CN112121144A - 一种刺梨组合物及其制备方法和用途 - Google Patents
一种刺梨组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明涉及一种刺梨组合物及其制备方法和用途。本发明以刺梨提取物为主,与降尿酸、护肝的中药提取物,以及葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,恰玛古提取物,葵花盘肽按比例进行复配获取治疗痛风配方。经药效学验证,所述刺梨组合物能够显著降低痛风小鼠血清尿酸、尿素氮、肌酐水平,并抑制黄嘌呤氧化酶活性。该方法将刺梨提取液与草本植物提取物成分进行合理复配,制成散剂、片剂、丸剂、胶囊剂、口服液用于治疗和预防痛风,同时刺梨组合物的复配方式能够全面提高产品的营养价值,在食品、保健品、医药等领域具有广泛的应用价值。
Description
技术领域
本发明属于刺梨技术领域,具体涉及一种刺梨组合物及其制备方法和用途。
背景技术
痛风是一种由于嘌呤生物合成代谢增加,尿酸产生过多或因尿酸排泄不良而致血中尿酸升高,尿酸盐结晶沉积在关节滑膜、滑囊、软骨及其他组织中引起的反复发作性炎症疾病。它是由于单钠尿酸盐结晶(MSU)或尿酸在细胞外液形成超饱和状态,使其晶体在组织中沉积而造成的一组异源性疾病。痛风可并发肾脏病变,严重者可出现关节破坏、肾功能损害,常伴发高脂血症、高血压病、糖尿病、动脉硬化及冠心病等。目前我国痛风的患病率在1%~3%,并呈逐年上升趋势。
刺梨为蔷薇科多年生落叶灌木缫丝花的果实,被称为第三代水果之王,富含纤维、蔗糖、果糖等碳水化合物,20多种氨基酸,丰富的维生素,10余种对人体有益的微量元素,以及超氧化物歧化酶(SOD),在心血管、消化系统和各种肿瘤疾病防治方面,应用十分广泛。其维生素C含量极高,是当前水果中最高的,每100克鲜果中含量841.58~3541.13毫克,是苹果的800倍、香蕉的400倍、柑橘的50倍、猕猴桃的10倍。其具有增强机体免疫,抗肿瘤,抗衰老,抗氧化,抗动脉粥样硬化,拮抗慢性氟中毒、铅中毒、镉中毒、锰中毒等功能,有利于人体身体健康以及补充丰富的营养物质。
目前国内公开的刺梨提取液制备及应用的研究中,例如CN201811371161.6公开了一种制备无籽刺梨果汁的制备方法,CN201911360475.0公开了一种采用复合酶法对刺梨汁进行脱涩的方法,CN201911333054.9公开了一种添加刺梨、桑葚、沙棘、枸杞、甜菊糖苷的刺梨复合植物饮品的制备方法,CN201810523463.4公开了一种消食健脾、生津止渴、消热解毒、补肾益精、养肝明目、补血安神、宁心安神、益智健脑、增强食欲的保健口服液制备方法,均未提到以刺梨提取物,降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,恰玛古提取物,以及葵花盘肽进行复配,制得刺梨草本植物复方制剂用于治疗和改善痛风。
发明内容
本发明针对现有技术中存在的技术问题,提供一种刺梨组合物及其制备方法和用途。
本发明解决上述技术问题的技术方案如下:
一种刺梨组合物,所述刺梨组合物的有效成分包括以下按质量份数计的组分:刺梨提取物40-50份,降尿酸、护肝的中药提取物20-30份,葛根提取物10-20份,恰玛古提取物4-10份,葵花盘肽3-8份,金钱草提取物3-5份,黄芪提取物2-4份,车前子提取物6-12份,甘草提取物5-10份,以及忧遁草提取物5-11份。
在上述技术方案的基础上,本发明还可以做如下改进。
优选的,所述刺梨组合物的有效成分包括以下按质量份数计的组分:刺梨提取物45份,降尿酸、护肝的中药提取物25份,葛根提取物15份,恰玛古提取物7份,葵花盘肽5份,金钱草提取物4份,黄芪提取物3份,车前子提取物9份,甘草提取物7份,以及忧遁草提取物8份。
优选的,所述降尿酸、护肝的中药提取物为菊苣提取物、蒲公英提取物、桑叶提取物、槐米提取物中的至少一种。
本发明的另一目的是提供一种刺梨组合物的制备方法。
具体的技术方案如下:
一种刺梨组合物的制备方法,包括以下步骤:
1)将清洗干净的刺梨进行破碎榨汁,得到刺梨汁液;
2)先在37℃温度下,对所述刺梨汁液进行加热;再在0-10℃温度下,对所述刺梨汁液进行冷却,得到冷却液;
3)对所述冷却液进行芳香回收,得到芳香回收液;
4)对所述芳香回收液进行酶解,得到刺梨酶解液;
5)对所述刺梨酶解液进行脱涩处理以及浓缩处理,得到浓缩液;
6)对所述浓缩液进行灭菌冻干,得到粉末状的刺梨提取物;
7)在45-60℃温度下,分别对清洗干净的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古进行烘干,并超微粉碎,过70-80目筛,得到粉末状的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古;
8)先对粉末状的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古进行混合,再加入蒸馏水,浸泡1.0-2.0h后于80-95℃煮30-60min,过滤取上清液,0.05-0.08kPa冻干得到降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,以及恰玛古提取物的混合粉末;
9)向葵花盘中加入10-15倍体积水,在50-60℃条件下进行提取,得到提取液;提取液离心15-20min,取上清液,加复合酶进行酶解,得到小分子肽提取液,0.05-0.08kPa冻干得到粉末状的葵花盘肽;
10)对粉末状的刺梨提取物与降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,恰玛古提取物,以及葵花盘肽进行混合,得到刺梨组合物。
进一步,所述步骤3)具体包括:将所述冷却液接入内循环式低压芳香回收系统中,依次经过平衡罐、分馏塔、精馏塔,得到芳香回收液;所述步骤5)具体包括:将所述刺梨酶解液在20℃条件下加入1%的明矾进行1h脱涩处理,而后过滤浓缩,得到浓缩液。
进一步,所述步骤4)和步骤9)中,采用果胶酶和β-葡萄糖苷酶组成的复合酶进行酶解。
进一步,所述步骤8)中,降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古混合粉末与蒸馏水的重量/体积比(g/ml)为1:40-60。
本发明的另一目的是提供一种刺梨组合物在制备治疗痛风的药品中的应用。
具体的技术方案如下:
一种刺梨组合物在制备治疗痛风的药品中的应用。
本发明的另一目的是提供一种用于治疗痛风的中药制品。
具体的技术方案如下:
一种用于治疗痛风的中药制品,所述中药制品的活性成分为上述刺梨组合物。
进一步,所述中药制品的剂型为:散剂、片剂、丸剂、胶囊剂、口服液。
本发明的有益效果是:
(1)发明人经过实验和研究,得出将刺梨提取物,降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,恰玛古提取物和葵花盘肽以特定比例互配所制得的刺梨组合物对改善和治疗痛风的效果显著,且所制得的刺梨组合物营养价值全面;
(2)本发明采用酶解、超滤、脱涩技术获取刺梨提取物,并对提取物进行合理灭菌,操作简便且绿色安全;
(3)本发明选用药膳同源的天然食用植物药为原料,各组分符合药政法规定;利用各味中药的综合作用治疗痛风,无化学甜味剂,对人体无毒无害;
(4)本发明无需煎煮,无苦涩感,营养丰富,饥则食,渴则引,服用方便,符合国家食品卫生法规定。
附图说明
图1为本发明测试小鼠血清尿酸(a)及尿素氮(b)水平;
图2为本发明测试小鼠第3周和第5周体重变化情况;
图3为本发明测试小鼠肝脏指数(a)和肾脏指数(b);
图4为本发明测试小鼠肝脏黄嘌呤氧化酶(a)及谷丙转氨酶(b)水平。
其中,N:空白组,M:模型组,P:别嘌呤醇对照组,CL:刺梨低剂量组,CH:刺梨高剂量组,FL:刺梨复方低剂量组,FH:刺梨复方高剂量组。
具体实施方式
以下结合附图对本发明的原理和特征进行描述,所举实例只用于解释本发明,并非用于限定本发明的范围。
果胶酶:由黑曲霉经发酵精制而得。外观呈浅黄色粉末状。主要用于果蔬汁饮料及果酒的榨汁及澄清,对分解果胶具有良好的作用。
β-葡萄糖苷酶:又称β-D-葡萄糖苷葡萄糖水解酶,别名龙胆二糖酶、纤维二糖酶和苦杏仁苷酶,属于纤维素酶类,是纤维素分解酶系中的重要组成成分,能够水解结合于末端非还原性的β-D-葡萄糖键,同时释放出β-D-葡萄糖和相应的配基。
本发明所设计的一种刺梨组合物,所述刺梨组合物的有效成分包括以下按质量份数计的组分:刺梨提取物40-50份,降尿酸、护肝的中药提取物20-30份,葛根提取物10-20份,恰玛古提取物4-10份,葵花盘肽3-8份,金钱草提取物3-5份,黄芪提取物2-4份,车前子提取物6-12份,甘草提取物5-10份,以及忧遁草提取物5-11份。
本发明所述降尿酸、护肝的中药提取物为菊苣提取物、蒲公英提取物、桑叶提取物、槐米提取物中的至少一种。即所述降尿酸、护肝的中药可以选用菊苣、蒲公英、桑叶、槐米中的至少一种。
各组分的药理作用分别如下:
菊苣为药食两用植物,菊科菊苣属,可提制代用咖啡,促进人体消化器官活动。菊苣具有清热解毒、利尿消肿、健胃等功效,主治湿热黄疸、胃炎水肿、胃脘胀痛、食欲不振等病症。菊苣中含有多种黄酮类物质,如芸香苷(芦丁)、槲皮素和山奈酚等,具有广泛的药理作用,有抗炎、抗氧化、抗过敏、抗菌、抗病毒、抗癌等作用,还有降尿酸效果以及一定的抗痛风作用。
蒲公英可生吃、炒食、做汤,是药食兼用的植物。广泛生于中、低海拔地区的山坡草地、路边、田野、河滩。蒲公英含有丰富的化学成分,包括胡萝卜素类、三萜类、甾醇类、黄酮类等。其中,黄酮类物质,例如槲皮素具有非常广泛的生理和药理活性,有抗炎、抗氧化、抗过敏、抗菌、抗病毒、抗癌等作用,还有降尿酸效果以及一定的抗痛风作用。
生蒲公英富含维生素A、维生素C及钾,也含有铁、钙、维生素B2、维生素B1、镁、维生素B6、叶酸及铜。蒲公英植物体中含有蒲公英醇、蒲公英素、胆碱、有机酸、菊糖等多种健康营养成分。其性味甘,微苦,寒。归肝、胃经。有利尿、缓泻、退黄痘、利胆等功效。功能主治:清热解毒,利尿散结,用于治急性乳腺炎、淋巴腺炎、瘰疬、疗毒疮肿、急性结膜炎、感冒发热、急性扁桃体炎、急性支气管炎、胃炎、肝炎、胆囊炎以及尿路感染。
桑叶性微寒,味甘、苦,归肺、肝经,有疏散风热、清肺润燥、清肝明目的功效,且有治疗风热感冒、肺热燥咳、头晕头痛、目赤昏花的作用。其主要成分为黄酮类、生物碱、植物甾醇、γ-氨基丁酸以及桑叶多糖。桑叶中黄酮类化合物占桑叶干重的1%-3%,是植物界中茎叶含量较高的一类植物。黄酮类化合物,例如槲皮素,具有广泛的药理作用,有抗炎、抗氧化、抗过敏、抗菌、抗病毒、抗癌等作用,还有降尿酸效果以及一定的抗痛风作用。韩国和日本学者从桑叶中分离出9中类黄酮,主要是芸香苷(芦丁)、槲皮素、异槲皮苷、槲皮素-3-三葡糖苷等化合物。生物碱是桑叶的主要活性成分,日本学者从桑叶中分离出多种多羟基生物碱,其中DNJ(1-脱氧野尻霉素)在植物界中,唯桑叶独有。桑叶中植物甾醇含量比一般植物高3-4倍。桑叶有清肺润燥、止咳、去热、化痰、治盗汗;补肾、清肝明目,治疗头晕眼花、失眠、消除眼部疲劳;消肿、清血,治疗痢疾、腹痛、减肥、除脚气、利大/小肠;抗应激、凉血、降血压、降血脂,预防心肌梗塞、脑溢血,祛头痛,长发;降血糖、抗糖病等作用。这些作用都与桑叶中含有的活性成分有关。桑叶中所含的槲皮素、酚类化合物、维生素C等成分能通过抑制或清除自由基来防止氧化损伤。桑叶具有类似人参的补益与抗衰老、稳定神经系统功能的作用,能缓解生理变化引起的情绪激动,提高体内超氧化物歧化酶的活性,阻止体内有害物质的产生,减少或消除已经产生并积滞于体内的脂褐质。
槐米为豆科植物槐的花蕾,性微寒、味苦,入肝、大肠经,具有清肝泻火、润肠通便、止血凉血的功效。每100克鲜品含水分78克、蛋白质3.1克、脂肪0.7克、碳水化合物15克、钙8.3克、磷69毫克、铁3.6毫克、胡萝卜素0.04毫克、维生素B1 0.04毫克、维生素B2 0.18毫克、尼克酸6.6毫克、维生素C 66毫克。此外,还含有三萜皂苷、脂肪酸、鞣质等成分。主治便血、痔血、血痢、崩漏、吐血、肝热目赤、头痛眩晕、高血压等病症。
槐米中含有多种黄酮类物质,如芸香苷(芦丁)、槲皮素等,具有广泛的药理作用,还有降尿酸效果以及一定的抗痛风作用。其中,槲皮素具有非常广泛的生理和药理活性,它具有抗炎、抗氧化、抗过敏、抗菌、抗病毒、抗癌等作用。芸香苷(芦丁)是具有增强毛细血管抵抗力的维生素,可增强血管壁弹性,提高毛细血管的韧性,对高血压患者有防止脑血管破裂的功效,可预防中风。槐米还具有降低血压、调节血脂、抗氧化以及抗菌等作用。
葛根为豆科植物野葛的干燥根,性凉、气平、味甘微辛,可药食两用,具清热、降火、排毒诸功效。葛根内含12%的黄酮类化合物,如葛根素、大豆黄酮苷、花生素等营养成分,还有蛋白质、氨基酸、糖以及人体必需的矿物质,是老少皆宜的名贵滋补品,具有滋补身体、预防高血糖、预防脂肪肝、降血压以及抗癌的作用,中药研究中用于治疗脾虚泄泻、热病口渴、主治外感发热、头颈痛强、麻疹透发不畅、温病口渴、胸痹心痛等病症。
恰玛古为十字花科芸薹属的草本植物,除了富含钙、铁、锌、钾等有益健康的碱性矿物元素及有机生物碱外,还含有十九种氨基酸、蛋白质、粗纤维、亚油酸、类黄酮、多糖、皂甙等物质,例如维生素B1、B2、维生素C,可以同时对身体的各个脏器进行全面的营养调节,达到酸碱平衡、改善体质的作用。恰玛古是一种含碱性很高的食物,它可以对酸性体质的人起到平衡的作用,还可以预防各种疾病的发生,用于治疗脱发、血压升高、免疫力下降、牙周炎等疾病。同时,它还可以抑制癌细胞的生长扩散,对治疗乳腺癌、淋巴癌、胆管癌、血癌等癌症有很好的疗效。此外,它含有的有机营养,可以起到清热解毒、利尿消肿、防治五脏衰竭的作用。
葵花盘属于菊科向日葵属,具有清热、平肝、止痛、止血等功效。秋季采收,去净果实,鲜用或晒干。其提取物有生物碱、黄酮、小分子肽。其中,小分子肽具有载体作用,可携带生物碱和黄酮快速进入血液,能快速降尿酸,溶解痛风石,修复受损的肝肾细胞,恢复肝肾功能。
金钱草为报春花科植物,别名过路黄、镜面草、对座草、钱叶草等。其味甘、微苦、性凉,具有预防结石、清热解毒、利尿排石、祛风止痛、消炎解毒的作用,主治肝胆及泌尿系结石、急慢性肝炎、黄疸型肝炎、胆囊炎、肾炎、泌尿系感染、扁桃腺炎、口腔炎及痈疔疗毒、毒蛇咬伤、乳痈、痢疾、疟疾、肺出血等病症。
黄芪根可以入药,味甘、性微温,具补气固表、利尿、强心、降压、抗菌、托毒、排脓、生肌、加强毛细血管抵抗力、止汗和类性激素的功效,主治表虚自汗、气虚内伤、脾虚泄泻、浮肿等病症。
车前子为车前科植物车前或平车前的干燥成熟种子。夏、秋二季种子成熟时采收果穗,晒干,搓出种子,除去杂质。车前子含较多黏液、车前子酸、车前子甙、车前烯醇酸、琥珀酸、腺嘌呤、胆碱、梓醇、蛋白质及各种脂肪酸,黏液中含酸性黏多糖车前聚糖,还含维生素A、B1。车前子味甘、淡,性微寒;归肾、膀胱、肝、肺经;质滑降利;具有清热利尿、渗湿通淋、明目祛痰的功效;主治小便不利、淋浊带下、血淋尿血、水肿胀满、黄疸、暑湿泄痢、目赤降翳、痰热咳嗽等病症。
甘草别名国老、甜草、乌拉尔甘草、甜根子。豆科、甘草属多年生草本,根与根状茎粗壮,是一种补益中草药。甘草含有很多化学成分,其中,甘草甜素和黄酮类物质是甘草中最重要的生理活性物质。其气微,味甜而特殊,功能主治清热解毒、祛痰止咳、脘腹等。甘草用于心气虚、心悸怔忡、脉结代、脾胃气虚以及倦怠乏力等。
忧遁草学名鳄嘴花,是一种生长在靠近赤道的低海拔疏林中或灌丛内潮湿砂质土壤里的野生灌木状草本植物。其味甘、辛、微苦、性平,入肝、肾经。忧遁草无毒,含有羽扇醇、白烨脂醇、五环三萜化合物、Beta-谷甾醇、钙元素、类黄酮含量极高。全株入药,具有清热解毒、散瘀消肿、消炎解酒、防癌抗癌等作用,能改进全身血流状态,增强心肌收缩能力,改善血压,含丰富的蛋白质,营养价值极高。
本发明所设计的一种刺梨组合物的制备方法,包括以下步骤:
1)将清洗干净的刺梨进行破碎榨汁,得到刺梨汁液;
2)先在37℃温度下,对所述刺梨汁液进行加热;再在0-10℃温度下,对所述刺梨汁液进行冷却,得到冷却液;
3)将所述冷却液接入内循环式低压芳香回收系统中,依次经过平衡罐、分馏塔、精馏塔,得到芳香回收液;
4)采用果胶酶和β-葡萄糖苷酶组成的复合酶对所述芳香回收液进行酶解,得到刺梨酶解液;
5)将所述刺梨酶解液在20℃条件下加入1%的明矾进行1h脱涩处理,而后过滤浓缩,得到浓缩液;
6)对所述浓缩液进行灭菌冻干,得到粉末状的刺梨提取物;
7)在45-60℃温度下,分别对清洗干净的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古进行烘干,并超微粉碎,过70-80目筛,得到粉末状的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古;
8)先对粉末状的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古进行混合,再加入蒸馏水,浸泡1.0-2.0h后于80-95℃煮30-60min,过滤取上清液,0.05-0.08kPa冻干得到降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,以及恰玛古提取物的混合粉末;
9)向葵花盘中加入10-15倍体积水,在50-60℃条件下进行提取,得到提取液;提取液离心15-20min,取上清液,加果胶酶-β-葡萄糖苷复合酶进行酶解,得到小分子肽提取液,0.05-0.08kPa冻干得到粉末状的葵花盘肽;
10)对粉末状的刺梨提取物与降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,恰玛古提取物,以及葵花盘肽进行混合,得到刺梨组合物。
所述步骤8)中,降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古混合粉末与蒸馏水的重量/体积比(g/ml)为1:40-60。
本发明将新鲜刺梨清洗挑拣后,进行破碎榨汁,对汁液进行加热冷却回收芳香物质,而后采取酶解、脱涩、浓缩、等工艺提升刺梨提取液营养、风味以及安全性。
所述刺梨组合物在制备治疗痛风的药品中的应用。
一种用于治疗痛风的中药制品,所述中药制品的活性成分为上述刺梨组合物。
所述中药制品的剂型为:散剂、片剂、丸剂、胶囊剂、口服液。
以下分别说明各种剂型的制剂过程:
(1)散剂的制备:取所得粉末状的刺梨组合物,直接制成散剂。
(2)片剂的制备:取所得粉末状的刺梨组合物,压制得片剂。
(3)丸剂的制备:取所得粉末状的刺梨组合物,水泛成丸,干燥,原色打光,制成丸剂。
(4)胶囊剂的制备:取所得粉末状的刺梨组合物,加入1%的羧甲基纤维素钠,混匀、制粒、充填,制成胶囊剂。
(5)口服液的制备:取所得粉末状的刺梨组合物,纯水溶解,搅拌均质,灌装入瓶,制成口服液。
实施例1
1)将清洗干净的刺梨进行破碎榨汁,得到刺梨汁液;
2)先在37℃温度下,对所述刺梨汁液进行加热;再在0℃温度下,对所述刺梨汁液进行冷却,得到冷却液;
3)将所述冷却液接入内循环式低压芳香回收系统中,依次经过平衡罐、分馏塔、精馏塔,得到芳香回收液;
4)采用果胶酶和β-葡萄糖苷酶组成的复合酶对所述芳香回收液进行酶解,得到刺梨酶解液;
5)将所述刺梨酶解液在20℃条件下加入1%的明矾进行1h脱涩处理,而后过滤浓缩,得到浓缩液;
6)对所述浓缩液进行灭菌冻干,得到粉末状的刺梨提取物;
7)在45℃温度下,分别对清洗干净的蒲公英、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行烘干,并超微粉碎,过70目筛,得到粉末状的蒲公英、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古;
8)先对粉末状的蒲公英、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行混合,再加入蒸馏水,浸泡1.0h后于80℃煮60min,过滤取上清液,0.05kPa冻干得到蒲公英提取物、葛根提取物、金钱草提取物、黄芪提取物、车前子提取物、甘草提取物、忧遁草提取物以及恰玛古提取物的混合粉末;
9)向葵花盘中加入12倍体积水,在50℃条件下进行提取,得到提取液;提取液离心20min,取上清液,加复合酶进行酶解,得到小分子肽提取液,0.08kPa冻干得到粉末状的葵花盘肽;
10)对粉末状的刺梨提取物40份与蒲公英提取物20份、葛根提取物10份、金钱草提取物3份、黄芪提取物2份、车前子提取物6份、甘草提取物5份、忧遁草提取物5份、恰玛古提取物4份以及葵花盘肽3份进行混合,得到刺梨组合物。
所述步骤8)中,蒲公英、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古混合粉末与蒸馏水的重量/体积比(g/ml)为1:40。
实施例2
1)将清洗干净的刺梨进行破碎榨汁,得到刺梨汁液;
2)先在37℃温度下,对所述刺梨汁液进行加热;再在3℃温度下,对所述刺梨汁液进行冷却,得到冷却液;
3)将所述冷却液接入内循环式低压芳香回收系统中,依次经过平衡罐、分馏塔、精馏塔,得到芳香回收液;
4)采用果胶酶和β-葡萄糖苷酶组成的复合酶对所述芳香回收液进行酶解,得到刺梨酶解液;
5)将所述刺梨酶解液在20℃条件下加入1%的明矾进行1h脱涩处理,而后过滤浓缩,得到浓缩液;
6)对所述浓缩液进行灭菌冻干,得到粉末状的刺梨提取物;
7)在50℃温度下,分别对清洗干净的桑叶、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行烘干,并超微粉碎,过75目筛,得到粉末状的桑叶、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古;
8)先对粉末状的桑叶、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行混合,再加入蒸馏水,浸泡1.7h后于90℃煮40min,过滤取上清液,0.06kPa冻干得到桑叶提取物、葛根提取物、金钱草提取物、黄芪提取物、车前子提取物、甘草提取物、忧遁草提取物以及恰玛古提取物的混合粉末;
9)向葵花盘中加入10倍体积水,在60℃条件下进行提取,得到提取液;提取液离心15min,取上清液,加复合酶进行酶解,得到小分子肽提取液,0.07kPa冻干得到粉末状的葵花盘肽;
10)对粉末状的刺梨提取物45份与桑叶提取物25份、葛根提取物15份、金钱草提取物4份、黄芪提取物3份、车前子提取物9份、甘草提取物7份、忧遁草提取物8份、恰玛古提取物7份以及葵花盘肽5份进行混合,得到刺梨组合物。
所述步骤8)中,桑叶、葛根、菊苣、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古混合粉末与蒸馏水的重量/体积比(g/ml)为1:50。
实施例3
1)将清洗干净的刺梨进行破碎榨汁,得到刺梨汁液;
2)先在37℃温度下,对所述刺梨汁液进行加热;再在6℃温度下,对所述刺梨汁液进行冷却,得到冷却液;
3)将所述冷却液接入内循环式低压芳香回收系统中,依次经过平衡罐、分馏塔、精馏塔,得到芳香回收液;
4)采用果胶酶和β-葡萄糖苷酶组成的复合酶对所述芳香回收液进行酶解,得到刺梨酶解液;
5)将所述刺梨酶解液在20℃条件下加入1%的明矾进行1h脱涩处理,而后过滤浓缩,得到浓缩液;
6)对所述浓缩液进行灭菌冻干,得到粉末状的刺梨提取物;
7)在55℃温度下,分别对清洗干净的菊苣、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行烘干,并超微粉碎,过80目筛,得到粉末状的菊苣、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古;
8)先对粉末状的菊苣、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行混合,再加入蒸馏水,浸泡1.3h后于85℃煮50min,过滤取上清液,0.07kPa冻干得到菊苣提取物、葛根提取物、金钱草提取物、黄芪提取物、车前子提取物、甘草提取物、忧遁草提取物以及恰玛古提取物的混合粉末;
9)向葵花盘中加入14倍体积水,在53℃条件下进行提取,得到提取液;提取液离心18min,取上清液,加复合酶进行酶解,得到小分子肽提取液,0.06kPa冻干得到粉末状的葵花盘肽;
10)对粉末状的刺梨提取物50份与菊苣提取物30份、葛根提取物20份、金钱草提取物5份、黄芪提取物4份、车前子提取物12份、甘草提取物10份、忧遁草提取物11份、恰玛古提取物10份以及葵花盘肽8份进行混合,得到刺梨组合物。
所述步骤8)中,菊苣、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古混合粉末与蒸馏水的重量/体积比(g/ml)为1:60。
实施例4
1)将清洗干净的刺梨进行破碎榨汁,得到刺梨汁液;
2)先在37℃温度下,对所述刺梨汁液进行加热;再在10℃温度下,对所述刺梨汁液进行冷却,得到冷却液;
3)将所述冷却液接入内循环式低压芳香回收系统中,依次经过平衡罐、分馏塔、精馏塔,得到芳香回收液;
4)采用果胶酶和β-葡萄糖苷酶组成的复合酶对所述芳香回收液进行酶解,得到刺梨酶解液;
5)将所述刺梨酶解液在20℃条件下加入1%的明矾进行1h脱涩处理,而后过滤浓缩,得到浓缩液;
6)对所述浓缩液进行灭菌冻干,得到粉末状的刺梨提取物;
7)在60℃温度下,分别对清洗干净的槐米、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行烘干,并超微粉碎,过80目筛,得到粉末状的槐米、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古;
8)先对粉末状的槐米、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古进行混合,再加入蒸馏水,浸泡2.0h后于95℃煮30min,过滤取上清液,0.08kPa冻干得到槐米提取物、葛根提取物、金钱草提取物、黄芪提取物、车前子提取物、甘草提取物、忧遁草提取物以及恰玛古提取物的混合粉末;
9)向葵花盘中加入15倍体积水,在57℃条件下进行提取,得到提取液;提取液离心17min,取上清液,加复合酶进行酶解,得到小分子肽提取液,0.05kPa冻干得到粉末状的葵花盘肽;
10)对粉末状的刺梨提取物47份与槐米提取物26份、葛根提取物18份、金钱草提取物4份、黄芪提取物3份、车前子提取物10份、甘草提取物8份、忧遁草提取物9份、恰玛古提取物8份以及葵花盘肽6份进行混合,得到刺梨组合物。
所述步骤8)中,槐米、葛根、金钱草、黄芪、车前子、甘草、忧遁草以及恰玛古混合粉末与蒸馏水的重量/体积比(g/ml)为1:60。
本发明实施例1-4的复合酶中,所述果胶酶和β-葡萄糖苷酶质量比为1:1。
实验例
一、实验目的
以实施例3制备的刺梨提取物和刺梨组合物进行调节高尿酸血症功能测试。
二、实验思路
采用氧嗪酸钾和次黄嘌呤联合诱导SPF级雄性KM小鼠以构建高尿酸血症模型,设空白组、模型组、阳性药物(别嘌呤醇)组作为对照。数据采用IBM SPSS Statics 22.0进行统计分析,GraphPad Prism 7.00绘制数据图。
三、实施方案
1、试验小鼠:试验用SPF级雄性KM小鼠,体重18-22g,足量食物及饮水供应,持续通风,固定室温24C,每日12h开关灯模仿日夜交替,保证小鼠基础生理需要。
2、小鼠分组:适应性喂养一周后,对小鼠进行称重分组和标记。本实验将50只小鼠随机分为五组,每组10只,即空白组(N)、模型组(M)、别嘌呤醇对照组(P,阳性对照组,10mg/kg)、刺梨低剂量组(CL,刺梨提取物1g/kg)、刺梨高剂量组(CH,刺梨提取物2g/kg)、刺梨复方低剂量组(FL,刺梨组合物1g/kg)、刺梨复方高剂量组(FH,刺梨组合物2g/kg)。
3、小鼠造模:除空白组以外,对其它组的小鼠连续14天进行次黄嘌呤300mg/kg和氧嗪酸钾250mg/kg灌胃处理,建立KM小鼠高尿酸血症(HUA)模型,当造模小鼠测得的血清尿酸浓度与正常组小鼠尿酸浓度有显著差异时,表示造模成功。造模剂均用0.5%的羟甲基纤维素钠(CMC-Na)溶液溶解,灌胃体积均为0.1mL·10g-1·d只,空白组注射0.5%CMC-Na溶剂。
4、小鼠给药:造模成功后,别嘌呤醇对照组、刺梨组和刺梨复配组的小鼠每天分别进行别嘌呤醇、刺梨提取物和刺梨组合物灌胃处理,空白组和模型组的小鼠同时给予等量生理盐水,连续给药14天后,每两周称重一次。
5、小鼠处死及器官采集:小鼠眼眶取血后脱颈处死,取小鼠肾脏、肝脏组织并进行脏器称重。
6、后期数据分析:检测血清中尿酸、尿素氮和肝脏黄嘌呤氧化酶、谷草转氨酶、谷丙转氨酶活性;以肝脏、肾脏与体重的重量比计算器官指数。
四、测试结果
1、刺梨及其复方缓解痛风效果分析
参见图1:测试小鼠血清尿酸(a)及尿素氮(b)水平,N:空白组,M:模型组,P:别嘌呤醇对照组,CL:刺梨低剂量组,CH:刺梨高剂量组,FL:刺梨复方低剂量组,FH:刺梨复方高剂量组。与正常组相比,*p<0.05,**p<0.01,与模型组比较,#p<0.05,##p<0.01。
高尿酸血症是指嘌呤代谢紊乱,尿酸(Uric acid,UA)排泄障碍引起的UA的生成增多或排泄减少,导致血清UA水平超过正常值的疾病。通过造模,小鼠血清尿酸水平持续性的维持在高水平,与其它组相比存在极显著差异,说明造模成功。经过刺梨及其复方的高低剂量处理后,药物处理组小鼠血清尿酸水平与正常组相比没有显著差异,且高剂量组的小鼠血清尿酸水平较低剂量组低,说明高剂量组具有更好的降尿酸效果(图1-a)。
尿酸是人体蛋白代谢的主要终产物,它构成了血液中绝大部分的非蛋白氨。血中尿素氮来源于肝脏,通过肾脏随尿液排出体外。肾脏功能衰竭、肾炎、泌尿阻塞等可使血液尿素氮(BUN)含量升高。因此尿素氮水平越高表明肾损伤程度越严重。与模型组相比,刺梨及其复方处理组小鼠血清尿素氮水平显著降低,特别地,刺梨复方高剂量处理组小鼠尿酸血清水平更低,说明刺梨复方高剂量组更能够减轻高尿酸血症小鼠肾损伤(图1-b)。
2、体重变化分析
参见图2:测试小鼠第3周和第5周体重变化情况,N:空白组,M:模型组,P:别嘌呤醇对照组,CL:刺梨低剂量组,CH:刺梨高剂量组,FL:刺梨复方低剂量组,FH:刺梨复方高剂量组。与正常组相比,*p<0.05,**p<0.01,与模型组比较,#p<0.05,##p<0.01。
造模结束时,造模液处理的小鼠体重均有所下降,说明造模液对小鼠体重产生一定的影响。第五周与第三周相比,模型组、别嘌呤醇对照组小鼠体重有所上升,而刺梨组和刺梨复方组均不同程度的下降(图2),其可能原因是刺梨及其复方通过影响小鼠的饮食摄入量来调节机体尿酸代谢。
3、脏器指数分析
参见图3:测试小鼠肝脏指数(a)和肾脏指数(b),N:空白组,M:模型组,P:别嘌呤醇对照组,CL:刺梨低剂量组,CH:刺梨高剂量组,FL:刺梨复方低剂量组,FH:刺梨复方高剂量组。
脏器指数又称脏体比,是试验动物某脏器的重量与其体重之比值。正常时各脏器与体重的比值比较恒定。动物染毒后,受损脏器重量可以发生改变,故脏器系数也随之而改变。脏器系数增大,表示脏器充血、水肿或增生肥大等;脏器系数减小,表示脏器萎缩及其他退行性改变。通过计算各组小鼠肝脏指数(图3-a)、肾脏指数(图3-b)不存在显著性差异,说明药物处理对小鼠的肝脏、肾脏产生无明显毒性作用。即通过脏器系数分析,刺梨及其复方组可维持痛风小鼠脏器与体重比值的恒定。值得注意的是刺梨复方低剂量组小鼠脏器指数稍低于其他组,其可能原因与小鼠体重偏低相关。
4、刺梨及其复方对痛风小鼠肝功能调节
参见图4:测试小鼠肝脏黄嘌呤氧化酶(a)及谷丙转氨酶(b)水平,N:空白组,M:模型组,P:别嘌呤醇对照组,CL:刺梨低剂量组,CH:刺梨高剂量组,FL:刺梨复方低剂量组,FH:刺梨复方高剂量组。与正常组相比,*p<0.05,**p<0.01,与模型组比较,#p<0.05,##p<0.01。
黄嘌呤氧化酶(XOD)属需氧脱氢酶类,是嘌呤核苷代谢途径限速酶,是尿酸合成关键酶,肝脏和小肠最多,在高尿酸血症的发病中有着重要的地位。在肝损伤时,XOD水平显著升高。此次测试发现,刺梨及其复方能明显减低XOD酶活性,提示刺梨可抑制XOD活性以降低血尿酸(图4-a)。
谷丙转氨酶(ALT)主要存在于肝脏、心脏组织细胞中,特异性较高,当这些组织发生病变时,该酶活力增多,可反映肝脏损伤活性。与模型组痛风小鼠相比,刺梨及其复方处理组小鼠肝脏的谷丙转氨酶活性显著降低,刺梨低剂量组小鼠的酶活力较其他药物处理组较高(图4-b)。结果表明,刺梨及其复方能够很好的改善痛风小鼠的肝功能损伤,且刺梨复方高剂量组更能够改善痛风小鼠的肝功能损伤。
五、分析总结
1、刺梨及其复方均表现出显著的降尿酸效果;高剂量的刺梨及其复方相较于比低剂量的刺梨及其复方表现出更好的降尿酸效果;刺梨复方组相较于刺梨组表现出更好的降尿酸效果。
2、刺梨及其复方能很好的调节高尿酸小鼠肝功能、肾功能,维持肝、肾指标在正常水平;刺梨复方组相较于刺梨组更能够调节高尿酸小鼠肝功能、肾功能;通过脏器系数分析,刺梨及其复方组可维持痛风小鼠脏器与体重比值的恒定。
由此可知,本发明利用协同效能,以刺梨提取物为主与降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,恰玛古提取物,以及葵花盘肽按比例进行配伍制得的刺梨组合物降尿酸、减轻肾损伤以及改善肝功能损伤的效果明显优于刺梨提取物。
以上所述仅为本发明的较佳实施例,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种刺梨组合物,其特征在于,所述刺梨组合物的有效成分包括以下按质量份数计的组分:刺梨提取物40-50份,降尿酸、护肝的中药提取物20-30份,葛根提取物10-20份,恰玛古提取物4-10份,葵花盘肽3-8份,金钱草提取物3-5份,黄芪提取物2-4份,车前子提取物6-12份,甘草提取物5-10份,以及忧遁草提取物5-11份。
2.根据权利要求1所述的刺梨组合物,其特征在于,所述刺梨组合物的有效成分包括以下按质量份数计的组分:刺梨提取物45份,降尿酸、护肝的中药提取物25份,葛根提取物15份,恰玛古提取物7份,葵花盘肽5份,金钱草提取物4份,黄芪提取物3份,车前子提取物9份,甘草提取物7份,以及忧遁草提取物8份。
3.根据权利要求1或2所述的刺梨组合物,其特征在于,所述降尿酸、护肝的中药提取物为菊苣提取物、蒲公英提取物、桑叶提取物、槐米提取物中的至少一种。
4.一种权利要求1-3中任一项所述的刺梨组合物的制备方法,其特征在于,包括以下步骤:
1)将清洗干净的刺梨进行破碎榨汁,得到刺梨汁液;
2)先在37℃温度下,对所述刺梨汁液进行加热;再在0-10℃温度下,对所述刺梨汁液进行冷却,得到冷却液;
3)对所述冷却液进行芳香回收,得到芳香回收液;
4)对所述芳香回收液进行酶解,得到刺梨酶解液;
5)对所述刺梨酶解液进行脱涩处理以及浓缩处理,得到浓缩液;
6)对所述浓缩液进行灭菌冻干,得到粉末状的刺梨提取物;
7)在45-60℃温度下,分别对清洗干净的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古进行烘干,并超微粉碎,过70-80目筛,得到粉末状的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古;
8)先对粉末状的降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古进行混合,再加入蒸馏水,浸泡1.0-2.0h后于80-95℃煮30-60min,过滤取上清液,0.05-0.08kPa冻干得到降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,以及恰玛古提取物的混合粉末;
9)向葵花盘中加入10-15倍体积水,在50-60℃条件下进行提取,得到提取液;提取液离心15-20min,取上清液,加复合酶进行酶解,得到小分子肽提取液,0.05-0.08kPa冻干得到粉末状的葵花盘肽;
10)对粉末状的刺梨提取物与降尿酸、护肝的中药提取物,葛根提取物,金钱草提取物,黄芪提取物,车前子提取物,甘草提取物,忧遁草提取物,恰玛古提取物,以及葵花盘肽进行混合,得到刺梨组合物。
5.根据权利要求4所述的制备方法,其特征在于,所述步骤3)具体包括:将所述冷却液接入内循环式低压芳香回收系统中,依次经过平衡罐、分馏塔、精馏塔,得到芳香回收液;所述步骤5)具体包括:将所述刺梨酶解液在20℃条件下加入1%的明矾进行1h脱涩处理,而后过滤浓缩,得到浓缩液。
6.根据权利要求4所述的制备方法,其特征在于,所述步骤4)和步骤9)中,采用果胶酶和β-葡萄糖苷酶组成的复合酶进行酶解。
7.根据权利要求4所述的制备方法,其特征在于,所述步骤8)中,降尿酸、护肝的中药,葛根,金钱草,黄芪,车前子,甘草,忧遁草,以及恰玛古混合粉末与蒸馏水的重量/体积比(g/ml)为1:40-60。
8.权利要求1-3中任一项所述的刺梨组合物在制备治疗痛风的药品中的应用。
9.一种用于治疗痛风的中药制品,其特征在于,所述中药制品的活性成分为权利要求1或2中所述的刺梨组合物。
10.根据权利要求9所述的中药制品,其特征在于,所述中药制品的剂型为:散剂、片剂、丸剂、胶囊剂、口服液。
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