Inorganic element profile of medicinal Cannabis extracts consumed by pediatric patients

Abstract The increasing number of reports of web-based experiences on the success of Cannabis-based therapies in controlling seizures in children suffering from refractory epilepsy have led to efforts by governments and associations to a recent change in legislation. The Brazilian Health Regulatory Agency (ANVISA) allowed the import of Cannabis extracts in 2015 and the registration of the first industrialized drug in 2017. In 2019, ANVISA approved procedures for the granting of a Sanitary Authorization for manufacturing and imports, establishing marketing requirements, prescribing, dispensing, monitoring and surveillance of cannabis products for medicinal purposes. Similar to other consumer products of health concern, is necessary to ensure the quality and health safety of these products worldwide. The aim of the present study to evaluate the presence of As, Cd, Pb, Ni, Cu, Co, Cr and Mn present in Cannabis extracts and resins used in the treatment of pediatric patients with neurological diseases. Samples (48 national and 24 imported) were analyzed by Inductively Coupled Plasma Mass Spectrometry - ICP-MS. The imported extracts presented more homogeneous inorganic element values, while national extracts showed varied levels, thus indicating the highest health risk.摘要 网络上有关基于大麻的疗法成功控制难治性癫痫患儿癫痫发作的经验报道日益增多，促使各国政府与相关协会推动了近期的立法修订。巴西卫生监管局（Brazilian Health Regulatory Agency, ANVISA）于2015年允许大麻提取物的进口，并在2017年完成了首款工业化药用大麻药物的注册审批。2019年，ANVISA批准了药用大麻产品生产与进口的卫生授权程序，明确了该类产品的营销、处方、调配、监测及监管要求。与其他关乎公众健康的消费品类似，全球范围内均需保障药用大麻产品的质量与健康安全性。 本研究旨在评估用于治疗儿科神经系统疾病患者的大麻提取物与树脂中砷（As）、镉（Cd）、铅（Pb）、镍（Ni）、铜（Cu）、钴（Co）、铬（Cr）及锰（Mn）的含量。研究共采集48份国产样品与24份进口样品，采用电感耦合等离子体质谱法（Inductively Coupled Plasma Mass Spectrometry, ICP-MS）进行分析。进口大麻提取物的无机元素含量更为均匀，而国产提取物的元素水平差异显著，由此提示其健康风险更高。