近红外光谱分析技术在制药领域中的应用研究进展

目的对近红外光谱分析技术在制药领域中的应用进行综述,为药品生产过程质量控制与优化提供参考。方法查阅国内外近年来文献,进行归纳总结。结果与结论近红外光谱分析技术作为一种有力过程分析工具,对于提高药品生产效率,强化对药品的质量控制具有重要意义,随着研究的深入,近红外光谱分析技术将在制药领域发挥更深刻的作用。     

傅立叶变换红外光谱在临床医药学中的应用进展

本文对近年来傅立叶变换红外光谱（FTIR）在临床医药学中的应用进展进行了综述，主要包括FTIR在药品质量检测方面和临床疾病诊断方面以及FTIR联用技术的应用等，为药物质量控制、临床诊断提供参考。     

近红外光谱技术及其在中药质量分析中的应用

目的:介绍近红外光谱技术在中药质量分析中的应用。方法:采用文献综述法,阐述国内近红外光谱技术在中药质量分析,包括药材鉴别、药品中间体质量控制、药材及制剂含量测定中的应用。结果:与传统方法比较,近红外光谱技术不需要对样品进行前处理;可用于在线分析;分析过程中不破坏样品;分析重现性好。结论:近红外光谱技术在中药质量分析中有广阔的应用前景。     

拉曼与近红外、中红外光谱在药品掺杂筛选应用中的前景分析

目的通过比较分析光谱法的原理、应用与药品快速检测需求,筛选最适合的快速检测信号采集方法。方法对比分析各类光谱定性分析基础、光谱数据信息采集手段、不同用户群的需求。结果红外、拉曼光谱比近红外光谱在定性鉴别方面更具优势,红外光谱可以作为实验室使用的初筛方法,拉曼光谱可以作为普筛方法使用。结论拉曼光谱为药品掺杂筛选一线首选信息采集方法。     

近红外光谱技术在药品质量控制中的应用与研究进展

目的:为借助近红外光谱技术高效、全面地控制药品质量提供参考。方法:查阅近年发表的近红外光谱技术用于药品质量控制的相关研究文献,进行归纳、总结和综述。结果与结论:近红外光谱技术可广泛用于药品来源的质量控制(包括中药材产地及品种、中药饮片和药品原辅料鉴别)、生产过程的质量控制(包括对中药材有效成分的提取、纯化、浓缩和药品混合均匀度的监控)以及上市后监控(包括水分测定、真伪鉴别和非法添加检测)。近红外光谱技术具有操作简便、无损、快速、无需试剂等优点,在药品质量控制中的应用前景广阔,但对于其普及应用的一些制约因素仍需加大研究投入、加以解决。     

振动光谱在药物晶型表征中的应用研究进展

固态药物的多晶型研究对药物质量控制、生产工艺选择、临床疗效评价等发挥重要作用。振动光谱是药物多晶型表征的有力手段之一。本文重点概述了近年来利用傅里叶变换红外(FTIR)光谱技术和拉曼(Raman)光谱技术在活性药物成分(APIs)及药物共晶/盐的多晶型表征中的应用研究进展,阐明两种光谱技术在APIs和药物复合物的晶型分析中的应用特点,为药物开发过程中的结构分析提供理论支持。     

红外光谱技术在中药质量控制中的应用

简述红外光谱在中药质量控制中的作用及应用方法,指出红外光谱鉴别中药材具有特征性强、取样量小、简便、迅速、无损等优点,对中药材的鉴别具有重要意义.     

维生素A的分子光谱分

目的:对维生素A的拉曼光谱与红外光谱进行分析,探讨其分子振动光谱与结构特征的相关性.方法:采用傅里叶变换红外光谱仪和便携式拉曼光谱仪对维生素A进行光谱检测.结果:获得了维生素A的分子光谱信息,为药物合成及质量控制提供了重要的参考价值.结论:拉曼光谱分析法与红外光谱分析法相互补充,结合两种方法,可得到较完整的分子光谱信息,有望成为药品日常监督中有效的鉴别手段.     

分子光谱法在微生物鉴别和生物制品及生化药品质量控制中的应用

《中国药典》中涉及的生物制品和生化药品的生物检查是保障药效和安全性的重要方面.本文综述了红外光谱(IR)、近红外光谱(NIR)、拉曼光谱(Raman)、荧光光谱(MFS)和紫外光谱(UV)等分子光谱法在微生物鉴别及生物制品和生化药品生物检查中的应用,例如生物制品和生化药品快速质量筛查中的应用;工艺杂质控制中的应用;蛋白...     

红外光谱技术在中药质量控制中的应用进展

综述红外光谱技术与化学计量学相结合在中药质量控制中的应用,包括利用导数校正(包括一阶、二阶求导)、标准正态变换、多元信号校正、小波变换、数据平滑等方法处理原始红外光谱,提高谱图的信噪比、改良分析信号的质量;利用正交偏最小方差判别分析、主成分分析、偏最小二乘法等校正方法处理红外光谱数据,可以迅速而准确地鉴别中药、定量分析中药有效成分;用SIMCA方法、聚类分析方法、红外指纹图谱法等化学模式识别红外光谱数据可以判断中药的产地、道地性和中成药的质量等;利用二维相关红外光谱法可以鉴别中药材的产地、研究中药炮制质量变化等。     

A procedural framework for good imaging practice in pharmacological fMRI studies applied to drug development #1: processes and requirements

There is increasing interest in the application of quantitative magnetic resonance imaging (MRI) methods to drug development, but as yet little standardization or best practice guidelines for its use in this context. Pharmaceutical trials are subject to regulatory constraints and sponsor company processes, including site qualification and expectations around study oversight, blinding, quality assurance and quality control (QA/QC), analysis and reporting of results. In this article, we review the processes on the sponsor side and also the procedures involved in data acquisition at the imaging site. We then propose summary recommendations to help guide appropriate imaging site qualification, as part of a framework of 'good imaging practice' for functional (f)MRI studies applied to drug development.     

PAT: From Western solid dosage forms to Chinese materia medica preparations using NIR‐CI

Near‐infrared chemical imaging (NIR‐CI) is an emerging technology that combines traditional near‐infrared spectroscopy with chemical imaging. Therefore, NIR‐CI can extract spectral information from pharmaceutical products and simultaneously visualize the spatial distribution of chemical components. The rapid and non‐destructive features of NIR‐CI make it an attractive process analytical technology (PAT) for identifying and monitoring critical control parameters during the pharmaceutical manufacturing process. This review mainly focuses on the pharmaceutical applications of NIR‐CI in each unit operation during the manufacturing processes, from the Western solid dosage forms to the Chinese materia medica preparations. Finally, future applications of chemical imaging in the pharmaceutical industry are discussed. Copyright © 2015 John Wiley & Sons, Ltd.     

Recent applications of Chemical Imaging to pharmaceutical process monitoring and quality control

Chemical Imaging (CI) is an emerging platform technology that integrates conventional imaging and spectroscopy to attain both spatial and spectral information from an object. Vibrational spectroscopic methods, such as Near Infrared (NIR) and Raman spectroscopy, combined with imaging are particularly useful for analysis of biological/pharmaceutical forms. The rapid, non-destructive and non-invasive features of CI mark its potential suitability as a process analytical tool for the pharmaceutical industry, for both process monitoring and quality control in the many stages of drug production. This paper provides an overview of CI principles, instrumentation and analysis. Recent applications of Raman and NIR-CI to pharmaceutical quality and process control are presented; challenges facing CI implementation and likely future developments in the technology are also discussed.     

Chemometric Methods for the Quantification of Crystalline Tacrolimus in Solid Dispersion by Powder X‐Ray Diffractrometry

The objective of this study was to develop powder X‐ray diffraction (XRPD) chemometric model for quantifying crystalline tacrolimus from solid dispersion (SD). Three SDs (amorphous tacrolimus component) with varying drug to excipient ratios (24.4%, 6.7%, and 4.3% drug) were prepared. Placebo SDs were mixed with crystalline tacrolimus to make their composition equivalent to three SD (crystalline tacrolimus component). These two components were mixed to cover 0%–100% of crystalline drug. Uniformity of the sample mixtures was confirmed by near‐infrared chemical imaging. XRPD showed three distinct peaks of crystalline drug at 8.5°, 10.3°, and 11.2° (2θ), which were nonoverlapping with the excipients. Principal component regressions (PCR) and partial least square (PLS) regression used in model development showed high R² (>0.99) for all the mixtures. Overall, the model showed low root mean square of standard error, standard error, and bias, which was smaller in PLS than PCR‐based model. Furthermore, the model performance was evaluated on the formulations with known percentage of crystalline drug. Model‐calculated crystalline drug percentage values were close to actual value. Therefore, these studies strongly suggest the application of chemometric‐XRPD models as a quality control tool to quantitatively predict the crystalline drug in the formulation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:2819–2828, 2014     

Characteristics of hydroxypropyl methylcellulose influencing compactibility and prediction of particle and tablet properties by infrared spectroscopy

Particle characteristics, chemical substitution, compaction behavior, and tablet properties of hydroxypropyl methylcellulose powders from two different suppliers were related using multivariate data analysis. By Principal Component Analysis it was shown that the the degree of substitution of the HPMC powders did not correlate to the particle and compaction properties as strongly as anticipated. Particle shape and powder surface area seem to be more important for the compaction behaviour of the powders than the degree of substitution. In addition, particle and tablet properties were predicted from infrared spectral data. Fourier transform infrared (FTIR) and near infrared (NIR) spectral data of the powders were combined with measured values of the particle characteristics, compaction behavior, and tablet properties using the multivariate data analysis program SIMCA 7.1. Properties like density, particle shape, tablet tensile strength, and drug release characteristics of the HPMC powders and corresponding tablets in this study could be predicted using Partial Least Squares models. In conclusion, the particle shape and powder surface area of HPMC powders seem to be important factors for the quality of tablet attained. Further, this study confirms that NIR and FTIR analysis used in combination with multivariate analysis are powerful tools for predicting the properties of materials and the quality of the end product.     

Terahertz pulsed spectroscopy and imaging in the pharmaceutical setting--a review

Terahertz pulsed spectroscopy (TPS) and terahertz pulsed imaging (TPI) are two novel techniques for the physical characterization of pharmaceutical drug materials and final solid dosage forms, utilizing spectral information in the far infrared region of the electromagnetic spectrum. This review focuses on the development and performance of pharmaceutical applications of terahertz technology compared with other tools for physical characterization. TPS can be used to characterize crystalline properties of drugs and excipients. Different polymorphic forms of a drug can be readily distinguished and quantified. Recent developments towards a better understanding of the fundamental theory behind spectroscopy in the far infrared have been discussed. Applications for TPI include the measurement of coating thickness and uniformity in coated pharmaceutical tablets, structural imaging and 3D chemical imaging of solid dosage forms.     

Process analytical technology: nondestructive evaluation of cyclosporine A and phospholipid solid dispersions by near infrared spectroscopy and imaging

The objective of this study was to evaluate near infrared (NIR) spectroscopy and imaging as approaches to assess phospholipid compartment within its solid dispersion with cyclosporine A (CyA). By varying dimyristoyl phosphatidylcholine (DMPC) to CyA weight ratio, five batches were prepared by the kneading technique and characterized by DSC and FTIR. A drug/DMPC ratio of 50:1 provided an enhanced dissolution of CyA. FTIR spectra and DSC thermograms revealed a significant interaction between the drug and DMPC which suggested incorporation of CyA within the formed DMPC liposomes. The developed NIR calibration model was able to assess DMPC concentrations within the kneaded products. The calibration and prediction linear plots showed slopes of 0.9711 and 0.9915, offsets of 0.1247 and 0.1080, correlation coefficients of 0.9854 and 0.9889 and root mean square standard errors of 0.43% and 0.42%, respectively. In contrast, NIR spectral imaging was capable of clearly distinguishing the kneaded products, both qualitatively and quantitatively. NIR imaging revealed the poor powder blending efficiency of the method used to prepare physical mixture compared to the efficient distribution of the kneaded products. In conclusion, NIR spectral imaging system provides a rapid approach for acquiring high-resolution spatial and spectral information on solid dispersions.     

Using Near-Infrared Spectrophotometry for the Identification of Pharmaceuticals and Drugs

The near infrared range (NIR) of the electromagnetic spectrum extends from 800 to 2500 nm, being confined between the middle IR and visible spectral regions. The method of NIR spectroscopy is based on a combination of spectrophotometry and statistical methods of multifactor analysis, which provides excellent possibilities for drug identification and quality control even without opening the package. We have studied a series of drugs including cefazolin sodium and generic drugs based on enalapril maleate. True and falsified variants of a given drug X were classified into groups according to “drug name,” “drug manufacturer,” and “falsified product” by means of NIR spectroscopic analyses performed using the NIR Fourier-transform instruments Multi Purpose Analyzer (Bruker, Germany) and Antaris (Thermo Electron Corporation, USA). The potential of this method for the identification of drugs without violation of their packing shows good prospects for introducing it into the drug quality control system. This method should be recommended for introduction into the future Russian State Pharmacopoeia as a general method of drug analysis. Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 42, No. 7, pp. 51–53, July, 2008.