近红外光谱分析技术用于酒石酸美托洛尔片厂家快速鉴别的研究

发布时间：2018-05-03 14:27

本文选题：酒石酸美托洛尔片 + 近红外光谱分析技术　；参考：《山东大学》2014年硕士论文

【摘要】：酒石酸美托洛尔片收载于《中国药典》2010年版二部,属于β肾上腺素受体阻滞剂,临床上主要用于治疗高血压、心绞痛、心肌梗死、肥厚型心肌病、主动脉夹层、心律失常、甲状腺机能亢进、心脏神经官能症等。酒石酸美托洛尔片作为治疗心血管病的常用处方药物之一,具有较高的效益风险比值,还具有口服吸收快、生物利用度高和安全性好等特点,因此被列入我国国家基本药物目录。由于酒石酸美托洛尔片具有较大的市场份额,加上经济利益的驱使,市场上酒石酸美托洛尔片的假药劣药层出不穷,这些假药劣药在市场上流通,不但干扰了药品正常的市场秩序,而且影响了广大人民群众的身体健康。目前造假分子的造假手段不断翻新,既有以非药品冒充药品的传统造假手段,也有利用现代高科技造假手段生产符合药品质量标准的假药,这使得假药识别的难度越来越大,对假药识别的要求越来越高。因此开展酒石酸美托洛尔片准确、快速的鉴别研究具有重要的现实意义。近红外光谱(Near-infrared Spectroscopy, NIRS)分析技术是20世纪80年代发展起来的一项可以实现无损检测的测试技术,该技术通过测定物质在近红外光谱区的特征光谱信息,主要为C-H、N-H、O-H和S-H等含氢基团的倍频与合频吸收信息,并结合化学计量学方法,对物质进行定性、定量分析的一种光谱分析技术。NIRS分析技术凭借快速高效、绿色环保、不破坏样品、可实现多组分同时分析和在线分析等优点,已被越来越多地应用于化工行业、医药行业、食品工业和农业等领域的质量检测。在药学领域,NIRS分析技术在中药材产地分析、制剂快速检测和在线质量控制等方面得到的较大的应用并取得很好的应用效果,《中国药典》2010年版附录已收载了近红外分光光度法指导原则。目前,近红外光谱分析仪广泛配备于食品药品监督管理部门的药品快检车中。另据国家食品药品监督管理总局(CFDA)的要求,到2015年底要实现近红外图谱快速比对分析模型的全国共享,可见NIRS光谱分析技术在药品快速鉴别中具有重要作用。本课题拟利用NIRS分析技术对来源于四个不同厂家的66个批次的酒石酸美托洛尔片进行真伪鉴别和厂家鉴别。本课题采用了三种采样方式进行采样,通过光谱预处理方法和参数的筛选和建模光谱区间的选择得到了最佳建模结果。混淆矩阵以及模型的准确率和否定率表明：三种采样方式均能有效的对来自四个不同生产厂家的样品进行有效的真伪识别和厂家识别。通过实验表明,建立的模型具有较高的准确度,验证集的预测结果具有较高的准确率。模型经过进一步修正后,可以用于酒石酸美托洛尔片的厂家鉴别,对药品市场的打假以及药品的快速筛查具有重要的现实意义。
[Abstract]:Metoprolol tartrate tablet is part two of the 2010 Chinese Pharmacopoeia. It is a beta adrenergic receptor blocker. It is mainly used in the treatment of hypertension, angina pectoris, myocardial infarction, hypertrophic cardiomyopathy, aortic dissection, arrhythmia. Hyperthyroidism, cardiac neurosis, etc. Metoprolol tartrate tablets, as one of the commonly used prescription drugs for the treatment of cardiovascular diseases, have high benefit risk ratio, fast oral absorption, high bioavailability and good safety. As a result, it is listed in the National essential drugs catalogue of our country. Because metoprolol tartrate tablets have a large market share and are driven by economic benefits, the fake and inferior drugs of metoprolol tartrate tablets appear in an endless stream on the market, and these counterfeit drugs are circulating in the market. Not only interferes with the normal market order of drugs, but also affects the health of the masses. At present, the counterfeiting methods of counterfeiters are constantly being renovated. Both the traditional counterfeiting means of non-pharmaceutical counterfeiting and the use of modern high-tech counterfeiting means to produce counterfeit drugs that meet the quality standards of medicines are becoming increasingly difficult to identify. The demand for identification of counterfeit drugs is getting higher and higher. Therefore, the accurate and rapid identification of metoprolol tartrate tablets has important practical significance. Near-infrared spectroscopic (NIRS) analysis technology is a kind of nondestructive testing technology developed in the 1980s. It can be used to measure the characteristic spectral information of matter in the near infrared spectrum region. It mainly consists of the frequency doubling and frequency-combining absorption information of hydrogen-containing groups such as C-H, N-HGO-H and S-H, and combining with the chemometrics method, a kind of spectrometric analysis technique for qualitative and quantitative analysis of substances. NIRS analysis technology, by virtue of its fast and high efficiency, green and environmental protection, does not destroy the samples. It can realize the advantages of simultaneous multicomponent analysis and on-line analysis, and has been applied more and more in the fields of chemical industry, medicine industry, food industry and agriculture. In the field of pharmacy, NIRS analysis technique was used to analyze the origin of Chinese medicinal materials. The rapid detection and on-line quality control of preparations have been widely used and achieved good results. The guidelines for near infrared spectrophotometry have been included in the appendix of the 2010 edition of Chinese Pharmacopoeia. At present, the near-infrared spectrum analyzer is widely used in the food and drug inspection vehicle. In addition, according to the request of State Food and Drug Administration (CFDAA), it is necessary to realize the national sharing of fast comparison and analysis model of near infrared spectrum by the end of 2015. It can be seen that NIRS spectrum analysis plays an important role in rapid drug identification. In this study, 66 batches of metoprolol tartrate tablets from four different manufacturers were identified by NIRS. In this paper, three sampling methods are adopted, and the optimal modeling results are obtained by spectral pretreatment method and parameter selection and the selection of modeling spectral interval. The accuracy and negation rate of the confusion matrix and the model show that the three sampling methods can effectively identify the true and false samples from four different manufacturers. The experimental results show that the model has higher accuracy and the prediction result of the verification set has higher accuracy. The model can be used for the factory identification of metoprolol tartrate tablets after further revision.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R927;TN219

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