CN101188948A - 包含木酚素的组合物 - Google Patents
包含木酚素的组合物 Download PDFInfo
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- CN101188948A CN101188948A CNA2006800198340A CN200680019834A CN101188948A CN 101188948 A CN101188948 A CN 101188948A CN A2006800198340 A CNA2006800198340 A CN A2006800198340A CN 200680019834 A CN200680019834 A CN 200680019834A CN 101188948 A CN101188948 A CN 101188948A
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- composition
- milligrams
- lignan
- tablet
- isoflavones
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- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
- DQWPFSLDHJDLRL-UHFFFAOYSA-N triethyl phosphate Chemical compound CCOP(=O)(OCC)OCC DQWPFSLDHJDLRL-UHFFFAOYSA-N 0.000 description 1
- ZIBGPFATKBEMQZ-UHFFFAOYSA-N triethylene glycol Chemical compound OCCOCCOCCO ZIBGPFATKBEMQZ-UHFFFAOYSA-N 0.000 description 1
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- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
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Abstract
提供了组合物,它包含木酚素以及另外的化合物例如异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素或葡糖胺。可以将所述组合物作为饮食增补剂以片剂、粉末或液体形式配制,或可以将其掺入食品中。还提供了通过施用所述组合物来处理各种疾病的方法。
Description
发明人:
Mark W. Empie
Brent D. Flickinger
Sam Z. Sun
领域
本发明涉及组合物,它包含:木酚素例如亚麻木酚素,和另一种植物次级代谢产物例如异黄酮、植物甾醇、虾青素、生育酚、儿茶素、多酚、花色素苷或葡糖胺。
背景
将饮食与疾病联系起来的传染病学研究提出,饮食组分可以导致一些人群中某些疾病的风险降低。例如,以大豆为主食的远东人群降低了乳腺癌、结肠癌和前列腺癌以及冠心病的比例,而在芬兰的人群降低了前列腺癌的比例。目前,研究人员正在研究具体的饮食化合物以理解这些流行病学观察的基础。
在饮食中消耗的一些植物是有益的植物化学品的丰富来源。大豆产品包含高浓度的异黄酮和皂草苷。未精制的谷类(包括含不限于小麦、欧车前、稻、亚麻和燕麦)都包含木酚素,其是与木质素最紧密相关的化合物。可可粉包含酚酸和儿茶素,其也出现在绿茶中。某些非饮食的植物也是这些相同的化学分子的来源,例如葛根和红三叶草中的木酚素和异黄酮。异黄酮和木酚素作为弱雌激素的物质。茶植物也是植物化学的丰富来源,其包括儿茶素和酚酸。
许多文献中的报道已经证明了植物化学亚麻子木酚素的好处。Rickard等人报道在5%亚麻子日常饮食水平的进料纯化木酚素可以显著降低动物的结肠和乳房致癌作用(Proceedings of the 57th FlaxInstitute of the United States,(Fargo,N.Dak.):8-13(1998))。Demark-Wahnefried等人也报道了亚麻子增补对前列腺的癌症生物学具有有益的影响(Demark-Wahnefried等人,Adult Urology58(1):47-52(2001))。
另外,已经报道了木酚素可以降低71%的I型和II型糖尿病发生率(Prasad,K.,Proc.of the American Diabetes Association(1999)),其作为降血压剂,降低了血压而不影响心率(申请于1999年6月16日的美国专利申请系列号60/140,972),其对防治狼疮肾炎提供了好处(美国专利号5,827,256),并降低了动物中高胆甾醇动脉粥样硬化(动脉粥样硬化132:69-76(1997))。此外,存在许多关于潜在抗氧化剂(Mol.&Cell.Biochem.202:91-100(1999)和木酚素抗癌性能(Anticancer Research 18:1405-1408(1998))的报道。
亚麻子,以全部研磨或脱脂形式已经引入动物饲料和粮食中,例如面包、曲奇饼、百吉圈和松饼。它也用作补充肉制品中的纤维水平(参见例如WO 00/19842)。
发明概述
提供了纯化的组合物,它们包含:木酚素,优选从亚麻中提取的木酚素,和另外的化合物例如异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素或葡糖胺。该组合物可以以剂型例如片剂、粉末或液态形式的配作饮食增补剂。该组合物可以用于食物、小吃或饮料产品。该组合物可以是任意适用于补充饮食的形式。
还提供了此处公开的处理病痛、条件、疾病或对付症状的施用组合物的方法。例如,该组合物可用于治疗心脏病(通过减轻与心脏病有关的症状,防止高胆甾醇动脉粥样硬化,降低心脏病的风险,降低血清胆固醇,降低缺血性损伤和增加内皮细胞的一氧化氮压榨);糖尿病(通过减轻与糖尿病有关的症状或延缓糖尿病发作,和调节血清葡萄糖的水平);骨质疏松症和关节炎(通过增加骨密度,降低随着年龄增长骨密度的损失,和减轻与关节炎相关的症状);前列腺癌(通过降低前列腺癌的风险,和延缓前列腺癌发作);和妇科条件(通过减轻与月经发作相关的症状,和减轻与绝经期发作有关相关的症状)。该组合物也可用于抑制巨噬细胞和内皮细胞的环加氧酶活性。该组合物也可用于防止或延缓转移。
还提供了使用此处公开的组合物治疗疾病的方法,其中该疾病可以通过使用血清特异性标记进行分析。该方法包括分析认为具有该疾病的人群的血清特异性标记,将组合物给药给这样的人群,然后再分析该血清特异性标记。在相对于第一次的第二次分析中,血清特异性标记的量的降低表明该化合物正有效地治疗该疾病。
提供一种组合物,其包含纯化的木酚素例如亚麻木酚素,和另外的纯化化合物,其可以是异黄酮例如大豆异黄酮,生育酚例如γ-生育酚,植物甾醇,多酚,儿茶素,花色素苷,虾青素,或葡糖胺例如葡糖胺硫酸盐。木酚素可以存在的量为:存在于组合物中的异黄酮重量的约4倍至约6倍、存在于组合物中的生育酚重量的约2倍至约6倍、存在于组合物中的植物甾醇重量的约1倍至约2倍、存在于组合物中的多酚重量的约1倍至约2倍、存在于组合物中的儿茶素重量的约1倍至约6倍、存在于组合物中的花色素苷重量的约2倍至约6倍、存在于组合物中的虾青素重量的约100倍至约400倍、或组合物中存在的葡糖胺重量的约1/5。该组合物可以是片剂、粉末或液体的形式。
还提供了一种包含该组合物的食品制品。任何食品制品可以尽可能地配制成包含该组合物。该食品制品可以单食用份的食品制品。食品制品可以包括约100毫克至约500毫克木酚素。食品制品也可以包括约15毫克至约120毫克异黄酮,约15毫克至约200毫克生育酚,约50毫克至约800毫克植物甾醇,约50毫克至约500毫克多酚,约15毫克至约300毫克儿茶素,约15毫克至约200毫克花色素苷,约0.25毫克至约5毫克虾青素,或约0.5克至约2克葡糖胺。
还提供了一种饮食增补剂,其包含纯化的木酚素例如亚麻木酚素,和另外的纯化化合物,其可以是异黄酮例如大豆异黄酮,生育酚例如γ-生育酚,植物甾醇,多酚,儿茶素,花色素苷,虾青素,或葡糖胺例如葡糖胺硫酸盐。该饮食增补剂可以是片剂、粉末或液体的形式。片剂形式的饮食增补剂可以包括约100毫克至约500毫克木酚素。片剂形式的饮食增补剂也可以包括约15毫克至约120毫克异黄酮,约15毫克至约200毫克生育酚,约50毫克至约400毫克植物甾醇,约50毫克至约500毫克多酚,约15毫克至约300毫克儿茶素,约15毫克至约200毫克花色素苷,约0.25毫克至约5毫克虾青素,或约0.5克至约2克葡糖胺。
本发明还提供了一种治疗人类的方法,其中该方法包括将此处公开的组合物给人施用,其中:如果该治疗是用于减轻与心脏病有关的症状,则该组合物包含纯化的木酚素和纯化的化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于防止高胆甾醇动脉粥样硬化,则该组合物包含纯化的木酚素和纯化的化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于降低心脏病的风险,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于降低血清胆固醇,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于降低缺血性的损伤,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于增加内皮细胞的一氧化氮压榨,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于抑制巨噬细胞中的环加氧酶活性,则该组合物包含纯化的木酚素和纯化的生育酚;如果该治疗是用于抑制内皮细胞中的环加氧酶活性,则该组合物包含纯化的木酚素和纯化的生育酚;如果该治疗是用于减轻与糖尿病有关的症状,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于防止或延缓糖尿病的发作,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于调节血清葡萄糖水平,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于增加骨密度,则该组合物包含纯化的木酚素和另外选自异黄酮和葡糖胺的纯化化合物。如果该治疗是用于降低随着年龄增长骨密度的损失,则该组合物包含纯化的木酚素和另外选自异黄酮和葡糖胺的纯化化合物。如果该治疗是用于减轻与关节炎相关的症状,则该组合物包含纯化的木酚素和另外选自异黄酮和葡糖胺的纯化化合物。如果该治疗是用于降低前列腺癌症的风险,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于延缓前列腺癌症的发作,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷和虾青素;如果该治疗是用于降低转移的风险,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素和葡糖胺;如果该治疗是用于延缓转移,则该组合物包含:纯化的木酚素和另外的纯化化合物,该化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素和葡糖胺;如果该治疗是用于减轻与月经发作的症状,则该组合物包含纯化的木酚素和纯化的异黄酮;或如果该治疗是用于减轻与绝经期发作的症状,则该组合物包含纯化的木酚素和纯化的异黄酮。
还提供了一种治疗疾病或条件的方法,其中该方法包括:在认为具有疾病或条件的受治疗者中分析用于疾病或条件的具体标记;将权利要求1的组合物给药给受治疗者;和再次在该受治疗者中分析该标记;其中所分析的标记的量的变化表明该疾病或条件正在进行治疗。
发明详述
除了此处公开的实施例,或除非另有明确的说明,即使术语“约”没有清楚地出现在值、量或范围之前,在说明书的下述部分和所附权利要求书中所有的数值范围、量、值和百分数例如用于材料的量、元素含量、反应时间和温度、量的比例等,也可以理解为以词语“约”开头。因此,除非有相反指示,在下列说明书和权利要求中提到的数值参数是近似值,其可以根据由本发明获得的所需性能改变。至少而不是试图限制等同原则应用于权利要求的范围,根据报告的有效数字和通过应用普通的舍入技术至少应当解释各个数值参数。尽管给本发明设置宽范围的数值范围和参数是近似值,但是在具体实施例中设置的数值应尽可能准确地进行报告。然而,任何数值固有地包含由在下面各自测试测量值中发现的标准偏差所必定产生的误差。此外,当在此处提出数值范围时,该范围包含所述范围的端点(即,可以使用端点)。当此处使用重量百分数时,所报告的数值以总重量为基准。
一方面,提供的纯化组合物包括木酚素优选亚麻木酚素,和另外的化合物。另外的化合物可以是异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素或葡糖胺。另一方面,提供的组合物是饮食增补剂形式、片剂、粉末或液体形式。还可以将组合物配制包含到任意食物组合物中。
还提供了此处公开的处理病痛、条件、疾病或对付症状的给药组合物、饮食增补剂和食物产品的方法。例如,组合物可以用于治疗心脏病,例如组合物可以用于减轻与心脏病有关的症状,防止高胆甾醇动脉粥样硬化,降低心脏病的风险,降低血清胆固醇,降低缺血性损伤和增加内皮细胞中的一氧化氮压榨。组合物还可以用于减轻与糖尿病有关的症状,防止或延缓糖尿病发作,和调节血清葡萄糖的水平。组合物还可以用于防止、降低或延缓转移的风险。可以将该组合物进行给药以增加骨密度,降低随年龄增长的骨密度的损失,减轻与关节炎相关的症状,降低前列腺癌的风险或延缓前列腺癌的发作,减轻与月经发作有关的症状,减轻与绝经期的发作有关的症状,和抑制巨噬细胞和内皮细胞内的环加氧酶活性。
已经发现许多次级植物代谢产物具有有益于健康的性能。通常,在日常饮食较高的,尤其是植物组分较高的人群中,通过显示降低发病率的流行病学研究,初步发现这些性能。消耗大量大豆的亚洲人群比西方人群的某些癌症的发生率低。
许多有证据说明对健康有益处的植物次级代谢产物列于如下。
木酚素
木酚素为次级植物代谢产物,其由莽草酸经由phenylpropanoid路径生产。木酚素由类黄酮前体产生,并有助于保护来自某些病原体和食肉动物的植物。木酚素定义为具有2,3-二苄基丁烷结构的化合物,并包括罗汉松树脂酚、裂环异落叶松脂素(secoisolaricinesinol)、落叶松脂素(lariuresinol)、异落叶松脂素、去甲二氢愈创木酸、松脂醇、橄榄树脂素和其它化合物,和其改性物,其包括二葡糖苷,但是不限于例如草棉黄素3,8-0-二吡喃葡糖苷、草棉黄素3,7-0-二甲醚和堪非醇3,7-0-二吡喃葡糖苷。甘油二酯是已知的两种重要的哺乳动物木酚素二苄基丁内酯肠内酯和二苄基丁烷肠二醇的前体(Setchell等人的,Biochem.J.197:447-458(1981))。
亚麻子(亚麻)是潜在地包括木酚素的植物雌激素的最富有的来源。在亚麻子中发现的伯木酚素是2,3-二(3-甲氧基-4-羟基二苄基)丁烷-1,4-二醇(闭联异松树脂醇),其以植物的天然状态保存为共轭闭联异松树脂醇二葡糖苷(SDG)。亚麻籽包含这些植物雌激素的水平,其比任何其它植物养料大75-800倍。植物木酚素,儿茶酚去甲二氢愈创木酸是之前食品工业使用的有效的抗氧化剂。根据美国专利号6,767,565公开的方法,亚麻木酚素也可以以分离纤维、压榨油或萃取的形式使用。木酚素也可以从2005年12月2日申请的,美国临时专利申请60/742,082公开的方法获得,其中的全部内容在此引入作为参考。
异黄酮
已经建议使用异黄酮治疗或防止乳腺癌、前列腺癌、皮肤癌和结肠癌。还建议使用异黄酮降低或防止多种与绝经期的发作和持续相关的症状,包括热毛刺和骨质疏松症,和使用异黄酮在某些心血管应用中是有效的,包括预防心脏病,降低胆固醇-脂类水平,调节血管生成,和提供其它有利的血管效果。此外,已经涉及异黄酮降低头疼、痴呆和炎症,治疗乙醇滥用,并且可以在免疫调整中起作用。
有时称为植物雌激素的异黄酮为杂环苯酚。大豆和其它植物例如红三叶草包含多种有益的异黄酮。在大豆蛋白质中发现的具体异黄酮的非限定性实例包括:糖苷例如染料木苷、黄豆苷和glycitin,和脱甲基化的糖苷配基形式例如染料木素、黄豆苷原和黄豆黄素。与异黄酮鸡豆黄素A和芒柄花黄素一起,红三叶草包含这些异黄酮。一次摄取这些化合物,它们就被认为是具有类似的活性。尽管不至于常规雌激素替代治疗,但是已经具体显示摄取大豆蛋白质可以明显降低绝经症状例如“热毛刺”。大豆蛋白质也可以用于治疗周期性的乳腺痛(与月经周期有关的胸部疼痛)。大豆异黄酮也是抗氧化剂,并可以增加骨密度,以及包含高水平异黄酮的大豆蛋白质已经显示具有降脂的效果。尽管常规的药物可用于获得所有的这些效果,但是通过寻求“天然”的替代物,大豆蛋白质通常用于激素替补治疗、钙补充物和降低胆固醇的药物,并有助于防止癌症。
吃高大豆饮食的人们显示降低了许多以上讨论的症状。因此,摄取大豆中发现的一定比例的某些植物化学的组合可以产生添加或协同效应。然而,高大豆饮食也具有某些不良效果包括胀气,和不受欢迎的味道,并且不管大豆具有上述健康的好处,但是西方消费者对改变他们的生活方式,在他们的饮食中引入大豆具有特有地迟疑。
生育酚
生育酚是抗氧化剂,并构成了各种维生素E。具有四个主要的生育酚的同系物,其就是α、β、γ和δ生育酚。尽管这四个维生素E的同系物表现出了生物活性,但是α-生育酚具有最高的生物活性。
在未加工的植物油例如大豆、向日葵、油菜、油菜籽、棉籽、棕榈油和米糠油中可以发现多种比例和浓度的生育酚。生育酚是植物油的有价值的组分,并具有许多实际应用。例如,生育酚帮助防止食品的氧化和变质,由于它们可以降低某些类型癌症的风险,因此也可以是有价值的饮食增补剂。
作为一类化合物,生育酚已经进行了广泛地研究。通过这些研究发现,某些生物学活性已经归因于生育酚。最值得注意的是,生育酚具有强抗氧化性。生育酚表现出较强地除去自由基的性能。因为该性能,生育酚包括在多种消费品中,包括食品和化妆品。
植物甾醇
植物甾醇是在结构上类似于胆固醇的植物甾醇,其多年来曾用于降低胆固醇吸收和血清胆固醇水平,而不在肠道中吸收。因此,植物甾醇可用于治疗血清胆固醇适度增加的个体,并包含在卖给通常人群的食品和饮食增补剂中。
化学上,自然出现的甾醇是在C17位置具有脂肪族侧链的C26-C30的甾族醇。胆固醇分子和植物甾醇分子之间的结构差异主要发现于基本结构的侧链结构。也可以将植物甾醇氢化生产植物甾烷醇,即植物甾醇。
多酚
植物酚类化合物作为自由单体或与其它植物化学结合出现,从而形成酯或糖苷。已知酚酸具有抗氧化剂活性。报告的亚麻子的主要含酚成分是香豆酸(4-葡糖基-肉桂酸)、咖啡酸(3-羟基-4-葡糖基-肉桂酸)、阿魏酸(3-甲氧基-4葡糖基肉桂酸)和羟甲基谷氨酸。这些化合物具有抗氧化剂和高胆甾醇性能。
在可可粉、咖啡、茶和其它可可属物质中发现多酚。多酚表现出抗氧化剂活性,并包括儿茶素、表儿茶素和原花青素。原花青素是包括儿茶素作为基本结构元素的聚合多酚。多酚对突变发生和致癌作用具有抑制效果。多酚被认为是可以有效地防止癌症、冠状和心血管病和发作、牙周病、动脉粥样硬化和高血压;抑制LDL氧化和DNA局部异构酶IT;和调节环加氧酶、脂肪氧合酶、一氧化氮或NO-合酶、细胞凋亡和血小板凝聚。它们也具有抗炎活性,并涉及延缓老化过程。这些抗氧化剂通常是水溶性的,并包含苯并二氢吡喃型化合物,例如儿茶素和表儿茶素(立体异构的2-(3,4-二羟苯基)-3,5,7-三羟基苯并二氢吡喃)和包括原花青素的低聚化结构。
儿茶素
儿茶素或黄烷-3-醇是一种多酚,其在绿茶、红茶、葡萄、葡萄酒和巧克力中出现。绿茶中的多酚儿茶素包括倍儿茶素(GC)、表焙儿茶素(EGC)、表儿茶素(EC)和表焙儿茶素没食子酸盐(EGCG)。它们具有有效的抗氧化剂性能,并正在研究它们的性能以防止癌症和心脏病。
花色素苷
花色素苷是一大类天然出现的给水果和蔬菜提供颜色的颜料。它们属于flavenoid类植物化合物,和按顺序flavenoids是植物多酚的亚纲。花色素苷具有抗氧化剂活性,并且正在研究它们的防癌活性,和降低LDL胆固醇含量和防止血凝的性能。
虾青素
虾青素是在甲壳类水生物和藻类天然出现的类胡萝卜素色素。它是一种有力的生物学抗氧化剂,表现出强烈的自由基清除活性和防止脂质过氧化作用和LDL-胆固醇、细胞膜、细胞和组织的氧化损伤。正在研究它可能在心血管疾病、眼睛健康、神经变性疾病、老化、免疫反应、氧化压力和癌症中起的作用。
类胡萝卜素是萜类化合物基团天然出现的黄色至红色颜料,其可以在植物、藻类、细菌和某些动物例如鸟和甲壳类水生物中发现。类胡萝卜素包括烃(胡罗卜素)和它们的氧化、醇衍生物(叶黄素)。类胡萝卜素包括海葵赤藓醇、虾青素、红木素、鸡油菌素、辣椒黄素、辣椒玉红素、β-8’-阿朴胡萝卜素醛(阿朴胡萝卜素醛)、β-12′-阿朴胡萝卜素醛、α-胡罗卜素、β-胡罗卜素、“胡罗卜素”(α-和β-胡罗卜素的混合物)、γ-胡罗卜素、β-隐黄素、叶黄素、番茄红素、violerythrin、玉米黄质和其含羟基或羧基组分的酯。许多类胡萝卜素实际上作为顺式和反式异构的形式出现,而合成化合物经常是外消旋混合物。
类胡萝卜素在生物学上具有活性的,由于它们对健康有益,所以用于食品、药物和营养增补剂领域。类胡萝卜素由于对涉及老化的黄斑变性、皮肤癌和心脏病有影响,所以已经进行了研究,和番茄红素也与降低心脏病和前列腺癌的风险有关。
葡糖胺
葡糖胺是在身体内产生的糖,并保持软骨。在甲壳类水生物的壳中发现少量葡糖胺,并将其通常认为是饮食增补剂以缓减关节炎的疼痛和硬化和其它退化关节病症。补充物形式包括葡糖胺硫酸盐、葡糖胺盐酸盐和正乙酰氨基葡萄糖。
通常消耗植物体可以摄取上述化合物,但是该量将受到通过个体可以消耗的植物体的数量的限制。可以将这些化合物进行萃取、浓缩和纯化,但是必须将其加工成适用于个体直接消耗的形式(例如,作为片剂、粉末或液体,至于饮食增补剂)或将其引入食品类。
如此处使用的,以上提到的木酚素或另一种化合物为通过以下方法从其天然源中“纯化”或“分离”,即通过从其原始环境中除去天然源,然后从天然源中关联的组分中完全或部分分离木酚素或其它化合物。因此,即使当“纯化”的时候,化合物也可以伴随有原始存在于天然源中的其它组分。在包含大量化合物的天然源的情况下,只有未加工的提纯是适合纯化该化合物所必须的。例如,采集并粉碎亚麻籽,以产生亚麻粉末可以是全部需要的纯化物,以净化亚麻籽中木酚素至所需水平。在这里使用的“纯化”包括术语“纯化”和“浓缩”通常理解的含义。此外该术语包括化合物的合成形式,其通常以纯化形式生产,并实际不需要纯化本身。例如,在包括在在这里描述组合物中之前,商业上可用的维生素E形式通常不需要进一步纯化。在这里使用的“饮食增补剂”包括预定要消耗配方,除了人正常的每日饮食。
木酚素和另外的化合物可以混合物存在于组合物中。例如,包括“生育酚”的组合物可以包括α生育酚,或可以包含α、β和γ生育酚的混合物。替代地,木酚素和另外的化合物可以是得自多种不同来源的混合物,例如包括“儿茶酚”的组合物可以包括得自绿茶和巧克力的儿茶酚混合物。
一个方面中,本发明提供一种组合物,包含木酚素,例如亚麻木酚素,和另外的化合物,选自:异黄酮、生育酚、植物甾醇、多酚、儿茶酚、花色素苷、虾青素、葡糖胺和其任何组合物。一个非限定实施方式中,配制组合物以提供约100毫克至约500毫克亚麻木酚素“食用份”。该非限定实施方式也可以提供一种或多种约15毫克至约200毫克生育酚,约15毫克至约120毫克异黄酮,约50毫克至约400毫克植物甾醇,约50毫克至约500毫克多酚,约15毫克至约300毫克儿茶酚,约15毫克至约200毫克花色素苷,约0.5克至约2克葡糖胺,和约50毫克至约500毫克多酚每食用份。患者每天可以采取优选约2食用份至约4食用份的剂量。
可以用木酚素和另外的化合物以相对百分数或比例配制组合物。例如,组合物可以包括木酚素和异黄酮,其中存在的木酚素是存在的异黄酮量的约4倍至约6倍(重量)。对于包括木酚素和生育酚的组合物,存在的木酚素量可以是存在的生育酚量的约2倍至约6倍(重量)。对于包括木酚素和植物甾醇的组合物,存在的木酚素量可以是存在的植物甾醇量的约1倍至约2倍(重量)。对于包括木酚素和多酚的组合物,存在的木酚素量可以是存在的多酚量的约1倍至约2倍(重量)。对于包括木酚素和儿茶酚的组合物,存在的木酚素量可以是存在的儿茶酚量的约1倍至约6倍(重量)。对于包括木酚素和花色素苷的组合物,存在的木酚素量可以是存在的花色素苷量的约2倍至约6倍(重量)。对于包括木酚素和虾青素的组合物,存在的木酚素量可以是存在的虾青素量的约100倍至约400倍(重量)。对于包括木酚素和葡糖胺的组合物,存在的葡糖胺量可以是存在的木酚素量的约5倍(重量)。
本发明组合物内化合物的所需食用份或剂量水平可以根据因素例如使用它们的人年龄、性别和重量而改变。可以调节每天的剂量水平,以根据预定用途提供最佳水平。然后可以调节的基本开始剂量可以是每天约2至约4“食用份”。
所述本发明组合物提供一定量化合物每天是指以规定量的单个每天剂量形成组合物,或每天的剂量分为多个食用份,目的使用者每天使用多个食用份以消耗每天剂量。每天的剂量在这里确定为通用准则,人使用该组合物将必然具有使用或多或少的选择。
用于生产此处组合物的木酚素和其它化合物可以从天然或合成来源获得。例如,包含木酚素和生育酚的组合物可以由粉碎亚麻籽和合成维生素E的组合物制成。组合物还可以包含得自复合源的单个化合物。例如,组合物内生育酚可以是天然和合成维生素E的混合物。
此处组合物中可以包括多种形式的化合物,例如高度净化形式或未加工形式。通常在可可粉和绿茶中发现儿茶酚。因此可以将绿茶萃取物形式的儿茶素加入组合物。替代地,可以将涂布在食品上巧克力形式的儿茶酚加入组合物,其中包含的巧克力量适于加入所需量儿茶酚。例如根据费用、生物可用性、配方便利和味道,本领域普通技术人员可以容易地选择来源。例如,组合物中可以包含亚麻纤维形式亚麻木酚素,或作为亚麻油。亚麻纤维可以包含约8毫克木酚素每1650毫克纤维,而亚麻油可以包含12毫克木酚素每15毫升油。
可以配制本发明组合物作为片剂、液体、粉末或任何其它合适的形式。片剂用于口服作为饮食增补剂,但是也可以可以溶于液体或粉碎并作为颗粒使用形式,单独或与食品混合。片剂可以是例如压缩粉末形式,或凝胶胶囊剂形式。亚麻油的木酚素含量通常高于亚麻纤维,因此可以更方便地提供包含亚麻油和任何另外化合物的凝胶胶囊剂形式木酚素。
还可以液态形式生产本发明组合物,以使用特定的体积,或可以生产组合物作为粉末。使用者可以将粉末混入其它产品,例如饮料,包括但不限于汁、牛奶、豆浆、婴儿配方、运动饮料、能量饮料、保健饮料和其它合适的饮料。例如,可以基于每“单位”基体以粉末递送组合物,其中一个单位(例如,一个量匙)提供所需单个食用份或每天组合物内化合物剂量。
组合物可以进一步包括天然和/或人造的调味品成分,染料或其他颜色添加剂,防腐剂,惰性赋形剂和其它本领域已知的传统食品增补剂添加剂。该成分可以包括由于香味、味道、颜色、结构、体积、溶度、溶解性或时间释放功能性原因加入的成分。
全部形式中,该组合物可以包含在食品中,例如包含在薄脆饼干、乳酪、酸奶、炸薯片、谷物、薄片、花生酱、曲奇饼、冰淇淋、椒盐卷饼、含明胶的小吃、布丁、米或其它谷物饼、压成块的加工食品(例如压成块的小吃或压成块的一餐,或作为加工食品中添加剂。例如,可以提供粉未状组合物,并混合面团用于烘烤产品。
该组合物还可以用于治疗一系列疾病或老化。一个实施方式中,分析人员中用于疾病或老化的特定标记物,该人员摄取该组合物一段时间以后,再次分析该标记物。标记物含量的减小(或增加,因为该标记物合适)表明正在治疗疾病。例如,适当的用于心脏病标记物包括但是不局限于,血清LDL胆固醇,c-反应蛋白、可溶的粘性分子和血清氧化LDL胆固醇。对于糖尿病,适当的标记物包括,但是不局限于HBAlc、禁食血清胰岛素、禁食血清葡萄糖、饭后血清胰岛素和饭后血清葡萄糖。HbAlc(血色素Alc,糖基化的血色素Alc,糖血红蛋白Alc)是多种血色素。HbAlc在两至三个月期间内,通过测量连接至血色素的分子数,测试分析平均血糖。对于前列腺疾病,适当的标记物包括但不限于前列腺特定抗原、峰尿流、IPSS得分。还可以使用其它特性得分。对于骨质疏松症,适当的标记物包括但是不局限于骨矿物含量和骨矿物密度。
还可以摄取该组合物用于一般健康,例如防止疾病或老化。
可以生产在这里公开的组合物,并以多种形式使用,并且优选是固体剂型。组合物的固体剂型可以是片剂、胶囊剂、锭、颗粒、微粒、凝聚、分时溶解胶囊、咀嚼药片、锭剂、颗粒状物、栓剂或片剂。本发明组合物可以药物组合物、非处方(OTC)组合物、食品增补剂、营养增补剂、健康食品、药品、保健食品、兽医产品和饲料的形式存在。优选剂型是片剂和凝胶锭。
优选,提供剂型为单次剂量或再分成几个包含合适量活性成分的单位剂量。单位剂型可以是包装制剂,该包装包含离散量制剂,例如包裹片剂、锭剂、颗粒或颗粒状物。单位剂型是片剂、胶囊剂、锭剂、颗粒或颗粒状物本身,或它是合适的数量任何包装形式。
术语“单位剂型”包括单个或多个剂量形式,其包含公开的活性成分量和一种或多种赋形剂,数量使得单个有利的给药通常需要一个或多个预定单位。在多次剂量形式例如刻痕片剂的情况下,预定单位将是一部分,例如多次剂量形式刻痕片剂的一半或四分之一。对于任何病人特定计量水平将取决于多种因素,包括治疗适应症、病人健康、年龄、性别、重量、食谱和药理学反应和其它因素。为了方便起见,全部每天剂量可以分开,如果需要,在白天给予部分或一次在早晨、午后、夜晚给予以及双相、三相等。控制、延迟(例如肠)和持续释放配方在本发明范围内,为了方便起见称为“控制释放”配方。
固体剂型的成分优选是细分散的,即粉末或颗粒,以提供整个剂型成分的均匀分布。细分散的成分在压片机和其它加工机械中流动较好,并且有助于生产具有有利性能的片剂,包括但不限于抗碎落性、均匀性等。
可以提供基本上任何可商购形式的用于本发明组合物的活性成分。例如可以作为聚集体提供。它们还可以涂布形式或非涂布形式提供。举例来说,可用于涂布这些活性成分的材料包括凝胶、单和二甘油酯(优选食品脂肪酸的单和二甘油酯,例如但是不限于DESCOTETTM或ROCOATTM)、硬脂酸、纤维素聚合物(例如但是不限于羧甲基纤维素、甲基纤维素、甲基纤维素、羟基丙基纤维素、羟丙基甲基纤维素、乙基纤维素等)、玉米蛋白质、醋酞纤维素或类似涂布剂。选择涂布剂不是关键的,并且该试剂的选择在熟练技术人员已知范围内。利用湿润造粒方法或干法成粒方法造粒一种或多种活性成分,以改善其可加工性。可以单独或结合聚集活性成分,并可以与一种或多种赋形剂聚集,例如,以形成一种聚集体,其包含至少约2 5%重量碳水化合物基材料、约1-10%重量水溶性粘合剂和保留重量的活性成分(一种或多种)。
可以预先处理并入片剂的成分,以形成颗粒。该方法已知为造粒。如通常定义的,“造粒”包括任何尺寸扩大方法,从而小颗粒同时聚集成为较大的,永久聚集产生具有合适一致性的自由流动组合物。该造粒组合物可以具有类似于干砂的一致性。可以通过在混合设备中搅拌或通过压缩、挤出或聚集实现造粒。本领域中已知任何湿润或干法成粒方法或下文形成的方法可用于造粒在这里公开的成分;使用的确切方法不是关键的。例如,干法成粒方法中,混合干燥成分(例如活性成分和赋形剂),以互相均匀分散它们。可以加入粘附干燥成分的造粒试剂。该成分与造粒试剂的粘性产生较大的均匀颗粒,其具有有利的处理性能。湿润造粒方法实例中,混合干燥成分,以互相均匀分散。将造粒溶液(即溶液中粘合剂)加入至混合干燥成分,该粘合剂粘合该成分。干燥该混合物,并任选碾磨。得到的产物包含也具有有利处理性能的颗粒。
还可以预先处理并入固体剂型的成分,以形成聚集体。生产聚集体的方法通常包括形成碳水化合物颗粒流化床的步骤,间歇地将液滴形式水溶性粘合剂溶液喷雾进入流化床,以导致均匀混合溶液和碳水化合物颗粒,并同时粘附碳水化合物颗粒,以形成团聚颗粒,间歇喷雾之间干燥流化床中颗粒,并连续喷雾和干燥,直至已经将所需溶液量喷雾进入床。
其后,干燥团聚颗粒至所需含水量或平衡含水量。可以混合碳水化合物基聚集体和活性成分,优选在低剪切混合机中。此外可以将润滑剂、香料和其它成分混合进入具有活性成分的聚集体。
优选聚集体包括下列材料:葡萄糖一水合物;葡萄糖一水合物和麦芽糖糊精;果糖;葡萄糖;甘露糖醇;果糖和麦芽糖糊精;蔗糖;蔗糖和麦芽糖糊精;乳糖;乳糖和麦芽糖糊精;麦芽糖;麦芽糖和麦芽糖糊精;木糖;木糖和麦芽糖糊精。下列材料的水溶液可以用作液体粘合剂溶液:淀粉糖浆固体;葡萄糖;蔗糖;聚(乙烯基吡硌烷酮);烹调浆糊;和上述的组合物,其任何组合物还可以包括麦芽糖糊精。
并入固体剂型之前,还可以涂布一种或多种成分。压缩成固体剂型之前,可以进一步涂布、聚集或造粒已经单独或组合涂布、造粒或聚集的成分。
通常生产片剂通过混合活性成分与一种或多种赋形剂,以形式混合物,其随后压缩成片剂。任选涂布该片剂。可以利用湿润或干法成粒方法,单独造粒活性成分和赋形剂,或可以在造粒之前混合这些的两种或更多种。如本领域已知,造粒成分可以改善其处理和加工性能,包括但不限于易于流动、易于与粉末、聚集或其它造粒产物混合等。
优选形成中混合活性成分与一种或多种赋形剂,并压缩形成片剂。然后用一种或多种涂层涂布片剂。除了活性成分(一种或多种),片剂的芯部和其涂层以及外层(如果具有)可以包括赋形剂,例如填料、粘合剂、崩解剂、润滑剂、助流剂、表面活性剂、染料和调味品。
可以包括在固体剂型中的药用可接受赋形剂包括例如粘合剂、酸化剂、碱化剂、吸附剂、增塑剂、防腐剂、抗氧化剂、缓冲剂、着色剂、分散剂、增稠剂、增溶剂、包被剂、增稠剂、防粘剂、稀释剂、涂布剂、崩解剂、助流剂、表面活性剂、润滑剂、不透明剂、抛光剂、染料、颜料、填料、香味料和脱硫剂。
术语“药用可接受的”包括在全部医药诊断范围内的化合物、材料、组合物和/或剂型,其适用于接触人类和动物组织,没有过度的毒性、刺激性、变态反应或其它问题或并发症,相应具有合理的效益/风险比例。
用于本发明片剂的填料是片剂配方领域中熟练技术人员已知的填料。该填料可以是可溶或不溶的,溶胀或不溶胀的,包括例如微晶纤维素、二碱价的磷酸钙、三碱价的磷酸钙、碳酸钙、石膏、葡萄糖、高岭石、乳糖、粉末纤维素、预糊化的淀粉、淀粉、蔗糖和其混合物。
本领域传统的润滑剂也可以用于外层,例如硬脂酸镁、硬脂酸锌、硬脂酸钙、硬脂酸、硬脂酰富马酸钠、氢化植物油、棕榈酸硬脂酸甘油酯、甘油基榆树酸酯、苯甲酸钠、十二烷硫酸钠、月桂基硫酸镁、矿物油、滑石和其混合物。
在这里使用的术语“涂布剂”包括用于涂布形成固体剂型的化合物,其用于防止大气氧或湿气分解活性成分,以提供给药后所需活性成分释放特性,以屏蔽活性成分物质的味道或气味,或用于美容目的。涂层可以具有多种类型,包括糖衣、薄膜涂层或肠溶衣。糖衣是水基的,并在形成的片剂周围产生变厚保护层。糖衣片通常以较高pH值溶解的肠中。薄膜涂层是在片剂或珠粒周围形成的薄保护层。除非它肠涂层,薄膜涂层将溶解在胃中。肠溶片或珠粒将通过胃,并在肠中粉碎。薄膜涂层例如上述包含在该定义内。
外涂层或层可以包括本领域传统的助流剂,例如胶体二氧化硅;本领域传统的崩解剂,例如羧甲基纤维素钙、羧甲基纤维素钠、硅酸铝镁、微晶纤维素、离子交换树脂钾、预糊化淀粉、海藻酸钠、淀粉羟基乙酸钠和其混合物。
外涂层中还可以包括表面活性剂。本领域传统的表面活性剂可以是阴离子(例如十二烷硫酸钠)、阳离子或中性表面活性剂离子盐(例如氯化钠)。
组合物中还可以通常用于片剂配方领域的染料、颜料和调味品。
这些配方还可以包含吸湿剂,其可以将水吸入片剂。该吸湿剂可以包括水溶性电解质、较小有机化合物、渗透调节剂,以增加剂型内渗透压力并吸收水。
本发明剂型可以包含任何多种疏水性或亲水性粘合剂。合适疏水性粘合剂的实例包括醋酸丁酸纤维素、醋酸丙酸纤维素、高分子量(200,000)丙酸纤维素、中等分子量(75,000)丙酸纤维素、低分子量(25,000)丙酸纤维素、醋酸纤维素、硝酸纤维素、乙基纤维素、聚醋酸乙烯酯和其它本领域普通技术人员已知的。合适的亲水性粘合剂实例包括聚(乙烯基吡硌烷酮)、乙烯醇聚合物、聚环氧乙烷、水溶性或水可膨胀的纤维素和淀粉衍生物和其它本领域普通技术人员已知的。
其它可以加入配方的粘合剂实例包括例如洋槐、黄芪胶、凝胶、淀粉、纤维素材料例如乙基纤维素、甲基纤维素、羟丙基甲基纤维素和羧甲基纤维素钠、藻酸及其盐、聚乙二醇、瓜耳豆胶、聚乙烯吡咯烷酮、多糖、糖、转化糖、波罗克赛默(包括但不限于PLURONICTMF68,PLURONICTMF127)、胶原蛋白、白蛋白、凝胶、非水溶剂中纤维素塑料、预糊化淀粉、浆糊和上述的组合物。其它粘合剂包括例如聚丙二醇、聚环氧乙烷-聚丙烯共聚物、聚乙烯酯、聚乙二醇、聚乙烯山梨糖醇酐酯、聚环氧乙烷或其组合物,和其它本领域普通技术人员已知的。
崩解剂包括有助于瓦解和/或溶解固体剂型和/或其成分的材料。崩解剂包括淀粉例如但是不限于玉米淀粉、马铃薯淀粉、其预胶化和变性淀粉;纤维素剂,例如但是不限于Ac二溶胶、蒙脱土、交联的PVP、甜味剂、膨润土、VEEGUMTM、微晶纤维素、藻朊酸盐、淀粉羟基乙酸钠;树胶例如但是不限于琼脂、瓜耳树胶、角豆荚果、刺梧桐、果胶和黄芪胶。
本发明固体剂型中可能需要增塑剂。举例来说,该增塑剂可以包括但是不限于低分子量聚合物、低聚物、共聚物、油剂、较小的有机分子、具有脂肪族羟基的低分子量多元醇、酯型增塑剂、乙二醇醚、聚(丙二醇)、多嵌段聚合物、单嵌段聚合物、低分子量聚(乙二醇)、柠檬酸酯、甘油三乙酸酯、丙二醇酞酸酯、磷酸酯、癸二酸酯、二醇衍生物、脂肪酸酯、丙三醇、乙二醇、1,2-丁二醇、2,3-丁二醇、苯代乙二醇、二乙二醇、二丙二醇、三甘醇、四甘醇和其它聚(乙二醇)化合物、单丙二醇单异丙醚、丙二醇单乙基醚、乙二醇单乙醚、二乙二醇单乙醚、山梨醇乳酸酯、乳酸乙酯、乳酸丁酯、乙醇酸乙酯、癸二酸二丁酯、癸二酸二甲酯、二-2-乙基己基癸二酸酯、磷酸三甲苯酯、磷酸三乙酯、磷酸三苯酯、乙酰化单酸甘油酯、矿物油、蓖麻油、三乙酸甘油酯、硬脂酸丁酯、单硬脂酸甘油酯、硬脂酸丁氧基乙酯、十八醇、邻苯二酸环己基乙酯、环己基甲基二丁基酞酸酯、邻苯二甲酸二乙酯、邻苯二甲酸二丁酯、二异丙基邻苯二甲酸酯、邻苯二甲酸二甲酯、邻苯二甲酸二辛酯、乙酰柠檬酸三丁酯、柠檬酸三乙酯、乙酰柠檬酸三乙酯、柠檬酸三丁酯、烯丙基甘醇酸酯和其组合物。所有这类增塑剂可从来源例如Aldrich或Sigma Chemical Co.或Morflex,Inc.商购。
在这里使用的术语“酸化剂”包括用于提供酸性介质的化合物,其用于产物稳定性。举例来说,该化合物包括但是不限于乙酸、柠檬酸、富马酸、盐酸和硝酸和其它本领域普通技术人员已知的。
在这里使用的术语“碱化剂”包括用于提供碱性介质的化合物,其用于产物稳定性。举例来说,该化合物包括但是不限于氨溶液、碳酸铵、二乙醇胺、单乙醇胺、氢氧化钾、四硼酸钠、碳酸钠、氢氧化钠、三乙醇胺和和其它本领域普通技术人员已知的。
此处使用的术语“吸附剂”包括能够用物理或化学(化学吸附)手段保持其它分子在其表面上的试剂。举例来说该化合物包括但是不限于粉末和活性木炭和其它本领域普通技术人员已知的。
此处使用的术语“防腐剂”包括用于防止微生物生长或防止一种或多种活性成分老化的化合物。举例来说该化合物包括但是不限于氯化苯甲烃铵、氯化苄乙氧铵、苯甲醇、氯化十六烷吡啶、氯代丁醇、苯酚、苯乙醇、硝酸苯汞和硫柳汞和其它本领域普通技术人员已知的。
此处使用的术语“抗氧化剂”包括抑制氧化的试剂,因此用于防止因为氧化过程制剂老化。举例来说该化合物包括但是不限于抗坏血酸、抗坏血酸棕榈酸酯、丁羟基大茴香醚、2,6-二叔丁基对甲酚、次磷酸、单硫甘油、培酸丙酯、抗坏血酸钠、亚硫酸氢钠、甲醛合次硫酸氢钠和焦亚硫酸钠以及其它本领域普通技术人员已知的。
此处使用的术语“缓冲剂”包括用于稀释或加入酸或碱时抗pH改变的化合物。举例来说,该化合物包括但是不限于偏磷酸钾、磷酸钾、一碱价乙酸钠和柠檬酸钠无水和二水合物以及其它本领域普通技术人员已知的。
此处使用的术语“着色剂”包括用于赋予固体药物制剂(例如片剂和胶囊剂)颜色的化合物。举例来说该化合物包括但是不限于FD&CRed No.3,FD&C Red No.20,FD&C Yellow No.6,FD&C Blue No.2,FD&C Green No.5,FD&C Orange No.5,FD&C Red No.8,焦糖和氧化铁、红颜料以及其它本领域普通技术人员已知的。着色剂还可以包括颜料、染料、色调剂、二氧化钛、天然着色剂例如葡萄皮提取物、甜菜红粉末、胡萝卜素、胭脂树、胭脂红、姜黄、红竦椒、CHROMAKOTETM以及其它本领域普通技术人员已知的。
此处使用的术语“香味料”包括天然或人造的化合物,或这些的一些组合物,用于赋予药物制剂令人愉快的香味和通常气味。并入组合物的香料可以选自天然和合成香料油剂和调味品芳族化合物和/或天然油剂,植物、叶子、花、果实和其组合物的萃取物。举例来说该化合物包括但是不限于茴香油、肉桂油、香草、香草醛、可可粉、巧克力、薄荷醇、葡萄色、薄荷油、冬绿油、丁香油、月桂油、茴香油、按树属、麝香草油、雪松叶油、肉豆蔻油、南欧丹参油、苦杏仁油、桂皮油;柠檬油剂例如柠檬、橘色、石灰和葡萄柚油剂;和水果香精,包括浆果、苹果、梨子、桃子、枣椰树、蓝莓、鹬鸵、草莓、树莓、野生浆果(wildberry)、樱桃、梅子、凤梨和杏子。全部这些香味料是可商购的。优选香味料包括香草醛和浆果。调味品的量可以取决于许多因素,包括所需感观影响。
此处使用的术语“脱硫剂”包括用于赋予制剂甜味的化合物。举例来说该化合物包括但是不限于甜味素、葡萄糖、丙三醇、甘露糖醇、糖精钠、山梨醇、蔗糖高果糖玉米糖浆、果糖低聚糖以及其它本领域普通技术人员已知的。
此处使用的术语“片剂防粘剂”包括防止生产期间成分粘附至压片机中冲孔和和模具的试剂。举例来说该化合物包括但是不限于硬脂酸镁、玉米淀粉、硅氧烷二氧化物、滑石以及其它本领域普通技术人员已知的。
此处使用的术语“片剂粘合剂”包括用于导致片剂造粒中粉末颗粒粘附的物质。举例来说该化合物包括但是不限于洋槐、藻酸、羧甲基纤维素钠、可压缩的糖(例如NUTABTM)、乙基纤维素、凝胶、液状葡萄糖、甲基纤维素、聚乙烯基吡咯烷酮、预糊化淀粉以及其它本领域普通技术人员已知的。
此处使用的术语“片剂和胶囊剂稀释剂”包括惰性物质,用作填料,以在片剂和胶囊剂的制剂中形成所需体积、流动特性和压缩特性。举例来说该化合物包括但是不限于二碱价的磷酸钙、高岭粘土、果糖、蔗糖、葡萄糖、乳糖、甘露糖醇、微晶纤维素、粉末纤维素、沉淀碳酸钙、山梨醇、硫酸钙、淀粉以及其它本领域普通技术人员已知的。
此处使用的术语“直接压缩赋形剂”包括用于直接压缩片剂配方的化合物。举例来说该化合物包括但是不限于二碱价的磷酸钙(例如,DITABTM)、喷雾干燥物或无水乳糖、微晶纤维素、(AVICELTM)、右旋糖酐(EMDEXTM)、蔗糖(NUTABTM)以及其它本领域普通技术人员已知的。
此处使用的术语“助流剂”包括用于片剂和胶囊剂配方的试剂,以减小片剂压缩期间的摩擦。举例来说该化合物包括但是不限于胶态的或烟化二氧化硅、硬脂酸镁、玉米淀粉和滑石以及其它本领域普通技术人员已知的。
此处使用的术语“润滑剂”包括用于片剂配方的物质,以减小片剂压缩期间的摩擦。举例来说该化合物包括但是不限于硬脂酸钙、硬脂酸镁、矿物油、硬脂酸氢化植物油、苯甲酸、聚(乙二醇)、NaCI、PRUVTM、硬脂酸锌以及其它本领域普通技术人员已知的。
此处使用的术语“片剂/胶囊不透明剂”包括用于使胶囊剂或片剂涂层不透明。可以使用不透明剂s本身或与着色剂结合。举例来说该化合物包括但是不限于二氧化钛以及其它本领域普通技术人员已知的。
此处使用的术语“抛光剂”包括用于赋予糖衣片剂吸引人光泽的化合物。举例来说该化合物包括但是不限于巴西棕榈蜡和白蜡以及其它本领域普通技术人员已知的。
还可以涂布固体剂型或一种或多种成分。涂布成分可以屏蔽与该成分有关的使人厌恶的或非所需味道或气味。此外,涂层还可以稳定成分,特别是暴露至环境因素例如光线、氧气或水分时(特别是长时间暴露)可能损失其生理活性或活性降低或抑制的成分。当此处公开的配剂是可咀嚼的或快速溶解的组合物时,考虑使人厌恶味道或气味成分的涂层。当配剂是片剂时,单个成分涂层通常是不需要的,尽管片剂涂层可以用于改善片剂的稳定性、外观、味道、气味或加工性能。
本发明压实剂型可以包含薄膜涂层和压缩固体芯。薄膜涂层包含一种或多种成膜剂,例如用于一些薄膜涂层实施方式的成膜剂组合物。该成膜剂的组合物可以提供一种配方,其具有结合延迟和控制释放治疗剂;然而优选立即释放剂型。基于剂型的薄膜涂层还可以包含香味料和/或着色剂,例如颜料或染料。用于压迫片剂的涂层优选是快速地溶解最终或抛光涂层,例如包含纤维素聚合物、着色剂、香味料和蜡。
术语“成膜剂”包括聚合物(天然、合成、半合成品或遗传工程来源),其将在配方的固体芯周围形成薄膜涂层。
使用的薄膜涂层可以包含具有pH依赖溶解性的聚合物,人身摄取片剂时,其将在胃、小肠、小肠中段、小肠或大肠释放一种或多种成分的主要部分。依照要求可以改变薄膜涂层的厚度。
可以制备薄膜涂层通过施加溶液、悬浮液或乳液至存在的芯部或固体,并除去液体部分以形成基本上干燥薄膜。举例来说薄膜涂层可以包括一种或多种下列,但是不限于:醋酸纤维素、乙基纤维素、蜡、EUDRAGITTME100、EUDRAGITTMRS和EUDRAGITTMRL、EUDRAGITTML、EUDRAGITTMS、醋酞纤维素、羟丙基甲基纤维素邻苯二甲酸酯、HPMC乙酸酯琥珀酸酯、醋酸丁酸纤维素、醋酸丙酸纤维素、丙酸纤维素、HPMC、卡拉胶、硝酸纤维素、亲水性纤维素试剂、羟丙基纤维素、甲基纤维素、羟乙基纤维素、乙基纤维素、聚醋酸乙烯酯和乳胶分散体、聚酸、肠聚合物、多糖、洋槐、黄芪胶、瓜耳豆胶、凝胶、蛋白质、白蛋白、聚乳酸、可生物降解的聚合物、聚谷氨酸、巴西棕榈蜡、DRIKLEARTM(Crompton&Knowles,纤维素基聚合物分散体)、CHROMAKOTETM(Crompton&Knowles,着色的分散体)和其组合物。
举例来说,薄膜涂层还可以包括但是不限于聚(乙二醇)3350(PEG3350)、山梨醇、蔗糖、多元醇、木糖醇、甘露糖醇、碳水化合物、糖、乳糖、麦芽糖、葡萄糖、水溶性环糊精、脲、果糖、蔗糖、甘露糖;a-醇酸例如柠檬酸、酒石酸、富马酸、丁二酸、乙醇酸、乳酸、其组合物和其盐;卤化物反离子例如溴化物、氟化物、碘化物和氯化物;二价金属阳离子例如镁和钙;阴离子试剂例如磷酸盐、硫酸盐、磺酸盐、硝酸盐、碳酸氢钠,其组合物和其盐;纤维素塑料例如HPC;聚(环氧乙烷);聚乙烯基吡咯烷酮;树胶和胶凝剂例如黄原胶、藻酸,其组合物和其盐;粘土例如蒙脱土、膨润土、Veegum、高岭粘土;其它种类例如硅藻土、硅酸镁、有机皂土、锂蒙脱石、PLURONICSTM、亲水性表面活性剂;多元醇例如山梨醇、甘露糖醇、木糖醇;蛋白质例如胶原蛋白;水溶性氨基酸;崩解剂例如淀粉、淀粉羟基乙酸钠、交联羧甲基纤维素;和水溶性有机化合物;和其组合物。
具有外部聚合物层的组合物中,举例来说该层可以包括但是不限于pH独立的亲水性聚合物(例如但是不限于羟丙基甲基纤维素)、一种或多种填料(例如但是不限于微晶纤维素、二碱价的磷酸钙)、润滑剂(例如但是不限于硬脂酰富马酸钠),和助流剂(例如但是不限于胶体二氧化硅)。外层可以包括pH独立的亲水性聚合物,例如但是不限于羟丙基甲基纤维素。
咀嚼药片和粉末营养增补剂是营养制品工业中已知的。这些制品是用于提供有营养和可生物获得的制品,同时提供具有良好味道或感观影响的制品。然而通常制品包含维生素和矿物质越多,制品的口味越小。已经发展味道屏蔽技术,用于制备可口的咀嚼药片。该技术通常需要在片剂中包封成分,或在将组合物配制成为片剂之前,加入糖、甜味剂、可接受调味剂,或这些的一些组合物。
当片剂是咀嚼药片时,它将优选包含碳水化合物基聚集体,并且优选具有比外部柔软的可评测内部(例如由品评小组成员或病人)。这类结构与聚集体结合促进片剂在咀嚼之后不久于口腔中快速溶解。此外,这类结构减小片剂的吸收大气水分程度,即具有减小的吸湿性。
一种示范性从碳水化合物基聚集体生产咀嚼药片的方法包括混合聚集体与活性成分以及润滑剂,以形成基本上均匀的混合物,将其放置于传统的形成片剂装置中,并压缩以足够保持片剂硬度,并且基本上破坏在片剂表面的聚集体开孔结构,同时基本上保持片剂内部中聚集体的开孔即较大表面积结构。因此,压缩聚集体使得片剂内部保持聚集体的基本多孔结构和其它物理性质,其使得能够在咀嚼时快速液化,同时在片剂表面主要改变聚集体的物理性质。
本发明咀嚼药片中包括一种或多种赋形剂。一种赋形剂包括但是不限于酸化剂、碱化剂、吸附剂、抗真菌防腐剂、抗氧化剂、缓冲剂、着色剂、崩解剂、包封剂、香味料、吸湿剂、增塑剂、增稠剂、脱硫剂、片剂防粘剂、片剂粘合剂、片剂和胶囊剂稀释剂、片剂涂布剂、片剂直接压缩赋形剂、片剂崩解剂、片剂助流剂、片剂润滑剂、片剂/胶囊剂不透明剂和片剂抛光剂。
通常生产胶囊剂通过混合活性成分(其可以是粉末、造粒、涂布、聚集的,或这些的一些组合物)与一种或多种赋形剂,以形成混合物,其随后装入胶囊剂。胶囊剂优选是硬胶囊。然后连接胶囊剂二等份。
还可以将伴随有立即释放颗粒或涂层的多种形式延伸释放颗粒或涂层并入本配方,以多种比例递送多种成分。具有不同释放分布图的颗粒组合物的配方是已知的,并根据普通技术人员已知的方法和技术制备。
一个方面中,本发明包括一种快速释放的片剂组合物,其可以包括含有活性成分的内芯和快速崩解的外涂层或层,以快速释放活性成分。当层或涂层处于“快速”崩解状态时,这意味着它在给药后例如小于30分钟周期内崩解,例如小于10分钟。
本发明可以包括一种延迟释放组合物,其可以包括含活性成分内芯和不快速崩解的外层或涂层,例如其包含pH独立的亲水性聚合物与一种或多种填料。通过溶解并腐蚀下列给药逐渐除去外层,并且一旦暴露快速地崩解内芯。当“逐渐”除去层或涂层时,这意味着给药后例如1-8小时除去它,例如1-3.5小时,2-5小时或4-6小时。
本领域熟练技术人员较好地理解术语“pH独立的亲水性聚合物”。以不取决于周围液体pH的速度给药后,该聚合物溶解/腐蚀。该聚合物包括例如纤维素醚、聚乙烯吡咯烷酮、天然亲水性树胶的混合物,例如瓜耳豆胶、刺梧桐树胶、黄芪胶和黄原胶,以及其混合物。优选使用纤维素醚,最优选羟丙基甲基纤维素。
“快速溶解”成分是已知化合物量将在小于约3小时内、优选小于约1小时内基本上饱和或完全溶解在足够体积唾液或胃肠液中的成分。
“缓慢溶解”成分是其中化合物量将在大于约3小时内基本上完全溶解在足够体积唾液或胃肠液中的成分,优选大于约8小时,更优选大于约12小时,甚至长达48小时(但是优选不大于24小时)。
一种形式固体剂型包含具有立即释放分布的成分和具有控制释放分布的成分。普通技术人员应该理解“控制释放”剂型包括提供持续释放、延伸释放和延时释放的剂型。
本发明快速释放形式中,快速崩解内芯和快速崩解外涂层可以具有相同组合物,其可以包括一种或多种填料(例如微晶纤维素乳糖)、粘合剂(例如聚乙烯吡咯烷酮、预糊化的淀粉)、崩解剂(例如微晶纤维素、预糊化的淀粉)和润滑剂((例如硬脂酰富马酸钠、硬脂酸镁)。
本发明组合物可以具有肠溶衣,其将延迟下层发生腐蚀/瓦解,直至片剂达到其中具体pH占优势的胃肠道区域。该肠溶片允许活性成分活性成分到达结肠。用于本发明片剂的肠溶衣是本领域中熟练技术人员已知的涂层。该涂层包括醋酞纤维素、聚醋酸乙烯酯邻苯二甲酸酯、虫胶、苯乙烯马来酸共聚物、甲基丙烯酸共聚物和羟丙基甲基纤维素邻苯二甲酸酯。当本发明药物组合物是肠溶衣组合物时,它们特别可用于治疗下部胃肠道疾病。
可以利用传统的压片机器,根据本领域已知传统方法可以制备本发明组合物。例如,可以将pH独立的亲水性聚合物与一种或多种填料和任选其它赋形剂共混,压缩到一种或多种内层的芯部上,其中每个内层包含活性成分。例如可以通过压缩干燥半成品、湿润造粒或干混合产生的材料,制备活性物质的芯部。可以以同样的方式制备快速崩解外涂层混合物,并压缩到pH独立的亲水性聚合物涂布芯部上。
通常制备直接干压缩片剂组合物或配方,通过首先在高剪切药物型混合器,例如Zanchetta Roto-G、Littleford毫克T、Baker-Perkins High Shear、Littleford FKM混合器等中干混合全部或部分成分,以形式第一干燥混合混合物。加入剩余成分并共混混合物。
明显的是得到的可接受片剂将取决于混合物的含水量和其它特征,其将取决于许多因素例如成分的含水量、进行生产操作的设备中空气的温度和相对湿度,总加工持续时间和最终产物的粒径。
可以干燥混合物,例如可以保持直至干燥,或可以将其送入连续干燥器或分批干燥器例如透平盘式干燥机、直接加热旋转式干燥器、鼓式干燥器、带式干燥器、喷雾干燥器、流化床式干燥机和化学工艺熟练技术人员已知的类似工业干燥器(参见例如Kirk-Othmer’sEncyclopedia of Chemical Technology中“干燥”,8卷,91-112页,1979)。替代地,可以通过用其中成分是不溶的微细体积药用可接受和无毒挥发性水可混溶溶剂例如丙酮处理它,进行混合物脱水。
通常利用传统的片剂装置例如Manesty转轮印刷机、Stokes转轮印刷机等直接tabletted最终混合物。例如在Schlesinger硬度测试仪中测量得到的片剂硬度。130转数后用EurikaTab脆碎性测定器测量20个片剂的脆性。调节成分和片剂工艺,直至产生具有所需硬度和脆性的片剂。利用U.S.Pharmacoepia XXI.中提出的试验方法测量崩解时间和溶解时间。可以参考REMINGTON′S PHARMACEUTICALSCIENCES(第17版,1985年)用于指导。
胶囊剂或“锭”可以将不溶于水的成分包封在柔性凝胶壳中。软胶囊通常包封液体或半流体填料,其中溶解或分散活性成分。典型填充或用于软胶囊填料主要包含三酸甘油酯(三酰甘油酯或TAG)油剂,其中溶解活性成分。TAG油通常是植物油,例如但是不限于玉米油、花生油、红花油、向日葵油剂和豆油。更具体地说,TAG油剂包含连接至丙三醇主链的三个脂肪酸。因为水基载体,用作活性成分载体的油将溶解和破坏软胶囊的完整性。软胶囊用于与水接触时破裂,例如通常在病人胃肠道中存在的。
包封多种制品的柔性凝胶包封是长期确立的。基本技术公开于美国专利号2,234,479中。柔性凝胶包封方法此外公开于美国专利号2,349,430;2,387,747;2,449,139;3,592,945;3,656,997;4,028,024;4,670,287;4,816,259;4,935,243;5,146,758;5,735,105;和6,656,500。
软胶囊通常包装液体或半流体填料或其中溶解、分散和/或另外分布活性成分的“填料”。生产这些胶囊剂包括用通常不溶于水的胶囊包封材料混合物填充水溶性壳。软胶囊生产中,通常最小化或抑制胶囊剂的水溶性部分和水或含水材料之间的相互作用。壳的含水量通常保持在最小,并快速干燥壳,以在壳和填料或药物之间很可能发生相互作用时,在生产后和胶囊剂完全硬化之前最短时间内,立即从壳除去尽可能多水分。在填料的水溶性成分可以转移进入壳体时,干燥之前壳的水含量是最高的。因此,使用不溶于水的填料例如油剂是非常合乎需要的。干燥并硬化壳体后,胶囊剂基本上不受壳体中通常携带物质和壳体与填充挡板之间的相互作用的影响。
通常利用高度挠性和可变形的柔性凝胶生产软胶囊。包封之前提供带状凝胶。壳体由本领域已知的任何合适方式制造,例如上述列举专利中所述。胶囊剂的壳体通常是水溶性的,并且包含成分例如但是不限于水、凝胶、丙三醇、氢化淀粉和淀粉水解物。用存在的水以及通过加入丙三醇、山梨醇或类似多元醇,增塑软胶囊。可以混合凝胶与其它成分,以改变其用于不同应用的特征。术语“凝胶”包括任何凝胶基组合物,其适用于包封方法。
通常在形成并刚好在密封之前,用填充材料或药物填充软胶囊。填料实际上不溶于水,以防止填料和壳体之间的相互作用。包封机器通常拉伸两个凝胶带状物至上料点,其中凝胶条部分密封在胶囊剂内容物(填料)周围。通常利用flat或滚压模技术实现包封。非限定实例中,在每个流延鼓上浇铸凝胶带状物,然后送至一对旋转模具之间表面间,在其中形成胶囊剂,并用注入楔填充。用清洁辊帮助从剩余带状物除去胶囊剂。另一个非限定实例中,包封机械具有旋转模具类型,用两个接收器进料,一个包含用于形成壳体的熔化凝胶物质,另一个包含填料配方。
包封方法的另一个实例中,熔化凝胶靠重力流通过热管到达两个加热布料器。该布料器同时浇铸凝胶物质进入两个带状物。用分级椰子油/卵磷脂的共混物润滑这些,并递送至旋转模具。填料靠重力流入漏斗,其用作进料包封泵的储蓄器。用正位移活塞泵将填料配方递送至装填点。将两个凝胶带状物送进两个旋转模具之间。模具包含成对的囊状槽,其形成软胶囊形状,并提供密封机制。在两个模具pockets准确校正的时候,通过嵌入凝胶带状物之间的包封注入填料配方。由于模具之间压力形成密封,并通过包封楔施加热量,以产生软胶囊。
通常用两相方法干燥软胶囊。首先,将胶囊剂转移到旋转式干燥器,在其中将它们置于温暖、低湿度、强制通风环境预定时间长度。从旋转式干燥器排放后第二阶段开始,在浅干燥塔板上扩散胶囊剂,并令低湿度空气经过它们。在几天内转移水往返于壳体,直至已经蒸发凝胶批量生产期间投入凝胶的水。进行胶囊剂硬度测定,以监测干燥过程。监测胶囊剂,直至硬度在特定范围内。然后将胶囊剂投入深处保持的塔板。用V.M.&P Naptha检查并抛光胶囊剂,以在分级和包装之前,除去胶囊剂表面上的润滑膜。
另一个软胶囊生产实例中,美国专利4,028,024公开了通过使用冷空气吹透有孔的运输带,从挤出机头输送期间,冷却新挤出的胶囊剂。
通过下面的非限定性实施例进一步说明本发明。下列实施例具体涉及口服片剂,然而通过改变剂型的形状和配方,可以具有其它固体剂型。
实施例
实施例1.片剂形式的木酚素和异黄酮组合物
可以配制片剂形式的组合物。例如,这里描述的含木酚素和异黄酮的片剂可以如下表A中所述片剂的形式制造。
表A.包含木酚素和异黄酮的片剂。
成分 | 量 |
亚麻木酚素浓缩物(75毫克SDG;木酚素浓度=35%SDG) | 215毫克 |
异黄酮类(50毫克总异黄酮;例如,Novasoy=40%异黄酮) | 125毫克 |
磷酸二钙 | 957毫克 |
山梨糖醇 | 60毫克 |
硬脂酸镁 | 3毫克 |
可以利用通常用于压片领域的方法混合各成分,并压成片剂。例如,在商业混合器中混合各成分,直至均匀混合。利用压片机将得到的混合物压成片剂。
该片剂还可以包含分散助剂、粘合剂(例如羟丙基纤维素)、溶剂、填充剂、调味品和其它成分。还可以将片剂包衣。
实施例2.片剂形式的木酚素和α-生育酚组合物
可以配制片剂形式的组合物。例如,这里描述的含木酚素和生育酚的片剂可以由如下表B中所述片剂的形式制造。
表B.包含木酚素和生育酚的片剂。
成分 | 量 |
亚麻木酚素浓缩物(75毫克SDG;木酚素浓度=35%SDG) | 215毫克 |
RRR-α-生育酚琥珀酸酯(50毫克RRR-α-生育酚) | 63毫克 |
磷酸二钙 | 779毫克 |
山梨糖醇 | 60毫克 |
硬脂酸镁 | 3毫克 |
可以利用通常用于片剂领域的方法混合各成分,并压成片剂。例如,在商业混合器中混合各成分,直至均匀混合。利用压片机将得到的混合物压成片剂。
该片剂还可以包含分散助剂、粘合剂(例如羟丙基纤维素)、溶剂、填充剂、调味品和其它成分。还可以将片剂包衣。
实施例3.粉末形式的木酚素和异黄酮组合物
可以配制干燥粉末形式的组合物。例如,此处公开的含木酚素和异黄酮的粉末可以如下表C中所述粉末的形式制造。
表C.包含木酚素和异黄酮的粉末。
成分 | 量 |
亚麻木酚素浓缩物(75毫克SDG;木酚素浓度=35%SDG) | 215毫克 |
异黄酮类(50毫克总异黄酮;例如,Novasoy=40%异黄酮) | 125毫克 |
磷酸二钙 | 957毫克 |
山梨糖醇 | 60毫克 |
可以利用通常用于配制干燥粉末的方法混合各成分。例如,在商业混合器中混合各成分,直至均匀混合。片剂还可以包含分散助剂、溶剂、填充剂、调味品和其它成分。还可以将该混合物干燥(例如喷雾干燥)和研磨。优选得到的粉末是易流动性粉末。
实施例4.粉末形式的木酚素和α-生育酚组合物
可以配制干燥粉末形式的组合物。例如,可以生产如下所述粉末形式的如此处描述的含木酚素和生育酚的粉末。
表B.包含木酚素和生育酚的粉末。
成分 | 量 |
亚麻木酚素浓缩物(75毫克SDG;木酚素浓度=35%SDG) | 215毫克 |
RRR-α-生育酚琥珀酸酯(50毫克RRR-α-生育酚) | 63毫克 |
磷酸二钙 | 779毫克 |
山梨糖醇 | 60毫克 |
可以利用通常用于配制干燥粉末的方法混合各成分。例如,在商业混合器中混合各成分,直至均匀混合。片剂还可以包含分散助剂、溶剂、填充剂、调味品和其它成分。还可以将该混合物干燥(例如喷雾干燥)和研磨。优选得到的粉末是易流动性粉末。
实施例5.包衣片剂形式的木酚素和异黄酮组合物
可以将根据上述实施例1制备的片剂包衣。例如,可以2∶1(按重量)的比例混合DRI KLEARTM和CHROMAKOTETM以及香味料,并将混合物喷雾到片剂上,以形成表面涂层。可以用巴西棕榈蜡抛光表面涂层。
实施例6.木酚素胶囊剂
将木酚素和选自异黄酮、生育酚、植物甾醇、多酚、儿茶酚、花色素苷、虾青素、葡糖胺及其任意组合的纯化化合物置于用于给受试者施用的胶囊剂或片剂中。胶囊剂或片剂可以放置在容器例如带有标记或说明的瓶子中,所述标记或说明指导使用者木酚素和纯化化合物的推荐剂量,其中所述纯化化合物选自异黄酮、生育酚、植物甾醇、多酚、儿茶酚、花色素苷、虾青素、葡糖胺及其任意组合。木酚素的推荐剂量可以是每天860-1720毫克木酚素,其是每天约300-600毫克SDG。
虽然已经参考优选实施方式说明并描述了本发明,但是本领域普通技术人员能够理解的是,在不脱离所附权利要求书包含的本发明范围的情况下,可以作出各种在形式和细节上的改变。
Claims (20)
1.组合物,它包含:
纯化的木酚素;和
选自下组的纯化的化合物:异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素、葡糖胺及其任意的组合。
2.权利要求1的组合物,其中所述木酚素是亚麻木酚素。
3.权利要求1的组合物,其中所述异黄酮是大豆异黄酮。
4.权利要求1的组合物,其中所述生育酚是γ-生育酚。
5.权利要求1的组合物,其中所述葡糖胺是葡糖胺硫酸盐。
6.权利要求1的组合物,其中所述组合物为片剂、粉末或液体的形式。
7.包含权利要求1的组合物的容器,其中该容器具有指导使用者组合物的推荐剂量的标记。
8.权利要求1的组合物,其中组合物中存在的木酚素的重量为:
存在于组合物中的异黄酮重量的约4倍至约6倍;
存在于组合物中的生育酚重量的约2倍至约6倍;
存在于组合物中的植物甾醇重量的约1倍至约2倍;
存在于组合物中的多酚重量的约1倍至约2倍;
存在于组合物中的儿茶素重量的约1倍至约6倍;
存在于组合物中的花色素苷重量的约2倍至约6倍;
存在于组合物中的虾青素重量的约100倍至约400倍;或
存在于组合物中的葡糖胺重量的约1/5。
9.饮食增补剂,它包含:
纯化的木酚素;和
选自下组的纯化的化合物:异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素、葡糖胺及其任意的组合。
10.权利要求9的饮食增补剂,其中所述木酚素是亚麻木酚素。
11.权利要求9的饮食增补剂,其中所述异黄酮是大豆异黄酮。
12.权利要求9的饮食增补剂,其中所述生育酚是γ-生育酚。
13.权利要求9的饮食增补剂,其中所述葡糖胺是葡糖胺硫酸盐。
14.权利要求9的饮食增补剂,其中所述饮食增补剂为片剂、粉末或液体的形式。
15.包含权利要求9的饮食增补剂的容器,其中该容器具有指导使用者饮食增补剂的推荐剂量的标记。
16.权利要求9的饮食增补剂,其中所述饮食增补剂包含
约100毫克至约500毫克的木酚素,和:
约15毫克至约120毫克异黄酮;
约15毫克至约200毫克生育酚;
约50毫克至约400毫克植物甾醇;
约50毫克至约500毫克多酚;
约15毫克至约300毫克儿茶素;
约15毫克至约200毫克花色素苷;
约0.25毫克至约5.0毫克虾青素;或
约0.5克至约2克葡糖胺。
17.食物组合物,它包含:
纯化的木酚素;和
选自下组的纯化的化合物:异黄酮、生育酚、植物甾醇、多酚、儿茶素、花色素苷、虾青素、葡糖胺及其任意的组合。
18.权利要求17的食物组合物,其中所述食品是压成块的加工食品、曲奇饼、薄脆饼干、乳酪、酸奶、炸薯片、谷类食物、薄片、花生酱、冰淇淋、椒盐卷饼、含明胶的小吃、布丁、或米粉糕或其它谷类粉糕。
19.权利要求17的食物组合物,其中所述食物组合物为饮料。
20.权利要求19的食物组合物,其中所述饮料选自汁、奶、豆浆、婴儿配方食品、运动饮料、能量饮料和保健饮料。
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EP (1) | EP1876914A2 (zh) |
JP (1) | JP2008537678A (zh) |
CN (1) | CN101188948A (zh) |
AU (1) | AU2006232344A1 (zh) |
BR (1) | BRPI0607651A2 (zh) |
CA (1) | CA2604595A1 (zh) |
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US8283338B2 (en) | 2007-11-30 | 2012-10-09 | Kao Corporation | GIP secretion inhibitor |
US8338389B2 (en) | 2009-06-17 | 2012-12-25 | Kao Corporation | Agent for preventing or ameliorating obesity |
CN106793823A (zh) * | 2014-07-21 | 2017-05-31 | 雅培制药有限公司 | 营养物递送系统 |
CN108324757A (zh) * | 2018-05-17 | 2018-07-27 | 山西大学 | 胡麻多酚的提取方法及抗肿瘤应用 |
CN110367259A (zh) * | 2019-06-25 | 2019-10-25 | 山东省农业科学院作物研究所 | 一种小麦玉米周年高产抗逆栽培调控剂及其制备方法 |
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JP2008239619A (ja) * | 2007-02-28 | 2008-10-09 | Fuji Chem Ind Co Ltd | 末梢血行改善組成物 |
US20090208603A1 (en) * | 2007-09-14 | 2009-08-20 | Tic Gums, Inc. | Super dispersible gums and powders and process for making the same |
SE532965C2 (sv) * | 2008-02-06 | 2010-05-25 | Edio Healthcare Ab | Förfarande för framställning av mikropartiklar innehållande växtsterol |
JP4409617B1 (ja) * | 2008-12-04 | 2010-02-03 | 富士化学工業株式会社 | カロテノイド色素の退色防止方法及びその容器体 |
BRPI1008607B1 (pt) | 2009-02-23 | 2017-04-18 | Unilever Nv | composição cosmética comestível para o tratamento da pele envelhecida, método cosmético para proporcionar benefícios para a pele, e, usos da referida composição. |
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- 2006-04-03 JP JP2008505409A patent/JP2008537678A/ja active Pending
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Cited By (5)
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US8283338B2 (en) | 2007-11-30 | 2012-10-09 | Kao Corporation | GIP secretion inhibitor |
US8338389B2 (en) | 2009-06-17 | 2012-12-25 | Kao Corporation | Agent for preventing or ameliorating obesity |
CN106793823A (zh) * | 2014-07-21 | 2017-05-31 | 雅培制药有限公司 | 营养物递送系统 |
CN108324757A (zh) * | 2018-05-17 | 2018-07-27 | 山西大学 | 胡麻多酚的提取方法及抗肿瘤应用 |
CN110367259A (zh) * | 2019-06-25 | 2019-10-25 | 山东省农业科学院作物研究所 | 一种小麦玉米周年高产抗逆栽培调控剂及其制备方法 |
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JP2008537678A (ja) | 2008-09-25 |
WO2006107820A2 (en) | 2006-10-12 |
EP1876914A2 (en) | 2008-01-16 |
IL186093A0 (en) | 2008-01-20 |
AU2006232344A1 (en) | 2006-10-12 |
CA2604595A1 (en) | 2006-10-12 |
WO2006107820A3 (en) | 2007-05-24 |
NO20075540L (no) | 2007-11-01 |
BRPI0607651A2 (pt) | 2009-09-22 |
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