CN113841887A - 一种辅酶类易缺营养素复合片剂及其制备方法 - Google Patents
一种辅酶类易缺营养素复合片剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种辅酶类易缺营养素复合片剂及其制备方法，包括有效成分和压片助剂，所述有效成分包括以下原料：复合果蔬酵素粉、富营养酵母粉、益生菌粉、类胡萝卜素、维生素A、维生素D3、维生素E、维生素K、硫胺素、核黄素、烟酰胺、烟酸、维生素b6、生物素、叶酸、甲钴胺、维生素C、α～硫辛酸、肌醇和胆碱。通过上述成分的复配，使得复合片剂能为人体补充辅酶类易缺营养素，维持人体正常的代谢机能，激活人体细胞，具有增强人体活力，提高人体免疫力、增强抗氧化、延缓衰老的作用。该复合片剂的制备方法，步骤简单，在0～10℃下混料和压片，能维持有效成分的活性，提高人体对营养素的吸收率。
Description
技术领域
本发明涉及保健品技术领域，具体涉及一种辅酶类易缺营养素复合片剂及其制备方法。
背景技术
随着人们的生活水平和生活质量逐渐提高，越来越多人关注自己的健康问题，保持健康的身体从外界原因来说需要适度的锻炼和保持合理的饮食，而从内部原因来说则依赖于人体中的营养物质。
维持人体正常新陈代谢所需要的主要营养素有几十种，分布在不同的食物中，根据国家卫健委推荐，每人每天需要平均吃15种以上的食物才能摄齐全所有这些营养素，由于食物多样性缺乏、工业加工和家庭烹调造成的营养素破坏和丢失、不合理的饮食习惯以及错误的营养观念，绝大部分人是不可能达到这个要求的，每个人或多或少都存在营养不足和缺乏的现象，导致控制人体细胞内代谢的酶的辅助因子类营养素缺乏。
酶是催化生化反应必不可少的活性物质，在发挥酶的催化活性时需要辅助因子参与，酶的辅助因子包括辅酶(coenzyme)、辅基(prosthetic group)和金属离子。辅酶是一类有机辅助因子的总称，是酶催化氧化还原反应、基团转移、异构反应的必须因子，在酶促生化反应中承担传递电子、原子或基团的功能。在酶促反应中，辅酶作为底物接受质子或基团后离开酶蛋白，参与另一酶促反应并将其所携带的质子或基团转移出去，或者相反。若缺少辅酶，则会引起酶系的活性失调，从而造成代谢失调，导致亚健康与慢性病的发生。
发明内容
为了克服现有技术的不足，本发明的目的之一在于提供一种辅酶类易缺营养素复合片剂，补充辅酶类易缺营养素，维护人体正常的代谢机能，从而防止因代谢问题导致的人体亚健康状态和慢性病；本发明的目的之二在于提供一种辅酶类易缺营养素复合片剂的制备方法，步骤简便，适合工业化生产。
本发明的目的之一采用如下技术方案实现：
一种辅酶类易缺营养素复合片剂，包括有效成分和压片助剂，所述有效成分包括以下按重量份计的原料：复合果蔬酵素粉10～100份、富营养酵母粉10～100份、益生菌粉10～100份、类胡萝卜素0.5～5份、维生素A0.5-5份、维生素D3 0.005-0.05份、维生素E5-50份、维生素K0.05-0.5份、硫胺素5-50份、核黄素0.5-5份、烟酰胺5-25份、烟酸5-25份、泛酸钙5-50份、维生素b65～50份、生物素0.5-5份、叶酸、0.1-1份、甲钴胺0.05-0.5份、维生素C10～100份、α～硫辛酸5～50份、肌醇5～50份和胆碱5～50份。其余为压片助剂(微晶纤维素、硬脂酸镁和麦芽糊精)。
维生素A在人体内的活性形式为视黄醇、11-顺式视黄醛、视黄酸，是调节糖蛋白合成的辅酶，具有维持正常视觉、维护上皮组织细胞的健康和促进免疫球蛋白的合成、维持骨骼正常生长发育、促进生长与生殖、抑制肿瘤生长的功能，缺乏维生素A易使人罹患夜盲症、干眼病等，还可使儿童生长发育缓慢、免疫力下降。
维生素D3是调节钙、磷代谢的辅酶，能提高小肠对钙和磷的吸收、促进生长和骨骼钙化、促进牙齿健全、维持血液中柠檬酸盐的正常水平、防止氨基酸通过肾脏损失的功能，人体缺乏维生素D3易产生佝偻病、骨质疏松症等。
维生素E又称生育酚，是促进血红素代谢的辅酶，具有抗氧化性，能保护人体内易被氧化的物质，减缓人体氧化损伤，有延缓衰老、促进长寿的作用，人体缺乏维生素E易使人体生殖系统的上皮细胞毁坏，易使男性睾丸退化、女性流产等。
维生素K是凝血因子γ-羧化酶的辅酶，具有促进伤口血液凝固的作用，且维生素K还参与维生素K依赖蛋白的合成，调节骨骼中磷酸钙的合成，促进骨骼代谢。
硫胺素在人体内经硫胺素激酶催化，可与三磷酸腺苷(ATP)作用转变成硫胺素焦磷酸(TPP)，TPP是丙酮酸脱羧酶、α-酮戊二酸脱羧酶、转酮醇酶的辅酶，硫胺素以辅酶形式参与糖异生、有氧氧化及磷酸戊糖途径代谢，缺乏硫胺素会导致人体糖氧化脱羧能力降低，使人体丙酮酸升高，导致“脚气病”。
核黄素在人体内以黄素单核苷酸(FMN)及黄素腺嘌呤二核苷酸(FAD)的形式存在，是多种黄素脱氢酶的辅基以及氧化还原酶的辅酶，主要起递氢作用，促进生物代谢、生物氧化，缺乏核黄素易导致人体细胞代谢失调，导致口腔炎症、角膜血管增生等疾病。
烟酰胺和烟酰胺是烟酰胺腺嘌呤二核苷酸(辅酶Ⅰ)和烟酰胺腺嘌呤二核苷酸磷酸(辅酶Ⅱ)的组成部分，在生物氧化呼吸链中起着递氢的作用，可促进生物氧化过程和组织新陈代谢，对维持正常组织(特别是皮肤、消化道和神经系统)的完整性具有重要作用，可防止人罹患糙皮病，缓解皮炎、口腔炎症、腹泻及烦躁、失眠感觉异常等症状，也用作血管扩张药治疗高脂血症，治疗血管性偏头痛、头痛、脑动脉血栓形成、肺栓塞、内耳眩晕症、冻伤、中心性视网膜脉络膜炎等。
泛酸钙在人体中能生成泛酸，泛酸是以4’-磷酸泛酰疏基乙胺和乙酰辅酶A的形式参与糖类、脂类和蛋白质的代谢过程，缺乏泛酸易导致肝脏中脂类增加，并使丙酮酸氧化脱羧过程受阻，导致人体生长迟钝或发育障碍等。
维生素B6在人体内的活性形式为磷酸吡哆醛(PLP)和磷酸吡哆胺，PLP是氨基酸脱羧酶、氨基酸转氨酶、δ-氨基-γ-酮戊酸合酶的辅酶，可传递氨基、催化氨基酸脱羧反应，是参与蛋白质合成与分解代谢所必需的物质。
生物素是人体内多种羧化酶的辅酶或辅基，参与人体固定二氧化碳的反应，人体缺少生物素会导致脱发、皮肤发炎等病症。
叶酸在人体的辅酶形式是四氢叶酸，是人体内生化反应中一碳单位转移酶系的辅酶，参与嘌呤和胸腺嘧啶的合成，DNA和RNA的合成，其在人体中还参与氨基酸代谢、参与血红蛋白及甲基化合物如肾上腺素、胆碱、肌酸等的合成，缺乏叶酸会导致巨幼红细胞性贫血，影响胎儿及婴幼儿身体发育。
甲钴胺是一种内源性的辅酶(辅酶B12)，参与一碳单位循环，在由同型半胱氨酸合成蛋氨酸的转甲基反应过程中起重要作用，其作为甲基转移酶的辅酶，参与蛋氨酸、胸腺嘧啶等的合成，并保护叶酸在细胞内的转移和贮存，缺乏甲钴胺易造成人体消化道上皮组织细胞失常、造血器官功能失常等情况。
维生素C是维持多种羟化酶(脯氨酸羟化酶等)活性所必需的辅酶，参与人体内的羟化反应，羟化反应是体内许多重要物质合成或分解的必要步骤，如胶原的合成、神经递质(5-羟色胺及去甲肾上腺素)的合成、类固醇的羟化、有机物或毒物的羟化解毒、混合功能氧化酶活性的提升、抗体的形成、人体对铁的吸收、四氢叶酸的形成等。
α-硫辛酸是丙酮酸脱氢酶系和α-酮戊二酸脱氢酶系的多酶复合物中的一种辅助因子，在丙酮酸脱氢酶复合体和α-酮戊二酸脱氢酶复合体中，催化酰基的产生和转移，α-硫辛酸含有双硫五元环结构，电子密度很高，具有显著的亲电子性和与自由基反应的能力，因此它具有抗氧化性，具有极高的保健功能和医用价值。
肌醇参与人体内的新陈代谢活动，参与代谢脂肪和胆固醇，具有降低血液胆固醇含量预防动脉硬化的作用，且肌醇能促进健康毛发生长，防止脱发及湿疹。
胆碱是构成人体内生物信息传递介质和人体细胞膜的物质，在人体内保证生物信息的传递，并可调控细胞的凋亡，此外胆碱还能促进脂肪代谢、降低血液胆固醇含量。
复合果蔬酵素粉富含各种维生素和矿物质元素，其作用如下：1、可以起到改善肠道功能的作用，具有促进胃肠道蠕动加速消化的功能。2、它还具有美容养颜的作用，对于青春期的人来说具有预防青春痘、色斑形成的作用，会让自己的皮肤变得更有水分。3、它还具有促进新陈代谢的作用。4、还具有降糖、血压、血脂的功效，从而预防肥胖的发生。5、此外，还有提高人体的免疫力，预防疾病的发生。
富营养酵母粉富含各种B族维生素和矿物质元素，是理想的营养源，它含有丰富的蛋白质、必需氨基酸、B族维生素、矿物质和膳食纤维，而糖、胆固醇和脂肪比较少。
益生菌粉富含各种维生素和矿物质元素，含有对人体健康有益的微生物，能维持肠道健康平衡，主要包括双歧杆菌类和乳杆菌类，具有肠道保健，增强免疫，调节作用等功能。类胡萝卜素(carotenoids)是一类重要的天然色素的总称,普遍存在于动物、高等植物、真菌、藻类的黄色、橙红色或红色的色素之中。
类胡萝卜素是体内维生素A的主要来源，同时还具有抗氧化、免疫调节、抗癌、延缓衰老等功效。
进一步，压片助剂作为片剂成型的基本物质载体，为了提高片剂的稳定性、润湿性和溶解性，以及增强有效成分的胶凝特性，选用微晶纤维素、硬脂酸镁和麦芽糊精。微晶纤维素作为复合片剂的干燥粘合剂，加入微晶纤维素能保证片剂的稳定性、安全性和混料时的均质性。加入硬脂酸镁后能使得制成的颗粒具有很好的流动性和可压性。具体地，当有效成分和所述压片助剂的重量份加和为1000份时，压片助剂原料的重量份为：微晶纤维素10～50份、硬脂酸镁10～50份和麦芽糊精10～50份。
所述有效成分和压片助剂的重量份数加和为1000份。
本发明的目的之二采用如下技术方案实现：
一种如上述的辅酶类易缺营养素复合片剂的制备方法，包括以下步骤：
1)将配方量的有效成分和压片助剂混合均匀，得到混合物；
2)将步骤1)的混合物进行压片，得到辅酶类易缺营养素复合片剂。
进一步，步骤1)中，在0～10℃下混合所述有效成分和所述压片助剂。
再进一步，步骤2)中，在0～10℃下进行压片。
相比现有技术，本发明的有益效果在于：
(1)本发明的辅酶类易缺营养素复合片剂所用的辅酶类营养素有效成分为维生素A、维生素D3、维生素E、维生素K、硫胺素、核黄素、烟酰胺、维生素B6、生物素、叶酸、甲钴胺、维生素C、α～硫辛酸、肌醇和胆碱的组合物，优选为上述成分的混合物，配伍更加科学合理，能起到促进能量转化，提升精力以及提高免疫力，延缓衰老的作用。
(2)本发明的辅酶类易缺营养素复合片剂的具体成分是复合果蔬酵素粉、富营养酵母粉、益生菌粉、类胡萝卜素、维生素A、维生素D3、维生素E、维生素K、硫胺素、核黄素、烟酰胺、维生素b6、生物素、叶酸、甲钴胺、维生素C、α～硫辛酸、肌醇和胆碱，通过上述成分的复配，使得复合片剂能为人体全面均衡补充辅酶类易缺营养素，维护人体正常的代谢机能，激活人体细胞和细胞能量的营养，具有提高人体免疫力、增强抗氧化、延缓衰老和增强人体活力的作用，从而防止因代谢问题导致的人体亚健康状态和慢性病，
(3)本发明辅酶类易缺营养素复合片剂的制备方法，步骤简单，在低温(0～10℃)下混料和压片，能维持有效成分的活性，提高人体对营养素的吸收率。
具体实施方式
下面，结合具体实施方式，对本发明做进一步描述，需要说明的是，在不相冲突的前提下，以下描述的各实施例之间或各技术特征之间可以任意组合形成新的实施例。
实施例1
一种辅酶类易缺营养素复合片剂，包括有效成分和压片助剂，有效成分和压片助剂的重量份加和为1000份，其中，所述有效成分包括以下按重量份计的原料：复合果蔬酵素粉10份、富营养酵母粉10份、益生菌粉10份、类胡萝卜素0.5份、维生素A 0.5份、维生素D30.005份、维生素E 5份、维生素K 0.05份、硫胺素5份、核黄素0.5份、烟酰胺5份、烟酸5份、泛酸钙5份、维生素B6 5份、生物素0.5份、叶酸0.1份、甲钴胺0.05份、维生素C10份、α-硫辛酸5份、肌醇5份和胆碱5份。其余由压片助剂为质量比为1：1：1的微晶纤维素、硬脂酸镁和麦芽糊精补足1000份。
辅酶类易缺营养素复合片剂的制备方法，包括以下步骤：
1)将配方量的有效成分和压片助剂在6℃下按逐级放大的混合方法混合均匀，得到混合物；
2)将步骤1)的混合物使用直径为0.8cm的冲模进行压片，在3℃下直接压片，得到规格为1000mg/片的辅酶类易缺营养素复合片剂。
实施例2
一种辅酶类易缺营养素复合片剂，包括有效成分和压片助剂，有效成分和压片助剂的重量份加和为1000份，其中，所述有效成分包括以下按重量份计的原料：复合果蔬酵素粉50份、富营养酵母粉50份、益生菌粉50份、类胡萝卜素2.5份、维生素A2.5份、维生素D30.025份、维生素E 25份、维生素K 0.25份、硫胺素25份、核黄素2.5份、烟酰胺10份、烟酸10份、泛酸钙25份、维生素B6 25份、生物素2.5份、叶酸0.5份、甲钴胺0.25份、维生素C 50份、α-硫辛酸25份、肌醇25份和胆碱25份。其余由压片助剂为质量比为1：1：1的微晶纤维素、硬脂酸镁和麦芽糊精补足1000份。
辅酶类易缺营养素复合片剂的制备方法，包括以下步骤：
1)将配方量的有效成分和压片助剂在0℃下按逐级放大的混合方法混合均匀，得到混合物；
2)将步骤1)的混合物使用直径为0.8cm的冲模进行压片，在0℃下直接压片，得到规格为1000mg/片的辅酶类易缺营养素复合片剂。
实施例3
一种辅酶类易缺营养素复合片剂，包括有效成分和压片助剂，有效成分和压片助剂的重量份加和为1000份，其中，所述有效成分包括以下按重量份计的原料：复合果蔬酵素粉100份、富营养酵母粉100份、益生菌粉100份、类胡萝卜素5份、维生素A5份、维生素D30.05份、维生素E 50份、维生素K0.05份、硫胺素50份、核黄素5份、烟酰胺25份、烟酸25份、维生素B6 50份、生物素5份、叶酸1份、甲钴胺0.5份、维生素C 100份、α-硫辛酸50份、肌醇50份和胆碱50份。其余由压片助剂为质量比为1：1：1的微晶纤维素、硬脂酸镁和麦芽糊精补足1000份。
辅酶类易缺营养素复合片剂的制备方法，包括以下步骤：
1)将配方量的有效成分和压片助剂在10℃下按逐级放大的混合方法混合均匀，得到混合物；
将步骤1)的混合物使用直径为0.8cm的冲模进行压片，在10℃下直接压片，得到规格为1000mg/片的辅酶类易缺营养素复合片剂。
对比例1
对比例1与实施例1的不同之处在于：不添加硫胺素，其余组分和制备方法均与实施例1相同。
对比例2
对比例2与实施例1的不同之处在于：不添加泛酸钙，其余组分和制备方法均与实施例1相同。
对比例3
对比例3与实施例1的不同之处在于：不添加生物素，其余组分和制备方法均与实施例1相同。
对比例4
对比例4与实施例1的不同之处在于：不添加甲钴胺，其余组分和制备方法均与实施例1相同。
对比例5
对比例5与实施例1的不同之处在于：对比例5的混料和压片步骤在20℃。
对比例6
对比例6与实施例1的不同之处在于：不添加复合果蔬酵素粉。其余组分和制备方法均相同。
对比例7
对比例7与实施例1的不同之处在于：不添加酵母粉。其余组分和制备方法均相同。
对比例8
对比例7与实施例1的不同之处在于：不添加益生菌粉。其余组分和制备方法均相同。
2)
性能测试
1、实验动物与分组：选择体重15～25g的240只雌性小鼠，实验动物由广州医科大学医学实验动物中心提供。每20只小鼠为一组，一共9组，其中11组为实验组，分别服用实施例1～3和对比例1～8的复合片剂，最后一组为对照组。
2、试验方法：实施例1～3和对比例1～8的复合片剂1g加蒸馏水定容至200mL，按0.1mL(10g·bw)体积给小鼠灌胃，对照组灌入相同体积的蒸馏水。每天一次，连续灌胃一个月。
3、免疫指标测定方法：根据《保健食品检验与评价技术规范》-2003免疫功能检测的程序，分别测定下列各项免疫指标：二硝基氟苯诱导的小鼠DTH实验(耳肿胀法)、小鼠碳廓清实验、NK细胞活性测定(乳酸脱氢酶测定法)。数据见表1～3。
表1实施例1～3和对比例1～8的样品对小鼠迟发型变态反应(DTH)的影响
表2实施例1～3和对比例1～8的样品对单核－巨噬细胞碳廓清的影响
表3实施例1～3和对比例1～8的样品对小鼠NK细胞活性的影响
由表1可知，实施例1～3和对比例1～8与对照组比较显著提高，差异具有统计学意义，表明实施例1～3和对比例1～8均具有促进小鼠迟发型变态反应的作用，其中实施例2为最优实施例。
由表2可知，实施例1～3和对比例5的吞噬指数与对照组相比，显著提高，差异具有统计学意义(P＜0.05)，表明实施例1～3具有促进小鼠的单核-巨噬细胞碳廓清功能的作用。但对比例5由于混料和压片过程中温度较高，会影响成分的活性，影响效果。而对比例1～4的样品对小鼠碳廓清能力无显著影响(P＞0.05)。
由表3可知，实施例1～3和对比例1～8的小鼠的NK细胞活性均高于对照组，但对比例1～8与阴性对照组的差异均无显著性(P＞0.05)，表明对比例1～8对小鼠的NK细胞活性无明显的提高作用。实施例1～3的小鼠NK细胞活性与对照组相比显著提高，差异具有统计学意义，表明实施例1～3对小鼠的NK细胞活性有明显的提高作用。
综上所述，实施例1～3通过限定复合果蔬酵素粉、富营养酵母粉、益生菌粉与辅酶复配，以及限定辅酶为维生素A、维生素D3、维生素E、维生素K、硫胺素、核黄素、烟酰胺、烟酸、泛酸钙、维生素B6、生物素、叶酸和甲钴胺维生素C、α～硫辛酸、肌醇和胆碱的复配，使得复合片剂除了能为人体补充辅酶类营养素外，还能维护人体正常的代谢机能，从而防止因代谢问题导致的人体亚健康状态和慢性病，能激活人体细胞和细胞能量的营养，具有提高人体免疫力、增强抗氧化、延缓衰老和增强人体活力的作用。
上述实施方式仅为本发明的优选实施方式，不能以此来限定本发明保护的范围，本领域的技术人员在本发明的基础上所做的任何非实质性的变化及替换均属于本发明所要求保护的范围。
Claims (7)
1.一种辅酶类易缺营养素复合片剂，其特征在于，包括有效成分和压片助剂，所述有效成分包括以下按重量份计的原料：复合果蔬酵素粉10～100份、富营养酵母粉10～100份、益生菌粉10～100份、类胡萝卜素0.5～5份、维生素A0.5-5份、维生素D3 0.005-0.05份、维生素E5-50份、维生素K0.05-0.5份、硫胺素5-50份、核黄素0.5-5份、烟酰胺5-25份、烟酸5-25份、泛酸钙5-50份、维生素b6 5～50份、生物素0.5-5份、叶酸0.1～1份、甲钴胺0.05～0.5份、维生素C 10～100份、α～硫辛酸5～50份、肌醇5～50份、胆碱5～50份。
2.如权利要求1所述的辅酶类易缺营养素复合片剂，其特征在于，所述有效成分和压片助剂的重量份加和为1000份。
3.如权利要求1所述的辅酶类易缺营养素复合片剂，其特征在于，所述营养素包括以下按重量份数计的原料：复合果蔬酵素粉20～80份、富营养酵母粉30～80份、益生菌粉30～80份、类胡萝卜素0.5～5份、维生素A0.5-5份、维生素D3 0.005-0.05份、维生素E5-50份、维生素K0.05-0.5份、硫胺素1～50份，核黄素0.5～5份、烟酰胺5～50份、烟酸5-25份、泛酸钙5-25份、维生素B6 5-50份、生物素0.5～5份、叶酸0.1～1份、甲钴胺0.05～0.5份、维生素C10-100份、α～硫辛酸5～50份、肌醇5～50份、胆碱5～50份。
4.如权利要求1所述的辅酶类易缺营养素复合片剂，其特征在于，所述压片助剂为微晶纤维素、硬脂酸镁和麦芽糊精。
5.一种如权利要求1～4任一项所述的辅酶类易缺营养素复合片剂的制备方法，其特征在于，包括以下步骤：
1)将配方量的有效成分和压片助剂混合均匀，得到混合物；
2)将步骤1)的混合物进行压片，得到辅酶类易缺营养素复合片剂。
6.如权利要求5所述的辅酶类易缺营养素复合片剂的制备方法，其特征在于，步骤1)中，在0～10℃下混合所述有效成分和所述压片助剂。
7.如权利要求5所述的辅酶类易缺营养素复合片剂的制备方法，其特征在于，步骤2)中，在0～10℃下进行压片。
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