CN104288566B - 降胆固醇和/或降血脂的中药组合物及其制备方法和应用 - Google Patents
降胆固醇和/或降血脂的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种具有降胆固醇和/或降血脂作用的中药组合物及其制备方法和应用,所述中药组合物的有效成分是由下述重量份的原料制备而成的:银杏叶5‑15份、山楂5‑15份、淡竹叶5‑15份、炒决明15‑25份、丹参10‑20份、枸杞子10‑20份、绞股蓝10‑20份、黄精20‑30份、桑椹10‑20份、荷叶3‑12份和松叶1‑10份;所述制备方法为:将上述药材加水或乙醇溶液提取,制成相应制剂,即可。本发明所述中药组合物安全无毒副作用,且具有显著地降低血清胆固醇、调节血脂、预防动脉粥样硬化和改善血管内血氧运送通道的作用。
Description
技术领域
本发明涉及中药领域,特别是涉及一种具有降胆固醇和/或降血脂作用的中药组合物及其制备方法和应用。
背景技术
随着人民生活水平的提高,物质和精神生活的丰富,肉类食物、油腻食物及酒的摄入增加,增减了人体胆固醇的含量;同时随着生活节奏的加快,人们长时间的精神压力,也可引起血胆固醇的升高;还有随着年龄的增长血总胆固醇的水平也在增加;而且从临床的数据也可以看出,胆固醇高的疾病是十分广泛的。众所周知,胆固醇高会严重危害人体健康,引起肥胖症、肝功能衰竭、高血脂、心血管阻塞等疾病。
2008年国家卫生部推荐了他汀类降脂药:他汀类药物能显著降低低密度脂蛋白胆固醇,同时也降低甘油三酯和轻度升高高密度脂蛋白胆固醇。近20年的临床研究显示,他汀类药物是降低胆固醇,预防心肌梗死和脑血栓有效的药物。然而是药三分毒,一般来说,降脂药都有副作用,长期用药会导致肝肾损伤。此外,还会有高胆固醇血脂症患者会对他汀类药物产生不耐受。因此,亟需一种专门针对高血脂人群的无毒副作用的药品或保健食品。
发明内容
基于此,本发明的目的在于提供一种具有降胆固醇和/或降血脂作用的中药组合物。
解决上述技术问题的具体技术方案如下:
一种具有降胆固醇和/或降血脂作用的中药组合物,所述中药组合物的有效成分是由下述重量份的原料制备而成的:银杏叶5-15份、山楂5-15份、淡竹叶5-15份、炒决明15-25份、丹参10-20份、枸杞子10-20份、绞股蓝10-20份、黄精20-30份、桑椹10-20份、荷叶3-12份、松叶1-10份。
在其中一些实施例中,所述中药组合物的有效成分是由下述重量份的原料制备而成的:银杏叶9-11份、山楂9-11份、淡竹叶9-11份、炒决明19-21份、丹参14-16份、枸杞子14-16份、绞股蓝14-16份、黄精24-26份、桑椹14-16份、荷叶7-9份、松叶4-6份。
本发明所述具有降胆固醇和/或降血脂作用的中药组合物各组分的药理如下:
银杏叶:活血化瘀,通络止痛,敛肺平喘,化浊降脂。用于瘀血阻络,胸痹心痛,中风偏瘫,肺虚咳喘,高脂血症。
山楂:消食健胃,行气散瘀,化浊降脂。山楂中的脂肪分解酶可促进脂肪类食物的消化。黄酮类和三萜类成分具有降压、增加冠脉流量、降血脂、抗心律失常等作用。
淡竹叶:清热泻火,除烦止渴,利尿通淋。用于热病烦渴,小便短赤涩痛,口舌生疮。
炒决明:清热明目,润肠通便。现代研究表明决明子具有较强降血脂、降压作用。
丹参:活血祛瘀,通经止痛,清心除烦,凉血消痈。现代研究表明丹参还具有抗缺氧、抗缺血、抗凝血、抗菌、抗肿瘤、降血压、降血脂、护肝等作用。
枸杞子:滋补肝肾,益精明目。现代研究表明枸杞子具有调节脂质代谢、降血糖、将血压,抑制呼吸兴奋、抗缺氧、促进造血功能、延缓衰老、增强免疫能力、加强肠胃功能等作用。
绞股蓝:补虚,清热,解毒。用于体虚乏力,虚劳失精,白细胞减少症,高脂血症,病毒性肝炎,慢性胃肠炎,慢性气管炎。
黄精:性平,味甘。补气养阴,健脾,润肺,益肾。现代研究表明其提取物对麻醉动物血压具有降压作用。
桑椹:滋阴补血,生津润燥。用于肝肾阴虚,眩晕耳鸣,心悸失眠,须发早白,津伤口渴,内热消渴,肠燥便秘。
荷叶:清暑化湿,升发清阳,凉血止血。用于暑热烦渴,暑湿泄泻,脾虚泄泻,血热吐衄,便血崩漏。
松叶:祛风燥湿,杀虫止痒,活血安神。现代研究表明松叶具有降血脂,延缓衰老,镇痛,抗炎,促进肠胃运动等作用。
本发明的另一目的在于提供一种上述具有降胆固醇和/或降血脂作用的中药组合物的制备方法,包括以下步骤:
取银杏叶、山楂、淡竹叶、炒决明、丹参、枸杞子、绞股蓝、黄精、桑椹、荷叶和松叶,加水或乙醇溶液提取,过滤,得提取液。
在其中一些实施例中,所述乙醇溶液中乙醇的浓度为20%-75%(体积分数)。
在其中一些实施例中,所述乙醇溶液中乙醇的浓度为30%-45%(体积分数)。
在其中一些实施例中,所述水或乙醇溶液的添加量为总药材量的8-10倍。
在其中一些实施例中,还包括浓缩和/或干燥。
本发明的另一目的在于提供上述的中药组合物在制备具有降胆固醇和/或降血脂作用的药品或保健品中的应用。
本发明的另一目的在于提供一种具有降胆固醇和/或降血脂作用的药品或保健品,所述药品或保健品包括有上述的具有降胆固醇和/或降血脂作用的中药组合物和药品或保健品上可接受的辅料。
本发明所述的一种具有降胆固醇和/或降血脂作用的中药组合物及其制备方法和应用具有以下优点和有益效果:
(1)本发明经发明人的大量实验,精选11种药食两用及可用于保健食品的药材,得出安全无毒副作用、可显著降低胆固醇和/或降血脂的中药组合物,并确定了其最佳组分和配比;所述中药组合物集祛瘀生新、降脂消导、润心肺、滋肝补肾及瘦身养颜于一体,可有效调节血脂、降低血清胆固醇、预防动脉粥样硬化,改善血管内血氧运送通道。
(2)本发明所述中药组合物的制备方法,工艺简单,易操作,适合大规模生产。
具体实施方式
以下将结合具体实施例对本发明做进一步说明。
实施例1
本实施例一种具有降胆固醇和/或降血脂作用的中药组合物,其有效成分是由下述重量份的原料制备而成的:银杏叶15份,山楂15份,淡竹叶15份,炒决明25份,丹参20份,枸杞子20份,绞股蓝20份,黄精30份,桑椹20份,荷叶12份,松叶10份。
上述中药组合物的制备方法,包括如下步骤:
按上述重量份,称取银杏叶,山楂,淡竹叶,炒决明,丹参,枸杞子,绞股蓝,黄精,桑椹,荷叶和松叶,充分混合,置于提取罐中,加75%乙醇溶液提取2次(加乙醇溶液的量分别为原料10倍量和8倍量),提取液滤过,合并,浓缩至相对密度1.20左右(60℃),干燥,粉碎,得干膏粉。
实施例2
本实施例一种具有降胆固醇和/或降血脂作用的中药组合物,其有效成分是由下述重量份的原料制备而成的:银杏叶10份,山楂10份,淡竹叶10份,炒决明20份,丹参15份,枸杞子15份,绞股蓝15份,黄精25份,桑椹15份,荷叶8份,松叶5份。
上述中药组合物的制备方法,包括如下步骤:
(1)按上述重量份,称取银杏叶、山楂、淡竹叶、炒决明、丹参、枸杞子、绞股蓝、黄精、桑椹、荷叶和松叶,充分混合,置于提取罐中,加45%乙醇溶液提取2次(加乙醇溶液的量分别为原料10倍量和8倍量),提取液滤过,合并,浓缩至相对密度1.20左右(60℃),干燥,粉碎,得干膏粉;
(2)于干膏粉中加入常规量的预胶化淀粉和糊精,得降胆固醇和/或降血脂颗粒剂。
实施例3
本实施例一种具有降胆固醇和/或降血脂作用的中药组合物,其有效成分是由下述重量份的原料制备而成的:银杏叶5份、山楂5份、淡竹叶5份、炒决明15份、丹参10份、枸杞子10份、绞股蓝10份、黄精20份、桑椹10份、荷叶3份、松叶1份。
上述中药组合物的制备方法,包括如下步骤:
按上述重量份,称取银杏叶,山楂,淡竹叶,炒决明,丹参,枸杞子,绞股蓝,黄精,桑椹,荷叶,松叶,充分混合,置于提取罐中,加20%乙醇溶液提取2次(加乙醇溶液的量分别为原料10倍量和8倍量),提取液滤过,合并,浓缩至相对密度1.20左右(60℃),干燥,粉碎,得干膏粉。
实施例4
本实施例一种具有降胆固醇和/或降血脂作用的中药组合物,其有效成分的组成和重量份与实施例2所述中药组合物的有效成分的组成和重量份相同。
上述中药组合物的制备方法,包括如下步骤:
按上述重量份,称取银杏叶、山楂、淡竹叶、炒决明、丹参、枸杞子、绞股蓝、黄精、桑椹、荷叶和松叶,充分混合,置于提取罐中,加水提取2次(加水量分别为原料10倍量和8倍量),提取液滤过,合并,浓缩至相对密度1.20左右(60℃),干燥,粉碎,得干膏粉。
实施例5
本实施例一种具有降胆固醇和/或降血脂作用的中药组合物,其有效成分是由下述重量份的原料制备而成的:银杏叶10份、山楂10份、淡竹叶10份、炒决明20份、丹参15份、枸杞子15份、绞股蓝15份、黄精25份、桑椹15份、荷叶8份、松叶5份。
上述中药组合物的制备方法,包括如下步骤:
(1)按上述重量份,称取银杏叶、山楂、淡竹叶、炒决明、丹参、枸杞子、绞股蓝、黄精、桑椹、荷叶和松叶,充分混合粉碎,加30%乙醇溶液(加乙醇溶液的量为原料8倍量,置于超声提取,提取两次,提取液滤过,合并,浓缩至相对密度1.20左右(60℃),干燥,粉碎,得干膏粉;
(2)于干膏粉加入常规量的预胶化淀粉和糊精,得颗粒剂,即可。
实施例6
一、实验目的
通过对比分析评价实施例2制得的干膏粉的降胆固醇和降血脂药效实验。
二、实验方法
取大鼠70只,体重200-240g,雌雄各半。按随机分组分成七组,分别为实施例2(干膏粉)高剂量组(1000mg/kg)、实施例2(干膏粉)中剂量组(500mg/kg)、实施例2(干膏粉)低剂量组(250mg/kg)、病理模型组(以等量生理盐水灌胃,按照《保健食品检验与评价技术规范(2003版)》中的指导方法进行造模)、阳性对照组(辛伐他汀mg/kg)、空白对照组和对比例1(其为干膏粉,具体配方、制备方法与实施例2基本相同,区别在于不含桑椹和荷叶;剂量为1000mg/kg);除空白对照组用普通饲料以外其他组均用高脂饲料喂养,喂养15d后灌胃给药给药,给药21d后取血测定大鼠胆固醇含量和甘油三酯含量。
高脂饲料配方:胆固醇0.03wt%、猪油0.1wt%、蛋黄粉0.1wt%、胆酸钠0.002wt%、甲基硫氧嘧啶0.01wt%、普通饲料75.8wt%。
普通饲料配方:玉米73.5wt%,麦麸20wt%,鱼粉5wt%,谷粉1wt%,食盐0.5wt%。
三、实验结果
结果参见表1:从表1可知,与各对照组相比,实施例2的干膏粉能显著降低大鼠血清的总胆固醇和甘油三酯含量,即其具有显著的调节血脂的功效,可进一步开发成保健食品;其中,与对比例1相比可知:实施例2所述配方中各组分是相互协同的,其共同起到降低总胆固醇和甘油三酯含量的功效。
表1各组别大鼠中总胆固醇和甘油三酯含量结果表
*P<0.05,表示与模型组比较有显著性差异。
实施例7急性毒理实验
1.实验目的
通过急性毒理实验分析评价实施例2所制得的干膏粉的安全性。
2.方法和结果
2.1实验方法
取wistar大鼠20只,雌雄各半,体重250g左右,动物购买后观察3-5天,试验前实验动物隔夜空腹,即禁食16h(不禁水),一次性给予大鼠最大灌胃容量的干膏粉水溶液,灌胃容量为20mL/kg BW,灌胃剂量为20g/kg BW,灌胃后持续观察,每天上、下午各观察1次,连续观察7~14天,观察记录实验大鼠毛色情况、活动情况、摄食情况、排泄情况及有无死亡等情况,若有死亡小鼠及时进行病理检验。
2.2实验结果
用最大使用浓度和最大灌胃容量给予20只大鼠灌胃后,观察大鼠,外观、毛色、光泽正常,社会行为、反应均正常,摄食、排泄正常;连续观察7-14天,未见任何大鼠死亡,则大鼠最大耐受剂量(Maximum Tolerated Dose,MTD)大于20g/kg BW,根据《保健食品检验与评价技术规范(2003版)》中急性毒性实验评价方法,确定药粉安全性级别为无毒级别。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (7)
1.一种具有降胆固醇和/或降血脂作用的中药组合物,其特征在于,所述中药组合物的有效成分是由下述重量份的原料制备而成的:银杏叶5-15份、山楂5-15份、淡竹叶5-15份、炒决明15-25份、丹参10-20份、枸杞子10-20份、绞股蓝10-20份、黄精20-30份、桑椹10-20份、荷叶3-12份、松叶1-10份。
2.根据权利要求1所述的具有降胆固醇和/或降血脂作用的中药组合物,其特征在于,所述中药组合物的有效成分是由下述重量份的原料制备而成的:银杏叶9-11份、山楂9-11份、淡竹叶9-11份、炒决明19-21份、丹参14-16份、枸杞子14-16份、绞股蓝14-16份、黄精24-26份、桑椹14-16份、荷叶7-9份、松叶4-6份。
3.一种权利要求1或2所述的具有降胆固醇和/或降血脂作用的中药组合物的制备方法,其特征在于,包括以下步骤:
取银杏叶、山楂、淡竹叶、炒决明、丹参、枸杞子、绞股蓝、黄精、桑椹、荷叶和松叶,加水或乙醇溶液提取,过滤,得提取液。
4.根据权利要求3所述的具有降胆固醇和/或降血脂作用的中药组合物的制备方法,其特征在于,所述乙醇溶液中乙醇的浓度为20%-75%。
5.根据权利要求3或4所述的具有降胆固醇和/或降血脂作用的中药组合物的制备方法,其特征在于,还包括浓缩和/或干燥。
6.权利要求1或2所述的中药组合物在制备具有降胆固醇和/或降血脂作用的药品或保健品中的应用。
7.一种具有降胆固醇和/或降血脂作用的药品或保健品,其特征在于,所述药品或保健品包括有权利要求1或2所述的具有降胆固醇和/或降血脂作用的中药组合物和药品或保健品上可接受的辅料。
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