CN107496850B - 一种调节肠道微生态制剂的配方及应用 - Google Patents
一种调节肠道微生态制剂的配方及应用 Download PDFInfo
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Abstract
本发明属于药食同源类配方与新资源食品技术领域,具体提供了一种供肠道微生态紊乱患者食用的食品、医学配方食品、特定医学配方食品、保健品和药品。该肠道微生态调节制剂的配方结合肠道微生态紊乱人群的体质特征,根据传统中医精髓理论和现代生物科学进展合理配伍。具体是将真空冷冻干燥益生菌菌粉,辅以益生元、谷物纤维和传统药食同源类中药等多重天然植物精华,通过混合、制粒等工艺制成可以有效形成益生菌肠道屏障、升阳补脾调中、抗炎止痛祛湿热的肠道微生态调节制剂。该肠道微生态调节制剂可有效改善由于肠道微生态紊乱造成的腹泻、肠炎及消化不良等胃肠疾病;同时人参的安神作用,可有效改善失眠多梦;葛根、姜黄可解酒护肝有效保护肝脏、缓解酒后不适。
Description
技术领域
本发明属于药食同源类配方与新资源食品技术领域。具体地说,涉及一种结合肠道微生态紊乱人群的体质特征,根据传统中医精髓理论和现代生物科学进展合理配伍,将药食同源中药、益生菌、益生元和谷物等多重天然植物精华合理搭配,制成肠道微生态调节类食品、特殊医学用途配方食品、医学配方食品、保健品和药品,该调节肠道微生态制剂具有缓解腹泻、肠炎作用的同时还可保肝、降血脂、促睡眠。
背景技术
肠道微生态与人体存在共生关系,是人体不可缺少的重要组成部分,现代科学研究显示,肠道微生态对人体的维生素等生物合成合成、促进生长发育和物质代谢以及免疫防御功能等都有重要的作用,对生理有巨大影响,是维持人体健康的必要因素,也是反映机体内环境稳定的一面镜子。肠道微生态失衡与许多疾病、特别是与大多数慢性病有关联。有科学依据表明,肠道微生态失衡会引起胃肠道疾病、肝病、神经系统疾病、精神疾病、呼吸系统疾病、心血管疾病、自身免疫性疾病、代谢性疾病及肿瘤等疾病的发生。
肠道微生态与胃肠道疾病。杨珍妮等在 《肠道菌群与结直肠癌发病关系的研究进展》 (《世界华人消化杂志》 2014; 22(18): 2547-2552)中提到:肠道菌群失调与众多消化系统疾病关系密切,包括慢性腹泻、胰腺炎、肝硬化、肠易激综合征(irritable bowelsyndrome,IBS)、炎症性肠病(inflammatory bowel disease,IBD),甚至CRC。人体肠道内寄生着大量且种类繁多的微生物,他们作为一个整体,参与到人体多项生理活动及代谢中,与人类的健康和疾病紧密相关。其中部分细菌及其代谢产物通过与受体结合、刺激炎症因子分泌、与其他变化一起,引起炎症反应,最终导致结直肠癌的发生。而益生菌则通过屏障作用、抑制DNA损伤等机制保护肠道黏膜,对人体起到保护作用,并可被用于预防及辅助治疗多种疾病。
肠道微生态与保肝作用。Sylvie Rabot等在Guidance for Substantiating theEvidence for Beneficial Effects of Probiotics: Impact of Probiotics onDigestive System Metabolism中介绍了两例临床实验研究,每天给肝紊乱患者服用市面上含有混合益生菌胶囊,两周后,患者血氨浓度有所下降。田丰伟等,在《鼠李糖乳杆菌CCFM1107对小鼠酒精性肝损伤的缓解作用>[C]// 乳酸菌与健康国际研讨会.2014,中介绍了鼠李糖乳杆菌对小鼠酒精性肝损伤的缓解作用。具有高抗氧化活性的益生菌可以减少酒精诱导的氧化应激,恢复正常肠道微生物菌群构成,因而改善酒精灌胃小鼠的肝脏损伤。结果显示鼠李糖乳杆菌CCFM1107能够显著抑制血清转氨酶和内毒素水平升高,降低血清和肝脏中甘油三脂和胆固醇的含量。谷胱甘肽、谷胱甘肽氧化酶和超氧化物歧化酶含量升高,而丙二醛水平降低。通过增加乳酸杆菌和双岐柑橘的数量,减少肠球菌和肠杆菌而恢复了酒精导致的肠道内稳态失调。组织形态分析结果证实了鼠李糖乳杆菌CCFM1107的保护效应与其他乳杆菌和药物不同之处在于,证实鼠李糖乳杆菌是通过降低氧化应激和恢复肠道菌群进而缓解了酒精性肝损伤。
肠道微生态与降血脂。Martin等发现:补充乳杆菌属类益生菌可显著影响牛磺结合胆汁酸和非牛磺结合胆汁酸的比例,以及氨基酸、短链脂肪酸和甲胺等的代谢,最终使血浆中极低密度脂蛋白(VLDL)和低密度脂蛋白(LDL)下降,并能有效提高糖酵解作用。Kawase等发现干酪乳杆菌(L. casei TMC0409)和嗜热链球菌(S. thermophilus TMC 1543)可降低血浆总胆固醇水平、甘油三酯,动脉粥样硬化指数[(总胆固醇-高密度脂蛋白胆固醇)/高密度脂蛋白胆固醇]从4.24下降到3.52。
中医认为“泄泻之本,无不由于脾胃。”中医理论认为,泄泻通常由食伤肠胃、湿热内蕴、脾胃气虚和脾肾阳虚所致。泄泻的病因:最主要的是七情内伤或饮食所伤,长期负于学习和工作压力而忧思伤脾胃;暴饮饱食、饥饱不定、经常过量饮酒等均能伤及脾胃之气,造成脾胃功能升降失调。饮食自倍、肠胃乃伤,《素问·痹论》。脾与胃相表里,有这种关系,最终是脾胃互伤,造成脾胃升降功能失调,就是脾应升则降,胃应降则逆,故水谷不化而停留胃肠,而出现脾胃功能失调的腹泻和呕恶。从中医学的脏腑整体观念出发,慢性腹泻与人体多个脏腑功能失调有关,尤其是与脾的运化功能、升降机制息息相关。脾主升清,《紊问·阴阳应象大论》也曰:“清气在下,则生飨泄。”指出脾不升清,水谷和糟粕浊物混杂下行,而致完谷不化之飨泄。脾木虚弱,是导致水谷运化失常的关键。《素问·脏气法时论》日:“毕病者……虚则腹满肠鸣,飨泄食不化。”反复泄泻,且持续时间较长,将会进一步损伤脾土。所以,补土健脾,益气助运为治疗慢性泄泻之正法。“无湿不成泻”。泄泻,多与湿邪外侵,或饮食油腻、湿热内生,或脾虚生湿等因素有关。五脏之中,脾喜燥恶湿,外来湿邪侵犯人体后,最易困阻脾土。使脾阳不振,升降失职。清浊不分,水谷混杂而下,发为泄泻。《素问·阴阳应象大论》曰:“湿盛则濡泻。” 化湿法在慢性腹泻的治疗中的作用十分重要,湿去则邪去。邪去则清浊得分,泻可自止。
“药食同源”是中华原创医学之中对人类最有价值的贡献之一;中医历来强调“药疗不如食疗”,食疗成为现代人追求返璞归真、健康饮食的最佳选择;让人们在享受美食的过程中祛除病痛,避免了打针、吃药,甚至手术之苦。目前市场上有利用以药食两用的葛根、人参、菊粉,及谷物成分薏米、燕麦、玉米、大豆等组成复合配方,还有利用益生菌为主要原料的产品,但还没有发现结合腹泻患者的体质特征,依据传统中医的精髓理论和现代肠道微生态调节研究结果,黄金配伍以多种药食两用的中药、多种益生菌、益生元、多种谷物纤维为主要原料制成的医学配方食品、特定医学配方食品或类似产品。综上,根据现代肠道微生态理论和传统中医理论,以食为药,调理脾胃、消炎祛湿和补充益生菌是缓解肠道微生态紊乱腹泻的合理选择。
发明内容
本发明提供一种治疗肠道微生态紊乱腹泻的复合配方,通过中药、益生菌、益生元、谷物的共同调理,实现调理脾胃、祛湿和形成肠道微生态平衡,治疗腹泻见效快、疗效好。
本发明治疗腹泻的复合配方,其特征在于益生菌、中药、益生元、谷物四种天然成分的组合形式,以及四种成分按照以下重量分数的配制:益生菌活菌数109-1010 CFU/g,葛根40%-55%,人参25%-35%,姜黄1%-2%,菊粉(益生元/膳食纤维)25%-35%,薏米5%-10%,燕麦1%-5%,玉米1%-5%,大豆1%-5%。
作为优选,按照以下重量分数配制,最终体系益生菌活菌数1010 CFU/g、葛根32.88%、菊粉25.97%、人参6.55%、姜黄1.44%、薏米7%、燕麦2.71%、玉米2%、大豆2%。
或按照以下重量分数配制,最终体系益生菌活菌数109 CFU/g、葛根39.16%、菊粉34.07%、人参3.89%、姜黄0.86%、薏米7.71%、燕麦3.71%、玉米2%、大豆2%。
较优的,益生菌菌粉选用冻干后微囊化菌粉,谷物粉选用经熟化的膨化粉。
制备方法是按照上述重量分数准确称取原料,按比例选取各组分80目-100目粉末,加入粘合剂羟丙基纤维素,混合均匀,加入适量蒸馏水润湿,采用湿法制粒制成颗粒。
本发明药理分析。
益生菌,可通过诱导多种宿主免疫反应而维护肠道健康。
①肠道表面益生菌屏障对病原微生物的拮抗作用。益生菌在肠上皮细胞表面形成一层排列紧密的屏障,竞争营养成分和附着位点而排斥病原微生物;益生菌还可提高粘液蛋白的表达和分泌,而形成一层良好的肠道表面保护屏障。
②益生菌能增强紧密连接的稳定性,减少肠道上皮细胞对管腔内的病原菌和毒素的渗透性。Shinji Fukuda等发现部分双歧杆菌,如长双歧杆菌(Bifidobacterium longumJCM 1217T),可抑制EHEC O157:H7分泌的类志贺氏毒素从肠腔到血液的转移。
③益生菌可加固机体的非特异免疫功能。益生菌可激活自然杀伤细胞(NK细胞)和具吞噬作用的中性粒细胞,这可能与益生菌的抗感染和抗癌作用紧密相关。益生菌细胞壁成分(如脂磷壁酸)可刺激肿瘤坏死因子α(TNF-α)和白细胞介素10(IL-10)的分泌,而提高宿主非特异免疫能力。现有报道:鼠李糖乳杆菌(Lactobacillus rhamnosus HN001)和干酪乳杆菌(Lactobacillus casei Shirota)可提高NK细胞的数量或细胞毒活性。
④益生菌激活和提高肠道黏膜的特异性免疫功能。益生菌通过刺激肠道黏膜固有层内IgA分泌细胞数量增多,分泌更多的IgA到粘液层。分泌型IgA是机体粘膜局部抗感染免疫的主要抗体,作为黏膜防御系统的主要成分覆盖在肠道表面。分泌型IgA可与某些病毒、细菌、细菌毒素等结合,而阻止其进入或破坏肠道表皮细胞;分泌型IgA还可附着细菌鞭毛,阻碍细菌活动性而更易被巨噬细胞吞噬。益生菌还可刺激细胞因子的产生而激活辅助T细胞核巨噬细胞。不同种/株的益生菌菌株可以诱导广泛的细胞因子反应。
⑤益生菌产生抗菌代谢物而抵抗病原微生物的入侵。益生菌常可产生抗菌肽、有机酸、游离脂肪酸和细菌素等抗菌物质,可以有效抑制食源性病原微生物。
益生菌对腹泻的预防和治疗作用。腹泻主要分为:急性腹泻和慢性腹泻。目前已有一系列实验研究证明和论述了益生菌对急性腹泻和慢性都有一定的预防和治疗效果。急性腹泻,指由于细菌性感染(大肠杆菌、沙门菌等)、病毒性感染(轮状病毒等)、滥用抗生素(如艰难梭菌腹泻)等因素导致,且持续的时间长度较短的一类腹泻总称。益生菌对预防和缓解由于轮状病毒引起的急性腹泻有一定的效果。Saavedra J. M.等发现两歧双歧杆菌和嗜热链球菌可阻碍轮状病毒感染。Thibault H等则发现短双歧杆菌c50和嗜热链球菌065可极显著地(P<0.01)减轻急性腹泻的严重程度。其他学者还发现:罗伊氏乳杆菌(L. reuteri)、鼠李糖乳杆菌(L. rhamnosus GG)、干酪乳杆菌(L.casei Shirota)和动物双歧杆菌(B. animalis Bb 12)均可缩短由轮状病毒引起的腹泻的持续时间或减少腹泻发病率。接受抗生素治疗患者群体中,有大约20%的不幸者都会不同程度上发生腹泻。临床过量使用抗生素,可导致艰难梭状芽孢杆菌(Clostridium difficile)等致病菌生长加快,引起肠道内菌群失衡。艰难梭状芽孢杆菌在结肠腔产生毒素A和毒素B,引起结肠炎而表现出腹痛、腹泻等症状。有研究表明:益生菌对可通过恢复肠道微生物平衡而防治由艰难梭状芽孢杆菌引起的结肠炎,可改善甚至根除因感染艰难梭状芽孢杆菌而引起的腹泻。慢性腹泻,是指由乳糖不耐症、肠易激综合征和肠道炎症性疾病等引起的,病程持续两月以上的腹泻或间歇期在2到4周内的复发性腹泻。益生菌可缓解乳糖不耐症。乳糖不耐受症指摄入乳糖后,由于缺少β-半乳糖苷酶而无法正常代谢乳糖,出现稀便、腹胀、腹痛等症状的一类病症。乳糖酶的活性在儿童或者是少年时期便开始降低,乳糖不耐症的症状就会出现。世界上约有2/3的成年人不同程度地遭受乳糖不耐症困扰。益生菌中含大量乳糖分解酶,当服用的益生菌被肠道内的胆汁裂解后,乳糖分解酶会释放到肠腔并分解食用的大量乳糖,从而缓解乳糖不耐症。如保加利亚乳杆菌和嗜热链球菌的发酵食品可有效缓解乳糖不耐症所引起的症状。益生菌可有效改善肠易激综合症(IBS)。IBS属肠道功能性紊乱疾病,常伴随着由排便异常而引起的腹部疼痛和不适等症状,在工业化国家总体发病率约10%。由动物模型和人体小肠活组织切片所得的实验结果表明,益生菌在治疗IBS表现出良好的效果。Kajander等给IBS患者服用含有费氏丙酸杆菌(P. freudenreichii ssp. shermanii JS)、鼠李糖乳杆菌(L. rhamnosusGG和L. rhamnosus Lc705)和动物双歧杆菌(B. animalis ssp. lactis Bb12),益生菌治疗5周后,腹胀、腹痛等病症明显减轻。另外,一系列涉及多种不同益生菌菌株的实验也都得出:益生菌可改善由IBS引起的多种腹部问题。涉及到植物乳杆菌(L. plantarum299v)、短双歧杆菌(B. breve Bb99)、两歧双歧杆菌(B. bifidum MIMBb75)和布拉酵母菌(S. boulardii)。
葛根,为豆科植物野葛的干燥根,习称野葛。味甘、辛,性平。归脾、胃、肺、膀胱经。功效:解肌退热;发表透诊;生津止渴;升阳止泻。葛根是老少皆宜的名贵滋补品,有“千年人参”之美誉。早在汉代张仲景的《伤寒论》中就有“葛根汤”这一著名方剂,至今仍是重要的解表方。《本草正义》谓葛根“最能开发脾胃清阳之气”。葛根既疏散肌腠经络之邪气,又鼓舞脾胃清阳之气上行,而生津止渴、升阳止泻。《药类法相》明确提出葛根乃治脾胃之药,谓葛根“治脾胃虚而渴,除胃热,善解酒毒,通行足阳明经之药。”葛根,因辛散之力且又入脾胃经,能鼓舞脾胃清阳之气上升,故具升举清阳之功。汪昂在《本草备要》中更将葛根称为“治脾胃虚弱泄泻之圣药”。葛根主治病症:湿热泻痢初起,脾虚泄泻。Jia Xu 等在Structuralmodulation of gut microbiota during alleviation of type 2 diabetes with aChinese herbal formula(The ISME Journal (2014), 1–11)中提到,葛根芩连汤(其中葛根为君药)可使肠道有益菌增加,改善肠道微生态而在许多代谢性疾病中发挥作用。黄伟强等在《葛根抗腹泻药效组分实验研究》(现代生物医学进,2010年 第1期)中提出:葛根素、大豆苷、大豆苷元、3’-羟基葛根素是葛根抗腹泻的药效组分。专利CN104694355A中,使用葛根复合其他中药制成护肝保健酒。专利CN106962735A一种速效溶脂降脂的中草药固体饮料,提到葛根因具有增加心肌供血,抗动脉粥样硬化及改善微循环之功效。专利CN106389575A、CN106472735A和CN105767355A均提到葛根具有解酒作用。
人参,为五加科植物人参的干燥根。性平、味甘、微苦,微温。归脾、肺经。功效:大补元气;补脾益肺;生津止渴;安神益智。人参被人们称为“百草之王”,为补气强身之要药,久服轻身延年。《别录》中记载人参可“疗肠胃中冷,心腹鼓痛,调中,破坚积”。人参乃健脾之要药。《长沙药解》曰:“人参气质醇厚,横走黄庭而补中气。中气健运,则升降复其原职,清浊归其本位,上下之呕泄皆止,心腹之痞胀俱消。”,《脏腑药式补正》亦称人参为“大补脾胃之健将”。故人参自古在补气健脾方中已多用之。脾胃气虚的病证,常有脾不升清,气虚下陷的表现。人参亦具补气升提之功,正如徐灵胎在《神农本草经百种录》中所述:“盖人参乃升提元气之要药,元气下陷,不能与精血流贯,人参能提之使起。”但配用葛根,可加强这一作用。人参主治病症涉及:脾气虚弱的食欲不振、呕吐泄泻、大便滑泄;心神不安,失眠多梦,惊悸健忘等。现代研究中,Shan-Shan Zhou等在Gut microbiota-involved mechanisms inenhancing systemic exposure of ginsenosides by coexisting polysaccharides inginseng decoction (Scientific RepoRts | 6:22474 | DOI: 10.1038/srep22474)中对独参汤与肠道微生态的研究表明:人参多糖能提高肠道对特定人参皂苷的吸收和代谢功能,同时能够恢复肠道微生态中被破坏的菌群,特别是能增加乳酸菌和拟杆菌,通过肠道菌群的重建,达到机体的平衡。Comparative Analysis of the Rats' Gut MicrobiotaComposition in Animals with Different Ginsenosides Metabolizing Activity(JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY,DOI:10.1021/acs.jafc.6b04848)研究了口服人参后,人参皂苷被肠道菌群代谢成为去糖基化的人参皂苷,之后被吸收进入血液发挥作用。郭素珍,单味人参治疗小儿腹泻的护理体会(《实用医学杂志》,199,15(2))叙述了其在临床护理工作中观察过5例用单味人参治疗的患儿。专利CN104694356B中,使用人参复合其他中药制成护肝保健酒。专利CN105168519A具有改善睡眠功能的组合物及其制备方法和应用,提到人参具宁心安神作用可用于惊悸怔仲,健忘恍惚的治疗。人参的主要成分为皂甙,能调节中枢神经系统兴奋过程和抑制过程的平衡。皂苷Rb类有中枢镇静作用,Rb1、Rb2、Rc混合皂甙具有安定作用。
姜黄,(拉丁学名:Curcuma longa L.)又名:郁金、宝鼎香、毫命、黄姜等。姜黄芭蕉目,姜科、姜黄属多年生草本植物。辛、苦,温。归脾、肝经。姜黄能行气破瘀,通经止痛。主治胸腹胀痛,肩臂痹痛,心痛难忍,产后血痛,疮癣初发,月经不调,闭经,跌打损伤。姜黄已经有很久的药用历史。这种草药在亚洲最为常见,经常作为香料添加到食物中。姜黄粉是最常见形式,是姜黄根茎经过煮熟干燥后碾成的橘黄色粉末。其主要化学成分姜黄素是姜黄的天然色素。世界卫生组织(WHO)和联合国粮农组织(FAO)同时将姜黄和姜黄素列为食品添加剂。姜黄是咖哩粉中的重要成分。此外,泡菜等食品也使用姜黄。作为食品添加剂,姜黄有很多好处。国卫办食品函〔2014〕975号,姜黄根茎仅作为调味品使用;使用量≤3克/天;在调味品中标示“根、茎”。 姜黄具有抗炎、止痛作用,善治气滞血瘀所致的心、胸、胁、腹诸痛。可消除肠道炎症、减轻腹部胀痛。姜黄色素在印度还被看作是天然消炎剂。姜黄素的抗炎作用是通过抑制主要炎症介质如环氧合酶( COX-1、COX-2) 、脂肪氧化酶( LOX)、肿瘤坏死因子α(T NF-α) 、干扰素γ( IFN-γ) 、诱 iNOS, 以及转录因子如核转录因子КB( NF-КB)和激活蛋白-1( AP-1) 而发挥效应 。姜黄素类化合物与抗炎作用的构效关系研究表明,苯环上 4 - 羟基、3, 5-供电子基、不饱和酮等是非常重要的。姜黄素目前是世界上销量最大的天然食用色素之一,具有显著的抗炎和抗氧化作用。姜黄素的抗氧化机制: 印度食物中的黄色香料姜黄素长久以来作为治疗感染性疾病的有效药物。姜黄素对某些疾病有效的预防或相应的治疗潜力也被认为与其抗氧化作用有关。Benqmark认为姜黄素抗氧化效应强于常规维生素。姜黄素是含有许多功能基团的独特的抗氧化剂,从化学结构分析,姜黄素有 2个如同肉桂醛的苯丙烯酰基骨架,两个苯环上各有一个酚羟基和一个甲氧基,丙烯基与一个β-双酮/ 烯醇式结构连接。很多研究确认:具有 1, 2-二羟基基团的酚类物质有很强的抗氧化活性, 因为此类化合物在抗氧化过程中会产生稳定性很好的醌类物质。
菊粉,来源于菊苣根(拉丁学名:Cichorium intybus var. sativum,Asteraceae),以菊苣根为原料,去除蛋白质和矿物质后,经喷雾干燥等步骤获得菊粉。我国卫生部公告2009年第5号文件,批准菊粉为新资源食品,规定食用量为≤15 g/天。2015年12月12日,欧盟发布法规(EU)2015/2314,批准菊苣菊粉(Chicory inulin)有助维持正常肠道功能的健康声称。菊粉及其次级酶解产物低聚果糖作为一种天然的膳食纤维,不仅可提供膳食纤维的功效,更可促进有益菌的生长。在预防便秘和腹泻、促进矿物元素的吸收、以及抑制有害发酵产物等方面也表现出较好的效果。越来越多的研究表明,菊粉作为膳食纤维可影响肠道微生物的生长,从而调节肠道微生态。不能被小肠吸收的菊糖进入大肠后会被细菌代谢,生成不同类的代谢物,不同的代谢底物导致优势菌群有显著差异,进而会影响肠道菌群结构。Charlotte Groot-aert等人的一项研究中,分别将阿拉伯木聚糖与菊粉对比,发现菊粉对短链脂肪酸的影响温和、可以调节微生物群落的形成;菊粉作为益生元在肠道被乳杆菌利用,成为乳杆菌的营养来源,乳杆菌的代谢可以减少肠道对甘油三酯和胆酸的吸收。Tom Van de Wiele等研究者通过对菊粉干预人体肠道微生物生态系统的模拟系统进行评估,观察肠道微生物群落,发现菊粉在近端到远端结肠都有益生作用。菊粉的一个突出特点就是能刺激肠道双歧杆菌等有益菌大量增殖,提高双歧杆菌活力,抑制致病菌生长和繁殖,维持肠道菌群平衡。有研究者对健康志愿者进行双盲实验,观察菊粉对粪便的影响,发现在烘焙产品中加入菊粉可以增加双歧杆菌的生长,可能有潜在的抑制致病菌的生长作用。膳食纤维能够结合金属离子,因此增加纤维的摄入量,可能降低肠道某些矿物元素的吸收。然而,菊粉作为一种可溶性膳食纤维,摄入后不会抑制矿物元素的吸收,相反能够促进矿物元素的吸收,如钙、镁、铁、锌等。
薏苡仁,又称薏米,为禾本科植物薏苡的种仁。其性凉,味甘、淡,入脾、肺、肾经。利水渗湿;健脾止泻;除痹;消热排脓。薏米的营养价值很高,被誉为“世界禾本科植物之王”;在欧洲,它被称为“生命健康之禾”。李时珍在《本草纲目》中记载:薏米能“健脾益胃,补肺清热,去风渗湿”。对脾虚泄泻有治疗效果。熟薏米突出了健脾止泻的作用,对于虚寒腹泻的患者来说,是很好的药食两用食材。腹泻后胃口欠佳,用熟薏米熬粥,不但可充饥,而且还有健运脾胃、补虚止泻的功效,是非常适合虚寒腹泻患者的药膳。
燕麦,(拉丁学名:Avena sativa L.)为禾本科植物,《本草纲目》中称之为雀麦、野麦子。性味甘平。具有健脾、益气、补虚、止汗、养胃、润肠的功效。1997年美国FDA认定燕麦为功能性食物,具有降低胆固醇、平稳血糖的功效。美国《时代》周刊评出的十大健康食品中,燕麦名列第五。
玉米,禾本科植物玉蜀黍的种子。性味甘平。入大肠、胃经。具有开胃、健脾、除湿、利尿功效。玉米中含有大量B族维生素,能增食欲,健脾胃。主治腹泻、消化不良、水肿等。另外,章红兵等在《膨化玉米对断奶仔猪肠黏膜形态和腹泻的影响》(《中国粮油学报》,2010,25 (1) :87-90)中指出:膨化玉米可显著降低断奶仔猪腹泻率和腹泻指数。
大豆,豆科植物大豆的黄色种子。性味甘平。入脾、大肠经。健脾宽中;益气。大豆可用于脾气虚弱、消化不良、疳积泻痢、腹胀羸瘦。现代研究《大豆低温脱溶粕中异黄酮、皂甙和低聚糖的提取与分离》(河南工业大学 , 2006)中,黄贤校认为:大豆低聚糖具有整肠效应、防止腹泻、生成营养物质、抑制肠内腐败产物生成和保护肝脏等作用。
葛根与人参配伍用于治疗脾胃气虚证的机理:
脾胃同居中焦,二者关系密切,水谷纳运相得、气机升降相因、阴阳燥湿相济,同为气血生化之源,后天之本。脾胃气虚,会导致多种病症的产生,例如倦怠乏力、腹痛、泻痢、呕吐等。故治疗当以补气健脾为主。人参葛根两者相配,一方面,针对脾胃清阳下陷的病机,人参具有补气升提的作用,而另一方面,配以风药葛根则可以其升散之性,直接生发脾胃阳气,从而使下流之谷气得以升提。此外,还可以风药舒肝,肝舒则有助于脾胃运化及气机升降,且“风能胜湿”,用葛根还能祛除脾虚后因运化无力而产生的水湿。故参葛相配则益气升提之力愈大。葛根属解表药,可能会因其发散之力造成正气的损伤,如陈士译所提“葛根耗人元气,原在无形”。但通过与人参的配伍,以人参的固涩之力可以制约葛根的发散之性,从而来增效减毒。
附图说明
图1是实施案例2所制备的颗粒形态的示意图。
图2是实施案例2所制备的产品真空包装的示意图。
图3是实施案例3微生态制剂对腹泻影响的实验结果图。
图4是实施案例5微生态制剂对高脂血症小鼠的降血脂作用实验结果图。
图5是实施案例6微生态制剂对小鼠睡眠状况的影响实验结果图。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例1。
按照以下重量分数配制,称取冷冻干燥的益生菌冻干粉,菌粉包含鼠李糖乳杆菌、唾液乳杆菌、植物乳杆菌、罗伊氏乳杆菌、保加利亚乳杆菌、发酵乳杆菌、干酪乳杆菌、副干酪乳杆菌和动物双歧杆菌。使最终体系益生菌活菌数1010 CFU/g。依次称取葛根32.88%、菊粉25.97%、人参6.55%、姜黄1.44%、薏米膨化粉7%、燕麦膨化粉2.71%、玉米膨化粉2%、大豆膨化粉2%。按上述比例称取各组分80目-100目粉末,加入粘合剂羟丙基纤维素,混合均匀,加入适量蒸馏水润湿,采用湿法制粒制成颗粒。制成的颗粒采用真空包装,每包2.4 g。服用打开真空铝箔袋后,将内容物直接倒入口中,用温水服下。一天一次,一次一包,时间随意。如果目的为改善睡眠,睡前1-3小时服用。如果目的为解酒,可于饮酒席间服用。
实施例2。
或按照最终体系益生菌活菌数109 CFU/g、葛根39.16%、菊粉34.07%、人参3.89%、姜黄0.86%、薏米7.71%、燕麦3.71%、玉米2%、大豆2%,制得颗粒,或直接以粉剂形式进行真空包装使用。
制得的颗粒形态和产品的真空包装,如图1、图2所示。
实施例3。
该调节肠道微生态制剂在动物腹泻中的应用,其步骤如下。
实验动物腹泻模型构建:选18—22 g小鼠30只。将模型动物随机分成三组(正常组、用药组、模型对照组),其中用药组和阴性对照组进行腹泻模型的建模。小鼠禁食4 h,每只鼠灌服蓖麻油0.2-0.3 mL后,把小鼠置于单养笼内,笼网下垫有滤纸或一般的白色吸水纸。观察一定时间内小鼠排除烂便及稀便的点数。
待出现明显腹泻症状后,将上述实施例1或例2中所得的肠道微生态调节剂分别溶于无菌蒸馏水中,采用灌胃的给药方式,给用药组小鼠灌入肠道微生态调节剂;正常组和对照组灌食等量生理盐水,观察小鼠灌胃后4小时内的排便情况,包括排便次数、腹泻率(排便的动物数占该组动物总数的百分比)。
观察、记录小鼠的排便状况。详见图3,用小鼠排便次数和腹泻率显示了微生态制剂对腹泻的影响。
与对照组相比,用药组小鼠在连续用药1-2次(每天一次),腹泻频率明显减少。表现出较好的止泻作用。
实施例4。
该调节肠道微生态制剂在动物溃疡性肠炎中的应用,其具体步骤如下。
实验动物溃疡性肠炎模型构建:选体重200-220g的Wistar大鼠,雌雄各半。脱去大鼠背部被毛,每天在鼠背部滴2% DNCB-丙酮液(2,4-二硝基氯苯 2g/丙酮100ml)1次,每次每只5滴,连续14天致敏。第15天用直径3mm的导尿管经肛门向肠管内插入8cm,注入0.1%DNCB酒精液(DNCB1g/50%酒精1000ml)0.25ml,2天后处死动物。造成急性溃疡性结肠炎模型,2-5周后为慢性表现。
将模型动物随机分成三组(正常组、用药组、模型对照组),将上述实施例1或例2中所得的肠道微生态调节剂分别溶于无菌蒸馏水中,采用灌胃的给药方式,给用药组小鼠灌入肠道微生态调节剂;对照组灌食等量生理盐水。4周后,处死动物后立即开腹取肛门上9-12cm肠段,进行病理学检查。
阴性对照组肠粘膜隐窝紊乱或消失,杯状细胞减少,固有层及黏膜下纤维增生严重,出现慢性炎性细胞浸润。与对照组肠粘膜状况相比,用药组肠粘膜有恢复至正常的表现。
实施例5。
该调节肠道微生态制剂在动物降血脂中的应用,其具体步骤如下。
小鼠高脂血症模型:选体重在18-25 g的雄性小鼠40只。对小鼠进行适应性喂养1周后,选用高脂饲料(10%胆固醇、20%猪油、2%胆酸钠、1%甲硫氧嘧啶、77%基础饲料)喂饲。连续喂饲上述高脂饲料7-14天,可形成高胆固醇血症,用于降血脂作用的研究。
将模型动物随机分成三组(正常组、用药组、模型对照组)。将上述实施例1或例2中所得的肠道微生态调节剂分别溶于无菌蒸馏水中,采用灌胃的给药方式,给用药组小鼠灌入肠道微生态调节剂;对照组灌食等量生理盐水。
用药组小鼠在连续用药2周后,对血液中TC(总胆固醇)、TG(甘油三脂)两项指标进行检测,详见图4,通过对比服用微生态制剂后对小鼠TC、TG的影响,来表现微生态制剂对高脂血症的影响。
结果显示与对照组相比实验组小鼠血液中TC、TG均有显著降低。该微生态调节剂表现出较好的降血脂作用。
实施例6。
该调节肠道微生态制剂在改善动物睡眠中的应用,其具体步骤如下。
选体重在18-25 g的小鼠50只,雌雄各半,将模型动物随机分成三组(用药组、模型对照组和正常组)。每日清晨7时30分,用药组、模型对照组经腹腔注射小剂量咖啡因(2mg/kg);空白对照组经腹腔注射生理盐水(0.1ml/10g),连续注射7天。第8日起按程序,用药组灌胃溶于无菌水的肠道微生态调节剂;模型对照组和空白对照组只按程序抓取不治疗。
观察小鼠睡眠期间是否安卧,有无嗅、举肢、理毛、走动;活动期间饮食、嬉戏情况,有无激惹、咬斗、易受惊、反应迟钝等。睡眠以翻正反射消失为指标。如超过30~60s不能翻正者,即认为翻正反射消失,进入睡眠。翻正反射恢复即为动物觉醒。记录溶剂对照组与受试物组入睡动物数。详见图5,通过进入睡眠动物数和睡眠率来表现微生态制剂对睡眠状况的影响。
与模型对照组相比,用药组小鼠睡眠状况和活动时的精神状态均有显著改善。
实施例7。
该调节肠道微生态制剂在动物保肝中的应用,其具体步骤如下。
酒精性肝病动物模型的建立:选择150-210 g的雄性Wistar大鼠80只,适应性饲养1周后,将大鼠随机分成三组(正常组、用药组、模型对照组)。大鼠每天给予40%酒精8g/kg体重,分3次灌胃。至第4周末,将酒精增至每天50%酒精9g/kg体重,分3次灌胃。至第8周末,酒精增至每天10g/kg体重,分3次灌胃,该剂量持续8周。实验周期16周。在每天酒精灌胃的同时,将上述实施例1或例2中所得的肠道微生态调节剂分别溶于无菌蒸馏水中,采用灌胃的给药方式,给用药组小鼠灌入肠道微生态调节剂;对照组灌食等量生理盐水。
于开始灌食酒精和肠道微生态调节剂后4、8、12和16周末,分别处死部分动物,取肝脏制备石蜡切片,HE和Masson三色染色,光学显微镜下分别观察肝细胞脂肪变性和胶原纤维沉积情况。
与对照组相比实验组小鼠肝细胞脂肪变性、坏死程度和胶原纤维面积均较轻。说明该肠道微生态调节剂可以减少酒精对肝脏细胞的损伤,具有较好的保肝作用。
虽然,上文中己经用一般性说明及具体实施方案对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (9)
1.一种调节肠道微生态制剂,其特征在于益生菌、中药、益生元、谷物四组天然成分的组合形式,以及四组成分按照以下重量分数配制:益生菌活菌数109-1010CFU/g,葛根40%-55%,人参25%-35%,姜黄1%-2%,菊粉25%-35%,薏米5%-10%,燕麦1%-5%,玉米1%-5%,大豆1%-5%;
所述益生菌包含鼠李糖乳杆菌、唾液乳杆菌、植物乳杆菌、罗伊氏乳杆菌、保加利亚乳杆菌、发酵乳杆菌、干酪乳杆菌、副干酪乳杆菌和动物乳杆菌;
所述中药包含葛根、人参、姜黄;
所述益生元为菊粉;
所述谷物为薏米、燕麦、玉米、大豆。
2.根据权利要求1所述的调节肠道的微生态制剂,其特征在于由以下重量分数配制:最终体系益生菌活菌数1010CFU/g、葛根32.88%、菊粉25.97%、人参6.55%、姜黄1.44%、薏米7%、燕麦2.71%、玉米2%、大豆2%。
3.根据权利要求1所述的调节肠道的微生态制剂,其特征在于由以下重量分数配制:最终体系益生菌活菌数109CFU/g、葛根39.16%、菊粉34.07%、人参3.89%、姜黄0.86%、薏米7.71%、燕麦3.71%、玉米2%、大豆2%。
4.根据权利要求1所述的调节肠道的微生态制剂,其特征在于,所述的肠道微生态调节类产品包括,但不限于食品、保健品和药品形式。
5.根据权利要求1所述的调节肠道的微生态制剂,其特征在于,所述制剂可制备成粉剂、颗粒剂、胶囊剂、片剂。
6.权利要求1所述的肠道微生态调节剂在制备治疗溃疡性肠炎、腹泻肠道紊乱病症药物中的应用。
7.权利要求1所述的肠道微生态调节剂在制备改善酒精性肝损伤药物中的应用。
8.权利要求1所述的肠道微生态调节剂在制备改善睡眠状况药物中的应用。
9.权利要求1所述的肠道微生态调节剂在制备降血脂药物中的应用。
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