本文選題：酒石酸美托洛爾片 + 近紅外光譜分析技術(shù)�。� 參考：《山東大學(xué)》2014年碩士論文

【摘要】：酒石酸美托洛爾片收載于《中國藥典》2010年版二部,屬于β腎上腺素受體阻滯劑,臨床上主要用于治療高血壓、心絞痛、心肌梗死、肥厚型心肌病、主動(dòng)脈夾層、心律失常、甲狀腺機(jī)能亢進(jìn)、心臟神經(jīng)官能癥等。酒石酸美托洛爾片作為治療心血管病的常用處方藥物之一,具有較高的效益風(fēng)險(xiǎn)比值,還具有口服吸收快、生物利用度高和安全性好等特點(diǎn),因此被列入我國國家基本藥物目錄。 由于酒石酸美托洛爾片具有較大的市場(chǎng)份額,加上經(jīng)濟(jì)利益的驅(qū)使,市場(chǎng)上酒石酸美托洛爾片的假藥劣藥層出不窮,這些假藥劣藥在市場(chǎng)上流通,不但干擾了藥品正常的市場(chǎng)秩序,而且影響了廣大人民群眾的身體健康。目前造假分子的造假手段不斷翻新,既有以非藥品冒充藥品的傳統(tǒng)造假手段,也有利用現(xiàn)代高科技造假手段生產(chǎn)符合藥品質(zhì)量標(biāo)準(zhǔn)的假藥,這使得假藥識(shí)別的難度越來越大,對(duì)假藥識(shí)別的要求越來越高。因此開展酒石酸美托洛爾片準(zhǔn)確、快速的鑒別研究具有重要的現(xiàn)實(shí)意義。 近紅外光譜(Near-infrared Spectroscopy, NIRS)分析技術(shù)是20世紀(jì)80年代發(fā)展起來的一項(xiàng)可以實(shí)現(xiàn)無損檢測(cè)的測(cè)試技術(shù),該技術(shù)通過測(cè)定物質(zhì)在近紅外光譜區(qū)的特征光譜信息,主要為C-H、N-H、O-H和S-H等含氫基團(tuán)的倍頻與合頻吸收信息,并結(jié)合化學(xué)計(jì)量學(xué)方法,對(duì)物質(zhì)進(jìn)行定性、定量分析的一種光譜分析技術(shù)。NIRS分析技術(shù)憑借快速高效、綠色環(huán)保、不破壞樣品、可實(shí)現(xiàn)多組分同時(shí)分析和在線分析等優(yōu)點(diǎn),已被越來越多地應(yīng)用于化工行業(yè)、醫(yī)藥行業(yè)、食品工業(yè)和農(nóng)業(yè)等領(lǐng)域的質(zhì)量檢測(cè)。在藥學(xué)領(lǐng)域,NIRS分析技術(shù)在中藥材產(chǎn)地分析、制劑快速檢測(cè)和在線質(zhì)量控制等方面得到的較大的應(yīng)用并取得很好的應(yīng)用效果,《中國藥典》2010年版附錄已收載了近紅外分光光度法指導(dǎo)原則。目前,近紅外光譜分析儀廣泛配備于食品藥品監(jiān)督管理部門的藥品快檢車中。另據(jù)國家食品藥品監(jiān)督管理總局(CFDA)的要求,到2015年底要實(shí)現(xiàn)近紅外圖譜快速比對(duì)分析模型的全國共享,可見NIRS光譜分析技術(shù)在藥品快速鑒別中具有重要作用。 本課題擬利用NIRS分析技術(shù)對(duì)來源于四個(gè)不同廠家的66個(gè)批次的酒石酸美托洛爾片進(jìn)行真?zhèn)舞b別和廠家鑒別。本課題采用了三種采樣方式進(jìn)行采樣,通過光譜預(yù)處理方法和參數(shù)的篩選和建模光譜區(qū)間的選擇得到了最佳建模結(jié)果�；煜仃囈约澳Ｐ偷臏�(zhǔn)確率和否定率表明：三種采樣方式均能有效的對(duì)來自四個(gè)不同生產(chǎn)廠家的樣品進(jìn)行有效的真?zhèn)巫R(shí)別和廠家識(shí)別。通過實(shí)驗(yàn)表明,建立的模型具有較高的準(zhǔn)確度,驗(yàn)證集的預(yù)測(cè)結(jié)果具有較高的準(zhǔn)確率。模型經(jīng)過進(jìn)一步修正后,可以用于酒石酸美托洛爾片的廠家鑒別,對(duì)藥品市場(chǎng)的打假以及藥品的快速篩查具有重要的現(xiàn)實(shí)意義。
[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.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R927;TN219

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