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      Quality Control of Traditional Cannabis Tinctures: Pattern, Markers, and Stability

      Scientia Pharmaceutica

      MDPI

      Cannabis sativa L., traditional tinctures, stability (HPLC, THC, CBN, CBG)

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          Abstract

          Traditional tinctures of Cannabis sativa L. became obsolete before elucidation of the main cannabinoids and routine quality testing for medicines. In view of increasing medicinal use of cannabinoids and associated safety concerns, tinctures from a Δ9-tetrahydrocannabinol (THC)-type chemovar were studied. High-performance liquid chromatography with diode-array detection (HPLC/DAD) was used to determine THC, Δ9-tetrahydrocannabinolic acid A (THCA), cannabinol (CBN), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabigerol (CBG), cannabigerolic acid (CBGA), cannflavin A/B, and total phenolics. Derived group and ratio markers describe absolute and relative profiles when varying plant part (flos, folium), extraction solvent (EtOH percentage), storage conditions (‘shelf’ or ‘fridge’ up to 15 months), and pasteurization (2 h 70 °C, 20 min 80 °C). Tinctures from female flowering tops contained ten-fold more cannabinoids than tinctures from leaves; tinctures (80%–90% EtOH) contained ten-fold more cannabinoids than tinctures (40% EtOH). The analysis of CBGA + CBG, the main co-cannabinoids aside from THCA + THC, appears more relevant than CBDA + CBD. The decarboxylation of THCA to THC—the main change during storage of freshly prepared tinctures—is after 15 months in the ‘fridge’ comparable to 3 months on the ‘shelf’. Minimally increased CBN totals did not correlate to diminished totals of THCA and THC (up to 15% after 3 months ‘shelf’, 45% after 15 months ‘fridge’). Instead, total cannabinoids or acidic/neutral cannabinoid ratios are better stability markers. Moderate changes after pasteurization and partial losses below 10% for total cannabinoids after 9 months ‘fridge’ indicate possibilities for a reasonable shelf life. Yet storage and use of non-stabilized tinctures remain critical without authorized specification and stability data because a consistent cannabinoid content is not guaranteed.

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          Most cited references 46

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          Pharmacokinetics and pharmacodynamics of cannabinoids.

          Delta(9)-Tetrahydrocannabinol (THC) is the main source of the pharmacological effects caused by the consumption of cannabis, both the marijuana-like action and the medicinal benefits of the plant. However, its acid metabolite THC-COOH, the non-psychotropic cannabidiol (CBD), several cannabinoid analogues and newly discovered modulators of the endogenous cannabinoid system are also promising candidates for clinical research and therapeutic uses. Cannabinoids exert many effects through activation of G-protein-coupled cannabinoid receptors in the brain and peripheral tissues. Additionally, there is evidence for non-receptor-dependent mechanisms. Natural cannabis products and single cannabinoids are usually inhaled or taken orally; the rectal route, sublingual administration, transdermal delivery, eye drops and aerosols have only been used in a few studies and are of little relevance in practice today. The pharmacokinetics of THC vary as a function of its route of administration. Pulmonary assimilation of inhaled THC causes a maximum plasma concentration within minutes, psychotropic effects start within seconds to a few minutes, reach a maximum after 15-30 minutes, and taper off within 2-3 hours. Following oral ingestion, psychotropic effects set in with a delay of 30-90 minutes, reach their maximum after 2-3 hours and last for about 4-12 hours, depending on dose and specific effect. At doses exceeding the psychotropic threshold, ingestion of cannabis usually causes enhanced well-being and relaxation with an intensification of ordinary sensory experiences. The most important acute adverse effects caused by overdosing are anxiety and panic attacks, and with regard to somatic effects increased heart rate and changes in blood pressure. Regular use of cannabis may lead to dependency and to a mild withdrawal syndrome. The existence and the intensity of possible long-term adverse effects on psyche and cognition, immune system, fertility and pregnancy remain controversial. They are reported to be low in humans and do not preclude legitimate therapeutic use of cannabis-based drugs. Properties of cannabis that might be of therapeutic use include analgesia, muscle relaxation, immunosuppression, sedation, improvement of mood, stimulation of appetite, antiemesis, lowering of intraocular pressure, bronchodilation, neuroprotection and induction of apoptosis in cancer cells.
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            Marihuana Chemistry

             R Mechoulam (1970)
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              Increasing delta-9-tetrahydrocannabinol (Δ-9-THC) content in herbal cannabis over time: systematic review and meta-analysis.

              The objective of this meta-analysis is to assess the data regarding changes in herbal cannabis potency over time (from 1970 to 2009). Systematic searches of 17 electronic scientific databases identified studies on this topic, within which 21 case series studies satisfied our inclusion criteria of reporting the mean tetrahydrocannabinol (THC) value per number of samples per year. No language, publication date, publication type or status restrictions were imposed. The study selection and data extraction processes were performed independently but uniformly by two authors, included screening, determination of eligibility and inclusion of the eligible studies in the systematic review, and a meta-analysis of the results on THC content in herbal cannabis samples. We considered papers and not monographic scientific publications, rejecting all studies that were not focused on the subject of this review. Meta-analysis by year was performed on 21 studies containing 75 total mean THC observations from 1979 to 2009 using the random effects model. The results revealed much variability between studies. Further, there was a significant correlation between year and mean THC in herbal cannabis. The combined data indicated the correlation between year and mean THC in herbal cannabis, revealing a temporal trend of increasing potency (5% above the mean THC value in the Poisson regression analysis). The results of the analysis suggest that there has been a recent and consistent increase in cannabis potency worldwide.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                Sci Pharm
                Sci Pharm
                scipharm
                Scientia Pharmaceutica
                MDPI
                0036-8709
                2218-0532
                18 April 2016
                2016
                : 84
                : 3
                : 567-584
                Affiliations
                Centre for Pharmacognosy and Phytotherapy, Department for Pharmaceutical and Biological Chemistry, The School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK; wieland.peschel@ 123456ema.europa.eu ; Tel.: +44-20-3660-7742
                Author notes
                [†]

                Present address: European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5EU, UK.

                Article
                scipharm-84-00567
                10.3390/scipharm84030567
                5064247
                © 2016 by the author; licensee MDPI, Basel, Switzerland.

                This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC-BY) license ( http://creativecommons.org/licenses/by/4.0/).

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