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是否可以在药物中找到乳糖的存在?-ATR-FTIR 光谱和化学计量学的初步研究。

Is it possible to find presence of lactose in pharmaceuticals? - Preliminary studies by ATR-FTIR spectroscopy and chemometrics.

机构信息

Singapore Synchrotron Light Source, 5 Research Link, 117603 Singapore, Singapore.

Singapore Synchrotron Light Source, 5 Research Link, 117603 Singapore, Singapore.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2017 Jan 15;171:280-286. doi: 10.1016/j.saa.2016.08.003. Epub 2016 Aug 4.

Abstract

Lactose and saccharose have the same molecular formula; however, the arrangement of their atoms is different. A major difference between lactose and saccharose with regard to digestion and processing is that it is not uncommon for individuals to be lactose intolerant (around two thirds of the population has a limited ability to digest lactose after infancy), but it is rather unlikely to be saccharose intolerant. The pharmaceutical industry uses lactose and saccharose as inactive ingredients of drugs to help form tablets because of their excellent compressibility properties. Some patients with severe lactose intolerance may experience symptoms of many allergic reactions after taking medicine that contains this substance. People who are specifically "allergic" to lactose (not just lactose intolerant) should not use tablets containing this ingredient. Fourier Transform Infrared (FTIR) spectroscopy has a unique chemical fingerprinting capability and plays a significant important role in the identification and characterization of analyzed samples and hence has been widely used in pharmaceutical science. However, a typical FTIR spectrum collected from tablets contains a myriad of valuable information hidden in a family of tiny peaks. Powerful multivariate spectral data processing can transform FTIR spectroscopy into an ideal tool for high volume, rapid screening and characterization of even minor tablet components. In this paper a method for distinction between FTIR spectra collected for tablets with or without lactose is presented. The results seem to indicate that the success of identifying one component in FTIR spectra collected for pharmaceutical composition (that is tablet) is largely dependent on the choice of the chemometric technique applied.

摘要

乳糖和蔗糖具有相同的分子式;然而,它们的原子排列是不同的。乳糖和蔗糖在消化和加工方面的一个主要区别是,并非所有人都对乳糖不耐受(大约三分之二的人在婴儿期后消化乳糖的能力有限),但对蔗糖不耐受则不太可能。制药行业将乳糖和蔗糖用作药物的无活性成分,以帮助形成片剂,因为它们具有优异的可压缩性。一些严重乳糖不耐受的患者在服用含有这种物质的药物后可能会出现许多过敏反应的症状。对乳糖(不仅仅是乳糖不耐受)特别“过敏”的人不应使用含有这种成分的片剂。傅里叶变换红外(FTIR)光谱具有独特的化学指纹识别能力,在分析样品的鉴定和表征方面发挥着重要作用,因此在制药科学中得到了广泛应用。然而,从片剂中采集的典型 FTIR 光谱包含隐藏在一族微小峰中的大量有价值信息。强大的多元光谱数据处理可以将 FTIR 光谱转化为一种理想的工具,用于对片剂的微量成分进行高通量、快速筛选和表征。本文提出了一种区分含有或不含乳糖的片剂 FTIR 光谱的方法。结果似乎表明,在对药物成分(即片剂)采集的 FTIR 光谱中识别一个成分的成功在很大程度上取决于所应用的化学计量技术的选择。

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