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大麻油盖伦制剂中大麻素浓度分析:意大利北部三个实验室之间的协调

Analysis of Cannabinoids Concentration in Cannabis Oil Galenic Preparations: Harmonization between Three Laboratories in Northern Italy.

作者信息

Palermiti Alice, Cafaro Alessia, Barco Sebastiano, Bucchioni Paolo, Franceschini Paolo, Cusato Jessica, De Nicolò Amedeo, Manca Alessandra, De Vivo Elisa Delia, Russo Eleonora, Cecchi Francesco, Pigliasco Federica, Lillo Flavia, Tripodi Gino, D'Avolio Antonio, Cangemi Giuliana

机构信息

Laboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, University of Turin, Amedeo di Savoia Hospital, 10149 Turin, Italy.

Chromatography and Mass Spectrometry Section, Central Laboratory of Analysis, IRCCS Istituto Giannina Gaslini, 16147 Genova, Italy.

出版信息

Pharmaceuticals (Basel). 2021 May 14;14(5):462. doi: 10.3390/ph14050462.

Abstract

Medical cannabis is increasingly being used in the treatment and support of several diseases and syndromes. The quantitative determination of active ingredients (delta-9 tetrahydrocannabinol, THC, and cannabidiol, CBD) in galenic oily preparations is prescribed by law for each produced batch. The aim of this work is to describe the organization of the titration activity centralized at three regional reference laboratories in Northern Italy. Pre-analytical, analytical, and post-analytical phases have been defined in order to guarantee high quality standards. A cross-validation between laboratories allowed for the definition of the procedures that guarantee the interchangeability between reference laboratories. The risk management protocol adopted can be useful for others who need to undertake this activity.

摘要

医用大麻越来越多地用于多种疾病和综合征的治疗与辅助治疗。法律规定,每一批生产的盖仑油性制剂都要对活性成分(δ-9四氢大麻酚、THC和大麻二酚、CBD)进行定量测定。这项工作的目的是描述集中在意大利北部三个区域参考实验室的滴定活动的组织情况。为保证高质量标准,已明确了分析前、分析和分析后阶段。实验室间的交叉验证有助于确定确保参考实验室之间可互换性的程序。所采用的风险管理方案可能对其他需要开展此项活动的人有用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1cfa/8157009/aa1718a43491/pharmaceuticals-14-00462-g001.jpg

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