CN107072278A - 加入亲脂性活性剂的食品和饮料组合物及其使用方法 - Google Patents

加入亲脂性活性剂的食品和饮料组合物及其使用方法 Download PDF

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Publication number
CN107072278A
CN107072278A CN201580031524.XA CN201580031524A CN107072278A CN 107072278 A CN107072278 A CN 107072278A CN 201580031524 A CN201580031524 A CN 201580031524A CN 107072278 A CN107072278 A CN 107072278A
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active agent
lipophilic active
agent
food product
bioavilability
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CN201580031524.XA
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M.E.华盛顿
M.雷略
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Powewa Tea Industry Co Ltd
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Powewa Tea Industry Co Ltd
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Publication of CN107072278A publication Critical patent/CN107072278A/zh
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/152—Milk preparations; Milk powder or milk powder preparations containing additives
    • A23C9/156—Flavoured milk preparations ; Addition of fruits, vegetables, sugars, sugar alcohols or sweeteners
    • A—HUMAN NECESSITIES
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    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/16—Agglomerating or granulating milk powder; Making instant milk powder; Products obtained thereby
    • A—HUMAN NECESSITIES
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    • A23F—COFFEE; TEA; THEIR SUBSTITUTES; MANUFACTURE, PREPARATION, OR INFUSION THEREOF
    • A23F3/00—Tea; Tea substitutes; Preparations thereof
    • A23F3/40—Tea flavour; Tea oil; Flavouring of tea or tea extract
    • A23F3/405—Flavouring with flavours other than natural tea flavour or tea oil
    • A—HUMAN NECESSITIES
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    • A23F5/00—Coffee; Coffee substitutes; Preparations thereof
    • A23F5/46—Coffee flavour; Coffee oil; Flavouring of coffee or coffee extract
    • A23F5/465—Flavouring with flavours other than natural coffee flavour or coffee oil
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    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
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Abstract

本文所述多个方面涉及加入亲脂性活性剂的食品和饮料组合物以及用于治疗多种病症的方法。更具体而言，本文所述多个方面涉及加入诸如大麻素、烟碱、非甾体抗炎剂(NSAIDs)和维生素的亲脂性活性剂的食品和饮料组合物，其在受试者中提供了增强的亲脂性活性剂的生物利用度，并且掩盖了亲脂性活性剂的讨厌味道。

Description

加入亲脂性活性剂的食品和饮料组合物及其使用方法
发明领域
本文所述多个方面涉及加入亲脂性活性剂的食品和饮料组合物以及用于治疗多种病症的使用方法。更具体而言，本文所述多个方面涉及加入诸如大麻素、烟碱、非甾体抗炎药(NSAIDs)和维生素的亲脂性活性剂的食品和饮料组合物，其在受试者中提供了增强的亲脂性活性剂的生物利用度，并且掩蔽亲脂性活性剂的讨厌味道。
背景技术
许多治疗剂是高度亲脂的，这表示它们可溶于脂质和一些有机溶剂，同时基本不溶或仅微溶于水。这些亲脂性药剂的差水溶性经常导致配制中的主要困难。当以油溶液或者一些种类的水和/或油悬浮液或乳状液施用时，亲脂性化合物通常显示差的生物利用度。
在本领域中已知有多种克服此局限性的方法。一种这样的方法包括将亲脂性化合物溶解在可与水混溶的有机溶剂如乙醇或丙二醇中。然而，当所得溶液与血液或胃肠液混合时，亲脂性化合物通常作为固体或液体乳状液沉淀，这会导致低的生物利用度。此外，对于许多亲脂性化合物来说，不存在可与水混溶的有机溶剂。
另一种方法涉及物理-化学增溶技术，诸如通过表面活性剂的胶束增溶(即，使用表面活性剂胶束来增溶和输送治疗剂)。在水溶液中，胶束可将亲脂性治疗剂加入该胶束的烃核心中，或者可将所述药剂缠结在胶束壁内的多个位置处。尽管胶束制剂可增溶多种亲脂性治疗剂，但常规胶束制剂的负荷容量受治疗剂在胶束表面活性剂中的溶解度所限。对于许多亲脂性治疗剂来说，这样的溶解度过低以至于无法提供能递送治疗有效剂量的制剂。
另一种方法包括制备在水中具有优于原始化合物的溶解度的亲脂性化合物的衍生物或类似物。例如，该衍生物可为通常保持原始生物活性的化合物的水溶性盐。然而，该方法仅适用于具有酸或碱性质的化合物。如果向原始化合物中引入更多修饰以改进其溶解度，则经常观察到化合物原始生物活性的降低乃至完全丧失。
另一种方法包括制备能在生理条件下释放原始生物活性化合物的水溶性前药。这样的前药通常改进化合物的生物利用度并且能确保化合物的定向投放或在一段时间的持续释放。然而，前药的使用并不是普遍适用的，这是因为它们通常需要在原始化合物中存在特定的官能团。此外，通过化学修饰改进化合物溶解度的合成方法相对复杂和昂贵。
其它方法涉及通过添加螯合剂形成配合物，诸如柠檬酸、酒石酸、氨基酸、巯基乙酸和乙二胺四乙酸二钠。仍然其它的方法是用缓冲剂，诸如乙酸盐、柠檬酸盐、谷氨酸盐和磷酸盐。然而，缓冲剂和螯合剂涉及在产品中赋予高铝含量，这会导致不良副作用。此外，某些螯合剂如EDTA涉及不良事件，诸如肾毒性和肾小管坏死。
因此，需要对有此需要的受试者施用亲脂性活性剂以治疗多种病症的改进组合物和方法。
发明内容
为全部或部分解决前述问题和/或本领域技术人员可能已观察到的其它问题，本公开提供了通过如下面阐述的例子所描述的组合物和方法。
在一个方面，提供了加入亲脂性活性剂的食品产品，其包括：(a)治疗有效量的亲脂性活性剂，其中所述亲脂性活性剂选自大麻素、烟碱、非甾体抗炎药(NSAID)和维生素；(b)生物利用度增强剂，其中所述生物利用度增强剂增强亲脂性活性剂的生物利用度；和(c)食品产品，其中所述食品产品选自茶叶、咖啡豆、可可粉、肉、鱼、水果、蔬菜、乳制品、豆、意大利面、面包、谷物、种子、坚果、香料和草药。在另一方面，所述加入亲脂性活性剂的食品产品可通过以下步骤获得：(i)将食品产品与包含亲脂性活性剂和生物利用度增强剂的油接触；和(ii)将食品产品脱水；从而制得加入亲脂性活性剂的食品产品。在进一步的方面，步骤(i)包括将食品产品在包含亲脂性活性剂和生物利用度增强剂的油中饱和。在仍然另一方面，加入亲脂性活性剂的食品产品还包括调味剂，具体而言，其中所述调味剂选自香草、香草醛、乙基香草醛、橙油、薄荷油、草莓、覆盆子及其混合物。在进一步的方面，加入亲脂性活性剂的食品产品是冻干的。
在另一方面，提供了加入亲脂性活性剂的饮料产品，其通过以下步骤获得：(i)提供如本文所述的加入亲脂性活性剂的茶叶、咖啡豆或可可粉；和(ii)将所述加入亲脂性活性剂的茶叶、咖啡豆或可可粉在液体中浸泡；从而制得加入亲脂性活性剂的饮料产品。
在其它方面，提供了制备加入亲脂性活性剂的食品产品的方法，其包括以下步骤：(i)将食品产品与包含亲脂性活性剂和生物利用度增强剂的油接触；和(ii)将食品产品脱水；从而制得加入亲脂性活性剂的食品产品；其中所述加入亲脂性活性剂的食品产品包括治疗有效量的亲脂性活性剂，和进一步地，其中：(a)所述亲脂性活性剂选自大麻素、烟碱、非甾体抗炎药(NSAID)和维生素；(b)所述生物利用度增强剂增强亲脂性活性剂的生物利用度；和(c)所述食品产品选自茶叶、咖啡豆、可可粉、肉、鱼、水果、蔬菜、乳制品、豆、意大利面、面包、谷物、种子、坚果、香料和草药。在另一方面，步骤(i)包括将食品产品在包含亲脂性活性剂和生物利用度增强剂的油中饱和。在另一方面，步骤(i)包括将食品产品与调味剂接触，特别是其中所述调味剂选自香草、香草醛、乙基香草醛、橙油、薄荷油、草莓、覆盆子及其混合物。在另一方面，所述方法还包括将加入亲脂性活性剂的食品产品冻干的步骤。在进一步的方面，其中所述加入亲脂性活性剂的食品产品是茶叶，所述方法还包括将茶叶包装在茶包中。
在另一方面，提供了制备加入亲脂性活性剂的饮料产品的方法，包括：根据本文所述任何方法制备加入亲脂性活性剂的茶叶、咖啡豆或可可粉；还包括将所述加入亲脂性活性剂的茶叶、咖啡豆或可可粉浸泡在液体中，从而制得加入亲脂性活性剂的饮料产品。
在其它方面，在本发明的组合物和方法中，亲脂性活性剂是大麻素。在另一方面，所述大麻素是非精神活性大麻素，诸如大麻二酚。
在其它方面，在本发明的组合物和方法中，所述亲脂性活性剂是选自以下的NSAID：乙酰水杨酸、布洛芬、对乙酰氨基酚、双氯芬酸、吲哚美辛和吡罗昔康。
在其它方面，在本发明的组合物和方法中，所述亲脂性活性剂是维生素E。
在其它方面，本发明的组合物和方法中的生物利用度增强剂，所述生物利用度增强剂是食用油或脂肪、保护胶体或者保护胶体与食用油或脂肪二者。在另一方面，所述生物利用度增强剂也是亲脂性活性剂味道掩蔽剂。在另一具体方面，当所述生物利用度增强剂既为保护胶体、食用油或脂肪又为亲脂性活性剂味道掩蔽剂时，所述生物利用度增强剂为脱脂奶粉。在进一步的方面，所述生物利用度增强剂基本不含Ω-6脂肪酸。在其它方面，亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约1.5倍、2倍、5倍或10倍。在进一步的方面，亲脂性活性剂在受试者中的生物利用度大于20％。
在进一步的方面，提供了治疗状况(condition)的方法，包括：对有此需要的受试者施用本文所公开的任何组合物。在一个方面，当本发明的组合物和方法中的亲脂性活性剂是大麻素时，所述状况选自：心脏疾病，诸如，心脏病、缺血性梗死和心血管代谢病；神经疾病，诸如，阿尔茨海默病、帕金森氏病、精神分裂症和人免疫缺损病毒(HIV)痴呆；肥胖症；代谢疾病，诸如胰岛素相关缺陷和血脂水平、肝脏疾病、糖尿病和食欲异常；癌症化疗；良性前列腺肥大；肠易激综合征；胆道疾病；卵巢疾病；大麻滥用；和酒精、鸦片、烟碱或可卡因成瘾。在另一方面，当本发明的组合物和方法中的亲脂性活性剂是烟碱时，所述状况是烟碱-相关病症。在另一方面，当本发明的组合物和方法中的亲脂性活性剂是如本文所述的NSAID时，所述状况是疼痛、发热和/或炎性相关疾病或病症。在另一方面，当本发明的组合物和方法中的亲脂性活性剂是如本文所述的维生素、特别是维生素E时，所述状况是维生素E缺乏和/或维生素E相关疾病或病症。
在进一步的方面，提供了增强亲脂性活性剂的生物利用度的方法，包括将本文所公开的任何组合物加热到高于或等于人体温度的温度。在一些方面，对有此需要的受试者口服施用本文所公开的任何组合物导致将该组合物加热至等于人体温度的温度。
当检验了以下附图和详细描述之后，本发明的其它组合物、方法、特征和优点将会或将趋于明显。这意味着所有这样的其它组合物、方法、特征和优点被包含在本说明书中、在本发明范围内和受所附权利要求所保护。
附图说明
参考以下附图可更好地理解本发明。附图中的组件不必是成比例的，而是强调的重点在于说明本发明的原理。在附图中，类似的附图标记在所有不同视图中指代对应部件。
图1是在本发明一个方面中使用的组分照片(奶粉、茶叶和大麻二酚油)。
图2是在本发明一个方面中使用的组分照片(奶粉)。
图3是在本发明一个方面中使用的组分照片(茶叶)。
图4是在本发明一个方面中使用的设备照片(食品脱水机)。
图5是在本发明一个方面中使用的组分照片(大麻二酚油)。
图6是本发明的一个方面的组合物(加入大麻二酚的茶叶)的照片。
具体实施方式
本发明涉及加入亲脂性活性剂的食品和饮料组合物，其在受试者中提供了增强的生物利用度，特别是其中掩蔽了亲脂性活性剂的讨厌味道。还提供了制备食品和饮料组合物的方法，以及治疗状况的方法，所述治疗状况的方法包括对有此需要的受试者施用本文所公开的任何组合物。
生物利用度是指活性部分(药物或代谢物)进入全身循环从而访问(access)作用部位的程度和速率。给定制剂的生物利用度提供了口服施用剂量中被吸收进入全身循环的相对分数的估算。生物利用度低最常见于水溶性差、吸收缓慢药物的口服剂型。在胃肠道中的吸收时间不足是生物利用度低的常见原因。如果药物不易溶解或不能穿透上皮膜(例如，如果其是高度离子化和极性的)，在吸收部位的时间可能会不足。口服施用药物必须穿过肠壁，然后通过门脉循环到达肝脏，二者都是首过代谢(在药物到达全身循环之前发生的代谢)的常见部位。因此，许多药物可能在达到足够血浆浓度之前即被代谢。
生物利用度通常通过测定血浆浓度-时间曲线(AUC)下方面积的方式来评估。AUC与到达全身循环的未改变药物的总量成正比。血浆药物浓度随吸收程度升高；最大(峰值)血浆浓度在药物消除速率等于吸收速率的时候达到。峰值时间为最常用的吸收速率一般指标；吸收越慢，峰值时间越晚。
一些药物的生物利用度在与食品共同施用时得到提高，尤其是诸如大麻素的药剂，其是Biopharmaceutical Drug Classification System(生物药物分类体系)下的二类药物(Kelepu et al.(2013)Acta Pharmaceutica Sinica B 3:361-372；Amidon et al.(1995)Pharm.Res.12:413-420；Charman et al.(1997)J.Pharm.Sci.86:269-282；Winstanley et al.(1989)Br.J.Clin.Pharmacol.28:621-628)。其是食品中的脂质成分，在亲脂性药物的吸收中有重要作用，并且导致增强的口服生物利用度(Hunt&Knox(1968)J.Physiol.194:327-336；Kelepu et al.(2013)Acta Pharmaceutica Sinica B 3；361-372)。这可归因于高脂膳食刺激胆和胰腺分泌、降低代谢和排出活性、提高肠壁渗透性和延长胃肠道(GIT)停留时间以及经由淋巴系统转运的能力(Wagnera et al.(2001)Adv.DrugDel.Rev.50:S 13-31；Kelepu et al.(2013)Acta Pharmaceutica Sinica B 3:361-372)。高脂膳食还提高富含甘油三酯的脂蛋白，后者与药物分子缔合并且增强肠淋巴转运，这导致药物分布的变化并改变难溶药物药理作用的动力学(Gershkovich et al.(2007)Eur.J.Pharm.Sci.32:24-32；Kelepu et al.(2013)Acta Pharmaceutica Sinica B 3:361-372)。然而，食品与亲脂性药物的共同施用需要在给予这样的药物时密切控制和/或监控食品的摄入量，并且还可能经历患者依从性的问题(Kelepu et al.(2013)ActaPharmaceutica Sinica B 3:361-372)。
本发明部分涉及加入亲脂性活性剂的食品和饮料组合物，所述组合物在受试者中提供增强的亲脂性活性剂的生物利用度。令人惊讶地发现，与通常的亲脂性活性剂的口服摄入相比，加入亲脂性活性剂的食品和饮料组合物的脂质含量和胶体性质提高了亲脂性活性剂在受试者中的生物利用度。加入亲脂性活性剂的食品和饮料组合物还允许获得与亲脂性药物和含脂质食品的共同施用相关的增强的口服生物利用度，而没有涉及与亲脂性活性剂在与食品和饮料分开的制剂中施用相关的剂量和依从性问题。此外，当与还包含抗氧化剂的食品和饮料(诸如黑茶)组合时亲脂性活性剂令人惊讶地通过肠粘膜更有效地输送，从而产生了亲脂性活性剂的吸收和生物利用度的协同效应。
本发明还部分涉及包含一种或多种亲脂性活性剂味道掩蔽剂的加入亲脂性活性剂的食品和饮料组合物。许多亲脂性活性剂具有令人不快的口味，这会阻碍口服摄入的亲脂性活性剂作为治疗处理剂的用途。特别是，令人惊讶地发现在制备本发明的加入亲脂性活性剂的食品和饮料组合物的方法中使用的奶粉可同时用作生物利用度增强剂和亲脂性活性剂味道掩蔽剂。
组合物
在一个方面，提供了加入亲脂性活性剂的食品产品，其包括：(a)治疗有效量的亲脂性活性剂，其中所述亲脂性活性剂选自大麻素、烟碱、非甾体抗炎药(NSAID)和维生素；(b)生物利用度增强剂，其中所述生物利用度增强剂增强亲脂性活性剂的生物利用度；和(c)食品产品，其中所述食品产品选自茶叶、咖啡豆、可可粉、肉、鱼、水果、蔬菜、乳制品、豆、意大利面、面包、谷物、种子、坚果、香料和草药。在另一方面，所述加入亲脂性活性剂的食品产品可通过以下步骤获得：(i)将食品产品与包含亲脂性活性剂和生物利用度增强剂的油接触；和(ii)将食品产品脱水；从而制得加入亲脂性活性剂的食品产品。在进一步的方面，步骤(i)包括将食品产品在包含亲脂性活性剂和生物利用度增强剂的油中饱和。在仍然另一方面，加入亲脂性活性剂的食品产品还包括调味剂，特别是其中所述调味剂选自香草、香草醛、乙基香草醛、橙油、薄荷油、草莓、覆盆子及其混合物。在进一步的方面，加入亲脂性活性剂的食品产品是冻干的。
在另一方面，提供了加入亲脂性活性剂的饮料产品，其可通过以下步骤获得：(i)提供如本文所述的加入亲脂性活性剂的茶叶、咖啡豆或可可粉；和(ii)将所述加入亲脂性活性剂的茶叶、咖啡豆或可可粉在液体中浸泡；从而制得加入亲脂性活性剂的饮料产品。
在其它方面，本发明的组合物和方法中的生物利用度增强剂，所述生物利用度增强剂是食用油或脂肪、保护胶体或者保护胶体和食用油或脂肪二者。在另一方面，所述生物利用度增强剂也是亲脂性活性剂味道掩蔽剂。在另一具体方面，当生物利用度增强剂是保护胶体、食用油或脂肪和亲脂性活性剂味道掩蔽剂二者时，所述生物利用度增强剂是脱脂奶粉。在进一步的方面，所述生物利用度增强剂基本不含Ω-6脂肪酸。在其它方面，亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约1.5倍、2倍、5倍或10倍。在进一步的方面，亲脂性活性剂在受试者中的生物利用度大于20％。
食用油在本文中定义为在体内在正常生理条件下在胰脂酶存在下能经受去酯化或水解的油。具体而言，可消化的油可为中链(C7-C13)或长链(C14-C22)脂肪酸与低分子量(最多C6)的一元醇、二元醇或多元醇的完全甘油三酯。因此用于本发明的可消化的油的一些例子包括：植物油、坚果油或种子油(诸如椰子油、花生油(peanut oil)、大豆油、红花油、玉米油、橄榄油、蓖麻油、棉籽油、花生油(arachis oil)、葵花籽油、椰子油、棕榈油、菜籽油、月见草油、葡萄籽油、小麦胚芽油、芝麻油、鳄梨油、扁桃仁油、紫草油、薄荷油和杏仁油)和动物油(诸如，鱼肝油、鲨鱼油和貂油)。
保护胶体的例子包括多肽(诸如明胶、酪蛋白和酪蛋白酸盐)、多糖(诸如淀粉、糊精、葡聚糖、果胶和阿拉伯树胶)以及全脂奶、脱脂奶、奶粉或这些的混合物。然而，也可以使用聚乙烯醇、乙烯基聚合物，例如聚乙烯吡咯烷酮、(甲基)丙烯酸聚合物和共聚物、甲基纤维素、羧甲基纤维素、羟丙基纤维素和藻酸盐。对于进一步的细节，可参考R.A.Morton,FastSoluble Vitamins,Intern.Encyclopedia of Food and Nutrition,Vol.9,PergamonPress 1970,pages 128-131。
口服施用构成了大多数药物的优选施用途径。然而，具有不理想味道或苦味的药物在口服施用剂型的情况中导致缺乏患者依从性。在这样的情况中，味道掩蔽是改进患者依从性的重要工具。由于亲脂性活性剂(例如，大麻素如大麻二酚)具有不理想的口味，为改进依从性，本文公开的组合物还包含一种或多种亲脂性活性剂味道掩蔽剂。亲脂性活性剂味道-掩蔽剂的例子包括如上所述的奶粉，以及薄荷醇、增甜剂、碳酸氢钠、离子交换树脂、环糊精包合物、吸附质等。
在进一步的方面，所述生物利用度增强剂基本不含Ω-6脂肪酸。
在其它方面，亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约1.5倍、2倍、2.5倍、3倍、3.5倍、4倍、4.5倍、5倍、5.5倍、6倍、6.5倍、7倍、7.5倍、8倍、8.5倍、9倍、9.5倍或10倍。
在进一步的方面，亲脂性活性剂在受试者中的生物利用度大于20％或至少约21％、22％、23％、24％、25％、26％、27％、28％、29％、30％、31％、32％、33％、34％、35％、36％、37％、38％、39％、40％、41％、42％、43％、44％、45％、46％、47％、48％、49％、50％或更高。
测量亲脂性活性剂生物利用度的实验和方法在本领域中是公知的(参见，例如，Rocci&Jusko(1983)Comput.Programs Biomed.16:203-215；Shargel&Yu(1999)Appliedbiopharmaceutics&pharmacokinetics(4th ed.).New York:McGraw-Hill；Hu&Li(2011)Oral Bioavailability:Basic Principles,Advanced Concepts and Applications,JohnWiley&Sons Ltd.；Karschner et al.(2011)Clinical Chemistry 57:66-75；Ohlsson etal.(1980)Clin.Pharmacol.Ther.28:409-416；Ohlsson et al.(1982)Biomed.Environ.Mass Spectrom.9:6-10；Ohlsson et al.(1986)Biomed.Environ.MassSpectrom.13:77-83；Karschner et al.(2010)Anal.Bioanal.Chem.397:603-611)。
在进一步的方面，本发明的加入亲脂性活性剂的食品产品是冻干的。冻干(Lyophilization)也称为冷冻干燥，是在将组合物冷冻之后将水从其中升华的方法。随后通常将冷冻溶液经历第一干燥步骤，其中温度在真空下在干燥室中逐渐升高以去除大部分水，随后经历第二干燥步骤，其通常在比第一干燥步骤中所采用的更高的温度进行以去除冻干组合物中的残余水分。随后将冻干组合物适当密封并储存以备后用。Tang et al.(2004)Pharmaceutical Research 21:191-200描述了与冷冻干燥相关的科学原理和设计合适的冷冻干燥工艺的指导。对冷冻干燥的进一步描述可见Remington(2006)The Scienceand Practice of Pharmacy,21st edition,Lippincott Williams&Wilkins,pp.828-831。
在其它方面，本发明的组合物还包括调味剂。合适的调味剂包括，但不限于，香草、香草醛、乙基香草醛、橙油、薄荷油、草莓、覆盆子及其混合物。
本发明的活性剂在广泛的剂量范围上有效。例如，在治疗成人时，本发明的组合物和方法包括如下剂量的亲脂性活性剂：0.01mg到1,000mg，0.5mg到500mg，1mg到100mg，5mg到50mg和10mg到25mg。或者可选地，当治疗成人时，本发明的组合物和方法包括如下剂量的亲脂性活性剂：0.01mg、0.05mg、0.1mg、0.25mg、0.5mg、0.75mg、1mg、5mg、10mg、15mg、20mg、25mg、30mg、35mg、40mg、45mg、50mg、55mg、60mg、65mg、70mg、75mg、80mg、85mg、90mg、95mg、100mg、150mg、200mg、250mg、300mg、350mg、400mg、450mg、500mg、550mg、600mg、650mg、700mg、750mg、800mg、850mg、900mg、950mg或1,000mg。
大麻素
大麻(Cannabis sativa L.)是用于消遣和药用用途的最广泛使用的植物之一。从大麻中已分离和鉴定出逾500种天然成分，涵盖了数个化学类别(Ahmed et al.(2008)J.Nat.Prod.71:536-542；Ahmed et al.(2008)Tetrahedron Lett.49:6050-6053；ElSohly&Slade(2005)Life Sci.78:539-548；Radwan et al.(2009)J.Nat.Prod.72:906-911；Radwan et al.(2008)Planta Medica.74:267-272；Radwan et al.(2008)J.Nat.Prod.69:2627-2633；Ross et al.(1995)Zagazig J.Pharm.Sci.4:1-10；Turner etal.(1980)J.Nat.Prod.43:169-170)。大麻素属于单萜基团(terpenophenolics)化学类别，其中至少85种仅在大麻中鉴定出来(Borgelt et al.(2013)Pharmacotherapy 33：195-209)。
大麻素是在人体内发现的大麻素受体(CB1,CB2)的配体(Pertwee(1997)Pharmacol.Ther.74:129-180)。大麻素通常分为以下几类：经典大麻素；非经典大麻素；氨基烷基吲哚-衍生物；和类花生酸(Pertwee(1997)Pharmacol.Ther.74:129-180)。经典大麻素是已从大麻中分离出来的那些或它们的合成类似物。非经典大麻素是四氢大麻酚(THC)的二-或三-环类似物(无吡喃环)。氨基烷基吲哚和类花生酸与经典和非经典大麻素相比在结构上有很大不同。最常见的天然植物大麻素(植物大麻素(phytocannabinoids))是大麻二酚(CBD)、大麻萜酚(CBG)、大麻色原烯(CBC)和大麻酚(CBN)。最具精神活性的大麻素(psychoactive cannabinoids)是Δ9-THC。
近年来，大麻毒品(marijuana)及其成分已在科技文献中报道为对抗多种状况的症状，所述状况包括但不限于多发性硬化和其它形式的肌痉挛；活动障碍；疼痛，包括偏头痛、头痛；青光眼；哮喘；炎症；失眠症；和高血压。大麻素还可用作下述用途：抗焦虑药、抗惊厥药、抗抑郁药、抗精神病药、抗癌药以及食欲促进剂。大麻素的药理学和毒理学研究已主要集中于Δ9-THC(可以通用名称屈大麻酚商购获得)的合成类似物。在1985年，屈大麻酚被FDA批准用于治疗化疗相关的恶心和呕吐，随后被批准用于治疗AIDS-相关的消耗病和厌食。
大麻素的治疗用途受一些化合物(例如，屈大麻酚)的精神活性性质以及它们在口服时生物利用度低的妨碍。生物利用度是指活性部分(药物或代谢物)进入全身循环从而访问作用部位的程度和速率。口服摄入的大麻素的低生物利用度(约6％到20％；Adams&Martin(1996)Addiction 91:1585-614；Agurell et al.(1986)Pharmacol.Rev.38:21-43；Grotenhermen(2003)Clin.Pharmacokinet.42:327-60)可归因于其溶解性差和大量首过代谢。
大麻素是直接或间接激活体内的大麻素受体的一组异态(heteromorphic)化合物。有三种主要类型的大麻素：仅存在于大麻植物中的草药大麻素，制造的合成大麻素，和体内产生的内源性大麻素。草药大麻素几乎不溶于水，但可溶于脂质、醇和非极性有机溶剂。这些天然大麻素富集于在被称为毛状体的腺样结构中产生的粘性树脂中。除了大麻素植物，这些树脂富含萜，后者对大麻植物的气味有极大责任。
1964年发生的将Δ9-四氢大麻素(THC)鉴定为主要的精神活性药物以及其化学合成开启了合成大麻素作为药物剂的新纪元。自发现大麻素受体和这些受体的内源性配体以来，关于大麻素的研究近年来惊人地增长。所述受体包括主要在大脑中表达的CB1和主要在免疫系统的细胞中发现的CB2。大麻素受体属于G-蛋白-偶联受体超家族。它们是具有七个跨膜α-螺旋的单个多肽，并且具有胞外糖基化N-末端和胞内C-末端。CB1和CB2大麻素受体均与G1/0-蛋白相连。除了这些受体之外，还发现了能够模仿THC的药理学作用的这些受体的内源性配体。这样的配体被称为内源性大麻素，并且包括花生四烯酸乙醇胺(anandamide)和2-花生四烯酸甘油(2-arachidonoyl glycerol，2-AG)。花生四烯酸乙醇胺在大脑和外周免疫组织如脾脏中产生。
与通过结合到CB1和CB2发挥其作用的THC不同，大麻二酚不与这些受体结合，因此没有影响精神的活性。相反，大麻二酚通过抑制分解花生四烯酸乙醇胺的酶(脂肪酰胺羟化酶，“FAAH”)而间接刺激内源性大麻素信号。大麻二酚还刺激2-AG的释放。大麻二酚已被报告具有免疫调节和抗炎性质，显示抗惊厥、抗焦虑和抗精神病活性，并且用作有效的神经保护抗氧化剂。
大麻中的大麻素通常经由吸烟吸入，但也可吞咽。吸食或吸入的大麻素已被报告具有2-56％的生物利用度，平均约30％(Huestis(2007)Chem.Biodivers.4:1770-1804；McGilveray(2005)Pain Res.Manag.10Suppl.A:15A-22A)。这种可变性主要可归因于吸烟动力学(smoking dynamics)中的差异。通过口中黏膜吸收的大麻素(口黏膜应用)的生物利用度为13％左右(Karschner et al.(2011)Clin.Chem.57:66-75)。相反，当大麻素被吞咽时，生物利用度通常降低至约6％(Karschner et al.(2011)Clin.Chem.57：66-75)。
因此，在其它方面，在本发明的组合物和方法中，所述亲脂性活性剂是大麻素。
在特定方面，本发明的组合物和方法中的至少一种大麻素选自以下：
CBC 大麻色原烯
CBCV 大麻色烯酸
CBD 大麻二酚
CBDA 大麻二酚酸
CBDV次大麻二酚酸
CBG 大麻萜酚
CBGV 大麻萜酚丙基变体
CBL 大麻环酚
CBN 大麻酚
CBNV 大麻酚丙基变体
CBO 二羟基大麻酚
THC 四氢大麻酚
THCA 四氢大麻酚酸
THCV 四氢次大麻酚
THCVA 四氢次大麻酚酸
在特定方面，本发明的组合物和方法中的至少一种大麻素是非精神活性大麻素，诸如，大麻二酚。在一些特别公开的方面，大麻素选自：
其中A是芳基，特别是
但不是诸如以下的蒎烯(pinene)：
R1-R5基团各自独立选自氢、取代或未取代的低级烷基、取代或未取代的羧基、取代或未取代的烷氧基、取代或未取代的醇以及取代或未取代的醚，且R6-R7是H或甲基。在特定方面，在环中没有氮，和/或在环上没有氨基取代。
在其它方面，大麻素选自：
其中在A环上可有0-3个双键，如A环上虚线所示的任选双键所示。C环是芳香性的，且B环可为吡喃。特定方面是二苯并吡喃和环己烯基苯二酚。本发明的大麻素的特定方面也可以是高度脂溶性的，在特定方面中，仅可微溶于水溶液中(例如，10mg/ml或更少)。在可用方面中，在中性pH下辛醇/水分配比为5000或更高，例如6000或更高。这种高脂溶性增强了药物进入中枢神经系统(CNS)中的渗透，如其1.5L/kg或更高的分布体积(Vd)所反应的，例如3.5L/kg、7L/kg或理想地10L/kg或更高，例如至少20L/kg。特定方面还可为能穿透CNS的高水溶性衍生物，例如，羧基衍生物。
R7-18独立选自H、取代或未取代的烷基(尤其是低级烷基，例如未取代的C1-C3烷基)、羟基、烷氧基(尤其是低级烷氧基，例如甲氧基或乙氧基)、取代或未取代的醇以及取代或未取代的羧基(例如COOH或COCH3)。在其它方面，R7-18也可为取代或未取代的氨基和卤素。
在特定方面，本发明的组合物和方法中的至少一种大麻素是非精神活性大麻素，这意味着所述大麻素基本上不具有由大麻素受体介导的精神活性(例如，在大麻素受体处的IC50大于或等于300nM，例如大于1μΜ，且Ki大于250nM，尤其是500-1000nM，例如大于1000nM)。
在其它特定方面，本发明的组合物和方法中的大麻素选自：
其中R19是取代或未取代的烷基，诸如低级烷基(例如甲基)，低级醇(诸如甲醇)或羧基(诸如羧酸)和氧(如＝O)；R20是氢或羟基；R21是氢、羟基或甲氧基；R22是氢或羟基；R23是氢或羟基；R24是氢或羟基；R25是氢或羟基；和R26是取代或未取代的烷基(例如n-甲基烷基)、取代或未取代的醇或取代或未取代的羧基。
在其它特定方面，本发明的组合物和方法中的大麻素选自：
其中显示了每个环位置处的编号规则，且R27、R28和R29独立选自H、未取代的低级烷基(诸如CH3)和羧基(诸如COCH3)。落入本定义范围内的非精神活性大麻素的特定例子是大麻二酚和
以及大麻二酚的其它结构类似物。
在其它特定方面，本发明的组合物和方法中的大麻素选自：
其中R27、R28和R29独立选自H、低级烷基(诸如CH3)和羧基(诸如COCH3)，特别是其中：
a)R27＝R28＝R29＝H
b)R27＝R29＝H；R28＝CH3
c)R27＝R28＝CH3；R29＝H
d)R27＝R28＝COCH3；R29＝H
e)R27＝H；R28＝R29＝COCH3。
当R27＝R28＝R29＝H时，则所述化合物为大麻二酚(CBD)。当R27＝R29＝H且R28＝CH3，则所述化合物为CBD一甲醚。当R27＝R28＝CH3且R29＝H时，所述化合物为CBD二甲醚。当R27＝R28＝COCH3且R29＝H时，所述化合物为CBD双乙酸酯。当R27＝H且R28＝R29＝COCH3，所述化合物为CBD一乙酸酯。
在仍然另一方面，加入大麻素的茶叶被包装在茶包中，其中每个茶包包括1到3克茶叶(干重)、0.10到1.0克奶粉和10到25mg大麻素油。在仍然另一方面，加入大麻素的茶叶被包装在茶包中，其中每个茶包包括1.5到12克茶叶(干重)、0.10到6.0克奶粉、10到25mg大麻油和1.0到12.0克大麻叶。
烟碱
全世界消耗的所有烟碱中的多于99％是通过吸食香烟递送的。根据the Centersfor Disease Control and Prevention(美国疾病控制与预防中心)，全世界范围内每年约6,000,000例死亡可主要归因于烟碱通过吸烟行为的递送，该中心还估算仅在美国每年即花费逾1,700亿美元在成人吸烟者的直接医疗护理费用上。在任何十二个月周期中，69％的美国成年吸烟者想要戒烟，且43％的美国成年吸烟者已试图戒烟。
2013年的世界范围香烟零售额为7,220亿美元，且超过5.7万亿支香烟被销售给超过10亿吸烟者。
经由本发明的组合物和方法递送烟碱(即在普通食品组中)以满足当前需求将减轻消费者对于香烟的需求。由于烟碱消费的大多数不良健康后果与递送方法相关并且与烟碱的实际摄入仅有较低程度的相关，通过减少吸食香烟可实现非常积极的公共卫生成果。
因此，在其它方面，在本发明的组合物和方法中，所述亲脂性活性剂是烟碱。
非甾体抗炎药(NSAIDs)
NSAIDs是世界上第二大类疼痛管理治疗选择。全球的疼痛管理市场在2011年估值为220亿美元，该市场中的54亿美元由NSAID提供。美国构成了全球市场的超过一半。阿片类药物市场(诸如吗啡)形成了最大的单种疼痛管理区，但已知其涉及严重依赖和耐受问题。
尽管NSAIDs通常是用于疼痛的安全有效的治疗方法，但它们与包括消化不良和胃出血在内的多种胃肠道问题相关。
通过本发明的组合物和方法递送NSAIDs将提供缓解疼痛的有利性质且具有较少的不良胃肠道效果，并且还递送较少剂量的活性成分且具有与现有的较高剂量药丸形式类似的疼痛管理成果。
因此，在其它方面，在本发明的组合物和方法中，所述亲脂性活性剂是NSAID，特别是其中所述NSAID选自乙酰水杨酸、布洛芬、对乙酰氨基酚、双氯芬酸、吲哚美辛和吡罗昔康。
维生素
根据Euromonitor(欧洲商情市场调研公司)，全球维生素和补充剂市场价值680亿美元。此类别既广泛又深入，包括许多流行的和一些较少为人所知的物质。在美国通常认为维生素有85亿美元的年度市场。美国是世界上最大的单个国家市场，中国和日本是第二和第三大的维生素市场。
维生素E是脂溶性的，并且可进入能保护其免受氧化损伤的细胞膜中。2013年天然来源维生素E的全球消耗量为10,900公吨，价值6.119亿美元。
通过本发明的组合物和方法递送脂溶性维生素将导致较少浪费和与现有的药丸形式所需者相比更低的剂量。此外，吞咽药丸对于许多人来说是不愉快的经历，因此通过普通食品组递送维生素将极大地扩展需求和使用。
因此，在其它方面，在本发明的组合物和方法中，所述亲脂性活性剂是维生素，特别是其中所述维生素是维生素E。
方法
在其它方面，提供了制备加入亲脂性活性剂的食品产品的方法，其包括以下步骤：(i)将食品产品与包含亲脂性活性剂和生物利用度增强剂的油接触；和(ii)将食品产品脱水；从而制得加入亲脂性活性剂的食品产品；其中所述加入亲脂性活性剂的食品产品包括治疗有效量的亲脂性活性剂，进一步地，其中：(a)所述亲脂性活性剂选自大麻素、烟碱、非甾体抗炎药(NSAID)和维生素；(b)所述生物利用度增强剂增强亲脂性活性剂的生物利用度；和(c)所述食品产品选自茶叶、咖啡豆、可可粉、肉、鱼、水果、蔬菜、乳制品、豆、意大利面、面包、谷物、种子、坚果、香料和草药。在另一方面，步骤(i)包括将食品产品在包含亲脂性活性剂和生物利用度增强剂的油中饱和。在另一方面，步骤(i)包括将食品产品与调味剂接触，特别是其中所述调味剂选自香草、香草醛、乙基香草醛、橙油、薄荷油、草莓、覆盆子及其混合物。在另一方面，所述方法还包括将加入亲脂性活性剂的食品产品冻干的步骤。
在进一步的方面，当加入亲脂性活性剂的食品产品是茶叶、咖啡豆或可可粉时，所述方法还包括将加入亲脂性活性剂的茶叶、咖啡豆或可可粉包装在单次或多次服务递送装置中，诸如茶包、透水膜、预包装饮料囊(beverage pods)，诸如Wakefield,MA的KeurigInc.生产和出售的包等。例子包括，但不限于，诸如以下文献中所述的递送装置和相关系统：美国专利3,450,024；5,325,765；5,840,189；和6,606,938。
在另一方面，提供了制备加入亲脂性活性剂的饮料产品的方法，包括：根据本文所述任何方法制备加入亲脂性活性剂的茶叶、咖啡豆或可可粉；还包括将所述加入亲脂性活性剂的茶叶、咖啡豆或可可粉浸泡在液体中的步骤，从而制得加入亲脂性活性剂的饮料产品。
治疗方法
在进一步的方面，提供了治疗状况的方法，其包括：对有此需要的受试者施用本文所公开的任何组合物。
在一个方面，当本发明的组合物和方法中的亲脂性活性剂是大麻素时，所述状况选自心脏疾病，诸如心脏病、缺血性梗死和心血管代谢病；神经疾病，诸如阿尔茨海默病、帕金森氏病、精神分裂症和人免疫缺陷病毒(HIV)痴呆；肥胖症；代谢疾病，诸如胰岛素相关缺陷和血脂水平、肝脏疾病、糖尿病和食欲异常；癌症化疗；良性前列腺肥大；肠易激综合征；胆道疾病；卵巢疾病；大麻滥用；和酒精、鸦片、烟碱或可卡因成瘾。
在另一方面，当本发明的组合物和方法中的亲脂性活性剂是烟碱时，所述状况是烟碱-相关病症，诸如烟草依赖/成瘾、帕金森氏病、溃疡性结肠炎(ulcerative colitis)、阿尔茨海默病、精神分裂症、注意缺陷多动障碍(ADHD)、妥瑞氏综合征、溃疡性结肠炎(ulcerous colitis)和戒烟后体重控制。
在另一方面，当本发明的组合物和方法中的亲脂性活性剂是如本文所述的NSAID时，所述状况是疼痛、发热和/或炎性相关疾病或病症，包括但不限于哮喘、慢性阻塞性肺病、肺纤维化、炎性肠病、肠易激综合征、炎性疼痛、发热、偏头痛、头痛、下背痛、纤维肌痛、肌筋膜病症、病毒感染(例如，流感、普通感冒、带状疱疹、丙型肝炎和AIDS)、细菌感染、真菌感染、痛经、烧伤、外科或牙科手术、恶性肿瘤(例如，乳腺癌、结肠癌和前列腺癌)、前列腺素E过多综合征、经典性巴特综合征、动脉硬化、痛风、关节炎、骨关节炎、幼年型关节炎、类风湿性关节炎、风湿热、强直性脊柱炎、霍奇金氏病、全身性红斑狼疮、血管炎、胰腺炎、肾炎、黏液囊炎、结膜炎、虹膜炎、巩膜炎、葡萄膜炎、创口愈合、皮炎、湿疹、牛皮癣、中风、糖尿病、神经退行性疾病如阿尔茨海默病和多发性硬化、自体免疫疾病、变态反应性疾病、鼻炎、溃疡、冠心病、肉状瘤病以及任何其它带有炎性成分的疾病。
在另一方面，当本发明的组合物和方法中的亲脂性活性剂是维生素时，所述状况是维生素缺乏或与亲脂性维生素相关的状况。在特定方面，当所述维生素是如本文所述的维生素E时，所述状况是维生素E缺乏和/或维生素E相关疾病或病症，诸如与维生素E缺乏相关的共济失调。
在进一步的方面，提供了增强亲脂性活性剂的生物利用度的方法，包括将本文所公开的任何组合物加热到高于或等于人体温度的温度。在一些方面，对有此需要的受试者口服施用本文所公开的任何组合物导致将该组合物加热到等于人体温度的温度。
在另一方面，提供了将本文所述的任何亲脂性活性剂施用给受试者的方法，包括口服施用本发明的任何组合物。这样的施用可用于任何目的，包括整体健康和保健、精神敏度、警觉、消遣等。
如本文所用的，通过本文所公开的方法的多个方面治疗的术语“受试者”理想地为人类受试者，尽管应理解本文所述方法对于所有脊椎动物物种均有效，后者也被确定包含在术语“受试者”中。因此，“受试者”可包括用于医疗目的的人类受试者，诸如用于已有疾病、病症、状况的诊断或治疗或者为防止疾病、病症或状况发作的预防性诊断或治疗，或者用于医疗、兽医目的或发育目的动物受试者。合适的动物受试者包括哺乳动物，包括但不限于灵长类动物，例如，人、猴、类人猿、长臂猿、黑猩猩、猩猩、猕猴等；牛科动物，例如，家牛(cattle)、牛(oxen)等；绵羊类动物，例如，绵羊等；山羊类动物，例如，山羊等；猪类动物，例如，家猪(pigs)、猪(hogs)等；马类动物，例如，马、驴、斑马等；猫类动物，包括野猫和家猫；犬类动物，包括狗；兔类动物，包括家兔、野兔等；和啮齿类动物，包括小鼠、大鼠、豚鼠等。动物可以是转基因动物。在一些方面，受试者是人，包括但不限于胎儿、新生儿、婴儿、幼儿和成人受试者。此外，“受试者”可包括罹患或怀疑罹患疾病、病症或状况的患者。因此，术语“受试者”和“患者”在本文中互换使用。受试者还可包括动物疾病模型(例如，在实验中使用的大鼠或小鼠等)。
治疗剂的术语“有效量”当在“治疗有效量”中时是指引起所需生理反应所必需的药剂量。如本领域技术人员将会意识到的，药剂的有效量可随诸如以下的多种因素而变化：所需的生物学终点、所要递送的药剂、药物组合物的组成、目标组织或细胞等。更具体而言，术语“有效量”是指足以产生所需效果的量，例如，降低或改善疾病、病症或状况或其一种或多种症状的严重性、持续时间、进展或发作；预防疾病、病症或状况的发展，引起疾病、病症或状况的消退；预防与疾病、病症或状况相关的症状的复发、发展、发作或进展，或者增强或改进另一种治疗的预防或治疗效果。
本文所公开的组合物中活性成分的实际剂量水平可发生变化从而得到针对特定受试者、组合物、施用途径和疾病、病症或状况有效实现所需治疗反应而不会对受试者有毒的活性成分量。所选择的剂量水平将取决于多种因素，包括所采用的特定组合物的活性，施用途径，施用时间，所采用的特定组合物的排泄速率，治疗的持续时间，与所采用的特定组合物组合使用的其它药物和/或物质，要被治疗的患者的年龄、性别、重量、状况、一般健康和先前病史，以及医药领域中公知的类似因素。
具有本领域普通技能的医师能容易地确定和给出本文所公开的组合物的所需有效量。因此，施用的剂量范围可根据需要由医师调节，如同本文其它地方所更完整描述的。
实施例
实施例1
开发了一系列具有不同口味的加入CBD和/或THC的茶包。
I.成分
叶片形式、油形式、冲泡形式的茶，有机和非有机的(图1和3)
蒸发干燥的脱脂奶粉(图1和2)
CBD油(图1和5)
用于摄入的大麻油或可相容油
大麻叶、芽、油；所有种类均含有THC和/或CBD
II.罂粟制剂
II A.CBD茶
将蒸发干燥的脱脂奶粉与任何和所有的茶(有机和非有机的)合并
将CBD油与茶叶掺合
将茶、CBD油和蒸发干燥的脱脂奶粉的混合物在食品脱水机中脱水(图4)
终产品是仅含有CBD增强物的罂粟茶(图6)
II B.THC/CBD茶
将蒸发干燥的脱脂奶粉与任何和所有茶叶(有机和非有机的)合并
将大麻或其它可摄入油与茶叶掺合
将大麻叶添加到上述混合物中
将茶叶、大麻或其它可摄入油、大麻叶和蒸发干燥脱脂奶粉的混合物脱水
终产品是含有THC和CBD的罂粟茶
III.罂粟制剂：规格
III A.CBD茶
茶：一个茶包包含1克到3克茶叶(干重)
蒸发干燥的脱脂奶粉：0.10-1.00克
CBD油：10mgs.-25mgs./茶包
III B.THC/CBD茶
茶：一个茶包包含1.5–12克茶叶(干重)/茶包
蒸发干燥的奶粉：0.10-6.00克/茶包
大麻油或其它可摄入油：10mgs.-25mgs./茶包
大麻叶：1.00-12.00克/茶包
III C.生产设备：
用于茶和/或大麻叶的市售研磨机
市售混合机
市售脱水器
市售茶包填料机
IV.调味剂
罂粟茶将提供添加到茶包或散茶选品的调味剂清单，包括但不限于薄荷、柑橘和香草。
实施例2
开发了将CBD和/或THC粘附到食品产品的方法。所述食品产品可选自肉、鱼、水果、蔬菜、乳制品、豆、意大利面、面包、谷物、种子、坚果、香料和草药。所述方法可涉及或不涉及将该食品产品与向日葵和/或蒸发干燥奶粉接触。所述方法包括以下步骤：
1.将食品产品用0-60克CBD和/或THC油或提取物饱和。
2.将该食品产品置于脱水纸上并在食品脱水机中放置0-24小时。
3.将该食品产品从脱水机中取出并在气密性容器中保存。
实施例3
用多种亲脂性活性剂配置黑茶。活性剂以约4.5mg活性成分/克终产品的浓度投配到茶中，使用脱脂奶粉和葵花籽油作为赋形剂。以下成分用于制剂：
453g散装叶黑茶
2265mg活性剂
45g蒸发干燥速溶脱脂奶粉
1132.5mg葵花籽油
将组分在不锈钢碗中合并，并用戴手套的手混合。
将均匀混合物在脱水机托盘上铺平并脱水30分钟。在冷却后，将配制好的茶放置到无菌拉链袋中。
所配制的活性成分是：ASA(阿司匹林)、布洛芬、对乙酰氨基酚、双氯芬酸、吲哚美辛、吡罗昔康、烟碱和维生素E(α-生育酚)。具体的每种活性剂的具体供应商信息和批号在下表1中显示。
表1–用于制剂的活性剂
化合物 CAS号 供应商 产品样本号 批号
ASA(阿司匹林) 50-78-2 Sigma-Aldrich A2093 #MKBQ8444V
布洛芬 15687-27-1 Sigma-Aldrich 14833 #MKBQ4505V
对乙酰氨基酚 103-90-2 Sigma-Aldrich A5000 #MKBS7142V
双氯芬酸 15307-79-6 Sigma-Aldrich D6899 #BCBN3367V
吲哚美辛 53-86-1 Sigma-Aldrich I8280 #MKBR4530V
吡罗昔康 36322-90-4 Sigma-Aldrich P0847 #SLBF3478V
烟碱 54-11-5 Sigma-Aldrich N3876 #1449194V
维生素E(α-生育酚) 10191-41-0 Sigma-Aldrich 258024 #MKBT5983V
所用的茶是来自Upton Tea Imports(Holliston,MA)的散装叶英国早餐茶。
葵花油是Whole Foods牌有机葵花油。
脱脂奶粉是NowFoods牌有机脱脂奶粉。
所用的脱水机是Presto Dehydrator，型号#06300。
将制剂的每个组分称取出来并如上面程序中所述进行合并。用于每个制剂的各活性剂的重量总结在下表2中。
表2–活性剂的配制
对于每个制剂，用手将成分混合，直到得到均匀混合物，随后就将其平铺在脱水机托盘上进行干燥。每个制剂在脱水机中干燥30分钟。在冷却后，将混合物放置到拉链袋中。在对分析天平将拉链袋去皮后，记录最终制剂的重量并计算制剂中活性成分的浓度(表2)。
说明书中提到的所有公开出版物、专利申请、专利和其它参考文献均表明本公开主题所属领域技术人员的水平。所有公开出版物、专利申请、专利和其它文献均通过引用并入本文，其程度如同每篇单独公开出版物、专利申请、专利和其它参考文献均被具体和单独指明通过引用并入一样。应理解尽管在本文中引用了多篇专利申请、专利和其它参考文献，这样的参考文献并非承认这些文件中的任何形成本领域的公知常识的一部分。
尽管为清楚理解的目的通过说明和例子的方式对前述主题进行了相当详细的描述，本领域技术人员应理解可在所附权利要求范围内实施某些改变和修饰。

Claims (52)

1.加入亲脂性活性剂的食品产品，包括：
(a)治疗有效量的亲脂性活性剂，其中所述亲脂性活性剂选自大麻素、烟碱、非甾体抗炎药(NSAID)和维生素；
(b)生物利用度增强剂，其中所述生物利用度增强剂增强所述亲脂性活性剂的生物利用度；和
(c)食品产品，其中所述食品产品选自茶叶、咖啡豆、可可粉、肉、鱼、水果、蔬菜、乳制品、豆、意大利面、面包、谷物、种子、坚果、香料和草药。
2.如权利要求1所述的加入亲脂性活性剂的食品产品，通过以下步骤获得：
(i)将食品产品与包含亲脂性活性剂和生物利用度增强剂的油接触；和
(ii)将食品产品脱水；
从而制成所述加入亲脂性活性剂的食品产品。
3.如权利要求2所述的加入亲脂性活性剂的食品产品，其中步骤(i)包括将所述食品产品在所述包含亲脂性活性剂和生物利用度增强剂的油中饱和。
4.如权利要求1-3中任一项所述的加入亲脂性活性剂的食品产品，其中所述生物利用度增强剂为食用油或脂肪。
5.如权利要求1-3中任一项所述的加入亲脂性活性剂的食品产品，其中所述生物利用度增强剂为保护胶体。
6.如权利要求1-3中任一项所述的加入亲脂性活性剂的食品产品，其中所述生物利用度增强剂是保护胶体和食用油或脂肪二者。
7.如权利要求6所述的加入亲脂性活性剂的食品产品，其中所述生物利用度增强剂也是亲脂性活性剂味道掩蔽剂。
8.如权利要求7所述的加入亲脂性活性剂的食品产品，其中作为保护胶体、食用油或脂肪以及亲脂性活性剂味道掩蔽剂的所述生物利用度增强剂是脱脂奶粉。
9.如权利要求1-8中任一项所述的加入亲脂性活性剂的食品产品，其中所述生物利用度增强剂基本不含Ω-6脂肪酸。
10.如权利要求1-9中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约1.5倍。
11.如权利要求1-9中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约2倍。
12.如权利要求1-9中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约5倍。
13.如权利要求1-9中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约10倍。
14.如权利要求1-9中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂在受试者中的生物利用度大于20％。
15.如权利要求1-14中任一项所述的加入亲脂性活性剂的食品产品，还包括调味剂。
16.如权利要求15所述的加入亲脂性活性剂的食品产品，其中所述调味剂选自香草、香草醛、乙基香草醛、橙油、薄荷油、草莓、覆盆子及其混合物。
17.如权利要求1-16中任一项所述的加入亲脂性活性剂的食品产品，进一步地，其中所述加入亲脂性活性剂的食品产品是冻干的。
18.如权利要求1-17中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂是非精神活性的大麻素。
19.如权利要求18所述的加入亲脂性活性剂的食品产品，其中所述非精神活性大麻素是大麻二酚。
20.如权利要求1-17中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂是选自以下的大麻素：
其中R27、R28和R29独立选自H、诸如CH3的低级烷基和诸如COCH3的羧基，特别是其中：
a)R27＝R28＝R29＝H
b)R27＝R29＝H；R28＝CH3
c)R27＝R28＝CH3；R29＝H
d)R27＝R28＝COCH3；R29＝H
e)R27＝H；R28＝R29＝COCH3。
21.如权利要求1-17中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂是选自以下的NSAID：乙酰水杨酸、布洛芬、对乙酰氨基酚、双氯芬酸、吲哚美辛和吡罗昔康。
22.如权利要求1-17中任一项所述的加入亲脂性活性剂的食品产品，其中所述亲脂性活性剂是维生素E。
23.加入亲脂性活性剂的饮料产品，通过以下步骤获得：
(i)提供根据权利要求1-23中任一项所述的加入亲脂性活性剂的茶叶、咖啡豆或可可粉；和
(ii)将所述加入亲脂性活性剂的茶叶、咖啡豆或可可粉浸泡在液体中；
由此制得所述加入亲脂性活性剂的饮料产品。
24.制备加入亲脂性活性剂的食品产品的方法，包括以下步骤：
(i)将食品产品与包含亲脂性活性剂和生物利用度增强剂的油接触；和
(ii)将食品产品脱水；
由此制得所述加入亲脂性活性剂的食品产品；其中所述加入亲脂性活性剂的食品产品包括治疗有效量的亲脂性活性剂，并且进一步地，其中：
(a)所述亲脂性活性剂选自大麻素、烟碱、非甾体抗炎药(NSAID)和维生素；
(b)所述生物利用度增强剂增强所述亲脂性活性剂的生物利用度；和
(c)所述食品产品选自茶叶、咖啡豆、可可粉、肉、鱼、水果、蔬菜、乳制品、豆、意大利面、面包、谷物、种子、坚果、香料和草药。
25.如权利要求25所述的方法，其中步骤(i)包括将所述食品产品在所述包含亲脂性活性剂和生物利用度增强剂的油中饱和。
26.如权利要求24-26中任一项所述的方法，其中所述生物利用度增强剂是食用油或脂肪。
27.如权利要求24-26中任一项所述的方法，其中所述生物利用度增强剂是保护胶体。
28.如权利要求24-26中任一项所述的方法，其中所述生物利用度增强剂是保护胶体和食用油或脂肪二者。
29.如权利要求29所述的方法，其中所述生物利用度增强剂也是亲脂性活性剂味道掩蔽剂。
30.如权利要求30所述的方法，其中作为保护胶体、食用油或脂肪以及亲脂性活性剂味道掩蔽剂的所述生物利用度增强剂是脱脂奶粉。
31.如权利要求24-31中任一项所述的方法，其中所述生物利用度增强剂基本不含Ω-6脂肪酸。
32.如权利要求24-32中任一项所述的方法，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约1.5倍。
33.如权利要求24-32中任一项所述的方法，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约2倍。
34.如权利要求24-32中任一项所述的方法，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约5倍。
35.如权利要求24-32中任一项所述的方法，其中所述亲脂性活性剂在受试者中的生物利用度比没有生物利用度增强剂时所述亲脂性活性剂在受试者中的生物利用度高至少约10倍。
36.如权利要求24-32中任一项所述的方法，其中所述亲脂性活性剂在受试者中的生物利用度大于20％。
37.如权利要求24-37中任一项所述的方法，进一步地，其中步骤(i)包括将所述食品产品与调味剂接触。
38.如权利要求38所述的方法，其中所述调味剂选自香草、香草醛、乙基香草醛、橙油、薄荷油、草莓、覆盆子及其混合物。
39.如权利要求24-39中任一项所述的方法，还包括将所述加入亲脂性活性剂的食品产品冻干的步骤。
40.如权利要求24-40中任一项所述的方法，其中所述亲脂性活性剂是非精神活性大麻素。
41.如权利要求41所述的方法，其中所述非精神活性大麻素是大麻二酚。
42.如权利要求24-42中任一项所述的方法，其中所述亲脂性活性剂是选自以下的大麻素：
其中R27、R28和R29独立选自H、诸如CH3的低级烷基和诸如COCH3的羧基，特别是其中：
a)R27＝R28＝R29＝H
b)R27＝R29＝H；R28＝CH3
c)R27＝R28＝CH3；R29＝H
d)R27＝R28＝COCH3；R29＝H
e)R27＝H；R28＝R29＝COCH3。
43.如权利要求24-40中任一项所述的方法，其中所述亲脂性活性剂是选自以下的NSAID：乙酰水杨酸、布洛芬、对乙酰氨基酚、双氯芬酸、吲哚美辛和吡罗昔康。
44.如权利要求24-40中任一项所述的方法，其中所述亲脂性活性剂是维生素E。
45.如权利要求24-45中任一项所述的方法，其中所述加入亲脂性活性剂的食品产品是茶叶，还包括将所述茶叶包装在茶包中。
46.制备加入亲脂性活性剂的饮料产品的方法，包括制备根据权利要求24-46中任一项所述的加入亲脂性活性剂的茶叶、咖啡豆或可可粉；还包括以下步骤：将所述加入亲脂性活性剂的茶叶、咖啡豆或可可粉浸泡在液体中，从而制得所述加入亲脂性活性剂的饮料产品。
47.治疗状况的方法，包括对有此需要的受试者施用如权利要求1-23中任一项所述的加入亲脂性活性剂的食品产品或者如权利要求24所述的加入亲脂性活性剂的饮料产品，其中所述亲脂性活性剂是大麻素，且其中所述状况选自心脏疾病，诸如心脏病、缺血性梗死和心血管代谢病；神经疾病，诸如阿尔茨海默病、帕金森氏病、精神分裂症和人免疫缺损病毒(HIV)痴呆；肥胖症；代谢疾病，诸如胰岛素相关缺陷和血脂水平、肝脏疾病、糖尿病和食欲异常；癌症化疗；良性前列腺肥大；肠易激综合征；胆道疾病；卵巢疾病；大麻滥用；和酒精、鸦片、烟碱或可卡因成瘾。
48.治疗状况的方法，包括对有此需要的受试者施用如权利要求1-23中任一项所述的加入亲脂性活性剂的食品产品或如权利要求24所述的加入亲脂性活性剂的饮料产品，其中所述亲脂性活性剂是烟碱，且其中所述状况是选自以下的烟碱-相关病症：烟草依赖/成瘾、帕金森氏病、溃疡性结肠炎(ulcerative colitis)、阿尔茨海默病、精神分裂症、注意缺陷多动障碍(ADHD)、妥瑞氏综合征、溃疡性结肠炎(ulcerous colitis)和戒烟后体重控制。
49.治疗状况的方法，包括对有此需要的受试者施用如权利要求1-23中任一项所述的加入亲脂性活性剂的食品产品或如权利要求24所述的加入亲脂性活性剂的饮料产品，其中所述亲脂性活性剂是NSAID，且其中所述状况是选自以下的疼痛、发热和/或炎性相关疾病或者病症：哮喘、慢性阻塞性肺病、肺纤维化、炎性肠病、肠易激综合征、炎性疼痛、发热、偏头痛、头痛、下背痛、纤维肌痛、肌筋膜病症、病毒感染(例如，流感、普通感冒、带状疱疹、丙型肝炎和AIDS)、细菌感染、真菌感染、痛经、烧伤、外科或牙科手术、恶性肿瘤(例如，乳腺癌、结肠癌和前列腺癌)、前列腺素E过多综合征、经典性巴特综合征、动脉硬化、痛风、关节炎、骨关节炎、幼年型关节炎、类风湿性关节炎、风湿热、强直性脊柱炎、霍奇金氏病、全身性红斑狼疮、血管炎、胰腺炎、肾炎、黏液囊炎、结膜炎、虹膜炎、巩膜炎、葡萄膜炎、创口愈合、皮炎、湿疹、牛皮癣、中风、糖尿病、神经退行性疾病诸如阿尔茨海默病和多发性硬化、自体免疫疾病、变态反应性疾病、鼻炎、溃疡、冠心病、肉状瘤病以及任何其它带有炎性成分的疾病。
50.治疗状况的方法，包括对有此需要的受试者施用如权利要求1-23中任一项所述的加入亲脂性活性剂的食品产品或如权利要求24所述的加入亲脂性活性剂的饮料产品，其中所述亲脂性活性剂是维生素E，且其中所述状况是维生素E缺乏和/或维生素E相关疾病或病症，诸如与维生素E缺乏相关的共济失调。
51.增强亲脂性活性剂的生物利用度的方法，包括将如权利要求1-23中任一项所述的加入亲脂性活性剂的食品产品或如权利要求24所述的加入亲脂性活性剂的饮料产品加热至高于或等于人体温度的温度。
52.如权利要求49所述的增强亲脂性活性剂的生物利用度的方法，包括对人受试者口服施用所述加入亲脂性活性剂的食品产品。
CN201580031524.XA 2014-06-11 2015-06-10 加入亲脂性活性剂的食品和饮料组合物及其使用方法 Pending CN107072278A (zh)

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