CN105920052B - 一种具有降血脂作用的红曲磷虾油软胶囊组合物 - Google Patents
一种具有降血脂作用的红曲磷虾油软胶囊组合物 Download PDFInfo
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- CN105920052B CN105920052B CN201610303684.1A CN201610303684A CN105920052B CN 105920052 B CN105920052 B CN 105920052B CN 201610303684 A CN201610303684 A CN 201610303684A CN 105920052 B CN105920052 B CN 105920052B
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- antarctic krill
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Abstract
一种具有降血脂作用的红曲磷虾油软胶囊组合物。本发明涉及一种以红曲米提取物及南极磷虾油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、服用剂量小、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及南极磷虾油具有更强的药理活性。体现了化学组合物的协同作用，可用于制备具有降血脂作用的药品、保健食品及食品。
Description
技术领域
本发明涉及一种以红曲米提取物及南极磷虾油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及南极磷虾油组方，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及南极磷虾油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。
南极磷虾油是从南极磷虾(Euphausia superba)中提取而成，含有磷脂、Omega-3脂肪酸、虾青素等多种活性成分。磷虾油是由磷脂与甘油三酯组成的。磷虾油中磷脂的主要类型为磷脂酰胆碱，长链的Omega-3脂肪酸主要与磷脂相连(Kidd PM，AlternativeTherapied in Health and Medicine，2007，12：207-227)。南极磷虾油可以显著提高血液中Omega-3脂肪酸水平、改善大脑健康、抑制肥胖以及抑制癌细胞生长等功能。南极磷虾油中相对低剂量的Omega-3脂肪酸可以显著降低肥胖者血浆中内源性大麻素的水平(FabianaP等，Nutrition&Metabolism，2011，8(51)：1-16)；磷虾油的Omega-3脂肪酸可以下调肝脏中的葡萄糖、脂肪以及胆固醇的合成代谢途径，促进线粒体的呼吸作用(Lena B等，Frontiersin Genetics，2011，2(45)：1-8)；磷虾油可以显著降低肥胖大鼠肝脏脂肪合成所需酶的活性，例如：三羧酸载体、乙酰辅酶A羧化酶、脂肪酸合成酶(Alessandra F，等，Plos One，2012，7(6)：1-14)。
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及南极磷虾油组成。
虽然现有技术中分别公开了红曲米、南极磷虾油都具有降脂作用，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，二者在降脂方面具有互补性，将红曲米提取物及南极磷虾油联合后，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及南极磷虾油具有更加明显的药理活性。因此，本发明的发明人对二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。二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及南极磷虾油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与南极磷虾油组成组合物，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，红曲米提取物与南极磷虾油按一定比例配方组成的组合物较单一红曲米提取物与南极磷虾油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，将可以食用的红曲米及南极磷虾油首次组合成组合物，首次用于保健食品或食品。本发明的磷虾油是由磷脂与甘油三酯组成的，与鱼油等动物油具有明显的不同，体现了本组方的显著特色及技术进步。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。
本发明以红曲米提取物与南极磷虾油组方。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)、显著提高血液中Omega-3脂肪酸水平、降低血浆中内源性大麻素水平、激活脂肪燃烧代谢途径、降低肝脏脂肪合成的关键酶活，从而达到降低血脂的作用。体现了中药化学成分之间协同增效，多靶点、多部位入手，从而到达防治高血症的作用，具有组方的新颖性和创新性。
本发明提供了一种具有降血脂作用的组合物，由红曲米提取物5-100份，南极磷虾油20-300份。组成。优选红曲米提取物50份，南极磷虾油150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分别从红曲米、南极磷虾中提取活性组分的方法及制成的制剂的方法，该方法包括：
(1)将红曲米用6-10倍量50-85％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)将南极磷虾加热灭酶灭菌，干燥，粉碎，用无水乙醇溶液在4～30℃下浸泡磷虾粉，固液比为1：2～1：10，时间为0.5～2小时；浸泡后的悬浊液用乳化机进行剪切提取，对剪切提取后的悬浊液继续进行静置或搅拌提取，分离提取液，再提取并分离提取液2～4次；将提取液在30～60℃、真空度在-0.05～-0.1MPa下蒸发，除去提取液中有机溶剂后得到南极磷虾油；
(3)将红曲米提取物，南极磷虾油按照比例混合均匀后，加入辅料均匀，即得。
本发明另一突出贡献在于，一种由红曲米提取物及南极磷虾油为主要原料的软胶囊的制备方法，本制备方法没有再加入其他植物油，只用了具有降血脂作用的南极磷虾油代替了植物油的作用，既达到具有降血脂的作用，又减少了制剂的辅料，降低了成本，具有明显的实用性。
取处方中红曲米提取物50g过120目筛加入南极磷虾油150g中，加热至60℃，边加热边搅拌至全部溶化后，过胶体磨3次备用。将TiO2用胶体磨粉碎，过120目筛，溶于热水中，备用。将色素溶于1.0kg热水中，备用。1.0kg明胶溶于水充分溶涨后加入甘油0.35kg，混匀后添加TiO2及色素，抽真空脱气后保温、静置、待用。将配好的药液倒入制丸机中制丸定型，置干燥室干燥、捡丸、刨光、包装，制成1000粒，即得。
由于本发明首次公开了由红曲米提取物与南极磷虾油组成的组合物具有降血脂的作用，因此，将本组合物单独或与其它活性组份或辅料配合制成药剂，只要是该药剂具有降血脂，均属于本发明的保护范围。本发明的组合物在制成任何一种剂型时，均具有降血脂的作用。同时，无论是按照本发明提取的南极磷虾油还是市场购买的南极磷虾油与红曲米提取物组合用于制备具有降血脂作用的组合物，均在本发明的保护范围。
由红曲米提取物及南极磷虾油组成的组合物(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；南极磷虾油为实例2提取的样品；本发明组合物是实例3制备的样品(红曲米提取物：南极磷虾油＝1：3)，所用的原料为实例1-2提取方法提取得到；本发明组合物1为实例4制备得到的样品(红曲米提取物：南极磷虾油＝5：1)，本本发明的一个端值；本发明组合物2为实例5制备得到的样品(红曲米提取物：南极磷虾油＝1：60)，为本发明的另一个端值。
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100只，随机分为10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及南极磷虾油均具有较强的活性。并且本发明端值组合物1或2较本发明的组合物活性差。
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及南极磷虾油均较组合物的活性差。并且本发明端值组合物1或2较本发明的组合物活性差。
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85％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50％为轻度脂肪肝，高剂量组肝脂变约为25％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(400mg/kg)肝脂变约为50％，为中度脂肪肝；南极磷虾油组(400mg/kg)肝脂变约为60％，为中度脂肪肝；本发明组合物1(400mg/kg)肝脂变约为45％，为轻度脂肪肝；本发明组合物2(400mg/kg)肝脂变约为50％，为轻度脂肪肝。说明单一红曲米提取 物及南极磷虾油较本发明组合物活性弱。并且本发明端值组合物1或2较本发明的组合物活性弱。
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及南极磷虾油组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南极磷虾油的制备方法
将南极磷虾20kg，加热灭酶灭菌，干燥，粉碎，用无水乙醇溶液在20℃下浸泡磷虾粉，固液比为1：6，时间为2小时；浸泡后的悬浊液用乳化机进行剪切提取，对剪切提取后的悬浊液继续进行静置或搅拌提取，分离提取液，再提取并分离提取液3次；将提取液在40℃、真空度在-0.05～-0.1MPa下蒸发，除去提取液中有机溶剂后得到南极磷虾油。
实施例3组合物的制备方法
称取红曲米提取物20g，南极磷虾油物60g，搅拌混合均匀，即得。
实例4组合物1制备方法
称取红曲米提取物50g，南极磷虾油物10g，搅拌混合均匀，即得。
实例5组合物2制备方法
称取红曲米提取物1g，南极磷虾油物60g，搅拌混合均匀，即得。
实例6软胶囊剂
取处方中红曲米提取物50g过120目筛加入南极磷虾油150g中，加热至60℃，边加热边搅拌至全部溶化后，过胶体磨3次备用。将TiO2用胶体磨粉碎，过120目筛，溶于热水中，备用。将色素溶于1.0kg热水中，备用。1.0kg明胶溶于水充分溶涨后加入甘油0.35kg，混匀后添加TiO2及色素，抽真空脱气后保温、静置、待用。将配好的药液倒入制丸机中制丸定型，置干燥室干燥、捡丸、刨光、包装，制成1000粒，即得。每次2粒、每日2次。
Claims (2)
1.一种具有降血脂作用的组合物，其特征在于：活性成分由红曲米提取物及南极磷虾油组成；所述组合物，由下述重量份的原料制成：红曲米提取物50份，南极磷虾油150份；
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50-85％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)将南极磷虾加热灭酶灭菌，干燥，粉碎，用无水乙醇溶液在4～30℃下浸泡磷虾粉，固液比为1：2～1：10，时间为0.5～2小时；浸泡后的悬浊液用乳化机进行剪切提取，对剪切提取后的悬浊液继续进行静置或搅拌提取，分离提取液，再提取并分离提取液2～4次；将提取液在30～60℃、真空度在-0.05～-0.1MPa下蒸发，除去提取液中有机溶剂后得到南极磷虾油；
(3)将红曲米提取物，南极磷虾油按照比例混合均匀后，加入辅料均匀，即得。
2.一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的组合物与药用辅料制成，该口服制剂为选自软胶囊、丸剂、口服液中的任意一种。
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