CN107205960A - 大麻提取物及其制备和使用方法 - Google Patents
大麻提取物及其制备和使用方法 Download PDFInfo
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- CN107205960A CN107205960A CN201580069806.9A CN201580069806A CN107205960A CN 107205960 A CN107205960 A CN 107205960A CN 201580069806 A CN201580069806 A CN 201580069806A CN 107205960 A CN107205960 A CN 107205960A
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- extract
- hemp
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- juice
- protoplasm
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Abstract
本发明涉及植物材料药物活性成分的提取,并且更具体地涉及制备植物性药物(BDS)用于加入药剂中。还涉及用于药物制剂的BDS。具体涉及包含通过提取大麻得到的大麻素的BDS。
Description
相关申请
本申请要求享有2014年10月21日提交的美国临时申请No.62/066,795和2014年10月24日提交的美国临时申请No. 62/068,278的优先权和利益,该临时申请的内容全部通过引用并入本文。
发明领域
本发明涉及植物材料药物活性成分的提取,并且更具体地涉及包括从大麻提取所获得的大麻素的植物性药物(BDS)。还包括使用该提取物治疗慢性疼痛、麻痹、神经病、克罗恩病、IBS、青光眼、PTSD、焦虑、癫痫发作、癫痫、自身免疫性疾病、孤独症、肿瘤和癌症的方法。
发明背景
大麻产品以各种形式被服用了几千年。第一次描述医疗用途是在公元一世纪的中国草药文本中。大麻产品在草药茶调配品中口服,因其缓解疼痛和引起睡眠的性质而被使用。
目前需要提供更有效且更安全的大麻提取物用于各种医疗用途,以及提供可用于治疗疼痛和各种医学病症的独特的活性化合物的提取方法。此外,目前已知的提取过程不能提供所需的活性成分用于特定医疗目的。本发明克服了这些限制,并提供其他相关的优点。
发明概述
本发明提供了提取物,该提取物含有至少95%的总大麻素和至少一种萜烯/类黄酮的混合物。所述提取物含有至少4、5、6、7或更多种大麻素。大麻素选自四氢大麻酚酸(THCa)、大麻二酚酸(CBDa)、大麻酚酸(CBNa)大麻色烯酸(CBCa)、四氢大麻酚(THC)、大麻酚(CBN)、大麻二酚(CBD)或大麻色烯(CBC)。在一些方面,大麻素是THCa和CBDa和至少两种选自CBNa、CBCa、THC、CBN和CBC的大麻素。在优选的实施方案中,所述大麻素是THC、CBN、CBC和CBD。在另一优选的实施方案中,所述大麻素是THCa、CBDa、CBNa和CBCa。在另一优选的实施方案中,所述大麻素是THCa、CBDa、THC、CBN和CBC。
萜烯/类黄酮例如为d-柠檬烯芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、β-月桂烯或β-丁子香烯、cannflavin A、芹菜素、槲皮素或胡薄荷酮。
本发明还提供了含有本发明提取物的制剂。例如,所述制剂含有用中链甘油三酯(MCT)浸泡的本发明的任何提取物。MCT例如NEOBEE 895。
优选地,所述制剂的pH为至少pH8.0。
在一些制剂中,浓度为:THCa大于或等于95%;CBDa小于1%;CBNa小于3%;CBCa小于1%。任选地,该制剂还含有d-柠檬烯、芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
在其他制剂中,浓度为:THCa小于或等于35%;CBDa大于或等于60%;THC小于1%;CBN小于1%;CBC小于1%。任选地,该制剂还含有d-柠檬烯、芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
在另一制剂中,浓度为:THCa大于或等于40%;CBDa大于或等于40%;THC小于1%;CBN小于1%;CBC小于1%。任选地,该制剂还含有β-月桂烯、β-丁子香烯、胡薄荷酮、α-松油醇、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
在又一种制剂中,浓度为:THC小于或等于9%;CBD大于或等于40%;CBN大于或等于40%;CBS小于1%。任选地,该制剂还含有β-月桂烯、β-丁子香烯、胡薄荷酮、α-松油醇、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
在不同方面,本发明的制剂被配制用于口服、舌下、含服或局部给药。舌下制剂进一步含有甜味剂,如甜菊提取物。任选地,舌下制剂进一步含有柠檬油、橙油或两者。
在其他方面,本发明提供了制备大麻提取物的方法,提供新鲜的或活的大麻植物材料;从该植物材料提取大麻素以产生第一提取物;冬化和清洗冬化提取物。任选地,该方法还包括提取前将植物大麻素脱羧。例如通过在约221℉的温度加热干燥的植物材料至少15分钟,接着在约284℉加热至少45分钟完成所述脱羧。在一些方面中,所述冬化提取物在284℉加热约45-74分钟,然后在约293℉加热至少约55-90分钟。
提取例如通过烃提取进行。冬化包括加冷乙醇到第一提取物或在约-20℉至约-75℉的温度存储所述第一提取物约48小时以产生蜡质沉淀并通过过滤去除蜡质沉淀。任选地,所述冬化提取物通过活性炭过滤。
所述大麻植物材料由花或花和叶组成。在一些方面中,将大麻植物材料在至少-10℉至-50℉的温度下冷冻至少36小时,然后提取。优选地,所述大麻植物材料已经从单一种子来源或具有特定比率的大麻素的组织培养物繁殖。在一些方面中,大麻植物材料得自具有最少15%THC和小于1%的CBD的大麻品系。在其他方面,所述大麻植物材料得自SourTsunami x Catatonic Sour Tsunami x Sour Tsunami, Sour Tsunami, Harlequin, R4ACDC品系。在其他方面,所述大麻植物材料得自CBD1, Sour Pineapple, CBD Diesel,Harlequin, ACDC或R4。在其他方面中,所述大麻植物材料得自Sour Tsunami xCatatonic, Sour Tsunami x Sour Tsunami, Sour Tsunami, Harlequin, R4, SwissGold, ACDC, CBD1, Sour Pineapple或CBD Diesel。
本发明还提供了制备大麻汁液的方法,该方法通过将得自营养阶段的大麻植物的新鲜大麻叶在冷水中漂白;在冷压榨汁机或撕捏榨汁机中将叶榨汁;和将汁液过滤通过过滤器以除去微粒。任选地,将过滤的汁液冷冻干燥。
榨汁机是例如冷压榨汁机或撕捏榨汁机。本发明还包括根据本发明的方法生产的汁液。在一些实施方案中,大麻汁液得自大麻花、大麻根或两者。
本发明还提供缓解与焦虑、创伤后应激障碍、慢性疼痛、或阿片依赖、麻痹、神经病、克罗恩病、炎性肠疾病、青光眼、癫痫发作、癫痫、孤独症或癌症相关的症状的方法,包括向有需要的受试者给予一种或多种本发明的制剂或汁液。制剂每天给药四次。例如,所述制剂在早晨、下午、晚上以及就寝时给药。
在特定的实施方案中,本发明提供治疗癌症的方法,通过给予受试者以下的总日剂量:20mg大麻素提取物和50mg原质大麻汁液7天;40mg大麻素提取物和50mg原质大麻汁液7天;80mg大麻素提取物和50mg原质大麻汁液7天;120mg大麻素提取物和50mg原质大麻汁液7天;和160mg大麻素提取物和100mg原质大麻汁液7天。在一些方面中,所述方法还包括给予总日剂量为200mg大麻素提取物和之后每天100mg原质大麻汁液或给予200mg大麻素提取物和100mg原质大麻汁液7天;和400mg大麻素提取物和之后每天100mg原质大麻汁液。
在另一实施方案中,本发明提供治疗阿片样物质依赖的方法,通过减少每天使用的阿片剂的量至少10%并给予受试者以下的总日剂量:31mg大麻素提取物和50mg原质大麻14天;56mg大麻素提取物和50mg原质大麻14天;84mg大麻素提取物和50mg原质大麻汁液14天;104mg大麻素提取物和50mg原质大麻14天;89mg大麻素提取物和50mg原质大麻14天;69mg大麻素提取物和50mg原质大麻14天;49mg大麻素提取物和50mg原质大麻14天;41mg大麻素提取物和50mg原质大麻14天。
任选地,该方法还包括给予总日剂量为36mg大麻素提取物和之后每天25mg原质大麻和每三天单剂量50mg原质大麻。
在另一实施方案中,本发明提供治疗焦虑/PTSD的方法,通过给予受试者总日剂量为约28mg-42mg的大麻素提取物。
在另一实施方案中,本发明包括治疗慢性疼痛的方法,通过给予受试者总日剂量为约36mg-48mg的大麻素提取物。
该制剂每天给药四次。例如,所述制剂在早晨、下午、晚上以及就寝时给药。
本发明的其他特征和优点将由于下面的详细描述和权利要求书而显而易见并且被下面的详细描述和权利要求书涵盖。
详细描述
本发明部分基于允许选择性地利用来自全大麻植物的各种大麻素分子和萜烯的提取方法和递送途径。这些不同的大麻素化合物被设计用于选择性地影响神经系统、免疫系统和其他组织的不同大麻素受体。该提取物是基于油的全植物产品,含有大麻植物中包含的惰性和活性化合物,例如大麻素、萜烯和/或黄酮。本发明的组合物和这里公开的提取方法提供具有通过单独路径和受体介导的特定的生理性质的提取物,提供许多益处和优点。
本发明所述提取物和/或递送方法允许对患者进行宽范围的预防、治疗和管理选项。在一些方面中,本发明所述递送方法采用微量给药,利用迭加方法,逐周地给予大麻素,直至达到基于响应、重量和每月-每季测试结果的某个饱和点。
令人惊奇的是,发现年龄或大麻植物材料、其存储和加工的温度是关键的,并且特定大麻素提取物的比例对于最终制剂的有效性是关键的。重要的是,为了使提取物维持非精神活性性质,大麻植物材料从不加热至高于160℉。优选地,根据本发明的非精神活性提取物在110℉或更低温度被配制。
大麻是显花植物类,包括三个不同的种:大麻(Cannabis sativa)、印度大麻(Cannabis indica)和Cannabis ruderalis。术语"大麻植物"包含野生型的大麻和其变体,包括大麻化学型,其天然含有不同量的单独的大麻素。例如,一些大麻品系已繁殖产生最低水平的THC,THC是导致与其相关联的高精神活性的主要精神活性成分,其他品系已选择性地繁殖以产生高水平的THC和其他精神活性大麻素。
大麻植物产生独特系列的萜烯酚化合物,称为大麻素,其产生个体由消费大麻而体验的“兴奋感”。已知483种可确认的化学成分存在于大麻植物中,至少85种不同的大麻素已经从植物分离。通常以最大丰度产生的两种大麻素是大麻二酚(CBD)和/或Δ9-四氢大麻酚(THC),但只有THC是具有精神活性的。大麻植物基于产生的THC的总量和THC与CBD的比率,通过它们的化学表型或“化学型”分类。尽管总的大麻素生产受环境因素的影响,THC/CBD比是遗传确定的,在植物的整个生命期间保持固定。非药物植物产生较低水平的THC和高水平的CBD,而药物植物产生高水平的THC和低水平的CBD。
被最佳研究的大麻素包括四氢大麻酚(THC)、大麻二酚(CBD)和大麻酚(CBN)。其他大麻素包括例如大麻色烯(CBC)、大麻萜酚(CBG)、cannabinidiol(CBND)、大麻环酚(CBL)、次大麻酚(CBV)、四氢次大麻酚(THCV)、次大麻二酚(CBDV)、次大麻色烯(Cannabichromevarin) (CBCV)、次大麻萜酚(Cannabigerovarin) (CBGV)、大麻萜酚单甲基醚(CBGM)。
大麻素是从其相应的2-羧酸(2-COOH)通过脱羧(热、光或碱性条件催化)衍生的。作为一般的规则,大麻素的羧酸形式具有生物合成前体的功能。
如在此所使用的THC、CBD、CBN、CBC、CBG、CBND、CBL、CBV、THCV、CBDV、CBCV,CBGV和CBGM指大麻素的脱羧形式。而THCa、CBDa、CBNa、CBCa、CBGa、CBNDa、CBLa、CBVa、THCVa、CBDVa、CBCVa、CBGVa和CBGM指大麻素的酸形式。
四氢大麻酚(THC)是大麻植物主要的精神活性组分。THC仅在其脱羧状态是精神活性的。羧酸形式(THCa)为非精神活性的。
Δ-9-四氢大麻酚(Δ9-THC,THC)和Δ-8-四氢大麻酚(Δ8-THC)模拟身体自然产生的神经递质花生四烯乙醇胺的作用。这两种THC通过结合脑中CB1大麻素受体产生与大麻相关的作用。THC显示缓解中度疼痛(镇痛),具有神经保护作用,同时还提供减少神经炎症和刺激神经发生的可能。THC对CB1受体和CB2受体具有大约相等的亲和力。
大麻二酚(CBD)不是精神活性的,并且被认为不影响THC的精神活性。然而,最近的证据表明,具有较高CBD/THC比的大麻的吸食者较少可能经历类似精神分裂症的症状。[15]这由精神测试所支持,其中当静脉THC与CBD共同给药时,参与者经历较不强烈的类似精神病的作用(如PANSS测试所测定的)。大麻二酚对CB1受体和CB2受体几乎没有亲和力,但作为大麻素激动剂的间接拮抗剂起效。近来,发现其为推测的新的大麻素受体GPR55的拮抗剂,GPR55是在尾状核和壳中表达的GPCR。大麻二酚也已经表明可用作5-HT1A受体激动剂,在其抗抑郁、抗焦虑和神经保护效果中涉及该作用。
它显示缓解惊厥、炎症、焦虑和恶心。CBD对于CB2受体具有比对于CB1受体更大的亲合力。CBD具有与THC共同的前体,是低THC大麻品系中主要的大麻素。CBD在防止哺乳动物与THC相关短期记忆丧失中明显具有作用。
大麻酚(CBN)是THC降解的主要产物,通常在新鲜植物中几乎没有CBN。CBN含量随着存储中THC降解而增加,且随着暴露于光和空气而增加。其仅有轻微精神活性。其与CB2受体的亲和力高于对CB1受体的亲和力。
大麻萜酚(CBG)为非拟精神病的,但仍然影响大麻的总体作用。它作为α2-肾上腺素能受体激动剂,5-HT1A受体拮抗剂和CB1受体拮抗剂。[31]它还结合到CB2受体[31]。
四氢次大麻酚(THCV)普遍存在于大麻的某些中亚和南非品系。其为CB1受体的THC拮抗剂,减轻THC的精神活性作用。
次大麻二酚(CBDV)通常为大麻素分布的次要成分。
大麻色烯(CBC)是非精神活性的,不影响THC的精神活性。在热带大麻品种中更常见。效果包括抗炎和镇痛。
除了大麻素,大麻植物还产生萜烯,其为不同类的有机烃,是大麻素的构成单元。
在大麻植物中已经确定了超过100种不同的萜烯,每一品系趋向于独特的萜烯类型和组成。萜烯与大麻素协同作用以提供治疗效果。大麻中发现的一些常见萜烯的例子包括:
莰醇-薄荷醇、樟脑、松木、木质。可以很容易地转化成薄荷醇。它被认为是中药中的“镇静剂”。它针对疲劳、疾病恢复和压力。
丁子香烯-辣、甜、木质、丁香、樟脑、辛辣。其与CB2受体弱结合。局部使用时,其是牙痛的抗炎和镇痛治疗的成分之一。大量使用时,其是钙和钾离子通道阻断剂。因此,它阻止心肌施加的压力。
桉叶素/桉叶醇-辣、樟脑、提神、薄荷味。它用来增加循环、缓解疼痛且容易穿过血脑屏障触发快速嗅觉反应。
Δ3蒈烯-甜、松、雪松、木质、刺激性。在芳香疗法中,柏木油富含D-3-蒈烯,用于干燥过量的流体、泪液、流鼻涕、过量月经和汗液。
柠檬烯-柑橘(橙子、橘子、柠檬和葡萄柚)、迷迭香、杜松、薄荷。排斥食肉动物。可在许多果实的皮和花中发现。在其他某些萜烯存在的情况下,柠檬烯可以抗菌、抗真菌、抗抑郁和抗致癌物质。它能够通过快速穿透细胞膜协同促进其他萜烯的吸收。结果可以是增加心脏收缩血压。
芳樟醇-花(春花)、百合、柑橘和蜜饯香料。具有抗焦虑和镇静性质。
月桂烯-丁香类、土质、绿色-植物性、柑橘、果味,具有热带芒果和薄荷香调。在大多数种类的大麻中发现的最普遍的萜烯。它是薄荷醇、香茅和香叶醇的构成单元。它具有抗微生物、抗菌、镇痛、抗氧化、抗致癌物、抗抑郁、抗炎和肌肉松弛效果。月桂烯影响细胞膜的渗透性,从而允许更多的THC到达脑细胞。
蒎烯-α:松针、迷迭香β:莳萝、欧芹、迷迭香、罗勒、洋蓍草、玫瑰、啤酒花,与松树和它们的树脂相关的熟悉的气味。蒎烯可以提高精神集中和能量,以及作为祛痰剂、支气管扩张剂和局部防腐剂。它容易穿过血脑屏障,在此抑制乙酰胆碱酯酶(乙酰胆碱酯酶破坏信息转移分子乙酰胆碱)活性,导致更好的记忆。它可以抵消THC的活性,THC的活性导致低的乙酰胆碱水平。
胡薄荷酮-薄荷、樟脑、迷迭香、糖果。胡薄荷酮是乙酰胆碱酯酶抑制剂。即,它阻止破坏乙酰胆碱的蛋白质的作用,乙酰胆碱被大脑用于存储记忆。
在各个方面,本发明提供了具有预定的大麻素比率的大麻提取物。用于大麻素分析的标准条件和计算大麻素含量(%)的方法在本领域中是众所周知的。
所述提取物是至少95%总大麻素的混合物,并且包括萜烯和/或黄酮。优选地,该提取物含有至少四种大麻素的混合物,例如四氢大麻酚酸(THCa)、大麻二酚酸(CBDa)、大麻酚酸(CBNa)大麻色烯酸(CBCa)、四氢大麻酚(THC)、大麻酚(CBN)、大麻二酚(CBD)和大麻色烯(CBC)。
在一些实施方案中,该提取物含有THCa和CBDa和至少两种选自CBNa、CBCa、THC、CBN和CBC的大麻素。在其他实施方案中,所述提取物包括THC、CBN、CBC和CBD。在进一步的实施方案中,所述提取物包括THCa、CBDa、CBNa和CBCa。在其他实施方案中,该提取物包括THCa、CBDa、THC、CBN和CBC。
提取物中的萜烯和/或黄酮包括例如,萜烯是芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、β-月桂烯、β-丁子香烯、d-柠檬烯、cannflavin A、芹菜素、槲皮素或胡薄荷酮。
本发明的提取物可用一种或多种药学上可接受的载体、稀释剂或赋形剂配制,或沉积在药学上可接受的表面上用于蒸发,以产生含有大麻素作为药物活性剂的药物制剂。
因此,在又一方面,本发明提供了制备药物组合物的方法,该药物组合物包含作为活性剂的物质,其为至少一种大麻植物品种的提取物。
单独的提取物可以从具有不同大麻素含量的单一大麻植物品种(例如高THC植物和高CBD植物)制备,然后混合或共混在一起,再配制产生最终的药物组合物。如果例如需要在最终制剂中获得限定的重量比的各大麻素,该方法是优选的。或者,来自一种或多种大麻植物品种的限定大麻素含量的植物材料可被混合在一起,再提取具有所需大麻素含量的单一植物性药物,然后可将其配制成最终的药物组合物。
该提取物可与任何便利的药学上可接受的稀释剂、载体或赋形剂配制以产生药物组合物。稀释剂、载体或赋形剂的选择将取决于所需的剂型,其又可取决于预期的用于患者的给药途径。优选的剂型包括用于通过泵作用或气雾剂喷雾给药的液体剂型、片剂、锭剂、凝胶、胶囊、栓剂、粉剂等和蒸发器。这样的剂型可根据本领域技术人员所熟知的标准的药物制剂原理制备。
特别优选液体制剂。不意欲限制本发明,特别优选的用于给予大麻素的制剂是用中链甘油三酯(MCT)浸泡的本发明提取物的液体制剂。MCT适于人服用。MCT可以由C-6;C-8;C-10:C12脂肪酸的任何组合组成。例如,MCT由97%∶3%的C-8:C10;C12脂肪酸组成(例如NEOBEE 895)。所述制剂的pH优选为至少pH8.0。所述制剂适于口服、舌下给药、含服给药或局部给药。当用于舌下给药时,所述制剂任选地包含甜味剂如甜菊提取物和或调味剂如柠檬油、橙油或两者。
优选的制剂包括大麻素混合物,其中THCa大于或等于95%;CBDa小于1%;CBNa小于3%;CBCa小于1%。在一些方面中,所述制剂还含有d-柠檬烯、芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、cannflavin A、芹菜素和槲皮素。该优选的制剂在本文中被称为PRANA 1。
另一种优选的制剂包括大麻素混合物,其中THCa小于或等于35%;CBDa大于或等于60%;THC小于1%;CBN小于1%;CBC小于1%。在一些方面中,所述制剂还含有d-柠檬烯、芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、cannflavin A、芹菜素和槲皮素。该优选的制剂在本文中被称为PRANA 2。
在另一优选的实施方案中,所述制剂包括大麻素混合物,其中THCa大于或等于40%;CBDa大于或等于40%;THC小于1%;CBN小于1%;CBC小于1%。在一些方面中,所述制剂还包括β-月桂烯、β-丁子香烯、胡薄荷酮、α-松油醇、β-谷甾醇、cannflavin A、芹菜素和槲皮素。该优选的制剂在本文中被称为PRANA 3。
在另一实施方案中,该制剂包括大麻素混合物,其中THC小于或等于9%;CBD大于或等于40%;CBN大于或等于40%;CBS小于1%。在一些方面中,所述制剂还包括β-月桂烯、β-丁子香烯、胡薄荷酮、α-松油醇、β-谷甾醇、cannflavin A、芹菜素和槲皮素。该优选的制剂在本文中被称为PRANA 4。
提取物被配制为用于口服使用(例如胶囊)的剂型,提供每剂量5 mg、10 mg、20 mg或50 mg总大麻素。对于舌下应用,所述提取物配制成提供每滴0.5、1 mg或2 mg。
在一些应用中,患者可能发现有利的是活化(即脱羧)本发明的提取物和制剂中惰性(即羧酸形式)的大麻素。本发明的提取物和制剂的惰性大麻素(例如,THCa和CBDa)可通过在高于160℉的温度加热提取物和制剂而转化成活性大麻素(THC和CBD)。例如,将含有本发明的提取物和制剂的容器置于沸水(212℉)中约30分钟。
本发明还涵盖具有与PRANA 1、PRANA 2和PRANA 3相同比例的大麻素的提取物及其制剂,其中THA和CBD处于其活化的脱羧形式。
本发明的方法可用于从大麻植物材料制备富含大麻素的提取物。所述方法包括提供新鲜的或活的大麻植物材料;从新鲜或活的植物材料提取大麻素以产生第一提取物;冬化所述第一提取物以产生冬化提取物,和清洗冬化提取物以产生大麻提取物。任选地,该方法包括在提取步骤之前将植物大麻素脱羧。
大麻素酸的脱羧依时间和温度而变,因而在较高的温度下将花费较短的时间使给定量的大麻素酸完全脱羧。但在选择适当的条件进行脱羧时,必须考虑使需要的药理学大麻素变为不需要的降解产物的热降解、特别是THC变为大麻酚(CBN)的热降解最小化。优选地,脱羧在多步加热过程中进行。例如,植物大麻素例如通过在约221℉的温度加热干燥的植物材料至少15分钟,接着在约284℉加热至少45分钟而脱羧。可以使用本领域中已知的将植物大麻素脱羧的其他适合的方法。
在一些方面中,得到的大麻提取物在284℉下加热约45-74分钟,然后在约293℉加热至少约55-90分钟。
所述大麻植物材料由花或花和叶组成。优选地,所述大麻植物材料在至少-10℉至-50℉的温度下冷冻至少36小时,然后干燥。
所述大麻植物材料已经从单一种子来源或具有特定比率的大麻素的组织培养物或无性系繁殖。
可以使用本领域已知的任何合适的提取方法。例如提取为烃提取、超临界CO2或NEOBEE 896 MCT。
第一提取物可以通过本领域已知的任何方法冬化。例如,所述第一提取物通过包括加入冷乙醇冬化或者通过将第一提取物存储在约-20℉至约-75℉的温度约48小时冬化。冬化产生蜡质沉淀。通过过滤除去蜡质沉淀。任选地,使冬化提取物通过活性炭。
在一些方面中,大麻植物材料得自具有最少15% THC和小于1% CBD的大麻品系。在其他方面中,所述大麻植物材料得自具有最少10% CBD和小于10% THC的大麻品系。例如,所述大麻植物材料得自Sour Tsunami x Catatonic Sour Tsunami x Sour Tsunami, SourTsunami, Harlequin, R4或ACDC品系。在其他实施方案中,所述大麻植物材料得自CBD1,Sour Pineapple, CBD Diesel, Harlequin, ACDC或R4。在另一实施方案中,所述大麻植物材料得自Sour Tsunami x Catatonic, Sour Tsunami x Sour Tsunami, Sour Tsunami,Harlequin, R4, Swiss Gold, ACDC, CBD1, Sour Pineapple, 或CBD Diesel。
本发明还提供制备大麻汁液的方法,包括将得自营养阶段的大麻植物的新鲜大麻叶在冷水中漂白;在冷压榨汁机或撕捏榨汁机中将叶榨汁;和将汁液过滤通过过滤器以除去微粒。任选地,将汁液冷冻干燥。榨汁机是冷压榨汁机或撕捏榨汁机。在一些方面中,所述汁液还包括得自大麻花、大麻根或两者的大麻汁液。
原质大麻的汁液提供独特的治疗益处。已知为大麻素酸的植物化学物质例如CBD-酸和THC-酸在收获后很快分解,所以这些化合物在传统的制剂如煮制‘药学食用大麻(medibles)’、吸食或蒸发中不可用。大麻素-酸的治疗益处只在该化学物质分解前存在很短的一段时间,因此需要在收获后快速进行榨汁。扇叶应该构成汁液的大部分,加入少量的大麻花可能是有益的。
大麻提取物和汁液对于许多医疗病症具有广泛的有益效果。
慢性疼痛、麻痹、神经病、克罗恩病、炎性肠病(IBS和IBD)、青光眼、PTSD、焦虑、癫痫发作、癫痫、自身免疫性疾病、孤独症、肿瘤和癌症都已经由几项研究显示可通过使用大麻控制。此外,已经显示通过使用大麻有助于不响应其他药物的恶心和呕吐。也已经显示通过使用大麻可控制对阿片剂的依赖。
因此,本发明还包括减轻与焦虑、创伤后应激障碍、慢性疼痛、或阿片依赖性、麻痹、神经病、克罗恩病、炎性肠疾病、青光眼、癫痫发作、癫痫、孤独症或癌症相关的症状的方法,包括给予受试者任何一种本发明的制剂。在一些实施方案中,受试者接受含有大麻提取物的制剂和汁液形式的原质大麻两者。
在一些实施方案中,所述制剂每日给药四次。例如,所述制剂在早晨、下午、晚上以及就寝时给药。给予该制剂使得大麻素的比率依日内给药时刻而不同。例如,含有较低量的THC(和较高量的THCa)的制剂在日内醒着的时间给予。而含有较高量的THC(和较低量的THCa)的制剂在就寝前给予。示例性的白天给予的制剂包括其中THCa大于或等于95%;CBDa小于1%;CBNa小于3%;且CBCa小于1%的大麻素混合物;其中THCa小于或等于35%;CBDa大于或等于60%;THC小于1%;CBN小于1%;且CBC小于1%的大麻素混合物;或其中THCa大于或等于40%;CBDa大于或等于40%;THC小于1%;CBN小于1%;且CBC小于1%的大麻素混合物。示例性的就寝给予的制剂包括其中THC小于或等于9%;CBD大于或等于40%;CBN大于或等于40%;且CBS小于1%的大麻素混合物。
优选地,在早晨给予包括大麻素混合物的制剂,该大麻素混合物中THCa大于或等于95%;CBDa小于1%;CBNa小于3%;且CBCa小于1%。优选地,在下午给予大麻素混合物,其中THCa小于或等于35%;CBDa大于或等于60%;THC小于1%;CBN小于1%;且CBC小于1%。优选地,在晚上给予大麻素混合物,其中THCa大于或等于40%;CBDa大于或等于40%;THC小于1%;CBN小于1%;且CBC小于1%。
在不同的方面中,本发明的方法包括通过采用递增给药方案给予含大麻素的化合物,其中大麻素的总量随时间增加。例如,给予的大麻素的量逐周增加,直至达到基于响应、重量和每月-每季测试结果的某个饱和点。为了治疗阿片样物质依赖,逐渐用大麻素代替阿片剂。
在优选的方法中,通过给予受试者以下的总日剂量治疗癌症:
a. 20 mg大麻素提取物和50 mg原质大麻汁液7天;
b. 40 mg大麻素提取物和50 mg原质大麻汁液7天;
c. 80 mg大麻素提取物和50 mg原质大麻汁液7天;
d. 120 mg大麻素提取物和50 mg原质大麻汁液7天;和
e. 160 mg大麻素提取物和100 mg原质大麻汁液7天。
在一些实施方案中,通过给予受试者总日剂量200mg大麻素提取物和之后每天100mg原质大麻汁液,遵循这种给药方案。在另一实施方案中,通过给予受试者200mg大麻素提取物和100mg原质大麻汁液7天;和之后每天400mg大麻素提取物和100mg原质大麻汁液,遵循这种给药方案。
实施例
实施例1:大麻的制备&存储
新鲜的大麻植物材料(花/花叶)是收获自从来自亲本植物的插条繁殖的植物,所述亲本植物源自单一种子来源或具有特定起始比率的大麻素的组织培养物。
大麻植物材料(花/花叶)在收获后立即储存在新鲜冷冻状态。
优选地,所述植物材料在-10℉至-50℉的温度快速冷冻10分钟。植物材料在提取之前存储在真空密封袋中最少36小时。起始大麻植物材料以90%的大麻素和/或植物大麻素浓缩形式进行提取。
实施例2:惰性大麻素的提取
在快速冷冻状态存储的大麻花(参见实施例1)在风干筛网上轻轻散布开,同时仍处于冷冻状态。将新鲜冷冻的植物材料在160u - 220u的筛网上轻轻地破碎和散布成小于0.7英寸的小尺寸的碎片以便空气干燥。
将植物材料(惰性的植物物质)放入闭环烃提取机如Emotek Obe Dos内的不锈钢圆筒,或满足这些特定要求的等同的超临界CO2提取设备/方法。
在-20℉至-75℉的温度下,使液态烃(99%)通过产品并保持在压力(45磅的压力)下约45分钟。
将所得材料冬化以除去惰性蜡质材料。通过施加二次气体到液体烃;滤出的冷乙醇洗液,或通过将提取物溶液存储在-20℉至-75℉约48小时完成冬化。产生的蜡质沉淀通过经20微米膜过滤而除去,并通过活性炭。
最后,将提取物在真空加压单元Across International Digital Vacuum DryingOven(Across International数字真空干燥箱)下用溶剂额定的回收泵以min 1/2 hp 3425rip无油压缩机清洗约48小时。
最终的产物被除去并且存储在琥珀色玻璃存储容器中避免光照,且存储在低于40℉的温度直到需要用于配制产品。
实施例3:活性大麻素的提取
将大麻花如实施例2所述进行空气干燥。一旦大麻花被空气干燥,将大麻植物材料放入科学无菌密闭箱于221℉保持15分钟,再于284℉保持45分钟。该方法按顺序将植物大麻素脱羧。一旦已经将大麻植物材料脱羧,提取其活性物。
将新鲜的大麻植物材料(活性的植物材料)放入闭环烃提取机内的不锈钢圆筒,在-20℉至-75℉的温度下,使液态烃(99%)通过产品并保持在压力(45磅的压力)下约45分钟。
将所得材料冬化以除去惰性蜡质材料。通过施加二次气体到液体烃;滤出的冷乙醇洗液,或通过将提取物溶液存储在-20℉至-75℉约48小时完成冬化。产生的蜡质沉淀通过经20微米膜过滤而除去,并通过活性炭。
最后,将提取物在真空加压单元Across International Digital Vacuum DryingOven(Across International数字真空干燥箱)下用溶剂额定的回收泵以min 1/2 hp 3425rip无油压缩机清洗约48小时。
所得脱羧的CBD∶THC油通过将该油在284℉加热45-75分钟,在293℉的第二温度加热55min-90min,转化为CBD∶CBN(定义为>90%的CBD∶THC)油。
最终的产物被除去并且存储在琥珀色玻璃存储容器中避免光照,且存储在低于40℉的温度直到需要用于配制产品。
实施例3:使用NEOBEE 895 MCT提取
起始原料为干燥的大麻花、花松香、印度大麻松香、印度大麻制剂或麻醉品,具有的特定起始大麻素比率为1:1、2:1、3:1、4:1、8:1、18:1、20:1、30:1、50:1、70:1。大麻花应该干燥至水分含量低于3%,轻轻破碎成小于0.7英寸的小尺寸的碎片,或细磨成2mm-3mm大小的碎片。将大麻花、花松香、印度大麻松香、印度大麻制剂或麻醉品与NEOBEE 895 MCT组合。基于起始材料、测试结果、比率和所需的毫克/毫升的结果确定大麻与MCT的比率。实施例50g的20%大麻花与100ml的MCT油组合。MCT油和起始大麻材料一起在泡煮器中、双层蒸锅中或热板上在41摄氏度/106华氏度下加热最少3小时以提取和浸泡所需的大麻素到MCT油中。所述油被滤过15微米不锈钢过滤器或丝网以便将大麻内容物与油分离。利用真空下布氏漏斗和5微米过滤系统将提供最佳过滤结果。将浸泡的大麻内容物挤压以除去所有剩余的油,过滤,加回到浓缩的浸泡的THCa和/或CBDa NEOBEE 895 MCT混合物。该初始混合物被认为是惰性状态,因为大麻素仍然处于THCa和/或CBDa的酸形式。浸泡的大麻和NEOBEE 895 MCT油可在105摄氏度/221华氏度加热15分钟,并在140摄氏度/284华氏度重复45min-120min,以便将植物大麻素活化成THC和/或CBD。脱羧大麻花、花松香、印度大麻松香、印度大麻制剂或麻醉品THC或CBN也可以组合至NEOBEE 895 MCT并一起在41摄氏度/106华氏度加热最少3小时,以便将活性内容物浸泡到MCT油中。该方法用于产生具有特定比率和毫克/毫升剂量的所有产品,用于胶囊、舌下制剂、局部制剂、经皮制剂等。
实施例4:花&印度大麻松香提取
大麻花风干至水分低于10%。一旦大麻花被风干,将大麻植物材料放入不锈钢或尼龙丝网套中,微米等级的范围包括15u,25u,90u和120u。所需的微米等级的使用是基于起始材料花vs仅称为泡沫印度大麻或麻醉品的分离的毛状体头。这些套中的花、印度大麻或麻醉品被置于PTFE 3x flourmer涂布的片或者非粘羊皮纸之间。所述片的宽度是尼龙或不锈钢网的至少2倍,以收集提取的大麻素油和树脂。使用机械热印压机,最小压力为2500 psi,在100-300度施加热,持续4秒至3分钟,这取决于所需的结果。此过程机械地分离具有THCa、THC、CBDa、CBD、CBGa、CBG、CBN、CBL浓度的原质大麻花中存在的大麻素和萜烯。树脂从PTFE或非粘羊皮纸收集,称重,并于32华氏度或更低的温度存储在塑料密封袋或派热克斯玻璃中。这种类型的机械分离的大麻树脂和提取物随后与NEOBEE 895 MCT组合得到所需制剂、比率和浓度,用于在此文件中描述的各种递送方法,即胶囊、局部、经皮、舌下递送。
实施例5:原质大麻素的制备
具有高CBD含量的植物对于榨汁是最好的,因为它们含有比非-CBD生产品系更多的CBD-酸。
方法:
1.我们只在营养阶段而不在开花期间移除新鲜大麻叶。
2.叶在冷水中漂白净化。
3.然后使用冷压榨汁机或市售撕捏榨汁机将叶榨汁。
4.汁液过滤通过不锈钢过滤器以除去任何微粒。
5.汁液立即倒入1 oz容器或10 oz容器并在-50华氏度冷冻干燥。
6.冷冻干燥的大麻汁液可用于胶囊形式、袋包或浸泡医疗食品。
实施例6:大麻提取物的制剂
将1克上述方法生产的大麻油与最少95%总大麻素浓度每40ml的NEOBEE 895在低于90℉但不低于70℉的温度在没有暴露于光的情况下混合约24小时。所得浸剂与NEOBEE 895混合产生5mg、10mg、20mg和50mg总大麻素的胶囊。对于舌下制剂,将0.5g或350 mg所得浸剂与9ml的NEOBEE 895和1ml的天然甜味剂和调味添加剂(甜菊、truvia、xyotol、柠檬、橙)组合。
实施例7:用于癌症/肿瘤治疗和管理的示例性迭加方案
第1周
早晨:
+加入到苹果汁、超级冰沙或抗炎汁液饮料的新鲜冷冻原质大麻汁液(50mg原质)或粉末原质大麻汁液的冷冻的1/4盎司专利共混物。
+ 5mg Prana P1胶囊
下午:
+ 5mg Prana P2胶囊
晚餐:
+ 5mg Prana P3胶囊
就寝时: (30min前)
+ 5mg Prana P4胶囊
每天吸收的总大麻素:20mg + 50mg原质
第2周
早晨:
+ 加入到苹果汁、超级冰沙或抗炎汁液饮料的新鲜冷冻原质大麻汁液(50mg原质)或粉末原质大麻汁液的冷冻的1/4盎司专利共混物。
+ 10mg Prana P1胶囊
下午:
+ 10mg Prana P2胶囊
晚餐:
+ 10mg Prana P3胶囊
就寝时: (30min前)
+ 10mg Prana P4胶囊
每天吸收的总大麻素: 40mg + 50mg原质
第3周(最小维持剂量)
早晨:
+ 加入到苹果汁、超级冰沙或抗炎汁液饮料的新鲜冷冻原质大麻汁液(50mg原质)或粉末原质大麻汁液的冷冻的1/4盎司专利共混物。
+ 20mg Prana P1胶囊
下午:
+ 20mg Prana P2胶囊
晚餐:
+ 20mg Prana P3胶囊
就寝时: (30min前)
+ 20mg Prana P4胶囊
每天吸收的总大麻素: 80mg + 50mg原质
第4周
早晨:
+ 加入到苹果汁、超级冰沙或抗炎汁液饮料的新鲜冷冻原质大麻汁液(50mg原质)或粉末原质大麻汁液的冷冻的1/4盎司专利共混物。
+ 30mg Prana P1胶囊
下午:
+ 30mg Prana P2胶囊
晚餐:
+ 30mg Prana P3胶囊
就寝时: (30min前)
+ 30mg Prana P4胶囊
每天吸收的总大麻素: 120mg + 50mg原质
第5周
早晨:
+加入到苹果汁、超级冰沙或抗炎汁液饮料的新鲜冷冻原质大麻汁液(100mg原质)或粉末原质大麻汁液的冷冻的0.5盎司专利共混物。
+ 40mg Prana P1胶囊
下午:
+ 40mg Prana P2胶囊
晚餐:
+ 40mg Prana P3胶囊
就寝时: (30min前)
+ 40mg Prana P4胶囊
每天吸收的总大麻素: 160mg + 100mg原质
第6周(后期的维持剂量)
早晨:
+加入到苹果汁、超级冰沙或抗炎汁液饮料的新鲜冷冻原质大麻汁液(100mg原质)或粉末原质大麻汁液的冷冻的0.5盎司专利共混物。
+ 50mg Prana P1胶囊
下午:
+ 50mg Prana P2胶囊
晚餐:
+ 50mg Prana P3胶囊
就寝时: (30min前)
+ 50mg Prana P4胶囊
每天吸收的总大麻素: 200mg + 100mg原质
第7周-第12周(后期阶段)
早晨:
+加入到苹果汁、超级冰沙或抗炎汁液饮料的新鲜冷冻原质大麻汁液(100mg原质)或粉末原质大麻汁液的冷冻的0.5盎司专利共混物。
+ 100mg Prana P1胶囊
下午:
+ 100mg Prana P2胶囊
晚餐:
+ 100mg Prana P3胶囊
就寝时: (30min前)
+ 100mg Prana P4胶囊
实施例7:用于焦虑/ PTSD的示例性方案
早晨
+ 5mg - 10mg Prana P2 CBD AM胶囊 (2:1至3:1,THC:CBD)
+ 2mg至4mg Prana P4 CBD:CBN 舌下 (1:1)
下午:
+ 2mg至4mg Prana P4 CBD:CBN 舌下 (1:1)
全天内当感到焦虑或PSTD时使用。
晚餐后:
+ 5mg - 10mg Prana P3 CBD PM胶囊 (2:1至1:1,THCa:CBDa)
+ 4mg Prana P4 CBD:CBN 舌下 (1:1)
就寝时:
+ 10mg Prana P4 CBN胶囊
实施例8:用于慢性疼痛的示例性方案
早晨:
+ 5mg Prana P2 CBD AM胶囊 (2:1至3:1,THC:CBD)
+ 2mg至4mg Prana P1 THCa 舌下
下午:
+ 5mg Prana P2 CBD AM胶囊 (2:1至3:1,THC:CBD)
+ 2mg至4mg Prana P1 THCa 舌下 (按需要)
晚餐:
+ 10mg Prana P3 CBD PM胶囊 (2:1至1:1, THCa:CBDa)
+ 2mg至4mg Prana P1 THCa 舌下
就寝时:
+ 10mg Prana P4 CBN胶囊
实施例9:用于阿片剂依赖的示例性方案
注:这是一个16周的程序。
第1周&第2周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 5mg Prana P1 Prana胶囊
+ 2mg Prana P2 CBD AM 舌下 (2:1至3:1,THC:CBD)
下午:
+ 5mg Prana P1 Prana胶囊
+ 2mg Prana P2 CBD AM 舌下 (2:1至3:1)
晚餐:
+ 5mg Prana P1 Prana胶囊
+ 2mg Prana P2 CBD AM 舌下 (2:1至3:1)
就寝时: (30min前)
+ 10mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 2mg Prana P4 舌下 CBD:CBN (1:1)
每天的总大麻素: 31mg + 50mg原质
阿片剂减少10%-20%
第3周&第4周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 10mg Prana P1胶囊
+ 4mg Prana P2 CBD AM 舌下 (2:1至3:1)
下午:
+ 10mg Prana P1 THCa胶囊
+ 4mg Prana P2 CBD AM 舌下 (2:1至3:1)
晚餐:
+ 10mg Prana P1 THCa胶囊
+ 4mg Prana P2 CBD AM 舌下 (2:1至3:1)
就寝时: (30min前)
+ 10mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 4mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 56mg + 50mg原质
阿片剂减少10%-20%
第5周&第6周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 15mg Prana P1 THCa胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
下午:
+ 15mg Prana P1 THCa胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
晚餐:
+ 15mg Prana P1 THCa胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
就寝时: (30min前)
+ 15mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 6mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 84mg + 50mg原质
阿片剂减少10%-20%
第7周&第8周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 20mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
下午:
+ 20mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
晚餐:
+ 20mg Prana P1 THC胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
就寝时: (30min前)
+ 20mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 6mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 104mg + 50mg原质
阿片剂减少10%-20%
第8周&第9周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 15mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
下午:
+ 15mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
晚餐:
+ 15mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
就寝时: (30min前)
+ 20mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 6mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 89mg + 50mg原质
阿片剂减少10%-20%
第10周&第11周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 10mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
下午:
+ 10mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
晚餐:
+ 10mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
就寝时: (30min前)
+ 15mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 6mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 69mg + 50mg原质
阿片剂减少10%-20%
第12周&第13周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 5mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
下午:
+ 5mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
晚餐:
+ 5mg Prana P1 Prana胶囊
+ 6mg Prana P2 CBD AM 舌下 (2:1至3:1)
就寝时: (30min前)
+ 10mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 6mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 49mg + 50mg原质
阿片剂减少10%-20%
第14周&第15周
早晨:
+ Prana P5 - 100gms原质或10gms粉末
+ 4mg Prana P1 THCa 舌下
+ 5mg Prana P2 CBD AM胶囊 (2:1至3:1)
下午:
+ 4mg Prana P1 THCa 舌下
+ 5mg Prana P2 CBD AM胶囊 (2:1至3:1)
晚餐:
+ 4mg Prana P1 THCa 舌下
+ 5mg Prana P2 CBD AM胶囊 (2:1至3:1)
就寝时: (30min前)
+ 10mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 4mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 41mg + 50mg原质
阿片剂应减少80-90%
第16周+
+ 每3天+ Prana P5 - 100gms原质或10gms粉末
早晨:
+ 10mg Prana P2 CBD AM胶囊 (2:1至3:1)
+ 4mg Prana P1 THCa 舌下 (仅根据需要用于疼痛)
下午:
+ 4mg Prana P1 THCa 舌下 (仅根据需要用于疼痛)
晚餐:
+ 10mg Prana P3 CBD PM胶囊 (2:1至1:1)
+ 4mg Prana P1 THCa 舌下 (仅根据需要用于疼痛)
就寝时: (30min前)
+ 4mg Prana P4 舌下 CBD:CBN (1:1)
每天吸收的总大麻素: 36mg + 25mg原质
阿片剂应减少90% - 100%。
其他实施方案
尽管本发明已经结合其详细说明进行了描述,前述说明旨在例证,而不是限制本发明的范围,本发明由所附权利要求的范围限定。其他方面、优点和修改均在以下权利要求的范围之内。
Claims (51)
1.一种提取物,该提取物含有至少95%的总大麻素和至少一种萜烯/类黄酮的混合物,其中大麻素包括至少四种选自以下的大麻素:四氢大麻酚酸(THCa)、大麻二酚酸(CBDa)、大麻酚酸(CBNa)、大麻色烯酸(CBCa)、四氢大麻酚(THC)、大麻酚(CBN)、大麻二酚(CBD)和大麻色烯(CBC)。
2.根据权利要求1的提取物,其中所述大麻素是THCa和CBDa,至少两种大麻素选自CBNa、CBCa、THC、CBN和CBC。
3.根据权利要求1的提取物,其中所述大麻素是THC、CBN、CBC和CBD(P4)。
4.根据权利要求1的提取物,其中所述大麻素是THCa、CBDa、CBNa和CBCa。
5.根据权利要求1的提取物,其中所述大麻素是THCa、CBDa、THC、CBN和CBC。
6. 根据前述权利要求中任一项的提取物,其中所述萜烯/类黄酮是d-柠檬烯芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、β-月桂烯或β-丁子香烯、cannflavin A、芹菜素、槲皮素或胡薄荷酮。
7. 一种制剂,该制剂包含用中链甘油三酯(MCT)浸泡的前述权利要求中任一项,其中所述制剂的pH为至少pH 8.0。
8. 根据权利要求7的制剂,其中所述MCT是NEOBEE 895。
9.根据权利要求7或8的制剂,其中浓度为:
a. THCa大于或等于95%;
b. CBDa小于1%;
c. CBNa小于3%;且
d. CBCa小于1%。
10. 根据权利要求9的制剂,还包括d-柠檬烯、芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
11.根据权利要求7或8的制剂,其中浓度为:
a. THCa小于或等于35%;
b. CBDa大于或等于60%;
c. THC小于1%;
d. CBN小于1%;且
e. CBC小于1%。
12. 根据权利要求11所述的制剂,还包括d-柠檬烯、芳樟醇、1,8-桉叶素(桉叶醇)、α-蒎烯、松油醇-4-醇、对-甲基异丙基苯、莰醇、Δ-3-蒈烯、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
13.根据权利要求7或8的制剂,其中浓度为:
a. THCa大于或等于40%;
b. CBDa大于或等于40%;
c. THC小于1%;
d. CBN小于1%;且
e. CBC小于1%。
14. 根据权利要求13的制剂,还包括β-月桂烯、β-丁子香烯、胡薄荷酮、α-松油醇、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
15.根据权利要求7或8的制剂,其中浓度为:
a. THC小于或等于9%;
b. CBD大于或等于40%;
c. CBN大于或等于40%;且
e. CBS小于1%。
16. 根据权利要求15的制剂,还包括β-月桂烯、β-丁子香烯、胡薄荷酮、α-松油醇、β-谷甾醇、cannflavin A、芹菜素、槲皮素。
17.根据权利要求9至16中任一项的制剂,该制剂用于口服、舌下、含服或局部给药。
18.根据权利要求17的制剂,其中所述舌下制剂进一步包括甜味剂。
19.根据权利要求18的制剂,其中所述甜味剂为甜菊提取物。
20.根据权利要求18或19的制剂,还包括柠檬油、橙油或两者。
21.制备大麻提取物的方法,包括:
a.提供新鲜的或活的大麻植物材料;
b.从该植物材料提取大麻素以产生第一提取物;
c.冬化步骤(b)的提取物以产生冬化提取物;
d.清洗步骤(c)的冬化提取物以产生大麻提取物。
22.根据权利要求21的方法,还包括在步骤(b)之前将植物大麻素脱羧。
23.根据权利要求22的方法,其中脱羧包括在约221℉的温度加热干燥的植物材料至少15分钟,接着在约284℉加热至少45分钟。
24.根据权利要求21的方法,还包括在284℉加热步骤(d)的提取物约45-74分钟,然后在约293℉加热至少约55-90分钟。
25.根据权利要求21的方法,其中所述大麻植物材料由花或花叶组成。
26.根据权利要求21的方法,其中所述大麻植物材料在至少-10℉至-50℉的温度下冷冻至少36小时,然后提取。
27.根据权利要求21的方法,其中所述大麻植物材料已经从单一种子来源或具有特定比率的大麻素的组织培养物繁殖。
28.根据权利要求21的方法,其中所述提取是烃提取。
29.根据权利要求21的方法,其中冬化包括加冷乙醇到第一提取物或在约-20℉至约-75℉的温度存储所述第一提取物约48小时以产生蜡质沉淀并通过过滤去除蜡质沉淀。
30.根据权利要求29的方法,还包括将所述冬化提取物通过活性炭过滤。
31.根据权利要求21的方法,其中所述大麻植物材料得自具有最少15%THC和小于1%的CBD的大麻品系。
32. 根据权利要求21的方法,其中所述大麻植物材料得自Sour Tsunami x CatatonicSour Tsunami x Sour Tsunami, Sour Tsunami, Harlequin, R4或ACDC品系。
33. 根据权利要求21的方法,其中所述大麻植物材料得自CBD1, Sour Pineapple,CBD Diesel, Harlequin, ACDC或R4。
34. 根据权利要求22的方法,其中所述大麻植物材料得自Sour Tsunami xCatatonic, Sour Tsunami x Sour Tsunami, Sour Tsunami, Harlequin, R4, SwissGold, ACDC, CBD1, Sour Pineapple或CBD Diesel。
35.一种制备大麻汁液的方法,包括:
a.将得自营养阶段的大麻植物的新鲜大麻叶在冷水中漂白;
b.在冷压榨汁机或撕捏榨汁机中将叶榨汁;
c.将汁液过滤通过过滤器以除去微粒。
36.根据权利要求35的方法,还包括在步骤(c)后冷冻干燥汁液。
37.根据权利要求35的方法,其中所述榨汁机是冷压榨汁机或撕捏榨汁机。
38.由权利要求35的方法得到的汁液。
39.根据权利要求34的汁液,还包括得自大麻花、大麻根或两者的大麻汁液。
40.一种用于缓解与焦虑、创伤后应激障碍、慢性疼痛、或阿片依赖、麻痹、神经病、克罗恩病、炎性肠疾病、青光眼、癫痫发作、癫痫、孤独症或癌症相关的症状的方法,包括向有需要的受试者给予一种或多种权利要求7-20的制剂或权利要求37和38的汁液。
41.根据权利要求40的方法,其中所述制剂每天给药四次。
42.根据权利要求41的方法,其中权利要求9或10的制剂在早晨给药;权利要求11或12的制剂在下午给药;权利要求13或14的制剂在晚上给药;权利要求15或16的制剂在就寝时给药。
43.一种治疗癌症的方法,包括给予受试者以下的总日剂量:
a.20mg大麻素提取物和50mg原质大麻汁液7天;
b.40mg大麻素提取物和50mg原质大麻汁液7天;
c.80mg大麻素提取物和50mg原质大麻汁液7天;
d.120mg大麻素提取物和50mg原质大麻汁液7天;和
e.160mg大麻素提取物和100mg原质大麻汁液7天。
44.根据权利要求43的方法,还包括给予总日剂量为200mg大麻素提取物和之后每天100mg原质大麻汁液。
45.根据权利要求43的方法,还包括给予200mg大麻素提取物和100mg原质大麻汁液7天;和400mg大麻素提取物和之后每天100mg原质大麻汁液。
46.根据权利要求43-45的方法,其中大麻素的总日剂量以4次剂量给予。
47.一种治疗阿片样物质依赖的方法,包括减少每天使用的阿片剂的量至少10%,并给予受试者以下的总日剂量:
a.31mg大麻素提取物和50mg原质大麻14天;
b.56mg大麻素提取物和50mg原质大麻14天;
c.84mg大麻素提取物和50mg原质大麻汁液14天;
d.104mg大麻素提取物和50mg原质大麻14天;
e.89mg大麻素提取物和50mg原质大麻14天;
f.69mg大麻素提取物和50mg原质大麻14天;
g.49mg大麻素提取物和50mg原质大麻14天;
h.41mg大麻素提取物和50mg原质大麻14天。
48.根据权利要求47的方法,还包括给予总日剂量为36mg大麻素提取物和之后每天25mg原质大麻和每三天单剂量50mg原质大麻。
49.一种治疗焦虑/PTSD的方法,包括给予受试者总日剂量为约28mg-42mg的大麻素提取物。
50.一种治疗慢性疼痛的方法,包括给予受试者总日剂量为约36mg-48mg的大麻素提取物。
51.根据权利要求47-50的方法,其中大麻素的总日剂量以4次剂量给予。
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JP2023078465A (ja) | 2023-06-06 |
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WO2016064987A1 (en) | 2016-04-28 |
EA201790880A1 (ru) | 2017-08-31 |
IL251821A0 (en) | 2017-06-29 |
CA2965493A1 (en) | 2016-04-28 |
US9730911B2 (en) | 2017-08-15 |
CO2017004974A2 (es) | 2017-11-10 |
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US11291650B2 (en) | 2022-04-05 |
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US20170360745A1 (en) | 2017-12-21 |
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JP2021042233A (ja) | 2021-03-18 |
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BR112017008301A2 (pt) | 2017-12-19 |
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US20200215026A1 (en) | 2020-07-09 |
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