School of Health Sciences, Universidade do Vale do Itajaí - UNIVALI, Itajaí/SC, Brazil.
Laboratory of Pharmacognosy and Quality Control of Phytomedicines, Faculty of Pharmacy, Universidade Federal do Rio Grande do Sul-UFRGS, Porto Alegre/RS, Brazil.
Planta Med. 2021 Oct;87(12-13):964-988. doi: 10.1055/a-1529-8339. Epub 2021 Aug 19.
Herbal medicines are important options for the treatment of several illnesses. Although their therapeutic applicability has been demonstrated throughout history, several concerns about their safety and efficacy are raised regularly. Quality control of articles of botanical origin, including plant materials, plant extracts, and herbal medicines, remains a challenge. Traditionally, qualitative (e.g., identification and chromatographic profile) and quantitative (e.g., content analyses) markers are applied for this purpose. The compound-oriented approach may stand alone in some cases (e.g., atropine in ). However, for most plant materials, plant extracts, and herbal medicines, it is not possible to assure quality based only on the content or presence/absence of one (sometimes randomly selected) compound. In this sense, pattern-oriented approaches have been extensively studied, introducing the use of multivariate data analysis on chromatographic/spectroscopic fingerprints. The use of genetic methods for plant material/plant extract authentication has also been proposed. In this study, traditional approaches are reviewed, although the focus is on the applicability of fingerprints for quality control, highlighting the most used approaches, as well as demonstrating their usefulness. The literature review shows that a pattern-oriented approach may be successfully applied to the quality assessment of articles of botanical origin, while also providing directions for a compound-oriented approach and a rational marker selection. These observations indicate that it may be worth considering to include fingerprints and their data analysis in the regulatory framework for herbal medicines concerning quality control since this is the foundation of the holistic view that these complex products demand.
草药是治疗多种疾病的重要选择。尽管它们的治疗适用性在历史上已经得到证明,但人们经常对其安全性和疗效提出一些担忧。包括植物材料、植物提取物和草药在内的植物来源制品的质量控制仍然是一个挑战。传统上,定性(例如,鉴定和色谱特征)和定量(例如,含量分析)标志物用于此目的。在某些情况下,化合物定向方法可能是独立的(例如,莨菪碱在 中)。然而,对于大多数植物材料、植物提取物和草药,仅基于一种(有时随机选择的)化合物的含量或存在/不存在来保证质量是不可能的。在这种意义上,已经广泛研究了面向模式的方法,引入了对色谱/光谱指纹的多元数据分析。还提出了使用遗传方法进行植物材料/植物提取物鉴定。在这项研究中,虽然重点是指纹在质量控制中的适用性,但也回顾了传统方法,突出了最常用的方法,并展示了它们的有用性。文献综述表明,面向模式的方法可成功应用于植物来源制品的质量评估,同时为化合物定向方法和合理标志物选择提供了方向。这些观察结果表明,考虑将指纹及其数据分析纳入草药质量控制的监管框架可能是值得的,因为这是这些复杂产品所需要的整体观点的基础。