CN112137088A - 一种具有抗氧化、延缓衰老功效的复方组合物及其制备方法与应用 - Google Patents
一种具有抗氧化、延缓衰老功效的复方组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种具有抗氧化、延缓衰老功效的复方组合物及其制备方法与应用,本发明通过将人参、茯苓、地黄、肉苁蓉、丹参、党参、桃仁、麦冬中的5‑8种单独提取得到的中药提取物与壳寡糖进行复配制备出一种具有抗氧化、延缓衰老功效的复方组合物,该复方组合物无毒副作用、易吸收,可用于延缓衰老,修复DNA损伤、抗氧化损伤,还能降低老年病的发生风险,并且本发明公开的复方组合物可作为膳食补充剂或保健食品原料,以提高端粒酶含量、延缓衰老,由此可见,本发明公开的复方组合物适于推广与应用。
Description
技术领域
本发明属于天然药物技术领域,具体为一种复方组合物及其制备方法与应用,尤其涉及一种具有抗氧化、延缓衰老功效的复方组合物及其制备方法与应用。
背景技术
传统中医认为,衰老是由多种原因所致,肾虚、脾虚可致衰老,瘀血、痰浊亦可致衰老;而补肾法、健脾益气法、活血化瘀法、化痰法均可延缓衰老。其中,补肾健脾益气是延缓衰老的基本途径,活血化痰是延缓衰老的重要方法,但虚实夹杂多因素致衰老更多见,其中“虚”多集中于脾肾两虚,“实”则集中在痰浊与瘀血两大类。
此外关于衰老原因,现代医学研究包括:衰老的自由基学说、端粒与端粒酶理论等。然而自由基水平的增加或抗氧化剂的缺失使机体抗氧化能力下降和细胞毒性增加,最终造成生物膜、氨基酸链及DNA的分子结构的不可逆改变损伤,导致机体衰老相关退行性疾病的产生,加速衰老进程;端粒作为端粒酶的底物,保证染色体复制时的完整性,决定细胞的寿命;且端粒长度与细胞分裂次数及寿命极限有关,科学家们在衰老细胞内表达了端粒酶,不仅逆转了细胞的衰老,还开始利用葡萄糖合成核苷酸,衰老的调节有赖于端粒酶对端粒的调控及端粒和端粒酶的联合作业。
目前具有抗衰老功能的保健食品或食品,大多以抗氧化、增强免疫力为切入点,主要应用葡萄籽提取物、白藜芦醇、虾青素等强抗氧化物质及西洋参、枸杞子等中药提升免疫力。同时细胞衰老、基因等深层次衰老也逐步进入大众视野。鉴于衰老机制本身的复杂性和不确定性致使衰老现象不能用单一机制进行阐释,必须进行多方面多层次的深入探究。同理,延缓衰老也需从多成分、多层次、多作用机制方面入手。
基于上述衰老是由多方原因造成的,现阶段,市面上已有的延缓衰老产品多从清除自由基切入,已有的自由基清除剂也主要是一些单一的提取物或维生素类产品等,如葡萄籽提取物、白藜芦醇、虾青素、维生素E等,清除自由基能力非常有限,及能够清除的自由基范围较窄,不能对所有自由基起到有效清除作用,因而难以真正弥补由于年龄增长带来的自身清除自由基能力下降问题,同时对具体的衰老表征、人体内衰老相关酶含量、调节因子的变化等未深入研究。
因此,开发一款能够促进健康的细胞老化及抗氧化,且无毒副作用、易吸收,并具有抗氧化、延缓衰老功效的复方组合物是本领域技术人员亟需解决的问题。
发明内容
有鉴于此,本发明的目的是针对现有技术中存在的问题,提供一种具有抗氧化、延缓衰老功效的复方组合物,该复方组合物无毒副作用、易吸收,能够作为膳食补充剂或者保健食品原料,用于延缓衰老,修复DNA损伤、抗氧化损伤,还能降低老年病的发生风险。
为了实现上述目的,本发明采用如下技术方案:
本发明通过中药传统复方琼玉膏加味与海洋现代成分壳寡糖的有机结合,从中医及现代科学两方面着手有效延缓衰老。通过选用经典古方琼玉膏,而琼玉膏具有滋阴润肺,补脾健肺之效,以及添加的肉苁蓉和丹参都可从多个方面起到延缓衰老的作用;且本发明为琼玉膏的应用开发出新途径。
一种具有抗氧化、延缓衰老功效的复方组合物,所述复方组合物是由中药提取物与壳寡糖按照质量比(3~8):1混合而成;
其中,所述中药提取物是由以下中药材单独提取后混合而得,按照质量百分比计:
人参7~15%;
茯苓14~35%;
地黄14~35%;
肉苁蓉14~35%;
丹参7~15%;
党参0~10%;
桃仁0~10%;
麦冬0~10%。
优选的,所述中药提取物是由以下中药材单独提取后混合而得,按照质量百分比计:
人参12~15%;
茯苓25~30%;
地黄20~25%%;
肉苁蓉20~25%;
丹参12~15%;
党参2~3%;
桃仁1~2%;
麦冬1~2%。
进一步优选的,所述中药提取物是由以下中药材单独提取后混合而得,按照质量百分比计:
人参13%;
茯苓26%;
地黄22%%;
肉苁蓉22%;
丹参13%;
党参2%;
桃仁1%;
麦冬1%。
值得说明的是,根据药典文献推荐的生药剂量,由本发明公开的工艺提取制备的复方组合物的日服用剂量1.8~3.6g,并根据后期动物药效试验筛选得到所述复方组合物的有效剂量。
此外,本发明公开的中药提取物所用中药材是通过科学的依据,根据中医经典成方、网络药理学、中国药典确定要添加的中药提取物及指标成分,具体为:
所添加的中药材为人参、茯苓、地黄、肉苁蓉、丹参、党参、桃仁、麦冬中的4-5种,指标成分分别为人参总皂苷或人参多糖、β-茯苓聚糖或茯苓多糖、地黄甙A、B、C、D或二氢梓醇甙或桃叶珊瑚甙、松果菊苷或肉苁蓉多糖或肉苁蓉总苷、丹参酮IIA或隐丹参酮或者丹酚酸B、党参皂苷或党参多糖、苦杏仁苷或桃仁多糖、麦冬总皂苷或高异黄酮或麦冬多糖。
进一步的,经中药提取物之间的有机结合,并根据中医理论配伍,而不是根据单一中药功效进行的简单叠加,具体的各种中药材的功效如下:
人参:人参甘、微苦,微温,归心、肺、脾经。大补元气,补脾益肺,生津止渴,安神益智。人参在《神农本草经》中被列为上品药物,具有“多服久服不伤身、轻身益气不老延年”的作用。
临床用于:①用于气虚欲脱,脉微欲绝的危重症候;②用于肺气虚弱得短气喘促,懒言声微,脉虚自汗等证;③用于脾气不足的倦怠乏力,食少便溏等证;④用于热病气津两伤之身热口渴及消渴等证;⑤用于气血亏虚的心悸,失眠,健忘等病症。
茯苓:味甘、淡,性平,归心、肺、脾、肾经。利水渗湿,健脾,宁心。《本草纲目》记载“茯苓气味淡而渗,其性上行,生津液,开腠理,滋水源而下降,利小便,故张洁古谓其属阳,浮而升,言其性也;东垣谓其为阳中之阴,降而下,言其功也”。
生地黄:甘,寒。归心、肝、肾经。滋阴补肾、养血补血、凉血。凡阴虚血虚肾虚者食之,颇有益处。《纲目》有载“填骨髓,长肌肉,生精血,补五脏、内伤不足,通血脉,利耳目,黑须发,男子五劳七伤,女子伤中胞漏,经候不调,胎产百病”。
肉苁蓉:味甘;咸;性温,归肾、大肠经。补肾阳、益精血、润肠道。具有抗衰老、调整内分泌、促进代谢及强壮、提高免疫、促进进脱氧核糖核酸合成、降压等作用。《神农本草经》记载“主五劳七伤,补中,除茎中寒热痛,养五脏,强阴,益精气,妇人症瘕”。
丹参:味苦,微寒。归心、肝经。活血祛瘀,通经止痛,清心除烦,凉血消痈。用于胸痹心痛,脘腹胁痛,症瘕积聚,热痹疼痛,心烦不眠,月经不调,痛经经闭,疮疡肿痛。《本草纲目》记载“活血,通心包络,治疝痛”。《别录》有载“养血,去心腹痼疾结气,腰脊强脚痹,除风邪留热。久服利人”。
党参:甘,平。补中益气,和胃生津,祛痰止咳。
桃仁:苦、甘,平。归心、肝、大肠经。活血祛瘀,润肠通便,润肠通便,止咳平喘。
麦冬:味甘、微苦,性微寒,归胃、肺、心经,有养阴润肺、益胃生津、清心除烦的功效。《神农本草经》将麦冬列为养阴润肺的上品,言其“久服轻身,不老不饥”。
琼玉膏由人参、生地黄、白茯苓、蜂蜜组成,出自宋·《洪氏集验方》,元·王好古《医垒元戎》中称此膏:“填精补髓,发白变黑,返老还童,行如飞羽”。明·李时珍《本草纲目》,“常服开心益智,发白返黑,齿落更生,辟谷延年”。
本发明以加味琼玉膏为基,严格遵循君臣佐使配伍原理,以人参补气生津、补脾益肺、安神益智,以大补元气,补益生津,为君;以肉苁蓉补肾阳,益精血,以生地黄滋补肾阴,二者为臣药,阴阳并补,助君药固本培元;以茯苓健脾利湿,以防滋腻、水湿内停;以丹参活血祛瘀,清心除烦以助气血运行,使补而不滞;以党参补中益气、和胃生津;以桃仁活血祛瘀;以麦冬养阴润肺、清心除烦;以上一味或几味为佐药。诸药合用,可气血阴阳、脏腑并补,行益气生津、补肾益精、养血活血、安神益智之功。
具体地,本发明的现代医学组方原理如下所述:
研究表明,传统中医中含有丰富的皂苷、多糖、黄酮、多酚等功能成分,具有抗疲劳、抗肿瘤、抗氧化、免疫调节、降低血糖血脂、调节血压、抑菌及促伤口愈合等多种生理活性;例如,人参中的人参皂苷、茯苓中的茯苓多糖、地黄甙、肉苁蓉松果菊苷、丹参酮或丹酚酸B、党参皂苷等,具有丰富的现代医学研究基础证明其具有抗氧化、支持血管健康、免疫调节等等生理功能。
此外,壳寡糖作为典型的海洋活性物质,具有功能多样、来源广泛、特异性强、毒副作用小等优势,已逐渐成为21世纪研究的热点,被广泛用于食品、化妆品、生物医药等领域。其是自然界中唯一带正电荷、呈碱性的低聚糖,不仅对体内呈负电的各类有毒物质有较强的吸附能力,还具有还原性,且其具有的碱性可中和酸性物质,改善体质,可与细胞特异性结合,提高免疫力。
更进一步的,协同作用是活性物质之间的一种常见反应,早在20世纪80年代,人们就发现不同物质之间存在协同作用,尤其是中药复合物,作为一种复杂的体系,成分多样,不同成分间可能存在一定协同作用,若添加比例适当,可以提升整个食品的的功效。因此,本发明利用中药提取物多糖、皂苷、黄酮等与海洋低聚糖壳寡糖的协同作用,在现代医学基础上达到延缓衰老的技术效果。
另外,在现有技术中,虽然每味中药的常用量是已知的,但是方剂是针对病症对多味药配伍后的有机整体,其药效不等同于其各药味在常用量基础上的简单叠加,根据每味中药的常用量通常并不能确定其在方剂中的药量,药材用量配比由其药材特性、君臣佐使配伍等各种考虑因素决定,并非简单的通过比较法、正交法等实验手段即可优选得出。
本发明还有一个目的,就是提供一种具有抗氧化、延缓衰老功效的复方组合物的制备方法,包括:将人参、茯苓、地黄、肉苁蓉、丹参、党参、桃仁和麦冬分别提取、纯化、浓缩及喷雾干燥制得中药提取物后与壳寡糖混合均匀制得;具体包括如下步骤:
(1)将中药材粉碎过筛后与乙醇溶液按照配比加热回流提取、过滤,并将药渣多次提取后的提取液合并,备用;
(2)将步骤(1)合并的所述提取液纯化、浓缩后喷雾干燥或真空干燥,过筛得到中药提取物;
(3)将步骤(2)中所述中药提取物按照上述公开的质量配比与所述壳寡糖混合均匀,得到具有抗氧化、延缓衰老功效的复方组合物。
优选的,所述步骤(1)中,中药材粉碎过筛目数为20~80目,添加中药材与乙醇溶液的体积比为1:(5~20),且中药材加热回流提取次数为1~3次,提取时间为1~3h,提取温度为80℃~100℃。
优选的,所述步骤(2)中,喷雾干燥设定温度为180℃~200℃,真空干燥温度为50℃~100℃,过筛目数为60~80目。
示范性的,所述步骤(2)还包括喷雾干燥或真空干燥前向浓缩后的提取液中添加β-环糊精混合均匀步骤;其中所述β-环糊精添加量为所述中药材质量的1~20%。
此外,本发明另外一个目的是提供上述公开的一种具有抗氧化、延缓衰老功效的复方组合物在制备保健品中的应用。
进一步的,所述复方组合物可以作为膳食补充剂或保健食品的原料,以提高端粒酶含量、延缓衰老,且所述复方组合物的剂型为胶囊剂、颗粒剂或片剂。
经由上述技术方案可知,与现有技术相比,本发明提供了一种具有抗氧化、延缓衰老功效的复方组合物及其制备方法与应用,具有如下优异效果:
1.本发明采用药材单独提取后复合的制备工艺,其相较传统中药提取方法提取质量更加稳定,可控性更高。
2.本发明公开保护的复方组合物通过药效实验确定了其具有良好的抗氧化、延缓衰老及提高端粒酶含量的作用。
3.本发明公开保护的复方组合物无毒副作用、易吸收,用于延缓衰老,修复DNA损伤、抗氧化损伤,还能降低老年病的发生风险,并且本发明公开的复方组合物可作为膳食补充剂或保健食品原料,以提高端粒酶含量、延缓衰老,由此可见,本发明公开的复方组合物适于推广与应用。
4.本发明公开采用多种制粒及制剂工艺,不仅能有效改善制剂的吸湿性,保证成品的稳定性,还能加大药物的药效,以最终提高成品复方组合物的效果。
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,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的实施例,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,还可以根据提供的附图获得其他的附图。
图1为本发明复方组合物对DPPH自由基的清除能力图。
图2为本发明复方组合物对羟基自由基的清除能力图。
具体实施方式
下面将结合说明书及相应的实施例对本发明公开的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
本发明实施例公开了一种无毒副作用、易吸收的复方组合物,该复方组合物可作为膳食补充剂或保健食品原料用于抗氧化、延缓衰老,及该复方组合物还能提高端粒酶含量,修复DNA损伤、抗氧化损伤,降低老年病的发生风险,适于市面推广。
为更好地理解本发明,下面通过以下实施例对本发明作进一步具体的阐述,但不可理解为对本发明的限定,对于本领域的技术人员根据上述发明内容所作的一些非本质的改进与调整,也视为落在本发明的保护范围内。
下面将结合具体实施例对本发明公开的技术方案作进一步的说明。
实施例1:
一种具有抗氧化、延缓衰老功效的复方组合物组成配方如下:
壳寡糖:50g、人参药材:100g、茯苓药材:200g、地黄药材:166g、肉苁蓉药材:168g、丹参药材:100g、硬脂酸镁:5g。
所述复方组合物的制备方法,具体制备步骤如下:
(1)人参药材粉碎成粗颗粒(过20目筛)加8倍量70%乙醇,加热回流提取2次,每次3小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得人参提取物;
(2)茯苓药材粉碎(过80目筛)加10倍量的水,加热回流提取1次,提取时间为100min,提取液浓缩至原体积的1/10,采用80%浓度乙醇醇沉12h,过滤、加10%β-环糊精,200℃喷干,过80目筛,得茯苓提取物;
(3)地黄药材粉碎(过20目筛)加8倍量60%乙醇,加热回流提取2次,每次1.5小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得地黄提取物;
(4)肉苁蓉药材粉碎(过20目筛)加8倍量75%乙醇,加热回流提取2次,每次1小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得肉苁蓉提取物;
(5)丹参药材加8倍量80%乙醇,加热回流提取2次,每次1.5小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得丹参提取物;
(6)将上述的制备得到的中药提取物与壳寡糖混合均匀,制粒,填充制成复方胶囊,为100倍日处方剂量。
实施例2
一种具有抗氧化、延缓衰老功效的复方组合物组成配方如下:
壳寡糖:40g、人参药材:72g、茯苓药材:144g、地黄药材:120g、肉苁蓉药材:180g、丹参药材:72g、硬脂酸镁:5g。
所述复方组合物的制备方法,具体制备步骤如下:
(1)人参药材粉碎成粗颗粒(过20目筛)加6倍量75%乙醇,加热回流提取2次,每次3小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得人参提取物;
(2)茯苓药材粉碎(过80目筛)加8倍量的水,加热回流提取1次,提取时间为120min,提取液浓缩至原体积的1/10,采用80%浓度乙醇醇沉12h,过滤、加10%β-环糊精,200℃喷干,过80目筛,得茯苓提取物;
(3)地黄药材粉碎(过20目筛)加10倍量70%乙醇,加热回流提取2次,每次1.5小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得地黄提取物;
(4)肉苁蓉药材粉碎(过20目筛)加6倍量80%乙醇,加热回流提取2次,每次1小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得肉苁蓉提取物;
(5)丹参药材加8倍量80%乙醇,加热回流提取2次,每次1.5小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得丹参提取物;
(6)将上述的制备得到的提取物与壳寡糖混合均匀得中药复方组合物,混合制粒,得到中药复方组合物颗粒,为100倍日处方剂量。
实施例3
一种具有抗氧化、延缓衰老功效的复方组合物组成配方如下:
壳寡糖:30g、人参药材:63g、茯苓药材:105g、地黄药材:84g、肉苁蓉药材:157g、丹参药材:63g、党参:52.5g、桃仁:52.5g、硬脂酸镁:5g。
所述复方组合物的制备方法,具体制备步骤如下:
(1)人参药材粉碎成粗颗粒(过20目筛)加4倍量80%乙醇,加热回流提取2次,每次3小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得人参提取物;
(2)茯苓药材粉碎(过80目筛)加6倍量的水,加热回流提取2次,每次1.5小时,提取液浓缩至原体积的1/10,采用80%浓度乙醇醇沉12h,过滤、加10%β-环糊精,200℃喷干,过80目筛,得茯苓提取物;
(3)地黄药材粉碎(过20目筛)加6倍量70%乙醇,加热回流提取2次,每次1.5小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得地黄提取物;
(4)肉苁蓉药材粉碎(过20目筛)加6倍量80%乙醇,加热回流提取2次,每次1小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得肉苁蓉提取物;
(5)丹参药材加8倍量80%乙醇,加热回流提取2次,每次1.5小时,合并提取液,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得丹参提取物;
(6)党参药材粉碎(过20目筛)加8倍量60%乙醇,加热回流提取1次,时间为40分钟,纯化、浓缩、加10%β-环糊精,200℃喷干,过80目筛,得党参提取物
(7)桃仁药材加10倍量的水,加热回流提取1次,时间为2小时,纯化,浓缩、加10%β-环糊精,200℃喷干,过80目筛,得桃仁提取物;
(8)将上述的制备得到的提取物与壳寡糖混合均匀得中药复方组合物,干式制粒,得到中药复方组合物颗粒,为100倍日处方剂量。
本说明书中各个实施例采用递进的方式描述,每个实施例重点说明的都是与其他实施例的不同之处,各个实施例之间相同相似部分互相参见即可。
另外,为了进一步说明本发明申请公开制备的复方组合物的药效,发明人进行如下试验用以评价:
(一)本发明体外抗氧化作用的试验研究
使用实施例1中制备的复合物制剂及其他药物组方,对本发明复合物的体外抗氧化作用进行检验。
1)试验样品分组:
供试物A:壳寡糖50g、人参药材100g、茯苓药材200g、地黄药材166g、肉苁蓉药材168g、丹参药材100g、硬脂酸镁5g,按实施例1的方法制备成100倍日处方剂量;
供试物B:壳寡糖50g、人参药材100g、茯苓药材200g、地黄药材166g、肉苁蓉药材168g、β-环糊精33.3g、硬脂酸镁:5g,按实施例1的方法制备成100倍日处方剂量;
供试物C:壳寡糖50g、人参药材100g、茯苓药材200g、地黄药材166g、党参:168g、桃仁:60g、硬脂酸镁:5g,按实施例1的方法制备成100倍日处方剂量;
供试物D:壳寡糖50g、人参药材100g、茯苓药材200g、地黄药材166g、丹参药材:100g、党参:168g、硬脂酸镁:5g,按实施例1的方法制备成100倍日处方剂量。
供试物E:壳寡糖50g、人参药材100g、茯苓药材200g、地黄药材166g、β-环糊精89.3g、硬脂酸镁:5g,按实施例1的方法制备成100倍日处方剂量。
试验样品配制:将上述供试物A-E用蒸馏水各自稀释成10,30,50和100mg/mL4个阶梯质量浓度。
2)试验方法:
1.DPPH自由基清除能力
取1mL样品溶液与1mL DPPH-乙醇溶液(0.125mol/L)于涡旋振荡器混匀后,置于室温下避光反应30min后置于517nm下测定其吸光度值,以无水乙醇作为空白对照,记为A0。所有样品进行3次平行测定,取平均值。DPPH自由基清除率计算公式如下:
其中:A1是没有DPPH溶液的样品的吸光值;A2是DPPH溶液与样品的吸光值。
2.羟基自由基清除率的测定
取1mL样品溶液,分别加入1.0mL FeSO4(9mmol/L),10mL水杨酸乙醇溶液(9mmol/L)和1mL H2O2(9mmol/L)。在37℃避光反应1h后,测定混合物在510nm处的吸光值。无水乙醇为空白对照,记为A0,所有样品进行3次平行测定。用公式(2)计算清除羟基自由基的能力:
其中:A1是蒸馏水代替H2O2的吸光值;A2是羟基自由基体系与样品的吸光值。
3)结果分析:
DPPH是一种稳定的以氮为中心的自由基,517nm处有较强的吸收峰,抗氧化剂提供的电子或氢原子与DPPH·发生反应,导致其在517nm的吸光值变小,根据吸光值的变化反映抗氧化剂的抗氧化能力。
从图1可以看出,各供试物对DPPH自由基的清除能力随着浓度的增加而增强,并且抗氧化能力:供试物A>供试物D>供试物C>供试物B>供试物E。因此可以说明供试物A的抗氧化效果最佳。
羟基自由基是活性氧系统中活性最高的化学物质,它可以很容易地穿过细胞膜,容易与生物分子如碳水化合物,蛋白质,脂质,核酸以及细胞中几乎任何生物成分发生反应并诱导组织损伤或导致细胞死亡。
从图2可以看出,随着供试物质量浓度的增加,各供试物对羟基自由基清除能力呈现稳定的增长,供试物A的清除能力在个质量浓度测量范围均大于其他供试物,当质量浓度为100.0mg/mL时,各供试物对羟基的清除能力达到最大。
综合以上结果,说明本发明具有显著的抗氧化效果。供试物A组各项指标均明显优于其余各组,即由壳寡糖、人参、茯苓、地黄、肉苁蓉、丹参这几种原料组成的复方组合物的抗氧化效果明显优于壳寡糖、人参、茯苓、地黄这几种原料与肉苁蓉、丹参、党参、桃仁、麦冬中的0-1种或两两组合制备得到的复方组合物的抗氧化效果,说明本发明抗氧化效果与本发明特定的原料组成有关,本发明原料配比合理,与本发明特定的原料提取方法一起,使得最终制备得到的复方组合物具有显著的抗氧化效果。
(二)人体试服试验
使用实施例1制备的本发明复合组合物胶囊,对本发明安全性、延缓衰老效果进行检验:
受试纳入标准:50-75岁,正常衰老或疾病导致的衰弱、体力和精力不济人员;
排除标准:患有以下疾病的人员;慢性过敏性肠炎或功能性腹泻;自身免疫性疾病或免疫缺陷;确诊为HIV、乙肝或丙肝阳性;诊断为严重心肺肾和肝功能异常史;在过去6个月内发生过重大心血管疾病;医学诊断的神经心理疾病或认知障碍;酗酒,高酒精摄入量的人员。
试验设计与分组:采用自身前后对照形式。
服用剂量及方法:每日2次,每次3粒,服用量为3.6g/日,连续90天观察指标:
(1)安全性观察:
①血常规:红细胞计数,平均红细胞体积,红细胞分布宽度,平均血红蛋白含量,平均红细胞血红蛋白浓度,白细胞计数,单核细胞计数,单核细胞比例,中性粒细胞计数,淋巴细胞比值,平均血小板体积,血小板压积;
②尿常规:尿液颜色,尿透明度,尿酸碱度,红细胞,白细胞,尿蛋白,尿酮体,尿糖;
③血生化:肝功能的检查:总胆红素、总蛋白质、白蛋白质、球蛋白质、白蛋白/球蛋白比质比例、谷草转氨酶、谷丙转氨酶等;
④肾功能的检查:肌酸酐(CR)、血中尿素氮(BUN);
⑤心电图。
(2)功效性观察:
①血压皮肤检测:皮肤弹性、胶原蛋白、黑色素异常
②血管调节因子:一氧化氮(NO)、血管内皮生长因子(VEGF)
③血清超氧化物歧化酶(SOD)活性、端粒酶(TE)含量
④体验人员跟踪服务量表:
衰老症状:共包含4项精力体力不济症状(行走或者活动后疲劳、日常生活中精力体力不济、头晕目眩、睡眠不佳),根据严重程度分为Ⅰ-Ⅳ级,统计积分值。
Ⅰ级(0分):保持一定运动,精力充沛;日常精力充沛;极少头晕目眩,仅在劳累过度后发生;30min内入睡,睡眠时间超过5h,不易惊醒,白天不犯困。
Ⅱ级(1分):多行走活动后(如行走2km)稍有疲感;轻微有感觉疲累,日常活动不受影响;一个月仅一两次会发生头晕目眩情况,生活基本不受影响;30min内入睡,睡眠时间少于5h,白天不犯困。
Ⅲ级(2分):介于Ⅱ和Ⅳ之间的感觉;易疲劳,日常活动受到一定影响;每周一两次发生头晕目眩情况,劳累后加重,影响日常生活;超过30min入睡,睡眠时间少于5h,易被惊醒,白天固定时间犯困。
Ⅳ级(3分):腰背酸软无力,头昏眼花,四肢乏力;疲劳感严重,日常活动严重受限;每天都有晕眩情况,稍有活动后即加重,严重影响日常生活;超过30min入睡,睡眠时间少于5h,半夜经常无故惊醒,白天经常犯困。
老年人疾病及亚健康症状:共包含6项(贫血、食欲不振、感冒感染等、精神不安/心悸、畏寒、疼痛),根据严重程度分为Ⅰ-Ⅳ级,统计积分值。
Ⅰ级(0分):无症状。
Ⅱ级(1分):进食欲望低,但还可以正常进食;轻微畏寒;轻微贫血,营养补充后不影响生活;有轻微痛感;每月仅一两次精神不安/心悸,能胜任一般日常活动,在稍重体力活动时,心悸加重;偶尔感冒,仅换季或劳累后容易生病。
Ⅲ级(2分):进食困难,有营养不良风险;较严重畏寒,与正常人存在明显差异;中度贫血;具体部位有较重的疼痛感;每周一两次精神不安/心悸,活动量稍大(行走2km)心悸严重,伴有精神不安;感冒频率介于Ⅱ和Ⅳ之间。
Ⅳ级(3分):完全不思进食,严重营养不良;极度畏寒,严重影响生活;严重贫血,需要药物维持正常生活;全身疼痛,严重影响生活质量;每天心悸,精神紧张,轻微活动即感心悸;经常性感冒,生病频繁,抵抗力差。
表2试食前一般状况
表3试食前后血常规检查结果分析(X±SD)
表4试食前后肝肾功能及血液生化指标结果分析(X±SD)
表5试食前后心率检查结果分析(X±SD)
受试者试食前、试食30天后胸透、心电图、腹部B超及尿常规检查均未见明显异常。试食期间,受试者未见不良反应或过敏反应等症状。
试验一:
表6:复方组合物对改善衰老症状、老年人疾病及亚健康症状的有效率
从上表6可以看出,复方组合物对衰老症状、老年人疾病及亚健康症状具有改善作用,且随着服用时间的延长,其有效率也是逐渐增大的;服用复方组合物60天后,对改善衰老症状的总有效率可达100%,说明本发明的复方组合物对衰老的改善效果极显著。
试验二:
表7:复方组合物对改善老年人皮肤状况的有效率
上述表7对受试者的皮肤状况进行检测发现,此复方组合物对老年人皮肤弹性、胶原蛋白、黑色素异常状况均有一定改善作用,并且其改善有效率随着服用时间的延长而增强。
试验三:
表8:复方组合物对改善老年人体内抗衰老酶含量的影响
注:与0天相比*p﹤0.05;与0天相比**p﹤0.01
上述表8对受试者体内的抗衰老酶含量进行检测发现,服用复方组合物时间越久,其体内的超氧化物歧化酶和端粒酶的含量越高,说明本发明的复方组合物可以有效提高老年人体内的抗衰老酶含量。
表9:复方组合物对改善老年人体内抗衰老酶的有效率
通过上表9中数据可知,本发明公开保护的复方组合物对改善老年人体内抗衰老酶有效率在受试第90天达最高,超氧化物歧化酶及端粒酶提高有效率分别为90.08%,86.07%,说明本发明的复方组合物会随着服用时间的延长逐步改善老年人体内的抗衰老酶的有效率,具有较好的抗氧化作用。
试验四:
表10:复方组合物对改善老年人体内血管调节因子含量的影响
注:与0天相比**p﹤0.01
由上述表10测定受试者的体内调节因子含量可知,服用本方法公开制备的复方组合物人群体内的一氧化氮和内皮生长因子含量均呈现上升趋势,且随着服用时间的延长而增多,说明此复方组合物具有增加体内血管调节因子含量的功效。
表11:复方组合物对改善老年人体内血管调节因子的有效率
由上表11数据可知,复方组合物对改善老年人体内血管调节因子的有效率是随着时间的延长而增加的,在受试的第90天,总有效率可达99.2%,一氧化氮和内皮生长因子提高有效率分别为97.10%,96.04%,提示本发明的复方组合物具有扩张血管,促进血管再生,保护心脑血管的作用。
综合上述实验结果分析可知,本发明公开保护的复方组合物具有显著的延缓衰老效果,可以有效改善老年人的衰老体征,包括衰老、疾病及亚健康症状,有效率极高,总体有效率可达100%;可以有效改善老年人的皮肤状况,同时对老年人体内抗衰老酶含量、血管调节因子含量均有增强效果。
以上结果表征,本发明公开保护的复方组合物具有抗氧化、延缓衰老的功效,该复方组合物无毒副作用、易吸收,可用于延缓衰老,修复DNA损伤、抗氧化损伤,还能降低老年病的发生风险,适于市面推广与应用。
对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (9)
1.一种具有抗氧化、延缓衰老功效的复方组合物,其特征在于,所述复方组合物是由中药提取物与壳寡糖按照质量比(3~8):1混合而成;
其中,所述中药提取物是由以下中药材单独提取后混合而得,按照质量百分比计:
人参7~15%;
茯苓14~35%;
地黄14~35%;
肉苁蓉14~35%;
丹参7~15%;
党参0~10%;
桃仁0~10%;
麦冬0~10%。
2.根据权利要求1所述的一种具有抗氧化、延缓衰老功效的复方组合物,其特征在于,所述中药提取物是由以下中药材单独提取后混合而得,按照质量百分比计:
人参12~15%;
茯苓25~30%;
地黄20~25%%;
肉苁蓉20~25%;
丹参12~15%;
党参2~3%;
桃仁1~2%;
麦冬1~2%。
3.根据权利要求1或2所述的一种具有抗氧化、延缓衰老功效的复方组合物,其特征在于,所述中药提取物是由以下中药材单独提取后混合而得,按照质量百分比计:
人参13%;
茯苓26%;
地黄22%%;
肉苁蓉22%;
丹参13%;
党参2%;
桃仁1%;
麦冬1%。
4.一种如权利要求1~3任一所述的具有抗氧化、延缓衰老功效的复方组合物的制备方法,其特征在于,包括:将人参、茯苓、地黄、肉苁蓉、丹参、党参、桃仁和麦冬分别提取、纯化、浓缩及喷雾干燥制得中药提取物后与壳寡糖混合均匀制得;具体包括如下步骤:
(1)将中药材粉碎过筛后与乙醇溶液按照配比加热回流提取、过滤,并将药渣多次提取后的提取液合并,备用;
(2)将步骤(1)合并的所述提取液纯化、浓缩后喷雾干燥或真空干燥,过筛得到中药提取物;
(3)将步骤(2)中所述中药提取物按照如权利要求1公开的质量配比与所述壳寡糖混合均匀,得到具有抗氧化、延缓衰老功效的复方组合物。
5.根据权利要求4所述的一种具有抗氧化、延缓衰老功效的复方组合物的制备方法,其特征在于,所述步骤(1)中,中药材粉碎过筛目数为20~80目,添加中药材与乙醇溶液的体积比为1:(5~20),且中药材加热回流提取次数为1~3次,提取时间为1~3h,提取温度为80℃~100℃。
6.根据权利要求4所述的一种具有抗氧化、延缓衰老功效的复方组合物的制备方法,其特征在于,所述步骤(2)中,喷雾干燥温度为180℃~200℃,真空干燥温度为50℃~100℃,过筛目数为60~80目。
7.根据权利要求4或6所述的一种具有抗氧化、延缓衰老功效的复方组合物的制备方法,其特征在于,所述步骤(2)还包括喷雾干燥或真空干燥前向浓缩后的提取液中添加β-环糊精混合均匀步骤;其中所述β-环糊精添加量为所述中药材质量的1~20%。
8.一种如权利要求1~3任一所述的具有抗氧化、延缓衰老功效的复方组合物或如权利要求4~7任一所述方法制备的复方组合物在制备保健食品中的应用。
9.根据权利要求8所述的一种具有抗氧化、延缓衰老功效的复方组合物的应用,其特征在于,所述复方组合物可以作为膳食补充剂或保健食品的原料,且所述复方组合物的剂型为胶囊剂、颗粒剂或片剂。
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