CN106420860A - 一种含有沙棘油和蜂胶的药物组合物 - Google Patents
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Abstract
本发明公开了一种含有沙棘油和蜂胶的药物组合物，其中，沙棘油与蜂胶的重量比例为8‑15：1。本发明药物组合物是将蜂胶和沙棘油按照比例充分溶解混匀而成，服用安全，具有显著的增强免疫力功能，且经现代工艺制成服用方便，利于吸收的产品形态。
Description
技术领域
本发明属于中药技术领域，具体涉及一种含有沙棘油和蜂胶的药物组合物。
背景技术
所谓免疫力，就是人体防御疾病的能力，免疫力低下就是防御疾病能力的减弱。人之所以能在各种环境中健康地生存，人体免疫系统起着决定性的作用。在我们的周围存在很多致病性因素，如细菌病毒能传播疾病。人类抵制细菌性或病毒性疾病的问题，就是依靠自身的免疫力。
另外，增强免疫力能够防治癌症。每个人体内均存在着癌症基因。身体受环境、饮食等诸种因素影响，大约有千万个细胞发生突变。当营养供给良好、免疫力强的时候，尽管有突变的细胞，但在强大的免疫系统的攻击下，都会被消灭。现实生活中，由于营养不良等多种因素引起免疫力降低，使得免疫活性细胞不能识别突变细胞，使其生长繁殖，最后发展成为癌症。
特别应强调指出的是，被称为身体健康卫士的淋巴T细胞，在免疫功能上发挥着重要的作用——通过免疫调节，识别并消灭癌细胞。体内还存在着许多种生物活性物质，其中很多就是淋巴细胞分泌的，它们可帮助免疫活性细胞杀伤癌细胞，如干扰素、白细胞介素等就起这样的作用。增强免疫力已成为当今人们日益重视的一个保健问题。
一般人如果有以下现象，都属于免疫力低下：容易感到疲劳，但是查不出器质性病变；经常感冒；伤口容易感染，愈合慢；肠胃差。这里主要是指稍微吃得不合适就上吐下泻。此外，经常服用抗生素的人、经常熬夜的人、工作压力大的人、慢性病患者和中老年人也需增强免疫力。
营养、免疫、疾病的关系是三角的关系，均衡的营养会使人的免疫系统充满活力，能够最大限度地保护机体不被入侵者杀伤。因此开发增强免疫力的保健食品是我国科研人员和企业一项至关重要的任务和责任。
发明内容
本发明是针对免疫力低下人群的需要而设计，旨在提高人们的健康水平，从传统中药中开发出可以增强免疫力的、改善免疫力低下者的生活质量、无副作用和不良反应的保健食品。使用现代制剂技术，较为先进的质量控制方法，使得产品做到安全、稳定、质量可控。
本发明的目的是通过以下方式实现的：
一种含有沙棘油和蜂胶的药物组合物，其中，沙棘油与蜂胶的重量比例为8-15：1。优选沙棘油与蜂胶的重量比例为10-12：1，最优选沙棘油与蜂胶的重量比例为455：45。
上述含有沙棘油和蜂胶的药物组合物的制备方法包括以下步骤：蜂胶和沙棘油按照比例充分溶解混匀。
上述药物组合物与药学上可接受的辅料制成制剂，优选所述的制剂为蜜丸、滴丸、胶囊剂、软胶囊。由于主要原料是油状液体，适宜做成软胶囊制剂，服用、携带、储藏、运输方便。
上述含有沙棘油和蜂胶的药物组合物可在制备提高免疫力的药物中应用。
上述含有沙棘油和蜂胶的药物组合物可在制备提高非特异性免疫、体液免疫和细胞免疫功能的药物中应用。
沙棘(hippophae rhamnoides L.)又名醋柳、酸刺、黑刺，为胡颓子科酸刺属的灌木或小乔木沙棘的成熟果实和叶。沙棘的主要功效为健脾消食，止咳祛痰，活血散散瘀。主要用于脾虚食少，食积腹痛，咳嗽痰多，胸痹心痛，瘀血经闭，跌打瘀肿。其化学成分主要有黄酮类、萜类、甾体类、蛋白质和氨基酸类、油和脂肪酸类、挥发油类、有机酸类、糖及微量元素等，是一种营养丰富、药用价值极高的植物。本发明所选用的沙棘油优选从沙棘籽中通过CO2超临界萃取提取出来的天然成分。
蜂胶是蜜蜂从植物的树芽、树皮等部位采集的树脂，再混以蜜蜂舌腺、蜡腺等腺体的分泌物，经蜜蜂加工转化而成的一种胶状物质。蜜蜂将这些物质涂布在整个蜂巢的表面；一方面起防腐、抗氧化作用，一方面来粘合蜂巢，堵塞缝隙等，使众多病菌无法在蜂巢内滋生。蜂胶能起到全面调理，平衡机体免疫功能的作用，据《中华本草》记载：蜂胶对糖尿病、高血脂、高血压、肿瘤、息肉、多种炎症、病菌引起的疾病等有很好的辅助治疗作用。本发明选用的蜂胶优选采用CO2超临界萃取而得蜂胶，色泽金黄，芳香，无溶残，可排除铅的存在，亦可减少过敏性物质，品质高。而且CO2超临界提取的蜂胶可完全溶解于沙棘油中，便于制得均一的软胶囊内容物。
与现有技术比较本发明的有益效果：本发明药物组合物能显著提高非特异性免疫、体液免疫和细胞免疫功能，以此判定该药物组合物具有显著的增强免疫力功能，且经现代工艺制成服用方便，利于吸收的产品形态。
具体实施方式
以下通过具体试验例对本发明进行进一步说明：
本产品主要原料为沙棘油和蜂胶。蜂胶来源于上海协美蜂产品有限公司。沙棘油来源于吉水县联兴药用香料有限公司。明胶来源于罗赛洛(温州)明胶有限公司，质量符合《中华人民共和国药典》的要求。甘油来源于嘉里油脂化学工业(上海)有限公司，质量符合中华人民共和国药典2010年版的要求。纯化水为本公司自制，质量符合中华人民共和国药典2010年版的要求。
实施例1
沙棘油 455g
蜂胶 45g
制成 1000粒
胶皮配方：
明胶 250g
甘油 80g
纯化水 250g
制成1000粒软胶囊，每粒0.5g。
蜂棘软胶囊的配方为455g沙棘油和45g蜂胶混合后灌成软胶囊1000粒，每粒软胶囊含内容物0.5g。蜂棘软胶囊的推荐服用量为6粒/天，即3g/人·天，其安全性及功能性试验所用剂量皆是以3g/人·天(其中沙棘油的服用量为2.73g/人·天，蜂胶的服用量为0.27g/人·天)为标准。
采用实施例1所述的软胶囊(以下简称蜂棘软胶囊)进行安全性及功效性，实验研究结果证明：蜂棘软胶囊雌、雄性小鼠急性经口MTD大于18g/kg·bw，属无毒级；蜂棘软胶囊以1.50g/kg·bw/d、3.25g/kg·bw/d、5.00g/kg·bw/d三个剂量给予大鼠30d，受试动物一般情况良好，体重、食物利用率、脏器重量、脏器系数均无异常改变。血液学指标及生化指标结果显示，各项指标均在正常范围。各脏器病理组织学检查均未见与受试样品有关的改变。经口给予小鼠不同剂量(0.25g/kg·bw、0.50g/kg·bw、1.50g/kg·bw)的蜂棘软胶囊1个月，进行小鼠细胞免疫功能、体液免疫功能、单核-巨噬细胞功能及NK细胞活性测定。结果显示，0.50g/kg·bw、1.50g/kg·bw组耳壳增重高于0g/kg·bw组；1.50g/kg·bw组溶血空斑数及血清半数溶血值高于0g/kg·bw；0.50g/kg·bw组的吞噬指数及1.50g/kg·bw组的吞噬百分率、吞噬指数均高于0g/kg·bw组；1.50g/kg·bw组NK细胞活性高于0g/kg·bw，且差异均有统计学意义(P<0.05)。
根据《保健食品检验与评价技术规范》之增强免疫力功能试验的结果判定，蜂棘软胶囊具有增强免疫力功能。
综合评价，蜂棘软胶囊的服用剂量选用3g/人·天。该软胶囊经急性毒理、30天喂养实验，均未出现任何副作用和不良反应。
根据3个月的加速稳定性试验结果，该软胶囊的有效成分含量稳定，性状无变化，保质期定为24个月。
实施例2
沙棘油400g，蜂胶40g，蜂胶和沙棘油按照比例充分溶解，混匀，按照蜜丸的制备方法制备得到蜜丸。
Claims (8)
1.一种含有沙棘油和蜂胶的药物组合物，其特征在于沙棘油与蜂胶的重量比例为8-15：1。
2.根据权利要求1所述的含有沙棘油和蜂胶的药物组合物，其特征在于沙棘油与蜂胶的重量比例为10-12：1。
3.根据权利要求1所述的含有沙棘油和蜂胶的药物组合物，其特征在于沙棘油与蜂胶的重量比例为455：45。
4.一种权利要求1、2或3所述的含有沙棘油和蜂胶的药物组合物的制备方法，其特征在于该方法包括以下步骤：蜂胶和沙棘油按照比例充分溶解，混匀。
5.根据权利要求1、2或3所述的含有沙棘油和蜂胶的药物组合物，其特征在于该药物组合物与药学上可接受的辅料制成制剂。
6.根据权利要求5所述的含有沙棘油和蜂胶的药物组合物，其特征在于所述的制剂为蜜丸、滴丸、胶囊剂、软胶囊。
7.权利要求1、2或3所述的含有沙棘油和蜂胶的药物组合物在制备提高免疫力的药物中的应用。
8.权利要求1、2或3所述的含有沙棘油和蜂胶的药物组合物在制备提高非特异性免疫、体液免疫和细胞免疫功能的药物中的应用。
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