CN105878801A - 一种具有降血脂作用的红曲虾青素组合物 - Google Patents
一种具有降血脂作用的红曲虾青素组合物 Download PDFInfo
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- CN105878801A CN105878801A CN201610303661.0A CN201610303661A CN105878801A CN 105878801 A CN105878801 A CN 105878801A CN 201610303661 A CN201610303661 A CN 201610303661A CN 105878801 A CN105878801 A CN 105878801A
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Abstract
本发明涉及一种以红曲米提取物、虾青素、植物甾醇为主要成分的组合物，该组合物具有调节血脂作用。本发明组合物具有成分明确、以三种不同的药效物质复配，利用不同的作用原理和靶点发挥调血脂作用，具有服用剂量小、药食同源的特点，是一种安全有效的降血脂的组合物，并且本发明组合物较单一红曲米提取物、虾青素及植物甾醇具有更强的降血脂活性。体现了复方组合物的协同作用，可用于制备具有降血脂作用的药品、保健食品。
Description
技术领域
本发明涉及一种以红曲米提取物、虾青素及植物甾醇为主要成分的组合物。该组合物具有降血脂作用，可用于预防和治疗由高血脂症引起的心脑血管疾病。本发明也涉及该药物的药物制剂，属于医药技术领域。
背景技术
脂肪代谢或运转异常使血浆一种或多种脂质高于正常称为高血脂症。高血脂症是一种全身性疾病，是指血中胆固醇(TC)和/或甘油三酯(TG)过高或高密度脂蛋白胆固醇(HDL-C)过低。高血脂症的主要危害是导致动脉粥样硬化，进而导致众多的相关疾病，该病对身体的损害是隐匿、逐渐、进行性和全身性的。它的直接损害是加速全身动脉粥样硬化，因为全身的重要器官都要依靠动脉供血、供氧，一旦动脉被粥样斑块堵塞，就会导致严重后果。动脉硬化引起的肾功能衰竭等，都与高血脂症密切相关。大量研究资料表明，高血脂症是脑卒中、冠心病、心肌梗死、心脏猝死独立而重要的危险因素。这些心脑血管性疾病的发病率高，危害大，病情进展凶险，其死亡率约占人类总死亡率的半数左右。目前调整血脂的药物很多，主要分为以下三类：(1)他汀类，以降低胆固醇为主，如舒降之、普拉固等；(2)贝特类：以降低甘油三酯为主，如诺衡、力平脂等；(3)天然药物类，对降低胆固醇和甘油三酯均有 效，且可以升高高密度脂蛋白，具有综合调节血脂的功效，且副作用小，如龙泰牌降脂宁等。因为血脂增高是一个缓慢的过程，血脂的调节特别是消除血脂的不良影响也同样需要一个持续作用的过程，因此患者应根据自身的不同情况，选择降脂作用明显的药物。因此，一个安全有效、毒副作用小的降脂药物，正是高血脂患者所需要的。我们发明的本专利正是符合本条件的天然药物在治疗高血脂方面的应用。
本发明具有利用中药“多靶点、多效应”的特点，科学合理的将红曲米提取物、虾青素及植物甾醇组方，可用于预防和治疗高血脂症，本发明完成前未发现有关以红曲米提取物、虾青素及植物甾醇组成的组合物作为防治高血脂疾病药物的报道，也未发现两者组方用于防治高血脂疾病的临床方面应用。
红曲米是以籼稻、粳稻、糯米等稻米为原料，用红曲霉菌发酵而成，为棕红色或紫红色米粒。红曲米提取物是利用红曲米经过乙醇提取得到的提取物。红曲米中主要作用成分是洛伐他丁及红曲色素。红曲色素是多种色素的混合物，主要有红色系和黄色系2大类，这些色素都是聚酮类化合物。应用价值主要集中在6种醇溶性的色素：红色的红斑红曲胺(Rubropunctamine)、红曲玉红胺(Monascrubramine)，橙色的红斑红曲素(Rubropunctatin)、红曲玉红素(Mon-ascorubrin)，黄色的安卡红曲黄素(Ankaflabin)、红曲素(Monascin)(Xijun Lian等，Dyes and Pigments，2007，(73)：121-125)。红曲米具有降低总胆固醇(TC)，降低低密度脂蛋白胆固醇(LDL-C)，降低甘油三酯(TG)，同时提 高高密度脂蛋白(HDL-C)，起到降血压、降血脂的作用。而且还有健脾消食、活血化瘀的功效。
虾青素是从红球藻属雨生红球藻(Haematococcus pluvialis)中提取分离得到。虾青素有较强的抗氧化活性，具有清除自由基、保护血管、降低胆固醇、护肤、保护视力、保护神经系统、预防老年痴呆、缓解关节疼痛等多方面的营养保健作用(Trends Biotechnol，2003，21(5)：210)。研究表明虾青素可以明显降低血液中LDL的水平以及升高HDL水平(ArchLatinoam Nutr，1992，42(4)：409-413)；罗仁勇研究表明，对高脂饮食动物同时给与天然虾青素30d后，TC、TG水平明显降低，而对照组TC及TG水平持续升高，而HDL-C水平虽然有降低趋势，但无统计学意义，说明天然虾青素确有降低TC与TG的作用(现代预防医学，2009年，第36卷第4期)；李红艳研究表明，虾青素具有良好的降脂功效，并对高脂诱发的主动脉及肝脏脂质过氧化损伤有明显抑制作用，高剂量(10mg/kg)虾青素改善效果更理想(河北医药，2012年，第34卷，第1期)；裴凌鹏研究表明，虾青素对高脂饲料喂养下大鼠诱发高脂血症过程中血脂代谢具有干预作用。虾青素组的TC、TG、LDL-C显著降低，而HDL-C升高，说明，虾青素可以对高脂饲料喂养大鼠诱发高脂血症过程中的血脂代谢产生影响，改善血脂变化(中国老年学杂志，2012年9月第32卷)；黄河儒研究表明，雨生红球藻提取物可显著降低造模糖尿病小鼠的血糖水平，缓解多饮、多食、多尿及体重减轻症状，显著改善病鼠机体的糖耐量及胰岛素耐量，提升其对葡萄糖的利用能力，有效调节病鼠 的血脂紊乱，改善血液环境，且对正常小鼠的血糖和血脂无显著影响(浙江大学学报农业与生命科学版，2015年，第41卷，642)。
植物甾醇(phytosterol or plant sterol)是植物中的一种活性成分，在结构上与动物性甾醇如胆甾醇相似。广泛存在于各种植物油、坚果和植物种子中，也存在于其它植物性食物如蔬菜水果中。具有降低血液胆甾醇含量、抑制肿瘤、防治前列腺肥大、抑制乳腺增生和调节免疫等方面都有重要作用。研究证明，植物甾醇能明显降低血液中总胆固醇(TC)和低密度脂蛋白(LDL)含量，而不降低高密度脂蛋白(HDL)和甘油三酯含量，使LDL与HDL比值降低，并且没有任何明显的副作用(Am J Med，1999，107(6)：588-594)。Blair等在实验中还证明了植物甾醇对高脂血症有辅助治疗效果(Am J Cardiol，2000，8(6)：46-52)；Becker等的研究也证明了严重家族性高脂血症的儿童服用谷甾醇可明显降低血脂水平，对降低其成年后心脑血管病有积极意义(J Pediatr，1993，122(2)：292-296)；Sierksma等对76名健康成人(平均年龄44岁)进行的双盲对照研究中发现，与对照组相比，服用大豆甾醇0.8g/d 3周后可显著降低血中TC和LDL，但不会引起血中其它脂溶性维生素如胡萝卜素水平的下降，因此现在科学家们普遍认为摄入或补充足量的植物甾醇有助于降低人群冠心病的发病率(Tidsskr Nor Laegeforen，2000，120(22)：2661-2665)。
上面列举的现有技术并未满足人类不断完善降脂的需求，特别是多靶点的要求以及进一步降脂的要求。
本发明的目的是提供一种从“多靶点、多效应”入手、具有降血 脂作用的组合物，活性成分由红曲米提取物、虾青素及植物甾醇组成。
虽然现有技术中分别公开了红曲米、虾青素及植物甾醇都具有降脂作用，但是，没有将其联合用于降脂的报道。本发明的发明人按照不同比例配方，经过大量筛选试验发现，三者原料复配后在降脂方面具有互补性，将红曲米提取物、虾青素及植物甾醇联合后，意想不到地获得了更好的效果。
本发明组合物较单一红曲米提取物、虾青素及植物甾醇具有更加明显的药理活性。因此，本发明的发明人对三者进行科学合理组方，得到了具有预防和治疗高血脂症组合物。三者从不同的角度入手达到降血脂的作用。本发明完成前，还未有由红曲米提取物、虾青素及植物甾醇组成的组合物具有防治高血脂症的报道。
发明内容
发明目的是提供一种由红曲米提取物、虾青素及植物甾醇组成组合物，用于预防和治疗高血脂症的作用。更进一步地，本发明的发明人通过进一步的研究发现，红曲米提取物、虾青素及植物甾醇按一定比例配方组成的组合物较单一红曲米提取物、虾青素及植物甾醇在调节血脂方面有更显著的作用。这种天然的药物组合物是本发明人首次通过实验筛选得到，也体现了复方中药的协同作用，具有突出的贡献及显著的技术进步。
本发明另一个突出贡献在于，将人们可以食用的红曲米中提取的提取物、雨生红球藻中提取的虾青素及植物甾醇组合，首次用于药品、保健食品或食品。
同时，本品制备工艺简单，体现了价格低廉的优点。并且本品疗效确切，无毒副作用，服用方便，剂型科学，体现了本发明的实用性。
本发明将含类胡萝卜素的含氧衍生物虾青素、含天然他汀类的红曲米提取物及含有类似胆固醇的植物甾醇组方，从不同的作用靶点入手、相互协同作用达到降血脂的作用。通过降低总胆固醇(TC)，降低低密度脂蛋白胆固醇(LDL-C)、降低甘油三酯(TG)、同时提高高密度脂蛋白(HDL-C)；通过体内竞争性地抑制胆固醇合成过程中的限速酶羟甲戊二酰辅酶A还原酶、使胆固醇的合成减少、也使低密度脂蛋白受体合成增加；通过具有能够抑制人体对胆固醇的吸收、促进胆固醇的降解代谢、抑制胆固醇的生化合成等作用；通过抢占坏胆固醇在肠道中的位置，并促使其排出体外，从而降低血液中总胆固醇和坏胆固醇的含量，同时并不影响好胆固醇的含量。从而达到降血脂的作用。
本发明提供了一种具有降血脂作用的组合物，由虾青素1-20份，植物甾醇10-450份，红曲米提取物20-500份组成。优选虾青素10份，植物甾醇350份，红曲米提取物350份。其按照比例混合组成活性成份与药用辅料制成的。
本发明的另一目的是提供了具有降血脂作用组合物的制备方法，包括如下步骤：
(1)将红曲米用6-10倍量50-85％食用乙醇提取2-3次，每次提取2-3小时，提取温度为50～80℃，提取液过滤，滤液回收乙醇，浓缩，干燥得到红曲米提取物；
(2)将雨生红球藻置闪式提取器中用60-95％食用乙醇提取2-3次，每次提取2-3小时，提取温度为50-80℃，过滤，回收乙醇，干燥得得红球藻虾青素；
(3)将红曲米提取物、虾青素及植物甾醇按照比例混合均匀后加入辅料均匀，制成口服制剂。
由红曲米提取物、虾青素及植物甾醇组成的组合物(简称组合物)具有防治高血脂症作用，通过以下药效学实验得到证实。
实验原料：本药效学中用到的组合物及单一提取物均为发明人提供。本药效学试验中提到的红曲米提取物为实例1提取的样品；虾青素为实例2提取的样品；植物甾醇购自大豆中提取的植物甾醇。本发明组合物是实例3制备的样品(红曲米提取物：植物甾醇：虾青素＝35：35：1)，所用的原料为实例1-2提取方法提取得到。
本药效学试验中用到的血脂康胶囊为北京北大维信生物科技有限公司生产，批号为：20150801。
1、本品组合物对大鼠TC、TG、HDL-C、LDL-C的影响
取雄性大鼠90只，随机分为9组，除空白对照组外，其余各组每天给予高脂饲料：2％胆固醇，10％猪油，0.5％胆酸钠，0.2％丙基硫氧嘧啶，87％基础饲料。除空白对照组自由饮水外，高脂模型组给予等量生理盐水，其余各组灌胃给药，每日1次，按照表1分组，给药，连续给药15d。用药后禁食12h，测定血清总胆固醇(TC)、甘油三脂(TG)、高密度脂蛋白胆固醇(HDL-C)、血清低密度脂蛋白胆固醇(LDL-C)含量，结果见表1。
表1、本品组合物对高脂血症大鼠血脂指标的影响结果
与模型对照组比较，*P<0.05；**P<0.01；
与正常组比较，△P<0.05；△△P<0.01；
结果表明，模型对照组血清TC、TG、LDL-C值明显升高，HDL-C明显下降。与模型对照组比较，本品组合物能明显降低血清总胆固醇(TC)、甘油三酯(TG)含量，显著降低血清低密度脂蛋白胆固醇(LDL-C)含量，显著升高血清高密度脂蛋白胆固醇(HDL-C)含量。同时，从实验数据表明，说明本发明组合物较单一红曲米提取物、虾青素及植物甾醇均具有较强的活性。
2、肝组织MDA及SOD测定
末次取血后将动物断头处死，取大鼠肝左叶0.1g制备10％组织匀浆，3000rpm离心15min，再取上清1500rpm离心10min，利用总蛋白试剂盒测定蛋白浓度(考马斯亮蓝法)，按试剂盒说明测定MDA含量及SOD活性。
表2、本品组合物对大鼠肝组织内MDA及SOD的影响
与模型对照组比较，*P<0.05；**P<0.01；
与正常组比较，△P<0.05；△△P<0.01；
结果显示，本品组合物高、中、低剂量组均有清除体内脂质过氧化产物MDA的能力，并随剂量的增加，效果加强。对SOD活力也有提高的能力。但是，无论是红曲米提取物、虾青素及植物甾醇均较组合物的活性差。
3、本品组合物对肝脂变的影响
取肝左叶，浸入20％中性甲醛溶液中固定，常规HE染色，光镜下观察。结果显示，空白组织无肝脂变，高脂模型肝脂变达90％以上为重度脂肪肝；本品组合物低剂量组肝脂变约为60％为中度脂肪肝，中剂量组肝脂变约为40％为轻度脂肪肝，高剂量组肝脂变约为20％为轻度脂肪肝。说明本发明组合物有抑制脂肪肝发展并逆转脂肪肝的作用。红曲米提取物组(500mg/kg)肝脂变约为55％，为中度脂肪肝；虾青素组(500mg/kg)肝脂变约为60％，为中度脂肪肝；本发明植物甾醇组(500mg/kg)肝脂变约为55％，为轻度脂肪肝。说明单一红曲米提取物、虾青素及植物甾醇较本发明组合物活性弱。
从以上的药效学实验可知，本品组合物具有较强降血脂的作用。药理试验数据说明，本发明组合物高、中、低剂量组与对照组相比均具有显著性差异，本发明组合物较红曲米提取物、虾青素及植物甾醇均表现出更强的药理活性，体现了本发明的创新性及显著的技术进 步。
本发明是通过下面的实施例进行详细的说明，但不意味着本发明仅限于此，具体实施方案如下：
实施例1红曲米提取物的制备方法
将红曲米10kg，用8倍量60％乙醇提取2次，每次提取2小时，提取温度为60℃，提取液过滤，滤液回收乙醇，浓缩，干燥得到红曲米提取物。
实施例2虾青素的制备方法
将雨生红球藻10kg置闪式提取器中用80％食用乙醇提取3次，每次提取2小时，提取温度为75℃，过滤，回收乙醇，干燥得得红球藻虾青素。
实施例3组合物的制备方法
称取红曲米提取物35g，植物甾醇35g，虾青素1g，搅拌混合均匀，即得。
实例4胶囊剂的制备方法
称取红曲米提取物105g，植物甾醇105g，虾青素3g，搅拌混合均匀，加入适量淀粉，混合均匀，制粒，干燥，整粒，装胶囊，制成1000粒。每日3次，每次2粒。
实例5片剂的制备方法
称取红曲米提取物105g，植物甾醇105g，虾青素3g，搅拌混合均匀，加入适量淀粉，混合均匀，制粒，干燥，整粒，压片，制成1000片。每日3次，每次2片。
Claims (5)
1.一种具有降血脂作用的组合物，其特征在于：活性成分由虾青素，植物甾醇，红曲米提取物组成。
2.根据权利要求1所述的一种具有降血脂作用的组合物，其特征在于，它是由下述重量份的原料制成：虾青素1-20份，植物甾醇10-450份，红曲米提取物20-500份。
3.根据权利要求2所述的一种具有降血脂作用的组合物，其特征在于，它是由下述重量份的原料制成：虾青素10份，植物甾醇350份，红曲米提取物350份。
4.根据权利要求1-3任意之一所述的具有降血脂作用组合物的制备方法，包括如下步骤：
(1)将红曲米用6-10倍量50-90％食用乙醇提取2-3次，每次提取2-3小时，提取温度为50～80℃，提取液过滤，滤液回收乙醇，浓缩，干燥得到红曲米提取物；
(2)将雨生红球藻置闪式提取器中用60-95％食用乙醇提取2-3次，每次提取2-3小时，提取温度为50-80℃，过滤，回收乙醇，干燥得得红球藻虾青素；
(3)将红曲米提取物、虾青素及植物甾醇按照比例混合均匀后加入辅料均匀，制成口服制剂。
5.一种具有降血脂作用的组合物口服制剂，其特征在于该制剂是由权利要求1-4任意之一所述的组合物与药用辅料制成，该口服制剂为选自胶囊、片剂，丸剂、颗粒剂中的任意一种。
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| CN106723023A (zh) * | 2016-11-29 | 2017-05-31 | 内蒙古医科大学 | 一种降脂保健食品及其制备方法 |
| CN108065392A (zh) * | 2017-12-05 | 2018-05-25 | 杭州鑫伟低碳技术研发有限公司 | 一种辅助治疗高血压、高血脂症状的组合物 |
| CN116327814A (zh) * | 2022-09-08 | 2023-06-27 | 健合香港有限公司 | 一种降血脂、降胆固醇的组合物及其制备方法和用途 |
| CN119279044A (zh) * | 2024-11-07 | 2025-01-10 | 广东兆禧健康产业投资有限公司 | 一种含有沉香叶普洱茶提取物的饮品及其制备方法 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106723023A (zh) * | 2016-11-29 | 2017-05-31 | 内蒙古医科大学 | 一种降脂保健食品及其制备方法 |
| CN108065392A (zh) * | 2017-12-05 | 2018-05-25 | 杭州鑫伟低碳技术研发有限公司 | 一种辅助治疗高血压、高血脂症状的组合物 |
| CN116327814A (zh) * | 2022-09-08 | 2023-06-27 | 健合香港有限公司 | 一种降血脂、降胆固醇的组合物及其制备方法和用途 |
| WO2024050864A1 (zh) * | 2022-09-08 | 2024-03-14 | 健合香港有限公司 | 一种降血脂、降胆固醇的组合物及其制备方法和用途 |
| CN116327814B (zh) * | 2022-09-08 | 2025-06-17 | 健合香港有限公司 | 一种降血脂、降胆固醇的组合物及其制备方法和用途 |
| CN119279044A (zh) * | 2024-11-07 | 2025-01-10 | 广东兆禧健康产业投资有限公司 | 一种含有沉香叶普洱茶提取物的饮品及其制备方法 |
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