CN114794478B - 一种能降低血压血脂血糖的组合物及应用 - Google Patents
一种能降低血压血脂血糖的组合物及应用 Download PDFInfo
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Abstract
本发明是涉及一种能同时降低血压、血脂和血糖的组合物，及其应用，属于保健品、药物技术领域。本发明所述的能降低血压血脂血糖的组合物各成分的重量比例为：三七总皂苷：罗汉果苷：茶氨酸＝1.5～2.5:0.5～1.5:1.5～2.5。本发明涉及这种组合物在制备治疗降低血压、血脂、血糖的药物中的应用。本发明涉及这种组合物在制备降低血压、血脂、血糖的保健品中的应用。本发明三七总皂苷、罗汉果苷、茶氨酸三者协同复配可以有效通过三七总皂苷的降脂作用和神经保护作用、罗汉果苷的抗氧化作用而维持血糖健康、茶氨酸的缓解、舒缓紧张情绪而达到抗焦虑、抗抑郁的作用。本发明降压、降糖、降脂起效迅速，维持时间持久。
Description
技术领域
本发明是涉及一种能同时降低血压、血脂和血糖的组合物，及其应用，属于保健品、药物技术领域。
背景技术
药物治疗是高血压、高血脂、高血糖患者的主要治疗方式，其在临床治疗中虽能够起到一定的作用效果，但是在长期的药物治疗过程中，容易产生药物副作用和不良反应，且最终会引发器质性病变，甚至引发癌症。
以降压药为例，大量研究已经证实通过降压药物将血压控制可以显著减少心脑血管事件等的发生。目前临床上常用的一线降压药包括：ACEIs/血管紧张素受体拮抗剂(angiotensin receptor blocker，ARB)、钙离子通道阻滞剂(calciumchannel blocker，CCB)、利尿剂、β受体阻滞剂和α受体阻滞剂。然而，《降压药物与肿瘤发生风险关系的研究进展》中提到，血管紧张素转换酶抑制剂(ACEIs)血管紧张素Ⅱ(angiotensinⅡ，AngⅡ)作为心血管稳态的重要调节因子参与了细胞增殖、血管形成、炎症和组织重塑的调节，因此有研究提出AngⅡ可能在癌症的发生发展中发挥作用。使用ACEIs患者的肺癌风险是使用ARB患者的1.36倍，并且ACEIs与肺癌发生风险存在剂量-反应和持续-反应关系。丹麦的一项恶性肿瘤的病例对照研究发现，服用ACEIs的患者结直肠癌、乳腺癌、前列腺癌和非吸烟相关癌症的风险显著升高，并且癌症风险与暴露时间正相关。CCB与癌症之间的关系同样存在许多不确定性，钙离子通道参与了细胞生长、增殖和凋亡相关的信号传递的重要环节。目前对CCB与肿瘤发生的相关机制主要是考虑到CCB可抑制细胞凋亡，从而可能诱导肿瘤发生。
另据调查发现，有0.5％～2.0％的他汀类降脂药使用患者，如果长时间应用他汀类降脂药物，就会发生肝脏转氨酶升高等情况。服用他汀类药物治疗的患者，有的还会出现严重的肌炎，或者肌肉疼痛和无力等情况，同时还会伴有肌酸。
降糖药主要造成胃肠系统损害、代谢和营养障碍以及皮肤附件损害等，临床表现则包括恶心、腹泻、腹痛、皮疹和低血糖等，其中累及系统-器官排名前五位的例次占总数的92.38％。
中国专利申请号201610319820.6公开了一种灯盏花素与三七总皂苷双纳米复合物粒子及其制备方法和用途。其中，含以灯盏花素的重量计(w/w％)，三七总皂苷重量比为50％-200％，保护剂的重量比为100％-200％。该双纳米复合粒子用于制备心脑血管疾病。
中国专利申请号200510010738.7公开了一种治疗脑血栓、冠心病、心绞痛的药物制剂，该制剂由5-95％的三七总皂苷、灯盏花素为组合物和余量的辅料组成。
中国专利申请号03104665.7公开了一种三七总皂苷1.5-100份，灯盏花素1份的治疗心脑血管疾病的药用组合物。
中国专利申请号201310213513.6公开了一种三七总皂苷和灯盏花素1:1-1:5的治疗冠心病组合物，其中，三七总皂苷中人参皂苷-Rb1﹥30％、人参皂苷-Rg1﹥20％，三七皂苷-R1﹥5％，总量﹥60％。
中国专利申请号201710106679.6公开了一种由神经酸24-60份、三七总皂苷48-90份和灯盏花素10-38份组成的组合物。
中国专利申请号202110248430.5公开了一种减压、抗焦虑的食品配方及其制备方法，其特征为，由软心珍珠和茶汤两部分组成，外形像珍珠奶茶；软心珍珠和茶汤的用量为，每600～800mL茶汤中加入软心珍珠10～20g。甜味剂可选用白砂糖、绵白糖、木糖醇、赤藓糖醇、罗汉果苷、甜菊糖苷及其他已商品化的代糖产品中的任一种或几种的组合物，用量根据甜味剂的甜度进行调整。
中国专利申请号202010471878.9公开了一种罗汉果苷IIE在制备消炎食品、保健品或药品中的应用。
中国专利申请号202010471884.4公开了一种罗汉果苷IIE在制备抗氧化食品、保健品或药品中的应用。
中国专利申请号201910623559.2公开了一种糖尿病人可食用的甜味颗粒的制备方法：将罗汉果提取物0.1-0.5份、木姜叶柯提取物0.3-0.8份溶解于10-30份的80℃的50％乙醇水，搅拌使其充分溶解，得甜味剂溶液；所述罗汉果提取物中罗汉果苷V的质量分数不小于90％；所述木姜叶柯提取物中根皮苷质量分数35％和三叶苷65％。
中国专利申请号202111554545.3公开了一种改善睡眠的植物饮料及其制备方法，以药食同源的原料(浮小麦、酸枣仁、大枣、茯苓和甘草)为基础，添加酪蛋白水解肽及新资源食品(γ-氨基丁酸和茶叶茶氨酸)协同改善睡眠。
中国专利申请号202111514395.3公开了一种对降三高及抗癌具备保健功能的营养奶粉，营养素包括菊粉30％、植物甾醇酯20％、荷叶粉20％、山楂粉10％，山药粉10％、茶叶茶氨酸粉2％、富硒酵母8％。
中国专利申请号202111349841.X公开了一种提高免疫力强筋骨助睡眠的配方奶粉及其制备方法，配方组成包括乳粉、固体玉米糖浆、脱脂乳清粉、菊粉、低聚异麦芽糖、乳清蛋白粉、乳铁蛋白、水解蛋黄粉、初乳碱性蛋白、β-羟基-β-甲基丁酸钙、L-茶氨酸、低脂木糖、复合微生物、药食同源粉和有机硒。
中国专利申请号202111342543.8公开了一种促进睡眠和肌肤修复的功效组合物及其在化妆品中的应用，促进睡眠和肌肤修复的功效组合物包括茶氨酸、山茶花提取物和昆诺阿藜籽提取物。
中国专利申请号202111237816.2公开了一种吸吸型睡眠功能果冻及其生产工艺，按质量分数包括以下组分：0.15％稳定剂、0.1％魔芋粉、0.05％卡拉胶、0.05％柠檬酸钠、1.75％白砂糖、77.88％水、0.15％乳酸钙溶液、7％果汁、0.03％VC、0.5％GABA、0.3％茶叶茶氨酸、0.3％酸枣仁粉、1％酪蛋白水解肽、0.01％香蜂草提取物、0.15％德国春黄菊花提取物、0.33％无水柠檬酸。
中国专利申请号202111261662.0公开了一种改善睡眠的调制乳粉，含有乳制品700-900份、辣木叶提取物2-30份、酸枣仁提取物5-30份、茯苓提取物1-20份、红枣粉10-50份、酸樱桃粉1-20份、茶叶茶氨酸1-20份、酪蛋白水解肽1-20份、维生素和矿物质4-20份。
发明内容
本发明的目的在于提供一种能降低血压血脂血糖的组合物。
本发明的另一目的是提供这种组合物在制备治疗降低血压、血脂、血糖的药物中的应用。
本发明所述的能降低血压血脂血糖的组合物各成分的重量比例为：三七总皂苷：罗汉果苷：茶氨酸＝1.5～2.5:0.5～1.5:1.5～2.5。
优选的，各成分的重量比例为：三七总皂苷:罗汉果苷:茶氨酸＝1.8～2.3:0.8～1.2:1.8～2.3。
本发明的创造性特点体现为，将三七总皂苷、罗汉果苷和茶氨酸三者的药效机制、生理保健功能有机地结合起来，三管齐下，协同发挥药效，长效、平稳且更好地发挥其保健功能，从而达到治疗和预防三高症的目的。
三七味甘，微苦，性温，具有止血止痛、活血化瘀的功效。三七总皂苷是三七的主要有效成分，含有多种单体皂苷，为人参皂苷Rg1、Rb1和三七皂苷R1等。广泛应用于脑梗死、急性心肌梗死等临床治疗。其最主要的作用机制是通过PI3K/Akt/mTOR和AMPK信号通路促进线粒体自噬，从而发挥神经保护作用。此外，三七总皂苷通过抑制脂多糖刺激促炎细胞因子的分泌和活性氧的生成，减轻脂多糖诱导的血脑屏障破坏和单核细胞对脑内皮细胞的粘附，从而发挥其对内皮细胞的保护作用。
罗汉果能够提神生津、清热润肺、祛火止咳,具有滑肠通便等效用，罗汉果在东南亚和西方国家有着“东方神国”和“长寿之果”的美誉。罗汉果苷为罗汉果中的独有成分，也是对罗汉果化学成分中最先被研究和利用的成分。《罗汉果水提物和罗汉果苷V治疗非酒精性脂肪肝炎的药效和机制研究》中，作者通过非酒精性脂肪肝炎(NASH)的小鼠模型中，发现罗汉果皂苷水提取物可通过抑制炎症相关基因表达TNF-α、IL-1β、IL-6进一步改善炎症反应，对NASH的治疗有效。在《Siraitia grosvenorii residual extract attenuatesovalbumin induced lung inflammation by down-regulating IL-4，IL-5，IL-13，IL-17，and MUC5AC expression in mice》中，作者发现罗汉果提取物(SGRE)可以降低卵清蛋白(OVA)诱导的哮喘模型小鼠的肺及支气管肺泡灌洗液(BAL)中的淋巴细胞总数，并通过降低在肺模型中炎症因子TNF-α，IL-17的高表达发挥抗炎抗氧化作用。有研究表明罗汉果皂苷V在肺癌、胰腺癌、结肠癌、喉癌中具有一定抑制细胞增殖、促进凋亡的作用。此外，罗汉果苷还具有增强免疫力、抗骨质疏松等作用。但罗汉果苷未见与三高有关的动物或人体治疗剂量的研究报道。
茶氨酸是茶叶特有一种氨基酸，茶氨酸的保健作用主要体现在对神经系统的影响。茶氨酸通过血脑屏障进入大脑，使脑细胞中线粒体内多巴胺含量显著增加，多巴胺是肾上腺素和去甲肾上腺素前驱体，是传达脑神经兴奋的重要神经递质，其释放对情绪有很大影响。研究证明L-茶氨酸对慢性不可预见温和应激诱发的抑郁症也有预防和治疗功效；作用机制主要是通过增加脑内单胺类递质分泌，调节下丘脑-垂体-肾上腺轴(HPA轴)相应激素的分泌以及清除自由基等多种途径达到抗抑郁作用。茶氨酸对情绪的舒缓镇静作用还可用于抑郁症的配合治疗和经期综合症的缓解。茶氨酸可通过多种途径实现神经保护功能。茶氨酸可与中枢神经系统中主要神经递质谷氨酸的离子型受体(NMDA、AMPA、KA)结合并产生生物学效应，从而减轻脑缺血时神经元大量释放谷氨酸导致的兴奋性神经毒性，茶氨酸可通过与AMPA受体的结合，促进抑制性神经递质甘氨酸的释放而提高多巴胺的含量，多巴胺对神经组织有一定的保护作用，影响到人的情感活动，其降低与脑功能障碍有关；茶氨酸还可通过对神经递质5-羟色胺(5-HT)含量的调节减轻脑缺血灌注损伤，改变多种酶的活性从而达到保护神经的作用。
长期处于高压力下工作的人群是心脑血管疾病的高发人群，压力会让人们精神过于紧张。同时，人在紧张、愤怒、压抑、焦虑、烦躁等状态下，体内交感神经兴奋，从而升高血压。研究显示，精神紧张者发生高血压的风险是正常人群的1.5倍左右。如果长期处于这样的状态就会使人体神经失调，新陈代谢发生紊乱。此外，持续的睡眠障碍将引发人体慢性疲劳、记忆力减退、免疫力低下、心血管损害及代谢性紊乱等多种相关疾病，而这些情况最终会导致主要器官功能失去平衡，易造成动脉硬化，从而引起冠心病和脑血栓。
我们用能缓解压力、促进睡眠、抗焦虑、抗抑郁的茶氨酸来消除产生高血压的病因，用抗氧化、调节血糖、护肝的罗汉果苷来保护血管，防止血管硬化，用保护神经元、保护内皮细胞、抗纤维化、降脂的三七总皂苷来进一步防止因三高而引起的神经元和内皮细胞损伤。我们针对这样的一些人群，将三种不同机制、不同作用靶点化合物进行组合后，通过在缓解压力、抗炎、抗氧化、保护内皮组织和神经组织等发挥多靶点、协同作用而达到降压、降脂、降糖。其联合运用的预防和治疗效果远超过单用效果，这是所属技术领域人员预料不到的。
本发明涉及这种组合物在制备治疗降低血压、血脂、血糖的药物中的应用。
本发明应用于药物制剂、保健品中，所述辅料包括填充剂、粘合剂、崩解剂、润滑剂中的一种或多种；其中：所述填充剂是指用来填充片剂的重量或体积的物质，从而便于压片。所述的填充剂选自淀粉、糊精、乳糖、微晶纤维素中的一种或两种以上的混合；所述粘合剂是指某些药物粉末本身不具有黏性或黏性较小，需要加入淀粉浆等黏性物质，使其粘合。所述粘合剂选自纯水、乙醇、羟丙基甲基纤维素、淀粉浆、羧甲基纤维素钠中的一种或两种以上的混合；所述的崩解剂是指除了缓(控)释片以及某些特殊作用的片剂以外，一般的片剂中都应加入崩解剂。所述崩解剂选自干淀粉、羧甲基淀粉钠、交联聚维酮中的一种或多种混合；所述润滑剂是指助流剂、抗粘剂和润滑剂的总称。所述的润滑剂选自滑石粉、硬脂酸镁、微粉硅胶中的一种或两种以上的混合。
本发明的制剂包括片剂、颗粒剂、散剂、口服液、胶囊和煎膏剂。
本发明提供的组合物具有以下有益效果：
(1)本发明三七总皂苷、罗汉果苷、茶氨酸三者协同复配可以有效通过三七总皂苷的降脂作用和神经保护作用、罗汉果苷的抗氧化作用而维持血糖健康、茶氨酸的缓解、舒缓紧张情绪而达到抗焦虑、抗抑郁的作用；
(2)本发明三七总皂苷、罗汉果苷、茶氨酸三者协同复配，多靶点协同增效，加快三七总皂苷、罗汉果苷等活性成分的吸收，降压、降糖、降脂等起效迅速，维持时间持久；
(3)本发明三七总皂苷、罗汉果苷、茶氨酸三者协同复配，所用原料安全性高；
(4)本发明涉及到的三七总皂苷、罗汉果苷、茶氨酸，以及含有以上成分的原料三七花、三七茎叶、罗汉果、茶叶等，都属于药食同源物质，其安全性能得到保障，不会产生毒性；
(5)本发明成本低，工艺周期短，污染小，耗能低，易于实现产业化。
(6)本发明克服了三七总皂苷、罗汉果苷、茶氨酸三者在三高有关的治疗上单用时均存在只能部分降低血压、血脂或血糖，或是使用剂量较高，而存在出现不良反应的可能。提供了一种能同时降低三高且治疗作用良好，在较低的治疗剂量上仍保持良好的治疗和预防效果的组合物。
为了进一步说明本发明所述的组合物的作用，申请人进行了大量的实验，并用实验数据证实了其作用。
本发明药效学试验：
先制备6种不同配比的制剂，分别为F-1、F-2、F-3、F-4、F-5、F-6，作为单一配方及两两配比的制剂，再将实施例1、实施例2、实施例3、实施例4、实施例5、实施例6作为给药组，为后续动物试验所需样品。参数设计如下：
(1)混合：分别将三七总皂苷、罗汉果苷、茶氨酸制备成样品，总质量为30g，各组成分加入比例见表1：
表1各组成分加入比例
(2)过筛：将混合均匀后的物料过60目泰勒标准筛获得均匀粉状的物料；
(3)灭菌：将步骤(2)的物料采用紫外线灭菌30min；
(4)包装：将灭菌后的物料进行包装每组可得到30袋粉剂，每袋装量1g。
1.降低血压、血脂、血糖动物药效学试验
1.1组合物对自发性高血压大鼠的影响
1.1.1实验动物
8周龄自发性高血压雄性大鼠
1.1.2主要仪器及试剂
动物血压测量仪(BP-2010A)
1.1.3动物分组、模型制备及给药方法
将自发性高血压大鼠根据体重、血压随机分为10组，每组10只，分别为高血压对照组、给药组、厄贝沙坦阳性对照组，另设WKY大鼠10只作为正常血压组对照。药物每日灌胃1次，每次1.0mL/100g，连续8周，正常组和高血压对照组大鼠灌服蒸馏水。
1.1.4大鼠尾动脉血压测定
在给药的第0、4、8周使用动物血压测量仪检测大鼠尾动脉收缩压(DiastolicBlood Pressure，DBP)、舒张压(Systolic Blood Pressure，SBP)，计算出平均动脉压(MeanArterial Pressure，MAP)。
1.1.5结果
表2对自发性高血压大鼠收缩压的影响
注：与正常对照组相比，*P≤0.05，**P≤0.01；与阴性对照组相比，ΔP≤0.05，ΔΔP≤0.01。
表3对自发性高血压大鼠舒张压的影响
注：与正常对照组相比，*P≤0.05，**P≤0.01；与阴性对照组相比，ΔP≤0.05，ΔΔP≤0.01。
1.1.6结果分析
1.1.6.1从以上结果来看，各组别对自发性高血压大鼠均有一定的抑制作用，具有统计学差异。
1.1.6.2从治疗效果来看，F-1、F-2、F-3、F-4、F-5、F-6对自发性高血压大鼠虽有统计学差异，但其治疗效果非常有限，大鼠的血压仍维持在高位，不利于大鼠后期的血压控制。
1.1.6.3从组合物的实施例1-6能同时降低自发性高血压大鼠的收缩压和舒张压，且随着给药时间的延长其治疗效果更好。
1.2组合物对高脂饲料所致高血脂、高血糖影响实验
1.2.1实验动物
SD大鼠(SPF级，雄性)，体重在180～220g之间，150只
1.2.2主要仪器及试剂
电子天平，赛多利斯-BS224S；低速台式离心机，北京时代北利-DT5-3；全自动生化分析仪，欧莱博BK-200VET。
1.2.3动物分组、模型制备及给药方法
150只SD雄性大鼠(SPF级)，于清洁级屏障系统实验室，适应性喂养5天，5天后根据大鼠体质量分组，随机性分成空白对照组(10只)和模型对照组(140只)，每周定时称量体重。模型对照组给予高脂饲料，喂养4周，不禁食取尾血，测定TC(胆固醇)、TG(甘油三酯)、血糖水平。根据TC、TG、血糖水平，将模型对照组140只大鼠随机分成14组(即高脂模型组、辛伐他汀阳性对照组、F-1、F-2、F-3、F-4、F-5、F-6、实施例1-6给药组)。
1.2.4实验动物给药
随机分组后，高、中、低三个剂量组，每天给予F-1～F-6、实施例1-6(现用现配)灌胃，空白对照组和高脂模型组蒸馏水灌胃，阳性对照组辛伐他汀溶液灌胃，空白对照组饲喂基础饲料，模型对照组、阳性对照组及高、中、低剂量组饲喂高脂饲料，并每周称量一次体重。
1.2.5结果与分析
表4实验样品对高脂饲料大鼠血脂的影响
注：与正常对照组相比，*P≤0.05，**P≤0.01；与阴性对照组相比，ΔP≤0.05，ΔΔP≤0.01。
表5实验样品对高脂饲料大鼠血糖的影响
1.2.6从以上结果来看，F-1、F-4、F-5、F-6对高脂饲料大鼠的血脂有一定的降低，具有统计学差异，对血糖无影响。
1.1.6.2从治疗效果来看，实施例1、2、3、4、5、6对高脂饲料大鼠的血脂和血糖均有一定的降低作用，与阳性药的药效相似。
以上动物实验看出，本发明组合物在药效靶点、治疗作用上得到良好的协同，在较低的剂量使用上可以起到同时降低血压、血脂、血糖的作用，且治疗效果良好、稳定，更为安全。而对于各成分的单用，或部分成分的合用在同等剂量下，只能部分降低血压、血脂、血糖，且对以上指标不能起到同时降低的作用，或虽起到降低部分指标，具有统计学差异，但其指标仍维持在高位，并未降低至理想值范围，对疾病的治疗仍不理想。当然，我们也能看出，部分组分的联用，有一定的治疗趋势。而只有本发明组合物，在给药剂量较低的情况下，对血压、血脂、血糖的降低较为理想，在本组合物的协同作用下，治疗效果良好。
2.人体试食
公开招募并选择符合纳入标准的志愿者72人，所选取的实验对象属于血压、血脂、血糖均偏高中的人群，无影响食用的其他疾病。
2.1纳入标准：年龄20-80岁。
2.1.1对血压、血脂、血糖值均不满意的人群，合格志愿者纳入试验组。
2.1.2自愿进行试验并能够完成调查表和记录。
2.1.3起病时间超过1个月者。
2.1.4排除标准：年龄＜20岁，妊娠或哺乳期妇女；精神病患者；未按规定服用受试样品。
本次试验共征集了72名符合要求的受试者，随机分为12组，每组6人，自身对照。
服用方法：每日餐后一小时服用，150mg实施例1-6样品及样品F-1～F-6，温水冲饮，连续服用一个月。
2.2试验结果及分析：
表6人体试食前和试食后血压指标比较
注：1.与正常对照组相比，*P≤0.05，**P≤0.01；
2.人体各项指标正常值范围：收缩压为120-139mmHg，舒张压为80-89mmHg。
表7人体试食前和试食后血脂指标比较
注：1.与正常对照组相比，*P≤0.05，**P≤0.01；
2.人体各项指标正常值范围：胆固醇：2.9-6.0mmol/L；甘油三酯：0.4-1.81mmol/L。
表8人体试食前和试食后血糖指标比较
注：1.与正常对照组相比，*P≤0.05，**P≤0.01；
2.人体各项指标正常值范围：血糖：3.89-6.10mmol/L。
由以上结果得知：
1.在相同剂量下，本发明所述的实施例1、实施例2、实施例3、实施例4、实施例5、实施例6对于血压、血脂、血糖，均有良好的改善作用，给药后的检测生化指标全部正常。
2.在相同剂量下，本发明所述的实施例1、实施例2、实施例3、实施例4的治疗效果最好，其生化检测值最为理想。
3.在本发明中，以三七总皂苷、罗汉果苷、茶氨酸构成的组合物，相较于单用和部分两两组合而言，在较低的剂量下，其对降压、降脂、降糖的效果均远大于前者，在较低的剂量下将各项生化指标均降至正常值范围，而对于F-1～F-6，因缺少协同作用，在同等剂量范围内只能看到一定的治疗趋势，或部分治疗效果具有统计学差异，但对于治疗效果不理想，这对于所属技术人员而言，是预料不到的。
4.参与人体试食的人员在试食期间，均无不良反应，反而感觉良好，大部分的人员反应除明显的降低三高外，还有缓解焦虑症状、改善睡眠质量等实际效果，证明该组合物有良好的安全性和广泛的人群适应性。
具体实施方式
为了对本发明的技术特征、目的和有益效果有更加清楚的理解，现对本发明的技术方案进行以下详细说明，但不能理解为对本发明的可实施范围的限定。实验分析：
一、总皂苷、茶氨酸的检测
1.总皂苷的检测：
三七总皂苷和罗汉果苷都属于总皂苷，我们将按照《保健食品功效成分检测方法白鸿》中《总皂苷的分光光度测定法》分别对两种皂苷进行检测。
1.1试样制备：
1.1.1固体试样
称取粉碎均匀的固体试样1g于100mL烧杯中，加入20-40mL85％乙醇溶液，超声振荡30min，再定容至50mL，摇匀，放置，吸取上清液1.0ml，挥干后以水溶解残渣，进行柱分离。
1.1.2液体试样
吸取1.0mL液体样品，(如浓度高或颜色深，需稀释一定体积后再取1.0ml)，直接进行柱分离。
1.2标准品的配制：
称取人参皂苷Re，配制成浓度为0.5mg/ml的溶液并稀释到1倍、2倍、3倍、4倍、5倍、6倍。
1.3样品检测：
三七花叶、三七花叶提取物、罗汉果、罗汉果提取物每份分别平行取三个样，按照《保健食品功效成分检测方法白鸿》中《总皂苷的分光光度测定法》分别对两种皂苷进行检测，检测结果计算平均值，做为后面实施例的计算依据，检测结果如下：
表9三七总皂苷、罗汉果苷检验结果
2.茶氨酸的检测
根据《GBT23193-2017茶叶中茶氨酸的测定高效液相色谱法》的检测方法对茶氨酸进行检测。
2.1仪器和试剂。
2.1.1高效液相色谱仪：包含梯度洗脱、紫外检测器及色谱工作站；
2.1.2茶氨酸标准品：纯度：99.6％，上学株式会社出品；
2.1.3HPLC流动相：流动相A：100％纯水，流动相B：100％乙腈；
2.1.4茶氨酸标准储备溶液：
称取0.05g茶氨酸，用水溶解后移入50ml容量瓶中，稀释至刻度，混匀；2.1.5茶氨酸标准使用液：
分别准确吸取茶氨酸标准储备溶液0ml、0.1ml、0.2ml、0.5ml、1.0ml、1.5ml、2.0ml，用水定容至10ml，得到浓度分别为0.0mg/ml、0.01mg/ml、0.02mg/ml、0.05mg/ml、0.1mg/ml、0.15mg/ml、0.20mg/ml的茶氨酸标准使用溶液。
2.2样品处理：
茶叶样品经磨碎混匀后，称取1.0g(准确至0.01g)于200ml烧杯中，加沸蒸馏水100ml。置于100℃的恒温水浴锅中浸提30min，过滤，转移到100ml容量瓶中，冷确后，用水定容至刻度，混匀。用0.45μm滤膜过滤，然后进液相分析。
2.3检测：
茶叶、茶叶提取物每份分别平行取两个样，根据《GBT23193-2017茶叶中茶氨酸的测定高效液相色谱法》的检测方法对茶氨酸进行检测，检测结果如下：2.4结果：
表10茶氨酸的检测结果：
实施例1：片剂的制备
(1)混合：将三七总皂苷、罗汉果苷、茶氨酸各功效成分加入量分别为60g、30g、60g；辅料由微晶纤维素265g、羧甲基淀粉钠60g、PVP-K30 18g、硬脂酸镁17g；
(2)湿法制粒：混合均匀后，喷雾方式加入10ml95％乙醇，进行湿法制粒；
(3)干燥：将湿法制粒后的物料放入烘箱中50℃恒温干燥4h，干燥后采用紫外线灭菌15min，得到整粒；
(4)压片：将干燥后的颗粒进行压片，制成1000片，每片为0.5g。
经检测，每片中含三七总皂苷60mg、罗汉果苷30mg、茶氨酸60mg。
用途：辅助降低血压、血糖、血脂的治疗用药。
用量：一天一次，一次一片。
实施例2：颗粒剂的制备
(1)提取：分别称取三七花叶、罗汉果各1000g，于100℃热水煮提，减压浓缩，得浓缩液；
(2)干燥：将三种浓缩液冷冻干燥，得三七花叶提取物、罗汉果提取物提取物；
(3)混合：称取三七花叶提取物19.70g、罗汉果提取物39.21g、茶氨酸4.8g、羧甲基淀粉钠100g、山梨糖醇74.8g、麦芽糊精86g、微晶纤维素110g、硬脂酸镁45.5g，得到混合物480g；
(4)湿法制粒：混合均匀后，喷雾方式加入10ml纯度75％乙醇，制成软材，使其手握成团，轻捻即散；
(5)过筛：将制好的软材过20目筛；
(6)烘干：将湿颗粒置于60℃烘箱烘干；
(7)灭菌：将步骤(4)的物料采用紫外线灭菌30min；
(8)包装：将灭菌后的物料进行包装可得到240袋颗粒剂，每袋装量2g。
经检测，每袋颗粒剂中含三七总皂苷25mg、罗汉果苷15mg、茶氨酸20mg。
用途：辅助降低血压、血糖、血脂的保健品
用量：一天三次，一次一袋。
实施例3：散剂的制备
(1)提取：分别称取三七花叶7.2g、罗汉果11.83g、绿茶12.11g，混合，于100℃热水共煎煮提，减压浓缩，得浓缩液；
(2)干燥：将三种浓缩液冷冻干燥，得混合提取物13.66g；
(3)混合：将混合提取物中加入麦芽糊精50g、交联聚维酮36g进行混合，得到混合物100g；
(4)灭菌：将步骤(3)的物料采用紫外线灭菌30min；
(5)包装：将灭菌后的物料进行包装可得到50袋颗粒剂，每袋装量2g。
经检测，每袋散剂中含三七总皂苷18mg、罗汉果苷8mg、茶氨酸23mg。
用途：辅助降低血压、血糖、血脂的保健品
用量：一天三次，一次一袋。
实施例4：口服液的制备
(1)提取：分别称取三七花叶、罗汉果各1000g，于100℃热水煮提，减压浓缩，得浓缩液；
(2)干燥：将三种浓缩液冷冻干燥，得三七花叶提取物、罗汉果提取物提取物分别称取三七花叶提取物7.55g、罗汉果提取物13.05g，加入茶氨酸0.9g，加水500ml；
(3)混合：加入食品添加剂山梨糖醇54g、柠檬酸25g，柠檬酸钠15g，山梨酸钾3g，充分混合，得混合液；
(4)过滤：将混合液体经0.45μm微孔滤膜过滤，得混合溶液；
(5)灌装：将灭菌后的溶液灌装成10ml/瓶的口服液，一共50瓶；
(6)灭菌：将混合溶液和包装瓶经过高压蒸汽灭菌，121℃，30分钟,即得。
经检测，每瓶口服液中含三七总皂苷23mg、罗汉果苷12mg、茶氨酸18mg。
用途：辅助降血压、血糖、血脂的保健品
用量：一天三次，一次一瓶。
实施例5：胶囊的制备
(1)提取：分别称取三七花叶、罗汉果各1000g，于100℃热水煮提，减压浓缩，得浓缩液；
(2)干燥：将三种浓缩液冷冻干燥，得三七花叶提取物、罗汉果提取物提取物；
(3)称量：分别称取三七花叶提取物34.79g、罗汉果提取物38.34g、茶氨酸8.88g、微粉硅胶100g、淀粉200g、微晶纤维素118g；
(4)混合：将称量好的样品充分混合20min，得到混合均匀的混合物500g；
(5)填充：用0号胶囊填充板将混合物填充，得710粒胶囊，每粒胶囊含药物0.7g；
(6)灭菌：将步骤(3)的物料采用紫外线灭菌30min，即得。
经检测，每粒胶囊中含三七总皂苷7.5mg、罗汉果苷2.5mg、茶氨酸12.5mg。
用途：辅助降血压、血糖、血脂的保健品
用量：一天三次，一次两粒。
实施例6：煎膏剂的制备
(1)提取：分别称取三七花叶、罗汉果各1000g，于100℃热水煮提，减压浓缩，得浓缩液；
(2)干燥：将三种浓缩液冷冻干燥，得三七花叶提取物、罗汉果提取物提取物；
(3)分别称取三七花叶提取物4.1g、罗汉果提取物8.17g、茶氨酸375mg、蜂蜜，加水800ml，使全部溶解。
(4)过滤：将混合液体经0.45μm微孔滤膜过滤，得混合溶液；
(5)浓缩：将混合溶液浓缩到含水量50％左右，得半流体煎膏剂，共500ml；
(6)分装：将煎膏剂用瓶子分装并密封盖子，每瓶100ml；
(7)灭菌：将煎膏剂和包装瓶经过高压蒸汽灭菌，121℃，30分钟，即得。
经检测，每20ml煎膏剂中含三七总皂苷25mg、罗汉果苷15mg、茶氨酸15mg。
用途：辅助降血压、血糖、血脂的药品
用量：一天三次，一次20ml。
以上所述，仅是本发明的较佳实施例，并非是对本发明作其它形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改变剂型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改变剂型，仍属于本发明技术方案的保护范围。
Claims (3)
1.一种能降低血压血脂血糖的组合物，其特征在于各成分的重量比例为：三七总皂苷：罗汉果苷：茶氨酸＝1.5～2.5:0.5～1.5:1.5～2.5。
2.如权利要求1所述的能降低血压血脂血糖的组合物，其特征在于各成分的重量比例为：三七总皂苷:罗汉果苷:茶氨酸＝1.8～2.3:0.8～1.2:1.8～2.3。
3.如权利要求1或2所述的能降低血压血脂血糖的组合物在制备降低血压、血脂、血糖的药物中的应用。
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| CN101199564A (zh) * | 2006-12-12 | 2008-06-18 | 上海中医药大学附属龙华医院 | 三七花总皂苷在制备治疗高血压病药物中的应用 |
| CN104814186A (zh) * | 2015-05-11 | 2015-08-05 | 广西梧州茂圣茶业有限公司 | 含六堡茶具有美容抗衰老的组合物 |
| CN105532991A (zh) * | 2016-02-01 | 2016-05-04 | 北京三奇本草科技有限公司 | 一种具有养颜美容功能的复合黑茶及其制备方法 |
| WO2021225918A1 (en) * | 2020-05-03 | 2021-11-11 | Seattle Gummy Company | Semi-solid chewable compositions and methods of making and using thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101199564A (zh) * | 2006-12-12 | 2008-06-18 | 上海中医药大学附属龙华医院 | 三七花总皂苷在制备治疗高血压病药物中的应用 |
| CN104814186A (zh) * | 2015-05-11 | 2015-08-05 | 广西梧州茂圣茶业有限公司 | 含六堡茶具有美容抗衰老的组合物 |
| CN105532991A (zh) * | 2016-02-01 | 2016-05-04 | 北京三奇本草科技有限公司 | 一种具有养颜美容功能的复合黑茶及其制备方法 |
| WO2021225918A1 (en) * | 2020-05-03 | 2021-11-11 | Seattle Gummy Company | Semi-solid chewable compositions and methods of making and using thereof |
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