CN113952393A - 一种用于提高免疫力的制剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种用于提高免疫力的制剂及其制备方法。该制剂由白刺、沙棘、枸杞、葛根、火麻仁、红景天、沙柳及辅料组成。原料用水和乙醇或异丙醇、或丙酮混合溶剂萃取;萃取液浓缩成固体并干燥备用;然后加入其他可接受的辅料,制备成需要的剂型。该制剂可明显提高艾滋病患者CD4‑T细胞的数量,全面提高机体抗病能力,保护和提高免疫功能,并能缓解艾滋病患者临床病症体征;尤其能显著缓解上呼吸道感染、皮肤瘙痒、腹泻和体能不佳患者的临床病症体征;该制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。制剂原料来源广泛,成本低廉,是抗艾滋病领域的一个创新发现。
Description
技术领域
本发明涉及药品、医疗保健食品及食品技术领域,具体涉及一种用于提高免疫力的制剂及其制备方法。
背景技术
艾滋病是一种慢性而致命的传染性疾病,艾滋病的病因主要为HIV病毒感染人体,引起人体免疫细胞T淋巴细胞(CD4-T细胞)的损伤和减少,同时导致其他免疫功能损伤,从而引起各种机会性感染,甚至肿瘤,最终导致患者死亡。
CD4-T淋巴细胞(简称为CD4细胞)是人体免疫系统中一种重要的免疫细胞。T淋巴细胞属于白细胞中的淋巴细胞类,在免疫系统中扮演很重要的角色。CD4细胞又被称为免疫系统的辅助手,能指挥身体对抗微生物,例如病毒。艾滋病病毒(HIV)的攻击对象是人体的CD4细胞,CD4细胞记数直接反映人体免疫功能。CD4细胞数量是HIV感染患者免疫系统损害状况最明确的指标。正常成人的CD4细胞为每立方毫米500~1600个,艾滋病病毒感染者的CD4细胞可能会出现进行性或不规则性下降,感染者一旦失去了大量CD4细胞,就可能出现严重的疾病危险,当CD4细胞小于每立方毫米200个时就可能会发生多种随机性感染或肿瘤。通过提高CD4细胞数量,可以提高抗病毒的能力和延长病人生存期。
目前,国际上主要通过利用抗艾滋病毒药物抑制病毒使艾滋病人逐渐提升CD4细胞数量。有相当一部分病人由于没有及时发现,用抗艾滋病毒药物治疗时CD4-T细胞数量已经非常低,通过用抗艾滋病毒药物抑制病毒,但是病人CD4-T细胞回升非常慢。而且,目前最大的难题是病毒对抗艾滋病病毒药物的耐药性的产生,治疗艾滋病还有很长的路要走。我们试图通过对植物的天然产物进行筛选,发现无毒或低毒性的天然成份用于抑制病毒,提高CD4-T细胞数量。
沙棘(Hippophae rhamnoides L.)是一种落叶性灌木,其特性是耐旱、抗风沙,可以在盐碱化土地上生存,因此被广泛用于水土保持。中国西北部大量种植沙棘,用于沙漠绿化。沙棘果实中维生素C含量高,素有维生素C之王的美称。沙棘是植物和其果实的统称。植物沙棘为胡颓子科沙棘属,是一种落叶性灌木。国内分布于华北、西北、西南等地。沙棘为药食同源植物。沙棘的根、茎、叶、花、果,特别是沙棘果实含有丰富的营养物质和生物活性物质,可以广泛应用于食品、医药、轻工、航天、农牧鱼业等国民经济的许多领域。沙棘果实入药具有止咳化痰、健胃消食、活血散瘀之功效。现代医学研究,沙棘可降低胆固醇,缓解心绞痛发作,还有防治冠状动脉粥样硬化性心脏病的作用。
枸杞,又称枸杞子、红耳坠,是茄科、枸杞属(Lycium)小灌木植物枸杞的成熟子实。枸杞子药食同源的历史悠久,是驰名中外的名贵中药材,早在《神农本草经》中就被列为上品,称其为“久服轻身不老、耐寒暑”;有延衰抗老的功效,又名“却老子”。枸杞子中含有多种氨基酸,并含有甜菜碱、玉蜀黍黄素、酸浆果红素等特殊营养成分,使其具有非常好的保健功效。
火麻仁为桑科植物大麻(Cannabis sativa L.)的干燥成熟种子,别名又叫大麻仁、火麻、线麻子。火麻在中国大部分地区有栽培,喜温暖湿润气候,对土壤要求不严,以土层深厚、疏松肥沃、排水良好的砂纸土壤或粘质土壤为宜。秋季果实成熟时采收,除去杂质,晒干后为火麻仁。火麻仁味甘,性平,归脾、胃、大肠经,功效润肠通便、润燥杀虫,临床用名有火麻仁、炒火麻仁。本品果实呈卵圆形,长4~5.5mm,直径2.5~4mm。表面灰绿色或灰黄色,有微细的白色或棕色网纹,两边有棱,顶端略尖,基部有圆形果梗痕,果皮薄而脆,易破碎。种皮绿色,子叶,乳白色,富油性。
白刺,灌木。常匍匐地面生长,株高30~50cm,多分枝,少部分枝直立,树皮淡黄色,小枝灰白色,尖端刺状,枝条无刺或少刺。白刺的适应性极强,耐旱、喜盐碱、抗寒、抗风、耐高温、耐瘠薄,为荒漠地区及荒漠平原典型植物,是我国寒温、温和气候区的盐渍土指示植物。白刺结的果肉质多汁,里面含一粒种子,可称为浆果状核果,熟时暗红色,汁液丰富。白刺果实酸甜可食,可治肺病和胃病;也能用以酿酒和制醋;果核还可榨油。秋季果实成熟采收,晒干;以果实入药。健脾胃,助消化,安神,解表,下乳。用于脾胃虚弱,消化不良,神经衰弱,感冒,乳汁不下。
葛根,中药名。为豆科植物野葛的干燥根,习称野葛。秋、冬二季采挖,趁鲜切成厚片或小块;干燥。甘、辛,凉。有解肌退热,透疹,生津止渴,升阳止泻之功。常用于表证发热,项背强痛,麻疹不透,热病口渴,阴虚消渴,热泻热痢,脾虚泄泻。具体有如下功效:(1)提高肝细胞的再生能力,恢复正常肝脏机能,促进胆汁分泌,防止脂肪在肝脏堆积;(2)促进新陈代谢,加强肝脏解毒功能,防止酒精对肝脏的损伤;(3)对高血脂形成的冠状动脉硬化,通过改善心肌缺血状态,防治冠心病、心绞痛、心肌梗塞等心血管疾病;(4)对高血脂形成的脑动脉硬化,通过改善脑缺血状态,防治脑梗塞、偏瘫、血管性痴呆等脑血管疾病;(5)强化肝胆细胞自身免疫功能,抵抗病毒入侵;(6)降血糖,具有延缓衰老、调节血脂血糖、促进造血功能等方面的作用,并应用于临床。
红景天,中药名。为景天科属植物红景天(Rholiola rosea Limn.)或大花红景天(R.euryphylla(Frod.)S.H.Fu.)的根茎。具有健脾益气,清肺止咳,活血化瘀的功效。主治脾气虚证,肺阴虚、肺热咳嗽。分布于日本、朝鲜、俄罗斯、蒙古以及中国大陆的吉林、河北、山西、新疆等地。生长于海拔1800~2700米的地区,多生长于山坡林下或草坡上,目前尚未由人工引种栽培。
沙柳为沙漠植物,也是极少数可以生长在盐碱地的一种植物。其幼枝黄色,叶线形或线状披针形,枝条丛生不怕沙压,根系发达,萌芽力强,是固沙造林树种,其天敌为沙柳毒蛾,生于河谷溪边湿地,分布内蒙古、河北、山西、陕西、甘肃、青海、四川等地。沙柳用于作北方防风沙的主力,是"三北防护林"的首选之一。祛风清热;散瘀消肿;主麻疹初起;斑疹不透;皮肤瘙痒;慢性风湿;疮疖痈肿;腰扭伤。
发明内容
基于上述技术问题,本发明利用青藏高原独特的浆果(沙棘、枸杞、白刺)、植物(红景天、沙柳)和葛根、火麻仁为原材料研发能够提高艾滋病人CD4细胞数量的制剂。目的是提供一种用于提高免疫力的制剂及其制备方法。
本发明保护一种用于提高免疫力的制剂,其中,该制剂包括重量份的如下组成:白刺6~16份、沙棘5~15份、枸杞4~12份、葛根3~9份、火麻仁1~7份、红景天2~9份、沙柳2~7份及余量辅料。
优选的,一种用于提高免疫力的制剂,其中,该制剂包括重量份的如下组成:白刺8~12份、沙棘7~11份、枸杞6~9份、葛根4~6份、火麻仁2~5份、红景天3~6份、沙柳3~5份及余量辅料。
进一步的,所述的辅料为医用药品、医用保健品或功能性食品上所接受的粘合剂、崩解剂、润滑剂、调味剂。
本发明还保护上述用于提高免疫力的制剂的制备方法,具体包括如下步骤:
步骤1:将上述比例的各组分原料,用4~6倍量的水和乙醇或异丙醇或丙酮混合溶剂萃取2~7次,每次1~15小时,合并萃取液;
步骤2:将步骤1的萃取液在20~100℃和负压条件下浓缩成固体,并在20~150℃和负压下干燥2~10小时得干燥粉末,备用;
步骤3:将步骤2所得的干燥粉末中加入医用药品、医用保健品或功能性食品上所接受的粘合剂、崩解剂、润滑剂、调味剂,制成片剂、胶囊剂、颗粒剂、散剂、丸剂或口服液。
进一步的,步骤1中,所述水和乙醇或异丙醇或丙酮的比例为1:2~3。
本发明还保护上述用于提高免疫力的制剂的用途,上述用于提高免疫力的制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。
相比于现有的技术,本发明具有如下有益效果:
本发明制剂可明显提高艾滋病患者CD4-T细胞的数量,全面提高机体抗病能力,保护和提高免疫功能,并能缓解艾滋病患者临床病症体征;尤其能显著缓解上呼吸道感染、皮肤瘙痒、腹泻和体能不佳患者的临床病症体征;该制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。制剂原料来源广泛,成本低廉,是抗艾滋病领域的一个创新发现,不仅为治疗艾滋病提供了一个新品种,而且为青藏高原植物的保护和利用开拓了一个崭新的领域。
附图说明
图1为对照组未感染HIV病毒的人源化小鼠试验后变化情况图;
图2为对照组HIV病毒感染的人源化小鼠试验后变化情况图;
图3为治疗组HIV病毒感染的人源化小鼠试验后变化情况图。
具体实施方式
下面将结合实施例对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种用于提高免疫力的制剂,其中,该制剂包括如下组成:白刺10g、沙棘7g、枸杞6g、葛根5g、火麻仁4g、红景天8g、沙柳4g及余量辅料。
上述用于提高免疫力的制剂的制备方法,具体包括如下步骤:
步骤1:将上述比例的各组分原料,用4倍量的水和乙醇混合溶剂萃取3次,其中,水和乙醇的比例为1:3,每次1小时,合并萃取液;
步骤2:将步骤1的萃取液在50℃和负压条件下浓缩成固体,并在80℃和负压下干燥7小时得干燥粉末,备用;
步骤3:将步骤2所得的干燥粉末中加入适量可溶性淀粉、硬脂酸镁0.9g、滑石粉6g,制粒,压片,制成片剂。
上述用于提高免疫力的制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。
实施例2
一种用于提高免疫力的制剂,其中,该组合物包括如下组成:白刺12g、沙棘7g、枸杞9g、葛根7g、火麻仁6g、红景天5g、沙柳6g及余量辅料。
上述用于提高免疫力的制剂的制备方法,具体包括如下步骤:
步骤1:将上述比例的各组分原料,用4倍量的水和异丙醇混合溶剂萃取2次,其中,水和异丙醇的比例为1:2,每次1.5小时,合并萃取液;
步骤2:将步骤1的萃取液在55℃和负压条件下浓缩成固体,并在950℃和负压下干燥5小时得干燥粉末,备用;
步骤3:将步骤2所得的干燥粉末加入蔗糖20g、香精18g,加水制成1000ml,摇匀,静置12小时,过滤,灌装,灭菌,制成口服液。
上述用于提高免疫力的制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。
实施例3
一种用于提高免疫力的制剂,其中,该组合物包括如下组成:白刺8g、沙棘11g、枸杞4g、葛根4g、火麻仁5g、红景天2g、沙柳7g及余量辅料。
上述用于提高免疫力的制剂的制备方法,具体包括如下步骤:
步骤1:将上述比例的各组分原料,用6倍量的水和丙酮混合溶剂萃取5次,其中,水丙酮的比例为1:2.5,每次1小时,合并萃取液;
步骤2:将步骤1的萃取液在20~100℃和负压条件下浓缩成固体,并在20~150℃和负压下干燥2~10小时得干燥粉末,备用;
步骤3:将步骤2所得的得干燥粉末加入硬脂酸镁0.9g、糊精2g,制粒,整粒,制成丸剂。
上述用于提高免疫力的制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。
实施例4
一种用于提高免疫力的制剂,其中,该组合物包括如下组成:白刺6g、沙棘5g、枸杞12g、葛根6g、火麻仁7g、红景天9g、沙柳2g及余量辅料。
上述用于提高免疫力的制剂的制备方法,具体包括如下步骤:
步骤1:将上述比例的各组分原料,用5倍量的水和乙醇混合溶剂萃取7次,其中,水和乙醇的比例为1:3,每次1~15小时,合并萃取液;
步骤2:将步骤1的萃取液在20~100℃和负压条件下浓缩成固体,并在20~150℃和负压下干燥2~10小时得干燥粉末,备用;
步骤3:将步骤2所得的得干燥粉末加入硬脂酸镁0.9g、糊精1.2g,制粒,整粒,制成颗粒剂。
上述用于提高免疫力的制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。
实施例5
本发明制剂的药效活性研究
通过人源化小鼠模型实施
1、人源化小鼠模型建立
5天大的NOD.Cg-Ragltm1Mom Il2rgtm1Wjl/SzJ(NRG)小鼠(30只)使用137Cs放射源用100cGy射线照射6小时后,给每只小鼠肝脏注射1.5-2×105CD34+人造血干细胞。两周后用于建立感染模型。感染前用流式细胞术定量分析外周血中人CD45+细胞的百分比来确定人造血干细胞植入水平。
2、HIV感染模型的建立
用CCR5-tropic HIV-1病毒分离物HIV-1YU2病毒腹腔内感染人源化小鼠,20天后用定量逆转录酶PCR检测方法定量分析HIV RNA在血浆中的量,确定HIV感染模型的成功与否。
3、CD4+T细胞的分析
CD4+与CD8+T细胞的比率用流式细胞术使用BD LSRFortessa流式细胞分析仪确定。具体方法是,从小鼠颞浅静脉采集200μl血,通过密度梯度离心,分离出的外周血单个核细胞,用anti-mouse CD45-PeCy7,anti-human CD3-Pacific-Blue,CD4-PE,CD8-FITC,CD16-Alexa700,CD19-APC和CD45-Pacific-Orange在4℃下染色25分钟,用水洗涤细胞,然后固定在4%多聚甲醛中。样品中加入AccuCheck计数微球以确定外周血中CD4+T细胞的绝对数量。
4、药效试验
人源化小鼠药效试验分为三组,每组5只小鼠(小鼠体重在16-20g)。组1,对照组,5只未感染HIV病毒的人源化小鼠。组2,对照组,5只HIV病毒感染的人源化小鼠。组3,治疗组,5只HIV病毒感染的人源化小鼠。组1和组3按照50mg/kg每天喂食一次实例4的颗粒。组2不喂食实例4的颗粒。在7周内,每7天采集颞浅静脉血用流式细胞术定量分析,计算CD4+/CD8+比例变化。试验结果详见附图1-3。从动物试验数据看出,实例4制剂明显提高HIV人源化小鼠的CD4-T细胞。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。
Claims (6)
1.一种用于提高免疫力的制剂,其特征在于,该制剂包括重量份的如下组成:白刺6~16份、沙棘5~15份、枸杞4~12份、葛根3~9份、火麻仁1~7份、红景天2~9份、沙柳2~7份及余量辅料。
2.根据权利要求1所述的一种用于提高免疫力的制剂,其特征在于,该制剂包括重量份的如下组成:白刺8~12份、沙棘7~11份、枸杞6~9份、葛根4~6份、火麻仁2~5份、红景天3~6份、沙柳3~5份及余量辅料。
3.根据权利要求1或2所述的一种用于提高免疫力的制剂,其特征在于,所述的辅料为医用药品、医用保健品或功能性食品上所接受的粘合剂、崩解剂、润滑剂、调味剂。
4.根据权利要求3所述的一种用于提高免疫力的制剂的制备方法,其特征在于,具体包括如下步骤:
步骤1:将上述比例的各组分原料,用4~6倍量的水和乙醇或异丙醇或丙酮混合溶剂萃取2~7次,每次1~15小时,合并萃取液;
步骤2:将步骤1的萃取液在20~100℃和负压条件下浓缩成固体,并在20~150℃和负压下干燥2~10小时得干燥粉末,备用;
步骤3:将步骤2所得的干燥粉末中加入医用药品、医用保健品或功能性食品上所接受的粘合剂、崩解剂、润滑剂、调味剂,制成片剂、胶囊剂、颗粒剂、散剂、丸剂或口服液。
5.根据权利要求4所述的一种用于提高免疫力的制剂的制备方法,其特征在于,步骤1中,所述水和乙醇或异丙醇或丙酮的比例为1:2~3。
6.根据权利要求1或2所述的一种用于提高免疫力的制剂的用途,其特征在于,上述提高免疫力的制剂还可以用于艾滋病患者、癌症患者、老年人或免疫力低下人群,以提高其免疫力。
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