CN112956649A - 防治老年痴呆复合制剂及其制备方法 - Google Patents
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Abstract
本发明属于保健品食品领域，具体涉及防治老年痴呆复合制剂及其制备方法。由以下配方组成：纳豆粉6份、磷脂酰丝氨酸0.3份、DHA藻油12份、脱脂奶粉2份、食用香精0.01份、三氯蔗糖0.04份、硬脂酸镁0.7份，本发明的配方独创，采用纳豆粉与DHA藻油、磷脂酰丝氨酸混合配比，纳豆粉中有纳豆激酶，对血管的堵塞有一定的抑制作用，DHA藻油、磷脂酰丝氨酸对大脑皮层、脑神经有明显的益处，两者结合可以有效溶化血栓、活化大脑、提高记忆力和注意，修复受损伤脑细胞。
Description
技术领域
本发明属于保健品食品领域，具体涉及防治老年痴呆复合制剂及其制备方法。
背景技术
纳豆(Natto)是以大豆为原料，经纳豆枯草芽孢杆菌(Bacillus subtilisnatto)发酵制成的即食豆制品。纳豆富含蛋白质、有机酸、纤维素、钙、铁、多种维生素等营养物质。此外，纳豆还富含纳豆激酶、益生菌、吡啶二羧酸、血管紧张肽转化酶抑制剂、维生素K2等多种具保健功能的活性物质，这些营养成分及活性物质对人体健康有重要作用。纳豆主要盛行于日本，也流行于朝鲜、韩国及欧美国家。我国对纳豆的重视起步较晚，传统纳豆的制作以黄豆为原料，如今纳豆的原料越来越多样化，不少研究采用不同的豆类、杂粮进行发酵。这利于纳豆品种的多样化生产，满足不同人群的喜好。虽然纳豆营养价值高，但由于我国消费者对纳豆独特风味的排斥，纳豆在中国的推广并不理想。
DHA，二十二碳六烯酸，俗称脑黄金，是一种对人体非常重要的多不饱和脂肪酸，属于Omega-3不饱和脂肪酸家族中的重要成员。DHA是神经系统细胞生长及维持的一种主要元素，是大脑和视网膜的重要构成脂肪酸，在人体大脑皮层中含量高达20％，在眼睛视网膜中所占比例最大，约占50％。对婴儿智力和视力发育至关重要。DHA藻油提取自海洋微藻，未经食物链的传递，相对更安全，其EPA含量非常低。
磷脂酰丝氨酸(Phosphatidylserine)又称复合神经酸。简称PS，由天然大豆榨油剩余物提取。是细胞膜的活性物质，尤其存在于大脑细胞中。其功能主要是改善神经细胞功能，调节神经脉冲的传导，增进大脑记忆功能，由于其具有很强的亲脂性，吸收后能够迅速通过血脑屏障进入大脑，起到舒缓血管平滑肌细胞，增加脑部供血的作用。
老年痴呆是一种慢性、大脑原发性、以进行性认知功能低下和行为损害为特征的中枢神经系统退行性疾病，临床症状有认知障碍、记忆障碍、精神行为障碍、性格孤僻淡漠以及时间和空间定向能力障碍等，最终导致死亡，多在老年人中发生。迄今，世界上约有4700万人罹患老年痴呆，至2050年这个数字可能增长到1.31亿，该病也带来巨大的经济影响，全球在痴呆病上花费的金额多达8180亿美元，老年痴呆已成为世界公共卫生面临的主要挑战之一。我国是人口大国，随着人口老龄化进程的加快，该疾病的危害也越来越引起大家的重视。
发明内容
基于上述背景技术中的问题，本发明拟提供一种风味良好，能够预防老年痴呆症的保健品或食品。
本发明是通过以下方法来制备的：
防治老年痴呆复合制剂及其制备方法，由以下配方组成：纳豆粉、磷脂酰丝氨酸、DHA藻油、脱脂奶粉、食用香精、三氯蔗糖、硬脂酸镁。具体的配方为：纳豆粉5-8份、磷脂酰丝氨酸0.1-0.5份、DHA藻油10-15份、脱脂奶粉1-3份、食用香精0.01-0.0.2份、三氯蔗糖0.01-0.05份、硬脂酸镁0.5-1份。
具体的配方为：纳豆粉6份、磷脂酰丝氨酸0.3份、DHA藻油12份、脱脂奶粉2份、食用香精0.01份、三氯蔗糖0.04份、硬脂酸镁0.7份。
所述的复合制剂，制备方式由以下步骤组成：
(1)称取处方量的纳豆粉：将纳豆破碎至500目，加入纳豆3倍体积当量的壁材羟丙基甲基纤维素酞酸酯；加入固化剂谷氨酰胺转氨酶，用量为壁材质量的1.5％；采用喷雾干燥法进行干燥制粒，控制进风温度为85℃，制成目数为1000目的微囊制剂；
(2)称取处方量的磷脂酰丝氨酸、DHA藻油、大豆磷脂和D-甘露糖醇，先在湿法混合制粒机中加入纳豆微囊，再加入D-甘露糖醇，磷脂酰丝氨酸、最后加入大豆磷脂，开机混合5分钟；
(3)加入乙醇溶解的DHA藻油，加入重量份为5份的水，再加入处方量的环糊精开搅拌切碎刀制成软材，过16目筛网，60℃干燥到水份小于3％，16目整粒，加入处方量的硬脂酸镁混匀即可。
所述制剂可以是片剂、压片糖果剂、固体饮料剂、胶囊、粒剂、水剂中任意一种。
本发明的有益效果为：
(1)本发明的配方独创，采用纳豆粉与DHA藻油、磷脂酰丝氨酸混合配比，纳豆粉中有纳豆激酶，对血管的堵塞有一定的抑制作用，DHA藻油、磷脂酰丝氨酸对大脑皮层、脑神经有明显的益处，两者结合可以有效溶化血栓、活化大脑、提高记忆力和注意，修复受损伤脑细胞、打通大脑与血液循环之间障碍，维持脑神经细胞的正常功能，并增强大脑神经系统功能，进而达到预防老年性痴呆症的功效。
(2)针对纳豆激酶在胃液中容易失去活性的问题，本发明首次将其做成了肠溶性微囊，在经过胃时不会被消化，在到达人体小肠时可以充分的释放出来。
具体实施方式
以下实施例用于进一步阐述本发明，但不应理解为对本发明权利要求书请求保护范围的限制。
实施例1
防治老年痴呆复合制剂及其制备方法：纳豆粉6份、磷脂酰丝氨酸0.3份、DHA藻油12份、脱脂奶粉2份、食用香精0.01份、三氯蔗糖0.04份、硬脂酸镁0.7份。
制备方式由以下步骤组成：
(1)称取处方量的纳豆粉：将纳豆破碎至500目，加入纳豆3倍体积当量的壁材羟丙基甲基纤维素酞酸酯；加入固化剂谷氨酰胺转氨酶，用量为壁材质量的1.5％；采用喷雾干燥法进行干燥制粒，控制进风温度为85℃，制成目数为1000目的微囊制剂；
(2)称取处方量的磷脂酰丝氨酸、DHA藻油、大豆磷脂和D-甘露糖醇，先在湿法混合制粒机中加入纳豆微囊，再加入D-甘露糖醇，磷脂酰丝氨酸、最后加入大豆磷脂，开机混合5分钟；
(3)加入乙醇溶解的DHA藻油，加入重量份为5份的水，再加入处方量的环糊精开搅拌切碎刀制成软材，过16目筛网，60℃干燥到水份小于3％，16目整粒，加入处方量的硬脂酸镁混匀即可。
所述制剂可以是片剂、压片糖果剂、固体饮料剂、胶囊、粒剂、水剂中任意一种。
实施例2
配方为：纳豆粉5份、磷脂酰丝氨酸0.3份、DHA藻油12份、脱脂奶粉2份、食用香精0.01份、三氯蔗糖0.01份、硬脂酸镁0.5份。
其余制备步骤同实施例1。
实施例3
配方为：纳豆粉8份、磷脂酰丝氨酸0.5份、DHA藻油15份、脱脂奶粉3份、食用香精0.02份、三氯蔗糖0.05份、硬脂酸镁1份。制备方式为：
(1)称取处方量的纳豆粉、磷脂酰丝氨酸、DHA藻油、大豆磷脂和D-甘露糖醇，先在湿法混合制粒机中加入纳豆粉，再加入D-甘露糖醇，磷脂酰丝氨酸、最后加入大豆磷脂，开机混合5分钟；
(2)加入乙醇溶解的DHA藻油，加入重量份为5份的水，再加入处方量的环糊精开搅拌切碎刀制成软材，过16目筛网，60℃干燥到水份小于3％，16目整粒，加入处方量的硬脂酸镁混匀即可。
所述制剂可以是片剂、压片糖果剂、固体饮料剂、胶囊、粒剂、水剂中任意一种。
实验验证：
1、细胞培养
取出保存于液氮冷冻的大鼠神经胶质瘤细胞C6细胞株，迅速置于37℃水浴中振荡至细胞融化后，转入已加入培养基的离心管中，以1000rpm离心5min，弃去上清液，加入少量培养基并轻轻吹吸均匀，培养基为含有10％胎牛血清、1％双抗的RPMI-1640培养基，将细胞悬液移入培养皿，在37℃、5％CO2、饱和湿度条件下培养。
2、细胞模型的制备
将对数生长期的C6细胞制成浓度为2.0×105个/mL的细胞悬液，接种于96孔板中，每孔100μL，培养24h后，按照如下分组进行处理，每组5个复孔：
对照组：更换为新鲜培养基继续培养3h；
Aβ25-35组(模型组)：更换为新鲜培养基继续培养3h；
盐酸多奈哌齐组(阳性药组)：更换为含20μM盐酸多奈哌齐的新鲜培养基继续培养3h；
本发明实施例组：更换为含5、10、20、30μM蒲公英甾酮的新鲜培养基继续培养3h。
按照上述分组继续培养3h后，Aβ25-35组、盐酸多奈哌齐组、实施例1-3组添加终浓度为10μM的凝聚态Aβ25-35，对照组加入等体积溶媒，继续培养18h后，各组加入20μLMTT溶液(浓度为5mg/mL)，37℃下继续培养4h。
继续培养4h后，小心吸弃孔内上清液，每孔加入150μLDMSO，震荡10min，使结晶充分溶解；选择490nm波长，在酶联免疫检测仪上测定各孔光吸收值(OD值)，取5个复孔OD值平均数，计算细胞存活率，对照组记为100％。
实验结果
各组细胞存活率如表1所示
表1.本发明实施例1-3对Aβ25-35组诱导的细胞损伤的影响
与Aβ25-35组相比、本实施例1-3组细胞存活率显著升高。盐酸多奈哌齐是美国食品与药物管理局(FDA)批准的用于治疗阿尔茨海默病的药物。
Claims (5)
1.防治老年痴呆复合制剂及其制备方法，其特征在于由以下配方组成：纳豆粉、磷脂酰丝氨酸、DHA藻油、脱脂奶粉、食用香精、三氯蔗糖、硬脂酸镁。
2.根据权利要求1所述的配方，其特征在于，具体的配方为：纳豆粉5-8份、磷脂酰丝氨酸0.1-0.5份、DHA藻油10-15份、脱脂奶粉1-3份、食用香精0.01-0.0.2份、三氯蔗糖0.01-0.05份、硬脂酸镁0.5-1份。
3.根据权利要求2所述的配方，其特征在于，具体的配方为：纳豆粉6份、磷脂酰丝氨酸0.3份、DHA藻油12份、脱脂奶粉2份、食用香精0.01份、三氯蔗糖0.04份、硬脂酸镁0.7份。
4.根据权利要求2所述的复合制剂，其特征在于制备方式由以下步骤组成：
(1)称取处方量的纳豆粉：将纳豆破碎至500目，加入纳豆3倍体积当量的壁材羟丙基甲基纤维素酞酸酯；加入固化剂谷氨酰胺转氨酶，用量为壁材质量的1.5％；采用喷雾干燥法进行干燥制粒，控制进风温度为85℃，制成目数为1000目的微囊制剂；
(2)称取处方量的磷脂酰丝氨酸、DHA藻油、大豆磷脂和D-甘露糖醇，先在湿法混合制粒机中加入纳豆微囊，再加入D-甘露糖醇，磷脂酰丝氨酸、最后加入大豆磷脂，开机混合5分钟；
(3)加入乙醇溶解的DHA藻油，加入重量份为5份的水，再加入处方量的环糊精开搅拌切碎刀制成软材，过16目筛网，60℃干燥到水份小于3％，16目整粒，加入处方量的硬脂酸镁混匀即可。
5.根据权利要求1-4任意一项所述的复合制剂，其特征在于，所述制剂可以是片剂、压片糖果剂、固体饮料剂、胶囊、粒剂、水剂中任意一种。
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