Laboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, University of Turin, Turin, Italy.
Unit of Infectious Diseases, Department of Medical Sciences, University of Turin, Turin, Italy.
J Pharm Pharmacol. 2018 Jan;70(1):143-149. doi: 10.1111/jphp.12845. Epub 2017 Oct 23.
Knowledge of the exact concentration of active compounds in galenic preparations is crucial to be able to ensure their quality and to properly administer the prescribed dose. Currently, the need for titration of extracts is still debated. Considering this, together with the absence of a standard preparation method, the aim of this study was to evaluate cannabinoids concentrations variability in galenic olive oil extracts, to evaluate the interlot and interlaboratory variability in the extraction yield and in the preparation composition.
Two hundred and one extracts (123 (61.2%) from Bedrocan , 54 (26.9%) from Bediol , 11 (5.5%) from Bedrolite , and 13 (6.5%) from mixed preparations) were analysed by liquid chromatography coupled with tandem mass spectrometry, quantifying cannabinoids (THC, CBD, THCA, CBDA and CBN) concentrations.
The RSD% of THC and CBD concentrations resulted higher than 50%. Specifically for Bedrocan , Bediol , Bedrolite (5 g/50 ml), these were THC 82%, THC 53% and CBD 91%, THC 58% and CBD 59%, respectively. The median extraction yields were greater than 75% for all preparations.
Our results highlighted a wide variability in THC and CBD concentrations that justify the need for titration and opens further questions about other pharmaceutical preparations without regulatory indication for this procedure.
了解制剂中活性化合物的确切浓度对于确保其质量和正确给予规定剂量至关重要。目前，关于提取物滴定的需求仍存在争议。考虑到这一点，以及缺乏标准的制备方法，本研究旨在评估药用橄榄油提取物中大麻素浓度的可变性，评估提取产率和制剂成分的批间和实验室间变异性。
采用液相色谱-串联质谱法对 201 种提取物（来自 Bedrocan 的 123 种（61.2%），来自 Bediol 的 54 种（26.9%），来自 Bedrolite 的 11 种（5.5%）和来自混合制剂的 13 种（6.5%））进行分析，定量测定大麻素（THC、CBD、THCA、CBDA 和 CBN）浓度。
THC 和 CBD 浓度的 RSD%高于 50%。具体来说，Bedrocan、Bediol、Bedrolite（5 g/50 ml）的 THC 分别为 82%、53%和 CBD 为 91%、58%和 59%。所有制剂的平均提取产率均大于 75%。
我们的研究结果表明 THC 和 CBD 浓度存在广泛的变异性，这证明了滴定的必要性，并对其他没有监管规定进行此程序的药物制剂提出了进一步的问题。
