CN112841642A - 用于抗骨质疏松的组合物 - Google Patents
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Abstract
本发明提供了一种组合物，该组合物具有抗骨质疏松、提高人体免疫力的功效。本发明具体表现为接骨木提取物、刺梨提取物与维生素D的组合，不仅可提供人体生理所需的多种营养物质，也表现在抗骨质疏松、提高免疫力方面协同增效的作用，特别是针对中老年人体对抗骨质疏松、提高免疫力的多功效天然成分组合。
Description
技术领域
本发明提供了一种组合物，可用于抗骨质疏松、提高免疫力。具体涉及到接骨木提取物、刺梨提取物及维生素D，是一种起到保健或辅助治疗作用的组合物。
背景技术
随着我国人口老龄化，患有骨折以及骨质疏松症的人也越来越多，患病率也在逐渐增加，这是我们需要重视的问题。骨质疏松症是一种骨骼新陈代谢出现问题的疾病，原因是骨质的密度降低使得骨结构变得脆弱而容易出现骨折。
骨质疏松和钙的流失有比较大的关系。所以那些缺钙、钙流失严重的人群就会容易出现骨质疏松。老年人由于年龄的原因，钙流失严重。如果年轻时钙储备不足，就非常容易出现钙流失。一般65岁以上人群是骨质疏松症易发多发人群，由于年龄增长，出现肝肾功能衰退，雌激素缺乏和维生素D的无法自身转化补充，是造成老年性骨质疏松症的主要原因。除了老年人外，女性也是骨质疏松的高发人群。一是老年女性停经后雌激素分泌停止，比较容易导致骨质疏松；二是怀孕女性，由于胎儿的骨骼发育需要大量的钙，如果饮食钙摄入不足，就会从孕妇的骨骼中分离钙质进入到胎儿中。没有外来的钙质补充，孕妇就容易出现骨质疏松。缺乏有效的体育锻炼，容易患骨质疏松症。运动能够增加骨强度，延缓骨量流失，也可以使身体强壮，肌肉健硕，从而有效保护骨骼免受伤害。
接骨木是忍冬科植物的一种，它的茎与枝都能入药，入药以后的药用价值特别高，不但能治疗多种疾病，还能滋养保护人类的肌肤。接骨木入药以后，具有良好的去湿功效，它是治疗人类风湿骨痛的常用药，具有祛风、利湿、活血、止痛的功效，可以治疗风湿筋骨疼痛、腰痛、水肿、风痒、瘾疹、产后血晕、跌打肿痛、骨折、创伤出血等症状。
刺梨是一种天然的药食两用植物，其果肉脆、甜酸，《本草纲目》及《中药大辞典》均有收载。刺梨含大量维生素，其中维生素C含量居各类水果之冠，维生素E为2.40～3.61mg/100g；维生素K1为0.67mg/100g；维生素B1为20.30μg/100g；维生素B2为1.67μg/100g；胡萝卜素为0.13mg/100g。刺梨还富含超氧化物歧化酶(SOD)、糖类物质、胡萝卜素、蛋白质、氨基酸和人体所需的其他营养物质。刺梨果实是一种强身健体、防病治病的药食两用型水果。
目前，市场上的各种保健食品很多，功效也各有侧重，但多数保健品的功效只是各类保健材料自身保健功效的叠加，效果单一，保健效果并不太理想，如含有刺梨的保健品其效果为补充维生素C作用，含有接骨木的保健品其效果为抵抗流行感冒及增强免疫力，维生素D则是促进骨骼生长及抵抗骨质疏松。
发明内容
本发明目的是提供一种组合物。该组合物具有协同抗骨质疏松、增强人体免疫力的用途。
为实现上述目的，本发明采用以下技术方案：
一种组合物，由接骨木提取物、刺梨提取物、维生素D及食品或药剂学可接受的辅料组成，其中，接骨木提取物为100～1000份、刺梨提取物为400～4000份、维生素D为0.005～0.025份。
作为一种优选，本发明提供的组合物中接骨木提取物为250～800份、刺梨提取物为400～2000份、维生素D为0.01～0.025份。
作为优选，本发明提供的组合物中，接骨木提取物为250～500份、刺梨提取物为400～1000份、维生素D为0.01～0.025份。
作为优选，本发明提供的组合物中，接骨木提取物为250～500份、刺梨提取物为800～2000份、维生素D为0.01～0.025份。
作为优选，本发明提供的组合物中，接骨木提取物为500～800份、刺梨提取物为400～1000份、维生素D为0.01～0.025份。
作为优选，本发明提供的组合物中，接骨木提取物为500～800份、刺梨提取物为800～2000份、维生素D为0.01～0.025份。
本发明中提供的组合物中还含有食品或药剂学可接受的载体的一种或几种物质的组合物，属于本领域常识。可制成普通片剂、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂等口服剂型，还可以制成功能食品常用形态，如固体饮料、果汁软糖等，从而易于服用，方便携带。
本发明还提供所述组合物用于抗骨质疏松、提高人体免疫力的用途，尤其是针对免疫力低下、易患骨质疏松的人群，如绝经后妇女及中老年人群。在本发明中，刺梨提取物、接骨木提取物和维生素D组合在一起，发挥提高人体免疫力、抗骨质疏松的作用，功效显著，非单个成分功效的简单加和，产生意料不到的协同作用。
下面结合具体实施方式对本发明做进一步说明，并非对本发明的限定，凡依照本发明内容进行的任何本领域的等同替换，均属于本发明的保护范围。
具体实施方式
实施例1接骨木提取物、刺梨提取物及维生素D组合物对骨质疏松大鼠的改善作用
模型制备及分组给药：3-4月龄SD大鼠250只，体重260-310g，雌性，普通日粮饲料喂养检疫7天后，随机选择10只大鼠作为假手术组，其余大鼠进行卵巢切除手术：用1.5％戊巴比妥钠溶液腹腔注射使大鼠麻醉，腹位固定，四肢固定于手术面板上。大鼠腰部脊柱两侧被毛，酒精消毒，在无菌条件下左右两侧各剪开一厘米左右的刀口(尽量小)，皮肤层，肌肉层，以无菌的眼科镊探入体内，将卵巢轻轻拉出，用剪刀将卵巢全部切除。关腹，分别缝合肌肉层和皮肤。碘酒清理伤口，最后涂以红霉素软膏。假手术处理：按上述方法操作，在找到卵巢后，只切除少量脂肪组织后依次缝合。手术1个月后，去卵巢组随机取6只，验证造模成功与否，使用造模成功大鼠进入下一步实验，按下表进行分组与给药，供试药物采用上述实施例中所制备的组合物制剂。
对骨质疏松模型大鼠作用试验组别设计
检测指标：(1)给药12周后各组大鼠血钙、血磷；(2)给药12周后各组大鼠尿钙/肌酐、尿磷/肌酐；(3)给药12周后各组大鼠股骨密度及股骨最大载荷。
结果：
(1)接骨木提取物、刺梨提取物及维生素D组合物对各组大鼠血钙、血磷的影响如表1所示，模型组大鼠血钙、血磷显著降低，与假手术组具有统计学差异，提示骨吸收增加，各组合给药组血钙、血磷水平上升，接骨木+刺梨+VD各剂量组上升更加明显，与二联及单药效果对比如下：
接骨木(a)+刺梨(b)+VD(c)组相比各单药组金正均Q值计算为：当把组合中两两组合药看为单药，剩余一种为另一种单药，计算两药联用的协同作用时Q[(a+b)+c]＝E(a+b)+c/[E(a+b)+Ec-E(a+b)*Ec]，Q[(a+c)+b]、Q[(b+c)+a]同理，Ea＝(1-Pa/P模型)，Eb＝(1-Pb/P模型)，Ec＝(1-Pc/P模型)。
在两药基础上，将金正均Q值进行拓展，用于判断三药联用是否具有协同作用，公式如下：Q＝Ea+b+c/(Ea+Eb+Ec-Ea*Eb-Ea*Ec-Eb*Ec-Ea*Eb*Ec)，根据以上公式计算各实验组Q值列表如下：
血钙：
血磷：
Q<0.85时认为两种或三药物联用为拮抗作用，0.85<Q<1.15时认为是相加作用，Q>1.15时认为是协同作用，由以上计算得出，依据血钙、血磷值计算结果，三药联用效果优于两药联用和单药使用效果，具有协同或相加作用，其中接骨木+刺梨+VD各组表现出明显的协同或相加的作用，见表1。
表1组合物对各组大鼠血钙、血磷的影响(
n＝9-10)
与假手术组比较，#P<0.05，##P<0.01；与模型组比较，*P<0.05，**P<0.01
(2)接骨木提取物、刺梨提取物及维生素D组合物对各组大鼠尿钙/肌酐、尿磷/肌酐的影响模型组大鼠尿钙/肌酐、尿磷/肌酐显著升高，与假手术组具有统计学差异，提示骨吸收增加，各给药组尿钙/肌酐、尿磷/肌酐水平降低，接骨木+刺梨+VD各剂量组减少骨钙、磷流失的效果更加明显，与二联及单药效果对比参考上述公式进行金正均Q值计算，结果如下：
尿钙/肌酐：
尿磷/肌酐：
Q<0.85时认为两种或三药物联用为拮抗作用，0.85<Q<1.15时认为是相加作用，Q>1.15时认为是协同作用，由以上计算得出，三药联用效果优于两药联用和单药使用效果，具有协同或相加作用，其中接骨木+刺梨+VD②、③、④及⑤组表现出明显的协同作用，见表2。
表2组合物对各组大鼠尿钙/肌酐、尿磷/肌酐的影响(
n＝9-10)
与假手术组比较，#P<0.05，##P<0.01；与模型组比较，*P<0.05，**P<0.01
(3)接骨木提取物、刺梨提取物及维生素D组合物对各组大鼠股骨密度、股骨最大载荷的影响模型组大鼠股骨密度、股骨最大载荷显著降低，与假手术组具有统计学差异，各给药组股骨密度、股骨最大载荷有所升高，接骨木+刺梨+VD各剂量组上升更加明显，与二联及单药效果对比参考上述公式进行金正均Q值计算，结果如下：
股骨密度：
股骨最大载荷：
Q<0.85时认为两种或三药物联用为拮抗作用，0.85<Q<1.15时认为是相加作用，Q>1.15时认为是协同作用，由以上计算得出，三药联用效果优于两药联用和单药使用效果，具有协同或相加作用，根据股骨最大载荷数据计算，其中接骨木+刺梨+VD③、⑤组表现出明显的协同作用，见表3。
表3组合物对各组大鼠股骨密度、股骨最大载荷的影响(
n＝9-10)
与假手术组比较，#P<0.05，##P<0.01；与模型组比较，*P<0.05，**P<0.01
综上可见，接骨木提取物、刺梨提取物及维生素D在较高剂量组合的情况下对骨质疏松大鼠模型具有协同改善血钙、血磷和股骨最大荷载水平、降低尿钙/肌酐、尿磷/肌酐水平的作用，表现出对骨质疏松显著的改善效果。
实施例2接骨木提取物、刺梨提取物及维生素D组合物提高人体免疫力的临床研究
受试者选择：性别不限，年龄45-75岁，无明显脑、心、肝、肺、肾、血液疾患，无长期服药史，并自愿保证配合研究。
受试者排除：妊娠或哺乳期妇女，对保健食品过敏者；有心、肝、肾和造血系统等严重疾病患者；短期内服用与受试功能有关的物品，影响到对结果判断者；不符合纳入标准者。
实验方法：采用随机、安慰剂对照的临床研究设计。选择48例受试者，随机分为2组，每组24例。其中第1组为安慰剂组，受试者服用不含任何活性成份的安慰剂，第2组为试验组，受试者食用接骨木提取物100mg+刺梨提取物800mg+VD10ug，每日服用一次，连续4周。研究结束时，对两组患者取静脉血5mL，检测T淋巴细胞亚群和免疫球蛋白IgG、IgA。
结果：
(1)接骨木提取物、刺梨提取物及维生素D组合物对人群T淋巴细胞亚群的影响
T淋巴细胞亚群主要参与细胞免疫，具有抵抗病毒和调节免疫系统功能的作用，其细胞功能取决于T淋巴细胞总值(CD3+)及其亚群(CD4+、CD8+)的相对组成。正常情况下，亚群间互相拮抗达到平衡；当免疫失衡，细胞数及比值发生紊乱，则易引发疾病。CD4+是具有诱导和辅助免疫的T细胞，CD3+与CD4+步调基本相同。
在本研究中，接骨木+刺梨+VD组血液CD3+、CD4+水平与安慰剂组比较明显升高，差异具有显著性，说明接骨木+刺梨+VD组合物使受试者免疫力提高，机体抗感染能力增强，见表4。
表4组合物对人群T淋巴细胞亚群的影响(
n＝24)
与安慰剂组比较，#P<0.05，##P<0.01；
(2)接骨木提取物、刺梨提取物及维生素D组合物对人群免疫球蛋白水平的影响
免疫球蛋白是一组具有抗体活性的蛋白质，主要存在于人体血液、组织液和外分泌液中，当机体出现感染、肿瘤、自身免疫病等应激状态时免疫球蛋白水平会升高，而在非应激状态下较高的基础免疫球蛋白水平也常预示机体有较好的免疫与抗感染能力储备。在本研究中，接骨木+刺梨+VD组患者治疗后IgG、IgA水平与安慰剂组比较明显提高，差异具有显著性，提示该组患者接受4周的接骨木+刺梨+VD干预后机体抗感染能力增强，见表5。
表5组合物对人群免疫球蛋白的影响(
n＝24)
与安慰剂组比较，#P<0.05，##P<0.01
综合以上研究结果，可以得出初步结论，即：长期给予中老年人服用含接骨木提取物、刺梨提取物与维生素D的组合物，能够显著提高机体免疫力。
Claims (6)
1.一种组合物，由100～1000份接骨木提取物、400～4000份刺梨提取物、0.005～0.025份维生素D及食品或药剂学可接受的辅料组成。
2.根据权利要求1所述的组合物，其特征在于：所述接骨木提取物为250～800份、刺梨提取物为400～2000份、维生素D为0.01～0.025份。
3.根据权利要求2所述的组合物，其特征在于：所述接骨木提取物为250～500份、刺梨提取物为400～1000份、维生素D为0.01～0.025份。
4.根据权利要求2所述的组合物，其特征在于：所述接骨木提取物为500～800份、刺梨提取物为800～2000份、维生素D为0.01～0.025份。
5.权利要求1所述的组合物在制备用于抗骨质疏松或提高免疫力的产品中的用途。
6.根据权利要求5所述的用途，其特征在于：所述的组合物是针对易患骨质疏松或免疫力低下的人群。
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