CN112089770A - 一种可提高免疫力的组合物及其制备方法 - Google Patents
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Abstract
本发明属于生物医药技术领域,尤其涉及一种可提高免疫力的组合物及其制备方法。一种可提高免疫力的组合物,包含炙黄芪、枸杞子、沙棘果油、西洋参、番茄红素。本发明所述的组合物质量可控,使用安全,具有增强免疫力的保健功能;发明所述的组合物适合于工业生产。
Description
技术领域
本发明属于生物医药技术领域,尤其涉及一种可提高免疫力的组合物及其制备方法。
背景技术
免疫力是人体自身的防御机制,是人体识别和消灭外来侵入的任何异物(病毒、细菌等),处理衰老、损伤、死亡、变性的自身细胞以及识别和处理体内突变细胞和病毒感染细胞的能力。现代免疫学认为,免疫力是人体识别和排除“异己”的生理反应。人体内执行这一功能的是免疫系统。数千年来,人类生活在一个既适合生存又充满危险的环境里,人类得以存续,也获得了非凡的免疫力。所以说免疫力是生物进化过程的产物。
据世界卫生组织(WHO)全球调查报告显示75%人群处于亚健康状态,亚健康状态一般是指机体虽没有器质性病变指标,但却呈现出免疫力下降,表现为疲劳、乏力,活动时气短、出汗、腰酸腿疼、心悸、心率不齐等;世界卫生组织(WHO)另一项全球调查报告显示全球约有35%以上的人处于疲劳状态,尤其是中年男性人群疲劳状态者高达60-75%,专家们指出,持续过度疲劳、长期睡眠不佳后果严重,易引发慢性咽喉炎、颈部或腋窝淋巴结肿痛、肌肉酸痛、多发性非关节炎性关节疼痛、头昏、头晕、头痛等病症,并最终导致免疫力下降,而免疫力下降之后,又使“疲劳综合症”更加突出和恶化,从而形成一个恶性循环;而提高免疫能力,及时进行营养补充,正是有效的康复措施之一。
目前,我国保健食品中“增强免疫力”的产品,约占保健食品的24%,居所有保健食品的首位。这些产品虽然都具有不同程度的增强免疫力的功效,但配方、原料、功效成分都不尽相同。从原料组成看可以分成六类,包括:第一类是以补充氨基酸、牛初乳、大豆分离蛋白、多肽为主要原料制成的产品,这类产品多是以补充人体所需的氨基酸为主的增强免疫力类产品。第二类是以补充人体所需的各种维生素的产品,如VC、叶酸及牛磺酸等。第三类是以灵芝或灵芝孢子粉、蜂胶为主的产品,这类产品多是利用其所含的多糖类或黄酮类达到增强免疫力的功效。第四类是以益生菌,如双歧杆菌、乳酸杆菌为主要原料,通过改善肠道益生菌菌群数量和环境来提高机体免疫力。第五类是以海产品,如海参、鲍鱼、海胆、牡蛎等酶解制成多肽类或用禽肉或其它动物肉如:乌鸡、蛇肉等制成的成品。第六类是利用卫生部卫法监发[2000]51号所列即是食品又是药品中原料及可用于保健食品中原料配伍组成的产品。这类产品多是通过“补气”、“补血”、“补阴”、“补阳”或是“双补”、“叁补”、“四补”增强免疫力。
发明内容
本发明提供一种可提高免疫力的组合物,各原料间具有较好的协同作用,能够显著的提高人体的免疫力。同时本发明的还提供了一种可提高免疫力的组合物的制备方法及该组合物的应用。
为达到上述目的,本发明所采取的解决方案是:
具体方法如下:
一种可提高免疫力的组合物,包含炙黄芪、枸杞子、沙棘果油、西洋参、番茄红素。
所述组合物,包含以下重量份的原料:
所述组合物,包含以下重量份的原料:
所述的组合物可以制备成胶囊、丸剂、片剂、颗粒剂。
所述的组合物中还可以加入常规的药物赋形剂,如溶剂、崩解剂、矫味剂、填充剂、着色剂。
一种可提高免疫力的中药软胶囊,包括囊芯和囊皮,其中所述囊芯包含以下重量份的原料:
一种可提高免疫力的组合物的制备方法,包括以下步骤:
步骤1:炙黄芪、枸杞子、西洋参经提取,浓缩,干燥,粉碎过筛,得干浸膏粉;
步骤2:所述干浸膏粉与番茄红素混合均匀后,与沙棘果油搅拌研磨,即得。
所述的浸膏在60℃时的相对密度为1.20-1.25。
一种可提高免疫力的中药软胶囊,包括以下步骤:
步骤1:炙黄芪、枸杞子、西洋参经提取,浓缩,干燥,粉碎过筛,得干浸膏粉;
步骤2:所述干浸膏粉与番茄红素混合,备用;
步骤3:在60~80℃下,将沙棘果油、玉米油、蜂蜡混合均匀,放至40~50℃;
步骤4:将步骤2所得的产物加入到步骤3的产物中,搅拌研磨,即得囊芯料液;
步骤5:将囊芯料液与囊皮胶液进行制丸,加入到软胶囊机中,得软胶囊。
所述的组合物在制备提高免疫力保健品中的用途。
方解:本品配方基于中医药理论与现代药理研究相结合而设计的配方,选用炙黄芪、枸杞子、沙棘果油、西洋参、番茄红素为主要原料制成的提高免疫力的保健食品。配方中,炙黄芪具有补中益气,升阳,固表,托毒敛疮,利水退肿的功效,为君;枸杞子为臣,滋肾,润肺,补肝,明目;佐之以西洋参,补气养阴,清热生津;并辅之以番茄红素及沙棘果油,能广泛地刺激机体的特异性和非特异性免疫反应,通过多种途径提高机体的免疫功能。
本发明组合物有益的技术效果:
(1)本发明组合物具有增强免疫力的保健功能。
(2)本发明所述的组合物质量可控,使用安全。
(3)本发明所述的组合物适合于工业生产。
具体实施例
提供下列实施例,以描述和进一步阐明本发明的某些实施方案和方面,并不能认为其是对本发明范围的限制。
实施例
实施例1:
步骤1:取1000g炙黄芪、825g枸杞子、350g西洋参,第一次加12倍量水浸泡2小时,煎煮2小时,滤过,滤液备用;滤渣加10倍量水,煎煮2小时,滤过,合并滤液,采用减压浓缩设备进行浓缩得浸膏相对密度为1.20~1.25(60℃热测),真空干燥(70℃,真空度-0.06~-0.08MPa)后粉碎,得干浸膏粉;
步骤2:将363g干浸膏粉与50g番茄红素、500g沙棘果油混合,搅拌研磨,即得。
实施例2:
步骤1:取600g炙黄芪、495g枸杞子、210g西洋参,第一次加12倍量水浸泡2小时,煎煮2小时,滤过,滤液备用;滤渣加10倍量水,煎煮2小时,滤过,合并滤液,采用减压浓缩设备进行浓缩得浸膏相对密度为1.20~1.25(60℃热测),真空干燥(70℃,真空度-0.06~-0.08MPa)后粉碎,得干浸膏粉;
步骤2:将216g干浸膏粉与30g番茄红素、300g沙棘果油混合,搅拌研磨,即得。
实施例3:
步骤1:取235g炙黄芪、30g枸杞子、71g西洋参,第一次加12倍量水浸泡2小时,煎煮2小时,滤过,滤液备用;滤渣加10倍量水,煎煮2小时,滤过,合并滤液,采用减压浓缩设备进行浓缩得浸膏相对密度为1.20~1.25(60℃热测),真空干燥(70℃,真空度-0.06~-0.08MPa)后粉碎,得干浸膏粉;
步骤2:将75g干浸膏粉与47g番茄红素、470g沙棘果油混合,搅拌研磨,即得。
实施例4
步骤1:取400g炙黄芪、330g枸杞子、140g西洋参,第一次加12倍量水浸泡2小时,煎煮2小时,滤过,滤液备用;滤渣加10倍量水,煎煮2小时,滤过,合并滤液,采用减压浓缩设备进行浓缩得浸膏相对密度为1.20~1.25(60℃热测),真空干燥(70℃,真空度-0.06~-0.08MPa)后粉碎,得干浸膏粉;
步骤2:将干浸膏粉与20g番茄红素混合,备用;
步骤3:在65℃下,将200g沙棘果油、120g玉米油、10g蜂蜡混合均匀,放至40℃;
步骤4:将步骤2所得的产物加入到步骤3的产物中,搅拌研磨,即得囊芯料液;
步骤5:将7g可可壳色素、1.5g二氧化钛、275g明胶、115g甘油混合,与热水混合制得溶胶,真空脱气,得囊皮胶液;
步骤6:将所得囊芯料液与囊皮胶液加入到软胶囊机中制丸,得软胶囊1000粒。
实验例1(组方筛选试验)
动物:SPF级昆明种健康雄性小鼠140只。分为II大组,每组70只。分别进行小鼠抗体生成细胞及半数溶血值(HC50)试验。每组再随机分为7小组,每小组10只。小鼠服用剂量均为最大剂量:1g/kg*bw即浓度为100mg/mL,A、B、C、D、E、F六组每日灌胃给予相应浓度的受试样品5ml/kg*bw。空白对照组灌胃相应量生理盐水,连续灌胃1月后测定小鼠抗体生成细胞及半数溶血值(HC50)。
药物:如表1,以下产物在使用前分别用蒸馏水10倍稀释。
表1各药物组组方
药物A组制备方法:将黄芪、枸杞子,第一次加12倍量水浸泡2小时,煎煮2小时,滤过,滤液备用;滤渣加10倍量水,煎煮2小时,滤过,合并滤液,采用减压浓缩设备进行浓缩得浸膏相对密度为1.20~1.25(60℃热测),真空干燥(70℃,真空度-0.06~-0.08MPa)后粉碎,得干浸膏粉。
药物B组制备方法:将黄芪、枸杞子、西洋参,第一次加12倍量水浸泡2小时,煎煮2小时,滤过,滤液备用;滤渣加10倍量水,煎煮2小时,滤过,合并滤液,采用减压浓缩设备进行浓缩得浸膏相对密度为1.20~1.25(60℃热测),真空干燥(70℃,真空度-0.06~-0.08MPa)后粉碎,得干浸膏粉。
药物C组制备方法:将药物B组制得的干浸膏粉与沙棘果油混合,搅拌研磨,即得。
药物D组制备方法:将药物B组制得的干浸膏粉与番茄红素混合,搅拌研磨,即得。
药物E组制备方法:将药物B组制得的干浸膏粉与番茄红素、沙棘果油混合,搅拌研磨,即得。
药物F组制备方法:将炙黄芪、枸杞子、西洋参,第一次加12倍量水浸泡2小时,煎煮2小时,滤过,滤液备用;滤渣加10倍量水,煎煮2小时,滤过,合并滤液,采用减压浓缩设备进行浓缩得浸膏相对密度为1.20~1.25(60℃热测),真空干燥(70℃,真空度-0.06~-0.08MPa)后粉碎,得干浸膏粉;
步骤2:将干浸膏粉与番茄红素、沙棘果油混合,搅拌研磨,即得。
组别 | 溶血空斑数(个/10<sup>6</sup>脾细胞) | HC<sub>50</sub> |
对照组 | 36±16 | 1247±26 |
药物A组 | 37±18 | 1262±27 |
药物B组 | 72±26 | 1270±28 |
药物C组 | 46±17 | 1275±32 |
药物D组 | 74±27 | 1281±22 |
药物E组 | 70±25<sup>#</sup> | 1267±24** |
药物F组 | 73±24<sup>#</sup> | 1264±28<sup>##</sup> |
注:与对照组相比:*P<0.05,**P<0.01;与药物A组相比:#P<0.05,##P<0.01
从表2的结果看出,小鼠抗体生成细胞(溶血空斑数)试验显示A、B、C、D、E、F组与对照组比较,差异均有显著性;且药物E、F组与药物A组比较,差异显著;而小鼠半数溶血值(HC50)试验显示,F组与空白组比较,差异有显著性,说明只有F组具有体液免疫功能,所以F组为最好的组合配方。
实验2、对免疫抑制模型小鼠胸腺指数、脾脏指数的影响
1.动物及分组:雌性ICR小鼠,体重18~22g,随机分组,每组10只,适应性饲养3天。(1)正常对照组:灌胃等容量蒸馏水;(2)模型对照组:灌胃等容量蒸馏水;(3)脾氨肽组:1.3g/kg;(4)实施例组合物:实施例1~3。
2.给药及实验方法:除正常组外,其余各组在连续灌胃3周后,以环磷酰胺40mg/kg,腹腔注射,连续两天,进行免疫抑制。连续灌胃4周后,脱椎处死小鼠,摘取胸腺及脾脏,用滤纸吸去表面脏污,称重,计算胸腺指数、脾脏指数。
表3对免疫器官重量的影响(n=10)
注:与正常组比较aP<0.05,aaP<0.01,与模型组比较bP<0.05,bbP<0.01,与脾氨肽组比较cP<0.05,ccP<0.01。
由上表可知,本发明组合物能够显著提高免疫抑制模型小鼠的胸腺指数及脾脏指数,对提高免疫抑制状态下机体的免疫力具有一定的作用,且疗效优于脾氨肽。
实验3、对免疫抑制模型小鼠血液白细胞数的影响
1.动物及分组:雌性ICR小鼠,体重18~22g,随机分组,每组10只,适应性饲养3天。(1)正常对照组:灌胃等容量蒸馏水;(2)模型对照组:灌胃等容量蒸馏水;(3)脾氨肽组:1.3g/kg;(4)实施例组合物:实施例1~3。
2.给药及实验方法:除正常组外,其余各组在连续灌胃3周后,以环磷酰胺40mg/kg,腹腔注射,连续两天,进行免疫抑制。连续灌胃4周后,测定血液白细胞数。以摘除小鼠眼球的方法采集全血,采用干净无菌的眼科镊子摘取小鼠一侧或双侧眼球,让血液自由滴入装有抗凝剂的1.5ml离心管中,采血过程中不断混匀血液与抗凝剂防止血液凝固,每只动物采集抗凝全血约1ml。在24h内以全血细胞分析仪检测白细胞总数和淋巴细胞数。
表4对外周血白细胞数的影响(n=10)
组别 | 白细胞总数10<sup>9</sup>/L | 淋巴细胞总数10<sup>9</sup>/L |
正常对照组 | 7.85±2.54<sup>bb</sup> | 4.83±0.513 |
模型对照组 | 3.92±0.32<sup>aa</sup> | 2.18±0.742<sup>a</sup> |
脾氨肽组 | 8.73±0.31<sup>bb</sup> | 5.32±0.321<sup>bb</sup> |
实施例1组 | 12.22±2.06<sup>aabbc</sup> | 8.87±1.752<sup>aabbcc</sup> |
实施例2组 | 12.18±1.98<sup>aabbc</sup> | 8.642±0.903<sup>aabbcc</sup> |
实施例3组 | 12.09±3.02<sup>aabbc</sup> | 8.167±2.013<sup>aabbcc</sup> |
注:与正常组比较aP<0.05,aaP<0.01,与模型组比较bP<0.05,bbP<0.01,与脾氨肽组比较cP<0.05,ccP<0.01。
由上表可知,本发明组合物能显著提高免疫抑制模型小鼠外周血白细胞数及淋巴细胞数,对提高机体的免疫力有一定的作用,且疗效优于脾氨肽。
实验4、对免疫抑制模型小鼠细胞免疫功能的影响
1.动物及分组:雌性ICR小鼠,体重18~22g,随机分组,每组10只,适应性饲养3天。(1)正常对照组:灌胃等容量蒸馏水;(2)模型对照组:灌胃等容量蒸馏水;(3)脾氨肽组:1.3g/kg;(4)实施例组合物:实施例1~3。
2.ConA诱导的小鼠脾淋巴细胞转化实验给药及实验方法:除正常组外,其余各组在连续灌胃3周后,以环磷酰胺40mg/kg,腹腔注射,连续两天,进行免疫抑制。连续灌胃4周后,脱椎处死小鼠。无菌取脾,置于盛有适量(3-5ml)无菌Hank's液平皿中,并在脾上面放置一块纱布,先用眼科剪将脾脏剪成小块后再用毛玻璃片轻轻将脾磨碎,制成单个细胞悬液。经200目筛网过滤,用Hank's液洗2次,每次离心10min(1000r/min)。然后将细胞悬浮于2mL的完全培养液中,用细胞计数板在显微镜下计数活细胞数(应在95%以上),调整细胞浓度为3×106个/mL。将细胞悬液分两孔加入24孔培养板中,每孔1mL,一孔加75μlConA液(相当于7.5μg/mL),另一孔作为对照,置5%CO2,37℃CO2孵箱中培养72h。培养结束前4h,每孔轻轻吸去上清液0.7mL,加入0.7mL不含小牛血清的RPMI1640培养液,同时加入MTT(5mg/mL)50μl/孔,继续培养4h。培养结束后,每孔加入1mL酸性异丙醇,超声震荡(2秒)或人工吹打混匀,使紫色结晶完全溶解。然后分装到96孔培养板中,每个孔分装3孔作为平行样,用酶联免疫检测仪,以570nm波长测定光密度值。
3.迟发型变态反应(DTH)给药及实验方法:除正常组外,其余各组在连续灌胃3周后,以环磷酰胺40mg/kg,腹腔注射,连续两天,进行免疫抑制。连续灌胃4周后,测定各项指标。每鼠腹部皮肤用8%硫化钡溶液进行脱毛,范围约3cm×3cm、用DNFB溶液50μl均匀涂抹致敏。5天后,用DNFB溶液10μl均匀涂抹于小鼠右耳(两面)进行攻击。攻击后24h颈椎脱臼处死小鼠,剪下左右耳壳。用打孔器取下直径8mm的耳片,称重,计算两耳之间的重量差值。
表5对免疫抑制模型小鼠细胞免疫功能的影响(n=10)
组别 | OD值 | 耳肿胀度mg |
正常对照组 | 0.063±0.04 | 4.318±0.653 |
模型对照组 | 0.041±0.021<sup>a</sup> | 3.108±1.413<sup>a</sup> |
脾氨肽组 | 0.068±0.031<sup>ab</sup> | 6.132±1.875<sup>abb</sup> |
实施例1组 | 0.165±0.011<sup>abcc</sup> | 6.864±0.982<sup>aabb</sup> |
实施例2组 | 0.180±0.008<sup>abcc</sup> | 6.912±1.863<sup>aabb</sup> |
实施例3组 | 0.151±0.012<sup>abcc</sup> | 6.981±1.091<sup>aabb</sup> |
注:与正常组比较aP<0.05,aaP<0.01,与模型组比较bP<0.05,bbP<0.01,与脾氨肽组比较cP<0.05,ccP<0.01。
由上表可知,本发明组合物能显著提高免疫抑制模型小鼠淋巴细胞转化率及小鼠的耳肿胀程度,促进免疫抑制模型小鼠淋巴细胞增殖,对提高机体的免疫力有一定的作用,且疗效优于脾氨肽。
综上,本发明组合物具有提高免疫抑制状态下的机体免疫功能,与市面同类型产品相比较,效应更佳。
Claims (10)
1.一种可提高免疫力的组合物,其特征在于,包含炙黄芪、枸杞子、沙棘果油、西洋参、番茄红素。
4.根据权利要求1所述组合物,其特征在于,所述的组合物可以制备成胶囊、丸剂、片剂、颗粒剂。
5.根据权利要求1所述组合物,其特征在于,所述的组合物中还可以加入常规的药物赋形剂,如溶剂、崩解剂、矫味剂、填充剂、着色剂。
7.一种可提高免疫力的组合物的制备方法,其特征在于,包括以下步骤:
步骤1:炙黄芪、枸杞子、西洋参经提取,浓缩,干燥,粉碎过筛,得干浸膏粉;
步骤2:将干浸膏粉与250g番茄红素、350g沙棘果油混合,搅拌研磨,即得。
8.根据权利要求7所述的制备方法,其特征在于,所述的浸膏在60℃时的相对密度为1.20-1.25。
9.一种可提高免疫力的中药软胶囊,其特征在于,包括以下步骤:
步骤1:炙黄芪、枸杞子、西洋参经提取,浓缩,干燥,粉碎过筛,得干浸膏粉;
步骤2:所述干浸膏粉与番茄红素混合,备用;
步骤3:在60~80℃下,将沙棘果油、玉米油、蜂蜡混合均匀,放至40~50℃;
步骤4:将步骤2所得的产物加入到步骤3的产物中,搅拌研磨,即得囊芯料液;
步骤5:将囊芯料液与囊皮胶液进行制丸,加入到软胶囊机中,得软胶囊。
10.根据权利要求1所述组合物,其特征在于,所述的组合物在制备提高免疫力保健品中的用途。
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