CN112022913A - 一种降血脂颗粒剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种降血脂颗粒剂，是采用罗布麻叶1～12重量份、连翘叶1～9重量份、重瓣红玫瑰1～6重量份为原料，加水煎煮后收集滤液，浓缩并加入辅料，干燥制粒得到。本发明通过“两叶一花”配伍，提供了一种具有浓郁茶香气但不含茶多酚的降血脂颗粒剂，既有较好的降血脂功效，又能理气活血，补养安神，特别是在晚间服用，可以降低夜间心血管疾病的发病风险。
Description
技术领域
本发明属于保健食品技术领域，涉及一种具有降血脂功效的中药组合物类功能食品。
背景技术
高血脂症(HLP)属于一种全身性疾病，是指血液中的总胆固醇(TC)和/或甘油三酯(TG)过高或者高密度脂蛋白胆固醇(HDL-C)过低，现代医学也称为血脂异常。祖国传统医学将HLP归结于痰浊、血瘀的辨证论治范畴。
近年来研究表明，HLP是动脉粥样硬化(AS)、脂肪肝(FL)及冠心病(CHD)等相关疾病的重要致病因素，也是继癌症、结核病后危害人类健康的第三大杀手。与此同时，与HLP相关的肥胖病、糖尿病、高血压和脂肪肝(FL)等代谢类相关疾病的发病率正呈现出惊人的上升速度。
此外，夜间血压下降缓慢、勺形消失、血压节律紊乱。因此，心血管疾病多发病于晚间至凌晨，是发生和加剧急性缺血性脑卒中的重要原因。
中草药是中国的“国粹”，具有悠久的历史。中药类降血脂保健食品健康天然、效果显著、无副作用，有着其它类产品难以比拟的优势和特点。因此，中药类降血脂保健食品在未来市场上必然具有广阔的发展前景。
目前市场上的中药类降血脂保健品以保健茶居多。茶叶中含有的茶多酚虽然有降低血压血脂、防治动脉硬化和血栓等心血管病的功能，但因其中也含有大量包括咖啡碱、可可碱和条碱在内的生物碱，会兴奋大脑神经、促进心脏机能，过量时使人心慌、头晕、四肢乏力，严重的则会导致胃酸分泌过多，引发胃溃疡甚至胃穿孔。
另外，现有的辅助降血脂中药保健食品大多具有组方大的特点，服用剂量较大。
发明内容
本发明的目的是提供一种以具有药用作用的植物叶与花组合而成的、具有浓郁茶香气但不含茶多酚的降血脂颗粒剂。
本发明所述的降血脂颗粒剂是以下述重量份数的组分为原料制备得到：罗布麻叶1～12份、连翘叶1～9份、重瓣红玫瑰1～6份。
进一步地，本发明所述降血脂颗粒剂优选的原料重量份数为：罗布麻叶3～6份、连翘叶3～9份、重瓣红玫瑰1～3份。
更进一步地，本发明所述降血脂颗粒剂最优选的原料重量份数为：罗布麻叶6份、连翘叶6份、重瓣红玫瑰3份。
本发明所述的降血脂颗粒剂是一种以两叶一花为原料制备的降血脂中药组合物，除具有安神助眠的作用外，还可以降低血糖血脂，特别是在晚间服用，可以降低夜间心血管疾病的发病率。
本发明降血脂颗粒剂的原料组分中，连翘叶(Forsythia suspensa leaves)是采自木犀科连翘属植物连翘(Forsythia suspensa (Thunb.) Vahl folium)的新鲜或干燥叶片。中药材中的连翘一般是指其果实。连翘叶不同于连翘果实，是一种新的食品原料。连翘叶味苦、性寒，归肺、心经，具有抗氧化性，保肝，保护心脏，降脂，降糖，抗疲劳，抑菌及抗肿瘤等多重功效。降血脂是连翘叶区别于连翘果实的主要药效，前期研究发现，连翘叶提取物中连翘苷含量是连翘果实提取物的10倍左右，连翘酯苷A的含量约为连翘果实的20倍左右，而苷类成分恰恰是连翘降血脂作用的主要药效成分（杨建雄,刘静,李发荣,等. 连翘叶茶抗氧化抗衰老作用的实验研究[J]. 营养学报, 2004, 26(1): 65.；杨建雄,刘静. 连翘叶茶保肝作用的实验研究[J]. 陕西师范大学学报:自然科学版, 2005, 33(3): 82.；侯改霞,杨建雄. 连翘叶茶提取物对力竭运动及恢复期小鼠心肌抗氧化酶和LDH同工酶活性的影响[J]. 中国运动医学杂志, 2006, 25(1): 90.；侯改霞,杨建雄. 连翘叶提取物对实验小鼠的降脂保肝作用研究[J]. 河南大学学报:自然科学版, 2010, 40(5): 504.；刘静,杨建雄. 连翘叶对糖尿病小鼠的降血糖作用研究[J]. 农业科学与技术:英文版, 2013, 14(1): 98.；黄亚亚. 连翘叶黄酮的抗疲劳作用研究[D]. 西安: 陕西师范大学, 2006.；马文兵,李红鹏. 连翘叶体外抑菌作用的实验研究[J]. 时珍国医国药, 2013, 24(2):379.；雷秋香. 连翘叶乙醇提取物对人食管癌细胞增殖抑制作用及其机制研究[D]. 石家庄: 河北医科大学, 2011.；赵咏梅,李发荣,杨建雄,等. 连翘苷降血脂及抗氧化作用的实验研究[J]. 天然产物研究与开发, 2005, 17(2): 157-159.）。
罗布麻叶为夹竹桃科植物罗布麻Apocynum venetum L.的干燥叶，味甘、苦，性凉，归肝经，属于可用于保健食品的范畴，是一种食药两用植物。黄酮类是罗布麻叶降血脂的的主要药效成分，包括金丝桃苷、异槲皮苷、芦丁、槲皮素、异嗪皮啶等，具有较强的降血压、降血脂、抗糖尿病血管病变、抗抑郁、抗氧化和保肝等作用。其中金丝桃苷和异嗪皮啶具有镇静作用，因此在《国家非处方药目录》中成药内科用药名单中，罗布麻茶被列为补养安神剂（侯晋军,韩利文,杨官娥,等. 罗布麻叶化学成分和药理活性研究进展[J]. 中草药,2006, 37(10): 附7-附9.；Kwan C Y, Zhang W B, Nishibe S, et al．A novel in vitroendothelium dependent vascular relaxant effect of Apocynum venetum Leafextract[J]. Clinical and Experimental Pharmacology and Physiology, 2005, 32(9): 789-795.；Kim DW, Yokozawa T, Hattori M, et al. Effects of AqueousExtracts of Apocynum venetum Leaves on Hypercholes terolaemic Rats[J].Phytotherapy Research, 1998, 12(1): 46-48.；虞颖映,邵建忠,王海明. 罗布麻茶对心血管系统的生物学效应研究[J]. 同济大学学报, 2006, 27(4): 40-42.；Yokozawa T,Nakagawa T. Inhibitory effects of Luobuma tea and its components againstglucose-mediated protein damage[J]. Food Chem Toxicol, 2004, 42(6): 975-981.；Butterweck V, Jurgenliemk G, Nahrstedt A, et al. Flavonoids from Hypericumshow antidepressant activity in the forced swimming test[J]. PlantaMedica,2000, 66(1): 3.；周本宏,刘刚,胡先明. 罗布麻对红细胞膜脂质过氧化损伤的保护作用[J]. 广东药学院学报, 2004, 20(5): 506-508.；Fan W, Tezuka Y, Xiong Q, et al.New phenylpro-panoid-substituted flavan-3-ols isolated from leaves ofApocynum venetum(Luobuma-Ye)[J]. Chemical and Pharmaceutical Bulletin, 1999,47(7): 1049-1050.；陈妙华,刘凤山. 罗布麻叶镇静化学成分的研究[J]. 中国中药杂志,1991, 16(10): 609.）。
重瓣红玫瑰性温、味甘、微苦，归肝脾二经，香气浓郁，是兼食药用于一体的蔷薇科植物，以其花蕾入药已有数百年历史。《本草正义》记载玫瑰花入药“清而不浊，和而不猛，柔肝醒胃，理气活血，宣统窒滞，而绝无辛温刚燥之弊，断推气分药之中， 最有捷效而最为驯良者，芳香诸品，殆无其匹”；《本草拾遗》记载了其“活血行血，理气，治风痹、乳痛，肿肝毒初起、肝胃气痛”的功效，是治疗妇科病、心脑血管病、跌打损伤、精神疾病的良药。
本发明降血脂颗粒剂以上述三种食药兼用原料制备，其中罗布麻叶、连翘叶配伍，既可以协同增强降脂保肝、保护心脏的作用，又可以降糖、降压，降低心血管疾病风险；重瓣红玫瑰的加入，既调和了二者的药性，又与罗布麻叶共奏理气、活血、安神功效；三者联用，为广大心血管疾病患者提供了一种具有多重保健作用的良方，久服延年益寿。
进而，本发明还提供了一种适合的所述降血脂颗粒剂的制备方法。
1）、采摘新鲜的连翘叶，阴干；夏季采收新鲜的罗布麻叶，除去杂质，低温干燥；日出前采摘重瓣红玫瑰花冠，低温烘烤。
2）、以所述重量份数的连翘叶、罗布麻叶与重瓣玫瑰花作为原料药，加水回流煎煮2次，每次加水量为原料药重量的10～15倍，煎煮时间20～30min，合并滤液，减压浓缩至相对密度1.0～1.3，加入辅料，干燥得到干燥粉末。
3）、在干燥粉末中加入润湿剂制成软材，制粒，二次干燥，制成降血脂颗粒剂。
其中，所述的辅料包括但不限于是淀粉、糊精、乳糖或麦芽糊精中的一种或几种。
其中，所述辅料的加入量优选为原料药重量的5～10%。
其中，所述干燥的方式为喷雾干燥或鼓风干燥。
其中，所述的润湿剂优选使用体积浓度85～90%的乙醇，润湿剂的用量为原料药重量的20～30%。
本发明降血脂颗粒剂采用连翘叶为主要原料，突破了连翘叶清热解毒的常用功效，通过与罗布麻叶和重瓣红玫瑰的“两叶一花”配伍，开发出了其较好的降血脂功效，同时又能够理气活血，补养安神，降低心血管疾病风险。同时，组方中还以重瓣红玫瑰调和了罗布麻叶与连翘叶偏凉的药性。
本发明制备的降血脂颗粒剂通过重瓣红玫瑰对罗布麻叶和连翘叶药性的调和，同时也使得颗粒剂的口感及服用依从性有了很大的改观，具有浓郁的茶香味，苦中回甘，回味醇厚，可以作为茶饮。又因其不含茶多酚，可以在晚间服用，有安神助眠的功效。
本发明降血脂颗粒剂组方精良，服用量小，饮用方便，适合于高血脂人群长期饮用。
具体实施方式
下面结合实施例对本发明的具体实施方式作进一步描述。以下实施例仅用于更加清楚地说明本发明的技术方案，从而使本领域技术人员能很好地理解和利用本发明，而不是限制本发明的保护范围。本发明以下实施例并没有详尽叙述所有的细节，也不限制本发明仅为以下所述实施例。本领域普通技术人员在不脱离本发明原理和宗旨的情况下，针对这些实施例进行的各种变化、修改、替换和变型，均应包含在本发明的保护范围之内。
实施例1。
采摘新鲜的连翘叶，阴干。
称取罗布麻叶6kg，连翘叶6kg，重瓣红玫瑰3kg，混合加入225kg水中，回流煎煮30min，300目滤布过滤，滤渣中再加入150kg水，回流煎煮30min，300目滤布过滤。
合并2次滤液，70℃减压浓缩至相对密度1.3，加入1.5kg麦芽糊精，喷雾干燥并过5号筛，加入3.75kg的85%乙醇，快速润湿分散制成软材，以16目筛制粒，60℃干燥，16目筛整粒，制成颗粒剂，以6g/袋包装。
实施例2。
采摘新鲜的连翘叶，阴干。
称取罗布麻叶6kg，连翘叶9kg，重瓣红玫瑰3kg，混合加入270kg水中，回流煎煮30min，300目滤布过滤，滤渣中再加入180kg水，回流煎煮30min，300目滤布过滤。
合并2次滤液，70℃减压浓缩至相对密度1.1，加入0.9kg麦芽糊精，喷雾干燥并过5号筛，再加入3.6kg的90%乙醇，快速润湿分散制成软材，以16目筛制粒，60℃干燥，16目筛整粒，制成颗粒剂，以5g/袋包装。
实施例3。
采摘新鲜的连翘叶，阴干。
称取罗布麻叶3kg，连翘叶6kg，重瓣红玫瑰3kg，混合加入180kg水中，回流煎煮30min，300目滤布过滤，滤渣中再加入120kg水，回流煎煮30min，300目滤布过滤。
合并2次滤液，70℃减压浓缩至相对密度1.2，加入0.6kg麦芽糊精，喷雾干燥并过5号筛，加入3.6kg的90%乙醇，快速润湿分散制成软材，以16目筛制粒，60℃干燥，16目筛整粒，制成颗粒剂，以4g/袋包装。
应用例1：连翘果实与连翘叶中连翘苷、连翘酯苷A含量比较。
分别选择三种不同产地的连翘果实和连翘叶，以10倍量水提取2次，每次1h，滤液合并浓缩后冷冻干燥。
参照2015版《中国药典》一部“连翘”中“含量测定”项中方法，测定连翘苷和连翘酯苷A含量。测定结果见表1。
根据《中国药典》一部及山西省中药材标准2014-SX-ZB003要求，连翘果实中连翘苷含量不得低于0.15%，连翘酯苷A含量不得低于0.25%；连翘叶中连翘苷含量不得低于1.9%，连翘酯苷A含量不得低于6.0%。根据实验结果，连翘叶中连翘苷含量是果实中的10倍左右，连翘酯苷A含量是果实中的23倍左右。
应用例2：降血脂颗粒剂的加速稳定性实验。
按照本发明实施例1制备3批降血脂颗粒剂，以复合膜袋包装得到3批供试样品。
采用加速试验法，在干燥器下部放置75%恒湿溶液，上部放置3批复合膜袋装的降血脂颗粒剂供试样品，将干燥器放入37℃、相对湿度75%的恒温试验箱中放置3个月，分别于0、1、2、3月末取样，按《中国药典》2015年版一部中方法，对供试样品的性状，水分，粒度，有效成分总黄酮、连翘苷、连翘脂苷A含量，溶化性等指标进行测定。
3批供试样品的加速稳定性测试结果见表2，其性状、粒度、水分、溶化性及有效成分总黄酮、连翘酯苷A、连翘苷含量均符合质量要求，各项指标测定结果均未发生明显变化，表明本发明制备工艺能够保证产品的稳定性和质量。
应用例3：降血脂颗粒剂的药理实验。
1、试验材料。
SPF级雄性Wistar大鼠50只，体重(200±20g)，生产许可证号：SCXK(军)2012-0004。
高脂饲料：蛋黄粉10%、猪油5%、胆固醇5%、胆盐0.5%、丙硫氧嘧啶0.2%、基础饲料79.3%。
降血脂颗粒剂：实施例1制备得到的降血脂颗粒剂。
对照降血脂颗粒剂：去掉重瓣红玫瑰，其他与实施例1方法完全相同，制备得到对照降血脂颗粒剂。
2、试验方法。
将大鼠在清洁级实验动物室进行饲养。饲养期间5只一笼，自由摄食和饮水，明暗周期12h，室温22～25℃，相对湿度40～60%，通风良好。
适应性喂养1周后，随机分为10只空白对照组和50只造模组。空白对照组饲喂基础饲料，造模组饲喂高脂饲料，2周后造模成功，再将造模组大鼠随机分为4组：阳性对照组，模型对照组，降脂1组，降脂2组。
空白对照组和模型对照组灌胃给予同等体积的蒸馏水，阳性对照组给予4mg/kg辛伐他汀灌胃，降脂1组给予0.3g/kg降血脂颗粒剂灌胃，降脂2组给予0.375g/kg对照降血脂颗粒剂灌胃。
实验期间，每周定时称量大鼠体重，计算给药量。
每日记录和观察大鼠精神状态，给药期间除空白对照组外，其余各组继续给予高脂饲料。每日上午定时给药四周。
末次给药后禁食12h，眼底静脉丛取血，3000r/min离心10min后取血清，采用全自动生化分析仪测定血清中总胆固醇TC、甘油三酯TG、低密度脂蛋白胆固醇LDL-C、高密度脂蛋白胆固醇HDL-C，计算AI指数：AI=([TC]-[HDL-C])/[HDL-C]。
其中，TC、TG、LDL-C和HDL-C是临床血脂检测基本项目，AI为观察动脉硬化程度指标，AI值的升高，能促进HDL-C将血液中的胆固醇运到肝脏进行转化和排泄，以降低血液中胆固醇浓度。
3、统计分析
数据处理采用SPSS l7.0统计软件进行方差分析，差异显著性用P<0.05(显著)或P<0.01(极显著)表示，实验数据以平均值±标准差(x±s)表示。
由表3可知，给药四周后，与模型对照组相比，TC含量阳性对照组、降脂1组均极显著降低（P<0.01）；TG含量三组均显著降低（P<0.05）；HDL-C含量阳性对照组、降脂1组显著升高（P<0.05）；AI指数三组均极显著降低（P<0.01）。
在观察大鼠的行为活动中发现，降脂2组大鼠较1组精神状态差，排泄次数增多。原因可能是连翘叶与罗布麻叶性凉，微寒，长期服用导致腹泻，加入重瓣红玫瑰佐治后，既调和了药性，与降脂2组相比，又与罗布麻叶协同发挥活血降脂的功效，恰到好处。
Claims (8)
1.一种降血脂颗粒剂，是以下述重量份数的组分为原料制备得到：罗布麻叶1～12份、连翘叶1～9份、重瓣红玫瑰1～6份。
2.根据权利要求1所述的降血脂颗粒剂，其特征是所述原料重量份数为：罗布麻叶3～6份、连翘叶3～9份、重瓣红玫瑰1～3份。
3.根据权利要求1所述的降血脂颗粒剂，其特征是所述原料重量份数为：罗布麻叶6份、连翘叶6份、重瓣红玫瑰3份。
4.权利要求1～3任一所述降血脂颗粒剂的制备方法，包括：
1）、采摘新鲜的连翘叶，阴干；夏季采收新鲜的罗布麻叶，除去杂质，低温干燥；日出前采摘重瓣红玫瑰花冠，低温烘烤；
2）、以所述重量份数的连翘叶、罗布麻叶与重瓣玫瑰花作为原料药，加水回流煎煮2次，每次加水量为原料药重量的10～15倍，煎煮时间20～30min，合并滤液，减压浓缩至相对密度1.0～1.3，加入辅料，干燥得到干燥粉末；
3）、在干燥粉末中加入润湿剂制成软材，制粒，二次干燥，制成降血脂颗粒剂。
5.根据权利要求4所述的制备方法，其特征是所述的辅料是淀粉、糊精、乳糖或麦芽糊精中的一种或几种。
6.根据权利要求4所述的制备方法，其特征是所述辅料的加入量为原料药重量的5～10%。
7.根据权利要求4所述的制备方法，其特征是所述干燥的方式为喷雾干燥或鼓风干燥。
8.根据权利要求4所述的制备方法，其特征是所述润湿剂使用体积浓度85～90%的乙醇，润湿剂用量为原料药重量的20～30%。
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