CN116763841A - 一种具有解酒护肝功效的酵母复合物 - Google Patents
一种具有解酒护肝功效的酵母复合物 Download PDFInfo
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Abstract
本发明提供了一种具有解酒护肝功效的酵母复合物,本发明提供的复合物以酵母和其他几种天然成分的配伍使用作为主要解酒护肝活性物质,含有多种生物活性成分,一方面能可有效减缓胃肠对酒精的吸收,并能提高体内乙醛脱氢酶的活性,加速酒精分解,另一方面可有效提高肝脏的抗氧化能力,清除体内自由基,保护肝细胞。
Description
技术领域
本发明涉及医药保健品技术领域,具体涉及一种具有解酒护肝功效的酵母复合物。
背景技术
酒作为一种重要的饮品之一,有着悠久的历史。据研究表明,适当饮酒有改善血液循环、解除疲劳和强身健体的功效,但与此同时,过量饮酒也伴随着高血压、痛风、急性肝损伤等疾病,严重时甚至死亡。近几十年间,随着经济的发展和生活质量的提高,因过度饮酒而引发的各类疾病的患病率也在逐年提升,其中较为常见的一种疾病为酒精性肝病(ALD),患者在初期会形成脂肪肝,随后进一步发展为酒精性肝炎,最终恶化为肝硬化。因此,鉴于过度饮酒对人类身体健康和社会发展构成的严重威胁,开发天然、有效的解酒护肝产品具有十分重要意义。
目前在临床上,主要大量应用抗生素类药物或者化学类药物来治疗过度或长期饮酒引起的各类疾病,虽然有一定的疗效,但这些药物所带来的副作用却不可忽视。例如,抗炎症类药物可以抑制肝细胞内炎症因子产生和分泌,但是一旦患者出现伤口感染或内出血等症状伤口难以愈合,副作用极大。相比之下,中草药作用温和、毒副作用小,个别中草药中的活性成分,还有多靶点作用的功效,比传统化药具有更大的优势。所以,以具有解酒、护肝作用的中药开发相关产品具有很大的前景。
有鉴于此,特提出本发明。
发明内容
针对现有技术的不足,本发明第一个目的在于提供一种具有解酒护肝功效的酵母复合物。
本发明的第二个目的是提供前文所述的酵母复合物的应用。
本发明的第三个目的是提供一种具有解酒护肝功效的酵母复合片的制备方法。
本发明的第四个目的是提供一种前文所述的复合物为有效成分或主要成分与药学上可接受的辅料制成的药物或保健食品。
为了实现本发明的上述目的,特采用以下技术方案:
第一方面,一种具有解酒护肝功效的酵母复合物,其特征在于,该酵母复合物由下述重量份的原料制成:酵母抽提物5~20份、姜黄素3~8份、葡萄籽粉1~5份、枳椇粉1~3份、刺梨粉1~3份、葛根粉1~3份、蒲公英粉1~3份。
在具体的实施方案中,该酵母复合物由下述重量份的原料制成:酵母抽提物8~12份、姜黄素3~6份、葡萄籽粉2~4份、枳椇粉1~3份、刺梨粉1~3份、葛根粉1~3份、蒲公英粉1~3份。
在更具体的实施方案中,该酵母复合物由下述重量份的原料制成:酵母抽提物10份、姜黄素5份、葡萄籽粉3份、枳椇粉2份、刺梨粉2份、葛根粉2份、蒲公英粉2份。
第二方面,本发明还保护前文所述的酵母复合物在制备具有解酒护肝功效的药物或保健食品中的应用。
在具体的实施方案中,所述药物的剂型为胶囊剂、片剂或颗粒剂;所述的保健食品为饮料、胶囊剂、片剂、粉剂、茶剂、口服液、冲剂或颗粒剂。
第三方面,本发明保护一种具有解酒护肝功效的酵母复合片的制备方法,包括以下步骤:1)原料处理:将前文所述的酵母复合物作为主料,称取主料及辅料,过筛备用,其中所述辅料由填充剂、黏合剂、润滑剂和崩解剂组成;
2)制软材:将步骤1)的主料与填充剂、部分崩解剂均匀混合,再加入黏合剂制软材;
3)制粒:湿法制粒,将软材压过分样筛即成颗粒;
4)干燥:将制得的湿粒干燥,干燥后含水量应控制在3%~5%;
5)整粒:将干燥完毕的颗粒过分样筛整粒,去除相互粘结成团块或条状的粒备用;
6)混合:在整粒料中加入润滑剂和剩下崩解剂混匀;
7)压片:将筛选得到的直径公差在合格范围内的颗粒放入模中,然后使用压片机压合成型。
在具体的实施方案中,所述步骤1)中,主料过筛时选择100目药典筛。
在具体的实施方案中,所述步骤1)中,填充剂为微晶纤维素;所述黏合剂为10%淀粉浆;所述崩解剂为羧甲基淀粉钠;所述润滑剂为硬脂酸镁、微粉硅胶或滑石粉。
在具体的实施方案中,所述步骤1)中,10%淀粉浆制备方法如下:
(1)称取10g淀粉于烧杯中,量取100ml蒸馏水备用,先用2~30mL蒸馏水解淀粉,搅拌至没有明显颗粒,再加入剩下的蒸馏水继续搅拌均匀;
(2)将淀粉溶液置于电炉上,边加热边搅拌防止糊底,冷却备用。
在具体的实施方案中,所述步骤2)中,主料与填充剂的比例为1:2~4,如1:2,1:3,1:4等,优选1:3。
在具体的实施方案中,所述步骤2)中,主料与黏合剂的比例为1~3,如1:1,1:1.25,1:1.5,1:3等,优选1:1.25。
在具体的实施方案中,所述步骤3)中,制粒时压软材的分样筛为40目筛。
在具体的实施方案中,所述步骤5)中,整粒时分样筛为40目筛。
在具体的实施方案中,所述步骤6)中,崩解剂添加类型为内加、外加,内加与外加的比例为3:1。
在具体的实施方案中,所述步骤7)中,压片模具选择直径为10mm的模具。
在具体的实施方案中,所述步骤7)中,模具选择合适的压力后压出的片剂均重400mg。
在具体的实施方案中,所述主料原料占片重比18%,填充剂占比53%,黏合剂占比20.75%,崩解剂占比7%,硬脂酸镁占比1.25%。
在具体的实施方案中,所述主料原料中酵母抽提物占总片重比例为6.92%,姜黄素占比3.46%,葡萄籽粉占比2.08%,枳椇子粉、刺梨粉、葛根粉、蒲公英粉均占比1.38%。
第四方面,本发明还保护前文所述的复合物为有效成分或主要成分与药学上可接受的辅料制成的药物或保健食品。
有益效果
本发明一方面中药中丰富多样的各种类草药具有解酒、清醒的作用,另一方面复方中药不仅可以保护肝脏、也能清除氧自由基,抗脂质过氧化,扩宽此类药品的应用领域,特别葡萄籽粉中的原花青素OPC能够增加肝脏超氧化物歧化酶(SOD)活性,消除乙醇在体内产生的自由基,阻止过氧化酯质的形成;酵母提取物能分解酒精,延迟酒精入血;同时枳椇子能加速乙醇代谢,降低乙醇浓度,缩短醒酒时间,与葛根、刺梨共同作用对增加乙醛脱氢酶(ALDH)活性和谷胱甘肽(GSH)含量有明显效果,其优越性和广阔的市场前景的不可言喻。
附图说明
图1不同浓度组合物DPPH清除率;
图2ALDH标准曲线。
具体实施方式
以下结合具体实施例来进一步说明本发明,但实施例并不对本发明做任何形式的限定。除非特别说明,本发明采用的试剂、方法和设备为本技术领域常规试剂、方法和设备。
除非特别说明,以下实施例所用试剂和材料均为市购。
实施例1
本实施例提供一种具有护肝功效的酵母复合片剂,该处方量一次能压1000片,由以下主料组成:酵母抽提物27.14g,姜黄素13.56g,葡萄籽粉8.14g,枳椇子粉、刺梨粉、葛根粉、蒲公英粉各5.43g。
本实施例提供一种具有护肝功效的酵母复合片剂制备方法,由以下辅料组成:微晶纤维素212g,10%淀粉浆适量,羧甲基淀粉钠28g,硬脂酸镁5g。
具体制备方法如下:
(1)原料处理:将采购到的主料和辅料过100目筛备用;
(2)制软材:将主料与辅料(微晶纤维素以及部分崩解剂,其中崩解剂羧甲基淀粉钠内加时添加量为总量的3/4即21g)均匀混合,再加入10%淀粉浆制软材,要求制成“捏之成团,触之即散”的状态;
(3)制粒:湿法制粒,将软材压过40目分样筛即成颗粒;
(4)干燥:将制得的湿粒平铺于方瓷盘中,置于60℃干燥箱中干燥2h,干燥后含水量应控制在3%~5%;
(5)整粒:将干燥完毕的颗粒过40目分样筛整粒,去除相互粘结成团块或条状的粒备用;
(6)混合:在整粒料中加入润滑剂硬脂酸镁和1/4(7g)的崩解剂羧甲基淀粉钠混匀;
(7)压片:将筛选得到的直径公差在合格范围内的颗粒放入10mm冲模中,然后使用压片机对整盘颗粒进行整体一次高效率的压合成型。
在复合片制备过程中,由于主料几种提取物粉粘度大,易吸潮,物料极易结块,本发明通过调节填充剂微晶纤维素和黏合剂10%淀粉浆与主料的比例和用量,解决此难题。
实施例2
本实施例提供一种具有护肝功效的酵母复合片剂制备方法,由以下主料组成:酵母抽提物13.6g,姜黄素6.8g,葡萄籽粉4g,枳椇子粉、刺梨粉、葛根粉、蒲公英粉各2.7g。
本实施例提供一种具有护肝功效的酵母复合片剂制备方法,由以下辅料组成:微晶纤维素106g,10%淀粉浆适量,羧甲基淀粉钠14g,硬脂酸镁5g。
具体制备方法如下:
(1)将采购到的主料和辅料过100目筛备用;
(2)将主料与辅料(微晶纤维素以及部分崩解剂,其中崩解剂羧甲基淀粉钠内加时添加量为总量的3/4即21g)均匀混合,加入10%淀粉浆制软材,要求制成“捏之成团,触之即散”的状态;
(3)湿法制粒,将软材压过40目分样筛即成颗粒;
(4)将制得的湿粒平铺于方瓷盘中,置于60℃干燥箱中干燥2h,干燥后含水量应控制在3%~5%;
(5)将干燥完毕的颗粒过40目分样筛整粒,去除相互粘结成团块或条状的粒备用;
(6)在整粒料中加入润滑剂硬脂酸镁和1/4(3.5g)的崩解剂羧甲基淀粉钠混匀;
(7)压片:将筛选得到的直径公差在合格范围内的颗粒放入10mm冲模中,然后使用压片机对整盘颗粒进行整体一次高效率的压合成型即得。
效果测试
1.40只小鼠随机分成4组,分别为空白组、模型组、阳性药组(海王金樽)、实验药组。
将所有小鼠空腹12h后,空白组、模型组灌胃0.3ml生理盐水,阳性药组给予0.43mg/10g海王金樽片,用0.3ml纯水溶解成混悬液灌服,实验药组给予0.43mg/10g该实验片剂,用0.3ml纯水溶解成混悬液灌服。半小时后,空白组小鼠灌胃生理盐水,模型组、阳性药组、实验药组小鼠根据体重以0.15ml/10g灌胃56度酒精,分别在给予酒精后0.5h、1.5h、3h、4h时间点采取断尾取血0.1ml,使用气相色谱检测手段,以血液乙醇浓度为指标,实验结果如下表所示:
表1不同组别对醉酒小鼠血液乙醇浓度的影响(mg/L)
通过小鼠实验,建立醉酒模型,实验结果显示服用本解酒片的模型小鼠血液乙醇浓度在同一时间点显著低于仅服用酒精的小鼠,说明该片剂具有解酒效果,且同一时间点的血液乙醇浓度也显著低于服用了阳性药模型小鼠的血液乙醇浓度,说明本解酒片能显著减少乙醇在体内的吸收,延长使用该解酒片的模型小鼠醉酒耐受时间,缩短醒酒时间,降低醉酒率,具有显著的解酒护肝功效。
2.称取5mg DPPH用甲醇溶解并定容至100mL,配置成50μg/mL的DPPH储备液。解酒组合物(不含辅料)用甲醇配制50、60、70、80、90、100、120、150、170、200μg/mL浓度的样品溶液,准确吸取不同浓度的样品100μL至96孔板,再分别加入100μL 50
μg/mL的DPPH储备液,室温避光30min,以甲醇为参比溶液,维生素C为对照,每组设置3个平行,在517nm测定吸光度,计算DPPH自由基清除率。
实验结果显示,组合物在50μg/mL-200μg/mL浓度范围内,对DPPH清除率逐渐升高,从75.76%增加到96.8%,在浓度80μg/mL时,清除率即达到90%。DPPH是体外抗氧化能力的主要评价指标之一,而清除自由基则是抗氧化剂发挥抗氧化作用的主要机制。因此可通过测定组合物对DPPH自由基的清除能力来确定其抗氧化能力。本试验结果表明,本配比组合物对DPPH的最大清除率与维生素C相近。
3.24只小鼠随机分成4组,分别为空白组、模型组、阳性药组(海王金樽)、实验药组。
将所有小鼠空腹12h后,空白组、模型组灌胃0.3ml生理盐水,阳性药组给予0.43mg/10g海王金樽片,用0.3ml纯水溶解成混悬液灌服,实验药组给予0.43mg/10g该实验片剂,用0.3ml纯水溶解成混悬液灌服。半小时后,空白组小鼠灌胃生理盐水,模型组、阳性药组、实验药组小鼠根据体重以0.15ml/10g灌胃56度酒精,酒后3h于冰上取小鼠同一部位肝脏,生理盐水冲洗后用滤纸吸净,剪切称取0.5g组织,加入4.5mL的pH7.2-7.4左右的PBS,用超声粉碎机将肝脏充分匀浆,3000转,离心20min,仔细收集上清液。根据试剂盒使用方法,检测小鼠肝脏组织ALDH酶活性。
表2不同组别对醉酒小鼠肝脏ALDH活力的影响(mg/L)
实验结果显示,与模型组相比,组合物组小鼠肝脏组织中ALDH活性显著升高,提示本组合物能加快乙醇代谢速率,降低血液中乙醇浓度,从而减轻乙醇及其代谢产物对机体的损伤,与小鼠血液乙醇浓度检测结果一致。
综上,该组合物配方既能减少乙醇在体内的吸收,降低血液中乙醇浓度,延长小鼠醉酒耐受时间,降低醉酒率,又能增强乙醇代谢过程中关键酶ALDH的活性,加快乙醇代谢物的分解,减少有毒醛类物质对机体的伤害,同时抗氧化作用能及时消除乙醇代谢过程中产生的自由基,减少脂质过氧化反应的发生,保护肝细胞。
本发明的保护内容不局限于以上实施例。在不背离发明构思的精神和范围下,本领域技术人员能够想到的变化和优点都被包括在本发明中,并且以所附的权利要求为保护范围。
Claims (10)
1.一种具有解酒护肝功效的酵母复合物,其特征在于,该酵母复合物由下述重量份的原料制成:酵母抽提物5~20份、姜黄素3~8份、葡萄籽粉1~5份、枳椇粉1~3份、刺梨粉1~3份、葛根粉1~3份、蒲公英粉1~3份。
2.根据权利要求1所述的具有解酒护肝功效的酵母复合物,其特征在于,该酵母复合物由下述重量份的原料制成:酵母抽提物8~12份、姜黄素3~6份、葡萄籽粉2~4份、枳椇粉1~3份、刺梨粉1~3份、葛根粉1~3份、蒲公英粉1~3份。
3.根据权利要求2所述的具有解酒护肝功效的酵母复合物,其特征在于,该酵母复合物由下述重量份的原料制成:酵母抽提物10份、姜黄素5份、葡萄籽粉3份、枳椇粉2份、刺梨粉2份、葛根粉2份、蒲公英粉2份。
4.权利要求1-3任一所述的酵母复合物在制备具有解酒护肝功效的药物或保健食品中的应用。
5.根据权利要求4所述的应用,其特征在于,所述药物的剂型为胶囊剂、片剂或颗粒剂;所述的保健食品为饮料、胶囊剂、片剂、粉剂、茶剂、口服液、冲剂或颗粒剂。
6.一种具有解酒护肝功效的酵母复合片的制备方法,其特征在于,包括以下步骤:
1)原料处理:将前文所述的酵母复合物作为主料,称取主料及辅料,过筛备用,其中所述辅料由填充剂、黏合剂、润滑剂和崩解剂组成;
2)制软材:将步骤1)的主料与填充剂、部分崩解剂均匀混合,再加入黏合剂制软材;
3)制粒:湿法制粒,将软材压过分样筛即成颗粒;
4)干燥:将制得的湿粒干燥,干燥后含水量应控制在3%~5%;
5)整粒:将干燥完毕的颗粒过分样筛整粒,去除相互粘结成团块或条状的粒备用;
6)混合:在整粒料中加入润滑剂和剩下崩解剂混匀;
7)压片:将筛选得到的直径公差在合格范围内的颗粒放入模中,然后使用压片机压合成型。
7.根据权利要求6所述的具有解酒护肝功效的酵母复合片的制备方法,其特征在于,所述步骤1)中,填充剂为微晶纤维素;所述黏合剂为10%淀粉浆;所述崩解剂为羧甲基淀粉钠;所述润滑剂为硬脂酸镁、微粉硅胶或滑石粉。
8.根据权利要求7所述的具有解酒护肝功效的酵母复合片的制备方法,其特征在于,所述步骤1)中,10%淀粉浆制备方法如下:
(1)称取10g淀粉于烧杯中,量取100ml蒸馏水备用,先用2~30mL蒸馏水解淀粉,搅拌至没有明显颗粒,再加入剩下的蒸馏水继续搅拌均匀;
(2)将淀粉溶液置于电炉上,边加热边搅拌防止糊底,冷却备用。
9.根据权利要求6所述的具有解酒护肝功效的酵母复合片的制备方法,其特征在于,所述步骤2)中,主料与填充剂的比例为1:2~4,所述主料与黏合剂的比例为1~3。
10.以权利要求1-3任一所述的复合物为有效成分或主要成分与药学上可接受的辅料制成的药物或保健食品。
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