本文關(guān)鍵詞： 抗瘧疾藥 高效液相色譜法 近紅外光譜法 快速檢測　出處：《湖北中醫(yī)藥大學(xué)》2014年碩士論文　論文類型：學(xué)位論文

【摘要】：快速檢測是一種約定俗成的概念，沒有經(jīng)典的定義，其包括樣品制備在內(nèi)，可以在短時間內(nèi)得出檢測結(jié)果的行為即稱為快速檢測[1]。藥品是關(guān)系公眾健康的特殊商品，采用怎樣的簡單、快速、靈敏的藥物分析方法，從而在基層現(xiàn)場篩選出假冒偽劣藥品是我們研究的主要問題。本文對抗瘧疾藥物的快速檢測方法進(jìn)行研究，主要工作有：一、高效液相色譜法的快速檢測方法的研究 HPLC快檢方法研究的思路:按藥品功能和結(jié)構(gòu)分組，用盡可能少的色譜系統(tǒng)實(shí)現(xiàn)對多種藥物的分離分析，少切換或者不切換流動相，從而達(dá)到快速檢測的目的；運(yùn)用相對保留時間和紫外光譜相似度雙指標(biāo)定性，既增強(qiáng)定性能力，，又適于現(xiàn)場快速鑒別；選擇分組中的一種藥品作為參比物質(zhì)，以實(shí)現(xiàn)少用對照品就能達(dá)到定性和定量的目的。該方法采用藥物的最小單位（片、囊、袋）（如制劑的主藥含量小，可適當(dāng)增大取樣量）進(jìn)行測定，并依據(jù)原法定方法的含量限度和裝量差異限度確定制劑的限度。授權(quán)方法限度（%）=原標(biāo)準(zhǔn)含量下限（%）×[1-原標(biāo)準(zhǔn)裝量差異限度（%）]。 高效液相色譜技術(shù)的優(yōu)點(diǎn)是檢測的靈敏度和分辨率高，重復(fù)性好，分析速度快，定量精度高，應(yīng)用范圍廣。主要適用于分析大分子、強(qiáng)極性、高沸點(diǎn)、熱穩(wěn)定性差的化合物。二、近紅外光譜法快速檢測方法研究 近紅外光（Near Infrared，NIR）是介于可見光（ⅥS）和中紅外光（MIR）之間的電磁波，按ASTM（美國試驗(yàn)和材料檢測協(xié)會）定義是指波長在780～2526nm范圍內(nèi)的電磁波。與常用的化學(xué)分析方法不同，近紅外光譜分析法是一種間接分析技術(shù)，是用統(tǒng)計(jì)的方法在樣品待測屬性值與近紅外光譜數(shù)據(jù)之間建立一個關(guān)聯(lián)模型(或稱校正模型，CalibrationModel)。因此在對未知樣品進(jìn)行分析之前需要搜集一批用于建立關(guān)聯(lián)模型的訓(xùn)練樣品(或稱校正樣品，Calibration Samples)，獲得用近紅外光譜儀器測得的樣品光譜數(shù)據(jù)和用化學(xué)分析方法(或稱參考方法，Referencemethod)測得的真實(shí)數(shù)據(jù)。建立近紅外光譜快速識別系統(tǒng)包括定性和定量分析兩部分。定性分析是通過采用聚類分析的方法，對藥物的近紅外光譜圖進(jìn)行分析，可見不同品種的藥物聚為不同的類群；選擇合適的光譜范圍，還可以使不同企業(yè)的藥物聚為不同的類群。定量分析的方法通常有標(biāo)準(zhǔn)曲線法、聯(lián)立方程式求解法、補(bǔ)償法、吸收強(qiáng)度比法等。 近紅外光譜技術(shù)具有分析速度快、操作簡便、無需耗損化學(xué)試劑和樣品，及易于實(shí)現(xiàn)現(xiàn)場分析等特點(diǎn)，更適用于對包裝材料、原料藥純度等的分析監(jiān)控[2]。近紅外光譜以它收集信息量大以及無需對樣品預(yù)處理等優(yōu)點(diǎn)作為一種快速掃描技術(shù)，有助于藥品快速分析的識別鑒定[3]。 本課題對抗瘧疾藥的快檢方法進(jìn)行了研究。文中建立的高效液相色譜法及近紅外光譜法這兩種快檢方法能快速的檢測出抗瘧疾藥物中有效成分的含量，可用于常規(guī)檢測。對抗瘧疾藥物進(jìn)行了新的擬定標(biāo)準(zhǔn)，完善了常用檢驗(yàn)方法，提高了實(shí)驗(yàn)效率。對方法進(jìn)行了驗(yàn)證，保證了方法的可行性。
[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.

【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R927;O657.72

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