CN111358815A - 一种改善睡眠的组合物及其制备方法和应用 - Google Patents
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Abstract
本发明涉及一种改善睡眠的组合物及其制备方法和应用,属于医药技术领域。本发明所述组合物的制备用原料包括鹿心、蛤蟆油、植物甾醇和芹菜籽提取物。本发明所述组合物成分明确,安全有效,无毒副作用,具有明显改善睡眠的作用,可用于制备具有改善睡眠功能的保健食品、健康食品,也可制成改善睡眠的药物制剂,容易被患者接受,符合社会发展总体趋势。
Description
技术领域
本发明涉及医药技术领域,具体涉及一种改善睡眠的组合物及其制备方法和应用。
背景技术
失眠是由于心神失养或心神不安而引起经常不能获得正常睡眠为特征的一类病症,主要表现为睡眠时间不足、睡眠深度不够,不能消除疲劳,不能恢复体力与精力。随着社会发展节奏加快及竞争日益激烈,失眠、焦虑患者与日俱增。失眠患者由于睡眠时间不足或睡眠不熟,醒后常见神疲乏力,头晕头痛,心悸健忘及心神不宁等症状。最新研究发现,睡眠不足还会导致记忆力明显下降,伴随神经元细胞营养不良、萎缩,乃至凋亡,与心脑血管病的发生直接相关。
目前治疗失眠主要采用镇静催眠类药物。这类药物虽疗效确切,短期可见效,但副作用较大,如头晕目眩、乏力、记忆力降低,易造成药物依赖性和后遗效应,因而寻找能改善睡眠的天然植物药十分必要。与西药相比,中药具有更高的安全性。但目前市场上中成药有些含有镇定安神的矿物药朱砂,会对人体造成一定损害,有些中成药还含有首乌藤,如果长期使用,其所含蒽醌类物质会造成严重的肝损伤。因此,开发具有有助于改善睡眠的食品或保健品,显得尤为重要。
发明内容
本发明的目的在于提供一种改善睡眠的组合物及其制备方法和应用。本发明所述组合物组合物成分明确,安全有效,无毒副作用,具有明显改善睡眠的作用。
本发明提供了一种改善睡眠的组合物,所述组合物的制备用原料包括鹿心、蛤蟆油、植物甾醇和芹菜籽提取物。
优选的是,所述组合物包括以下重量份的组分:鹿心2~80份,蛤蟆油2~80份,植物甾醇2~100份和芹菜籽提取物3~130份。
优选的是,所述组合物包括以下重量份的组分:鹿心8份,蛤蟆油10份,植物甾醇8份和芹菜籽提取物15份。
优选的是,所述芹菜籽提取物的制备方法包括以下步骤:芹菜籽用8倍质量的体积百分含量为70%的乙醇回流提取2次,每次2~3个小时,得到乙醇提取液,回收乙醇,得到乙醇提取物,干燥,粉碎,得到芹菜籽提取物。
优选的是,所述组合物的剂型包括口服制剂,所述口服制剂包括粉剂、颗粒剂、片剂或丸剂。
本发明还提供了上述技术方案所述组合物的制备方法,包括以下步骤:
1)将清洗后的鹿心切成块,冷冻干燥,粉碎,得到鹿心粉;
2)将清洗后的蛤蟆油进行冷冻干燥,粉碎,得到蛤蟆油粉;
3)将所述步骤1)得到的鹿心粉、步骤2)得到的蛤蟆油粉和芹菜籽提取物加热灭菌,干燥,得到微粉;
4)将步骤3)所述微粉和植物甾醇混合,得到组合物;
所述步骤1)和2)没有时间先后顺序的限定。
本发明还提供了上述技术方案所述组合物或上述技术方案所述制备方法制备得到的组合物在制备改善睡眠的药物和/或保健食品中的应用。
本发明提供了一种改善睡眠的组合物及其制备方法和应用。本发明以既是食品又是药品的纯天然鹿心、蛤蟆油、植物甾醇和芹菜籽为原料,成分明确,安全有效,无毒副作用,制备得到的组合物具有明显改善睡眠的作用,可用于制备具有改善睡眠功能的保健食品、健康食品,也可制成改善睡眠的药物制剂,容易被患者接受,符合社会发展总体趋势。试验结果表明,本发明组合物较单一使用其中任何一种组分都具有更好的改善睡眠作用,协同增效效果显著。
附图说明
图1为本发明实施例6提供的实验组对小鼠直接睡眠影响结果图;
图2为本发明实施例6提供的实验组对戊巴比妥钠诱导的小鼠睡眠时间影响结果图。
具体实施方式
本发明提供了一种改善睡眠的组合物,所述组合物的制备用原料包括鹿心、蛤蟆油、植物甾醇和芹菜籽提取物。
在本发明中,所述组合物包括以下重量份的组分:鹿心2~80份,蛤蟆油2~80份,植物甾醇2~100份和芹菜籽提取物3~130份。
本发明所述组合物包括2~80份的鹿心,更优选为8份。本发明对所述鹿心的来源没有特殊限定,采用本领域技术人员熟知的常规鹿心市售产品即可。本发明所述鹿心优选为梅花鹿Cervus nippon Temminck或马鹿C.elaphus L.的带血心脏。鹿心主要含微量元素、氨基酸、脂肪酸、维生素、前列腺素、磷脂、激素、生物胺、草胺、胺化合物、多肽蛋白质等生物活性成分。本发明所述组合物中加入鹿心,可调节心肌功能,增强血液循环,改善人体新陈代谢,养气安神,改善神经衰弱症状;并且对因疲劳过度、惊吓、神经衰弱引起的心律过速和心血亏损等症及心绞痛、冠心病、风湿性心脏病,脑动脉硬化均有很好的疗效,可有效改善心慌、心跳、心律不齐、失眠、无力、低血压等,从而达到治疗失眠的作用。
本发明所述组合物还包括2~80份的蛤蟆油,更优选为10份。本发明对所述蛤蟆油的来源没有特殊限定,采用本领域技术人员熟知的常规蛤蟆油市售产品即可,蛤蟆油为中国雌性林蛙输卵管。本发明所述蛤蟆油主要含有维生素、三碘甲状腺原氨酸T3、甲状腺素T4、促绒毛膜性腺激素HCG、氨基酸、脂肪酸、磷脂磷、甾体激素和微量元素等。由于五脏藏精、化气、生神对于睡眠有直接作用。心藏神、肝藏魂、肺藏魄、脾藏意、肾藏志,别无所累而常多不寐者,总属真阴精血之不足,阴阳不交,致神有不安其室耳。本发明中加入蛤蟆油,具有“补肾益精,养阴润肺”之功效,常用于身体虚弱、病后失调等消耗性疾病,对经血不足,神经衰弱等具有良好的功效,从而能通过补养五脏达到安神宁志的作用。
本发明所述组合物还包括2~100份的植物甾醇,更优选为8份。本发明对所述植物甾醇的来源没有特殊限定,采用本领域技术人员熟知的植物甾醇常规市售产品即可。本发明加入植物甾醇具有保护心脏及对中老年的前列腺炎和前列腺增生具有明显的改善作用,防治由于心脏不适导致的失眠,同时防治由于前列腺炎及前列腺增生引起的尿频尿急,频繁起夜,从而改善睡眠治疗。
本发明所述组合物还包括3~130份的芹菜籽提取物,更优选为15份。本发明对芹菜籽的来源没有特殊限定,采用本领域技术人员熟知的常规芹菜籽市售产品即可。在本发明中,所述芹菜籽提取物的制备方法优选包括以下步骤:芹菜籽用8倍质量的体积百分含量为70%的乙醇回流提取2次,每次2~3个小时,得到乙醇提取液,回收乙醇,得到乙醇提取物,干燥,粉碎,得到芹菜籽提取物。在本发明中,所述体积百分含量为70%的乙醇指的是含体积百分含量为70%的乙醇的水溶液。本发明通过提取富集了有效成分,使制剂的服用量减少,方便服用人群。芹菜籽提取物中含有丁基苯酞具有镇静安神的作用;含有黄酮类成分具有降压安神、保护血管和增强免疫等作用,本发明中加入芹菜籽提取物,具有镇静安神的作用,并且可以改善由于抑制由去甲肾上腺素引起的血管暂时性紧张收缩,抗脑缺血、减轻脑损伤,从而达到改善睡眠的作用。
在本发明中,所述组合物的剂型包括口服制剂,所述口服制剂包括粉剂、颗粒剂、片剂或丸剂。
本发明从“改善血脂、养气安神、调节心肌功能、补养五脏、镇静等方面入手,多靶点、多效应”起到改善睡眠的作用,以鹿心、蛤蟆油、植物甾醇及芹菜籽作为原料,按照不同比例配方,经过大量筛选试验发现,鹿心、蛤蟆油、植物甾醇及芹菜籽的组合物含有甾醇类、氨基酸、维生素、脂肪酸、微量元素及黄酮类化合物,在改善睡眠方面具有互补性,将它们联合后,较单一鹿心、蛤蟆油、植物甾醇或芹菜籽具有更明显的药理活性,能够从不同角度起到改善睡眠的作用,具体的,本发明所述组合物能够通过调节神经,养护心神,从而达到有助于改善睡眠的作用。本发明所述组合物体现了中药化学成分之间协同增效,从而到达有助于改善睡眠的作用。本发明所述组合物疗效确切,无毒副作用,服用方便,剂型科学。
本发明还提供了上述技术方案所述组合物的制备方法,包括以下步骤:
1)将清洗后的鹿心切成块,冷冻干燥,粉碎,得到鹿心粉;
2)将清洗后的蛤蟆油进行冷冻干燥,粉碎,得到蛤蟆油粉;
3)将所述步骤1)得到的鹿心粉、步骤2)得到的蛤蟆油粉和芹菜籽提取物加热灭菌,干燥,得到微粉;
4)将步骤3)所述微粉和植物甾醇混合,得到组合物;
所述步骤1)和2)没有时间先后顺序的限定。
本发明将清洗后的鹿心切成块,冷冻干燥,粉碎,得到鹿心粉。在本发明中,所述鹿心优选为新鲜的常规市售鹿心。本发明优选使用去离子水对鹿心进行清洗。本发明优选切成边长为2~3cm的方块。本发明对所述冷冻干燥和粉碎的操作没有特殊限定,采用本领域技术人员熟知的常规操作即可。
本发明将清洗后的蛤蟆油进行冷冻干燥,粉碎,得到蛤蟆油粉。本发明优选使用去离子水对蛤蟆油进行清洗。本发明对所述冷冻干燥和粉碎的操作没有特殊限定,采用本领域技术人员熟知的常规操作即可。
本发明将鹿心粉、蛤蟆油粉和芹菜籽提取物加热灭菌,干燥,得到微粉。本发明对所述加热灭菌和干燥的方式没有特殊限定,采用本领域技术人员熟知的常规操作方法即可。
本发明将所述微粉和植物甾醇混合,得到组合物。本发明制备工艺简单,价格低廉。
本发明还提供了上述技术方案所述组合物或上述技术方案所述制备方法制备得到的组合物在制备改善睡眠的药物和/或保健食品中的应用。
下面结合具体实施例对本发明所述的一种改善睡眠的组合物及其制备方法和应用做进一步详细的介绍,本发明的技术方案包括但不限于以下实施例。
实施例1
鹿心粉的制备方法
将新鲜的鹿心用去离子水洗净,切成2~3厘米方块,进行冷冻干燥,粉碎成细粉,即得。
实施例2
蛤蟆油微粉的制备方法
将新鲜的蛤蟆油用去离子水洗净,进行冷冻干燥,粉碎成细粉,即得。
实施例3
植物甾醇微粉的制备方法
将植物甾醇,粉碎,过300目筛,即得。
实施例4
芹菜籽提取物的制备方法
芹菜籽5kg,用8倍量70%乙醇回流提取2次,每次3小时,过滤,滤液回收乙醇,得乙醇提取物,干燥,粉碎,备用。
实施例5
组合物的制备方法
将实施例1制备得到的鹿心细粉60g,实施例4制备得到的芹菜籽提取物细粉300,实施例2制备得到的蛤蟆油细粉60g加热灭菌,干燥,制成微粉,再与实施例3制备得到的植物甾醇微粉80g混合均匀,即得。
实施例6
鹿心为实施例1制备的样品;蛤蟆油为实施例2制备的样品;植物甾醇为实施例3制备的样品;芹菜籽为实施例4制备的样品;本发明组合物是实施例5制备的样品(鹿心:蛤蟆油:植物甾醇:芹菜籽=8:10:8:15),所用的原料为实施例1~4制备方法制备得到。
1、动物分组及给药剂量
昆明种雄性小鼠,体重(20±2g)。选80只小鼠,随机分为组合物低(1g/kg)、中(2g/kg)、高(4g/kg)三个剂量实验组、鹿心组(4g/kg)、蛤蟆油组(4g/kg)、植物甾醇组(4g/kg)、芹菜籽和空白对照组,每组10只。实验组分别灌胃给予各样品,阴性对照组给予等量的蒸馏水,灌胃量为0.2mL/10g。
2、实验方法
2.1直接睡眠实验
取小鼠90只,小鼠分组及给药剂量同上述“动物分组及给药剂量”项。各组每日上午9:00-10:00灌胃给药1次,连续30d,末次给药后观察小鼠的睡眠情况。睡眠以翻正反射消失为判断指标,当小鼠置于背卧位时,能立即翻正身位,如超过60s不能翻正者,即认为翻正反射消失,进入睡眠,从翻正反射消失至翻正反射恢复的时间为小鼠睡眠时间,观察各组小鼠的睡眠发生率、入睡动物数及睡眠时间。如试验组入睡动物数及睡眠时间增加并与阴性对照组有显著性差异,即判定该项试验结果为阳性。
2.2延长戊巴比妥钠睡眠时间实验
取小鼠80只,小鼠分组及给药剂量同上述“动物分组及给药剂量”项。在末次给药20min后,各组小鼠按50mg/kg BW剂量腹腔注射戊巴比妥钠,注射量为0.2mL/20g BW。以小鼠的翻正反射消失为睡眠判断指标,观察小鼠对戊巴比妥钠诱导小鼠睡眠时间延长的影响。如实验组小鼠的睡眠时间比阴性对照组延长并有统计学意义,即判定该项试验结果为阳性。
3、试验结果
3.1直接睡眠实验
各剂量实验组小鼠在给予各样品后,小鼠多表现为安静和活动减少,组合物低、中、高剂量组有翻正反射消失者,阴性对照组动物全部清醒,表明发明组合物各对小鼠有直接睡眠作用,其余鹿心组、蛤蟆油组、植物甾醇组及芹菜籽组对小鼠也有直接睡眠作用,但是效果没有组合物好(实验组对小鼠直接睡眠影响结果如图1所示。
3.2延长戊巴比妥钠诱导的小鼠睡眠时间实验
各剂量实验组小鼠的睡眠时间均比阴性对照组的时间长,且组合物中、高剂量组与阴性对照组的差异均具有显著性(P<0.05)。表明组合物能延长戊巴比妥钠诱导的小鼠睡眠时间,并且较鹿心组、蛤蟆油组、植物甾醇组及芹菜籽组活性具有明显提高(实验组对戊巴比妥钠诱导的小鼠睡眠时间影响结果如图2所示)。
4、试验结论
通过以上实验证实了组合物有诱导小鼠安然入睡,延长小鼠睡眠时间的作用。人体长期食用,必然起到宁心安神、改善睡眠质量的保健作用。并且较单一鹿心、蛤蟆油、植物甾醇及芹菜籽活性更好。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (7)
1.一种改善睡眠的组合物,其特征在于,所述组合物的制备用原料包括鹿心、蛤蟆油、植物甾醇和芹菜籽提取物。
2.根据权利要求1所述的组合物,其特征在于,所述组合物包括以下重量份的组分:鹿心2~80份,蛤蟆油2~80份,植物甾醇2~100份和芹菜籽提取物3~130份。
3.根据权利要求2所述的组合物,其特征在于,所述组合物包括以下重量份的组分:鹿心8份,蛤蟆油10份,植物甾醇8份和芹菜籽提取物15份。
4.根据权利要求2或3所述的组合物,其特征在于,所述芹菜籽提取物的制备方法包括以下步骤:芹菜籽用8倍质量的体积百分含量为70%的乙醇回流提取2次,回流提取2次,每次2~3个小时,得到乙醇提取液,回收乙醇,得到乙醇提取物,干燥,粉碎,得到芹菜籽提取物。
5.根据权利要求1所述的组合物,其特征在于,所述组合物的剂型包括口服制剂,所述口服制剂包括粉剂、颗粒剂、片剂或丸剂。
6.权利要求1~5任一项所述组合物的制备方法,包括以下步骤:
1)将清洗后的鹿心切成块,冷冻干燥,粉碎,得到鹿心粉;
2)将清洗后的蛤蟆油进行冷冻干燥,粉碎,得到蛤蟆油粉;
3)将所述步骤1)得到的鹿心粉、步骤2)得到的蛤蟆油粉和芹菜籽提取物加热灭菌,干燥,得到微粉;
4)将步骤3)所述微粉和植物甾醇混合,得到组合物;
所述步骤1)和2)没有时间先后顺序的限定。
7.权利要求1~5任一项所述组合物或权利要求6所述制备方法制备得到的组合物在制备改善睡眠的药物和/或保健食品中的应用。
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CN111728985A (zh) * | 2020-08-03 | 2020-10-02 | 赵全成 | 一种以蛤蟆油为主要成分的组合物及其用途 |
CN111728985B (zh) * | 2020-08-03 | 2023-07-21 | 赵全成 | 一种以蛤蟆油为主要成分的组合物及其用途 |
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