapid examination of drug quality(近红外光谱一致性检验方法用于快速判断药品质量的研究).Chin J Pharm Anal(药物分析杂志),2011,31(3):603
12 GUO Peng-cheng(郭鹏程),LIU Yan-yun(柳艳云).Construction of conformity test models for jiangzhong jianweixiaoshi tablets by near infrared reflectance spectroscopy(江中健胃消食片近红外一致性检验模型的建立).Chin Pharm Aff(中国药事),2012,27(3):276
13 DAI Yong(戴涌),LI Xiao-an(李小安),LIU Xue-feng(刘雪峰),et al.Conformity test on nitrofurantoin enteric tablets by near infrared absorption spectrometry(运用近红外光谱法对呋喃妥因肠溶片进行一致性检验).Chin J Pharm Anal(药物分析杂志),2010,30(11):2153
14 YE Jie-sheng(叶杰胜).Study on conformity test of allopurinol tablets by near infrared diffuse reflectance spectroscopy(运用近红外漫反射光谱法对别嘌醇片进行一致性检验的研究).Chin Pharm(中国药业),2011,20(19):27
15 TAN Jia-qun(谭家群),QIN Li-ming(秦黎明),ZHANG Rui(张锐).Application of near-infrared spectroscopic conformity test in the quality monitor of AIDS drugs in the entire supply chain(近红外光谱一致性检验方法在艾滋病防治药品供应链全程质量监控中的应用).Chin J Pharm Anal(药物分析杂志),2012,32(8):1479