Does Cannabis Extract Obtained From Cannabis Flowers With Maximum Allowed Residual Level of Aflatoxins and Ochratoxin a Have an Impact on Human Safety and Health?

Tijana Serafimovska,Marija Darkovska Serafimovska,Joachim Erler,Jasmina Tonic Ribarska,Gjoshe Stefkov,Trajan Balkanov,Marija Mitevska,Zlatko Keskovski,Sasho Stefanovski

doi:10.3389/fmed.2021.759856

Tijana Serafimovska, Marija Darkovska Serafimovska + Show 7 more

Open Access

https://doi.org/10.3389/fmed.2021.759856

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Abstract

Aim: The aim of this study was to investigate whether the cannabis extract obtained from cannabis flowers that contain the maximum allowed level of mycotoxins affects human safety and health. For that purpose, a novel liquid chromatography with tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of aflatoxins and ochratoxin A (OchA) in cannabis extracts to demonstrate that this analytical method is suitable for the intended experimental design.Methods: Experimental design was done by adding maximum allowed concentration of aflatoxins (B1, B2, G1, G2) and OchA according to the European Pharmacopeia related to cannabis flowers. The concentration of aflatoxins and OchA was determined using the same LC/MS/MS analytical method in the starting material (dry flower) before preparing the spiked sample and after obtaining decarboxylated extract with ethanol 96%.Results: The results obtained indicate that aflatoxins and OchA, primarily added to the cannabis dried flowers, were also determined into the obtained final extract in amounts much higher (m/m) than in the starting plant material.Conclusion: With this experiment, we have shown that mycotoxins, especially aflatoxins, which are extremely toxic secondary metabolites, can reach critical values in cannabis extracts obtained from dry cannabis flowers with the maximum allowed quantity of mycotoxins. This can pose a great risk to consumers and their health especially to those with compromised immune systems.

Highlights

Medicinal products based on Cannabis sativa L. (Cannabaceae) in traditional medicine, have been used for thousands of years in the treatment of various diseases [1]
Liquid standards of aflatoxin B1 (AfB1) Cat.No.TSL-104-10, aflatoxin B2 (AfB2) Cat.No.TSL-105-10, aflatoxin G1 (AfG1) Cat.No.TSL106-10, aflatoxin G2 (AfG2) Cat.No.TSL-107-10, and ochratoxin A (OchA) Cat.No.TSL-504-5 were supplied by R-Biopharm (Germany)
The results obtained indicate that aflatoxins and OchA, well soluble in ethanol, after evaporation of the solvent, remain in the final extract in an amount much higher than the amount in which we added them

Summary

Introduction

Medicinal products based on Cannabis sativa L. (Cannabaceae) in traditional medicine, have been used for thousands of years in the treatment of various diseases [1]. Medicinal products based on Cannabis sativa L. There is a lack of evidence-based medical information that can prove the potential benefit of the therapy with medicinal cannabis preparations, recently, an increasing number of pharmacists have issued cannabis preparations to individual patients prescribed by their physicians [2]. To obtain cannabis-based preparations, standardized concentrated cannabinoid extracts, produced by a suitable extraction process of cannabinoids from cannabis flowers are used [2]. A variety of herbal monographs are listed under the general monographs in Ph.Eur.: herbal drugs, herbal drug extracts, and herbal drug preparations. These general monographs are created to cover products and quality parameters, which are not mentioned in the individual monographs. It is necessary to apply the individual monograph always in combination with these quality requirements [5]

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