CN114747766A - 具有降尿酸保健食品组合物及制备方法和应用 - Google Patents
具有降尿酸保健食品组合物及制备方法和应用 Download PDFInfo
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Abstract
本发明公开一种具有降尿酸保健食品组合物及制备方法和应用,所述组合物原料包括可用于保健食品的原料5~14份,药食同源原料10~21份,普通食品原料1~3份;可用于保健食品原料至少包括:土茯苓1~3份、车前草2~5份、骨碎补1~3份、鳖甲1~3份中的两种原料;所述药食同源原料至少包括:栀子2~4份、薏苡仁3~5份、菊苣2~4份、葛根1~3份、蒲公英2~4份中的两种原料;所述普通食品原料包括:玉米须1~3份。本发明还公开一种具有降尿酸保健食品组合物制备方法和应用。本发明提供一种利用醇提和微波辅助酶解提取技术制备的一种具有降低尿酸和预防痛风的新型保健食品组合物及制备方法与应用。
Description
技术领域
本发明涉及保健食品生产和应用领域,特别涉及一种具有降尿酸保健食品组合物及制备方法和应用。
背景技术
近年来随着生活方式的改变特别是饮食结构的改变,高尿酸血症及痛风的发病率明显升高,食物及大量饮酒,高尿酸血症已成为常见病和多发病,保守估计目前我国约有高尿酸血症患者1.2亿,占总人口的大约10%[胡大一,丁荣晶.无症状高尿酸血砬合并心血管疾病诊治建议专家共识.2013.]。同时,高尿酸血症还可引起血管内皮损伤从而加重动脉粥样硬化的程度,是心脑血管疾病的重要危险因素。同时,2017版中国肾脏疾病高尿酸诊治实践指南指出:高尿酸还是慢性肾脏病(Chronic Kidney Disease,CKD)新发和促进其进展的独立危险因素[中国医师协会肾脏内科医师分会.中国肾脏疾病高尿酸血症诊治的实践指南(2017版).中华医学杂志,2017,97(25):1927-1936.]。
对于高尿酸血症患者,除生活方式管理外,降尿酸的西药为主要治疗手段,西药从抑制嘌呤合成和促进尿酸排泄两个方面降低血尿酸水平,前者的代表药物是别嘌呤醇,后者是苯溴马隆,但是由于西药具有发生肝肾损害、过敏等风险,长期服用令人担忧[MaiuoloJ,Oppedisano F,Gratteri S,et a1.Regulation of uric acid metabolism andexcretion.Int J Cardiol,2016,15(213):8-14.]。除西药外,中药也同样可以发挥良好的降尿酸作用。中医药降尿酸以清热利湿配合活血化瘀及顾护脾胃之品为主,著名的方剂有四妙丸(苍术、黄柏、牛膝、薏苡仁)、当归拈痛汤(当归、防风、黄芪、甘草、黄柏、玄参、人参、茯苓、白术、苍术、葛根、升麻、知母、茵陈、羌活)等[石晗,佟雅婧,杨钊田,等.中医药降尿酸的用药规律.世界中医药,2021,16(21):3241-3245.],其中土茯苓、薏苡仁、牛膝等中药的使用频率较高。
除中药外,某些保健食品也具有降低尿酸的作用。保健食品(食健字号)是声称并具有特定保健功能或者以补充维生素、矿物质为目的的食品[食品安全国家标准保健食品.GB 16740—2014.北京:中国标准出版社.2014.]。保健食品可以宣称的保健功能中虽没有辅助降尿酸这一功能,但是某些可用于保健食品原料却具有明显的降尿酸作用,如土茯苓、车前子、丹参、玄参等[汪玉芳,黄远英,殷光玲.保健食品原料降尿酸作用机理研究.中国保健营养,2016(14):268-269]。
专利N201610113265.1[刘志伟,高延辉.一种高尿酸血症和痛风患者适用的特殊膳食植物饮品]公开了一种适用于高尿酸和痛风患者的特殊膳食植物饮品,其成分主要包括青木瓜、红薯藤、马齿苋、黄秋葵、乌龙茶、茯苓、栀子、蛹虫草、甘草等。
本发明在现有降尿酸保健食品和药食同源功能食品的基础上,根据中医君臣佐使的理论,以可用于保健食品的原料[原卫生部公布的《卫生部关于进一步规范保健食品管理的通知》(卫法监发(2001)51号)附录2中]和药食同源原料[原卫生部公布的《卫生部关于进一步规范保健食品管理的通知》(卫法监发(2001)51号)附录1中既是食品又是药品的物品清单中的中药物质]为主,组成既可以降低尿酸、又可以降低尿酸引起的机体炎症反应和防止高尿酸引起的各种并发症的复方制剂。
本发明以可用于保健食品原料中的土茯苓、车前草、骨碎补、鳖甲为主要成分,同时配合药食同源的栀子、薏苡仁、菊苣、葛根、蒲公英,再加上普通食品原料玉米须而组成。其中,土茯苓、骨碎补和鳖甲为君药,土茯苓具有解毒、除湿、通利关节的功效以疏通高尿酸血症和痛风患者的关节痹湿;骨碎补补肾强骨、强筋止痛;鳖甲滋阴潜阳,退热除蒸,软坚散结,三者结合强筋骨、除湿痹、通经络、止骨痛;车前草、葛根、栀子为臣药,车前草清热利尿,渗湿通淋;葛根解肌退热,生津止渴;栀子清热利湿,凉血解毒,三者结合凉血清热,滋阴生津;蒲公英、菊苣为佐药,清热解毒、消炎止痛;玉米须为使药,利尿并排出毒素。君臣佐使相互配合,起到舒筋活络、通痹止痛、除湿利尿、强骨健体、消炎止痛、排出毒素,以降低尿酸缓解痛风导致的关节疼痛的作用。
另外,本组合物的组方也得到了现代药理学证据的支持。其中,土茯苓、车前草、栀子、薏苡仁、菊苣、葛根均具有一定的降尿酸作用。例如,土茯苓富含落新妇苷[(2R,3R)-花旗松素-3-O-α-L-吡喃鼠李糖苷],具有抑制黄嘌呤氧化酶活性,减少嘌呤分解代谢的作用[梁巧静,梁维萍,李琼,等.土茯苓抗痛风作用研究进展.世界中医药,2018,13(11):2937-2940.];车前草含大车前苷,车前草的醇提物具有降低尿酸的作用[钱莺,傅旭春,王建平,等.车前草降血尿酸有效成分提取工艺的研究.浙江大学学报(理学版),2010,37(5):560-562,567.];菊苣具有清肝利胆、利尿消肿之效,菊苣含有酚酸类、香豆素、倍半萜等化合物,具有降血糖、降尿酸、利尿保肝等作用[徐慧哲,王雨,毛秋月,等.菊苣化学成分及其防治尿酸相关代谢性疾病研究进展.世界中医药,2021,16(1):35-40.];葛根能够降低机体的胰岛素抵抗、保护肝肾和降低尿酸的作用,还能缓解痛风性关节肿胀程度[于瑞丽,陈素红,吕圭源,等.葛根提取物对高尿酸血症模型大鼠尿酸及血脂的影响.浙江中医药大学学报,2011,35(3):455-458.]。薏苡仁和玉米须合用具有健脾利尿渗湿,增加尿酸排泄的作用[冯文韬.清热利湿通络法治疗急性痛风性关节炎的临床观察.江苏:南京中医药大学学位论文,2017;律广富,仇志凯,常诗卓,等.玉米须总黄酮提取物对痛风性肾病大鼠肾脏尿酸排泄的影响.中成药,2018,40(6):1373-1376.],蒲公英消炎止痛并可保护高尿酸血症导致的肾脏损伤[邹传宗,王红娟,李纪纲,等.蒲公英对急性高尿酸血症大鼠肾脏的保护作用[J].中国民族民间医药,2020,29(3):10-12.],而鳖甲和骨碎补则可以提高免疫力和预防高尿酸导致的肝肾功能损伤。因此本发明在具有较强降低尿酸、抑制痛风症状的同时,对肝肾功能也具有较强的保护作用,特别是在避免高尿酸导致肾功能损伤方面具有独特优势。
同样的组方,不同的提取和制备工艺,所提取的有效物质的种类和含量不同,最终得到的提取物的效果也不相同。传统蒸煮水提的方法提取效力低且有效成分容易在长时间蒸煮的过程中被破坏,因此其功效受到影响。近年来随着药物提取工艺的进步,新型的中药提取工艺得到很大的发展[魏晓楠,郝铁成.中药提取新技术研究进展.中国野生植物资源,2020,39(9):47-50.],其中某些中药提取的工艺同样也可以用于保健食品原料的提取过程,其中酶解-微波(或超声)辅助提取工艺不但提取效率高,同时还避免了有效成分的破坏,从而提高了有效物质的含量。这是因为酶解技术可以在温和条件下酶解多种原料的细胞壁以加速有效物质的溶出[纪学慧,张华.补气升血方药纤维素酶提取法和超声提取法的药效学比较.辽宁中医药大学学报,2013,15(7):73-75.],再结合微波提取技术进一步提高有效物质快速溶出,提高了提取效率并提高有效物质的含量[朱亚伟,王立涛,安娟艳,等.响应面优化酶解—微波辅助提取桑叶多糖的工艺研究.植物研究,2020,40(4):635-640]。
本发明在科学组方和反复调整配方比例的基础上,首次将乙醇提取与酶解-微波相结合的技术并应用于保健食品原料的提取过程,提高了组合物中降低尿酸的有效物质含量,提高了降低尿酸和预防痛风的功效,同时也使得提取过程更加高效、环保和节能。
总之,本发明充分利用可用于保健食品的原料、药食同源物质以及普通食品原料的各自优势和特性,从高尿酸血症的发病机制入手,以中医的君臣佐使理论为指导,以现代药理学研究为依据,通过严格选材,通过醇提和酶解辅助微波提取的方法制备的一种降低尿酸和预防痛风的新型组合物。该组合物添加适当的辅料和调味剂后最终制备为片剂和颗粒剂。其最终目的是在健康管理的基础上通过多靶点的精准干预,降低血液尿酸水平,预防痛风导致的关节疼痛症状,同时保护肝肾功能免受高尿酸血症的损伤,提高高尿酸及痛风患者生活质量。
发明内容
本发明的主要目的是提供一种利用醇提和微波辅助酶解提取技术制备的一种具有降低尿酸和预防痛风的新型保健食品组合物及制备方法与应用。
为实现上述第一发明目的,本发明提出一种具有降尿酸保健食品组合物,所述组合物的原料包括可用于保健食品的原料5~14份,药食同源原料10~21份,普通食品原料1~3份。
所述可用于保健食品原料至少包括:土茯苓1~3份、车前草2~5份、骨碎补1~3份、鳖甲1~3份中的两种原料;
所述药食同源原料至少包括:栀子2~4份、薏苡仁3~5份、菊苣2~4份、葛根1~3份、蒲公英2~4份中的两种原料;
所述普通食品原料包括:玉米须1~3份。
所述组合物原料重量比为:土茯苓:车前草:骨碎补:鳖甲:栀子:薏苡仁:菊苣:葛根:蒲公英:玉米须=2:4:2:2:3:3:4:2:4:1。
本发明另一发明目的是:本发明提出一种具有降尿酸保健食品组合物制备方法和应用。
为实现上述发明目的,本发明所述的一种具有降尿酸保健食品组合物制备方法包括以下步骤:
步骤S1:制备原料的乙醇提取液:准确称取土茯苓1~3份、骨碎补1~3份、葛根1~3份、栀子2~4份,将上述原料粉碎至20目,用10倍体积60%乙醇浸泡2小时,在50℃条件下用60%乙醇提取2次,再用50%乙醇提取一次,过滤并将三次滤液混匀得到醇提液,经减压浓缩至相对密度1.05~1.10得到第一浓缩液;
步骤S2:酶解和微波提取制备原料的水提取液:准确称取鳖甲1~3份、车前草2~5份、薏苡仁3~5份、菊苣2~4份、蒲公英2~4份、玉米须1~3份,粉碎至20目后,与S1醇提过滤后的药渣混合,用10被体积的纯净水浸泡2小时/次,共2次,沥干水分后加入15倍体积的含2%维素酶和1%果胶酶的酶解液酶解20min,沥出酶解液后80℃加热5分钟以灭活酶活性得到酶解提取液;然后残渣加10倍的纯净水,微波连续提取2次,每次15分钟,沥出液体得到微波提取液,将酶解提取液和微波提取液成充分混合,经减压浓缩至相对密度1.05~1.10,得到第二浓缩液;
步骤S3:制备原料提取物的粉剂:将步骤S1和步骤S2制备的第一浓缩液和第二浓缩液充分混合,加入抗性糊精,经喷雾干燥制备为原料提取物的粉剂。
该方法还包括将步骤S3制备的组合物的粉剂,添加赋形剂二氧化硅和硬脂酸镁压制为片剂或者添加甜味剂和酸味剂造粒制备为颗粒剂或者制备为膏滋。
本发明还提出一种具有降尿酸保健食品组合物在动物模型和高尿酸患者中的应用。
经动物实验证明,本组合物能提高注射环磷酰胺导致免疫力低下大鼠模型的免疫力,并可提高肿瘤中晚期免疫功能低下患者的体液和细胞免疫水平,促进肿瘤患者的康复。
本发明提供技术方案的有益效果是:1)本发明充分利用可用于保健食品的原料、药食同源物质以及普通食品原料的各自优势和特性,从高尿酸血症的发病机制入手,以中医的君臣佐使理论为指导,以现代药理学研究为依据,通过严格选材,通过醇提和酶解辅助微波提取的方法制备的一种降低尿酸和预防痛风的新型组合物。该组合物添加适当的辅料和调味剂后最终制备为片剂和颗粒剂。其最终目的是在健康管理的基础上通过多靶点的精准干预,降低血液尿酸水平,预防痛风导致的关节疼痛症状,同时保护肝肾功能免受高尿酸血症的损伤,提高高尿酸及痛风患者生活质量;2)本发明在在健康管理的基础上,通过多靶点的精准干预,降低血液尿酸水平,抑制关节的炎症反应以减轻痛风得症状,修复受损的肾脏功能,造福于高尿酸血症的患者;3)另一方面本发明有利于控制成本而在更大范围内进行推广,从而产生巨大的社会和经济价值。
本发明目的的实现、功能特点及优点将结合实施例,做进一步说明。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明的一部分实施例,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作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。
需要说明,本发明实施例中所有方向性指示(诸如上、下、左、右、前、后……)仅用于解释在某一特定姿态下各部件之间的相对位置关系、运动情况等,如果该特定姿态发生改变时,则该方向性指示也相应地随之改变。
在本发明中,除非另有明确的规定和限定,术语“连接”、“固定”等应做广义理解,例如,“固定”可以是固定连接,也可以是可拆卸连接,或成一体;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系,除非另有明确的限定。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
另外,在本发明中如涉及“第一”、“第二”等的描述仅用于描述目的,而不能理解为指示或暗示其相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。另外,各个实施例之间的技术方案可以相互结合,但是必须是以本领域普通技术人员能够实现为基础,当技术方案的结合出现相互矛盾或无法实现时应当认为这种技术方案的结合不存在,也不在本发明要求的保护范围之内。
实施例1
本发明提出一种具有降尿酸保健食品组合物。
在本发明一实施例中,该一种具有降尿酸保健食品组合物,所述组合物原料包括可用于保健食品的原料5~14份,药食同源原料10~21份,普通食品原料1~3份。
本实施例,优选地,所述可用于保健食品原料至少包括:土茯苓1~3份、车前草2~5份、骨碎补1~3份、鳖甲1~3份中的两种原料;
所述可用于保健食品原料至少包括两种原料,也就是说,包括两种或两种以上原料;
所述药食同源原料至少包括:栀子2~4份、薏苡仁3~5份、菊苣2~4份、葛根1~3份、蒲公英2~4份中的两种原料;
所述药食同源原料至少包括两种原料,也就是说,包括两种或两种以上原料;
所述普通食品原料包括:玉米须1~3份。
本实施例,优选地,所述组合物原料重量比为:土茯苓:车前草:骨碎补:鳖甲:栀子:薏苡仁:菊苣:葛根:蒲公英:玉米须=2:4:2:2:3:3:4:2:4:1。
本发明上述组合物的原料经醇提和微波辅助酶解提取后,经过喷雾干燥制成提取物粉剂,增加辅料后制备为片剂和颗粒剂,应用于高尿酸血症和痛风患者。
实施例2保健食品的制备方法
本发明还提供一种具有降尿酸保健食品组合物方法和应用。
本发明利用醇提和微波辅助酶解提取技术制备的一种具有降低尿酸和预防痛风的新型保健食品组合物。
该一种具有降尿酸保健食品组合物方法,该方法包括以下步骤:
按照土茯苓:车前草:骨碎补:鳖甲:栀子:薏苡仁:菊苣:葛根:蒲公英:玉米须=2:4:2:2:3:3:4:2:4:1的比例。准确称取符合2020年版《中华人民共和国药典》一部标准的中药饮片土茯苓200g、车前草400g、骨碎补200g、鳖甲200g、栀子300g、薏苡仁300g、菊苣400g、葛根200g、蒲公英400g、玉米须100g,将上述原料粉碎并过20目筛。
步骤S1:制备原料的乙醇提取液:将上述粉碎并过20目筛后的土茯苓、骨碎补、葛根、栀子,用10倍体积60%乙醇浸泡2小时,在50℃条件下用60%乙醇提取2次,再用50%乙醇提取一次,过滤并将三次滤液混匀得到醇提液,经减压浓缩至相对密度1.05~1.10得到第一浓缩液;
步骤S2:酶解和微波提取制备原料的水提取液:准确称取鳖甲、车前草、薏苡仁份、菊苣2~4份、蒲公英2~4份、玉米须1~3份,粉碎至20目后,与S1醇提过滤后的药渣混合,用10被体积的纯净水浸泡2小时/次,共2次,沥干水分后加入15倍体积的含2%维素酶和1%果胶酶的酶解液酶解20min(pH=6.0,酶解温度50℃),沥出酶解液后80℃加热5分钟以灭活酶活性得到酶解提取液;然后残渣加10倍的纯净水,微波连续提取2次,每次15分钟(微波功率480瓦、提取温度60℃),沥出液体得到微波提取液,将酶解提取液和微波提取液成充分混合,经减压浓缩至相对密度1.05~1.10,得到第二浓缩液;
步骤S3:制备原料提取物的粉剂:将S1和S2制备的第一浓缩液和第二浓缩液充分混合,加一定量的抗性糊精,经喷雾干燥制备为原料提取物的粉剂;
本实施例,优选地,本发明方法还包括:
步骤S4:制备组合物粉剂:准确称取购买海参肽1~2份,与S3制备的组合物粉剂充分混合,制备为组合物的粉剂。
具体提取方法如下:将粉碎后中药材放置发酵罐后,加15倍体积的纯净水常温下浸泡1.5小时,用15倍体积的含2%纤维素酶和1%果胶酶纤维素酶的酶溶液37℃条件下酶解2次,每次20min,室温下抽滤分离固体残渣和滤液,得到滤液1;再向固体残渣内加10倍的纯净水,移入微波快速反应系统内,微波连续提取2次,每次15分钟(微波功率480瓦、提取温度60℃),室温下抽滤分离固体残渣和滤液,合并两次滤液得到滤液2,滤液1和滤液2混合后,减压浓缩至相对密度1.05~1.10的浓缩液,在浓缩液的基础上加适量抗性糊精喷雾干燥制备为降尿酸试制物的粉剂。
取上述降尿酸试制物的粉剂500g,添加微晶纤维素20g、二氧化硅5g,硬脂酸镁7.5g,充分混匀后压制成0.8g/片的片剂备用。
另取上述降尿酸试制物的粉剂500g,加甜菊糖苷、柠檬粉调味后制成颗粒剂,分装成8g/袋备用。
实施例3降尿酸试制物对高尿酸模型大鼠血尿酸的影响
本发明还提出一种具有降尿酸保健食品组合物在动物模型和高尿酸患者中的应用。
(1)本实施例,动物分组及模型制备
参照文献报道的方法,应用氧嗪酸钾联合酵母膏制备高尿酸血症大鼠模型[李媛媛,周海燕,吴绿英,等.大鼠高尿酸血症模型的建立与研究.中国实验动物学报,2019,27(6):747-752.]。具体方法如下:取SPF级SD大鼠(购自于上海某新药研究中心)48只,体重120~140g,分为正常对照组、模型对照组、阳性对照组和保健食品试制物组,每组12只。所有动物适应性喂养7天后,正常对照组大鼠给予正常饲料喂食,上午9:00~10:00灌注同体积的溶媒(0.5%羧甲基纤维素钠混悬液),其余3组每日按照750mg/kg体重给予氧嗪酸钾灌胃,同时自由摄食含10%的酵母饲料,连续21d。在造模前和造模21d结束后,眼眶取血离心后测定尿酸,以尿酸值大于200μmol/L为造模成功。
(2)降尿酸保健食品试制物对高尿酸模型大鼠尿酸的干预作用
正常对照组上午9:00~10:00AM继续进行溶媒(0.5%羧甲基纤维素钠混悬液)灌胃,其余三组继续给予750mg/kg体重给予氧嗪酸钾灌胃,同时自由摄食含10%的酵母饲料。每日下午4:00~5:00PM,空白对照组和模型对照组灌胃双蒸水1ml,阳性对照组给予0.05%别嘌呤醇水溶液1ml/kg体重灌胃,试制物组给予实施例2制备的10%的降尿酸试制物水溶液1ml/kg,连续14天。末次灌胃结束后当天22:00时断食,正常饮水,次日上午09:00~11:00断头取血,4℃温度下3500rpm离心10min,取其上清液即得血清,将血清分装后放置于-20冷冻保存,备用。采用尿酸(UA)测试盒测定尿酸含量,具体指标见表1。
表1保健食品试制物对高尿酸模型大鼠血清尿酸值的影响
注:与正常对照组相比:**:p<0.01;与模型对照组相比:#:p<0.05,##p<0.01。
从表1可以看到,造模前各组大鼠尿酸水平相近,造模结束后正常对照组尿酸水平明显高于正常对照组,普遍高一倍以上,而干预14天后,模型对照组的尿酸水平与干预前相比无明显变化,但是阳性对照组和保健食品试制物组尿酸水平与干预前相比明显降低,并且明显低于模型对照组,说明本发明所试制的降尿酸组合物具有明显的降尿酸作用,其下降幅度虽不及阳性对照药物别嘌呤醇,但与别嘌呤醇干预已经没有统计学差异,说明本发明试制的保健食品降尿酸组合物具有明显的降尿酸作用。
实施例4试制物对高尿酸血症人群尿酸值的影响
选取34~57岁的男性高尿酸人群共62例,均在三甲医院门诊确诊为高尿酸血症患者,排除高血压、心脑血管疾病和精神疾病后,在征得患者自愿的基础上签订知情同意书,根据体质量随机分为高尿酸对照组和试验组,每组31例。其中,对照组平均年龄(43.4±3.83)岁;试验组平均年龄(45.4±4.32)岁。对照组只进行健康教育和调整饮食结构;试验组在健康教育和调整饮食结构基础上给予实施例2试制的保健食品颗粒剂,每次1袋,每袋8g,一日三次,3餐前前半小时用温开水送服,连续干预4周后。在干预的第7天、14天、21天、28天早晨空腹分别经肘静脉抽血,检测尿酸浓度,具体结果见表2。
表2降尿酸试制物对高尿酸血症患者尿酸水平的影响(μmol/L,x±SD)
注:与干预前相比,*:p<0.05;与对照组相比,与对照组相比,#:p<0.05。
从表2的数据可以看出,对照组在整个干预过程中由于生活方式的改善,尿酸水平略有下降,试验组在健康管理的基础上加上试制的保健食品,经过7天的干预后尿酸值就开始下降,干预14天明显下降且与对照组和干预前相比均具有统计学意义,干预到21天以后进一步降低,28天平均值降到正常水平以下,表明试制的降尿酸保健食品试制物可以迅速降低尿酸,最终将尿酸降到正常水平。
实施例5试制的降尿酸组合物对高尿酸患者干预作用的典型案例
牛X平,男,48岁,工会机关干部,平时有喝酒和经常吃海鲜的经历,于2018年3月份开始偶尔发现右侧大姆指关节疼痛,2020年10月份病情加重,右侧大踇指关节疼痛发作次数增多,发作时出现明显的红肿疼痛,到医院化验血尿酸浓度为623μmol/L,被诊断为痛风急性发作,开始口服非布司他和苯溴马隆,尿酸一般维持在480μmol/L,症状也得到缓解即自作主张停掉所有西药。从2020年12月份开始由于天气寒冷又出现痛风症状,按要求每天口服实验2试制的降尿酸固颗粒剂,8g/次,3次/日,饭前半小时服用,服用一周后感觉脚趾疼痛消失,2周后化验血尿酸降到424μmol/L,一个月后达到398μmol/L,后来每次1袋,每天2次,长期维持,血尿酸一直维持在380~400μmol/L,且从此之后再没有发生痛风。
综上所述,本发明充分利用可用于保健食品原料、药食同源原料和普通食品原料的各自优势和特性,从高尿酸血症和痛风的发病机制入手,以中医理论为指导,以现代科学研究为依据,通过严格选材、反复进行动物实验和人体试食以调整各组分之间的比例,再结合醇提与微博辅助酶解提取技术,制备了一种具有降尿酸功能的新型保健食品组合物。该组合物添加适当的辅料和调味剂后最终制备为片剂和颗粒剂。其最终目的是在健康管理的基础上,通过多靶点的精准干预,降低尿酸水平,防止痛风的发作,降低高尿酸患者的心脑血管疾病的发病风险,造福于大众。
以上所述仅为本发明的优选实施例,并非因此限制本发明的专利范围,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,凡是在本发明的发明构思下,利用本发明说明书内容所作的等效结构变换,或直接/间接运用在其他相关的技术领域均包括在本发明的专利保护范围。
Claims (6)
1.一种具有降尿酸保健食品组合物,其特征在于:所述组合物的原料包括可用于保健食品的原料5~14份,药食同源原料10~21份,普通食品原料1~3份。
2.根据权利要求1所述的具有降尿酸保健食品组合物,其特征在于:所述可用于保健食品原料至少包括:土茯苓1~3份、车前草2~5份、骨碎补1~3份、鳖甲1~3份中的两种原料;
所述药食同源原料至少包括:栀子2~4份、薏苡仁3~5份、菊苣2~4份、葛根1~3份、蒲公英2~4份中的两种原料;
所述普通食品原料包括:玉米须1~3份。
3.根据权利要求2所述的具有降尿酸保健食品组合物,其特征在于:所述组合物原料重量比为:土茯苓:车前草:骨碎补:鳖甲:栀子:薏苡仁:菊苣:葛根:蒲公英:玉米须=2:4:2:2:3:3:4:2:4:1。
4.一种具有降尿酸保健食品组合物制备方法,其特征在于:该方法包括以下步骤:
步骤S1:制备原料的乙醇提取液:准确称取土茯苓1~3份、骨碎补1~3份、葛根1~3份、栀子2~4份,将上述原料粉碎至20目,用10倍体积60%乙醇浸泡2小时,在50℃条件下用60%乙醇提取2次,再用50%乙醇提取一次,过滤并将三次滤液混匀得到醇提液,经减压浓缩至相对密度1.05~1.10得到第一浓缩液;
步骤S2:酶解和微波提取制备原料的水提取液:准确称取鳖甲1~3份、车前草2~5份、薏苡仁3~5份、菊苣2~4份、蒲公英2~4份、玉米须1~3份,粉碎至20目后,与S1醇提过滤后的药渣混合,用10被体积的纯净水浸泡2小时/次,共2次,沥干水分后加入15倍体积的含2%维素酶和1%果胶酶的酶解液酶解20min,沥出酶解液后80℃加热5分钟以灭活酶活性得到酶解提取液;然后残渣加10倍的纯净水,微波连续提取2次,每次15分钟,沥出液体得到微波提取液,将酶解提取液和微波提取液成充分混合,经减压浓缩至相对密度1.05~1.10,得到第二浓缩液;
步骤S3:制备原料提取物的粉剂:将步骤S1和步骤S2制备的第一浓缩液和第二浓缩液充分混合,加入抗性糊精,经喷雾干燥制备为原料提取物的粉剂。
5.根据权利要求4所述的一种具有降尿酸保健食品组合物制备方法,其特征在于:该方法还包括将步骤S3制备的组合物的粉剂,添加赋形剂二氧化硅和硬脂酸镁压制为片剂或者添加甜味剂和酸味剂造粒制备为颗粒剂或者制备为膏滋。
6.根据权利要求1所述的一种具有降尿酸保健食品组合物在动物模型和高尿酸患者中的应用。
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