近红外光谱技术在活血止痛胶囊质量控制中的应用

目的：探讨近红外光谱技术在中药质量控制中的应用。方法：采用3种不同方式采集活血止痛胶囊的漫反射光谱，分别建立真伪鉴别、厂家区分和多成分含量测定模型，并对近红外光谱在中成药的均一性和稳定性评价中的应用进行初探，同时比较了光谱采集方式对模型预测能力的影响。结果：定性分析模型误判数均为0，水分（A）、阿魏酸（B）、11-羰基-β-乙酰乳香酸（C）和龙脑（D）的定量分析模型相对验证标准偏差在5.4%～12.8%之间，均一性和稳定性评价模型可准确反映样品的差异和变化。结论：所建方法简便、快速、无损，可用于活血止痛胶囊的快检初筛和全面质量控制，为近红外光谱技术在中药分析领域的应用提供了新的思路。

Objective: To discuss the application of near infrared spectroscopy(NIRS)in quality control of TCM. Methods: Diffuse reflectance spectra of Huoxue Zhitong capsules were collected in 3 different ways and models for sample identification,manufacturer differentiation and multi-content determination were established separately.Besides,application of NIRS in homogeneity and stability evaluation was discussed primarily.Meanwhile,the influence of spectra collection on predictive ability of models was studied. Results: The results indicated that no misclassified sample was detected by qualitative models and the relative standard errors of prediction of quantitative models for water(A),ferulic acid(B),acetyl-11-keto-β-boswellic acid(C)and borneol(D)were between 5.4%-12.8%.As to homogeneity and stability evaluation models,difference and change of samples could be reflected accurately. Conclusion: The proposed methods are simple,fast,non-destructive and applicable for rapid screening and overall quality control of Huoxue Zhitong capsules,which offer a new approach for the application of NIRS in TCM analysis.

[1] LEI Yi(雷毅),LUO Zhuo-ya(罗卓雅),WANG Cai-mei(王彩媚).Rapid detection of caffeine content in Tankejing powder with NIR spectroscopy(近红外光谱快速检测痰咳净散中咖啡因的含量)[J]. Chin J Pharm Anal(药物分析杂志),2011,31(6):1040
[2] JIN Ye(金叶),DING Hai-ying(丁海樱),WU Yong-jiang(吴永江),et al.Near- infrared spectroscopy on-line and real-time monitoring of extraction process of Xuebijing injection(近红外光谱技术用于血必净注射液提取过程的在线检测研究)[J]. Chin J Pharm Anal(药物分析杂志),2012,32(1):1214
[3] DU Min(杜敏),WU Zhi-sheng(吴志生),LIN Zhao-zhou(林兆洲),et al.Effect of optical path length on the NIR quantitative determination of baicalin in Qingkailing injection(光程对清开灵注射液中黄芩苷近红外定量模型的影响)[J]. Chin J Pharm Anal(药物分析杂志),2012,32(10):1796
[4] Lin H,Zhao JW,Chen QS, et al.Discrimination of Radix Pseudostellariae according to geographical origins using NIR spectroscopy and support vector data description[J].Spectrochim Acta A Mol Biomol Spectrosc,2011,79(5):1381
[5] Storme-Parisa I,Rebiereb H,Matogaa M, et al. Challenging near infrared spectroscopy discriminating ability for counterfeit pharmaceuticals detection[J]. Anal Chim Acta,2010,658(2):163
[6] LEI De-qing(雷德卿),HU Chang-qin(胡昌勤),FENG Yan-chun(冯艳春).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)[J].Acta Pharm Sin(药学学报),2010,45(11):1421
[7] ChP 2010.VolⅠ(中国药典2010年版.一部)[S].2010:132
[8] NIE Li-xing(聂黎行),LIU Yan(刘燕),DAI Zhong(戴忠),et al.Study on quality standards of Huoxue Zhitong preparations(活血止痛制剂质量标准研究)[J].Chin Pharm J(中国药学杂志),2012,47(12):989
[9] HU Qi-zhi(胡奇志),NIE Li-xing(聂黎行),LIU Yan(刘燕),et al.Limit test of camphor and determination of borneol in Huoxue Zhitong preparations(活血止痛制剂中樟脑的限量检查和冰片的含量测定)[J].Chin J Exp Tradit Form(中国实验方剂学杂志),2012,18(18):117
[10] HU Chang-qin(胡昌勤),FENG Yan-chun(冯艳春).Rapid Analysis of Drug by NIRS(近红外光谱法快速分析药品)[M].Beijing(北京):Chemical Industry Press(化学工业出版社),2006:293
[11] McCarthy WJ.TQ Analyst User's Guide[Z].Madison,WI.Thermo Nicolet Corp,2000
[12] WANG Jia-jun(王家俊),LIANG Yi-zeng(梁逸曾),WANG Fan(汪帆).Simultaneous determination of tar,nicotine and carbon monoxide insmoking by partial least squares and Fourier transform near infrared transmission spectrometry(偏最小二乘法结合傅里叶变换近红外光谱同时测定卷烟焦油、烟碱和一氧化碳的释放量)[J].Chin J Anal Chem(分析化学),2005,33(6):793
[13] YAN Yan-lu(严衍禄).Foundation and Application of Near Infrared Spectrum Analysis(近红外光谱分析基础与应用)[M].Beijing(北京):China Light Industry Press(轻工业出版社),2005:33