近红外光谱技术对上市药品质量控制的应用研究

发布时间：2018-04-05 12:25

本文选题：近红外光谱　切入点：药品快速检验　出处：《湖北中医药大学》2014年硕士论文

【摘要】：药品作为特殊的商品，其旨在预防、治疗、诊断人的疾病，有目的地调节人的生理机能，但许多不法厂商，希望通过制造、销售假、劣药来牟取暴利，据WHO报道，假药占全世界药品市场额6%，假药在全球的年销售额达320亿美元，且造假行为大部分在发展中国家[1]，药品质量问题及要害事件的发生难以避免和消除。加强对上市药品的质量控制，是保证用药安全极重要的一步。但是目前上市药品质量监管存在一系列不和谐的问题，从稽查方面看，检查手段和能力不够，监督抽样的针对性不强；从检验方面看，监督检验周期长、效率低、成本大、资源浪费，基层监管缺乏简单有效的筛查手段等。近红外光谱技术以其快速无损、配合检测车可实现实时实地分析等特点可为上市药品的质量控制提供有力的技术支持，解决药品质量监管存在的一些不和谐的问题。目前近红外光谱在应用上还存在一些难题，主要包括近红外光谱模型覆盖不足、近红外光谱模型验证优化工作必不可少、近红外光谱模型无应用系统。本研究以上市药品为研究对象，结合实际研究任务和工作计划开展近红外光谱技术应用研究工作，根据工作实践总结近红外光谱应用体系运行的一般方法，探索研究近红外光谱技术对上市药品质量控制的应用体系，为近红外光谱技术的应用发展，解决实际问题做出贡献，主要工作有: “三抗”类药物近红外光谱模型建立研究，研究建立了复方磺胺甲VA唑片、小儿复方磺胺甲VA唑颗粒、氟胞嘧啶片等9个品种一系列近红外快速比对模型,针对各品种、各厂家建立快速比对，并对模型的专属性和稳定性进行验证。同时建立了小儿复方磺胺甲VA唑颗粒通用性水分定量模型。根据研究工作总结了快速比对模型和水分定量模型的一般建模思路。阿昔洛韦片定量模型的验证优化，结合国家评价性抽验任务，对已有的近红外光谱分析模型进行验证、优化，以2012年国评品种为研究对象，首先对样品进行法定检验，将法检合格的样品用于已有模型的验证、优化，并总结了近红外光谱模型验证优化工作的基本方法。近红外光谱模型在省抽任务中的应用，利用成熟的近红外光谱分析模型，对省药品抽验中的样品进行快速的定性、定量分析，对于经近红外光谱分析判定为可疑的样品，进行法定方法检验，确定其是否合格，如检验合格，则需要对现有的模型进行更新优化。通过近红外光谱快速筛查切实提高了药品检验的效率、节约成本，也以此总结了近红外光谱模型应用的一般过程本次研究为应用研究，根据实际需要，研究建立近红外光谱模型，结合抽样计划验证优化模型，将优化后的模型应用与日常药品检验中，通过这个过程探索总结近红外药品检验体系运行的一般技术方法，为近红外光谱技术的应用发展，为提高药品检验效率，，实现科学监管做出切实的贡献。
[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.
【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R927;O657.33

【参考文献】