CN1777415B - 含可食用酸或其酸性盐的药物组合物及其用途 - Google Patents
含可食用酸或其酸性盐的药物组合物及其用途 Download PDFInfo
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- CN1777415B CN1777415B CN2004800105169A CN200480010516A CN1777415B CN 1777415 B CN1777415 B CN 1777415B CN 2004800105169 A CN2004800105169 A CN 2004800105169A CN 200480010516 A CN200480010516 A CN 200480010516A CN 1777415 B CN1777415 B CN 1777415B
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- acid
- hydrogen
- sodium
- potassium
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Abstract
本发明涉及降低体液的pH值而治疗或缓解免疫疾病的药物组合物;可食用酸和/或酸性盐,或含有可食用酸和/或酸性盐的酸性水果或其制品,在制备可用于改善个体免疫力的食品,饮料或保健品中的用途;制备引起过敏的风险降低的食品的方法;药剂可用于感冒、虫咬、皮肤炎、镇痛、抗痒、预防或治疗处理中、用作手套处理剂或其处理物、经皮吸收剂。
Description
【发明所属技术领域】
本发明涉及降低体液的pH值而治疗或缓解免疫疾病的药物组合物,其中含有可食用酸和/或酸性盐作为活性成分,可用于降低体液的pH值而治疗或缓解免疫疾病;可食用酸和/或酸性盐,或者含有所述酸和/或酸性盐的酸性水果或其制品在制备可用于改善个体免疫力的药品、食品、饮料或保健品中的用途;降低引起过敏风险的食品及其制备方法;可用于降低体液的pH值而作为治疗或缓解因虫咬所引起疾病的药物组合物、感冒药物组合物、抗炎药物组合物、皮肤炎的药物组合物、沐浴药物组合物、和皮肤接触物品如手套、衣物之处理药物组合物及其处理物、经皮吸收药物组合物、及心血管血栓防治药物组合物。
【背景技术】
由免疫反应机制(immunological mechanisms)所造成组织伤害的过敏性免疫反应(hypersensitivity)有四型:第I型为实时型(immediatetype)过敏性免疫反应,是由IgE抗体为介质的过敏性免疫反应,这种过敏性所引起的疾病有例如过敏性鼻炎、过敏性休克(anaphylaxis)、异位性皮肤炎(atopic dermatitis)、哮喘(asthma)、巴金森氏症(Parkinsonism)、枯草热(hay fever)、食物过敏(food allergy)等;第II型为细胞毒害型(cytotoxic type),是由IgM和IgG抗体为介质的过敏性免疫反应,这种过敏性所引起的免疫疾病有例如幼儿溶血病(haemolytic disease)、自体免疫性溶血性贫血(autoimmune haemolyticanaemia)、急性风湿热(acute rheumatism fever)、肾炎(nephropathy)、药物过敏(drug allergy)和肝炎(hepatitis)等;第III型为免疫复合体型(immune complex type)的过敏性免疫反应,这种过敏性所引起的免疫疾病有例如狼疮肾炎(lupus nephritis)、Arthus反应、类风湿性关节炎(rheumatoid arthritis)、血管炎(vasculitis)、和血清病(serumsickness)等;第IV型为迟缓型(delayed-type)过敏性免疫反应,是由T细胞为介质的过敏性免疫反应,这种过敏性所引起的免疫疾病有例如局部过敏(local allergy),组织过敏如第I型、红斑、糖尿病(diabetes)和多发性硬皮症等。
免疫缺陷疾病可分为先天性免疫缺陷疾病和获得性免疫缺陷综合症(acquired immune deficiency syndrome)二种,后者是由人类免疫缺陷病毒(human immunodeficiency virus,HIV)介导的疾病。前者所引起的疾病有例如呼吸道感染、疱疹病毒(herpes simplex virus)、慢性肺炎、流行性感冒和皮肤炎症(skin inflammatory)等疾病。大部分受HIV感染的病人会经过一段安静的病情,在此段期间HIV不断地复制,而使CD4 T细胞的数量和功能日渐减少,最后仅剩下少量的CD4 T细胞。药物只能短时地阻止HIV的复制和提升CD4 T细胞数量,但最后都会演变成获得性免疫缺陷综合症而死亡。虽然科学家努力想发展好的疫苗,但尚无良药。
肿瘤也是目前的难症之一,要杀死癌细胞而不影响到正常的细胞是不可能的。据研究结果知道,T细胞是肿瘤免疫的参与物,要治疗肿瘤必须先了解为何变异蛋白不能在患者体内诱导出毒性T细胞的机制。这个研究可能是免疫学家最大的挑战,因为这些变异蛋白非但是肿瘤的独特抗原,也是致癌的原因。疫苗为基础的肿瘤抗原是对T细胞为介质的癌免疫治疗理想的方向,所以这是很好的治疗目标。抗原特异性疫苗可由肿瘤共有的主要抗原所制备,这确实是理想的T细胞媒介免疫治疗剂。可是要鉴定可充作疫苗的肿瘤共同抗原仍需费时日,尚未成功。
适应性免疫系统作用在自体抗原,以致造成组织伤害的疾病都称为自体免疫疾病;参与免疫反应的介质是自体抗原或自体反应性T细胞,组织伤害是直接攻击含有自体抗原的细胞、免疫复合物的形成或局部发炎的结果。T细胞不但直接参与发炎和细胞破坏,而且是自体抗体持续反应时所需的因素,而B细胞则为维持抗原特异性T细胞持续作用的重要抗原呈递细胞。要控制自体免疫疾病需要知道如何鉴定T细胞所识别的自体抗原,和如何控制T细胞的活化。
目前对免疫紊乱(immune disorder)的疾病治疗药剂可分为三组:第一组为皮质类固醇类(cordicosteroid)的抗炎剂,如肾上腺皮质酮(prednisone)和抗组胺药(antihistamine);第二组为细胞毒性剂(cytotoxic agent),如硫唑嘌呤(zathioprime)和环磷酰胺(cyclophosphamide);第三组为抑制T细胞内信号传导的霉菌或细菌衍生物,如环孢菌素A(cyclosporine A)和雷帕霉素(rapamycin)。
这些抗炎剂虽然可以广为抑制免疫系统,可是同时也产生伤害。皮质类固醇类的功能是抗发炎,不过也有许多不利的严重副作用,例如体内水份的滞留、体重增加、糖尿病、骨质流失和皮肤变薄等,这是因为皮质类固醇类的使用导致自体激素功能衰退,连带降低自体的免疫功能的结果。细胞毒性剂是以杀死细胞而达到抑制免疫效果,也造成严重的副作用,包括降低免疫功能、贫血(anemia)、伤害肠道上皮细胞、脱发和胎儿伤害或死亡等。霉菌和细菌衍生物药剂,不但毒害肾和其它器官,治疗费用也昂贵,因为这种药剂是复合的天然物,制备不易,当然不便宜,而且必须长期服用。
在过敏反应时常引起伤害的分泌物之一是组胺(histamine),这是一种强而有力的、能引起许多种生理反应的介质。它是由组氨酸(histidine)经酶的脱二氧化碳而成,因此可以视为起源于生物的胺。它以无活性的形态存在于肥大细胞(mast cells)的异染粒(metachromaticgranula)、嗜酸性粒细胞(eosinophils)和嗜碱性白细胞(basophilicleukocytes)内,几乎分布在人体所有器官的组织和体液中。肥大细胞、嗜酸性粒细胞和嗜碱性白细胞一旦经抗原的刺激,则爆发性地释放出大量的组胺和其它物质,进入四周的组织和体液中。释放过程中,组胺的作用是在几乎所有的器官和组织里,引发许多生理和病理反应,此时马上产生血管壁的扩大,让血液流入附近的组织。这种反应的结果通常会使血管的液体耗尽,而引起通常熟知的组胺中毒或组胺休克。
控制像枯草热这样的过敏症状、关节炎和帕金森症时,通常使用抗组胺药(antihistamine)。这种药可以缓和流鼻涕、打喷嚏,也在某种程度上可降低结膜炎和呼吸困难,亦能缓和搔痒和由食物过敏引起的疡肿(发疹)。由化学的观点看,抗组胺药物包含许多种,一个人不能仅靠一样药物而治疗全部的病症,同样地对某人有效的药也不一定对其他人有效。此药的副作用有头晕、昏睡和注意力不能集中。服用抗组胺药的人不可以饮酒,或作须集中注意力的工作如驾驶,因此这种药的效果值得怀疑。除此之外,传统的抗组胺药无法阻止肥大细胞、嗜酸性粒细胞和嗜碱性粒细胞释放组胺等物质,无法中和体液中的组胺,无法完全降低血管的透过性,无法抑制发炎,无法增强细胞的免疫力,这些都是传统抗组胺药的缺点。
抑制组胺TH1受体的抗组胺药物可以减少肥大细胞及嗜酸性粒细胞释放出组胺引起荨麻疹。传统抗组胺药是由胺化合物所构成。众所周知,胺是具高碱性、对人体有毒性、伤胃等会造成严重的生理伤害、也大都是难溶于水的物质,因此胺原本是不适合作为药剂。为了改善它的缺点,化学家就利用酸包括无机酸和有机酸来中和胺化合物,制成胺盐,以降低胺的危害性和提高溶解性。常使用的无机酸有盐酸;而常用的有机酸有马来酸、富马酸、酒石酸、柠檬酸、苹果酸、单宁酸和琥珀酸等等。
例如,以传统抗组胺药剂如苯海拉明体系(diphenhydraminesystem)和氯苯那敏体系(chlorpheniramine system)的例子来说明,制备的方法是将苯海拉明和盐酸作用,生成苯海拉明盐酸盐的化合物;或将氯苯那敏和盐酸作用,生成氯苯那敏盐酸盐的化合物;同样地其它的例子,有用马来酸、柠檬酸、单宁酸、水杨酸、苹果酸等的有机酸,和胺中和作用后,生成的化合物则为:氯苯那敏马来酸盐(chlorpheniramine maleate)、苯海拉明柠檬酸盐(diphenhydraminecitrate)、苯海拉明单宁酸盐(diphenhydramine tannate)、苯海拉明水杨酸盐(diphenhydramine salicylate)、氯苯那敏苹果酸盐(chlorpheniramine malate)等。在这些传统抗组胺药剂商品中所含有的酸成份,如盐酸、马来酸、酒石酸、柠檬酸、苹果酸、单宁酸、水杨酸盐等,在抗组胺药剂中的功能都是单纯地作为胺的修饰剂,降低胺对人体的危害和提高水溶性。这是广泛用于过敏性免疫疾病治疗的传统抗组胺药剂的由来。
日常生活中毒,有食物中毒和昆虫咬伤中毒,前者如因吃含病菌或腐败食物所引起的病菌毒素中毒,后者为昆虫咬伤后所注入的毒素引起的中毒。这些中毒也是引起剧烈的免疫反应,从广义上说也是免疫疾病的一种。其治疗大都用抗毒素和抗毒血清,抗毒素和抗血清类毒素(如白喉、破伤风)或血清(如蛇、黑寡妇)是由反复接种于动物身上制备的,因含大量抗体,在施用于人体以中和毒素时会产生过敏反应,使用前必须先作过敏试验,无特殊过敏性史方可使用,这是其缺点。
以上种种免疫疾病的治疗现状和药剂的缺点,促使申请人致力于研究改善,从而完成本发明。
【发明内容】
经申请人研究的结果知道,在免疫生理机制上,要维持一个人的免疫能力,首先必须要确保吞噬细胞、T细胞和B细胞等能正常运作的低pH值环境,也就是体液的酸性条件,即降低体液的pH值是相当重要的,现在列举其理由如下:
1、免疫系统的补体(complement)是一种血浆蛋白质系统,它可以和病原体作用形成标记而被吞噬细胞等摧毁,它也活化T淋巴细胞。补体系统补充大量各种不同的血浆蛋白质,互相作用以调理病原体使之被摧毁,同时引发一系列的发炎反应,以协助对抗感染。补体蛋白是一种蛋白酶,它可以藉蛋白酶切割(proteolytic cleavage)使本身活化。此种蛋白酶储存在细胞中,为未活化的前体酶,只有在酸性环境下才能有活化作用(Frank,S.T.,and Nealis,A.S.,Immunol.Today 12,322~326,1991;Todd,J.A.,and Steinman,L.,Curr.Opin Immunol.5,83~89,1993)。故酸性条件是补体发挥功能的必要条件。
2、对于在细胞囊泡内(intravesicular)的病原体,要进行免疫作用时的生理机制,是先将病原体和第二类主要组织兼容性复合体(MHCclass II)结合,然后呈递给CD4 T细胞,对呈递细胞的影响是活化CD4T细胞,去杀死内吞噬泡(endocytic vesicles)内的细菌和寄生虫,其中细胞内液胞的pH值必须是在低的条件下(Chapman,H.A.,Curr.Opi.Immunol.10,93~102,1998;Pietes,J.,Adv.Immunol.Curr Opin.Immunol.75,159~208,2000)。故活化CD4 T细胞,去杀死细胞内液胞内的细菌和寄生虫,细胞内囊泡的pH值必须是酸性,这是一个必要条件。
3、至于细胞外病原体及毒素(extracellular pathogens and toxins),要进行免疫作用时的生理机制,是先将病原体和第二类主要组织兼容性复合体(MHC class II)结合,然后呈递给CD4 T细胞,对呈递细胞的影响是活化B细胞,以分泌Ig而将细胞外细菌及毒素排除。当时细胞内囊泡的pH值,也必须是在低的条件下(Morrison,L.A.et al.,J.Exp.Med.163,903,1968;Paulnock,D.M.,Curr.Opin. Immunol 4,344~349,1992)。故要将胞外细菌及毒素排除,细胞内囊泡的pH值必须是酸性,这是一个必要条件。
4、有些微生物如病原分枝杆菌是细胞内寄生性病原体,主要存在于巨噬细胞内的吞噬溶酶体(phagolysosome)中,能逃避抗体和细胞毒性T细胞的反应。原因是这种微生物能防止溶酶体和吞噬泡的融合,或者抑制吞噬泡产生酸化作用,此酸化作用是活化溶酶体蛋白酶发挥免疫功能所必需的。要消除这些微生物必须由TH1细胞活化巨噬细胞才行,因此pH值必须是在低的条件下。
对于细胞质内的病原体调理后,其由病毒外膜等和第一类主要组织兼容性复合体(MHC class I)相结合、然后呈递给毒性细胞(CD8 T细胞)的过程,是利用蛋白酶反应,将天冬酰胺(asparagine)置换成天冬酰氨酸(aspartic acid),从而将普遍存在膜上或分泌型蛋白质上、与天冬胺残基相连接的碳水化合物从细胞内排除。天冬酰胺的酶促水解反应必须在酸性的条件下才可以完成。
当细胞发生肿瘤性转化时,经常和第一类主要组织兼容性复合体(MHC class I)分子的大量减少有关。例如,被腺病毒-12感染的细胞,其癌基因的变化与因抗原处理转送因子TAP-1&-2太少而导致MHCclass I高度减少有关连。以乳腺癌来说,约60%的介静态肿瘤都缺少MHC class I(York,I.A.,et al.,Immunol.Rev.,172,49-66,1999)。
5、细胞突变时,常造成第一类主要组织兼容性复合体分子的减少或不表现,从而导致癌细胞转移能力的增强,这种结果显示癌细胞被T细胞攻击的机会减少。因此防癌的基本要件可能是提高补体(complement)的大量生产制造,也就是低pH值的问题(Niedermann,G.,et al.,Immunol.Rev.172,29~48,1999;Charles A.J.,Immunobiology5ed,161~179,Garland Publishing,NY,2001)。
6、有机体进行有氧呼吸时,约有2%的氧会产生超氧自由基(superoxide anion,·O2 -)。超氧自由基为非常活泼的物质,可与蛋白质、糖、脂肪酸、核酸反应,破坏细胞正常结构并干扰其正常功能,造成各种损害包括:癌、心血管疾病如主要的高血压、阿尔兹海默氏病(Alzheimer’s disease)、痴呆(dementia)、老人免疫缺陷、白内障(cataracts)、帕金森病、糖尿病、关节炎、发炎病、老化等自体免疫之疾病,这类疾病的产生都和自由基所引损伤有关。(Harman,D.,Age7,111-131,1984)。
人类首要用来对抗自由基伤害的方法是用抗氧化剂,也就是抗氧化酶如超氧化物歧化酶(Superoxide Dismutase,SOD)、GPX(Glutathione peroxidase)、GSH(tripeptide glutathione)等,这些酶能协助破坏自由基,如下文所述。
从化学的反应立场可以知道,自由基、尤其氧自由基的产生是在碱性的环境中才会有,如果在酸性环境中则无从发生,因为它会被质子即氢的离子所化解,也就是本发明的药剂刚好是消除自由基的良好抗自由基剂。
7、和人类生理密切相关的活性肽包括:SOD、类吗啡肽(Opioidpeptides,OP)、免疫活性肽(Immunopeptides)、抗高血压肽(Antihypertensive Peptides,AP)即血管紧张素转化酶抑制剂(Angiotensin I-Converting Enzyme Inhibitor,ACEI)、抗凝肽(Antithrombotic Peptides,ATP)、矿物质结合肽、CaseinPhosphopeptides(CPP)等,其形成当然是靠低pH值时的蛋白质分解,而且其活性的表现也必须要有低pH值的条件。
例如SOD,能捕获自由基的反应是在酸性条件下进行的。如果不是在酸性的条件,反应方程式是不会往右边偏移的,则无法进行氧自由基的消除工作。其反应式如下:
对各种疾病的治疗和预防,本发明药剂都有广阔的优越性能,其原因是本发明药剂能消除体内的自由基,因为自由基是所有一切疾病的根源,一旦能将引起疾病的根本原因-自由基清除,则疾病便无从发生。
血管紧张素转化酶抑制剂即ACE抑制肽,也就是抗高血压肽,其结构-活性的必要条件,是在C-端精氨酸和赖氨酸支链的氨基上的正电荷,这对抑制作用具实质性的功能。至于CPP对钙的亲和性,是由于磷酸丝氨酸残基的高度极性和酸性区对磷酸钙胶体的稳定作用,也证明了氨基酸残基对其理化性质的影响,尤其是对离子的结合能力,其条件也是由酸性来决定。基于此原因,本发明药剂具有提高对高血压的预防和抑制的功能。
在体内组织中,花生四烯酸(Arachidonic acid,AA)经由脂肪氧化酶(Lipoxygenase,LO)作用转变为羟基衍生物,如12-羟基廿碳四烯酸(12-Hydroxyeicosatetraenoic acid,12-HETE)和白三烯素(Leukotriene,LT)等,这些生成物会引起发炎和过敏症状;AA经由环氧化酶(Cycloxygenase,CO)作用可产生前列环素(Prostacyclin,PGX,PGI2)、前列凝素A2(Thromboxanes,TxA2)、PGA2、PGE2等。12-HETE对人的粒细胞具活化的作用(Siegel,M.I.et al,Proc.Natl.Acad.Sci.,77,308~312,1980);5-HETE为迟缓型过敏免疫反应物质(Slow-reacting-substance,SRS)的前体,因此,如果能抑制脂肪氧化酶,也就能抑制过敏和发炎的症状。凡是动物性及植物性的脂肪氧化酶(大豆)都具有生化学的活性,能作为抑制植物脂肪氧化酶的抑制剂,大都具有可以抑制由血液的血小板或由白血球诱导的脂肪氧化酶,这是已被证明的(Baumann,J.,et al.,Prostaglandins:20,627~639,1980)。
在AA经由环氧化酶作用产生前列环素(PGX,PGI2)和前列凝素A2的过程中,脂质过氧化作用和前列腺代谢之间关系密切,此关系就是有效的抗氧化剂保护作用。脂质过氧化作用需要痕迹量的氢氧化物与在酶活性部位的铁(III)血红素相互起作用,以形成一种过氧自由基,此自由基然后从花生四烯酸抽取一氢原子并促进反应进行。因此,如果能预先消除该自由基,也就可以阻止AA转变成前列凝素A2等的级联(Cascade)。非类固醇抗炎药如阿司比林(Asprin)的作用,是抑制环加氧酶的活力而抑制血小板的聚集力(赵克然,氧自由基与临床,37~40,合记图书出版社,2003)。
血小板活化导致血栓和栓子(Thrombus versus embolus)是因为血管受伤而引起一连串的复杂相互作用,于是凝血级联(Coagulationcascade)就展开。由AA产生的TxA2释放到血浆中,促进在止血小栓子快速形成时重要的团块生成作用(Clumping process)。
本发明药剂能抑制环加氧酶活力,因而也就抑制了整个前列腺素产生的过程,使前列腺凝素(thromboxane)等的释出受限制,可免除栓子(embolus)和血栓(thrombus)的生成导致中风之脑溢血和心肌梗塞等心血管疾病,因为血小板释放出的前列腺凝素是引发血小板加强凝集的信息,即是血块形成的第一步,所以如果能够抑制前列腺素的释放,或是能抑制环加氧酶活力,也就可抑制整个前列腺素生物合成,最后是消除可能产生的血栓。
人体在正常的状况下都具有先天性的免疫力,但是在体力衰弱时就失去免疫力。要恢复天然防护的免疫能力,当然要强化身体,其最重要且根本的方法,是依循免疫生理的机制,确保提高补体(complement)的大量生产制造,并且营造吞噬细胞、CD4 T细胞和B细胞等能正常运作的环境,也就是体液要维持低的pH值为必要条件,即降低体液的pH值。因为如果体内的体液缺乏低的酸度条件,就无法执行免疫的生理机制,其原因已如上所述。因此申请人经研究发现,利用天然可食性的酸或酸性盐降低体液的pH值,可以提高补体的生产制造、增强吞噬细胞、CD4 T细胞和B细胞等的作用力,达到增强或恢复免疫力的效果,由此完成了本发明。本发明解决了长久以来人类对许多免疫疾病无法解决的问题。
食物中毒和昆虫毒液如被蜘蛛等昆虫咬后所引起中毒的治疗,皆为引起人体内免疫保护的问题。由于是免疫问题,则本发明的药物组合物亦能作为食物中毒和昆虫毒液,如被蜘蛛等昆虫咬后所引起的中毒的治疗和防护,因为除了增加酸性而杀菌之外,最重要还是提高中和毒性和免疫能力。已知毒素大都含蛋白质,因此本发明的酸可以使该毒素变性而解毒或中和毒性。
唾液是体液的一种。通常人的唾液的pH值在pH6.8左右。为了验证实际测试作参考,现在一个人经过刷牙后,在服用700mg的柠檬酸后,测试其唾液的pH值随时间的变化,其结果如下表一所示,很显然pH值开始降低,在约60分钟时达到最低,二小时后再恢复到原状,这是体液的自然功能。
表一、唾液的pH值受酸性物质的影响
经过时间,分钟 | 0 | 20 | 60 | 90 | 120 |
pH值 | 6.8 | 6.45 | 6.26 | 6.6 | 6.8 |
虽然,在人体生理的机制上,任何酸性物质进入体内后,尿和唾液的pH值随着起变化,而血液则会受体内的缓冲作用,而快速地恢复到中性附近。也就是由骨释出钙离子中和有机酸,故表观上体液虽然稍为偏酸地恢复到近中性,但是体液中已有充分的氢离子和钙离子。多余的氢离子参与酸性相关的反应,而钙离子则参与传递免疫信号和活化钙调磷酸酶(calcineurin),因为钙调磷酸酶自身会随淋巴细胞的活化作用,所引起的细胞内钙离子的增加而活化。其实本发明药剂经身体吸收代谢后并不会残留任何东西。
过敏反应的结果是身体器官的严重发炎,本发明的药剂具有降低体液的pH值而治疗或缓解免疫疾病的功能,当然对于发炎有抑制功效,所以是抗发炎的最好药剂。
因此,本发明一方面提供了一种用于降低体液的pH值而治疗或缓解免疫疾病的药物组合物,其中含有有效量的可食用酸和/或酸性盐作为活性成分,以及任选地药学上可接受的载体。
本发明在另一方面提供了可食用酸和/或酸性盐在制备可用于降低体液的pH值而治疗或缓解免疫疾病的药物组合物中的用途。
在另一个方面,本发明提供了可食用酸和/或酸性盐,或含有可食用酸和/或酸性盐的酸性水果或其制品,在制备可用于改善个体免疫力的食品、饮料或保健品中的用途。
本发明还提供了一种制备降低过敏风险的食品的方法,包括用含有可食用酸和/或酸性盐的溶液处理所述食品。
本发明又提供了一种以含有可食用酸和/或酸性盐作为活性成分,降低体液的pH值而治疗或缓解食物中毒和昆虫毒液疾病的药物组合物,其中含有有效量的可食用有机酸和/或酸性盐作为活性成分以及任选地药学上可接受的载体。
本发明再提供了一种以含有可食性酸和/或酸性盐作为活性成分,降低体液的pH值而作为抗炎药剂的药物组合物。
本发明也提供了一种以含有可食性酸和/或酸性盐作为活性成分,用于降低体液pH值的感冒药物组合物、沐浴药物组合物、治疗头皮屑药物组合物、皮肤接触物品处理药物组合物及其被处理物、经皮吸收药物组合物、心血管血栓防治药物组合物、消除体内自由基的药物组合物、抗疼痛药物组合物。
本发明的其它方面,虽然未列在以上所陈述的范围内,但根据以下的说明、举例、以及所附专利申请范围各项中所示内容,普通技术人员将可以轻易地明白。
由于本发明是天然可食性的有机酸或酸性盐,所以对人体完全无害。而且,本发明是从最基本的消除体内自由基和免疫生理机制上作用,而非仅抑制某一种功能,例如抗组胺药仅能阻止一种受体(receptors)的作用而已。这是本发明和通常利用化学药物治疗的方式最大不同的地方,也是本发明的特征所在。本发明药物组合物中的可食用酸或酸性盐可以和肥大细胞、嗜酸性细胞和嗜碱性细胞释放出来的组胺结合,同时亦能封闭受体。进一步地,本发明的药物组合物可以提高体液和细胞的酸度,从而提高补体的生产制造,增进吞噬细胞、T细胞、B细胞等的免疫能力,恢复免疫机能,并且能抗炎镇痛,降低血管的通透性。传统的药剂如抗组胺药用于治病的机制是和体内的组胺互相竞争对组胺受体(histamine receptor)相结合的作用,由此封锁并降低组胺的作用。抗组胺药如果不能先和组胺受体结合,则抗组胺药剂不能发挥作用,而且抗组胺药无法阻止肥大细胞、嗜酸性细胞和嗜碱性细胞释放组胺,这也就是严重的过敏反应者首先不用抗组胺药而用肾上腺素(epinephrine)的原因。因此患者在预防过敏疾病时,必须全天候服用抗组胺药剂,以防有过敏原的进入引起反应。如此一来,病人就必须忍受二十四小时受药物副作用的折磨。而本发明药物组合物中不含胺成分,所以没有传统抗组胺药的副作用。另外值得一提的是,本发明的许多有效药剂都是人体代谢的成分,药剂本身经代谢后转变成能源,直接供应细胞执行免疫作用的活力。这些药剂成分又是良好的抗氧化剂,所以可有效地消除体内的自由基,无形中也提高人体的免疫力和阻遏疾病的产生。以上的这些特征都是传统药剂所不具有的。
如盘尼西林(penicillin)等易于产生过敏性休克(anaphylaxis),是因为盘尼西林内的β-内酰胺环(β-lactam ring)会和人体内蛋白质的氨基酸形成共价键。这种经过修饰的盘尼西林的自体肽,在某些个体中会引起TH2反应,进而活化与盘尼西林结合的B细胞,产生对盘尼西林半抗原相作用的IgE抗体。盘尼西林可作为B细胞抗原,或借着修饰的自体肽成为T细胞抗原。这样与肥大细胞上的IgE分子交叉结合,引起过敏反应,从而产生过敏性休克。如果以本发明的成分和盘尼西林配合则可以消除这样的过敏性休克。同样道理,疫苗的接种时如果也使用本发明药物配合,也可以降低因疫苗接种而引起的死亡。防止的方法是与本发明的药剂配合使用,可以先用本发明药剂、一起用药、或后续给予本发明药剂。
本发明药物组合物的优点还在于,由于其中的酸及酸性盐属天然食物成分,所以可以大量服用。另外,它们还可以和其它食品或其它药品配合,甚至加工时处理在食物表面上。
在本发明中,可以使用任何可以食用的酸或酸性盐、或者其任意组合,所述酸有无机酸如磷酸及其酸性盐,和有机酸及其酸性盐。无机磷酸及其酸性盐包括例如磷酸、磷酸二氢钠、磷酸二氢钾、磷酸氢二钠、磷酸氢二钾;有机酸及其酸性盐,例如富马酸(fumaric acid)、琥珀酸(succinic acid)、甲羟基酸、苹果酸(malic acid)、酒石酸(tartaric acid)、柠檬酸(citric acid)、乳酸(lactic acid)、甲羟基辛酸(α-hydroxy octanoicacid)、葡糖酸内酯(gluconolactone)、乙醇酸(glycollic acid);酸性柠檬酸盐,包括柠檬酸二氢钠(sodium dihydrogen citrate)、柠檬酸氢二钠(disodium hydrogen citrate),柠檬酸二氢钾(potassium dihydrogencitrate)、柠檬酸氢二钾(dipotassium hydrogen citrate);酸性琥珀酸盐,包括琥珀酸氢钠(sodium hydrogen succinate)和琥珀酸氢钾(potassium hydrogen succinate);酸性酒石酸盐,包括酒石酸氢钠(sodium hydrogen tartarate)和酒石酸氢钾(potassium hydrogentartarate);酸性苹果酸盐有苹果酸氢钠(sodium hydrogen malate)和苹果酸氢钾(potassium hydrogen malate);酸性富马酸盐有富马酸氢钠(sodium hydrogen fumarate)和富马酸氢钾(potassium hydrogenfumarate);乙酸、丙酸等;及其混合物等,它们对于治疗免疫疾病均具有良好的效果。
本发明药剂,在美国食品和药物管理局(the Food and DrugAdministration)列为GRAS(Generally recognized as safe)级,所以无毒性问题。在针剂如果直接注入病灶(如肿瘤)时应注意采用小剂量外,其它只关连到个人承受酸度的强弱和个人体质问题而已,与一般的药物相比有较大的范围,使用量并无特别的限制。本发明药剂的治疗,可分为口服和非口服二种,通常其一般剂量为0.1~300mg/kg/day,在特殊情况下其剂量可提高。依已知的药品制备方法,可以制成各种药剂,甚至和其它药剂一起调配。
本发明的药剂可经胃肠外途径给药,也包括皮下、肌肉、静脉、皮内、关节、肠内、肿瘤内注射,鼻腔(吸入和气溶胶)等,和体外用。
非口服体外用剂可依照传统的制药方法制备,其形态包括液体、膏状、气溶胶、喷雾剂、酒酊、皮肤贴剂等。液态的溶剂包括水、酒精、其它醇等。
针剂以无菌条件下用除菌水调制,常利用蔗糖和食盐调配成等渗溶液。溶剂除水以外,还可以用乙二醇和多醇类,如甘油、丙二醇、液态聚乙二醇、和其混合物。利用真空干燥法制成粉末更为理想。
本发明的药物组合物作为口服剂时,其中可以含无活性物质,包括可食用稀释剂、载体、甜味料、香料、生药、食品、其它营养品、和其任意混合物等,以及其它兼容性的活性物质。
口服剂的型态,可以制成胶囊剂、锭剂、片剂、粒剂、散剂、丸剂、口碇剂、糖浆、药液、悬浊液、掺于食品中等。
在本发明中,所述可食用酸或酸性盐也可用于制备饼干、蛋糕、糖果、口香糖、布丁、乳制品、花生制品、饮料、罐头、烹饪料理和其它加工食品,作为其覆层或含在其中。其中本发明有机酸和/或酸性盐成分量为0.06%~10%,优选地0.1%~7%,更优选地0.2%~4%,最优选地0.3%~2%(wt/wt)(由后面表五实施例验证)。
在本发明中,所述可食用酸和/或酸性盐还可用于制备饮料,包括如果汁、酒(如水果酒、威士忌、米酒、白兰地、清酒、啤酒、药酒)、清凉饮料、碳酸饮料、非碳酸饮料、茶、矿泉水、含酒精饮料、运动饮料、机能性饮料、咖啡、可乐、莎士、乳制品如发酵乳、药液等,其含本发明的有效药剂成分量为0.06%~10%,优选地0.1%~7%,更优选地0.2%~4%,最优选地0.3%~2%(wt/wt)(由后面表五实施例验证)。
在本发明中,所述降低体液pH值的可食用酸和/或酸性盐也可以用于对食品中的活性蛋白质进行变性处理,以使完全变性为止。故可食用酸和/或酸性盐的使用量视食品的情形而定,最好在反应的化学当量以上。
在本发明中,所述降低体液pH值的可食用酸和/或酸性盐可以施用于和皮肤接触的物质,如手套、衣物等表面,对其中含有的过敏原或蛋白质成分进行变性处理,以减少所接触皮肤的过敏作用。
同样道理,目前经皮吸收贴付药剂也使用胶质作为支持药剂的基材,该基材的胶质物容易引发贴付皮肤处过敏而生痒,以往都用水杨酸或抗组胺药作为防止贴付皮肤处过敏。水杨酸为伤肾药,而抗组胺药的缺点如前述。本发明之药剂除可以发挥抗炎、抗过敏的特性之外,也可以促进皮肤的活化而加速其它药剂经皮的吸收。
在本发明中,所述降低体液pH值的可食用酸和/或酸性盐,由于它的抗炎性及抗过敏性作用,同样可以作为头皮疾病如发痒、生头皮屑等的预防药剂,如清洁剂或护发剂。因为洗发时常用碱性肥皂洗涤,使头皮和头发变成碱性,细菌容易滋生而在发根处产生毛囊炎,生头皮屑和生痒。利用本发明药剂可以改善为酸性,抑制炎症和止痒,效果良好。
在本发明中,所述降低体液pH值的可食用酸和/或酸性盐,由于它的抗炎性及抗过敏性作用,同样可以作为心血管血栓的防治剂。
在本发明的口服组合物、食品或饮料中,可以包含其它常规的成分,包括:结合剂,如淀粉、甘油、聚乙烯吡咯烷酮、丙烯酸异-冰片酯共聚物、丙烯酸2-乙基己酯、Ca-CMC、CMC、明胶、糖胶树胶、醋酸乙烯脂、胶酯、聚乙烯、阿拉伯胶、黄蓍胶;增粘剂,如丙二醇海藻酸钠;软化剂,如D.B.P;分散剂,如碳酸钙、聚乙二醇、硬脂醇、流动腊;乳化剂,如Span-60;防腐剂,如对羟苯甲酸乙酯;润滑剂,如硬脂酸镁、滑石粉;酵素,如菠萝酵素、木瓜酵素、无花果浸质;甜味料,如砂糖、葡萄糖、黑糖、水饴、糖浆、蜂蜜、果糖、寡糖;香料,如薄荷、薄荷油、香精油绿油、草莓精油、异吉草酸乙酯、丁酸异戊酯、可口子萃取液;色料,如焦糖色料、叶绿素;生药,如棕儿茶、槟榔及其制品、蒜、葱、白党参、玉竹、桂皮、川牛漆、川芎、韭、姜、冬归、甘草、黄蓍、杏仁、人参、熟地、何乌首、具母、白术、法半夏、陈皮、天门冬、苏子、生地黄、紫苏、知母、白芥子、桑白皮、百合、胡麻、咖啡或咖啡因、茶等之粉或其萃取物;其它营养品,如矿物质、维生素、乳制品、花生制品、菜籽油、烹饪料理之菜肴、氨基酸;及其任意混合物。
含有本发明可食用有机酸和/或酸性盐成分0.3%以上的酸性水果,也可直接作为治疗药剂,如酸橘、脐橘、柠檬、梅果、葡萄柚、酸杨桃、桑果、草莓、菠萝等;由水果加工后之制品,其含可食用有机酸和/或酸性盐成分量为0.06%以上,最好达0.3%以上者,同样可以使用。
本发明的药物组合物可作为口服剂。当和其它成分一起制成食品状时,由于摄取该食品量的多寡,会影响到有效成分的摄取量,可食用有机酸和/或酸性盐的含量低时则需进食大量食物。以平常之药剂量300mg/dose来说,一个人一次能饮食的食物一般约为500ml或500克,此时如含有一次的药剂量300mg/dose,则此食物含的药剂为0.06%。不过通常的饮食的食物量约为250ml或250克,此时如含有一次的药剂量300mg/dose,则此食物含的药剂为0.12%。而一般病人吞服药片时,常用的开水量约100ml或100克,则此食物含的药剂为0.3%。
基于这样的关系,在药物组合物中可食用酸和/或酸性盐的含量,应为0.06%~100%,优选地0.1%~100%,更优选地0.2%~100%,最优选地0.3%~100%(wt/wt)(由后面表四实施例验证)。
在本发明可用于改善个体免疫力的食品、烹饪料理、饮料或保健品中,可食用酸和/或酸性盐的添加量可以达到0.06%~10%,优选地0.1%~7%,更优选地0.2%~4%,最优选地0.3%~2%(以食品、饮料或保健品总量计,wt/wt)。
根据本发明,可食用酸和/或酸性盐还可以用于加工食品。
通常所谓的过敏食品,是因食品中含有蛋白质,该蛋白质有活性而使食用者引起过敏的缘故,例如牛乳、乳粉等。如果能使该活性的蛋白质变成无活性,则可以消除过敏的作用。使用本发明的成分可以使蛋白质变性,所以利用此特性,将食品所含的全部蛋白质,用本发明成份进行处理,使其成为变性的蛋白质,就可防止食品的过敏作用。其中可食用酸和/或酸性盐的浓度为0.06%~10%,优选地0.1%~7%,更优选地0.2%~4%,最优选地0.3%~2%。
海产物在加工时加入适当量的本发明药剂成分,对于容易过敏的人是非常有益的,因为能起过敏的人,从来就不能吃海产。海产物中加入本发明的成分,非但能提供海鲜给过敏的人食用。而且,海鲜体内含有大量高度不饱和脂肪酸,由于盐分的存在,受空气的氧化而使鱼产品的品质劣化,而本发明的药剂为抗氧化剂,因此能使鱼产品保持良好的品质,这是本发明另外的特征。
本发明药剂的治疗功效,依其所含的酸基数多寡而定,以柠檬酸为例,其功能的强弱顺序如下:
柠檬酸>二氢柠檬酸盐>单氢柠檬酸盐
在本发明中,“个体”是指任何脊椎动物,尤其是哺乳动物,更优选是人。
【具体实施方式】
由以下例子,可以明白本发明的精神,不过这些例子只是用来说明本发明,而并非用来限定本发明的范围。
例1~29:抗过敏反应
这是用48/80(Sigma,St.MO,USA)(一种碱性多胺)作为抗原,来刺激肥大细胞等后,利用本发明药剂和其它药剂处理时,对其抑制组胺释放游离的功效作比较。
(1)、由小鼠的体内制备浸出的细胞液。
在已杀死且放血的小鼠体内,注入10ml含0.1%牛血清蛋白(Bovine albumin,Sigma)的洛克液(Locke’s solution),经轻轻按摩鼠体后取出体液,加入5ml的洛克液洗涤。二液合并,以600rpm离心处理5分钟。沉淀物用5ml的洛克液洗涤再分离。向收集的全部液体中再加入3ml冷洛克液,这些液体作为小鼠的体内制备浸出的细胞液。(Locke’s solution的组成为(w/v):NaCl 9.1%,KCl 0.2%,CaCl2 0.15%,glucose 1.0%,其它为蒸馏水)。
(2)、用48/80化合物作为抗原时,药剂抑制组胺释放游离的功效。
表一中所列各种药剂分别先用含NaHCO3 1%的生理盐水溶解,然后用洛克液稀释成100(μg/ml)的浓度。各种溶液各取1.0ml分别加入0.3ml小鼠浸出细胞液和0.5ml洛克液后,在37℃培养5分钟,然后加入0.2ml 48/80化合物的洛克液(1mg/100ml),再在37℃培养10分钟,随即冷却停止反应,并于2,500rpm离心分离10分钟,得到1.7ml的上清液和0.3ml的沉淀物。
上清液部分加入水0.1ml和100%三氯乙酸0.2ml。沉淀物部分加入洛克液1.5ml和100%三氯乙酸0.2ml,在室温放置30分钟后以3,000rpm分离15分钟。上清液部分和对沉淀物洗涤的上清液,各取0.35ml,分别各加入水1.65ml、1N NaOH 0.4ml,再加入0.5%邻苯二醛(OPT)的甲醇溶液0.1ml后,使在室温反应4分钟。接着加入2M柠檬酸0.2ml中止反应,最后用荧光光度计测定各试样的荧光度。这样测定的数值,可以计算出各药剂的组胺抑制效率。
对照组(control group)试验是用洛克液替代药剂,而空白组(blankgroup)是用洛克液替代药剂成分和48/80化合物的液体,其它操作都与试验组相同。
组胺游离率(%)以(A)表示,其值等于:在上清液部分所含的组胺量(Hs),和沉淀物部分洗涤液所含的组胺量(Hr),两者之总量作为分母,而上清液部分的组胺量(Hs)作为分子,乘以100%。即:
组胺游离率(A)(%)=(Hs)/{(Hs)+(Hr)}×100%
抑制率(%)=100-{(药剂的A值-空白组的A值)/(对照组
的A值-空白组的A值)}×100%。
计算结果列如下表二所示:
表二、药剂的抑制效果
实验例号 | 实验药剂100(μg/ml) | 组胺游离率(%) | 抑制率(%) |
对照组空白组(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21) | 对照组空白组甘草酸钠苯海拉明盐酸盐苯海拉明柠檬酸盐琥珀酸柠檬酸乳酸苹果酸酒石酸富马酸甲羟基乙酸甲羟基辛酸葡糖酸内酯乙酸丙酸抗坏血酸柠檬酸二氢钠柠檬酸氢二钠柠檬酸二氢钾柠檬酸氢二钾琥珀酸氢钠琥珀氢酸钾 | 90.59.065.564.760.28.98.78.99.08.98.99.09.08.99.09.09.09.058.69.057.99.09.0 | --30.932.137.510010010010010010010010010010010010010039.110040100100 |
(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34) | 酒石酸氢钠酒石酸氢钾苹果酸氢钠苹果酸氢钾马来酸氢钠马来酸氢钾富马酸氢钠富马酸氢钾磷酸磷酸二氢钠磷酸二氢钾磷酸氢二钠磷酸氢二钾 | 9.09.09.09.09.09.09.09.09.040.540.021.020.0 | 10010010010010010010010010038.638.014.713.4 |
表二中的甘草酸钠(Trisodium glycyrrhizinate)、苯海拉明柠檬酸盐(diphenhydramine citrate)、苯海拉明盐酸盐(diphenhydramine HCl)三项是传统市售的抗组胺药。由其中结果可以明白地看出,它们对组胺的游离抑制率都很低,相反地,本发明的药剂则有完全的抑制功效。尤其须注意柠檬酸和苯海拉明柠檬酸盐的功效比较,后者是传统的抗组胺药剂,而前者是本发明药剂。
能抗组胺形成的功效,也就是同时能抑制因受外来刺激,由免疫机制而诱导出的其它成分,如12-HETE、LT、PGX、PGI2、Tx A2、PGA2、PGE2等等,当然也不会有血栓之类的后果。
实施例35~45:抗迟缓型过敏免疫反应效果比较实验
重量20~30克的实验用小鼠,用噁唑酮(oxazolone)酒精溶液(0.5w/v%)0.1ml,涂于除毛的腹部。经五日后,用噁唑酮的丙酮溶液(0.5w/v%)溶解各项药剂,用微吸管取各10μl的药剂液,涂在小鼠的右耳的两面。二十四小时后将小鼠处死,取左右两耳相对应位置的部分,各切取直径5.5mm的圆面积(右耳有涂药剂的部分和没涂药剂左耳的部分),再予以称重量,以左耳的重量为基准算出其肿大率,计算如下式:
肿胀抑制率(%)={(涂有药剂右耳的重量)-(没涂药剂左耳的重
量)}/
(没涂药剂左耳的重量)
对照组和药剂组的肿胀抑制率如表二所示。
表三、肿胀抑制效果
实验例号 | 测试的药剂 | 涂在耳部的剂量(mg/ear) | 小鼠数 | 抑制率(%) |
(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45) | 苯海拉明盐酸盐苯海拉明柠檬酸盐琥珀酸柠檬酸乳酸苹果酸酒石酸富马酸甲羟基乙酸甲羟基辛酸葡糖酸内酯 | 11111111111 | 66776776667 | 20259610097969798989497 |
由表三可以清楚地看出,传统药剂的抗炎效率非常不理想。相反地,本发明药剂的效果则很佳。能抗炎,同样能抗痛。
实施例46:吃海鲜的实验
一位四十五岁男人,他对虾很敏感,已经四十多年不敢吃海鲜。在吃以前服用二粒本发明胶囊药剂(每粒500mg,含30wt%蒜和70wt/%柠檬酸),结果吃了许多数十年不敢吃的虾,一切平安无事,并无任何免疫疾病的症状发生。
上例同一人,在二周后,服用二粒传统的强力抗过敏药剂,然后吃蟹料理,不久之后开始不适、全身难受,最后送到医院就医。
实施例47~52:药剂含量下限浓度的试验
本发明药剂如锭剂、胶囊等形态的口服剂,可以比照一般剂数的增加来提高一次的口服量。但如果药剂是和其它食物掺杂时,其一次的摄入剂量受食物总量的限制。因此对食物中有效药剂成份的含量有一定要求,以口服食物一次100ml来说明。
有六份不同药剂量的试验液,每一份药剂的基质为水100ml,其内含丙二醇海藻酸钠0.1g、果糖10g、蒜粉300mg、姜粉100mg、当归粉10mg、蜂蜜3g、杏仁粉10mg都一样。另外,各份加入不同的药剂量,为10mg、60mg、100mg、200mg、300mg、600mg的苹果酸。这六组的药剂分别给六组初患感冒者服用,每二小时服一次药剂,每组为五人。随时间观察感冒治愈的情形,计算症状中止的大致时间,结果如表四所示。
表四、剂量对感冒的效果
实施例 | 47 | 48 | 49 | 50 | 51 | 52 |
苹果酸的含量,mg | 10 | 60 | 100 | 200 | 300 | 600 |
苹果酸在100ml中的百分含量,% | 0.01 | 0.06 | 0.10 | 0.2 | 0.3 | 0.6 |
症状大为改善所需的天数 | 8 | 4.5 | 3.2 | 2.2 | 1.6 | 1.1 |
评语 | 差 | 尚可 | 可 | 良 | 优 | 优 |
因此本发明药剂的用药含量应以0.06%~100%,优选0.1%~100%,更优选0.2%~100%,最优选0.3%~100%为宜。这是本发明药物组合物一次服用的浓度范围,当然浓度愈大则口服量可以愈小。一般有毒性的药通常用mg/day/kg来表示。如前所述,本发明的药剂为可食性,故以一次能吃的食物量,其所含的药剂浓度来说明较为恰当。
实施例53~63:药剂用于食品时其含量上限浓度对口感的试验。
本发明药剂用于食品、降低过敏风险的食品或健康食品时,如以药效而言,当然药剂含量愈高愈好,可是药剂含量多时,会使酸性提高而影响到食品的口感问题,所以对食品的含量上限有所限制。
以250克的乌龙茶,用80℃热水冲泡茶8.3升,加入420克蔗糖。分装11杯,每杯100ml,加入不同量的苹果酸,其量如下表所示。让六个人试饮,口感的好坏以最优选、更优选、优选、勉强可接受四种阶段,分级让其选择,统计结果为如下:
表五、剂量对食品的口感的影响
实施例 | 苹果酸含量,% | 最优选 | 更优选 | 优选 | 勉强可接受 |
53 | 1.0 | 6 | |||
54 | 2.0 | 6 | |||
55 | 3.0 | 2 | 4 | ||
56 | 4.0 | 6 | |||
57 | 5.0 | 3 | 3 | ||
58 | 6.0 | 1 | 5 | ||
59 | 7.0 | 6 | |||
60 | 8.0 | 4 | 2 | ||
61 | 9.0 | 2 | 4 | ||
62 | 10.0 | 6 | |||
63 | 12. | 难接受 |
由此结果可以知道,药剂掺于食品,其口感接受的浓度上限为:勉强可接受为小于10%、优选小于7%、更优选小于4%和最优选小于2%。如果再配合前项测试药剂含量的下限值时,则食品中含有机酸的浓度优选为0.06~10%、更优选为0.1~7%、进一步优选0.2~4%、最优选0.3~2%。
实施例64:橙皮糖浆口服液
甜橙皮酊50ml(62%醇)、柠檬酸50g、滑石粉15g、砂糖850g和适量蒸馏水,总量为1000ml。
甜橙皮酊、柠檬酸、滑石粉等加水400ml研磨均匀,过滤后加入砂糖搅拌溶解,再加适量蒸馏水总量为1000ml,经过滤、装瓶为成品。
实施例65:针剂
柠檬酸36g、柠檬酸二氢钾34g、灭菌的纯水适量,总量为1000ml。
在无菌室,将柠檬酸和柠檬酸二氢钾溶于经过灭菌的纯水,成为1000ml,该溶解液经素陶过滤后,分装于10ml的安瓿瓶,在氮气的气氛下熔封,再经通常的高压蒸气杀菌程序,便成为针剂成品。
实施例66:软膏剂
酒石酸1g、酒石酸氢钾0.5g、轻质流动腊10g、白凡士林适量,总量为100g。
其制法为按通常的方法研磨混合并调制装瓶,成为含酒石酸氢钾1.5%的软膏剂。
实施例67:胶囊剂
柠檬酸350g、蒜粉200g、姜粉50g、当归粉10g、杏仁粉10g、果糖300g。
将各成分研磨混合后,装填于硬质胶囊,共得1000粒胶囊。
实施例68:颗粒和锭剂
马来酸30g、玉米淀粉20g、乳糖20g、Ca-CMC 5g、聚乙烯吡咯烷酮5g、滑石粉10g,为药剂处方原料。
先把马来酸、玉米淀粉、乳糖研磨成细料,然后以聚乙烯吡咯烷酮的5%水溶液作为结合剂,依常法以颗粒机制成1~2m/m的颗粒。
进一步用滑石粉作为润滑剂,以打锭机制成锭状100粒,每锭中含本发明成份马来酸300mg。
实施例69:散剂
富马酸50g、微结晶纤维素400g、玉米淀粉550g、总量1000g。
先将富马酸溶于水,然后吸收于微结晶纤维素,干燥后和玉米淀粉混合,依常法制成散剂。或者三成分经研磨混合而制成散剂。本发明为将富马酸调制成20倍散。
实施例70:丸剂
琥珀酸50g、磷酸二氢钾1g、甘草粉50g、人参粉5mg、姜粉1g、淀粉5g和蜂蜜50g。
先将琥珀酸研磨成细粉后,再和其它成份混合捏合,用制丸器制成药丸150粒,每丸含琥珀酸320mg。
实施例71:口锭剂
甲羟基辛酸100g、明胶80g、甘油200g、金合欢胶20g、芳香水160g为成分原料。
原料甲羟基辛酸先予以研磨粉成末,另外明胶和金合欢胶加适量水软化,加入甘油,再加热则得透明之溶液,乘温加入甲羟基辛酸粉末,搅拌成均匀后,注入模型中凝结成为制品。
实施例72:悬浊液剂
琥珀酸100g、span-60 20g、对羟苯甲酸乙酯100mg、花生油适量,总量为1000ml。
先将琥珀酸和span-60以研磨机磨细化,然后加入对羟苯甲酸乙酯和花生油,用搅拌机激烈搅拌三分钟,装罐为成品。
实施例73:乙醇酸液剂(非酒精溶液)
乙醇酸6g、硬脂醇47g、乙二醇47g,总量为100g。
将硬脂醇和乙醇酸二者于蒸气浴上熔融,再加入乙二醇搅拌至完全混合,自蒸浴上取下,即得含6%乙醇酸的非酒精液剂。
实施例74:外用面霜
甲成分:硬脂酸15g、十六醇5g、聚乙二醇-400 5g、流动腊4g、柠檬酸5g。
乙成分:甘油10g、加入纯水至总量为100g。
甲和乙二组成分先个别予以调制,然后依照常法混合二组混合物均匀,总量为100g,为含5.0%的外用面霜。
实施例75:吸入剂(喷雾剂)
柠檬酸0.25wt%、乙醇33wt%、其余为推进剂12/114(20∶80)、总量为100wt%。
先将柠檬酸溶于乙醇,在冷却过程中首先将成品冷却,并定量的充入容器中,而后将推进剂冷却到-30℃,并定量将推进剂充入容器中,立即装上阀门就成为制品。
实施例76:掺于食品(鱼罐头)
将10kg的沙丁鱼清洗后去除头尾内脏后,裁成适当大小,在溶有食盐和柠檬酸(20升水中含食盐1.2kg和柠檬酸800g)中煮熟后,向四号罐中各装入350g鱼肉,再注入蕃茄糊75g,封罐后,再经通常程序热处理杀菌,成为制品。
实施例77:掺于食品(饼干)
面粉10kg、砂糖3.5kg、酥油0.8kg、水饴1kg、食盐0.03kg、酸粉0.2kg、乙醇酸0.62kg为原料。
以通常的饼干制造方法,即先将面粉、砂糖、食盐、乙醇酸分别粉碎磨细,固体成分经细筛后混合,酸粉及一部分淀粉亦过筛加入混合,再加入水饴和酥油充分混合,整形,烘盘均匀涂上少量生菜油,以在前部180~200℃,中央部220~250℃,后部150~205℃范围的温度烘焙而成。实施例78:掺于食品(蛋糕)
面粉1kg、砂糖1kg、蛋1kg、葡糖酸内酯150g、水300g等为原料。
先将蛋白用打泡机打泡,然后将蛋黄、砂糖、葡糖酸内酯和水等其它原料加入其中并搅拌均匀,再将面粉过筛后加入,轻轻和匀,注入模型中烘焙即成。
实施例79:掺于食品(糖果)
白砂糖430g、淀粉糖浆350g、转化糖浆170g、干片明胶50g、柠檬酸二氢钾20g、柠檬酸二氢钠20g、香草精2ml等为原料。
先将明胶片剪成粒片,加水约三倍在二层夹锅加热软化。依照软糖的制造方法,经溶解白砂糖、淀粉糖浆、转化糖浆煮糖后,加入柠檬酸二氢钾、柠檬酸二氢钠和香料混匀。其次加入已溶化的明胶溶液,经小心搅拌、除气泡、粉模成型、切块、包装等工程而成。
实施例80:掺于食品(口香糖,片剂)
聚乙酸乙烯酯50%液500g、软化剂(D.B.P)150g、碳酸钙200g、面粉50g等为胶质材料。
从其混物共取210g,再和苹果酸50g、砂糖650g、水饴100g、薄荷3ml等捏混,再经挤、辊压、切块、包装而制成每片3g的成品。
实施例81:掺于食品(含矿物质乳酸饮料)
脱脂乳1kg、砂糖1.5kg、乳酸15g、乳酸钙5g、丙二醇海藻酸酯4g为原料。
将脱脂乳加热到约50℃,加入砂糖使砂糖溶解后,再加入丙二醇海藻酸酯和乳酸钙,在80℃保持20分钟,杀菌后过滤,冷却至15℃下。乳酸先加水成75ml后,在不断搅拌中加入上述滤液,然后装入瓶中成为成品。
实施例82:掺于食品(花生制品)
花生仁1kg、食盐20g、富马酸25g、磷脂质50g、菠萝酵素20mg、酒精2ml为原料。
先将花生仁在160℃焙炒1小时,十分干燥后用粉碎机予以粉碎,筛除皮及胚芽,添加入食盐、磷脂质、菠萝酵素(先溶于酒精)、和富马酸,磨成细浆,装入500g瓶成制品。
实施例83:掺于食品(布丁)
牛乳750ml、蛋6个、砂糖150g、酒石酸21g、异吉草酸乙酯2滴、焦糖液原料(砂糖100g,水6g)为10人份原料。手续是先用平底锅将砂糖和水加热调制成焦糖液,然后将焦糖液平均地分配加入于十个先涂有少量奶油的各布丁容器中。以打泡机将蛋和砂糖一起打起泡,另以湿底锅加入牛乳和香料,加热到要沸腾时加入打泡液的部分,搅拌混合液后,小心将混合液注入布丁容器中,在蒸器内用中火160℃,加热蒸30分钟,就成为布丁。
实施例84:橙子果汁饮料
取糖度10度、酸1.0%的桔子汁5kg、果糖(无水)0.85kg、桔子精油1ml、柠檬酸150g等为原料。
将原料混合溶解后,加纯水后总量成为10升的橙子果汁饮料,分装为成品。
实施例85:清凉果汁饮料(含橙汁清凉饮料)
取桔子果汁(糖度50度,酸度6%)5kg、砂糖1.2kg、苹果酸200g、桔子精油5ml、水适量,总量成为10升。
将原料混合均匀后,装瓶,再以常法加入二氧化碳气体。
实施例86~95:以水果为原料的制剂
含有本发明可食用有机酸成分量达0.3%以上,选自酸橘、脐橘、柠檬、梅果、葡萄柚、葡萄、苹果、酸杨桃、草莓、菠萝等的水果原料,依通常制造罐头的方法,经选果、清洗、去蒂、裁切头尾、剥皮去芯、去芽目、切片、选出装罐、秤量、加糖液、杀菌、冷却、检察、包装等程序制作成罐头。
另外,前述实施中,所使用的有机酸皆为纯粹的药品。现在直接由含酸的水果,作为有机酸的物质,添加于前述的实施例中。含酸度较低者,在研磨或压榨制成果汁时,可以经过浓缩操作,使酸的含量提高,再以其酸含量计算,用于上述各实施例中的有机酸剂量的替代。
以实施例84为例,制造10升的橙子果汁饮料需桔子果汁(酸度1.0%的桔子汁5kg)5kg和柠檬酸150g,概略以柠檬酸来计算,约需柠檬酸200g。现在用下列水果,去替代所需的酸(柠檬酸200g),计算结果列于下表的第三栏。
表六、水果为原料时的剂量换算
实施例 | 水果名 | 所含酸度,% | 相当于柠檬酸200g所需的水果重量,kg | 备注 |
86 | 酸桔 | 6 | 3.33 | |
87 | 脐桔 | 4 | 5 | |
88 | 柠檬 | 7.0 | 2.85 | |
89 | 梅果 | 3.8 | 5.2 | |
90 | 葡萄柚 | 2.0 | 10 | 须浓缩 |
91 | 葡萄 | 1 | 20 | 须浓缩 |
92 | 苹果 | 0.5 | 40 | 须浓缩 |
93 | 酸杨桃 | 5.0 | 4 | |
94 | 草莓 | 0.8 | 25 | 须浓缩 |
95 | 菠萝 | 4.5 | 4.4 |
由表可以看出实施例90、91、92、94,其所需的水果量皆大于10kg,所以应该在使用前先予以浓缩,以便减少体积,符合实际需要。
本发明的药剂是可食用有机酸,故含有机酸的水果利用其内的有机酸是很自然的,其它成分都是不重要的,正像是任选地药学上可接受的载体一样。
实施例96:水果(柠檬)
含酸6%的柠檬1kg、砂糖粉0.5kg、蜂蜜0.3kg、甘草膏1g、食盐0.2g,最后共成为1.6kg的制品。
原料之柠檬先经挑选后削皮、清洗、切片、装瓶、瓶装半量,砂糖粉、蜂蜜、甘草膏、食盐等原料经激烈搅拌后,加入等量于瓶中,封瓶后再经加热杀菌处理,冷却后为制品;或不经过加热处理。
实施例97:水果(酸杨桃)
酸度5%的酸杨桃1kg、砂糖0.5kg、蜂蜜0.3kg、甘草膏1g、食盐0.2g等为原料。
先将杨桃挑选、清洗、切头尾、裁成3/4英寸长块状,装瓶半量,砂糖粉、蜂蜜、甘草膏、食盐等原料经激烈搅拌后,加入等量于瓶中,封瓶再经加热杀菌处理,冷却后为制品;或不经过加热处理。
实施例98:咖啡(速溶咖啡和利乐包咖啡)
咖啡豆10kg、苹果酸1.5kg、砂糖9.6kg、奶精7.2kg、水适量。
由焙炒的咖啡豆10kg,经磨碎加压热水萃取,得浓度30%的萃取液10升,加入苹果酸1.5kg,此溶液以常法冻结浓缩,再氮气下冻结干燥,得4.5kg含苹果酸33%的咖啡精。
此咖啡精加砂糖9.6kg和奶精7.2kg相混合,分装成17g的铝箔包,成为速溶随身包咖啡成品。
前述30%萃取液10升,加入苹果酸1.5kg、加砂糖9.6kg、奶精7.2kg、最后加水成总量240升,再经煮沸、降温后分装于200ml利乐包,可得1200包咖啡饮料制品。
实施例99:苹果汽水
砂糖1.4kg、苹果酸40g、异吉草酸异戊酯4g、核黄素(维生素B1)20mg、水适量,总量为10升。
糖先溶成56%溶液。将酸、香料、核黄素溶于水,再和糖液混合后,经过过滤,再依常法冷却、高压下和二氧化碳气体接触、装瓶成为成品,其瓶压力在15℃时为50lb,成为10升的苹果汽水。
实施例100:莎士
沙士萃取液100ml、酒精24ml、砂糖500g、果糖390g、五氧化二磷5.5g、焦糖色料10g、香草精1ml、柠檬酸100g、水适量,总量为10升,为原料。
将香料溶于酒精后和沙士萃取液混合,然后和其它成分溶于清纯的水成10升,再依制造汽水的手续进行装瓶、二氧化碳气体接触等工程,最后为成品。
实施例101:可乐
可乐子萃取液100ml、酒精24ml、砂糖500g、果糖390g、五氧化二磷5.5g、焦糖色料10g、香草精1ml、咖啡碱1.4g、柠檬酸100g、水适量,总量为10升,为原料。
制程如同莎士一样。
实施例102:发酵乳饮料
脱脂乳10升、脱脂乳粉2kg、水饴5kg、砂糖3kg、CMC 100g、柠檬酸50g、磷酸10g、乳酸菌引子180ml、香草精1ml等为原料。
脱脂乳和脱脂乳粉混合后加热至80℃,经30分钟杀菌,冷却至40℃时,加发酵引子,于38℃发酵20小时,发酵程度以酸度1.4%为宜,经激烈搅拌,更加热至60℃而均质化,使凝结的凝乳分散乳化,再加糖、水饴、磷酸、搅拌同时加热使溶解,达到80℃时保持20分钟杀菌,趁热过滤、冷却,最后加入溶于少量酒精的香料,装瓶密封为成品。
如最后不加热杀菌,而直接过滤后加入香料,装瓶密封则成为含活菌之乳酸菌饮料(乳酸菌机能性饮料)。
实施例103:啤酒
由台湾公卖局酿造的啤酒10升,其比重为1.0075,浸出物含量为3.4%,pH 4.2,酸度为1.3。以此作为原料。加入柠檬酸45g和柠檬酸二氢钾25g,混合后补充二氧化碳气后装瓶,成为制品。
实施例104:水果酒
柠檬1.5kg、蒜300g、姜50g、果糖200g、米酒2升、蜂蜜300g为原料。
柠檬先削皮后切片,蒜则先剥皮后在微波炉加热1分钟,冷后加入瓶中。姜则切片加入,最后加入蜂蜜和米酒,封瓶置放一个月就可以饮用。
实施例105:其它酒,如威士忌、米酒、白兰地、清酒、高粱酒、葡萄酒等
各种酒在酿造中都会产有机酸,如葡萄酒(0.5~3%)、高粱酒(0.055~0.07%)、米酒(0.4~0.6%)、清酒(0.15%),故本发明的酒类配合剂都是现成酒,酸度以2~3%为目标。不足此者,都添加有机酸。
实施例106:五加皮药酒
药材20g(包括五加皮0.5g、桂皮1.9g、当归1.5g、玉竹5g、白党参0.4 g、川芎0.7g、甘草.7g、何乌首1.5g、川牛漆0.5g、熟地7.5)、酒精3.07升、焦糖色素1.5g、水饴400g、白糖400g、酱色20g、柠檬酸380g、丁酸异戊酯1g等共2.3升。
除熟地及玉竹之外全部粉碎混合,装入袋中浸于酒精中二周。熟地及玉竹切碎后加水用二层锅熬煮八小时,用沸水溶水饴,加入浸药的酒精和煮过水溶液混合,调整酒精含量至25%,再加入色素及香料等,充分搅拌并放置一周后,经沉淀、贮藏、装瓶等工程后成为制品。
实施例107~111:酊剂(酒精溶液)抗炎、镇痛、抗痒实验
柠檬酸10g、甘油5g、酒精(70v/v)90ml为原料,混合此三种成分成为酊剂。
各药剂一天涂三次,各项症状治疗人数为五人,结果大约如下表七所示。本发明药剂有良好的功能,而且没有颜色,不会污染衣服。破皮处涂上时会有刺激,但随即不痛。显然本发明药剂的抗炎、镇痛、抗痒的功能非常良好,可作为抗炎剂、镇痛剂和抗痒剂。
表七、酊剂治疗外伤的效果实验
实施例 | 病例 | 本发明 |
107 | 痤疮(痛) | 一日结疤,消痛 |
108 | 虫咬(肿痒、痛) | 半小时止痒,三小时消肿,消痛 |
109 | 痒疹 | 一日见效 |
110 | 破皮挫伤(痛) | 干后伤口不会紧绷,愈合快,消痛 |
111 | 脓疱(痛) | 一日脓疱缩小,二日结疤,消痛 |
实施例112:降低过敏风险的乳制品
牛乳10升、柠檬酸15g、Ca-CMC 3g,为原料。
将牛乳在搅拌中加入Ca-CMC,混匀后,再加入柠檬酸搅拌均匀,就成为降低过敏风险的牛乳。
将此降低过敏风险的牛乳,进一步利用喷雾干燥机制成乳粉,装瓶成为制品,作为降低过敏风险的乳粉。
实施例113:虾皮的加工
小虾米10kg、食盐360g、柠檬酸360g、水20升等为原料。
将小虾米置于笼内,在水槽中先去除泥沙后沥水,干后放入含有食盐360g、柠檬酸360g的已经煮沸的20升水溶液中。经25分钟煮熟后,捞起已熟的虾米,薄摊在草席上日光晒干,然后分装250g重量于塑料袋中为成品。这种经本发明药剂处理的海鲜,不但容易长期保存新鲜,而且供过敏的人食用时不会产生免疫上的问题。
实施例114:鱼脯(鱼干)的加工
小沙丁鱼10kg、食盐1.2kg、柠檬酸1kg、水20升等为原料。
食盐和柠檬酸溶于釜中的20升水,作为煮液。将小沙丁鱼在水槽中清洗,捞出装于十层相迭的蒸笼内,放进沸腾的煮液中。当原料放入后,釜中再沸腾时为煮熟时间,釜中加入新煮液,将上层油渍等浮游物冲洗后,取出蒸笼,连同蒸笼一起日晒,每日将蒸笼反转一次,使小沙丁鱼放到另一边的蒸笼,夏天约三天可以晒干,装袋为成品。
实施例115:盐干沙丁鱼
沙丁鱼10kg、食盐1kg、苹果酸400g为原料。
将新鲜的沙丁鱼以清水清洗后,浸渍于溶有食盐和苹果酸的6升浸液里,经8小时后,捞出沙丁鱼晒干为制品。
实施例116:虾肉罐头
帝王虾肉2kg、食盐50g、苹果酸100g为原料。
将食盐和苹果酸溶于1.5升的水溶液置于,此水溶液煮沸后,将虾肉放入,虾肉变红白时捞出,装罐,再经封罐、加压杀菌、冷却、检查等手续而成制品。
实施例117:蛋制品(加琥珀酸芙蓉蟹料理)
蟹罐头1/2罐、米酒10ml、蛋6个、琥珀酸6g、盐3g、味素1g、花生油15g、青豌豆5g,为四人份原料。
先将蟹肉加酒,加入去壳蛋、琥珀酸、盐和味素调和。加4大汤匙的花生油入锅内,在开始起烟时加入蟹肉调和物、青豌豆,炒混至半熟,再翻另一面稍微煎一下,就成为加琥珀酸芙蓉蟹料理。
实施例118:鱼罐头掺入两种活性成分(柠檬酸和乳酸链菌肽)
实施例76在掺于食品鱼罐头的制品制造过程中,在加入蕃茄糊前,该75g的蕃茄糊先和10mg的乳酸链菌肽混合,然后封罐,再经通常之程序热处理杀菌后,成为制品。
这样除了本发明的活性成分之外,也含有第二活性成分的乳酸链菌肽。
实施例119:经皮吸收贴付药剂
基材组成:丙烯酸异-冰片酯齐(分子量)共聚物(C4~C8)47%,混合物(96%的丙烯酸2-乙基己酯,4%的正-乙烯基-2-吡咯烷酮)53%,再和5%2-(4-(2-羟基-2-甲基-1-含氧丙基)苯氧基)-2-丙烯酯硬化剂混合。
经皮吸收贴付剂之组成:薄荷0.9g,薄荷油1.2g,樟脑0.8g,柠檬酸1.2g,再和上述胶质基材调配为100g。此药剂均匀涂布于处理过的纸张上,再经300W/inch的紫外线照射1分钟,就成为压粘性经皮吸收剂。
本经皮吸收贴付药剂效果之实验,选取五个平常容易因贴药膏而生过敏的病人,给予连续贴用,经过多天试用结果,皆显示不但无过敏症状和发痒的发生,而且经皮吸收的药效比传统药剂更好。
实施例120:抗过敏之医用手套制造
处方为天然乳胶液(pH10.5,含氨,固体成分50%,Taiping,Perak,Malaysia)200份、硼酸处理之酪蛋白(固体成分10%)75.0份、氧化锌分散液(固体成分50%)10.0份、表氯醇(Epichlorohydrin)交联处理之玉米淀粉泥浆(slurry,固体成分50%)133.0份、硫粉1份、分子量500,000~1,000,000之羧基聚亚甲基聚合物(Carboxy polymethylenepolymer)0.05份、其余为去离子水稀释成为固体成分含量10%。凝聚液为硝酸钙45%之去离子水溶液。
依目前已知之手套制造法。首先用手模具经浸渍凝聚液、干燥、浸渍乳胶、干燥、浸渍乳胶、干燥、折口、干燥、交联化、洗涤、干燥、浸渍5%的柠檬酸水溶液、干燥、打粉(粒度5~40u的MgO)、脱模、分装为制品。
上述制法如果不用液体浸渍本发明的药剂,可以将粒度5~40u的本发明的药剂细粉,以4%含率和粉剂混合,作为打粉剂使用施于手套内部。经本发明药剂处理之手套,给对乳胶过敏的医院人员五人使用,都没有再发生过敏的现象。
实施例121:头皮屑防止治疗剂
混合薄荷油1.2%,甘油6%,叶绿素0.2%,苹果酸2%,酒精60%,精馏水30.6%,成为护髮精。
选择五人男人进行实验测试,在头发洗后,用本剂全面涂布头皮,每天涂二次后,可以消除头皮屑和搔痒症状。
实施例122:葡萄糖注射液剂(含有其它活性成分)
在无菌室以经高压蒸气灭菌的纯水10升,溶解500克的右旋葡萄糖和10克的柠檬酸,经过滤无菌处理,再依GMP规定装瓶为500ml的产品。
实施例123:抗自由基实验
本实验测试自由基的含量,是使用BioVitale Inc.(Irvine,La.,USA)的个人用自由基检测剂组(individual free radical testing kit)。方法是由受检人的尿液,依添附的滴管取一定量的尿液,打开试剂的安瓶盍后,将滴管内的尿液加入安瓶内,摇动安瓶等五分钟,再比较安瓶内液体的频色和试剂组所附颜色对照表。对照表自由基含量共分最适宜(0)、低含量(+1)、中含量(+2)和高含量(+3)等四级,检索自由基的含量程度。
挑选四十~五十岁的人,测其尿中的自由基含量为中等含量的二人,为高含量的人三人,进行测试。方法是这五人,分别给予实施例五十一的药剂,各人一天服三次,二天后取尿液测验自由基。结果如表八所示,证明本发明制品具良好的抗自由基功效。
表八、尿液中自由基的含量
项目 | 测试前尿中自由基含量 | 服用本发明制品后尿中自由基的含量 |
受测人1 | +2 | 0 |
受测人2 | +2 | 0 |
受测人3 | +3 | 0 |
受测人4 | +3 | 0 |
受测人5 | +3 | 0 |
实施例124~128:抑制酶活性的实验
由上述实验例1~45、实施例107~111可知本发明药剂能抑制组胺、发炎、镇痛、抗痒症状之产生,从药理学的立场也应该理解同时亦抑制了前列腺素等的产生,当然不会有栓子和血栓产生,可免除栓子和血栓的生成而导致中风之脑溢血和心肌梗塞等心血管疾病,因为血小板释放出的前列腺凝素是引发血小板加强凝集之信息,即是血块形成之第一步。实施例123的自由基抑制实验结果也清楚表明前列腺素所需的环加氧酶活性要求的过氧化物自由基不存在。过氧化物自由基产生的过程,能用黄嘌呤氧化酶(Xanthine oxidase)基质在体外作实验。(Fridowich,I.,1970,J.Biol.Chem.,215,4053~4057)。所以用此法来验证本发明药剂的功能。
抑制黄嘌呤氧化酶之实验采用的是H.M.Kalckar的方法(J.Biol.Chem.:167,429~443,1947)。其基本原理是黄嘌呤(Xanthine)受黄嘌呤氧化酶的作用,由黄嘌呤转变成尿酸,再用分光光度法测定尿酸的含量,以此计算出药剂抑制黄嘌呤氧化酶活性的效果。
操作顺序是,在分光光度计的1cm样品槽(cell)中加入最终浓度成为0.01U/ml的黄嘌呤氧化酶,接着加入0.05M(pH=7.4)的磷酸缓冲剂或抑制药剂。反应时间自加入黄嘌呤使其最终浓度成为5×10-5M时算起。对照组是用经煮沸的黄嘌呤氧化酶再加黄嘌呤和药剂用减轻样品吸收的误差。
在波长295nm的条件下测试,在2分钟内,每30秒观测并记录其数据。所测试的各种抑制剂的活性表示方法,是用各种抑制剂各种剂量对所添加酶的活性抑制率(%)表示。黄嘌呤氧化酶的活性计算单位为0.001M/min的变化量。将所填加各种抑制药剂的浓度(M)作为抑制率(%)的函数,用对数纸记录数据,最后以线性回归法求出酶活性抑制率达到50%时所需要的药剂浓度。
测试的药剂有琥珀酸、柠檬酸、苹果酸、酒石酸、富马酸、叶酸,其中的叶酸为比较目标。结果如表九所示,本发明药剂具良好的抑制效果。
表九、抑制酵素活性
实施例 | 药剂 | IC50(50%抑制浓度) |
124125126127128 | 琥珀酸柠檬酸苹果酸酒石酸富马酸 | 1.18×10-7M1.00×10-7M1.12×10-7M1.02×10-7M1.01×10-7M |
129 | 叶酸 | 6.62×10-7M |
实施例130:抗疼痛的实验
将本发明之药剂组合物(内含苹果酸300mg、酒石酸300mg、柠檬酸300mg、咖啡因50mg、儿茶素10mg)给与有生理痛和头痛的五人服用,经10~30分钟后疼痛皆开始缓解。
Claims (28)
1.可食用酸或其酸性盐在制备一种用于降低体液的pH值而治疗或缓解免疫疾病的药物组合物中的用途,其中所述药物组合物中含有有效量的可食用酸或其酸性盐作为活性成分;其中所述可食用酸或其酸性盐选自富马酸、马来酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、乙酸、丙酸、磷酸、柠檬酸二氢钠、柠檬酸氢二钠、柠檬酸二氢钾、柠檬酸氢二钾、酒石酸氢钠、酒石酸氢钾、苹果酸氢钠、苹果酸氢钾、马来酸氢钠、马来酸氢钾、富马酸氢钠、富马酸氢钾、磷酸二氢钠、磷酸二氢钾、磷酸氢二钠、磷酸氢二钾、或者其任意组合,含量为0.06~100(wt/wt)%;其中所述免疫疾病为过敏,条件是所述含量不为100(wt/wt)%。
2.权利要求1的用途,其中所述药物组合物为口服剂或非口服剂。
3.权利要求2的用途,其中所述非口服剂为外用制剂。
4.权利要求1的用途,其中所述药物组合物为口服剂型,选自胶囊剂、锭剂、片剂、颗粒剂、散剂、丸剂、糖浆剂、药液、悬浊液、掺于食品中之一种。
5.权利要求1的用途,其中所述药物组合物为针剂。
6.权利要求1的用途,其中所述药物组合物为吸入剂。
7.权利要求1的用途,其中所述药物组合物为非口服体外用剂,选自液状、膏状、喷雾、经皮肤吸收剂。
8.权利要求1的用途,其中所述药物组合物为酊酒,作为一般外伤之药剂。
9.权利要求1的用途,其中所述可食用酸或其酸性盐选自富马酸、马来酸、琥珀酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、丙酸、磷酸、及其酸性钠盐或钾盐,其中所述药物组合物作为感冒之药剂。
10.权利要求1的用途,其中所述可食用酸或其酸性盐选自马来酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、乙酸、丙酸、磷酸、及其酸性钠盐或钾盐,其中所述药物组合物作为昆虫咬伤治疗之药剂。
11.权利要求1的用途,其中所述药物组合物中还含有其它活性成分。
12.可食用酸或其酸性盐,或含有可食用酸或其酸性盐的酸性水果或其制品,在制备一种降低体液的pH值而用于改善个体免疫力的保健品中的用途;其中所述可食用酸或其酸性盐的浓度为0.06~10(wt/wt)%,选自富马酸、马来酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、乙酸、丙酸、磷酸、柠檬酸二氢钠、柠檬酸氢二钠、柠檬酸二氢钾、柠檬酸氢二钾、酒石酸氢钠、酒石酸氢钾、苹果酸氢钠、苹果酸氢钾、马来酸氢钠、马来酸氢钾、富马酸氢钠、富马酸氢钾、磷酸二氢钠、磷酸二氢钾、磷酸氢二钠、磷酸氢二钾、或者其任意组合;其中所述含有可食用酸或其酸性盐的酸性水果或其制品,系含有0.06(wt/wt)%以上的有机酸或其酸性盐的加工酸性水果,选自酸橘、脐橘、柠檬、梅果、葡萄柚、葡萄、苹果、酸杨桃、草莓、菠萝;其中所述免疫力为过敏免疫力。
13.权利要求12的用途,其中所述保健品是口服剂,掺于饼干、蛋糕、糖果、口香糖、罐头、乳制品、花生制品、布丁、蛋制品、烹饪料理食品中。
14.权利要求12的用途,其中所述保健品包括果汁;酒,选自水果酒、米酒、威士忌、白兰地、清酒、高粱酒、葡萄酒、啤酒、药酒;清凉饮料;茶;咖啡;可乐;莎士;乳制品,选自发酵乳;药液。
15.一种制备降低过敏风险的食品的方法,包括用含有可食用酸或其酸性盐的溶液处理所述食品,其中所述酸或其酸性盐的浓度为0.06~10(wt/wt)%,选自富马酸、马来酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、乙酸、丙酸、磷酸、柠檬酸二氢钠、柠檬酸氢二钠、柠檬酸二氢钾、柠檬酸氢二钾、酒石酸氢钠、酒石酸氢钾、苹果酸氢钠、苹果酸氢钾、马来酸氢钠、马来酸氢钾、富马酸氢钠、富马酸氢钾、磷酸二氢钠、磷酸二氢钾、磷酸氢二钠、磷酸氢二钾、或者其任意组合。
16.权利要求15的方法,其中所述食品是选自鱼、虾、蟹、牛乳或乳粉。
17.可食用酸或其酸性盐在制备一种用于通过降低体液的pH值而改善个体过敏免疫力的保健品中的用途,其中所述保健品中添加了可食用酸或其酸性盐,其中所述可食用酸或其酸性盐的浓度为0.06~10(wt/wt)%,选自富马酸、马来酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、乙酸、丙酸、磷酸、柠檬酸二氢钠、柠檬酸氢二钠、柠檬酸二氢钾、柠檬酸氢二钾、酒石酸氢钠、酒石酸氢钾、苹果酸氢钠、苹果酸氢钾、马来酸氢钠、马来酸氢钾、富马酸氢钠、富马酸氢钾、磷酸二氢钠、磷酸二氢钾、磷酸氢二钠、磷酸氢二钾或者其任意组合。
18.权利要求1的用途,其中所述可食用酸或其酸性盐选自马来酸、琥珀酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、丙酸、磷酸、及其酸性钠盐或钾盐,其中所述药物组合物作为抗炎药剂。
19.权利要求1的用途,其中所述药物组合物作为头皮屑药剂。
20.权利要求1的用途,其中所述药物组合物作为处理和皮肤相接触的物品的药剂。
21.权利要求1的用途,其中所述药物组合物作为经皮贴付吸收药剂。
22.权利要求1的用途,其中所述可食用酸或其酸性盐选自富马酸、马来酸、琥珀酸、苹果酸、酒石酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、丙酸、磷酸、及其酸性钠盐或钾盐,其中所述药物组合物作为镇痛剂。
23.权利要求1的用途,其中所述药物组合物作为消除体内自由基的药剂,其中所述可食用酸为有机酸或其酸性盐,选自葡糖酸内酯和磷酸。
24.权利要求1的用途,其中所述药物组合物作为脊椎动物之药剂。
25.权利要求1的用途,其中所述药物组合物作为哺乳动物之药剂。
26.权利要求1的用途,其中所述药物组合物作为人之药剂。
27.可食用酸或其酸性盐在制备一种致敏性降低的物品中的用途,其中所述可食用酸或其酸性盐用于处理该物品;其中所述可食用酸或其酸性盐之浓度为0.06~10(wt/wt)%,选自富马酸、马来酸、琥珀酸、苹果酸、酒石酸、柠檬酸、乳酸、甲羟基辛酸、葡糖酸内酯、乙醇酸、乙酸、丙酸、磷酸、及其酸性钠盐或钾盐。
28.权利要求27的用途,其中所述物品是手套。
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2004
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- 2004-04-26 CN CN2004800105169A patent/CN1777415B/zh not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
---|---|
WO2004112773A1 (fr) | 2004-12-29 |
JP5937291B2 (ja) | 2016-06-22 |
WO2004093862A1 (fr) | 2004-11-04 |
AU2003236156A1 (en) | 2005-01-04 |
JP2019203012A (ja) | 2019-11-28 |
WO2004093863A1 (fr) | 2004-11-04 |
CA2530216C (en) | 2010-08-17 |
US20060251703A1 (en) | 2006-11-09 |
JP2006524193A (ja) | 2006-10-26 |
CA2530216A1 (en) | 2004-11-04 |
JP2016106140A (ja) | 2016-06-16 |
CA2521531A1 (en) | 2004-11-04 |
CN1777415A (zh) | 2006-05-24 |
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