CN110693969A - 一种用于降血糖血脂的药食两用组合物、制备方法及用途 - Google Patents
一种用于降血糖血脂的药食两用组合物、制备方法及用途 Download PDFInfo
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Abstract
本发明涉及一种用于降血糖血脂的药食两用组合物、制备方法及用途,组合物由以下重量配比的原材制成:杜仲叶1~7份;枸杞叶1~5份;桑叶1~4份;本产品由杜仲叶、枸杞叶、桑叶组成,具有平肝补肾、滋阴生津、疏风明目、健脾利水、清肺润燥、清热凉血、降脂降糖降压的功效,通过调整气阴两虚的身体亚健康状态达到预防和治疗上述疾病的目的。
Description
技术领域
本发明涉及预防和治疗早期糖尿病中药药食两用的复方产品技术领域,更具体地说,涉及一种用于降血糖血脂的药食两用组合物、制备方法及用途。
背景技术
现今伴随肥胖或有肥胖趋向,以及血脂、血压、血糖早期异常所致代谢综合征患病率的升高,转求于中医药防治代谢综合征的患者亦愈来愈多,需要一种预防和治疗早期指标异常的药食两用复方产品。
发明内容
本发明要解决的技术问题在于,针对现有技术的上述缺陷,提供一种用于降血糖血脂的药食两用组合物、制备方法及用途。
本发明解决其技术问题所采用的技术方案是:
构造一种用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~7份;
枸杞叶 1~5份;
桑叶 1~4份。
本发明所述的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~6份;
枸杞叶 1~3份;
桑叶 1~3份。
本发明所述的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~6份;
枸杞叶 1~3份;
桑叶 1~2份。
本发明所述的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~6份;
枸杞叶 1~2份;
桑叶 1~2份。
本发明所述的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 3~5份;
枸杞叶 3~5份;
桑叶 1~3份。
本发明所述的用于降血糖血脂的药食两用组合物,其中,所述用于降血糖血脂的药食两用组合物中杜仲叶、枸杞叶、桑叶通过水提或者醇提方法获取活性成分。
一种用于降血糖血脂的药食两用组合物的制备方法,根据上述的用于降血糖血脂的药食两用组合物,其中,包括如下步骤:
第一步:净制的干品经粉碎、过筛后称取各重量配比的原料,入煎煮罐内,加水煎煮三次,三次水量分别为6~10倍量、5~8倍量和4~7倍量,合并煎煮液;
第二步:煎煮液过滤,滤液浓缩;
第三步:喷雾干燥,得浸膏粉。
一种用于降血糖血脂的药食两用组合物的制备方法,根据上述的用于降血糖血脂的药食两用组合物,其中,包括如下步骤:
第一步:净制的干品经粉碎、过筛后称取各重量配比的原料,入煎煮罐内,加乙醇煎煮两次,乙醇浓度:40~80%,两次乙醇加量分别为6~10倍量、5~8倍量,合并煎煮液;
第二步:煎煮液过滤并回收乙醇,滤液浓缩;
第三步:喷雾干燥,得浸膏粉。
一种制品,根据上述的用于降血糖血脂的药食两用组合物的制备方法,其特征在于,所述制品中每单位制剂含所述浸膏粉不少于100mg,含粗多糖不少于1.5mg。
一种用于降血糖血脂的药食两用组合物的用途,根据上述的用于降血糖血脂的药食两用组合物,其特征在于,所述药食两用组合物用于制备治疗降血糖血脂的药食两用制剂或口服液。
本发明的有益效果在于:本产品由杜仲叶、枸杞叶、桑叶组成,具有平肝补肾、滋阴生津、疏风明目、健脾利水、清肺润燥、清热凉血、降脂降糖降压的功效,通过调整气阴两虚的身体亚健康状态达到预防和治疗上述疾病的目的。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将结合附图及实施例对本发明作进一步说明,下面描述中的附图仅仅是本发明的部分实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他附图:
图1是本发明较佳实施例的用于降血糖血脂的药食两用组合物制备方法流程图;
图2是本发明另一实施例的用于降血糖血脂的药食两用组合物制备方法流程图;
图3:是第12周对照A组的个体牛犊喂食正常乳品后2、4、6和8小时的血浆葡萄糖浓度示意图;
图4:是第12周实验B组的个体牛犊喂食正常乳品后2、4、6和8小时的血浆葡萄糖浓度示意图;
图5:是第12周实验C组的个体牛犊喂食正常乳品后2、4、6和8小时的血浆葡萄糖浓度示意图;
图6:第20周牛犊口服糖耐量试验示意图。
具体实施方式
为了使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的技术方案进行清楚、完整的描述,显然,所描述的实施例是本发明的部分实施例,而不是全部实施例。基于本发明的实施例,本领域普通技术人员在没有付出创造性劳动的前提下所获得的所有其他实施例,都属于本发明的保护范围。
本发明较佳实施例的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~7份;
枸杞叶 1~5份;
桑叶 1~4份;
本产品由杜仲叶,枸杞叶,桑叶组成,具有平肝补肾,滋阴生津,疏风明目,健脾利水,清肺润燥,清热凉血,降脂降糖降压的功效,通过调整气阴两虚的身体亚健康状态达到预防和治疗上述疾病的目的。
本发明的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~6份;
枸杞叶 1~3份;
桑叶 1~3份。
本发明的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~6份;
枸杞叶 1~3份;
桑叶 1~2份。
本发明的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 1~6份;
枸杞叶 1~2份;
桑叶 1~2份。
本发明的用于降血糖血脂的药食两用组合物,其由以下重量配比的原材制成:
杜仲叶 3~5份;
枸杞叶 3~5份;
桑叶 1~3份。
在上述的多种组成中,杜仲叶来源于杜仲(学名Eucommia ulmoides Oliver),为杜仲科杜仲属植物的干燥叶子。枸杞叶来源于为茄科植物枸杞或宁夏枸杞(Lyciumchinense Mill.Lycium barbarum L.)春季采摘、干燥后的茎叶。桑叶来源于桑科植物桑(Morus alba L.)的成熟干燥叶。
优选的,上述多种组成成分组成的用于降血糖血脂的药食两用组合物由杜仲叶、枸杞叶、桑叶的水提或者醇提物为活性成分,加上药学/食品上可以接受的辅料或者辅助性成分如食品添加剂等制备而成。
优选的,用于降血糖血脂的药食两用组合物中杜仲叶、枸杞叶、桑叶通过水提或者醇提方法获取活性成分;
本领域中的普通技术人员可以根据各原料所含有效成分采取不同的提取方法,例如,各原料共同或分别采取水提醇沉、醇提水沉、超临界流体萃取、超声提取、酶提取压榨提取、免加热提取等工艺,制剂的各制粒工艺、食品的各生产工艺,产品内外包装的材质、图案等,都属于本发明的保护范围。
一种用于降血糖血脂的药食两用组合物的制备方法,根据上述的用于降血糖血脂的药食两用组合物,如图1所示,包括如下步骤:
S01:净制的干品经粉碎、过筛后称取各重量配比的原料,入煎煮罐内,加水煎煮三次,三次水量分别为6~10倍量、5~8倍量和4~7倍量,合并煎煮液;
S02:煎煮液过滤,滤液浓缩;
S03:喷雾干燥,得浸膏粉。
一种用于降血糖血脂的药食两用组合物的制备方法,根据上述的用于降血糖血脂的药食两用组合物,如图2所示,包括如下步骤:
S11:净制的干品经粉碎、过筛后称取各重量配比的原料,入煎煮罐内,加乙醇煎煮两次,乙醇浓度:40~80%,两次乙醇加量分别为6~10倍量、5~8倍量,合并煎煮液;
S12:煎煮液过滤并回收乙醇,滤液浓缩;
S13:喷雾干燥,得浸膏粉。
一种制品,根据上述的用于降血糖血脂的药食两用组合物的制备方法,其特征在于,制品中每单位制剂含浸膏粉不少于100mg,含粗多糖不少于1.5mg。
一种用于降血糖血脂的药食两用组合物的用途,根据上述的用于降血糖血脂的药食两用组合物,其特征在于,药食两用组合物用于制备治疗降血糖血脂的药食两用制剂或口服液。
糖尿病类似中医的“消渴病”,其病机“阴虚血燥,燥热伤津”;治则:“滋阴润燥清热、凉血解毒化瘀”守此大法,既能降糖又能改善体内代谢紊乱,防止许多并发症的发生。
杜仲叶:性味微辛;性温,归经入肝;肾经。功效有:补肝肾;强筋骨;用于肝肾不足,头昏目眩,腰膝酸痛,筋骨萎软,可使用于保健食品。张红霞等(2014)报道杜仲叶乙醇提取物可以通过抑制α~葡萄糖苷酶活性,降低葡萄糖吸收来实现降血糖的效果;
枸杞叶:味甘、苦、性凉;入肝、脾、肾经,功效:补虚益精,清热,止渴,祛风明目,生津补肝,是中国各地的传统食品。魏志清(2012)等报道于宁夏枸杞叶对糖尿病小鼠均有降血糖作用,春季枸杞叶的降血糖作用更明显;
桑叶:性味归经味甘,苦;性寒。归肺,肝经。功效有:疏散风热、清肺润燥、平肝明目、凉血止血的功效,作用于风热感冒、瘟病初起、肺热咳嗽、肝阳上亢、目赤昏花、血热妄行的咳血、吐血等症。桑叶为桑属植物桑(Morus alba L.)的叶子,为药食两用品。浙江大学硕士研究表明:桑叶中的多糖具有降血糖的功效,桑叶正丁醇提取物具有辅助降血脂的功效;
本方针对糖尿病初、中期或代谢出现障碍而设,重在降糖固精,通浊升清,消脂通便,出入进退有序。故重用杜仲为君,意在降糖而又补肝肾、强筋骨,护阳气;加枸杞叶滋阴凉血,养肝明目,润燥清热,生津降糖;再以桑叶,疏散风热、清肺润燥、平肝明目、凉血止血。全方共奏滋阴润燥,清热止渴,祛风明目,消脂通便,降糖降压之用。
服此方后,有少数患者,初服泻肚,日泻4次之多,切勿惊,腹泻后头脑特别清爽,身体舒适,如果连续3~5天均腹泻4次以上,就改为隔日一服,服到10天半月后,大便转为正常,日1~2次。
主治:肥胖或有肥胖趋向,高血脂、高血压、高血糖、糖尿病初、中期、烦渴多饮,口舌干燥,乏力多汗,或尿频量多,大便干燥秘结,舌尖红,苔薄或舌红少苔体肥健患者。
本中药复方制剂以传统中医理论为指导,结合最新医药学技术,通过调整气阴两虚的身体亚健康状态达到预防和治疗上述疾病的目的。
具体实施方式可以采用如下方式:
实施例一
净制的干品经粉碎、过筛后称取各重量配比的原料:杜仲叶6份枸杞叶1份,桑叶3份,入煎煮罐内,加水煎煮3次(水量分别为6~10倍量、5~8倍量、4~7倍量),合并煎煮液;煎煮液过滤,滤液浓缩(浓缩至比重1.0~1.35);喷雾干燥,(条件:进风温度:160~175 0C,出风温度70~95 0C,进塔负压300~600Pa,出塔负压900~1300pa,喷嘴压力0.8~0.9MPA)得浸膏粉;浸膏粉按比例称重,加入药学上常用的辅料混匀,用一步制粒机制粒,以水为润湿剂,进风温度60~800C,出风温度40~600C,制成的颗粒可分装得颗粒剂;可填充入空心胶囊得胶囊剂,分包装;
实施例二
净制的干品经粉碎、过筛后称取杜仲叶5.5份,枸杞叶2.5份,桑叶2份,按实施例一的操作,制成颗粒剂后,加入适量的润滑剂、崩解剂,可通过压片机压片得片剂,分包装;
实施例三
净制的干品经粉碎、过筛后称取杜仲叶5.5份,枸杞叶2.5份,桑叶2份,按实施例一的操作,制成浸膏粉后,加入植物油、甘油,研磨均匀后,以明胶为囊材,采用软胶囊机制成软胶囊,分包装;
实施例四
净制的干品经粉碎、过筛后称取杜仲叶6份,枸杞叶2份,桑叶2份,按实施例一的操作,制成浸膏粉后,加入蜂蜜与水制成软材,用制丸机制丸,干燥,分包装;
实施例五
净制的干品经粉碎、过筛后称取杜仲叶4份,枸杞叶4份,桑叶2份,入煎煮罐内,加乙醇煎煮2次(乙醇浓度:40~80%,加量分别为6~10倍量、5~8倍量),合并煎煮液;.煎煮液过滤并回收乙醇,滤液浓缩(浓缩至比重1.0~1.35),加表面活性剂配制,超滤,灌封,得口服液包装;
本发明的原料杜仲叶、枸杞叶、桑叶配伍使用,发挥协同增效作用,效果可靠,为市场提供了一种新的产品。显然,根据本发明的上述实例形式的具体实施方式内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其他多种形式的修改、替换和变更,但不应将此理解为本发明上述主题的范围仅限于以下的实例,凡基于本发明上述内容所实现的技术均属于本发明的范围。
安全性和药效学实验
安全性:
文献报道杜仲叶、枸杞叶及桑叶毒性试验的情况:
杜仲叶、桑叶作为保健食品,在国家药监局网站的数据库查到有44个批文、桑叶有218个批文,而早在明代,李时珍在《本草纲目》中提到"春采枸杞叶,名天精草",这里所说的天精草即特指"根茎与花实,收拾无弃物"的枸杞叶嫩芽。据枸杞叶茶的百科介绍,枸杞虽然是药效上佳的滋补保建珍品,但其温热身体的效用十分明显,并不适宜高血压患者、性情急躁者、营养过剩者。枸杞叶茶却并非如此,它"甘平而润",《本草汇言》中赞它"能使气可充,血可补,阳可生,阴可长,风湿可去,有十全之妙焉",长期饮用枸杞叶茶不会产生副作用。说明这三味叶类组合的产品,是安全有效的。查询现代毒理研究文献,也证明了其安全有效性。
贵州省药品检验所黄武光等对杜仲叶冲剂进行主要药效学及急性毒性研究急性毒性实验取小鼠22只,雌雄各半,用杜仲叶冲剂最大浓度(1g/ml),空腹ig给药一次(0.8ml/只),用药后观察7天。结果:7天内小鼠生理状态均正常,全部健康活泼,体重增加,无一死亡。实验求得冲剂一次口服的最大耐受量为40g/Kg,相当于临床每日服用量(10g/次,2次/d)的400倍,表明本品毒性低,服用安全。
中科院西北高原研究所已鉴定的中国科技创新成果表明:研制开发的枸杞叶黄酮复合软胶囊,毒理学试验表明其无急慢性毒性。
浙江大学医学院附属儿童医院吴友苹等通过小鼠急性毒性试验、鼠伤寒沙门氏菌试验(Ames试验)、中国仓鼠肺成纤维细胞(CHL)染色体畸变试验和小鼠骨髓嗜多染红细胞微核试验,考察桑叶水提液急性毒性和遗传毒性。结果桑叶水提液40g/kg小鼠灌胃给药未出现死亡,体质量与正常对照组比较无明显差异(P>0.05)。经Ames试验、CHL细胞染色体畸变试验、小鼠微核试验,桑叶水提液的结果均为阴性。结论本实验条件下,桑叶水提液的小鼠灌胃给药最大给药剂量为40g/kg,且未表现出遗传毒性。
药效学实验
近些年,由于大众对天然食品和药物的推崇,用于降糖和控制胰岛素抵抗的纯天然植物提取物(单独或组合使用)已经引起社会的广泛关注。据报道,在糖尿病患者中(体内和体外),有200多种纯植物化学物质可产生降血糖作用。除降血糖作用外,Bailey CJ博士及其同事,以及Broadhurst CL博士的研究小组发现植物性产品还可以改善脂质代谢并增强胰岛素活性。
在生产实践中发现,荷斯坦弗里斯兰公牛犊在生长早期会出现早期代谢综合征症状,大大影响产肉量。因此,使用本复方产品喂食荷斯坦弗里斯兰公牛犊,不仅为研究并找到有效的预防/治疗牛犊早期代谢综合征提供可能的解决方案,同时此实验也作为本复方产品的药效学实验,为本复方产品的功效提供科学实验证据。
实验方法
正式实验前,先将30头荷斯坦弗里斯兰公牛犊(±2周龄,起始体重约为49公斤)单独放在保育箱中6周。在育肥牛犊的第6周,称重并分组,将其分为对照A组(n=10),实验B组(n=10)和实验C组(n=10)。从育肥期的第1周到第10周,所有30头牛犊喂食正常乳品。从第10周开始,针对2个实验组(B,C)开始实验方案。A组牛犊作为对照组,仍保持喂食正常乳品。实验B组的牛犊在喂食正常乳品的同时,在第70-80天添加喂食本复方产品。实验C组在保持和实验B组同样喂食的基础上,在第126-136天再次喂食本复方产品。实验组的每只动物每天喂食剂量相当于人类每天5克服用剂量。第12周和第20周,分别在牛犊喂食前约30分钟采集血样,以获得基础值。在时间点t=0,牛犊喂食正常乳品。在喂食后2、4、6和8小时采集血样,以确定血浆葡萄糖浓度。
实验结果
实验周期第12周,实验C组的个体牛犊喂食正常乳品后2、4、6和8小时的血浆葡萄糖浓度(平均值:8.00mmol/L)明显低于对照A组(平均值:10.00mmol/L)。第20周,进行牛犊口服糖耐量试验。相较于t=0的基础血浆葡萄糖浓度,进食4小时(t=4)后,实验C组的血浆葡萄糖浓度显著低于对照A组(P<0.05)。因此,药效学实验结果表明:二次加量喂食本复方产品(实验C组)可以明显降低血糖和控制胰岛素抵抗。
图3-5所示:第12周,个体牛犊喂食正常乳品后2、4、6和8小时的血浆葡萄糖浓度。实验C组的个体牛犊血浆葡萄糖浓度明显低于对照A组。对照A组牛犊喂食正常乳品。实验B组在第70-80天添加喂食本复方产品。实验C组在第70-80天和126-136天喂食本复方产品。
图6:第20周,牛犊口服糖耐量试验。相较于t=0的基础血浆葡萄糖浓度,进食4小时(t=4)后,实验C组的血浆葡萄糖浓度显著低于对照A组(P<0.05)。对照A组牛犊喂食正常乳品。实验B组在第70-80天添加喂食本复方产品。实验C组在第70-80天和126-136天喂食本复方产品。
应当理解的是,对本领域普通技术人员来说,可以根据上述说明加以改进或变换,而所有这些改进和变换都应属于本发明所附权利要求的保护范围。
Claims (10)
1.一种用于降血糖血脂的药食两用组合物,其特征在于,其由以下重量配比的原材制成:
杜仲叶1~7份;
枸杞叶1~5份;
桑叶1~4份。
2.根据权利要求1所述的用于降血糖血脂的药食两用组合物,其特征在于,其由以下重量配比的原材制成:
杜仲叶1~6份;
枸杞叶1~3份;
桑叶1~3份。
3.根据权利要求1所述的用于降血糖血脂的药食两用组合物,其特征在于,其由以下重量配比的原材制成:
杜仲叶1~6份;
枸杞叶1~3份;
桑叶1~2份。
4.根据权利要求1所述的用于降血糖血脂的药食两用组合物,其特征在于,其由以下重量配比的原材制成:
杜仲叶1~6份;
枸杞叶1~2份;
桑叶1~2份。
5.根据权利要求1所述的用于降血糖血脂的药食两用组合物,其特征在于,其由以下重量配比的原材制成:
杜仲叶3~5份;
枸杞叶3~5份;
桑叶1~3份。
6.根据权利要求1-5任一所述的用于降血糖血脂的药食两用组合物,其特征在于,所述用于降血糖血脂的药食两用组合物中杜仲叶、枸杞叶、桑叶通过水提或者醇提方法获取活性成分。
7.一种用于降血糖血脂的药食两用组合物的制备方法,根据权利要求1-6任一所述的用于降血糖血脂的药食两用组合物,其特征在于,包括如下步骤:
第一步:净制的干品经粉碎、过筛后称取各重量配比的原料,入煎煮罐内,加水煎煮三次,三次水量分别为6~10倍量、5~8倍量和4~7倍量,合并煎煮液;
第二步:煎煮液过滤,滤液浓缩;
第三步:喷雾干燥,得浸膏粉。
8.一种用于降血糖血脂的药食两用组合物的制备方法,根据权利要求1-6任一所述的用于降血糖血脂的药食两用组合物,其特征在于,包括如下步骤:
第一步:净制的干品经粉碎、过筛后称取各重量配比的原料,入煎煮罐内,加乙醇煎煮两次,乙醇浓度:40~80%,两次乙醇加量分别为6~10倍量、5~8倍量,合并煎煮液;
第二步:煎煮液过滤并回收乙醇,滤液浓缩;
第三步:喷雾干燥,得浸膏粉。
9.一种制品,根据权利要求7或8所述的用于降血糖血脂的药食两用组合物的制备方法,其特征在于,所述制品中每单位制剂含所述浸膏粉不少于100mg,含粗多糖不少于1.5mg。
10.一种用于降血糖血脂的药食两用组合物的用途,根据权利要求1-6任一所述的用于降血糖血脂的药食两用组合物,其特征在于,所述药食两用组合物用于制备治疗降血糖血脂的药食两用制剂或口服液。
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