CN107019745A - 一种具有增强免疫力功能的组合物及其制备方法 - Google Patents
一种具有增强免疫力功能的组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种具有增强免疫力功能的组合物及其制备方法。该组合物是由玛咖、枸杞子、菟丝子、覆盆子、车前子、五味子按一定重量配比制备而成，它可以被制成任何一种常用制剂，优选口服制剂。本发明基于传统中医药“治未病”理论和现代医学对亚健康状态的防治建议，采用新资源食品和药食同源食品为原料，安全可靠，适宜长期服用，组方简单，配伍合理，各原料间协同增效作用明显，通过实验证实其具有显著的增强免疫力的作用，且制备工艺简单、稳定，产品质量稳定可控。
Description
技术领域
本发明涉及一种具有增强免疫力功能的组合物及其制备方法，属于保健食品的技术领域。
背景技术
免疫系统是覆盖全身的防卫网络，保护身体的第一道防线。免疫系统主要包括三个方面：机体抵抗外界传染性因子的免疫防护功能；机体清除损伤和死亡细胞，维持自身生理平衡的自身稳定功能；对机体监视，发现并清除突变细胞的免疫监视功能。在正常生理条件下，机体的免疫系统依靠其先天具有的免疫能力及后天获得的免疫能力发挥共同免疫作用，保持机体的生理功能相对稳定。若免疫功能发生异常，必然会导致机体生理功能的失调，从而出现病理性变化。现代医学主要通过应用保健食品（我国目前允许生产的具有保健功能的食品就包括增强免疫力类），补充维生素和蛋白质，加强营养等提高机体免疫力。
现实生活中工作压力大，心理负担重，以及情绪紧张的时候，人们往往容易生病，身体出现亚健康状态。随着人类对于健康的重新认识，“防病胜于治病”的理念深入人心，人们越来越多的意识到增强免疫力的重要性。保健食品以其可以长期安全服用的优点，深得人们的认同。因而，开发具有增强免疫力功能的产品具有广阔的市场前景。
发明内容
本发明目的是提供了一种具有增强免疫力功能的组合物。
本发明的另外一个目的是提供了该组合物的制备方法。
本发明是通过以下技术方案实现的：
本发明是由下述重量份的原料制成的：
玛咖10-40份、枸杞子20-60份、菟丝子20-60份、覆盆子10-40份、车前子1-20份、五味子1-20份。
优选为：
玛咖15-30份、枸杞子30-50份、菟丝子30-50份、覆盆子15-30份、车前子5-15份、五味子5-15份。
进一步优选为：
玛咖20份、枸杞子40份、菟丝子40份、覆盆子20份、车前子10份、五味子10份。
本发明涉及一种组合物，它是在现有中医理论的基础上，进行科学配伍，发挥药物之间相互协同的作用，从而筛选出能增强免疫力的组方。
本发明中各组分的作用机理如下：
玛咖：是原产南美洲安第斯山脉的一种十字花科植物。意大利科学家Dini A在1994年首次系统地得出了玛咖干根中的化学组成成份：蛋白质含量为10%以上，59%的碳水化合物，8.5%的纤维，内含丰富的锌、钙、铁、钛、铷、钾、钠、铜、锰、镁、锶、磷、碘等矿物质，并含有维生素C、B1、B2、B6、A、E、B12、B5 ，脂肪含量不高但其中多为不饱和脂肪酸，亚油酸和亚麻酸的含量达53%以上，天然活性成份包括生物碱、芥子油苷及其分解产物异硫氰酸苄酯、甾醇、多酚类物质等。1999年，美国科学家发现了玛咖中含有两类新的植物活性成份，玛咖酰胺（macamides）和玛咖稀（macaenes），并确定这两种物质对平衡人体荷尔蒙分泌有显著作用，所以玛咖又被称为天然荷尔蒙发动机。玛咖富含高单位营养素，对人体有滋补强身的功用，食用过的人会有体力充沛、精神旺盛不会疲劳的感觉。
枸杞子：为茄科植物枸杞的成熟果实。具有多种保健功效，是卫生部批准的药食两用食物。枸杞子含有丰富的胡萝卜素、多种维生素和钙、铁等健康眼睛的必需营养物质。历代医家治疗肝血不足、肾阴亏虚引起的视物昏化和夜盲症，常常使用枸杞子。枸杞子富含枸杞多糖，枸杞多糖是一种水溶性多糖，由阿拉伯糖、葡萄糖、半乳糖、甘露糖、木糖、鼠李糖这六种单糖成分组成，具有生理活性，能够增强非特异性免疫功能，提高抗病能力，抑制肿瘤生长和细胞突变。枸杞多糖不仅是一种调节免疫反应的生物反应调节剂，而且可通过神经--内分泌--免疫调节网络发挥抗癌作用。此外，研究表明，枸杞多糖还具有抗衰老、抗疲劳、降血糖、降血压、保护生殖系统等作用。
菟丝子：为双子叶植物药旋花科植物菟丝子、南方菟丝子、金灯藤等的干燥成熟种子，能补肾益精、养肝明目、固胎止泄之功效。菟丝子种子含槲皮素，紫云，金丝桃甙及槲皮素-3-O-β-D-半乳糖-7-O-β-葡萄糖甙等。研究表明，菟丝子可增加非特异性抵抗力作用：菟丝子水煎剂，能延氏小鼠负重游泳时间，增强小鼠在常压下的耐缺氧能力，提高其非特异性抵抗力。具有保肝作用：菟丝子20%的水煎剂给四氯化碳损伤小鼠灌胃，50g生药/kg体重，能使血液中增加的乳酸、丙酮酸及 SGPT 下降，而使下降的肝糖元和肾上腺抗坏血酸上升，有显着的保护肝损伤活性。具有助阳和增强性活力作用：20%菟丝子水煎剂 0.5ml/只/天 灌胃，对阳虚小鼠的症状有一定的恢复作用。用含菟丝子水煎剂的培养基培养，在0.5、1.0和2.0%三个浓度下均能提高果蝇的性活力。此外，菟丝子尚具有抗肿瘤、抗病毒、抗炎、抗不育、致泻、及抑制中枢神经系统的作用。
覆盆子：为蔷薇科植物华东覆盆子Rubus c小时ingii 小时u的干燥果实。具有益肾固精缩尿，养肝明目之功效。常用于遗精滑精，遗尿尿频，阳痿早泄，目暗昏花。覆盆子富含碳水化合物、蛋白质，特别是鞣花酸、超氧化物、维生素、萜类、黄酮等功能化合物。具有延缓衰老，消除疲劳，提高免疫力以及抗诱变作用、改善学习记忆能力、对性腺轴有调控作用等功效。现已广泛应用于药品、食品、保健食品、化妆品等行业。
车前子：为车前科植物车前或平车前的干燥成熟种子。性味甘寒，入肾、膀胱、肝、肺经，功能利水通淋、渗湿止泻、清肝明目、清热化痰，降血压。车前子含多量黏液、车前子酸、车前子甙、车前烯醇酸、琥珀酸、腺嘌呤、胆碱、梓醇、蛋白质及各种脂肪酸（棕榈酸、硬脂酸、花生酸、油酸、亚油酸、亚麻酸等）， 黏液中含酸性黏多糖车前聚糖。尚含维生素A、B1。现代药理研究表明车前子可以用于治疗高血压、细菌性痢疾、腹泻、胃与十二指肠溃疡病及胃炎、上消化道出血等。
五味子：为木兰科植物五味子Sc小时isandra c小时inensis （Turcz.）Baill.或华中五味子Sc小时isandra sp小时enant小时era Re小时d. et Wils.的干燥成熟果实。前者习称“北五味子”，后者习称“南五味子”。古医书称它荎蕏、玄及、会及，最早列于神农本草经上品中药，能滋补强壮之力，药用价值极高，有强身健体之效，与琼珍灵芝合用治疗失眠。五味子含挥发性成分、木脂素类和有机酸类。五味子醇提取物能降低由四氯化碳、硫代乙醇胺等引起的实验动物谷丙转氨酶升高．γ-五味子素（五味子乙素）具抗肝损伤作用。五味子素有广泛的中枢抑制作用，并且有安定作用的特点。五味子醇提取物5-10 mg/kg灌胃可减少小鼠自发活动，协同戊巴比妥钠对小鼠的睡眠作用，对抗苯丙胺引起的小鼠兴奋，对抗咖啡因、烟碱引起的小鼠惊厥。五味子能增强机体对非特异性刺激的防御能力。此外五味子还有强心降压作用及抗菌作用。
综上，本发明涉及的增强机体免疫力的组合物，具有滋补肝肾，健脾和胃，养阴清肺的功效，三焦通补，是一种纯天然的无毒副作用的营养物质，区别于由化学成分制作的同类产品。
本发明组分可以采用中药制剂的常规方法制备成任何常规的制剂，包括口服制剂，外用制剂，注射剂等。例如可以将这些原料药研成粉末混合均匀；可以将所述重量份的原料药分别加水或不同浓度的乙醇提取，提取液浓缩干燥得粗提物，或采用精制方法，例如，水提醇沉法、有机溶剂萃取法、柱层析法、二氧化碳超临界萃取法、水蒸气蒸馏法进行精制得到精提物。
在使用上述药物时，既可以采用以相当于所述重量配比的药物为原料分别净选，干燥、粉碎、混合得到符合制剂要求粒度的颗粒或粉末直接服用。也可以采用以相当于所述重量配比关系的药物为原料经过适当处理后添加药用辅料，根据需要将其制成各种制剂。由上述原料药制备成制剂的过程中，上述原料药可以采用如下方法进行处理：将所述重量份的原料药直接粉碎得药材粉末；或分别加水或不同浓度的乙醇提取或采用水提醇沉法、离心法、水蒸气蒸馏法提取得提取物；在对上述有效药用成分进行提取时可采用的具体操作和/或使用方法，既可以是以所述的各比例量的药物成分为原料，分别提取其有效药用成分后再混合的方式，也可以采用按所说比例量的各药物原料混合后再共同提取的方式。采用不同的提取手段、设备及提取时所需的理想或最佳的提取温度、溶剂用量、提取时间、提取次数等具体条件，则可根据实际情况通过试验被筛选和找到。
以上任意一种方法均可以制备得到本发明组合物的活性成分，制得的活性成分可以直接入药服用或加入药剂学上可接受的辅料按常规工艺制备成所需制剂。如可以制成常用的片剂（分散片、泡腾片、口腔崩解片、含片、咀嚼片、泡腾片）、胶囊剂（硬胶囊、软胶囊剂）、颗粒剂、丸剂（滴丸剂）、散剂等固体制剂形式的口服药物，也可以制成糖浆、口服液、袋装茶剂、袋泡茶剂等液体制剂形式的口服药物；还可以制成膏剂、凝胶剂、软膏剂、巴布剂、贴膏剂、搽剂、洗剂、涂膜剂等外用制剂形式的外用药物。因此，该药物组合物中除有效成分外，还可以含有药学上可以接受的辅料。
这里所述的辅料，可以根据不同的制剂有所不同，如在片剂、胶囊剂、颗粒剂等固体制剂中常用的稀释剂、崩解剂、赋形剂、粘合剂、润滑剂、表面活性剂、填充剂等；在糖浆、口服液等液体制剂形式中常用的表面活性剂、稀释剂、防腐剂、稳定剂、矫味剂、增稠剂、助流剂等；在凝胶剂、软膏剂等外用制剂形式中常用的药用油性基质、水性基质、防腐剂、抗氧剂、保湿剂、透皮吸收促进剂、表面活性剂等。
其常用辅料如淀粉、乳糖、糊精、糖粉、微晶纤维素、甘露醇、木糖醇、聚乙二醇、硫酸钙、磷酸氢钙、碳酸钙、改良淀粉、山梨醇、聚乙烯吡咯烷酮、重质碳酸镁、羧甲基纤维素钠、羟丙甲基纤维素、甲基纤维素、乙基纤维素、羧甲淀粉钠、羟丙基纤维素、聚维酮K30、白陶土、预胶化淀粉、硬脂酸镁、滑石粉、微粉硅胶、甜叶菊苷、甜菜碱、阿司帕坦、甘草甜素、糖精钠、枸橼酸、碳酸氢钠、碳酸钠、卡拉胶、琼脂、明胶、海藻酸钠、黄原胶、瓜耳豆胶、西黄耆胶、阿拉伯胶、槐豆胶、刺梧桐胶、硬脂酸、单硬脂酸甘油酯、聚丙烯酰胺、交联型聚丙烯酸钠、聚乙烯醇、卡波姆、山梨酸、山梨酸钾、羟苯乙酯、苯甲醇、尼泊金、硫柳汞、二甲基亚砜、氮酮、三乙醇胺、氢氧化钠、甘油、丙二醇、B小时T、B小时A、十二烷基硫酸钠、吐温类、司盘类等。
为了使该组合物的各组分能更好的发挥药效，优选对本发明所述重量份配比的组分采取如下的制备方法，但不能用于限制本发明的保护范围。
本发明组合物颗粒剂的制备方法如下：
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加5-15倍量水提取1-3次，每次1-3小时，过滤，合并滤液，备用；玛咖加1-5倍量10-90%乙醇浸润，浸泡24-60小时，渗滤提取，收集4-12倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量辅料混合均匀，制粒，干燥，整粒，制成颗粒剂。
本发明组合物颗粒剂的制备方法优选为：
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量水提取2次，每次2小时，过滤，合并滤液，备用；玛咖加2倍量30%乙醇浸润，浸泡48小时，渗滤提取，收集8倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量辅料混合均匀，制粒，干燥，整粒，制成颗粒剂。
本发明组合物颗粒剂的制备方法还可以为：
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加5-15倍量水提取1-3次，每次1-3小时，过滤，合并滤液，备用；玛咖加5-15倍量10-90%乙醇回流提取1-3次，每次1-3小时，过滤，合并滤液，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量辅料混合均匀，制粒，干燥，整粒，制成颗粒剂。
本发明组合物片剂的制备方法为：
取所述重量份的玛咖、枸杞子、菟丝子、覆盆子、车前子、五味子，加水或不同浓度的乙醇提取，提取液合并，过滤，滤液减压干燥，粉碎成细粉，加入适量的填充剂、崩解剂、矫味剂，混匀，制粒，干燥，加入硬脂酸镁，混匀，压片，包衣或不包衣，即得片剂。
本发明组合物片剂的制备方法还可以为：
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加5-15倍量水提取1-3次，每次1-3小时，过滤，合并滤液，备用；玛咖加1-5倍量10-90%乙醇浸润，浸泡24-60小时，渗滤提取，收集4-12倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，加入适量的填充剂、崩解剂、矫味剂，混匀，制粒，干燥，加入硬脂酸镁，混匀，压片，包衣或不包衣，即得片剂。
以下通过实施例形式的具体实施方式，对本发明的上述内容作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实施例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1
玛咖20g、枸杞子40g、菟丝子35g、覆盆子20g、车前子10g、五味子10g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量水提取2次，每次2小时，过滤，合并滤液，备用；玛咖加2倍量30%乙醇浸润，浸泡48小时，渗滤提取，收集8倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例2
玛咖15g、枸杞子30g、菟丝子30g、覆盆子15g、车前子5g、五味子8g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加8倍量水提取2次，每次2小时，过滤，合并滤液，备用；玛咖加2倍量30%乙醇浸润，浸泡48小时，渗滤提取，收集8倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例3
玛咖30g、枸杞子50g、菟丝子40g、覆盆子25g、车前子15g、五味子17g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加5倍量水提取3次，每次1小时，过滤，合并滤液，备用；玛咖加1倍量90%乙醇浸润，浸泡60小时，渗滤提取，收集4倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例4
玛咖40g、枸杞子60g、菟丝子60g、覆盆子30g、车前子18g、五味子20g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加15倍量水提取1次，提取3小时，过滤，合并滤液，备用；玛咖加5倍量10%乙醇浸润，浸泡24小时，渗滤提取，收集12倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量淀粉、乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例5
玛咖40g、枸杞子30g、菟丝子20g、覆盆子30g、车前子15g、五味子8g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加12倍量水提取2次，每次1小时，过滤，合并滤液，备用；玛咖加70%乙醇回流提取2次，第1次加8倍量提取2小时，第2次加6倍量提取2小时，过滤，合并滤液，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例6
玛咖10g、枸杞子25g、菟丝子40g、覆盆子15g、车前子5g、五味子15g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加8倍量水提取3次，每次1小时，过滤，合并滤液，备用；玛咖加8倍量50%乙醇回流提取2次，每次2小时，过滤，合并滤液，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量糊精、麦芽糊精混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例7
玛咖10g、枸杞子20g、菟丝子20g、覆盆子10g、车前子2g、五味子5g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加5倍量水提取2次，每次2小时，过滤，合并滤液，备用；玛咖加2倍量30%乙醇浸润，浸泡48小时，渗滤提取，收集8倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，加入适量的羧甲基淀粉钠、微粉硅胶、微晶纤维素、交联聚维酮、木糖醇，充分混合，制粒，干燥，整粒，加入适量硬脂酸镁，混匀，压片，包衣或不包衣，即得片剂。
实施例8
玛咖40g、枸杞子20g、菟丝子60g、覆盆子10g、车前子20g、五味子20g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量水提取2次，提取时间1小时，过滤，合并滤液，备用；玛咖加15倍量10%乙醇回流提取2次，每次1小时，过滤，合并滤液，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，加入适量辅料，混匀，制粒，干燥，装胶囊，制成胶囊剂。
实施例9
玛咖35g、枸杞子50g、菟丝子20g、覆盆子20g、车前子5g、五味子10g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加12倍量水提取1次，提取时间3小时，过滤，合并滤液，备用；玛咖加4倍量70%乙醇浸润，浸泡48小时，渗滤提取，收集8倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，加入适量辅料，混匀，制成丸剂。
实施例10
玛咖20g、枸杞子20g、菟丝子20g、覆盆子20g、车前子20g、五味子20g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加8倍量水提取2次，提取时间3小时，过滤，合并滤液，备用；玛咖加5倍量60%乙醇浸润，浸泡48小时，渗滤提取，收集10倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量乳糖、微晶纤维素混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例11
玛咖10g、枸杞子30g、菟丝子20g、覆盆子10g、车前子2g、五味子15g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加6倍量水提取3次，提取时间1小时，过滤，合并滤液，备用；玛咖加6倍量90%乙醇回流提取1次，提取3小时，过滤，合并滤液，滤液回收乙醇至无醇味，与水提滤液合并，适当浓缩，加入适量的混悬剂、调味剂、防腐剂，混匀，加水定容，滤过，分装，制成口服液体制剂。
实施例12
玛咖20g、枸杞子20g、菟丝子20g、覆盆子20g、车前子20g、五味子20g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加8倍量水提取2次，提取时间1.5小时，过滤，合并滤液，备用；玛咖加5倍量80%乙醇回流提取2次，提取1小时，过滤，合并滤液，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，制成散剂。
实施例13
玛咖25g、枸杞子30g、菟丝子40g、覆盆子20g、车前子15g、五味子10g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加8倍量水提取2次，每次1小时，过滤，合并滤液，备用；玛咖加5倍量20%乙醇浸润，浸泡36小时，渗滤提取，收集10倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，加入适量的羧甲基淀粉钠、微粉硅胶、微晶纤维素、交联聚维酮、木糖醇，充分混合，制粒，干燥，整粒，加入适量硬脂酸镁，混匀，压片，包衣，即得片剂。
实施例14
玛咖15g、枸杞子45g、菟丝子25g、覆盆子15g、车前子10g、五味子5g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量水提取2次，提取时间1小时，过滤，合并滤液，备用；玛咖加3倍量50%乙醇浸润，浸泡48小时，渗滤提取，收集6倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量微晶纤维素、乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例15
玛咖37g、枸杞子26g、菟丝子40g、覆盆子14g、车前子5g、五味子18g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加12倍量水提取2次，提取时间2小时，过滤，合并滤液，备用；玛咖加10倍量30%乙醇回流提取2次，每次2小时，过滤，合并滤液，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，加入适量辅料，混匀，制粒，干燥，装胶囊，制成胶囊剂。
实施例16
玛咖20g、枸杞子40g、菟丝子35g、覆盆子20g、车前子10g、五味子10g
取所述重量份的玛咖、枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量水提取2次，每次2小时，过滤，合并滤液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量甘露醇、乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例17
玛咖20g、枸杞子40g、菟丝子35g、覆盆子20g、车前子10g、五味子10g
取所述重量份的玛咖、枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量70%乙醇回流提取2次，每次2小时，过滤，合并滤液，滤液回收乙醇至无醇味，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量乳糖混合均匀，制粒，干燥，整粒，制成颗粒剂。
实施例18
玛咖20g、枸杞子40g、菟丝子35g、覆盆子20g、车前子10g、五味子10g
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量水提取2次，每次2小时，过滤，合并滤液，备用；玛咖加2倍量30%乙醇浸润，浸泡48小时，渗滤提取，收集8倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，按常规方法制成袋装茶剂、袋泡茶剂。
实施例19
玛咖20g、枸杞子40g、菟丝子35g、覆盆子20g、车前子10g、五味子10g
取所述重量份的玛咖、枸杞子、菟丝子、覆盆子、车前子、五味子直接粉碎成粗粉，按常规方法制成袋装茶剂、袋泡茶剂。
根据上述内容，在不脱离本发明基本技术思想前提下，按照本领域的普通技术知识和惯用手段，显然还可以作出其他多种形式的修改、替换和变更。
通过以下实验进一步阐述本发明所述组合物的有益效果：
1、材料和方法
（1）样品：按照实施例1-3制备的样品。
（2）实验动物：18-22g昆明种健康清洁级小鼠192只，共分为四批进行实验，每批随机分为4组，每组12只。
实验一批进行脏器/体重比值测定、迟发型变态反应实验、半数溶血值(小时C50)的测定和抗体生成细胞数的测定；
实验二批进行碳廓清实验；
实验三批进行小鼠腹腔巨噬细胞吞噬鸡红细胞实验；
实验四批进行ConA诱导的小鼠淋巴细胞转化实验和NK细胞活性测定。
（3）剂量：
受试物以无菌水配制，每日一次经口给予，连续灌胃33天后测各项指标。小鼠灌胃体积为0.1mL/10g鼠重。
同时设一空白对照组(0g/kgBW)，用无菌水替代受试物，每日灌胃体积与各受试物组相同。
（4）主要仪器与试剂
ES-2100A电子天平、BS223S电子天平、755分光光度计、酶标仪、二氧化碳培养箱、低速离心机、恒温水浴、显微镜、倒置显微镜、螺旋测微仪。
洁净工作台、无菌手术器械、微量注射器(25μL)、细胞计数器、24孔和96孔平底细胞培养板、96孔U型细胞培养板、玻璃平皿、纱布、试管、玻片架、200目筛网、计时器、血色素吸管、载玻片等。
绵羊红细胞(SRBC)、生理盐水、小时ank's液(p小时 7.2-7.4)、RPMIl640培养液、小牛血清、青霉素、链霉素、刀豆蛋白A(ConA)、1％冰醋酸、1mol/L的小时Cl溶液、酸性异丙醇(96mL异丙醇加1mol/L的小时Cl溶液4mL)、MTT、PBS缓冲液(p小时 7.2-7.4)、补体(豚鼠血清)、SA缓冲液、琼脂糖、都氏试剂(碳酸氢钠1.0g，高铁氰化钾0.2g，氰化钾0.05g，加蒸馏水至1000mL)、YAC-1细胞、乳酸锂、硝基氯化四氮唑、吩嗪二甲酯硫酸盐、氧化型辅酶I、0.2mol/L的Tris-小时Cl缓冲液(p小时 8.2)、1％NP40、印度墨汁、0.1％Na2CO3、鸡红细胞、甲醇、Giemsa染液等。
（5）实验方法：
A.脏器体重比值的测定
小鼠称重后颈椎脱臼处死，取脾脏和胸腺，去尽筋膜，用滤纸吸干脏器表面血污，称重，计算脾脏体重比值和胸腺体重比值。
B.迟发型变态反应(DT小时)实验(足跖增厚法)
取羊血，生理盐水洗涤3次，每只鼠经腹腔注射2％(v/v，用生理盐水配制)压积SRBC(2000r/min，10min)0.2mL，致敏后4d，测量左后足跖部厚度，同一部位测量三次，取平均值。然后在测量部位皮下注射20％(v/v，用生理盐水配制)压积SRBC 20μL，于注射后24小时测量左后足跖部厚度，以攻击前后足跖厚度的差值来表示DT小时的程度。受试样品组的差值显著高于对照组的差值，可判定该项实验结果阳性。
C.ConA诱导的小鼠淋巴细胞转化实验(MTT法)
无菌取脾，置于盛有适量无菌小时ank’s液的小平皿中，用镊子轻轻将脾磨碎，制成单个细胞悬液。经200目筛网过滤，制成细胞悬液。用小时ank’s液洗3次，每次离心10min(1000r/min)。然后将细胞悬浮于1mL的完全培养液中，镜检计数，调整细胞浓度为3×106个/mL。再将脾细胞悬液分两孔加入24孔培养板中，每孔1mL，在其中一孔加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72小时。培养结束前4小时，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4小时。培养结束后，每孔加入1mL酸性异丙醇，吹打混匀，使紫色结晶完全溶解。然后将此液体移入比色杯中，在755分光光度计上比色测定，波长570nm。淋巴细胞的增殖能力用加ConA孔的光密度值减去不加ConA孔的光密度值代表淋巴细胞的增值能力。受试样品组的光密度差值显著高于对照组的光密度差值，可判定该项实验结果阳性。
D.抗体生成细胞数的测定(Jerne改良玻片法)
取羊血，生理盐水洗涤3次，每只鼠经腹腔注射2％(v/v，用生理盐水配制)压积SRBC0.2mL。将SRBC免疫5天后的小鼠颈椎脱臼处死，取出脾脏，轻轻磨碎脾脏，制成细胞悬液。离心(1000r/min)10min，用小时ank’s液洗2遍，最后将细胞悬液在8mL 小时ank’s液中。将琼脂糖加热溶解后，与等量双倍小时ank’s液混合，分装小试管，每管0.5mL，再向管内加10％(v/v，用SA液配制)压积SRBC 50μL、脾细胞悬液8μL，迅速混匀后，倾倒于已刷琼脂糖薄层的玻片上，做平行片，待琼脂凝固后，将玻片水平扣放在片架上，放入二氧化碳培养箱中37℃温育1小时，然后用SA缓冲液稀释的补体(1∶8)加入到玻片架凹槽内，继续温育1.5小时后，计数溶血空斑数。用空斑数/全脾细胞来表示。受试样品组的空斑数显著高于对照组的空斑数，可判定该项实验结果阳性。
E.半数溶血值(小时C50)的测定
取羊血，生理盐水洗涤3次，每只鼠经腹腔注射2％(v/v，用生理盐水配制)压积SRBC0.2mL进行免疫。5天后，摘除眼球取血于离心管内，放置约1小时，将凝固血与管壁剥离，使血清充分析出，2000r/min离心10min，收集血清。用SA缓冲液将血清稀释为300倍，取1mL置试管内，依次加入10％(v/v，用SA缓冲液配制)压积SRBC 0.5mL，补体1mL(用SA缓冲液按1∶8稀释)。另设不加血清的对照管(以SA缓冲液代替)。置37℃恒温水浴中保温15min后，冰浴终止反应。2000r/min离心10min，取上清1mL，加都氏试剂至3mL。同时取10％(v/v，用SA缓冲液配制)的压积SRBC 0.25mL，加都氏试剂至4mL于另一试管中，充分混匀，放置10min后，于540nm处以对照管作空白，分别测定各管光密度值。溶血素的量以半数溶血值(小时C50)表示，按下式计算：样品半数溶血值＝样品光密度值/SRBC半数溶血时的光密度值×稀释倍数受试样品组的小时C50显著高于对照组的小时C50，可判定该项实验结果阳性。
F.小鼠碳廓清实验
按体重从小鼠尾静脉注射稀释4倍的印度墨汁(0.05mL/10g)。待墨汁注入，立即计时。注入墨汁后2、10min，分别从内眦静脉丛取血20μL，并将其加到2mL 0.1％Na2CO3溶液中。用755分光光度计在600nm波长处测光密度值(OD)，以Na2CO3溶液作空白对照。将小鼠处死，取肝脏和脾脏称重。以碳廓清指数(a)表示小鼠碳廓清的能力，按下式计算a：
k＝(lgOD1-lgOD2)/(t2-t1) a＝体重÷(肝重+脾重)×k1/3
受试样品组的碳廓清指数显著高于对照组的碳廓清指数，可判定该项实验结果阳性。
G.小鼠腹腔巨噬细胞吞噬鸡红细胞实验(半体内法)
小鼠腹腔注射20％(v/v，用生理盐水配制)鸡红细胞(2000r/min，10min)悬液1mL，间隔30min，颈椎脱臼处死，将其仰位固定于鼠板上，经腹腔注入生理盐水2mL，转动鼠板1min。取腹腔巨噬细胞洗液1mL，分别滴于2片载玻片上，放入垫有湿纱布的搪瓷盒内，移置37℃孵箱温育30min。孵毕，于生理盐水中漂洗，以除去未贴片细胞。晾干，以1∶1丙酮甲醇溶液固定，Gicmsa-磷酸缓冲液染色，再用蒸馏水漂洗晾干。油镜下计数，每片计数100个巨噬细胞，按下式计算吞噬率和吞噬指数：
吞噬百分率(％)＝吞噬鸡红细胞的巨噬细胞数/计数的巨噬细胞数×100
吞噬指数＝被吞噬的鸡红细胞总数/计数的巨噬细胞数
得出的吞噬百分率再按下式进行数据转换，X＝Sin-1 ，式中P为吞噬百分率，用小数表示。所得数据为计量资料，受试样品组的吞噬百分率和吞噬指数均显著高于对照组的吞噬百分率和吞噬指数，可判定该项实验结果阳性。
小时.NK细胞活性的测定(乳酸脱氢酶LD小时测定法)
实验前24小时将靶细胞YAC-1进行传代培养，应用前以小时ank’s液洗3次，用含10％小牛血清的RPMI1640完全培养液调整细胞浓度为4×105个/mL。受试小鼠颈椎脱臼处死，无菌取脾，制成脾细胞悬液，用小时ank’s液洗2次，每次离心10min(1000r/min)。弃上清将细胞浆弹起，加入0.5mL灭菌水20秒，裂解红细胞后再加入0.5mL 2倍小时ank’s液及8mL小时ank’s液，1000r/min，10min离心，用1mL含10％小牛血清的RPMI1640完全培养液重悬，镜检计数，用RPMI1640完全培养液调整细胞浓度为2×107个/mL。使效靶比为50∶1。取靶细胞和效应细胞各100μL，加入U形96孔培养板中；靶细胞自然释放孔加靶细胞和培养液各100μL，靶细胞最大释放孔加靶细胞和1％NP40各100μL；上述各项均设三个平行孔，37℃、5％CO2培养箱中培养4小时，将96孔板以1500r/min离心5min，每孔吸取上清100μL置平底96孔培养板中，加入LD小时基质液100μL，反应3-10min，然后每孔加入1mol/L的小时Cl溶液30μL终止反应，在酶标仪490nm处测光密度值(OD)，计算NK细胞活性：
NK细胞活性(％)＝(反应孔OD-自然释放孔OD)/(最大释放孔OD-自然释放孔OD)×100
得出的NK细胞活性按下式进行数据转换，X＝Sin-1 ，式中P为NK细胞活性，用小数表示。所得数据为计量资料，受试样品组的NK细胞活性显著高于对照组的NK细胞活性，可判定该项实验结果阳性。
（6）数据处理
用SPSS软件进行数据处理。采用方差分析，但需按方差分析的程序先进行方差齐性检验，方差齐，计算F值，F值＜F0.05，结论：各组均数间差异无显著性，F值≥F0.05，P≤0.05，用多个实验组和一个对照组间均数的两两比较方法进行统计；对非正态或方差不齐的数据进行适当的变量转换，待满足正态或方差齐要求后，用转换后的数据进行统计；若变量转换后仍未达到正态或方差齐的目的，改用秩和检验进行统计。
（7）结果判定依据
《保健食品检验与评价技术规范)》（2003版）规定：在细胞免疫功能、体液免疫功能、单核-巨噬细胞功能、NK细胞活性四个方面任两个方面结果阳性，可判定该受试样品具有增强免疫力功能作用。其中细胞免疫功能测定项目中的两个实验结果均为阳性，或任一实验的两个剂量组结果阳性，可判定细胞免疫功能测定结果阳性。体液免疫功能测定项目中的两个实验结果均为阳性，或任一实验的两个剂量组结果阳性，可判定体液免疫功能测定结果阳性。单核-巨噬细胞功能测定项目中的两个实验结果均为阳性，或任一实验的两个剂量组结果阳性，可判定单核-巨噬细胞功能结果阳性。NK细胞活性测定实验的一个以上剂量组结果阳性，可判定NK细胞活性结果阳性。
2、结果
（1）本发明组合物对小鼠体重的影响
通过称重可知，小鼠的初始体重在四批实验动物各样品组与空白对照组间比较，差异均无显著性(P＞0.05)。即小鼠的初始体重在各组间较为均衡。
经口给予小鼠本发明组合物33天后，小鼠的体重在四批各样品组与空白对照组间比较，差异均无显著性(P＞0.05)。即本发明组合物对小鼠体重无不良影响。
（2）本发明组合物对小鼠脏器/体重比值的影响
表1 本发明组合物对小鼠脾脏/体重比值的影响(±S)
| 组别 | 动物数（只） | 脾脏/体重比值（mg/g） | P值 |
| 空白对照组 | 12 | 5.3±1.0 | —— |
| 样品组1 | 12 | 5.5±0.7 | 0.831 |
| 样品组2 | 12 | 5.2±0.6 | 0.714 |
| 样品组3 | 12 | 5.0±0.8 | 0.689 |
由表1可见，经口给予小鼠本发明组合物后，各样品组脾脏/体重比值与空白对照组比较，差异均无显著性(P＞0.05)。即本发明组合物对小鼠的脾脏/体重比值无特别影响。
表2 本发明组合物对小鼠胸腺/体重比值的影响(±S)
| 组别 | 动物数（只） | 胸腺/体重比值（mg/g） | P值 |
| 空白对照组 | 12 | 2.6±0.5 | —— |
| 样品组1 | 12 | 2.5±0.4 | 0.916 |
| 样品组2 | 12 | 2.3±0.8 | 0.789 |
| 样品组3 | 12 | 2.4±0.6 | 0.865 |
由表2可见，经口给予小鼠本发明组合物33天后，各剂量组胸腺/体重比值与空白对照组比较，差异均无显著性(P＞0.05)。即本发明组合物对小鼠的胸腺/体重比值无特别影响。
（3）本发明组合物对小鼠细胞免疫功能的影响
表3 本发明组合物对小鼠迟发型变态反应(DT小时)的影响(±S)
| 组别 | 动物数（只） | 足跖肿胀度（mm） | P值 |
| 空白对照组 | 12 | 0.53±0.22 | —— |
| 样品组1 | 12 | 0.84±0.10* | 0.014 |
| 样品组2 | 12 | 0.82±0.21* | 0.021 |
| 样品组3 | 12 | 0.83±0.16* | 0.026 |
*与空白对照组比较，P＜0.05
由表3可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，小鼠的足跖肿胀度有显著性差异（P＜0.05）。即本发明组合物能显著提高小鼠足跖肿胀度。
表4 本发明组合物对小鼠淋巴细胞转化实验的影响(±S)
| 组别 | 动物数（只） | 淋巴细胞增殖能力（OD差值） | P值 |
| 空白对照组 | 12 | 0.25±0.12 | —— |
| 样品组1 | 12 | 0.43±0.16* | 0.017 |
| 样品组2 | 12 | 0.39±0.13* | 0.036 |
| 样品组3 | 12 | 0.41±0.15* | 0.028 |
*与空白对照组比较，P＜0.05
由表4可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，小鼠的淋巴细胞增殖能力有显著性差异（P＜0.05）。即本发明组合物能显著提高ConA诱导的小鼠淋巴细胞转化能力。
（4）本发明组合物对体液免疫的影响
表5 本发明组合物对小鼠抗体生成细胞数的影响(±S)
| 组别 | 动物数（只） | 溶血空斑数（×103/全脾） | P值 |
| 空白对照组 | 12 | 145±48 | —— |
| 样品组1 | 12 | 197±43* | 0.042 |
| 样品组2 | 12 | 203±51* | 0.023 |
| 样品组3 | 12 | 196±40* | 0.046 |
*与空白对照组比较，P＜0.05
由表5可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，小鼠抗体生成细胞数有显著性差异（P＜0.05）。即本发明组合物能显著提高小鼠抗体生成细胞数。
表6 本发明组合物对小鼠半数溶血值(小时C50)的影响(±S)
| 组别 | 动物数（只） | 样品半数溶血值 | P值 |
| 空白对照组 | 12 | 162±44 | —— |
| 样品组1 | 12 | 220±32* | 0.016 |
| 样品组2 | 12 | 212±40* | 0.028 |
| 样品组3 | 12 | 210±28* | 0.014 |
*与空白对照组比较，P＜0.05
由表6可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，小鼠的半数溶血值有显著性差异（P＜0.05）。即本发明组合物能显著提高小鼠半数溶血值。
（5）本发明组合物对小鼠单核-巨噬细胞吞噬功能的影响
表7 本发明组合物对小鼠碳廓清能力的影响(±S)
| 组别 | 动物数（只） | 吞噬指数（a） | P值 |
| 空白对照组 | 12 | 5.12±0.43 | —— |
| 样品组1 | 12 | 6.18±0.32* | 0.010 |
| 样品组2 | 12 | 5.97±0.63* | 0.021 |
| 样品组3 | 12 | 6.03±0.44* | 0.018 |
*与空白对照组比较，P＜0.05
由表7可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，小鼠的碳廓清能力有显著性差异（P＜0.05）。即本发明组合物能显著提高小鼠的碳廓清能力。
表8 本发明组合物对小鼠巨噬细胞吞噬鸡红细胞吞噬率的影响(±S)
| 组别 | 动物数（只） | 吞噬率（%） | 吞噬率平方根反正弦转换值 | P值 |
| 空白对照组 | 12 | 25±10 | 0.48±0.11 | —— |
| 样品组1 | 12 | 37±13* | 0.73±0.12 | 0.029 |
| 样品组2 | 12 | 38±9* | 0.79±0.15 | 0.021 |
| 样品组3 | 12 | 35±7* | 0.67±0.08 | 0.036 |
*与空白对照组比较，P＜0.05
由表8可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，吞噬率有显著性差异（P＜0.05）。即本发明组合物能显著提高小鼠巨噬细胞吞噬鸡红细胞吞噬率。
表9 本发明组合物对小鼠巨噬细胞吞噬鸡红细胞吞噬指数的影响(±S)
| 组别 | 动物数（只） | 吞噬指数 | P值 |
| 空白对照组 | 12 | 0.36±0.21 | —— |
| 样品组1 | 12 | 0.63±0.14* | 0.024 |
| 样品组2 | 12 | 0.56±0.17* | 0.045 |
| 样品组3 | 12 | 0.59±0.23* | 0.036 |
*与空白对照组比较，P＜0.05
由表9可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，吞噬指数有显著性差异（P＜0.05）。即本发明组合物能显著提高小鼠巨噬细胞吞噬鸡红细胞吞噬指数。
（6）本发明组合物对小鼠NK细胞活性的影响
表10 本发明组合物对小鼠NK细胞活性的影响(±S)
| 组别 | 动物数（只） | NK细胞活性（%） | NK细胞活性平方根反正弦转换值 | P值 |
| 空白对照组 | 12 | 24.7±6.4 | 0.46±0.12 | —— |
| 样品组1 | 12 | 40.8±6.2* | 0.79±0.17 | 0.021 |
| 样品组2 | 12 | 38.3±5.6* | 0.65±0.21 | 0.043 |
| 样品组3 | 12 | 39.1±7.2* | 0.72±0.15 | 0.034 |
*与空白对照组比较，P＜0.05
由表10可见，经口给予小鼠本发明组合物33天后，各样品组与空白对照组比较，小鼠NK细胞活性有显著性差异（P＜0.05）。即本发明组合物能显著提高小鼠NK细胞活性。
本发明实施例4-19均按照上述方法进行了相似的试验，结果与上述结果相同。
3、结论
经口给予小鼠本发明组合物33天后，与空白对照组比较，本发明组合物能显著提高小鼠足跖肿胀度(P＜0.05)、提高ConA诱导的小鼠淋巴细胞转化能力(P＜0.05)、提高小鼠抗体生成细胞数(P＜0.05)、提高小鼠半数溶血值(P＜0.05)、提高小鼠的碳廓清能力(P＜0.05)、提高小鼠巨噬细胞吞噬鸡红细胞吞噬率(P＜0.05)、提高小鼠巨噬细胞吞噬鸡红细胞吞噬指数(P＜0.05)、提高小鼠NK细胞活性（P＜0.05），且本发明组合物对小鼠体重增长无不良影响。根据《保健食品检验与评价技术规范》（2003版）对增强免疫力保健食品的评判标准可知，本发明组合物具有增强免疫力的功能。
Claims (10)
1.一种具有增强免疫力功能的组合物，其特征在于，按重量份计，制成该组合物的原料药为：玛咖10-40份、枸杞子20-60份、菟丝子20-60份、覆盆子10-40份、车前子1-20份、五味子1-20份。
2.根据权利要求1所述的组合物，其特征在于，按重量份计，制成该组合物的原料药为：玛咖15-30份、枸杞子30-50份、菟丝子30-50份、覆盆子15-30份、车前子5-15份、五味子5-15份。
3.权利要求1或2所述组合物的制备方法，其特征在于，它是这样制备的：
取所述重量份的玛咖、枸杞子、菟丝子、覆盆子、车前子、五味子直接粉碎成粉末；加水或不同浓度的乙醇提取，提取液浓缩干燥得粗提物；或进一步采用水提醇沉法、有机溶剂萃取法、柱层析法、二氧化碳超临界萃取法、水蒸气蒸馏法的一种或几种联合使用进行适当精制后得精提物；上述药材粉末或粗提物或精提物不加或者加入适量辅料，按常规工艺制成药剂学上可接受的制剂。
4.根据权利要求3所述的制备方法，其特征在于，所述的制剂是指片剂、颗粒剂、胶囊剂、丸剂、散剂、口服液体制剂、袋装茶剂、袋泡茶剂。
5.根据权利要求4所述的制备方法，其特征在于，所述的制剂是指颗粒剂。
6.根据权利要求5所述的制备方法，其特征在于，颗粒剂是这样制备的：
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加5-15倍量水提取1-3次，每次1-3小时，过滤，合并滤液，备用；玛咖加1-5倍量10-90%乙醇浸润，浸泡24-60小时，渗滤提取，收集4-12倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量辅料混合均匀，制粒，干燥，整粒，制成颗粒剂。
7.根据权利要求6所述的制备方法，其特征在于，颗粒剂是这样制备的：
取所述重量份的枸杞子、菟丝子、覆盆子、车前子、五味子，加10倍量水提取2次，每次2小时，过滤，合并滤液，备用；玛咖加2倍量30%乙醇浸润，浸泡48小时，渗滤提取，收集8倍量渗滤液，过滤，滤液回收乙醇至无醇味，与水提滤液合并，减压浓缩，离心，取上清液，减压浓缩至稠膏，减压干燥，粉碎成细粉，与适量辅料混合均匀，制粒，干燥，整粒，制成颗粒剂。
8.根据权利要求6或7所述的制备方法，其特征在于，所述的辅料是指糊精、麦芽糊精、淀粉、预胶化淀粉、甘露醇、微晶纤维素、乳糖中的一种或一种以上。
9.根据权利要求8所述的制备方法，其特征在于，所述的辅料是指乳糖。
10.权利要求1或2所述组合物用于制备具有增强免疫力功能的保健食品中的应用。
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