CN101878035A - 用于缓解酒精引起的宿醉的包含枳椇子的双和汤组合物 - Google Patents
用于缓解酒精引起的宿醉的包含枳椇子的双和汤组合物 Download PDFInfo
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- CN101878035A CN101878035A CN2008801183939A CN200880118393A CN101878035A CN 101878035 A CN101878035 A CN 101878035A CN 2008801183939 A CN2008801183939 A CN 2008801183939A CN 200880118393 A CN200880118393 A CN 200880118393A CN 101878035 A CN101878035 A CN 101878035A
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Abstract
一种用于缓解酒精引起的宿醉的组合物,以含有枳椇子的加味双和汤或乳酸杆菌发酵的双和汤作为有效成分。具体地说,该组合物包括含有枳椇子提取物的双和汤,或通过接种、培养、发酵和乳酸杆菌制得的乳酸杆菌发酵的双和汤。该组合物用于缓解酒精引起的宿醉,且在摄入酒精期间作为一种保健食品使用时,用于降低血液中的酒精浓度。
Description
发明领域
本发明涉及一种缓解酒精引起的宿醉的组合物,该组合物以含有枳椇子(Hovenia dulcis Thunberg)的加味双和汤或乳酸杆菌发酵的双和汤作为有效成分。
背景技术
双和汤(Ssangwhatang),也称作双和散(Ssangwhasan),据东医宝鉴“各种疾病”章节的“虚弱和疲劳”项中记载作为缓解疲劳的处方。双和汤是通过将“四物汤”(Samultang,包括熟地黄、白芍、川芎和当归)加到“理中汤”(Yijungtang,包括人参、白术、干姜和甘草)中获得。双和汤可用于感觉疲劳、患有血液疾病、重症后虚弱、缺乏精力以及多汗的人群。
双和汤包括草药,如白芍(Paeonia japonica)、熟地黄(Rehmannia glutinosa)、黄芪(Astragalus membranaceus),当归(Angelica gigas)、川芎(Cnidium officinale)、肉桂(Cinnamonus cassia),甘草(Glycyrrhiza uralensis),干姜(Zingiber officinale)和大枣(Zizyphus jujube)制备成汤药以供服用。就草药的有效成分来说,肉桂激活胃和肠道的功能,并且可以在消化器官受冷引起消化不良或者当腹部受冷引起腹痛或腹泻时使用。人们已经知道,当归能够有效促进血液循环、预防癌症、降低血压、缓解疼痛和痉挛、通过刺激大肠运动减轻便秘、以及消除渗出的血液。
白芍可减轻神经和肌肉的过度紧张,从而止痛、养血和缓解疼痛。熟地黄可以有效养血。黄芪,与高丽参一起用于补充能量,止冷汗和治疗肿胀。
川芎有助于血液循环和减轻疼痛,从而广泛用于治疗头痛。它也可激活肝和肠的功能,在用于治疗贫血时具有造血功能。干姜用于治疗消化不良、呕吐、腹泻,并加速血液循环。大枣加强胃和肠,有助于能量和血液的循环,和胃、护脾,治疗精力缺乏并协调各种药物的性质。
同时,关于将微生物加到草药中并使所得的混合物发酵来获得对人有效的药物方面,韩国专利No.185619披露了一种使用乳酸杆菌的技术,其来自草药的浴压溶液,对生长有益并且有好闻的味道。然后该乳酸杆菌经混合、培养和发酵,从而获得消化功能的协同效应。此外,韩国专利申请No.2004-0078030披露了一种技术,其选择谷物和草药,并且通过快速低温的过程使该混合物与发酵大豆的结合物发酵,从而保持了各组分的原始性质,并使效力加倍。然而,已知技术中没有关于如何发酵双和汤的文献。
本发明人用酒精处理大鼠,并且在宿醉前后服用乳酸杆菌发酵的双和汤或者含枳椇子的加味双和汤,以便确认宿醉是否缓解。
发明内容
本发明的多种实施方式旨在提供一种缓解酒精宿醉的组合物,该组合物以含枳椇子的加味双和汤或者乳酸杆菌发酵的双和汤作为有效成分。
优选实施方式的详细说明
本发明提供一种用于缓解酒精宿醉的组合物,包括含枳椇子的加味双和汤,其中加味双和汤是将枳椇子加到含白芍(Paeonia japonica)、熟地黄(Rehmannia glutinosa)、黄芪(Astragalus membranaceus)、当归(Angelica gigas)、川芎(Cnidium officinale)、肉桂(Cinnamonus cassia)、甘草(Glycyrrhiza uralensis)、干姜(Zingiber officinale)和大枣(Zizyphus jujube)的双和汤中,并用热水提取制备而成。该组合物包括枳椇子10-15重量份,熟地黄6-17重量份、黄芪6-17重量份、当归6-17重量份、川芎6-17重量份、肉桂3-14重量份、甘草3-14重量份、干姜2-14重量份和大枣4-8重量份,基于白芍10重量份计算。
此外,本发明提供一种用于缓解酒精宿醉的组合物,包括乳酸杆菌发酵的双和汤,其中该发酵的双和汤是通过在热水提取的含白芍、熟地黄、黄芪、当归、川芎、肉桂、甘草、干姜和大枣的双和汤中接种乳酸杆菌制备而成,该组合物包括熟地黄6-17重量份、黄芪6-17重量份、当归6-17重量份、川芎6-17重量份、肉桂3-14重量份、甘草3-14重量份、干姜2-14重量份和大枣4-8重量份,基于白芍10重量份计算。
优选地,用于制备本发明的发酵双和汤的乳酸杆菌可包括乳酸杆菌属(Lactobacillus spp.)菌株。根据本发明的优选实施方式,将发酵乳杆菌(Lactobacillus fermentum)作为接种源经种子细胞培养,并以0.1%至10%(v/v)接种到双和汤原液中。将该接种溶液在孵育室中通风培养,并发酵成液体,由此获得乳酸杆菌发酵的双和汤。种子细胞培养和发酵是在20℃至40℃的孵育温度下进行,优选30℃至40℃,时间为1~10天,优选1~5天。
所述乳酸杆菌可以选自加氏乳杆菌(Lactobacillus gasseri)、干酪乳杆菌(Lactobacillus casei)、嗜酸乳杆菌(Lactobacillus acidophilus)、鼠李糖乳杆菌(Lactobacillus rhamnosus)和发酵乳杆菌(Lactobacillus fermentum),但不局限于此。所述培养基可以选自适用于各种乳酸杆菌的Man-Rogosa-Sharpe(MRS)、乳糖、M17和APT培养基,但不局限于此。另外,双和汤可以直接用商业可得的产品制备或使用。
在本发明的优选实施方式中,在用酒精处理大鼠前后,给大鼠服用普通双和汤、含有枳椇子的加味双和汤以及乳酸杆菌发酵的双和汤,以便了解宿醉缓解的程度。结果表明,通过服用加味双和汤和乳酸杆菌发酵的双和汤,降低了血清中的酒精含量(见表3和表5)。
本发明人在酒精处理之后进行血液生化测试。具体地说,在用酒精处理大鼠前后,服用普通双和汤,含有枳椇子的加味双和汤和乳酸杆菌发酵的双和汤。然后,提取大鼠的血液以测定天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)和乳酸脱氢酶(LDH)的含量。结果显示,通过服用加味双和汤和乳酸杆菌发酵的双和汤,用酒精处理小鼠的上述酶活性增加被减小(见表6和表7)。因此,本发明含枳椇子的加味双和汤和乳酸杆菌发酵的双和汤在酒精处理前后接种大鼠时,具有缓解宿醉的作用。
本发明的组合物包括作为活性成分的含有枳椇子的加味双和汤和乳酸杆菌发酵的双和汤。含有枳椇子的加味双和汤和乳酸杆菌发酵的双和汤在临床用药中可以口服给药,并且可以与一般药物一起作为药品使用。优选地,药物包括口服药物如片剂、硬质或软质胶囊、液体药物、悬浮液,它们可以使用药学上可接受的载体来制备。例如,口服药物可以用赋形剂、粘合剂、分散剂、润滑剂、增溶剂、悬浮剂、防腐剂或膨胀剂来制备。
在该组合物中,包含枳椇子的加味双和汤和乳酸杆菌发酵的双和汤的剂量可以根据不同因素来确定,如患者的状况、年龄、性别以及并发症。一般来说,剂量范围为1-8ml/成人1kg/天,优选4-6ml。乳酸杆菌发酵的双和汤的一天的剂量或者每单位配方的1/2、1/3或1/4剂量可以每天给药1至6次。然而,在长期服用的情况下,可使用上述剂量或更少、和/或更多剂量,因为有效成分不存在稳定性的问题。
另外,本发明提供缓解酒精宿醉的保健食品,其包括含有枳椇子的加味双和汤和乳酸杆菌发酵的双和汤。
当含有枳椇子的加味双和汤和乳酸杆菌发酵的双和汤用作食品时,它们本身,或者与其他食品或食品成分一起,可通过常规方法适当地使用。有效成分的混合物的量可以基于用法确定(如预防、保健或治疗)。一般而言,本发明的含枳椇子的加味双和汤和乳酸杆菌发酵的双和汤可以基于食品或饮料的制备成分的5-30wt%的量添加,优选10-20wt%。含枳椇子的加味双和汤和乳酸杆菌发酵的双和汤在保健食品中的有效剂量可以基于药物组合物的有效剂量来使用。然而,为了保健和卫生或者健康调节,在长期服用的情况下,可以以上述范围、或更少,和/或更多的量来使用,因为有效成分没有稳定性的问题。对于与健康食品一起使用没有特别的限制。
有益效果
本发明的组合物可在摄入酒精期间当作保健食品服用,用于缓解酒精引起的宿醉并降低血液中的酒精浓度。
实施例
在下文中,将通过实施例和优选实施方式进行详细说明本发明,实施例和优选实施方式仅是说明性的,因此不限制本发明。
<实施例1>制备加味双和汤
将枳椇子(502g)、白芍(468g)、熟地黄(187g)、黄芪(187g)、当归(187g)、川芎(187g)、肉桂(140g)、甘草(140g)、干姜(74g)和大枣(100g)混合,并用热水提取,以获得含枳椇子的加味双和汤。将双和汤的原液(10L)加入到玻璃瓶(Pylex 19L)中,用NaOH(1M)调节pH至7.0。所得混合物在121℃在1.5atm下高压灭菌15分钟。
<实施例2>制备乳酸杆菌发酵的双和汤
<2-1>乳酸杆菌的分配
由韩国食品研究所的食品微生物基因库(KFRI)提供乳杆菌属的七种菌株,由韩国典型菌种保藏中心(KCTC)提供乳杆菌属的一种菌株。将它们用在本实验中(见表1)。
表1:发酵中使用的乳杆菌属菌株
表1
菌株号. | 菌株 |
KFRI 128 | 嗜酸乳杆菌 |
164 | 发酵乳杆菌 |
菌株号. | 菌株 |
345 | 保加利亚乳杆菌 |
442 | 德氏乳杆菌赖氏亚种 |
658 | 加氏乳杆菌 |
692 | 干酪乳杆菌 |
693 | 干酪乳杆菌 |
KCTC 5033 | 鼠李糖乳杆菌 |
<2-2>种子细胞培养
将<2-1>中提供的8种细菌菌株在倾斜培养基和液体培养基中亚培养,并用于本实验。具体地说,将乳酸杆菌接种在倾斜培养基中,并在孵化箱中于37℃培养24小时。当形成乳酸杆菌菌落时,通过石蜡膜拦截氧气防止其进入乳酸杆菌菌落,并将乳酸杆菌菌落保存在冷藏室中。由于乳酸杆菌的活性可能降低或者乳酸杆菌菌落可能被各种细菌污染,将乳酸杆菌菌落每隔2至3周转移至新的琼脂斜面培养基,在实验中接种至液体培养基中,并在孵箱中于37℃培养24小时。
用于种子细胞培养的培养基包括MRS培养基(Becton Dickinson,U.S.A),MRS+0.5%葡萄糖培养基,MRS+0.5%乳糖培养基,M17培养基(Becton Dickinson,U.S.A)或ATP培养基(Becton Dickinson,U.S.A)。
<2-3>制备乳酸杆菌发酵的双和汤
将白芍(468g)、熟地黄(187g)、黄芪(187g)、当归(187g)、川芎(187g)、肉桂(140g)、甘草(140g)、干姜(74g)和大枣(100g)混合,并用热水提取,获得含枳椇子的加味双和汤。将双和汤的原液(10L)加入玻璃瓶(Pylex 19L)中,用NaOH(1M)调节pH至7.0。
所得混合物在121℃在1.5atm下高压灭菌15分钟,并冷却至室温。冷却的混合物用先前在<2-2>中培养的种子细胞溶液接种至1%(v/v)。所得混合物在37±1℃的孵育室中通风培养48小时以便液体发酵。
<实验实施例1>确认酒精引起的宿醉的缓解
将获得自Orientbio Inc.(Korea)的8周大的雄性大鼠在韩国韩医学研究院的动物实验室进行两周的隔离和纯化。从这些大鼠中选择健康大鼠,并用于本实验。
<1-1>分组和动物识别
大鼠的分组如下。测量在纯化期间判定为健康的大鼠的体重,并且每隔5g划分开,然后选出108只接近平均重量的大鼠。通过随机的方法用随机数目和分级的重量对108只大鼠进行分配,使得每组中包含6只相同体重的大鼠。通过毛发的颜料染色方法和个体标识卡显示方法来识别大鼠。
<1-2>分析血清-酒精浓度的变化
进行实验A以查明宿醉前的缓解作用。在服用试验物质(15ml/kg)如含有枳椇子的加味双和汤和乳酸杆菌发酵的双和汤之后30分钟,口服60%乙醇10ml/kg(见表2)。在服用乙醇2小时后,从尾部静脉收集血液,并通过酶方法用以下乙醇脱氢酶测定血清-酒精含量。
在378nm的吸收处定量生成的NADH。使用1,3-二氨基-2-羟丙烷作为试剂和缓冲溶液以捕获乙醛。
结果,与阴性对照组(267.8mg/dl)比较,血清中的酒精含量降低SHT 9%、HST 25%、SMT 39%和S 16426%。(见表3)
表2:在酒精处理之前,用试验物质处理的实验组
表2
组别 | 性别 | 动物数 | 乙醇(ml/kg) | AD体积a)(ml/kg) | 剂量(ml/kg) |
CON | 雄性 | 1~6 | 0 | 10 | 0 |
NCT | 雄性 | 7~12 | 10 | 10 | 0 |
SHT | 雄性 | 13~18 | 10 | 10 | 15 |
HST | 雄性 | 19~24 | 10 | 10 | 15 |
GMT | 雄性 | 25~30 | 10 | 10 | 15 |
CDT | 雄性 | 31~36 | 10 | 10 | 15 |
YMT | 雄性 | 37~42 | 10 | 10 | 15 |
SMT | 雄性 | 43~48 | 10 | 10 | 15 |
S164 | 雄性 | 49~54 | 10 | 10 | 15 |
NCT:阴性对照组
SHT:双和汤
HST:枳椇子
GMT:阳性对照组1(服用“Good Morning”,Korea Ginseng Bio Science Co.,LTD),
CDT:阳性对照组2(服用“Condition”,CJ corporation)
YMT:阳性对照组3(服用“Yeomyung 808”,GLAMI Co.,Ltd.)
SMT:双和汤+30%枳椇子
S164:包括乳酸杆菌酵母的双和汤发酵组
a):服用量
表3:在酒精处理之前,对服用试验物质的大鼠进行酒精分析
表3
进行实验B以查明酒醉之后的缓解宿醉的作用。口服60%乙醇10ml/kg之后2小时,口服试验物质,如含有枳椇子的加味双和汤或乳酸杆菌发酵的双和汤(15ml/kg)。在服用试验物质2小时后,从尾部静脉收集血液,用COBAS Integra 800(Roche Co.,Switzerland)分析血清-酒精含量(见表4)。
结果,与阴性对照组(257.7mg/dl)相比,血清中的酒精含量降低了SHT13%、HST 9%、GMT 20%、CDT 18%、YMT 19%、SMT 29%和S164 34%(见表5)。
表4:在酒精处理后,用试验物质处理的实验组
表5:在酒精处理后,服用试验物质的大鼠的酒精分析
表4
组别 | 性别 | 动物数 | 乙醇(ml/kg) | AD体积a)(ml/kg) | 剂量(ml/kg) |
CON | 雄性 | 55~60 | 0 | 10 | 0 |
NCT | 雄性 | 61~66 | 10 | 10 | 0 |
SHT | 雄性 | 67~72 | 10 | 10 | 15 |
HST | 雄性 | 73~78 | 10 | 10 | 15 |
GMT | 雄性 | 79~84 | 10 | 10 | 15 |
组别 | 性别 | 动物数 | 乙醇(ml/kg) | AD体积a)(ml/kg) | 剂量(ml/kg) |
CDT | 雄性 | 85~90 | 10 | 10 | 15 |
YMT | 雄性 | 91~96 | 10 | 10 | 15 |
SMT | 雄性 | 97~102 | 10 | 10 | 15 |
S164 | 雄性 | 103~108 | 10 | 10 | 15 |
表5
<1-3>血液生化测试
重复如实验A和B相同的程序,用于血液生化测试。从尾部静脉收集血液(5ml),在室温下凝结,并用离心机(Avanti 30,Beckman Coulter,Inc.,U.S.A.)在5000rpm下离心10分钟。血清分离后,用生化分析仪(Advia 1650,Shimas Co.,JAPAN)测量天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)和乳酸脱氢酶(LDH)的含量。
通过Dunnett测试由平均偏差和标准偏差获得阴性对照组和试验物质服用组之间的统计学显著差异(*p<0.0.5,**p<0.01)。
结果,在服用试验物质,如含有枳椇子的加味双和汤和乳酸杆菌发酵的双和汤30分钟后,进行酒精摄入测试,阴性对照组的AST活性为184.6IU/L,比正常组(170IU/L)增加8%,与阴性对照组相比降低SHT 15%,GMT 21%,CDT 11%,YMT 16%,SMT 9%和S164 16%。不过,HST增加了1%。
ALT在正常组中测定值为63.8IU/L,在酒精处理组中增加至83.0IU/L。试验物质(15ml/kg)服用组比阴性对照组降低SHT 27%,HST 20%,GMT 22%,CDT 30%,YMT 30%,SMT 23%和S16427%。
酒精处理组中的LDH含量比正常组增加49%。当经酒精处理的试验动物口服试验物质15ml/kg时,LDH含量降低了SHT 10%,GMT 27%,CDT 10%,YMT 22%,SMT 12%以及S16418%。血清中的LDH量增加了HST 9%(见表6)。
然而,在摄入酒精2小时和服用试验物质2小时的试验中,AST、ALT和LDH的含量在所有测试组中都没有变化(CON、NCT、SHT、HST、GMT、CDT、YMT、SMT和S164)(见表7)。
根据以上试验的分析结果,在酒精处理2小时后,在AST、ALT和LDH的含量变化方面没有出现酒精处理后的严重毒性变化。然而,在服用含有枳椇子的加味双和汤或乳酸杆菌发酵的双和汤(15ml/kg)时,血液生化肝毒性指标物质AST、ALT和LDH的含量显示有所降低。
表6:在酒精处理前服用试验物质的大鼠的血液生化测试
表7:在酒精处理后服用试验物质的大鼠的血液生化测试
表6
表7
<1-4>尸检结果
尽管在单一时间口服乙醇和试验物质没有观察到异常的损害,但肉眼观察到摄入酒精引起的胃部出血。然而,当以15ml/kg的剂量服用试验物质时,酒精摄入的胃部出血显示降低。
<制备实施例1>制备药物组合物
<1-1>制备软胶囊
通过一般的制药规定中的软胶囊制备方法,向一个胶囊中加入由实施例1或2获得的加味双和汤或乳酸杆菌发酵的双和汤(100.0mg)、豆油(175.0mg)、黄蜡(45.0mg)、椰树油(127.5mg)、大豆磷脂(21.0mg)、胶质(212.0mg)、甘油(比重1.24)(50.0mg)、di-山梨醇(76.0mg),对羟基苯甲酸甲酯(0.54mg),对羟基苯甲酸丙酯(0.90mg),甲基香兰素(0.56mg),黄No.203(适量)。
<1-2>制备片剂
将由实施例1或2获得的加味双和汤或乳酸杆菌发酵的双和汤(100.0mg)、玉米淀粉(90.0mg)、乳糖(175.0mg)、L-羟丙基纤维素(15.0mg)、聚乙烯吡咯烷酮(5.0mg)和乙醇(适量)均匀地混合,通过湿磨法制粒。向颗粒中加入硬脂酸镁(1.8mg),压片,每片可为40mg。
<制备实施例2>制备保健食品
<2-1>制备胶囊
将由实施例1或2获得的加味双和汤或乳酸杆菌发酵的双和汤(100.0mg)、玉米淀粉(83.2mg)、乳糖(175.0mg)、硬脂酸镁(1.8mg)均匀地混合,每粒胶囊可为360mg。
<2-2>制备饮料
将由实施例1或2获得的加味双和汤或乳酸杆菌发酵的双和汤(0.48mg~1.28mg)、蜂蜜(522mg)、硫辛酸酰胺(5mg)、盐酸核黄素钠(3mg)、盐酸吡哆醇(2mg)、肌醇(30mg)、乳清酸(50mg)和水(200ml)通过常规方法混合以制备饮料。
<2-3>制备粉剂
将实施例1或2获得的加味双和汤或乳酸杆菌发酵的双和汤(2g)和乳糖(1g)混合,并填充在密封胶囊中以制备粉剂。
Claims (10)
1.一种用于缓解酒精引起的宿醉的组合物,含有包含枳椇子(Hovenia dulcis Thunberg)的加味双和汤,其中所述加味双和汤是通过将枳椇子添加到含白芍(Paeonia japonica)、熟地黄(Rehmannia glutinosa)、黄芪(Astragalusmembranaceus)、当归(Angelica gigas)、川芎(Cnidium officinale)、肉桂(Cinnamonus cassia)、甘草(Glycyrrhiza uralensis)、干姜(Zingiber officinale)和大枣(Zizyphus jujube)的双和汤中,并用热水提取制成。
2.如权利要求1所述的组合物,其中所述组合物包括基于白芍10重量份计,枳椇子10-15重量份,熟地黄6-17重量份、黄芪6-17重量份、当归6-17重量份、川芎6-17重量份、肉桂3-14重量份、甘草3-14重量份、干姜2-14重量份和大枣4-8重量份。
3.如权利要求1所述的组合物,其中在摄入酒精前后服用所述组合物时,所述组合物降低血液中的酒精含量。
4.如权利要求1所述的组合物,其中所述组合物是以保健食品的形式提供。
5.一种用于缓解酒精引起的宿醉的组合物,含有乳酸杆菌发酵的双和汤,其中所述乳酸杆菌发酵的双和汤是通过在热水提取的含白芍、熟地黄、黄芪、当归、川芎、肉桂、甘草、干姜和大枣的双和汤中接种乳酸杆菌而制成。
6.如权利要求5所述的组合物,其中所述组合物包括基于白芍10重量份计,熟地黄6-17重量份、黄芪6-17重量份、当归6-17重量份、川芎6-17重量份、肉桂3-14重量份、甘草3-14重量份、干姜2-14重量份和大枣4-8重量份。
7.如权利要求5所述的组合物,其中所述乳酸杆菌选自发酵乳杆菌、加氏乳杆菌、干酪乳杆菌、嗜酸乳杆菌和鼠李糖乳杆菌。
8.如权利要求5所述的组合物,其中所述乳酸杆菌是发酵乳杆菌。
9.如权利要求5所述的组合物,其中在摄入酒精前后服用所述组合物时,所述组合物降低血液中的酒精含量。
10.如权利要求5所述的组合物,其中所述组合物是以保健食品的形式提供。
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