抗疟疾药物的快检方法研究

发布时间：2018-02-03 01:32

本文关键词： 抗疟疾药高效液相色谱法近红外光谱法快速检测　出处：《湖北中医药大学》2014年硕士论文　论文类型：学位论文

【摘要】：快速检测是一种约定俗成的概念，没有经典的定义，其包括样品制备在内，可以在短时间内得出检测结果的行为即称为快速检测[1]。药品是关系公众健康的特殊商品，采用怎样的简单、快速、灵敏的药物分析方法，从而在基层现场筛选出假冒伪劣药品是我们研究的主要问题。本文对抗疟疾药物的快速检测方法进行研究，主要工作有：一、高效液相色谱法的快速检测方法的研究 HPLC快检方法研究的思路:按药品功能和结构分组，用尽可能少的色谱系统实现对多种药物的分离分析，少切换或者不切换流动相，从而达到快速检测的目的；运用相对保留时间和紫外光谱相似度双指标定性，既增强定性能力，，又适于现场快速鉴别；选择分组中的一种药品作为参比物质，以实现少用对照品就能达到定性和定量的目的。该方法采用药物的最小单位（片、囊、袋）（如制剂的主药含量小，可适当增大取样量）进行测定，并依据原法定方法的含量限度和装量差异限度确定制剂的限度。授权方法限度（%）=原标准含量下限（%）×[1-原标准装量差异限度（%）]。高效液相色谱技术的优点是检测的灵敏度和分辨率高，重复性好，分析速度快，定量精度高，应用范围广。主要适用于分析大分子、强极性、高沸点、热稳定性差的化合物。二、近红外光谱法快速检测方法研究近红外光（Near Infrared，NIR）是介于可见光（ⅥS）和中红外光（MIR）之间的电磁波，按ASTM（美国试验和材料检测协会）定义是指波长在780～2526nm范围内的电磁波。与常用的化学分析方法不同，近红外光谱分析法是一种间接分析技术，是用统计的方法在样品待测属性值与近红外光谱数据之间建立一个关联模型(或称校正模型，CalibrationModel)。因此在对未知样品进行分析之前需要搜集一批用于建立关联模型的训练样品(或称校正样品，Calibration Samples)，获得用近红外光谱仪器测得的样品光谱数据和用化学分析方法(或称参考方法，Referencemethod)测得的真实数据。建立近红外光谱快速识别系统包括定性和定量分析两部分。定性分析是通过采用聚类分析的方法，对药物的近红外光谱图进行分析，可见不同品种的药物聚为不同的类群；选择合适的光谱范围，还可以使不同企业的药物聚为不同的类群。定量分析的方法通常有标准曲线法、联立方程式求解法、补偿法、吸收强度比法等。近红外光谱技术具有分析速度快、操作简便、无需耗损化学试剂和样品，及易于实现现场分析等特点，更适用于对包装材料、原料药纯度等的分析监控[2]。近红外光谱以它收集信息量大以及无需对样品预处理等优点作为一种快速扫描技术，有助于药品快速分析的识别鉴定[3]。本课题对抗疟疾药的快检方法进行了研究。文中建立的高效液相色谱法及近红外光谱法这两种快检方法能快速的检测出抗疟疾药物中有效成分的含量，可用于常规检测。对抗疟疾药物进行了新的拟定标准，完善了常用检验方法，提高了实验效率。对方法进行了验证，保证了方法的可行性。
[Abstract]:Rapid detection is a conventional idea, not a classic definition, including sample preparation, the test results can be obtained in a short period of time the behavior is called [1]. for rapid detection of drug is a special commodity related to public health, the kind of simple, rapid, sensitive method for analysis of the drug, resulting in the grass field screening of counterfeit drugs is the main problem of our study. To study the rapid detection method of the anti malaria drugs, the main work is: A Study on the rapid detection method of high performance liquid chromatography.
Rapid detection of HPLC's idea: according to the structure and function of the drug group, with little chromatographic system realizes separation of many kinds of drug analysis, less switching or not switching the mobile phase, so as to achieve the purpose of rapid detection; the relative retention time and UV spectral similarity index of double qualitative and qualitative and can enhance the ability. Suitable for the rapid identification of the scene; choose a drug group as reference material, to achieve less control can achieve the purpose of qualitative and quantitative methods. The smallest unit of drugs (tablet, capsule, bag) (such as drug content preparation, may be appropriate to increase the sampling volume) were measured. The preparation and limits are determined based on the original legal content limit method and load difference limit. Authorization method limit (%) = the lower limit of the original standard content (%) * [1- original standard load difference limit (%).
The advantages of high performance liquid chromatography is the detection sensitivity and high resolution, good repeatability, fast analysis speed, high precision and wide application range. Mainly applicable to the analysis of large molecules, strong polar compounds, high boiling point, low thermal stability. Two, the rapid detection of near infrared spectroscopy
Near infrared (Near Infrared NIR) is between visible light and infrared light (S) (MIR) electromagnetic wave, according to ASTM (American Association for testing and materials testing) is defined in the wavelength range of 780 ~ 2526nm. The electromagnetic wave with the commonly used methods for chemical analysis of near infrared spectroscopy analysis is an indirect analysis technique is to establish a correlation model between using statistical methods to measure the attribute value in the sample and the near infrared spectral data (or correction model, CalibrationModel). So before the analysis of unknown samples need to collect a number of training samples are used to establish the correlation model (or calibration sample, Calibration Samples) get the samples, the measured spectral data using near infrared spectroscopy instrument and chemical analysis method (Referencemethod or reference method) real measured data. The establishment of near infrared spectroscopy for rapid identification system includes qualitative Quantitative analysis and qualitative analysis. The two part is by using the method of cluster analysis, the near infrared spectrum of drugs were analyzed, different varieties of drugs visible grouped into different groups; select the appropriate spectral range, but also can make the drugs of different enterprises gather into different categories. There is usually the method of quantitative analysis standard curve method, compensation method of solving simultaneous equations method, the absorption intensity ratio method.
Near infrared spectroscopy is fast analysis, simple operation, without loss of chemical reagents and samples, and is easy to realize the scene analysis, more suitable for packaging materials, [2]. raw material purity monitoring analysis of near infrared spectroscopy to it collects large amount of information, without the need for sample pretreatment and other advantages as a fast scanning technology, contribute to the rapid analysis of drug identification [3].
Fast detection method of this project against malaria drugs were studied. The two kinds of fast detection method of high performance liquid chromatography was established in this paper and near infrared spectroscopy can detect the content of effective components of anti malaria drugs in fast, can be used for routine detection of anti malaria drugs. A new quasi standard, perfect the commonly used test methods, improve the efficiency of the experiment. The method was validated to ensure the feasibility of the method.

【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;O657.72

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