CN109394874A - 一种荷叶复方组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种采用分级超滤、超微粉碎联用方法制备荷叶复方组合物,它属于中医中药以及食品工业领域。一种荷叶复方组合物,它主要是由下述原料按所述重量份数制备而成:荷叶10‑20份,陈皮6‑12份,山楂1‑5份,菊花1‑5份。本发明组合物可清暑利湿、升发清阳、消食健脾、理气燥湿,可促进脂肪代谢与分解,维持正常的生理机能。本发明的制备方法,它采用分级超滤、超微粉碎联用技术制备荷叶复合组合物,它采用分级超滤、超微粉碎破坏原料细胞壁而使细胞中有效成分析出,能耗低,同时不会对有效成分结构造成破坏,使制得的荷叶复方组合超微粉末能很快发挥疗效。
Description
技术领域
本发明涉及一种采用分级超滤、超微粉碎联用方法制备的荷叶复方组合物,它属于中医中药以及食品工业领域。
背景技术
肥胖是一种由多种因素引起的慢性代谢性疾病,以体内脂肪细胞的体积和细胞数增加导致体脂占体重的百分比异常增高,并在某些局部过多沉积脂肪为特点。热量摄入多于热量消耗使脂肪合成增加是肥胖的物质基础。当日进食热卡超过消耗所需的能量时,除以肝、肌糖原的形式储藏外,几乎完全转化为脂肪,储藏于全身脂库中。糖原储量有限,脂肪为人体热能的主要贮藏形式,如经常性摄入过多的中性脂肪及糖类,则使脂肪合成加快,成为肥胖症的外因,往往在活动过少的情况下,如停止体育锻炼,减轻体力劳动或疾病恢复期卧床休息,产后休养等出现肥胖。
肥胖症的危害可分为机械性的与内分泌性的,机械性的主要是由于体重过重,从而对身体各个脏器造成了损伤;内分泌性的主要是由于肥胖会导致患者出现内分泌紊乱,如胰岛素增高,并更容易发生糖尿病、动脉硬化、脑梗、心梗、肿瘤等疾病,对于青少年,还会抑制他们的性发育;除此以外,由于肥胖会受到别人的歧视、失去很多机会,因此患者会产生自卑感。
西医对于肥胖一是通过减少热量摄入的药物包括食欲抑制剂、消化吸收阻滞剂、脂肪合成阻滞剂等;二是增加热量消耗的药物包括胰岛素分泌抑制剂、代谢刺激剂、脂肪细胞增殖抑制剂。尽管药物的确可以使某些患者体重下降,但在肥胖治疗中并不列为首选,而且其每一种都有禁用人群,不适用于所有人使用,有副作用。
中医将肥胖分为五个证型,脾虚湿阻、胃热湿阻、气滞血瘀、脾肾两虚、阴虚火旺。常见减脂减肥的中药有山楂、荷叶、泽泻、决明子、大黄、芦荟等。就药物减肥而言,中药的减肥效果不如西药迅速和明显,但中药的不良反应小,对各种并发症的防治作用是西药所无可比拟的。
中药化学成分复杂,传统的入药方式以煎煮为主,煎煮过程伴随着大量成分流失,并且药用成分不能完全析出,并且工艺时间长,能耗高。随着现代医药学科技发展,以传统的经验提取技术已不能满足预防治疗的需要,并且中药有效成分通常分布在细胞壁包裹着的细胞内部,要提高目标产物的提取率和充分利用资源,需采取有效方法破坏其细胞壁而使细胞中有效成分析出,同时不会对有效成分结构造成太大的破坏,可见中药有效成分的提取越来越重要了。
发明内容
针对现有技术存在的不足,本发明的目的之一是提供一种调理减脂的荷叶复方组合物,它选用药食同源的中药材为原料,清暑利湿、升发清阳、消食健脾、理气燥湿,可促进脂肪代谢与分解,维持正常的生理机能,在不用药、不厌食、不伤害身体的情况下轻松减肥,安全有效,无毒无副作用。
本发明的另一目的是提供一种荷叶复方组合物及其制备方法,它使药用成分完全析出,能耗低,它采用分级超滤—超微粉碎破坏原料细胞壁而使细胞中有效成分析出,同时不会对有效成分结构造成破坏,使制得的荷叶复方组合超微粉末能很快发挥疗效。
为实现上述目的,本发明提供如下技术方案:
一种荷叶复方组合物,它主要是由下述原料按所述重量份数制备而成:荷叶10-20份,陈皮6-12份,山楂1-5份,菊花1-5份。
上述的一种荷叶复方组合物,它主要是由下述原料按所述重量份数制备而成:荷叶15 份、陈皮9份、山楂3份、菊花3份。
上述荷叶复方组合物的制备方法,其制备方法步骤如下:
(1)称取符合所述重量份数的荷叶、陈皮、山楂、菊花,经混合粉碎至10-40目,得粗药粉备用;
(2)将粗药粉置于药锅中,第一次加水量为粗药粉重量的18-22倍,浸泡0.5-1.5小时,加入0.35-0.55重量份的纤维素酶,采用柠檬酸-柠檬酸钠调pH值为4.0-6.0,于40℃-60℃酶解锅中恒温酶解1-3小时,酶解结束后,升温至93-97℃灭酶;
(3)灭酶后,将酶处理体系煮沸,微沸煎煮1-3小时,滤过,收集滤液;滤渣第二次加水量为粗药粉重量的16-20倍,煮沸后,微沸煎煮0.5-1.5小时,滤过,收集滤液;滤渣第三次加水量为粗药粉重量的13-17倍,煮沸后,微沸煎煮0.5-1.5小时,滤过,收集滤液;
(4)将步骤(3)所得的三次滤液合并,4000-6000r/min离心10-20min,收集上清液;
(5)将步骤(4)收集的上清液,分别采用截留按分子量300K、100K、10K中空纤维超滤柱进行超滤,收集超滤液;
(6)将步骤(5)所得的超滤液,在40-50℃条件下,采用膜截留相对分子质量300-600Da 进行纳滤浓缩,浓缩液体积为原液体积的1/4-3/4,得浓缩液;
(7)向步骤(6)所得的浓缩液里添加浓缩液重量0.1-0.3倍的麦芽糊精,搅拌均匀后进行喷雾干燥,喷雾干燥条件如下:进风温度110-130℃,出风温度80-100℃,雾化压力750-850Pa,喷液速度8-12%,得干燥粉末;
(8)将步骤(7)所得干燥粉末放入超微粉碎机进行超微粉碎,通过高能纳米冲击磨罐体内的磨介撞击研磨5-15min,使超微粉的平均粒径达到900-1500nm,即得荷叶复方组合超微粉末。
上述步骤(1)原料混合后粉碎至20目。
上述步骤(2)中第一次加水量优选为药材重量的20倍,浸泡时间优选1小时,纤维素酶加入量优选0.45份,pH值优选5.0,酶解温度优选50℃,酶解时间优选2小时,灭酶温度优选95℃。
上述步骤(3)中煎煮时间优选为2小时,第二次加水量优选为粗药粉重量的18倍,煎煮时间优选为1小时,第三次加水量优选为粗药粉重量的15倍,煎煮时间优选为1小时。
上述步骤(4)中离心速率优选为5000r/min,离心时间优选为15min。
上述步骤(6)中纳滤温度优选为45℃,膜截留分子量优选为450Da。
上述步骤(7)中麦芽糊精的添加量优选为浓缩液重量的0.2倍;喷雾干燥进风温度优选120℃,出风温度优选90℃,雾化压力优选800Pa,喷液速度优选10%。
上述步骤(8)中研磨优选10min,超微粉的平均粒径为1200nm。
由于采用上述技术方案,使得本发明与现有技术相比,具有如下特点和有益效果:
本发明所用中药原料的功效如下:荷叶:基源:莲科莲属多年生草本挺水植物莲荷的叶;性味:平,苦;归经:入肝、脾、胃。功能主治:清热解暑,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。陈皮:基源:芸香科植物橘及其栽培变种的干燥成熟果皮。性味:味苦、辛,性温;归经:入肺、脾经。功能主治:理气健脾,燥湿化痰;用于脘腹胀满,食少吐泻,咳嗽痰多。山楂:基源:蔷薇科植物山里红或山楂的干燥成熟果实。性味:酸甘,微温;归经:入脾、胃、肝经。功能主治:消食积,散瘀血,驱绦虫;治肉积,症瘕,痰饮,痞满,吞酸,泻痢,肠风,腰痛,疝气产后儿枕痛,恶露不尽,小儿乳食停滞。菊花:基源:菊科植物菊的头状花序;性味:味苦、甘,性微寒;归经:入肺、肝经。功能主治:散风清热,平肝明目,清热解毒;用于主治风热感冒,头痛眩晕,目赤肿痛,眼目昏花,疮痈肿毒。
本发明调理减脂的荷叶复方组合所用的中药材,甄选国家药食同源目录内药材为原料,也是传统药膳中常选用的原料。以中医理论为基础,秉承治未病的中医学说,按君臣佐使为原则进行组方,严格控制各组分的配比,具有清暑利湿、升发清阳、消食健脾、理气燥湿的功效,控制脂肪吸收,促进脂肪代谢,调解内分泌,改善人体微循环。本发明将上述荷叶、陈皮、山楂、菊花按所述用量进行组合,使得各原料产生协同增效作用,复合物中指标性成分荷叶碱含量较单一荷叶可提升三倍。陈皮、山楂、菊花作为臣佐药,加强荷叶减肥消脂、调理微循环的作用,并针对肥胖引起的慢性代谢反应起到改善作用,使得由肥胖引起的内分泌紊乱、糖尿病、动脉硬化、脑梗、心梗、肿瘤等症状得以调理减轻。
本发明应用分级超滤、超微粉碎联用技术制备荷叶复方组合物,将传统中药提取工艺与现代生物技术工艺相结合,保留传统水煎汤剂的提取方式,利用酶解前处理工艺将细胞壁上的蛋白质、纤维素、果胶质等阻碍胞内有效成分溶出的主要屏障降解,从而使细胞壁疏松、破裂,减少胞内有效成分扩散阻力,提高提取率。本发明针对组合物中原料来源,采用纤维素酶能有效分解细胞壁及细胞壁间的纤维素。酶解温度对酶解程度较为重要,酶解温度升高,酶活性上升,反应物能量增加,使反应速度加快,只有在一定温度范围内,酶才能发挥较高的效能。当温度超过酶的最适宜温度后,会引起酶蛋白变性,使酶活力大大减弱,直至完全丧失活力,反应速度下降,从而影响对细胞的分解,所以酶解温度选择在40℃-60℃之间。因原料特性酶解时间过长,药材细胞破坏严重,产品活性下降,故酶解时间定为1-3小时。在研究过程中发现,酶解酸度对指标性成分收率有一定影响,只有在一定的pH值范围内才能发挥催化作用。当pH值在4.0-6.0之间时,收率达到峰值,pH 值再升高,收率反而下降。通过酶解参数优化后,荷叶碱指标含量提升六倍。采用生物超滤技术去除水提取液中淀粉、蛋白质等大分子惰性物质,同时减少有效成分损失,再利用纳滤生物技术滤过除水,富集有效成分,同时在浓缩提取液时可避免高温蒸煮料液,提高有效成分保留率,减少热能损耗。得到的超微粉经水溶解后,液体澄清透明,无残渣沉淀现象。同时本发明在制备工艺中,未引入有机溶剂和化学试剂,不破坏药材内部成分结构,保护药材特性,更好地发挥保健疗效。
本发明调理减脂的荷叶复方组合物可用于制备代用茶。
本发明应用分级超滤、超微粉碎联用技术制备荷叶复方组合物,经制备得到的超微粉可用于制备荷叶复方组合饮料系列产品。
本发明应用分级超滤、超微粉碎联用技术制备荷叶复方组合物在调理减脂方面的效果较好,可有效控制脂肪吸收,促进脂肪代谢,同时清理肠胃,促进体内毒素并减少蓄积,减肥效果较为明显,能有效预防肥胖病症及其带来的其他健康问题。
本发明应用分级超滤—超微粉碎联用技术制备荷叶复方组合物,所选材料皆为药食同源中药,原料易得,取天然草本植物之药性,饮其之茶味,两者相辅相成,达到茶借药力,药借茶功之效。无任何毒副作用,能够减轻使用者的身体肝肾负担和经济负担。
本发明应用分级超滤—超微粉碎联用技术制备荷叶复方组合物,经口服后,半小时内机体可达到最大血药浓度,并且口服给药方式比注射给药在体内代谢半衰期时间长,可以看出荷叶复方组合物口服给药后能在体内被充分的吸收代谢,生物利用度可达到70%以上,对于高脂模型能有效促进脂肪代谢吸收,清理体内垃圾蓄积,分解体内脂肪,达到瘦身减脂的目的。
本发明的制备方法,它使药用成分完全析出,能耗低,它采用分级超滤、超微粉碎破坏原料细胞壁而使细胞中有效成分析出,同时不会对有效成分结构造成破坏,使制得的荷叶复方组合超微粉末能很快发挥疗效。
具体实施方式
下面结合实施例对本发明进行进一步描述。以下实施例仅为本发明的几个具体实施例,但本发明的设计构思并不局限于此,凡利用此构思对本发明进行非实质性的改动,均应属于侵犯本发明保护范围的行为。
下述实施例中的方法,如无特别说明,均为常规方法。
下述实施例中的百分含量,如无特别说明,均为质量百分含量。
下述实施例中的份数均为重量份数。
实施例1
一种荷叶复方组合物,它是由下述原料按所述重量份数制备而成:荷叶10份,陈皮12份,山楂5份,菊花5份。
荷叶复方组合物的制备方法,步骤如下:
(1)称取10重量份荷叶、12重量份陈皮、5重量份山楂、5重量份菊花,经混合粉碎至10目,得粗药粉备用;
(2)将粗药粉置于药锅中,第一次加水量为粗药粉重量的18倍,浸泡0.5小时,加入0.35重量份的纤维素酶,采用柠檬酸-柠檬酸钠调pH值为4.0,于40℃酶解锅中恒温酶解1小时,酶解结束后,升温至93℃灭酶;
(3)灭酶后,将酶处理体系煮沸,微沸煎煮1小时,滤过,收集滤液;滤渣第二次加水量为粗药粉重量的16倍,煮沸后,微沸煎煮0.5小时,滤过,收集滤液;滤渣第三次加水量为粗药粉重量的13倍,煮沸后,微沸煎煮0.5小时,滤过,收集滤液;
(4)将步骤(3)所得的三次滤液合并,4000r/min离心10min,收集上清液;
(5)将步骤(4)收集的上清液,分别采用截留按分子量300K、100K、10K中空纤维超滤柱进行超滤,收集超滤液;
(6)将步骤(5)所得的超滤液,在40℃条件下,采用膜截留相对分子质量300Da 进行纳滤浓缩,浓缩液体积为原液体积的1/4,得浓缩液;
(7)向步骤(6)所得的浓缩液里添加浓缩液重量0.1倍的麦芽糊精,搅拌均匀后进行喷雾干燥,得干燥粉末;喷雾干燥条件如下:进风温度110℃,出风温度80℃,雾化压力750Pa,喷液速度8%;
(8)将步骤(7)所得干燥粉末放入超微粉碎机进行超微粉碎,通过高能纳米冲击磨罐体内的磨介撞击研磨5min,使超微粉的平均粒径达到900nm,即得荷叶复方组合超微粉末。
实施例2
一种荷叶复方组合物,它是由下述原料按所述重量份数制备而成:荷叶12份,陈皮10份,山楂4份,菊花4份。
荷叶复方组合物的制备方法,步骤如下:
(1)称取12重量份荷叶、10重量份陈皮、4重量份山楂、4重量份菊花,经混合粉碎至16目,得粗药粉备用;
(2)将粗药粉置于药锅中,第一次加水量为粗药粉重量的19倍,浸泡0.8小时,加入0.4重量份的纤维素酶,采用柠檬酸-柠檬酸钠调pH值为4.5,于45℃酶解锅中恒温酶解1.5小时,酶解结束后,升温至94℃灭酶;
(3)灭酶后,将酶处理体系煮沸,微沸煎煮1.5小时,滤过,收集滤液;滤渣第二次加水量为粗药粉重量的17倍,煮沸后,微沸煎煮0.8小时,滤过,收集滤液;滤渣第三次加水量为粗药粉重量的14倍,煮沸后,微沸煎煮0.8小时,滤过,收集滤液;
(4)将步骤(3)所得的三次滤液合并,4500r/min离心12min,收集上清液;
(5)将步骤(4)收集的上清液,分别采用截留按分子量300K、100K、10K中空纤维超滤柱进行超滤,收集超滤液;
(6)将步骤(5)所得的超滤液,在43℃条件下,采用膜截留相对分子质量400Da 进行纳滤浓缩,浓缩液体积为原液体积的1/4,得浓缩液;
(7)向步骤(6)所得的浓缩液里添加浓缩液重量0.15倍的麦芽糊精,搅拌均匀后进行喷雾干燥,得干燥粉末;喷雾干燥条件如下:进风温度115℃,出风温度85℃,雾化压力780Pa,喷液速度9%;
(8)将步骤(7)所得干燥粉末放入超微粉碎机进行超微粉碎,通过高能纳米冲击磨罐体内的磨介撞击研磨8min,使超微粉的平均粒径达到1000nm,即得荷叶复方组合超微粉末。
实施例3
一种荷叶复方组合物,它是由下述原料按所述重量份数制备而成:荷叶15份,陈皮9 份,山楂3份,菊花3份。
荷叶复方组合物的制备方法,步骤如下:
(1)称取15重量份荷叶、9重量份陈皮、3重量份山楂、3重量份菊花,经混合粉碎至20目,得粗药粉备用;
(2)将粗药粉置于药锅中,第一次加水量为粗药粉重量的20倍,浸泡1小时,加入0.45重量份的纤维素酶,采用柠檬酸-柠檬酸钠调pH值为5.0,于50℃酶解锅中恒温酶解 2小时,酶解结束后,升温至95℃灭酶;
(3)灭酶后,将酶处理体系煮沸,微沸煎煮2小时,滤过,收集滤液;滤渣第二次加水量为粗药粉重量的18倍,煮沸后,微沸煎煮1小时,滤过,收集滤液;滤渣第三次加水量为粗药粉重量的15倍,煮沸后,微沸煎煮1小时,滤过,收集滤液;
(4)将步骤(3)所得的三次滤液合并,5000r/min离心15min,收集上清液;
(5)将步骤(4)收集的上清液,分别采用截留按分子量300K、100K、10K中空纤维超滤柱进行超滤,收集超滤液;
(6)将步骤(5)所得的超滤液,在45℃条件下,采用膜截留相对分子质量450Da 进行纳滤浓缩,浓缩液体积为原液体积的1/2,得浓缩液;
(7)向步骤(6)所得的浓缩液里添加浓缩液重量0.2倍的麦芽糊精,搅拌均匀后进行喷雾干燥,得干燥粉末;喷雾干燥条件如下:进风温度120℃,出风温度90℃,雾化压力800Pa,喷液速度10%;
(8)将步骤(7)所得干燥粉末放入超微粉碎机进行超微粉碎,通过高能纳米冲击磨罐体内的磨介撞击研磨10min,使超微粉的平均粒径达到1200nm,即得荷叶复方组合超微粉末。
实施例4
一种荷叶复方组合物,它是由下述原料按所述重量份数制备而成:荷叶17份,陈皮8 份,山楂2份,菊花2份。
荷叶复方组合物的制备方法,步骤如下:
(1)称取17重量份荷叶、8重量份陈皮、2重量份山楂、2重量份菊花,经混合粉碎至30目,得粗药粉备用;
(2)将粗药粉置于药锅中,第一次加水量为粗药粉重量的21倍,浸泡1.2小时,加入0.5重量份的纤维素酶,采用柠檬酸-柠檬酸钠调pH值为5.5,于55℃酶解锅中恒温酶解2.5小时,酶解结束后,升温至96℃灭酶;
(3)灭酶后,将酶处理体系煮沸后,微沸煎煮2.5小时,滤过,收集滤液;滤渣第二次加水量为粗药粉重量的19倍,煮沸后,微沸煎煮1.2小时,滤过,收集滤液;滤渣第三次加水量为粗药粉重量的16倍,煮沸后,微沸煎煮1.2小时,滤过,收集滤液;
(4)将步骤(3)所得的三次滤液合并,5500r/min离心18min,收集上清液;
(5)将步骤(4)收集的上清液,分别采用截留按分子量300K、100K、10K中空纤维超滤柱进行超滤,收集超滤液;
(6)将步骤(5)所得的超滤液,在47℃条件下,采用膜截留相对分子质量500Da 进行纳滤浓缩,浓缩液体积为原液体积的3/4,得浓缩液;
(7)向步骤(6)所得的浓缩液里添加浓缩液重量0.25倍的麦芽糊精,搅拌均匀后进行喷雾干燥,得干燥粉末;喷雾干燥条件如下:进风温度125℃,出风温度95℃,雾化压力830Pa,喷液速度11%;
(8)将步骤(7)所得干燥粉末放入超微粉碎机进行超微粉碎,通过高能纳米冲击磨罐体内的磨介撞击研磨12min,使超微粉的平均粒径达到1300nm,即得荷叶复方组合超微粉末。
实施例5
一种荷叶复方组合物,它是由下述原料按所述重量份数制备而成:荷叶20份,陈皮6 份,山楂1份,菊花1份。
荷叶复方组合物的制备方法,其具体步骤如下:
(1)称取20重量份荷叶、6重量份陈皮、1重量份山楂、1重量份菊花,混合粉碎至 40目,得粗药粉;
(2)将粉碎后的粗药粉置于药锅中,第一次加水量为粗药粉重量的22倍,浸泡1.5小时,加入0.55重量份的纤维素酶,采用柠檬酸-柠檬酸钠调pH值为6.0,于60℃酶解锅中恒温酶解3小时,酶解结束后,升温至97℃灭酶;
(3)灭酶后,将酶处理体系煮沸,微沸煎煮3小时,滤过,收集滤液;滤渣第二次加水量为粗药粉重量的20倍,煮沸后,微沸煎煮1.5小时,滤过,收集滤液;滤渣第三次加水量为粗药粉重量的17倍,煮沸后,微沸煎煮1.5小时,滤过,收集滤液;
(4)将步骤(3)所得的三次滤液合并,6000r/min离心20min,收集上清液;
(5)将步骤(4)收集的上清液,分别采用截留按分子量300K、100K、10K中空纤维超滤柱进行超滤,收集超滤液;
(6)将步骤(5)所得的超滤液,在50℃条件下,采用膜截留相对分子质量600Da 进行纳滤浓缩,浓缩液体积为原液体积的3/4,得浓缩液;
(7)向步骤(6)所得的浓缩液里添加浓缩液重量0.3倍的麦芽糊精,搅拌均匀后进行喷雾干燥,得干燥粉末;上述步骤(7)喷雾干燥条件如下:进风温度130℃,出风温度 100℃,雾化压力850Pa,喷液速度12%;
(8)将步骤(7)所得干燥粉末放入超微粉碎机进行超微粉碎,通过高能纳米冲击磨罐体内的磨介撞击研磨15min,使超微粉的平均粒径达到1500nm,即得荷叶复方组合超微粉末。
实施例1、2、3、4、5中步骤(1)所得粗药粉可应用于制备荷叶复方代用茶。
实施例1、2、3、4、5中步骤(8)所得荷叶复方组合超微粉末可用于荷叶复方组合饮料系列产品。
试验例1
本发明实施例1、2、3、4、5方法制备的荷叶复方组合超微粉末成分的检测与含量分析方法及结果如下:
色谱条件C18色谱柱(4.6*250mm,5μm),采用流动相梯度洗脱见表1,流速 1.0mL/min,柱温30℃,检测波长270nm,进样量20μL。
表1流动相梯度洗脱程序
时间min | 0.1%三乙胺溶液 | 乙腈 |
0 | 80 | 20 |
15 | 20 | 80 |
18 | 10 | 90 |
20 | 80 | 20 |
25 | 80 | 20 |
对照品溶液制备取荷叶碱对照品适量,精密称定,用甲醇定容至浓度为0.05mg/mL,即得对照品溶液。
供试品溶液制备精密称取1、2、3、4、5方法制备的荷叶复方组合超微粉末各0.5g分别置于50mL具塞锥形瓶中,加入30mL甲醇超声提取30min。取出冷却至室温,将样品全部转移至50mL量瓶中,用15mL甲醇分数次清洗锥形瓶内,合并清洗液至50mL 量瓶中并用甲醇定容至刻度,摇匀后,静置5min。取上清液过0.45μm有机微孔滤膜,取续滤液作为供试品溶液。
荷叶单味药制备精密称取荷叶,按实施例3提取方法提取,按供试品溶液方法制备,即得荷叶单味药溶液。
传统水煎剂组样品制备按实施例3步骤(1)比例称取荷叶15份、陈皮9份、山楂 3份、菊花3份,混合后进行粉碎至20目。第一次加水量为药材量的20倍,浸泡1小时,微沸煎煮2小时,滤过,收集滤液;滤渣第二次加水量为药材量的18倍,煮沸后,微沸煎煮1小时,滤过,收集滤液;滤渣第三次加水量为药材量的15倍,煮沸后,微沸煎煮1 小时,滤过,收集滤液。合并三次滤液,水分挥干。精密称取1.0g浸膏,按供试品溶液方法制备,即得传统水煎剂组样品溶液。
分别精密吸取荷叶碱对照品溶液2、4、6、8、10mL于25mL量瓶中,加甲醇稀释至刻度,依次注入高效液相色谱仪中测定,以对照品取样量为横坐标,峰面积为纵坐标,绘制标准曲线,计算回归方程。
样品测定将制得的样品按标准曲线绘制方法对荷叶复方组合中荷叶碱含量进行测定,进样量为20μL,计算荷叶碱含量。
实验结果
表2对照品浓度与峰面积线性关系表
荷叶碱浓度/mg/mL | 0.10 | 0.20 | 0.40 | 0.60 | 0.80 |
峰面积 | 0.145 | 0.261 | 0.514 | 0.758 | 0.979 |
标准曲线方程为Y=4*107C-18553,相关系数R=0.9996
表3荷叶碱含量测定对比
分组 | 荷叶碱含量% |
实施例1组 | 1.28 |
实施例2组 | 1.35 |
实施例3组 | 1.53 |
实施例4组 | 1.44 |
实施例5组 | 1.43 |
荷叶单味药组 | 0.35 |
传统水煎剂组 | 0.26 |
表4营养成分测定对比
试验例2
一种用于调理减脂的荷叶复方组合用于营养性肥胖动物模型试验。
(1)动物分组及给药:将90只SD大鼠,雄性,体重200g,常规饲养3天,随机分为9组,每组10只,每只分笼饲养。9组分别为:空白对照组,肥胖模型组,实施例1、2、3、 4、5组、荷叶单味药组和组方传统水煎剂组。空白对照组给予正常饲料,其余各组均给予营养饲料。
(2)干预方法:除空白对照组和肥胖模型外,其余7组均于喂养营养饲料,给药剂量为 2.35g/kg,灌胃体积10mL/kg。空白对照组和肥胖模型组给予等容量的蒸馏水。每日1次,连续40天。
(3)观察指标:
3.1体质量和Lee’s指数:大鼠末次给药后禁食12h,不断水,测量其体质量、体长(鼻尖到***的距离),计算Lee’s指数,Lee’s指数=体质量(g)1/3*103/体长(cm),断颈处死,取血,室温静置后,低温离心(3000r/min)10min,取血清置于-20℃冰箱待检,并迅速取出肝脏、脾脏称重。
3.2血脂及其他生化指标的观察:血液处理后采用试剂盒酶比色法测定血清总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白(HDLC)、低密度脂蛋白(LDLC),计算动脉粥样硬化指数(AI)。
(4)实验结果:
表5荷叶复方组合物对高脂血症大鼠减肥作用的影响
注:与空白对照组比较,#P<0.05,##P<0.01
与肥胖模型组比较,*P<0.05,**P<0.01
与荷叶单味药组比较,△P<0.05,△△P<0.01
与传统水煎剂组比较,▲P<0.05,▲▲P<0.01
表6荷叶复方组合物对高脂血症大鼠减肥作用的影响
注:与空白对照组比较,#P<0.05,##P<0.01
与肥胖模型组比较,*P<0.05,**P<0.01
与荷叶单味药组比较,△P<0.05,△ΔP<0.01
与组方传统水煎剂组比较,▲P<0.05,▲▲P<0.01
由表5-6可知,荷叶复方组合物对高脂血症大鼠体质量及肝脾脏器重量的影响,与肥胖模型组比较,各实施例组荷叶复方组均可抑制大鼠体质量及肝脾重的增长(P<0.05, P<0.01),降低Lee’s指数(P<0.01),且实施例3组的抑制效果最好,血清TC、TG、LDLC 含量均明显下降(P<0.05,P<0.01),HDLC含量均明显升高(P<0.05,P<0.01)。从粥样硬化指数(AI)结果看,荷叶复方组合各组AI指数均显著下降,而荷叶单味药组和组方传统水煎剂组对模型大鼠各高血脂指征无改善作用,不能起到很好的辅助治疗作用。
Claims (10)
1.一种荷叶复方组合物,其特征在于它主要是由下述原料按所述重量份数制备而成:荷叶10-20份,陈皮6-12份,山楂1-5份,菊花1-5份。
2.根据权利要求1所述的一种荷叶复方组合物,其特征在于它主要是由下述原料按所述重量份数制备而成:荷叶15份、陈皮9份、山楂3份、菊花3份。
3.一种权利要求1或2所述荷叶复方组合物的制备方法,其特征在于其制备方法步骤如下:
(1)称取符合所述重量份数的荷叶、陈皮、山楂、菊花,经混合粉碎至10-40目,得粗药粉备用;
(2)将粗药粉置于药锅中,第一次加水量为粗药粉重量的18-22倍,浸泡0.5-1.5小时,加入0.35-0.55重量份的纤维素酶,采用柠檬酸-柠檬酸钠调pH值为4.0-6.0,于40℃-60℃酶解锅中恒温酶解1-3小时,酶解结束后,升温至93-97℃灭酶;
(3)灭酶后,将酶处理体系煮沸,微沸煎煮1-3小时,滤过,收集滤液;滤渣第二次加水量为粗药粉重量的16-20倍,煮沸后,微沸煎煮0.5-1.5小时,滤过,收集滤液;滤渣第三次加水量为粗药粉重量的13-17倍,煮沸后,微沸煎煮0.5-1.5小时,滤过,收集滤液;
(4)将步骤(3)所得的三次滤液合并,4000-6000r/min离心10-20min,收集上清液;
(5)将步骤(4)收集的上清液,分别采用截留按分子量300K、100K、10K中空纤维超滤柱进行超滤,收集超滤液;
(6)将步骤(5)所得的超滤液,在40-50℃条件下,采用膜截留相对分子质量300-600Da进行纳滤浓缩,浓缩液体积为原液体积的1/4-3/4,得浓缩液;
(7)向步骤(6)所得的浓缩液里添加浓缩液重量0.1-0.3倍的麦芽糊精,搅拌均匀后进行喷雾干燥,喷雾干燥条件如下:进风温度110-130℃,出风温度80-100℃,雾化压力750-850Pa,喷液速度8-12%,得干燥粉末;
(8)将步骤(7)所得干燥粉末放入超微粉碎机进行超微粉碎,通过高能纳米冲击磨罐体内的磨介撞击研磨5-15min,使超微粉的平均粒径达到900-1500nm,即得荷叶复方组合超微粉末。
4.根据权利要求3所述的荷叶复方组合物的制备方法,其特征在于,步骤(1)原料混合后粉碎至20目。
5.根据权利要求3所述的荷叶复方组合物的制备方法,其特征在于,步骤(2)中第一次加水量为粗药粉重量的20倍,浸泡时间为1小时,纤维素酶加入量为0.45份,pH值为5.0,酶解温度为50℃,酶解时间为2小时,灭酶温度为95℃。
6.根据权利要求3所述的荷叶复方组合物的制备方法,其特征在于,步骤(3)中酶解后第一次煎煮时间为2小时,第二次加水量为粗药粉重量的18倍,煎煮时间为1小时,第三次加水量为粗药粉重量的15倍,煎煮时间为1小时。
7.根据权利要求3所述的荷叶复方组合物的制备方法,其特征在于,步骤(4)中离心速率为5000r/min,离心时间为15min。
8.根据权利要求3所述的荷叶复方组合物的制备方法,其特征在于,步骤(6)中纳滤温度为45℃,膜截留分子量为450Da。
9.根据权利要求3所述的荷叶复方组合物的制备方法,其特征在于,步骤(7)中麦芽糊精的添加量为浓缩液重量的0.2倍,喷雾干燥条件如下:进风温度120℃,出风温度90℃,雾化压力800Pa,喷液速度10%。
10.根据权利要求3所述的荷叶复方组合物的制备方法,其特征在于,步骤(8)中研磨10min,超微粉的平均粒径为1200nm。
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CN114832073A (zh) * | 2022-04-28 | 2022-08-02 | 成都中医药大学 | 化痰除湿方与降脂饮联合使用在制备治疗痰湿内阻型***症的药物中的用途 |
CN114832073B (zh) * | 2022-04-28 | 2023-09-05 | 成都中医药大学 | 化痰除湿方与降脂饮联合使用在制备治疗痰湿内阻型***症的药物中的用途 |
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