在巴西评估基于大麻的产品:当前的法规如何影响其标签质量?
Andrea Donatti Gallassi1,2, André Wagner Carvalho de Oliveira3,4, Nathália Silva Mendes4
1Graduate Program in Health Sciences and Technology (Programa de Pós-Graduação em Ciências e Tecnologias em Saúde), Faculdade de Ciências e Tecnologias em Saúde (FCTS), Universidade de Brasília (UnB), Centro Metropolitano 1, Conjunto A, Ceilândia Sul, ZIP 72220-900, Brasília-DF, Brasil. andrea.gallassi@gmail.com.
Journal of cannabis research
|February 22, 2025
概括
巴西大麻 (CBD) 产品的标签质量因法规而异. 与N660/2022进口产品相比,N327/2019的产品显示出更好的处方和安全信息.
科学领域:
- 药理学和药品质量评估的药理学
- 医疗保健中的监管科学
- 基于大麻的产品分析
背景情况:
- 人们对巴西可用的大麻制品,特别是大麻 (CBD) 的质量存在担忧.
- 现有的法规,N660/2022对于进口产品和N327/2019对于临时许可,规范CBD产品的营销.
- 标签质量对于确保消费者和处方者的安全至关重要.
研究的目的:
- 根据N660/2022和N327/2019法规在巴西销售的CBD产品的标签质量进行评估和比较.
- 评估四个关键领域的标签差异:处方,良好制造实践 (GMP),实验室测试和使用安全.
- 为巴西关于CBD产品质量和相关风险的持续讨论提供数据.
主要方法:
- 开发了一个基于45个标准的评分系统,根据用户和处方者安全的相关性加权.
- 标签信息从制造商网站和电子邮件咨询中收集.
- 曼 - 惠特尼U测试用于比较N327/2019和N660/2022下授权的产品之间的质量评分.
主要成果:
- 在148个选定的产品中,评估了105个,其中大多数被归类为令人满意的 (47),其次是不太令人满意的 (39) 和非常令人满意的 (19).
- 与N660/2022相比,根据N327/2019授权的产品显示了更容易获得的信息.
- 在处方和安全使用领域观察到有利于N327/2019产品的显著差异.
结论:
- 巴西的CBD产品标签质量是可变的,受监管机构授权的影响.
- 与N660/2022产品相比,N327/2019产品通常在处方和安全信息方面提供更优质的标签.
- 这项研究强调,需要改善和标准化CBD产品的标签实践,以减轻风险.
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