CN108175808A - 一种药物组合物及其应用 - Google Patents
一种药物组合物及其应用 Download PDFInfo
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- CN108175808A CN108175808A CN201810053021.8A CN201810053021A CN108175808A CN 108175808 A CN108175808 A CN 108175808A CN 201810053021 A CN201810053021 A CN 201810053021A CN 108175808 A CN108175808 A CN 108175808A
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Abstract
本发明提供一种药物组合物及其应用,所述药物组合物包括以下重量百分比的组分:蜂蛹冻干粉10‑92.68%,蜂王浆冻干粉5‑80%,磷脂酰丝氨酸0.5‑10%,γ‑氨基丁酸0.5‑10%,顺‑15‑二十四碳烯酸0.5~10%,植物提取物0.5‑50%,助剂0.2‑18%,抗氧剂0.12‑18%,其中,所述各组分的重量百分比之和为100%,本发明配方合理巧妙,起效快,对不同病因引起的阿尔茨海默症均有很好的治疗效果,且本发明配方安全、可靠,无任何毒副作用,在药物治疗中有较高的应用前景与应用价值。
Description
技术领域
本发明属于药物化学领域,涉及一种药物组合物及其应用。
背景技术
阿尔茨海默症(Alzheimer's disease,AD),是一种以进行性认知障碍和记忆损伤为主的神经系统退行性疾病,是老年痴呆症最常见的一种形式。国际老年痴呆协会1994年在英国爱丁堡第十次会议上确定每年的9月21日为“世界阿尔茨海默病日”。临床上以记忆障碍、失语、失认、视空间技能损害、执行功能障碍以及人格和行为改变等全面性痴呆表现为特征。特征性病理改变为β淀粉样蛋白沉积形成的细胞外老年斑和tau蛋白过度磷酸化形成的神经细胞内神经原纤维缠结,以及神经元丢失伴胶质细胞增生等。
随着我国老龄化程度的加剧,AD会成为影响老年人健康的主要疾病之一,有效预防和治疗AD成为摆在我们面前的又一重大课题。AD的发病机制十分复杂,该病的发病机制至今仍不明确。随着AD临床和病理研究的不断深入,国际上关于AD治疗的研究的也越来越多,但迄今AD尚无可治愈的方法,相关研究任重而道远。
AD病因复杂、病程漫长、且发病环节较多,需要长期服药,目前主要的抗阿尔茨海默病药物乙酰胆碱酯酶抑制剂(如多奈哌齐、加兰他敏)和N-甲基-D-天冬氨酸受体(NMDA受体)拮抗剂(如美金刚),但上述药物价格昂贵,药物不良反应较多,服药后幻觉、意识混沌、头晕、头痛、恶心、腹痛、腹泻和疲倦等副作用显著,且其药效只能延缓病情,却不能最终控制或逆转患者病情。
而中药组合物科学配伍,具有多靶点、多种活性组分的特征,可以克服西药药物靶点单一的不足之处。因此筛选出治疗AD的中药组合物,前景非常广阔,对治疗有极大的帮助。
发明内容
针对现有技术的不足,本发明的目的在于提供一种药物组合物及其应用。
为达到此发明目的,本发明采用以下技术方案:
本发明提供一种药物组合物,所述药物组合物包括以下重量百分比的组分:
其中,所述各组分的重量百分比之和为100%。
本发明配方合理巧妙,起效快,对不同病因引起的阿尔茨海默症均有很好的治疗效果,且本发明配方安全、可靠,无任何毒副作用。
作为优选技术方案,所述药物组合物包括以下重量百分比的组分:
其中,所述各组分的重量百分比之和为100%。
在本发明中,蜂蛹冻干粉的重量百分比为10-92.68%、例如可以是10%、20%、35%、40%、55%、60%、70%、80%、90%或92.68%。
优选地,所述蜂蛹冻干粉为雄蜂蛹的冻干粉、蜂王的蜂蛹冻干粉或工蜂的蜂蛹冻干粉中的任意一种。
蜂蛹是蜜蜂的幼虫,含有十八种必须氨基酸,丰富的维生素、钙磷锌等微量元素。通过用蜂蛹粉喂食记忆力减退的白鼠,发现蜂蛹粉能活化脑细胞特别是脑中心部的蛋白,且管理记忆的区域发生了显著改善。因此,蜂蛹可以活化脑部细胞,对预防脑部老化及老年痴呆有显著效果。
在本发明中,蜂王浆冻干粉的重量百分比为5-80%,例如可以是5%、10%、30%、40%、50%、60%、70%或80%。
蜂王浆是蜂王的食物。一只蜂王的寿命在5-7年,而食用花粉和蜜蜂的普通蜜蜂寿命仅1-6个月。蜂王浆富含优质蛋白和多肽类,含有类胰岛素成分,多种维生素特别是B族元素,多种矿物质元素和乙酰胆碱。蜂王浆保健功能非常多,特别对心血管疾病包括血糖血脂血压的调节具有非常好的效果,还可以抗氧化、抗衰老。由于其含有乙酰胆碱,对老年痴呆具有直接治疗的功效。
在本发明中,磷脂酰丝氨酸的重量百分比为0.5-10%,例如可以是0.5%、1%、2%、3%、4%、5%、6%、7%、8%、9%或10%。
磷脂酰丝氨酸,又称复合神经酸。英文名Phosphatidylserine,简称PS。它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。
在本发明中,γ-氨基丁酸的重量百分比为0.5-10%,例如可以是0.5%、1%、2%、3%、4%、5%、6%、7%、8%、9%或10%。
γ-氨基丁酸是中枢神经系统中很重要的抑制性神经递质,它是一种天然存在的非蛋白组成氨基酸,具有极其重要的生理功能,它能促进脑的活化性,健脑益智,抗癫痫,促进睡眠,美容润肤,延缓脑衰老机能,能补充人体抑制性神经递质,具有良好的降血压功效等。γ-氨基丁酸能进入脑内三羧酸循环,促进脑细胞代谢,同时还能提高葡萄糖代谢时葡萄糖磷酸酯酶的活性,增加乙酰胆碱的生成,扩张血管增加血流量,并降低血氨,促进大脑的新陈代谢,恢复脑细胞功能。
在本发明中,γ-氨基丁酸与磷脂酰丝氨酸同时发挥作用,起到加快起效时间、延长药物作用效果的作用。
在本发明中,顺-15-二十四碳烯酸的重量百分比为0.5-10%,例如可以是0.5%、1%、2%、3%、4%、5%、6%、7%、8%、9%或10%。
神经酸,英文名Nervonic Acid,学名:顺-15-二十四碳单烯酸(Cis-15-Tetracosenic Acid),别名鲨鱼酸(Selacholeic Acid),是一种单不饱和脂肪酸。分子式为C24H46O2,分子量为366.6,化学结构式为CH3-(CH2)7-CH=CH-(CH2)13-COOH,纯品在常温下为白色片状晶体,能溶于醇,不溶于水,熔点39-40℃。由于早期发现于哺乳动物的神经组织,故命名为神经酸。
1925年,Klenk从人和动物的大脑里分离出脑苷脂,脑苷脂水解为半乳糖,脂氨醇和不饱和脂肪酸3部分,脑苷脂水解后从中分离得到了神经酸。1926年,Tsujimoto等人从鲨鱼油里分离出神经酸。
国内方面的文献较多:神经酸可以修复疏通受损大脑神经通路——神经纤维,并促使神经细胞再生的双效物质。神经酸是大脑神经纤维和神经细胞的核心天然成分。神经酸的缺乏将会引起脑中风后遗症。老年痴呆、脑瘫、脑萎缩、记忆力减退、失眠健忘等脑疾病,但未提供相关的实验证据。
国际文献较少,仅有的研究结论如下:神经酸可增强大脑功能并防止脱髓鞘(Chemical Land21)。神经酸与肥胖相关的危险因素存在负相关关系(PMID:16394593)。肾上腺髓质营养不良(ALD)和多发性硬化,其中鞘脂中神经酸水平降低。在本发明中,磷脂酰丝氨酸和γ-氨基丁酸可以加快药物组合物起效,使得药物组合物快速发挥治疗作用。
在本发明中,植物提取物的重量百分比为1-50%,例如可以是1%、5%、10%、20%、30%、40%或50%。
优选地,所述植物提取物为缬草提取物、绿薄荷提取物、银杏提取物、假马齿苋提取物、天麻提取物、西洋参提取物、猴头菇提取物、迷迭香提取物、葡萄籽提取物、啤酒花提取物或远志提取物中的一种或至少两种的组合。
缬草、天麻、啤酒花、猴头菇提取物中有效成分均能改善睡眠,缓解压力,进而提高记忆力;绿薄荷提取物中的多酚物质可以抗氧化,增强神经递质水平,促进神经元的生长,临床上可以全面提高工作记忆力;银杏提取物中的银杏黄酮可以抑制β-淀粉样蛋白的生成并促进其分解;假马齿苋提取物含有可以增强蛋白激酶生物活性的成分,能促进新神经元的生成提高大脑的学习和记忆能力,此外假马齿苋提取物还有缓解焦虑的作用;西洋参提取物对AD的影响表现在对神经递质、神经元、β-淀粉样蛋白、脑血流量等均有正面影响;迷迭香提取物具有镇静安神、醒脑作用,可用于治疗失眠、心悸、头痛、消化不良等多种疾病,还能改善语言、视觉、听力方面的障碍,增强注意力,治疗风湿痛,强化肝脏功能,降低血糖,有助于动脉硬化的治疗,帮助麻痹的四肢恢复活动能力。外用可治疗外伤和关节炎。还具有强壮心脏、促进代谢、促进末梢血管的血液循环等作用;葡萄籽提取物是从葡萄籽中提取的一种人体内不能合成的新型高效天然抗氧化剂物质。其抗氧化活性为维生素E的50倍、维生素C的20倍,它能有效清除人体内多余的自由基,具有超强的延缓衰老和增强免疫力的作用。抗氧化、抗过敏、抗疲劳增强体质、改善亚健康状态延缓衰老、改善烦躁易怒、头昏乏力、记忆力减退等症状;远志提取物具有安神益智、祛痰、消肿的功效,用于失眠多梦、健忘惊悸、神志恍惚等症状。
在本发明中,助剂的重量百分比为0.2-18%,例如可以是0.2%、2%、5%、10%、12%、14%、16%或18%。
优选地,所述助剂为色氨酸和/或茶氨酸。
色氨酸是人体必需的氨基酸,它可以促进大脑神经细胞分泌血清素。血清素具有抑制大脑思维活动的作用。血清素是一种抑制性神经递质,最早于血清中发现,广泛存在于哺乳动物组织中,在大脑皮层质及神经突触内含量很高。在外周组织,血清素是一种强血管收缩剂和平滑肌收缩刺激剂。血清素能增强记忆力,并能保护神经元免受“兴奋神经毒素”的损害。如谷氨酸即对受损的神经细胞有很大的毒性,因此充足的血清素能在老化过程中防止脑损害发生。
茶氨酸(L-Theanine)是茶叶中特有的游离氨基酸,茶氨酸是谷氨酸γ-乙基酰胺,有甜味。茶氨酸在化学构造上与脑内活性物质谷酰胺、谷氨酸相似。茶氨酸具有提高记忆力的功效。很多研究证明茶氨酸的这种提高学习和记忆能力的作用是来自活化中枢神经递质多巴胺的结果。
在本发明中,抗氧剂的重量百分比为0.12-18%,例如可以是0.12%、1%、5%、8%、10%、13%、15%或18%。
优选地,所述抗氧剂为虾青素、维生素C或维生素E中的一种或至少两种的组合。
虾青素(英语:Astaxanthin,又称变胞藻黄素或虾红素),是类胡萝卜素的一种,为一种非常强的天然抗氧化剂。虾青素具有保护皮肤和眼睛,抵抗辐射、心血管老化、老年痴呆和癌症等功效。人体的衰老,主要是由于自由基所造成的氧化所至。而虾青素特殊的分子构造,可以穿越人体细胞外壁,直接清除细胞内的氧自由基,增强细胞再生能力,维持人体机能平衡和减少衰老细胞的堆积,由内而外保护细胞和DNA健康。日本研究者发现,虾青素可通过增加流向大脑的血液流量、氧化数量和营养成分,预防血管性痴呆症。
维生素E是应用较为广泛的脂溶性抗氧化剂,对羟基、超氧阴离子、含氮自由基都有明显的清除作用,可以有效防止活性氧引起的细胞损伤,具有保护细胞、延缓衰老的作用。
维生素C又叫L-抗坏血酸,是一种水溶性维生素。维生素C的主要作用是提高免疫力,预防癌症、心脏病、中风,保护牙齿和牙龈等。维生素C是很强的抗氧化剂,可以清除人体中的自由基。而且维生素C可以促进神经递质(5-羟色胺及去甲肾上腺素)合成。这2种神经递质在促进脑活动中发挥重要作用。
在本发明中,所述药物组合物还包括食用辅料。
优选地,所述食用辅料为稳定剂和/或矫味剂。
食用辅料的添加可以进一步增强药物组合物的稳定性,并且改善药物组合物的口味。
优选地,所述药物组合物的剂型为固体制剂、液体制剂或半固体制剂中的任意一种。
本发明提供一种药物组合物在治疗阿尔茨海默症的药物制备中的应用。
本发明提供一种药物组合物在食品中的应用。
相对于现有技术,本发明具有以下有益效果:
本发明配方合理巧妙,起效快,对不同病因引起的阿尔茨海默症均有很好的治疗效果,且本发明配方安全、可靠,无任何毒副作用,在药物治疗中有较高的应用前景与应用价值。
附图说明
图1是本发明实施例1中药物组合物治疗阿尔茨海默症大鼠测定的平均逃避潜伏期曲线图。
图2是本发明实施例2中药物组合物治疗阿尔茨海默症大鼠测定的穿越平台次数图。
具体实施方式
下面通过具体实施方式来进一步说明本发明的技术方案。本领域技术人员应该明了,所述实施例仅仅是帮助理解本发明,不应视为对本发明的具体限制。
实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件,或者按照产品说明书进行。所用原料、辅料、试剂或仪器未注明生产厂商者,均为可通过正规渠道商购获得的常规产品。
实施例1
在本实施例中,药物组合物包括如下质量分数的组分组成:
其中植物提取物包含缬草提取物、绿薄荷提取物、银杏提取物、假马齿苋提取物、天麻提取物、西洋参提取物、猴头菇提取物、迷迭香提取物、葡萄籽提取物、啤酒花提取物和远志提取物,食用辅料为稳定剂和矫味剂。
实施例2
在本实施例中,药物组合物包括如下质量分数的组分组成:
其中植物提取物包含缬草提取物、绿薄荷提取物、银杏提取物、假马齿苋提取物、天麻提取物、西洋参提取物、猴头菇提取物、迷迭香提取物、葡萄籽提取物、啤酒花提取物和远志提取物,食用辅料为稳定剂和矫味剂。
实施例3
在本实施例中,药物组合物包括如下质量分数的组分组成:
其中植物提取物包含绿薄荷提取物、银杏提取物和假马齿苋提取物。
实施例4
在本实施例中,药物组合物包括如下质量分数的组分组成:
其中植物提取物为缬草提取物,食用辅料为稳定剂和矫味剂。
实施例5
在本实施例中,药物组合物包括如下质量分数的组分组成:
其中植物提取物天麻提取物和西洋参提取物,食用辅料为稳定剂和矫味剂。
实施例6
在本实施例中,药物组合物包括如下质量分数的组分组成:
其中植物提取物包含猴头菇提取物、迷迭香提取物和葡萄籽提取物,食用辅料为稳定剂和矫味剂。
实施例7
将实施例1中药物组合物进行功效验证:
实验动物及分组:取Wistar大鼠,雄性,9周龄,体质量260±20g。
共40只。室温饲养,动物自由摄食饮水。适应环境一周后,先将动物进行Morris水迷宫初筛,去除潜伏期小于50s和游泳姿势不良者,将合格大鼠随机分为空白对照组10只,AD模型组10只,本发明组合物干预组10只,阳性对照组(选用多奈哌齐)10只。
模型制备:大鼠灌胃给予AlCl3 28mg·kg-1,同时腹腔注射D-半乳糖63mg·kg-1,共90天复制老年痴呆症大鼠模型。
方法:AD模型组、阳性对照组、干预组于每天下午2:00复制老年痴呆症大鼠模型,阳性对照组每天上午8:00按生药量给予组合物粉水溶液1mg·kg-1,干预组每天上午8:00按生药量给予组合物粉水溶液1g·kg-1,空白对照组每天给予等量生理盐水;共计90天。空白对照组、老年痴呆症模型组、阳性对照组和干预组于实验第85天进行持续6天的行为学评价(Morris水迷宫)。
实验结果:在Morris水迷宫定位航行实验过程中,与空白对照组大鼠相比,老年痴呆症模型组大鼠逃避潜伏期时间显著延长,差异具有统计学意义(P<0.05,P<0.01);与老年痴呆症模型组大鼠相比,干预组大鼠逃避潜伏期时间显著缩短,差异具有统计学意义(P<0.05,P<0.01);且组合物干预组与阳性对照组平均潜伏次数对比后,具有一定的优势,具体结果如图1所示。
实施例8
将实施例1中药物组合物进行功效验证:
实验动物及分组:取Wistar大鼠,雄性,9周龄,体质量260±20g。
共40只。室温饲养,动物自由摄食饮水。适应环境一周后,先将动物进行Morris水迷宫初筛,去除潜伏期小于50s和游泳姿势不良者,将合格大鼠随机分为空白对照组10只,AD模型组10只,本发明组合物干预组10只,阳性对照组(选用多奈哌齐)10只。
模型制备:大鼠灌胃给予AlCl3 28mg·kg-1,同时腹腔注射D-半乳糖63mg·kg-1,共90天复制老年痴呆症大鼠模型。
方法:AD模型组、阳性对照组、干预组于每天下午2:00复制老年痴呆症大鼠模型,阳性对照组每天上午8:00按生药量给予组合物粉水溶液1mg·kg-1干预组每天上午8:00按生药量给予组合物粉水溶液1g·kg-1,空白对照组每天给予等量生理盐水;共计90天。空白对照组、老年痴呆症模型组、阳性对照组和干预组于实验第85天进行持续6天的行为学评价(Morris水迷宫)。
实验结果:在Morris水迷宫空间搜索实验中,与空白对照组大鼠相比,老年痴呆症模型组大鼠穿越平台次数显著减少,差异具有统计学意义(P<0.01);与老年痴呆症模型组大鼠相比,组合物干预组和阳性对照组大鼠穿越平台次数显著增加,差异具有统计学意义(P<0.05,P<0.01);且组合物干预组与阳性对照组穿越平台次数对比后,具有一定的优势,具体结果如图2所示。
对比例1
与实施例1不同的是,本对比例不含有磷脂酰丝氨酸,γ-氨基丁酸的质量为5%。
对比例2
与实施例1不同的是,本对比例不含有γ-氨基丁酸,磷脂酰丝氨酸的质量为5%。
对比例3
与实施例1不同的是,本对比例不含有γ-氨基丁酸和磷脂酰丝氨酸,雄蜂蛹的冻干粉质量分数为23%。
将实施例1-6及对比例1-3进行药物起效时间测试,测试具体结果如下表1所示:
表1
样例 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 实施例6 | 对比例1 | 对比例2 | 对比例3 |
时间(d) | 24 | 26 | 23 | 20 | 30 | 35 | 36 | 38 | 40 |
通过人群试服,实施例与对比例比较,试用人员入睡时间缩短,并延长了深睡眠,同时,注意力集中且压力减缓、情绪稳定,说明了磷脂酰丝氨酸与γ-氨基丁酸在本发明药物组合物中起到了加快起效时间,延长药物作用时间的作用。
申请人声明,本发明通过上述实施例来说明本发明的一种药物组合物及其应用,但本发明并不局限于上述工艺步骤,即不意味着本发明必须依赖上述工艺步骤才能实施。所属技术领域的技术人员应该明了,对本发明的任何改进,对本发明所选用原料的等效替换及辅助成分的添加、具体方式的选择等,均落在本发明的保护范围和公开范围之内。
Claims (10)
1.一种药物组合物,其特征在于,所述药物组合物包括以下重量百分比的组分:
其中,所述各组分的重量百分比之和为100%。
2.根据权利要求1所述的药物组合物,其特征在于,所述药物组合物包括以下重量百分比的组分:
其中,所述各组分的重量百分比之和为100%。
3.根据权利要求1或2所述的药物组合物,其特征在于,所述蜂蛹冻干粉为雄蜂蛹的冻干粉、蜂王的蜂蛹冻干粉或工蜂的蜂蛹冻干粉中的任意一种。
4.根据权利要求1-3任一项所述的药物组合物,其特征在于,所述植物提取物为缬草提取物、绿薄荷提取物、银杏提取物、假马齿苋提取物、天麻提取物、西洋参提取物、猴头菇提取物、迷迭香提取物、葡萄籽提取物、啤酒花提取物或远志提取物中的一种或至少两种的组合。
5.根据权利要求1-4任一项所述的药物组合物,其特征在于,所述助剂为色氨酸和/或茶氨酸。
6.根据权利要求1-5任一项所述的药物组合物,其特征在于,所述抗氧剂为虾青素、维生素C或维生素E中的一种或至少两种的组合。
7.根据权利要求1-6任一项所述的药物组合物,其特征在于,所述药物组合物还包括食用辅料;
优选地,所述食用辅料为稳定剂和/或矫味剂。
8.根据权利要求1-7任一项所述的药物组合物,其特征在于,所述药物组合物的剂型为固体制剂、液体制剂或半固体制剂中的任意一种。
9.根据权利要求1-8任一项所述的药物组合物在治疗阿尔茨海默症的药物制备中的应用。
10.根据权利要求1-8任一项所述的药物组合物在食品中的应用。
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