Greencare Pharma

Cannabis sativa L., a member of the Cannabaceae family, has been thoroughly investigated for its diverse therapeutic properties, primarily attributed to cannabinoids such as delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Secondary, metabolites like terpenes also exhibit pharmacological effects. This study examined the genotoxicity of a whole Cannabis sativa flower extract 160.32 mg/mL using three OECD-recommended protocols: the Ames test, micronucleus test, and comet assay. Five groups of six Wistar rats were used. Three doses of the extract (500, 1000, and 2000 mg/kgbw) or negative control (placebo) were administered orally, while cyclophosphamide monohydrate (20 mg/kgbw) was used as a positive control via intraperitoneal injection. Blood was collected for the comet test, and the animals were euthanized for bone marrow collection for the micronucleus test. The Cannabis extract did not increase the number of revertant bacterial colonies at (375, 250, 125, and 62.5 μg/plate) in TA100 or TA98, nor did it affect the number of micronucleated polychromatic erythrocytes (MNPCEs) or the ratio of polychromatic to normochromatic erythrocytes (PCEs/NCEs). It also did not alter the index or frequency of DNA damage in hematopoietic cells. These results suggest no genotoxic effects, supporting its potential therapeutic use.

Cannabinoids offer a novel pharmacotherapeutic approach and can complement other medications to address unmet clin. needs in numerous patients, which has led to a global increase in the use of these products.No significant safety concerns have been identified in preclin. studies involving CBD and THC.However, the available data on the toxicity of combined CBD and THC are still inconclusive.Evaluating full-spectrum Cannabis sativa extracts is even more complex since whole extracts and isolated phytomols. do not act in the same way.Given the growing interest in cannabinoid-containing products for human use and the fact that most cannabis treatments utilize entire inflorescence rather than isolated compounds, the current studies aim to evaluate the preclin. safety of a full-spectrum composition (THC, CBD, minor cannabinoids, terpenes, and flavonoids) Cannabis sativa extract (CSE).This research includes acute (single dose, with animals monitored for 14 days to assess potential effects) and long-term treatments (6 mo for rodents and 9 mo for rabbits) to assess safety and tolerance.This study demonstrates that a full-spectrum Cannabis sativa extract has a favorable safety profile in both acute and prolonged toxicity studies in rodents and rabbits.In acute toxicity tests, the extract did not show any significant behavioral or physiol. changes after oral or i.p. administration.Addnl., administering the extract acutely to rabbits had minimal impact on the central nervous, cardiovascular, and respiratory systems, with only a temporary reduction in motor activity at the highest dose.Prolonged administration of 6 mo in rats and 9 mo in rabbits did not lead to significant changes in organ histopathol., body weight, or behavior.Although liver enzymes were elevated at the highest doses, other biochem. and hematol. parameters remained unchanged.CSE was well-tolerated, as no serious adverse effects were observed; however, a reduction in motor activity was noted in the highest dose group, highlighting the need for further investigation, which is proposed for future studies.