CN107875295A - 一种保健产品及其制备方法与应用 - Google Patents
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- CN107875295A CN107875295A CN201711108042.7A CN201711108042A CN107875295A CN 107875295 A CN107875295 A CN 107875295A CN 201711108042 A CN201711108042 A CN 201711108042A CN 107875295 A CN107875295 A CN 107875295A
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Abstract
本申请涉及一种保健产品及其制备方法与应用,具体的涉及一种辅助胃黏膜修复的产品,其特征在于,所述产品中活性组分由下述组分组成:三七花60‑120份,黑果枸杞60‑100份,葛花60‑100份,槐花40‑80份,天麻40‑80份,基质适量,并包括一种软胶囊的制备方法,所得产品各有效组分配合,对受损胃黏膜具有修复作用。
Description
技术领域
本发明涉及保健产品领域,具体的涉及一种保健产品及其制备方法与应用。
背景技术
胃黏膜由覆盖于胃腔表面的上皮细胞层、固有层(内含丰富胃腺,如贲门腺、泌酸腺、幽门腺)及黏膜肌层共同组成。生理情况下,胃黏膜防御因子和侵袭因子处于一个动态平衡。当防御因子(主要是黏液-碳酸氢盐屏障和胃黏膜屏障)和侵袭因子(如HP、高浓度酒精、非甾体类抗炎药、胃酸及胃蛋白酶等)间的平衡失调时,则易引胃黏膜损伤。预防胃病的发生,不仅要减少各种侵袭因子对胃黏膜的刺激,同时还需不断修复和保护已受损胃黏膜。
目前对胃黏膜损伤形成的原因有多种解释,由氧自山基介导的细胞损伤在胃黏膜损伤中一直被关注。乙醇具有脂溶性,大剂量高浓度乙醇可直接破坏胃壁细胞,引起血流阻滞,使组织细胞缺血缺氧致胃黏膜损伤,而胃黏膜组织在缺血等病理状况下可产生大量氧自由基,后者引起黏膜细胞脂质过氧化,导致组织损伤。在胃保护中,SOD催化超氧化物歧化为过氧化氢,后者被谷胱甘肽过氧化物酶催化为水,SOD活力的高低间接反映了机体清除氧自由基的能力。而MDA是脂质过氧化产生的有害物质,在乙醇诱导的胃黏膜损伤时含量上升,MDA含量的高低,间接反映了机体细胞受氧自由基攻击的严重程度。
无水乙醇或高浓度乙醇具脱水作用,能凝固组织蛋白。乙醇还是一种有机溶剂,对胃粘膜有很强的腐蚀性,破坏表面黏液层和黏液细胞,进而破坏胃粘膜的正常代谢所需的生理环境。乙醇在胃粘膜代谢为乙醛后,乙醛与胃蛋白结合,参与了对胃粘膜的损伤。(罗永祥等,乙醇对胃粘膜损伤的机制研究概况,西南军医,2011年,第13卷第1期,122-123页)。
而目前饮酒造成的胃黏膜损伤对人体的胃部机能造成了很大的伤害,加之前期重视程度不够,不能很好的预防胃黏膜病变,此外,服用甾体类等药物造成的胃黏膜损伤也使患者在结束服用上述药物后,由于胃部病变而导致身体不能很好的得到恢复。而天然药物,特别是一些药食两用的原料在这方面具有很好的辅助效果;此外,基于中医思维治未病出发,开发具有辅助治疗效果的产品不仅符合当前大健康理念,而且相关产品研发对综合利用植物资源也具有一定的积极意义。
发明内容
本发明的目的在于提供一种能有效改善胃黏膜修复的产品,并充分利用三七花资源。
本发明涉及一种辅助胃黏膜修复的产品,其特征在于,所述产品中活性组分由下述组分组成:三七花60-120份,黑果枸杞60-100份,葛花60-100份,槐花40-80份,天麻40-80份,基质适量。
如上所述辅助胃黏膜修复的产品,其特征在于,各组分用量为:三七花100份,黑果枸杞80份,葛花80份,槐花60份,天麻60,基质适量。
如上所述辅助胃黏膜修复的产品,其特征在于,所述基质包括分散剂,增塑剂,表面活性剂,抗氧化剂。
如上所述辅助胃黏膜修复的产品,其特征在于,所述分散剂选自PEG-400、PEG-4000、PEG-6000、植物油,所述增塑剂选自甘油,所述表面活性剂选自单硬脂酸甘油酯、双硬脂酸甘油酯,抗氧化剂选自对羟基苯甲酸甲酯、对羟基苯甲酸丙酯。
如上所述辅助胃黏膜修复的产品制备方法,其特征在于,所述活性组分提取方法为:
a.三七花、葛花经净选后,置于40-80℃烘箱真空干燥4-8h,将所得干燥三七花、葛花分别用超微粉碎机粉碎至200-300目筛之间粉体,将所得三七花粉体、葛花粉体按比例混合均匀,置于高效球磨机粉碎,得到三七花、葛花粉体;
b.将黑果枸杞、槐花、天麻粉碎,过筛留50-80目,按比例置于回流提取器中,加入6-10倍量40-60%食用乙醇回流提取2-3次,提取液浓缩至无醇味后,继续浓缩至60℃下相对密度为1.30-1.35浸膏备用;
c.将步骤a中所得三七花、葛根粉粉体置于步骤b所得浸膏中搅拌均匀。
如上所述辅助胃黏膜修复的产品制备方法,其特征在于,所述产品制备方法为:
a.三七花、葛花经净选后,置于50℃烘箱真空干燥5h,将所得干燥三七花、葛花分别用超微粉碎机粉碎至200-300目筛之间粉体,将所得三七花粉体、葛花粉体按比例混合均匀,置于高效球磨机粉碎,得到三七花、葛花粉体;
b.将黑果枸杞、槐花、天麻粉碎,过筛留50-80目部分,过按比例置于回流提取器中,加入10倍量55%食用乙醇回流提取2次,提取液浓缩至无醇味后,继续浓缩至60℃下相对密度为1.30-1.35浸膏备用;
c.将步骤a中所得三七花、葛根粉粉体置于步骤b所得浸膏中搅拌均匀;
d.将步骤c中所得搅拌均匀浸膏置于搅拌器中,加入10-20%分散剂,10-20%增塑剂,0.1-0.5%表面活性剂,1-2%抗氧化剂,搅拌30-50min,既得所述产品内容物;
e.囊皮制备:以明胶-甘油-去离子水-β-胡萝卜素为制备囊皮基材,以1:0.6:1.1:0.3为比制备囊皮,按照上述比例量取纯化水放入水浴式化胶缸内,待水浴升至70-71℃时,将经胶体磨分散均匀的甘油、β-胡萝卜素缓慢投入化胶缸内,并搅拌;待缸内温度升回至70℃时,投入明胶,密闭,于75-76℃保温搅拌至明胶全部溶解,得胶液混合物料。减压抽真空,将胶液中的气泡抽净,过滤除杂,放入保温胶桶内60℃保温,得囊皮液;
f.采用软胶囊制备机制备得软胶囊。
一种制备辅助胃黏膜修复软胶囊的制备方法,其特征在于,如权利要求6所述的制备方法,分散剂为PEG-400和植物油,增塑剂为甘油,表面活性剂为单硬脂酸甘油酯,抗氧化剂为对羟基苯甲酸甲酯。
一种如上所述制备方法制得的产品,所述产品为软胶囊、硬胶囊、颗粒剂、咀嚼片。
除了将该组合物制备成软胶囊,该组合物中加入的基质还可以是淀粉、蔗糖、乳糖、甘露醇、硅衍生物、纤维素及其衍生物、明胶、甘油、琼脂、碳酸钙、表面活性剂、糊精等或者是上述辅料的一定配比混合物;所制成的剂型还可以是片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、膏剂、丹剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、喷雾剂、滴丸剂等。
一种如上所述产品在制备辅助胃黏膜修复保健品中的应用。
如上所述在制备辅助胃黏膜修复保健品中的应用,其特征在于所述保健品可以是用于辅助增强胃动力、改善胃部血液微循环、缓解胃溃疡。
本发明采用的活性组分说明如下:
三七花味性凉,有凉血的功效,能够中和体内热气,同时还能调理气血运行,活血通脉、疏通经络,促进热毒排出体外,提取物能调节中枢神经系统,改善大脑的兴奋与抑制过程;三七花中总皂甙,在动物实验中有短暂的降低犬动脉搏血压和外周阻力的作用。三七多糖是促进免疫的有效成分,三七花的两种多糖均能促经巨噬细胞的功能。三七总苷在一定程度上提高体液免疫抗体的生成。机体内脂质过氧化物(Lipid peroxide,LPO)的异常积累破坏生物膜的正常功能,促进衰老以及动脉粥样硬化等各种疾病发生。实验证明,三七粉用蒸馏水调成糊浆,可使大鼠血液中LPO的含量明显减少,脑组织中的LOP减少最为显著,具有抗衰老作用。
黑果枸杞为茄科枸杞属植物黑果枸杞的果实,藏药名“旁玛”。《维吾尔药志》记载,维吾尔医生常用黑果枸杞果实及根皮治疗尿道结石、癣疥、齿龈出血等,民间用作滋补强壮、明目及降压药。《四部医典》、《晶珠本草》等藏药经典著作记载黑枸杞用于治疗心热病、心脏病、月经不调、停经等,且药效显著。民间作滋补强壮,降压用药。黑果枸杞味甘、性平,富含蛋白质、脂肪、糖类、游离氨基酸、有机酸、矿物质、微量元素、生物碱、维生素C、B1、B2等各种营养成分。而且含有丰富的黑果色素-天然原花青素,其OPC(普通原花青素)含量超过蓝莓。
葛花,《本经逢原》记载能解酒毒,葛花解酲汤用之,必兼人参。但无酒毒者不可服,服之损人天元,以大开肌肉,而发泄伤津也。葛花中的皂角苷,异黄酮类具有氧化还原作用,加速酒精氧化,可使乙醇失去毒性,收缩和保护胃肠黏膜,减缓酒精的吸收,阻碍酒精快速大量地进入血液循环。酒前服用,提前在肝、胃形成保护膜,起到护肝养胃,增大酒量作用;酒中饮用抗醉,酒后饮用解酒,源于葛花中异黄酮类可吸附酒中致醉物质,降低酒精浓度,降低心肌耗氧量,保护心血管,并通过加速排尿、排汗排泄分解,缓解头痛、眩晕、恶心等不舒服状态,减轻醉酒程度。
槐花味苦,性平,无毒,具有清热、凉血、止血、降压的功效。对吐血、高脂血症、血管硬化、大便带血、糖尿病等有显著疗效;槐花能增强毛细血管的抵抗力,减少血管通透性,可使脆性血管恢复弹性的功能,从而降血脂和防止血管硬化。槐花中的成分芸香甙及其甙元槲皮素能保持毛细血管正常的抵抗力,减少血管通透性,可使因脆性增加而出血的毛细血管恢复正常的弹性,槲皮素可增强豚鼠、大鼠皮肤毛细血管的抵抗力(用负压引起正常及肝素化动物皮肤出现瘀点的方法),降低血管通透性(用兔-氯仿法),其对毛细血管稳定性的作用较芸香甙强1/3。近年报道槲皮素等黄酮醇型化合物对Arthus phenomenon(致敏动物皮下注射抗原,引起局部水肿及坏死)有抑制作用。
天麻中含量较高的主要成分是天麻甙,也称天麻素,其他成分包括对-羟甲基苯-β-D-吡喃葡萄糖甙,含量约为0.025%;另含天麻醚甙,其化学组成为双-(4-羟苄基)-醚-单-β-D-吡喃葡萄糖甙。又含对-羟基苯甲基醇,对羟基苯甲基醛,4-羟苄基甲醚,4-(4'-羟苄氧基)苄基甲醚[4-(4'-hydroxybenzyloxy)-benzyl methyl ether],双(4-羟苄基)醚[bis(4-hydroxybenzyl)ether],三[4-(β-D-吡喃葡萄糖氧基)苄基]枸橼酸酯,天麻含香荚兰醇、香荚兰醛、维生素A类物质、苷、结晶性中性物质、微量生物碱、黏液质等。天麻性辛、温、无毒,有抗癫痫,抗悸厥,抗风湿;镇静,镇痉,镇痛,补虚,平肝息风的功效。功能主治平肝息风止痉。用于头痛眩晕,肢体麻木,癫痫抽搐,破伤风。头昏眼花,神经衰弱,风寒湿痹,小儿惊风等症。临床应用证明,对血管性神经性头痛、脑震荡后遗症等有显著疗效。
具体实施方式
实施例1
原料组成:三七花100份,黑果枸杞80份,葛花80份,槐花60份,天麻60份,PEG-400 10%,植物油10%,甘油12%,单硬脂酸甘油酯0.2%,对羟基苯甲酸甲酯1.5%。
实施例2
原料组成:三七花60,黑果枸杞100份,葛花100份,槐花80份,天麻80份,PEG-400 10%,植物油10%,甘油12%,单硬脂酸甘油酯0.2%,对羟基苯甲酸甲酯1.5%。
实施例3
原料组成:三七花80份,黑果枸杞80份,葛花80份,槐花60份,天麻60份,PEG-400 10%,植物油10%,甘油12%,单硬脂酸甘油酯0.2%,对羟基苯甲酸甲酯1.5%。
实施例4
原料组成:三七花120份,黑果枸杞80份,葛花80份,槐花60份,天麻60份,PEG-400 10%,植物油10%,甘油12%,单硬脂酸甘油酯0.2%,对羟基苯甲酸甲酯1.5%。
为考察各活性原料在产品中所能起到的作用,采用撤药拆方法,以实施例1为基础,分为全方组、去三七花组、去黑果枸杞组、去葛花组、去槐花组、去天麻组,上述全方组制备方法如下:
a.三七花、葛花经净选后,置于50℃烘箱真空干燥5h,将所得干燥三七花、葛花分别用超微粉碎机粉碎至200-300目筛之间粉体,将所得三七花粉体、葛花粉体按比例混合均匀,置于高效球磨机粉碎,得到三七花、葛花粉体;
b.将黑果枸杞、槐花、天麻粉碎,过筛留50-80目部分,过按比例置于回流提取器中,加入10倍量55%食用乙醇回流提取2次,提取液浓缩至无醇味后,继续浓缩至60℃下相对密度为1.30-1.35浸膏备用;
c.将步骤a中所得三七花、葛根粉粉体置于步骤b所得浸膏中搅拌均匀;
d.将步骤c中所得搅拌均匀浸膏置于搅拌器中,加入PEG-400,植物油,甘油,单硬脂酸甘油酯,对羟基苯甲酸甲酯,既得所述产品内容物。
对去三七花组、去黑果枸杞组、去葛花组、去槐花组、去天麻组,则在上述全方组制备方法的基础上,分别选择减去相应得药材制备而成。
本发明全方组、去三七花组、 去黑果枸杞组、 去葛花组、去槐花组、去天麻组辅助胃粘膜修复的效果及其安全性由下述实验考察。
1、乙醇致大鼠胃溃疡模型的预防作用研究
1.1 实验动物和分组SD大鼠90只,体重(200 ±20),雌雄各半,随机分为正常模型组、模型对照组、雷尼替丁组、 全方组、三七花组、 去黑果枸杞组、去葛花组、去槐花组、去天麻组,每组10只。
1.2 方法
1.2.1 给药方法 按体量灌胃连续给药7 d,1次/d,全方组、三七花组、 去黑果枸杞组、去葛花组、去槐花组、去天麻组分别予0.6 g/kg的三七粉混悬液,雷尼替丁组0.03 mg/kg,正常模型组、模型对照组予等容等温生理盐水。
1.2.2 胃缺血再灌注模型的制备 给药7天后禁食12小时,10%水合氯醛350 mg/kg腹腔注射,大鼠麻醉仰卧固定,腹部正中切口5-7 cm,用无齿镊轻轻地把胃提出切口外,置于右侧,打开后腹膜,分离并用小动脉夹将腹腔动脉夹闭,使胃缺血30 min后,松开动脉夹血流复灌60 min制备胃缺血再灌注黏膜损伤模型,正常模型组未作任何处理。(Zhang YM,Wei EQ,Hu X,et al. The role of nuclear factor-kappa B in the effect ofangiotensin II in the paraventricular nucleus in protecting the gastricmucosa from ischemia-reperfusion injury in rats [J].J Gastroenterol,2008,43(9):687-698;马小波,杜东书,李豫,等.大鼠胃缺血后处理模型的建立[J]. 郑州大学学报:学版,2011,46( 3):399-401.)
1.2.3胃黏膜SOD活性以及MDA含量检测 分别采用黄嘌呤氧化酶法和硫代巴比妥法,严格按照说明书操作。
1.2.4 胃黏膜溃疡指数测定 计算溃疡指数(ulcer index,UI):斑点状溃疡为1分,糜烂长度<1 mm为2分,1-2 mm为3分,3-4 mm为4分,>4mm为5分,溃疡宽度>1 mm则分值×2。将每只大鼠的所有得分相加,即为该大鼠的胃黏膜UI(PH Guth,D Auras,G Paulsen.Topical aspirin plus HCI gastric lesions in the rat [J] . Gastroenterology,1979,76(1):88-93.)。
表 1 各组大鼠胃黏膜UI、SOD、MDA含量比较`x±s
*与正常模型组比较P <0.05;△与模型对照组比较P <0.05
正常模型组几无肉眼观察胃黏膜损伤,与正常模型组相比,模型对照组有大量肉眼可见出血灶,胃黏膜UI显著增加(P <0.05)。与模型对照组相比,雷尼替丁组、全方组胃黏膜UI减少(P <0.05)。而去三七花组和去黑果枸杞组与模型对照组比较差异无统计学意义(P <0.05)。与模型对照组相比,雷尼替丁组和全方组的胃黏膜SOD活性升高(P <0.05);与正常模型组相比,模型对照组胃黏膜SOD活性明显降低(P <0.05)。与模型对照组相比,雷尼替丁组和全方组的胃黏膜MDA含量明显降低(P <0.05);与正常模型组相比,模型对照组胃黏膜MDA含量显著增加(P <0.05)。与全方组比较,去三七花组、去黑果枸杞组胃黏膜UI 减少、胃黏膜SOD活性升高、胃黏膜MDA含量明显降低方面也具有显著意义;在本发明个拆方组之间比较,去葛花组、去槐花组、去天麻组在上述指标方面表现均不及去三七花组、去黑果枸杞好,证明三七花和黑果枸杞在产品组中起到非常重要的作用;各拆方组与模型对照组比较,均表现出一定的治疗效果,表明产品中各有效组分配合,对胃黏膜修复具有治疗作用。
MDA是脂质过氧化的中间产物,反映体内脂质过氧化的程度,间接地反映机体细胞受自由基攻击的损伤程度。胃肠黏膜富含氧自由基生成酶系统,氧自由基作用以细胞中脂类物质时,发生脂质过氧化反应,产生如MDA等一些分解产物,实验结果表明,胃缺血再灌注后模型对照组胃黏膜MDA含量明显增加,而经全方组处理的小鼠胃黏膜MDA含量明显降低。SOD是体内重要的抗氧化酶,当体内自由基生成增多时,它与超氧阴离子反应生成过氧化氢,再由过氧化氢酶和谷胱甘肽过氧化酶转变成水,从而清除自由基,保护细胞免受损伤。因此SOD活性的高低间接反映了机体清除氧自由基的能力。实验结果表明, 全方组可使胃缺血再灌注黏膜SOD活力明显升高。
2、安全性考察
2.1 急性经口毒性试验结果:对雌、雄昆明种小鼠的最大耐受剂量(MTD)均大于20.0mL/kg·体重,属无毒级。
2.2三项遗传毒性试验结果:Ames试验、小鼠骨髓嗜多染红细胞微核试验,小鼠精子畸形试验结果均为阴性。
2.3 30天喂养试验结果:以1.7mL/kg·体重、3.3mL/kg·体重、6.7mL/kg·体重剂量的产品大鼠灌胃30天,结果显示,动物生长发育好,各剂量组体重、增重、食物利用率、血常规指标、血生化指标、脏器重量及脏器/体重比值与对照组比较,无显著性差异,大体解剖和组织病理检查未见与样品有关的异常改变。
Claims (10)
1.一种辅助胃黏膜修复的产品,其特征在于,所述产品中活性组分由下述组分组成:三七花60-120份,黑果枸杞60-100份,葛花60-100份,槐花40-80份,天麻40-80份,基质适量。
2.如权利要求1所述的辅助胃黏膜修复的产品,其特征在于,各组分用量为:三七花100份,黑果枸杞80份,葛花80份,槐花60份,天麻60,基质适量。
3.如权利要求1或2所述辅助胃黏膜修复的产品,其特征在于,所述基质包括分散剂,增塑剂,表面活性剂,抗氧化剂。
4.如权利要求3所述辅助胃黏膜修复的产品,其特征在于,所述分散剂选自PEG-400、PEG-4000、PEG-6000、植物油,所述增塑剂选自甘油,所述表面活性剂选自单硬脂酸甘油酯、双硬脂酸甘油酯,抗氧化剂选自对羟基苯甲酸甲酯、对羟基苯甲酸丙酯。
5.如权利要求1或2所述辅助胃黏膜修复的产品制备方法,其特征在于,所述活性组分提取方法为:
a.三七花、葛花经净选后,置于40-80℃烘箱真空干燥4-8h,将所得干燥三七花、葛花分别用超微粉碎机粉碎至200-300目筛之间粉体,将所得三七花粉体、葛花粉体按比例混合均匀,置于高效球磨机粉碎,得到三七花、葛花粉体;
b.将黑果枸杞、槐花、天麻粉碎,过筛留50-80目,按比例置于回流提取器中,加入6-10倍量40-60%食用乙醇回流提取2-3次,提取液浓缩至无醇味后,继续浓缩至60℃下相对密度为1.30-1.35浸膏备用;
c.将步骤a中所得三七花、葛根粉粉体置于步骤b所得浸膏中搅拌均匀。
6.如权利要求1或2所述辅助胃黏膜修复的产品制备方法,其特征在于,所述产品制备方法为:
a.三七花、葛花经净选后,置于50℃烘箱真空干燥5 h,将所得干燥三七花、葛花分别用超微粉碎机粉碎至200-300目筛粉体,将所得三七花粉体、葛花粉体按比例混合均匀,置于高效球磨机粉碎,得到三七花、葛花粉体;
b.将黑果枸杞、槐花、天麻粉碎,过筛留50-80目部分,过按比例置于回流提取器中,加入10倍量55%食用乙醇回流提取2次,提取液浓缩至无醇味后,继续浓缩至60℃下相对密度为1.30-1.35浸膏备用;
c.将步骤a中所得三七花、葛根粉粉体置于步骤b所得浸膏中搅拌均匀;
d.将步骤c中所得搅拌均匀浸膏置于搅拌器中,加入10-20%分散剂,10-20%增塑剂,0.1-0.5%表面活性剂,1-2%抗氧化剂,搅拌30-50min,既得所述产品内容物;
e.囊皮制备:以明胶-甘油-去离子水-β-胡萝卜素为制备囊皮基材,以1:0.6:1.1:0.3为比制备囊皮,按照上述比例量取纯化水放入水浴式化胶缸内,待水浴升至70-71℃时,将经胶体磨分散均匀的甘油、β-胡萝卜素缓慢投入化胶缸内,并搅拌;待缸内温度升回至70℃时,投入明胶,密闭,于75-76℃保温搅拌至明胶全部溶解,得胶液混合物料;
减压抽真空,将胶液中的气泡抽净,过滤除杂,放入保温胶桶内60℃保温,得囊皮液;
f.采用软胶囊制备机制备得软胶囊。
7.一种辅助胃黏膜修复软胶囊的制备方法,其特征在于,如权利要求6所述的制备方法,分散剂为PEG-400和植物油,增塑剂为甘油,表面活性剂为单硬脂酸甘油酯,抗氧化剂为对羟基苯甲酸甲酯。
8.一种如权利要求5所述制备方法制得的产品,所述产品为软胶囊、硬胶囊、颗粒剂、咀嚼剂、散剂。
9.一种如权利要求8所述产品在制备辅助胃黏膜修复保健品中的应用。
10.如权利要求9所述在制备辅助胃黏膜修复保健品中的应用,其特征在于所述保健品可以是用于辅助增强胃动力、改善胃部血液微循环、缓解胃溃疡。
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