医用大麻产品中大麻素测定方法的发展

IF 0.5 4区化学 Q4 CHEMISTRY, MULTIDISCIPLINARY

Quimica Nova Pub Date : 2023-05-08 DOI:10.21577/0100-4042.20230001

A. Dantas, Matheus Levy Almeida Taveira de Souza, Patrícia Ferreira Alexandre De Lima, M. Lima, D. Santana, Ricardo Maranho, A. Colonese, S. Ochs, M. Monteiro

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引用次数: 0

摘要

开发一种测定药用大麻产品中大麻素的方法。在巴西可以获得以大麻植物为基础的医药产品，其中包括药品、大麻产品、个人进口产品和患者协会提供的产品。尽管如此，在巴西药典(BP)或其他可接受的药典中没有大麻素评价的专著。因此，本工作旨在开发一种快速简便的方法来定量药用授权产品中的大麻素。该方法采用HPLC-UV，甲酸在乙腈和水中组成梯度洗脱，流速为0.6 mL min-1，检测波长为220 nm。可以分辨出大麻二酚(CBD)、四氢大麻酚(THC)、大麻二酸和大麻酚的峰，并定量测定CBD (105.35%;104.07%)和THC(106.62%)。结果表明，该方法在精密度、准确度、线性度、选择性等方面均满足要求。这个程序已经在四种大麻产品上进行了测试，以证明其有效性。考虑到建立药品最低质量要求的重要性，以及考虑到巴西可获得的产品，我们发现，在制定的方法中评估其他产品的实施情况是很重要的，以便将来验证和以后纳入BP。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

DESENVOLVIMENTO DE METODOLOGIA PARA DETERMINAÇÃO DE CANABINOIDES EM PRODUTOS À BASE DE CANNABIS PARA FINS MEDICINAIS

DEVELOPMENT OF A METHODOLOGY FOR THE DETERMINATION OF CANNABINOIDS IN CANNABIS-BASED PRODUCTS FOR MEDICINAL PURPOSES. Medicinal products based on the Cannabis sativa plant are available in Brazil, among them, drug, cannabis products, individual import products, and those provided by patient associations. Despite this, there is no monograph for the evaluation of cannabinoids in Brazilian Pharmacopoeia (BP) or other compendia accepted. Therefore, this work aimed to develop a quick and easy method to quantify cannabinoids in authorized products for medicinal purposes. The method was developed by HPLC-UV, gradient elution composed of formic acid in acetonitrile and water, the flow rate of 0.6 mL min-1 and 220 nm detection. It was possible to resolve the peaks of cannabidiol (CBD), tetrahydrocannabinol (THC), cannabidiolic acid and cannabinol and to quantify CBD (105.35%; 104.07%) and THC (106.62%). The developed method was applied to two products and met the established requirements of precision, accuracy, linearity, and selectivity. This procedure has been tested on four cannabisbased products to attest to its effectiveness. Considering the importance of establishing minimum quality requirements for medicinal products and considering the available products in Brazil, it was found that it is important to evaluate the implementation of other products in the method developed for future validation and later inclusion in the BP.

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来源期刊

Quimica Nova 化学-化学综合

CiteScore

1.60

自引率

12.50%

发文量

审稿时长

2-4 weeks

期刊介绍： Química Nova publishes in portuguese, spanish and english, original research articles, revisions, technical notes and articles about education in chemistry. All the manuscripts submitted to QN are evaluated by, at least, two reviewers (from Brazil and abroad) of recognized expertise in the field of chemistry involved in the manuscript. The Editorial Council can be eventually asked to review manuscripts. Editors are responsible for the final edition of QN.