CN110960586A - 蚂蚁助眠胶囊及制备方法 - Google Patents
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Abstract
本发明提供一种蚂蚁助眠胶囊，包括如下质量份数的组分：拟黑多刺蚂蚁600～800份；灵芝200～350份；酸枣仁450～550份；丹参450‑550份。本发明原料针对性强，配伍精当：以拟黑多刺蚂蚁为君药，丹参、酸枣仁为臣，灵芝为佐，黄精为使，具有益气养血、滋阴养阳、祛风除湿等功效，起到气血双补、阴阳并调之作用。可增强人体免疫力、改善睡眠。
Description
技术领域
本发明涉及保健食品领域，具体为一种蚂蚁助眠胶囊及其制备方法。
背景技术
失眠亦称不寐，首载于《内经》，称“目不明”“不得卧”，《难经》始称不寐，主要以睡眠时间、睡眠深度及睡眠质量不能满足机体日常需要为特征。失眠临床表现为入睡困难、寐而易醒或醒后不能再寐，部分患者时寐时醒，严重者整夜不能眠。长期失眠不仅使患者日间功能下降，影响他们的正常生活和工作，甚至还会导致身体机能紊乱，引发全身性躯体疾病，如心脏病、高血压等，而且这类人群患上焦虑和抑郁症的概率也会上升。2019年7月15日，规划发展与信息化司发布了详细的《健康中国行动(2019-2030)》报告中的数据显示，中国2016年的失眠现患率为15％，这代表着当年有2.07亿人口存在睡眠问题或睡眠障碍症，并且失眠人数还在逐年增加。
从整体角度分析，失眠的病机就是阴阳失调。中医研究不寐证型主要将重点放在心肾不交、肝火扰心、心胆气虚以及心脾两虚等方面。而根据现代社会生活基本特点，导致不寐的主要原因就是情志和饮食，而病机则包括心神失养和肝郁脾虚等。由于现代社会竞争愈加激烈，人们的工作与学习压力较大，思虑过度加之情志不遂，长此以往很容易出现肝郁症状。若长期处于肝郁状态，脾气自然会虚弱，肝藏血的功能受到直接影响，而疏泄功能也有所下降。人体一旦肝失疏泄且气机郁滞就会出现气机升降的情况，从中医角度分析，很容易受气血生化不足因素的影响而心失所养，最终失眠。在临床治疗中，西医采用苯二氮卓类催眠药物以及非苯二氮卓类药物，但不良反应发生率较高。而中医以辨证论治为核心，对患者机体进行调节，保证脏腑的平衡性，在阴阳沟通的基础上，达到失眠治疗的目的，且副作用小，目前常用的中药有“柏子养心丸”、“磁硃丸”、“归脾丸”、“逍遥丸”、“天王补心丹”、“养血安神片”、“睡得安”(又名高枕无忧散)等等，均以滋养心阴、补血镇静安神为则，此类药物较前法虽然毒副作用低，但适用范围受限，而对大部分重症患者不能彻底治愈，只是改善症状。综上所述，目前尚无此类病症的理想药物。
发明内容
本发明目的在于提供一种蚂蚁助眠胶囊，用于解决目前中药尚无可以治疗重症失眠的技术问题。
为达成上述目的，本发明提出如下技术方案：
蚂蚁助眠胶囊，包括如下质量份数的组分：
拟黑多刺蚂蚁600～800份；灵芝200～350份；酸枣仁450～550份；丹参450-550份。
进一步的，在本发明中，各组分的质量份数的配比如下：
拟黑多刺蚂蚁750份；灵芝250份；黄精250份；酸枣仁500份；丹参500份。
本发明同时还公开了上述蚂蚁助眠胶囊的制备方法，以拟黑多刺蚂蚁600～800份、灵芝200～350份、酸枣仁450～550份、丹参450-550份的质量份数配比各组分；
并对各进行加工，包括：
将灵芝采用6～10倍量水为提取溶剂，加热回流提取2次，滤液获得第一溶液备用；
将灵芝药渣与其余4种药材以6～10倍量的乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇后与第一溶液提液混合浓缩至1.25g/cm3～1.25g/cm3的清膏；
加入辅料，混合，干燥，粉碎，50-80目过筛，装入胶囊，即得。
有益效果：
本申请蚂蚁助眠胶囊的原料针对性强，配伍精当：以拟黑多刺蚂蚁为君药，丹参、酸枣仁为臣，灵芝为佐，黄精为使，具有益气养血、滋阴养阳、祛风除湿等功效，起到气血双补、阴阳并调之作用。可增强人体免疫力、改善睡眠。
具体的，从中药配伍角度，拟黑多刺蚂蚁为君药，祛风湿，补肝肾，现代人每多贪凉饮冷易生寒湿，熬夜透支肝肾精血，拟黑多刺蚂蚁既可补益肝肾精血，挽回透支气血，又可散寒祛湿，以通经络，令邪去正复，经络通畅，则有助于“阳入于阴”，从而帮助快速入睡；丹参、酸枣仁为臣，可养血安神，有助睡眠；灵芝宁心安神为佐，黄精为使，补益中土，令脾胃畅其生化气血之源，气血充足，自能濡养心神。全方合用，具有益气养血、滋阴养阳、祛风除湿等功效，起到气血双补、阴阳并调之作用。可改善睡眠，同时诸药经现代药理研究，均可增强人体免疫力。故而在改善睡眠的同时，也可增强免疫力，符合现代社会人群的需求。
从加工工艺角度来说，蚂蚁助眠胶囊非药材粉末直接入药而是药材经过加热回流提取的提取物入药，增强有效成分溶出，增强疗效，通过药效学实验对比研究，发现本发明生产效率高、产品质量稳定、疗效显著，适合大规模生产。
从食用安全角度来书哦，本发明处方药材拟黑多刺蚂蚁、灵芝、黄精、酸枣仁等均为药食同源药材，安全系数更高。
从营养脚趾角度来说，现代营养学分析，蚂蚁含20种游离氨基酸，有8种人体必需氨基酸。处方中调配灵芝、黄精、酸枣仁、丹参不仅增强药酒营养价值，同时缓和药味。
应当理解，前述构思以及在下面更加详细地描述的额外构思的所有组合只要在这样的构思不相互矛盾的情况下都可以被视为本公开的发明主题的一部分。
下面的描述中可以更加全面地理解本发明教导的前述和其他方面、实施例和特征。本发明的其他附加方面例如示例性实施方式的特征和/或有益效果将在下面的描述中显见，或通过根据本发明教导的具体实施方式的实践中得知。
具体实施方式
为了更了解本发明的技术内容，特举具体实施例说明如下。
本公开的实施例不必定意在包括本发明的所有方面。应当理解，上面介绍的多种构思和实施例，以及下面更加详细地描述的那些构思和实施方式可以以很多方式中任意一种来实施，这是因为本发明所公开的构思和实施例并不限于任何实施方式。另外，本发明公开的一些方面可以单独使用，或者与本发明公开的其他方面的任何适当组合来使用。
蚂蚁助眠胶囊，包括如下质量份数的组分：
拟黑多刺蚂蚁600～800份；灵芝200～350份；酸枣仁450～550份；丹参450-550份。
作为优先的，各组分的质量份数的配比如下：
拟黑多刺蚂蚁750份；灵芝250份；黄精250份；酸枣仁500份；丹参500份。
上述蚂蚁助眠胶囊的制备方法，以拟黑多刺蚂蚁600～800份、灵芝200～350份、酸枣仁450～550份、丹参450-550份的质量份数配比各组分，并对各进行加工，包括：
步骤一、将灵芝采用6～10倍量水为提取溶剂，加热回流提取2次，滤液获得第一溶液备用；
步骤二、将灵芝药渣与其余4种药材以6～10倍量的乙醇为提取溶剂，所述乙醇的酒精度为55％-65％，加热回流提取2次，滤液回收乙醇后与第一溶液提液混合浓缩至1.25g/cm3～1.30g/cm3的清膏；
步骤三、加入辅料，混合，干燥，粉碎，50-80目过筛，装入胶囊，即得。
实施例1
取拟黑多刺蚂蚁750g，灵芝250g，黄精250g，酸枣仁500g，丹参500g。灵芝采用8倍量水为提取溶剂，加热回流提取2次，滤液备用；灵芝药渣与其余4种药材以8倍量60％乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇后与灵芝水提液混合浓缩至60℃下1.25g/cm3～1.30g/cm3的清膏，加入糊精等辅料适量，混合，干燥，粉碎，60目过筛，装入胶囊，每2.25Kg药材制成1000粒，即得。
实施例2
称取拟黑多刺蚂蚁650g，灵芝200g，黄精300g，酸枣仁550g，丹参550g。灵芝采用6倍量水为提取溶剂，加热回流提取2次，滤液备用；灵芝药渣与其余4种药材以6倍量55％乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇后与灵芝水提液混合浓缩至60℃下1.25g/cm3～1.30g/cm3的清膏，加入糊精等辅料适量，混合，干燥，粉碎，50目过筛，装入胶囊，每2.25Kg药材制成1000粒，即得。
实施例3
称取拟黑多刺蚂蚁800g，灵芝300g，黄精200g，酸枣仁500g，丹参450g。灵芝采用10倍量水为提取溶剂，加热回流提取2次，滤液备用；灵芝药渣与其余4种药材以10倍量65％乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇后与灵芝水提液混合浓缩至60℃下1.25g/cm3～1.30g/cm3的清膏，加入糊精等辅料适量，混合，干燥，粉碎，80目过筛，装入胶囊，每2.25Kg药材制成1000粒，即得。
对比例1
称取拟黑多刺蚂蚁750g，以8倍量60％乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇，浓缩至60℃下1.25g/cm3～1.30g/cm3的清膏，加入糊精等辅料适量，混合，干燥，粉碎，60目过筛，装入胶囊，每2.25Kg药材制成1000粒，即得。
对比例2
取拟黑多刺蚂蚁750g，灵芝250g，黄精250g。灵芝采用8倍量水为提取溶剂，加热回流提取2次，滤液备用；灵芝药渣与其他两味药以8倍量60％乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇后与灵芝水提液混合浓缩至60℃下1.25g/cm3～1.30g/cm3的清膏，加入糊精等辅料适量，混合，干燥，粉碎，60目过筛，装入胶囊，每2.25Kg药材制成1000粒，即得。
对比例3
取灵芝250g，黄精250g，酸枣仁500g，丹参500g。灵芝采用8倍量水为提取溶剂，加热回流提取2次，滤液备用；灵芝药渣与其余3种药材以8倍量60％乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇后与灵芝水提液混合浓缩至60℃下1.25g/cm3～1.25g/cm3的清膏，加入糊精等辅料适量，混合，干燥，粉碎，60目过筛，装入胶囊，每2.25Kg药材制成1000粒，即得。
试验例1
1.实验材料：
1.1药品戊巴比妥钠(上海创赛科技有限公司)，解郁安神颗粒(辽宁富东制药有限公司)，蚂蚁助眠胶囊(自制)。
1.2动物
昆明种小鼠，体重18～25g，均为雄鼠。
2.实验方法：
2.1对小鼠催眠时间的影响
80只昆明小鼠随机分为8组：空白组、解郁安神颗粒组、蚂蚁助眠胶囊实施例1、实施例2、实施例3、对比例1、对比列2、对比列3。各组分别灌胃给药，空白组灌胃等体积蒸馏水，每天1次，每次0.05ml/g。末次给药后1h，每只小鼠腹腔注射戊巴比妥钠50mg/kg，观察记录30min内翻正反射消失达1min以上的小鼠数，入睡潜伏期(翻正反射消失时间)和睡眠持续时间(翻正反射消失至恢复的时间)。实验结果见表1、2。
2.2对小鼠自发活动的影响
80只昆明小鼠随机分为8组：空白组、解郁安神颗粒组、蚂蚁助眠胶囊实施例1、实施例2、实施例3、对比例1、对比列2、对比列3。各组分别灌胃给药，空白组灌胃等体积蒸馏水，每天1次，每次0.05ml/g。末次给药后30min后，用程控自主活动箱测2min内小鼠自发活动次数。实验结果见表3。
3实验结果
表1
注:与空白组比较*P<0.05；**P<0.01。
蚂蚁助眠胶囊可使小鼠快速进入睡眠，明显缩短戊巴比妥钠致小鼠入睡的潜伏时间，延长睡眠持续时间，蚂蚁助眠胶囊实施例1效果明显优于其他蚂蚁助眠胶囊组合物组，同空白组比较，差异具有统计学意义。
表2
蚂蚁助眠胶囊增加小鼠戊巴比妥钠阈下剂量催眠发生率，其中蚂蚁助眠胶囊实施例1半小时内翻正反射消失达1min以上的小鼠数相比空白对照组明显增加，且效果优于其他组。
表3
注:与空白组比较*P<0.05；**P<0.01。
蚂蚁助眠胶囊能明显迟缓小鼠活动，使反应迟钝，其中实施例1效果最明显，实施例2、3次之，与空白组比较，差异具统计学意义。
虽然本发明已以较佳实施例揭露如上，然其并非用以限定本发明。本发明所属技术领域中具有通常知识者，在不脱离本发明的精神和范围内，当可作各种的更动与润饰。因此，本发明的保护范围当视权利要求。
Claims (4)
1.蚂蚁助眠胶囊，其特征在于：包括如下质量份数的组分：
拟黑多刺蚂蚁600～800份；灵芝200～350份；酸枣仁450～550份；丹参450-550份。
2.根据权利要求1所述的蚂蚁助眠胶囊，其特征在于：各组分的质量份数的配比如下：
拟黑多刺蚂蚁750份；灵芝250份；黄精250份；酸枣仁500份；丹参500份。
3.蚂蚁助眠胶囊的制备方法，其特征在于：
以拟黑多刺蚂蚁600～800份、灵芝200～350份、酸枣仁450～550份、丹参450-550份的质量份数配比各组分；
并对各进行加工，包括：
将灵芝采用6～10倍量水为提取溶剂，加热回流提取2次，滤液获得第一溶液备用；
将灵芝药渣与其余4种药材以6～10倍量的乙醇为提取溶剂，加热回流提取2次，滤液回收乙醇后与第一溶液提液混合浓缩至1.25g/cm3～1.25g/cm3的清膏；
加入辅料，混合，干燥，粉碎，50-80目过筛，装入胶囊，即得。
4.根据权利要求3所述的蚂蚁助眠胶囊的制备方法，其特征在于：所述乙醇的酒精度为55％-65％。
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