本文選題：近紅外光譜　切入點：藥品快速檢驗　出處：《湖北中醫(yī)藥大學》2014年碩士論文

【摘要】：藥品作為特殊的商品，其旨在預防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機能，但許多不法廠商，希望通過制造、銷售假、劣藥來牟取暴利，據(jù)WHO報道，假藥占全世界藥品市場額6%，假藥在全球的年銷售額達320億美元，且造假行為大部分在發(fā)展中國家[1]，藥品質(zhì)量問題及要害事件的發(fā)生難以避免和消除。加強對上市藥品的質(zhì)量控制，是保證用藥安全極重要的一步。但是目前上市藥品質(zhì)量監(jiān)管存在一系列不和諧的問題，從稽查方面看，檢查手段和能力不夠，監(jiān)督抽樣的針對性不強；從檢驗方面看，監(jiān)督檢驗周期長、效率低、成本大、資源浪費，基層監(jiān)管缺乏簡單有效的篩查手段等。近紅外光譜技術以其快速無損、配合檢測車可實現(xiàn)實時實地分析等特點可為上市藥品的質(zhì)量控制提供有力的技術支持，解決藥品質(zhì)量監(jiān)管存在的一些不和諧的問題。目前近紅外光譜在應用上還存在一些難題，主要包括近紅外光譜模型覆蓋不足、近紅外光譜模型驗證優(yōu)化工作必不可少、近紅外光譜模型無應用系統(tǒng)。本研究以上市藥品為研究對象，結合實際研究任務和工作計劃開展近紅外光譜技術應用研究工作，根據(jù)工作實踐總結近紅外光譜應用體系運行的一般方法，探索研究近紅外光譜技術對上市藥品質(zhì)量控制的應用體系，為近紅外光譜技術的應用發(fā)展，解決實際問題做出貢獻，主要工作有: “三抗”類藥物近紅外光譜模型建立研究，研究建立了復方磺胺甲VA唑片、小兒復方磺胺甲VA唑顆粒、氟胞嘧啶片等9個品種一系列近紅外快速比對模型,針對各品種、各廠家建立快速比對，并對模型的專屬性和穩(wěn)定性進行驗證。同時建立了小兒復方磺胺甲VA唑顆粒通用性水分定量模型。根據(jù)研究工作總結了快速比對模型和水分定量模型的一般建模思路。 阿昔洛韋片定量模型的驗證優(yōu)化，結合國家評價性抽驗任務，對已有的近紅外光譜分析模型進行驗證、優(yōu)化，以2012年國評品種為研究對象，首先對樣品進行法定檢驗，將法檢合格的樣品用于已有模型的驗證、優(yōu)化，并總結了近紅外光譜模型驗證優(yōu)化工作的基本方法。 近紅外光譜模型在省抽任務中的應用，利用成熟的近紅外光譜分析模型，對省藥品抽驗中的樣品進行快速的定性、定量分析，對于經(jīng)近紅外光譜分析判定為可疑的樣品，進行法定方法檢驗，確定其是否合格，如檢驗合格，則需要對現(xiàn)有的模型進行更新優(yōu)化。通過近紅外光譜快速篩查切實提高了藥品檢驗的效率、節(jié)約成本，也以此總結了近紅外光譜模型應用的一般過程 本次研究為應用研究，根據(jù)實際需要，研究建立近紅外光譜模型，結合抽樣計劃驗證優(yōu)化模型，將優(yōu)化后的模型應用與日常藥品檢驗中，通過這個過程探索總結近紅外藥品檢驗體系運行的一般技術方法，為近紅外光譜技術的應用發(fā)展，為提高藥品檢驗效率，，實現(xiàn)科學監(jiān)管做出切實的貢獻。
[Abstract]:As a special commodity, drugs are designed to prevent, treat, diagnose human diseases and regulate human physiological function purposefully. But many illegal manufacturers hope to make huge profits by making, selling fake or inferior medicines, according to WHO.Counterfeit drugs account for 6% of the world's drug market. The annual sales of counterfeit drugs in the world amount to 32 billion US dollars, and most of the counterfeiting activities are in developing countries [1]. It is difficult to avoid and eliminate the problems of drug quality and the occurrence of critical events.To strengthen the quality control of listed drugs is an important step to ensure the safety of drug use.However, at present, there are a series of disharmonious problems in the quality supervision of listed drugs. In terms of inspection, the means and ability of inspection are not enough, and the pertinence of supervision sampling is not strong. In terms of inspection, the supervision and inspection period is long, the efficiency is low, and the cost is large.Waste of resources, grass-roots supervision and lack of simple and effective screening methods and so on.Near-infrared spectroscopy (NIR) can provide powerful technical support for the quality control of listed drugs and solve some disharmonious problems in drug quality supervision because of its fast nondestructive and real-time field analysis.At present, there are still some difficulties in the application of NIR spectroscopy, including the inadequate coverage of NIR model, the essential work of NIR model verification and optimization, and the lack of application system of NIR model.In this study, taking the listed drugs as the research object, combining with the actual research task and the work plan to carry out the application research work of the near infrared spectroscopy technology, the general method of the operation of the near infrared spectrum application system was summarized according to the work practice.To explore and study the application system of near infrared spectroscopy technology to the quality control of listed drugs, to contribute to the application and development of near infrared spectroscopy technology and to solve practical problems. The main work is as follows:The establishment of near infrared spectral model of "three antibodies" drugs was studied. A series of NIR rapid comparison models were established for nine varieties, such as compound sulfamethazol tablets, children's compound sulfamethasone granules, fluorocytosine tablets, and so on.Each manufacturer establishes a quick comparison and verifies the specificity and stability of the model.At the same time, a general water quantitative model of compound sulfamethazol granules in children was established.Based on the research work, the general modeling ideas of rapid comparison model and water quantitative model are summarized.The quantitative model of acyclovir tablets was verified and optimized by combining with the task of national evaluative sampling, and the existing near infrared spectrum analysis model was verified and optimized. The 2012 national evaluation variety was taken as the research object, and the samples were first tested by law.The qualified samples were used to verify and optimize the existing models, and the basic methods for verification and optimization of NIR models were summarized.Application of Near-Infrared Spectroscopy Model in provincial pumping task. By using mature NIR spectral analysis model, the samples in drug sampling and testing in the province were quickly qualitatively and quantitatively analyzed, and the samples identified as suspicious by NIR spectrum analysis.It is necessary to update and optimize the existing models.The rapid screening of NIR spectrum can effectively improve the efficiency of drug inspection and save the cost. The general process of application of NIR model is also summarized.This study is an application study, according to the actual needs, the establishment of near-infrared spectrum model, combined with the sampling plan to verify the optimization model, the optimized model will be used in daily drug inspection,Through this process, the general technical methods for the operation of NIR drug inspection system are summarized, which can contribute to the application and development of NIR spectroscopy, to improve the efficiency of drug inspection and to realize scientific supervision.
【學位授予單位】：湖北中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R927;O657.33

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