开发可靠的大麻素定量标准化分析程序:为新兴的大麻制药业奠定基础。

Q1 Medicine Medical Cannabis and Cannabinoids Pub Date : 2019-02-25 eCollection Date: 2019-09-01 DOI:10.1159/000496868
Matthew T Welling, Lei Liu, Arno Hazekamp, Ashley Dowell, Graham J King
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引用次数: 0

摘要

大麻属植物多产独特的药用代谢物,通常称为大麻素。采用可靠的标准化方法对植物和药物形式中的大麻素进行定量分析,是以大麻为基础的新兴制药业向前迈出的关键一步,该行业有望迅速发展壮大。尽管用于量化大麻素的分析方法越来越多,但采用国际认可准则进行验证的方法却寥寥无几。此外,还没有开发出适用于不同生产阶段以及不同加工和提炼水平的标准化方法。本文对建立健全的大麻基药物定量标准化方法的验证参数进行了认真讨论。在严格和多变的监管环境中,确定异质植物基质之间适当的特异性(鉴别)水平以及评估准确性(回收率)和实验室间精密度(再现性)是建立可靠分析程序的潜在障碍。我们认为,虽然其中一些挑战仍是大麻所独有的,但其他挑战则是基于植物的药物开发和生产所面临的共同挑战。为了解决分析方法标准化的潜在障碍,我们提出了一项包括学术和商业利益相关者在内的合作研究计划。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry.

The plant genus Cannabis is a prolific producer of unique pharmaceutically relevant metabolites, commonly referred to as cannabinoids. Robust and standardised methods for the quantification of cannabinoids within botanical and drug forms is a critical step forward for an emerging Cannabis-based pharmaceutical industry, which is poised for rapid expansion. Despite a growing body of analytical methods for the quantification of cannabinoids, few have been validated using internationally accredited guidelines. Moreover, standardised methods have yet to be developed for application at various stages of manufacture as well as for different levels of processing and refinement. Validation parameters for establishing robust standardised methods for cannabinoid quantification within Cannabis-based drug forms are critically discussed. Determining an appropriate level of specificity (discrimination) among heterogeneous botanical matrices as well as evaluating accuracy (recovery) and inter-laboratory precision (reproducibility) within strict and volatile regulatory environments are potential obstacles to the establishment of robust analytical procedures. We argue that while some of these challenges remain unique to Cannabis, others are common to botanical-based drug development and manufacture. In order to address potential barriers to analytical method standardisation, a collaborative research initiative inclusive of academic and commercial stakeholders is proposed.

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来源期刊
Medical Cannabis and Cannabinoids
Medical Cannabis and Cannabinoids Medicine-Complementary and Alternative Medicine
CiteScore
6.00
自引率
0.00%
发文量
18
审稿时长
18 weeks
期刊最新文献
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