CN104306555B - 一种治疗失眠的食品、保健品或药物组合物 - Google Patents
一种治疗失眠的食品、保健品或药物组合物 Download PDFInfo
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- CN104306555B CN104306555B CN201410542574.1A CN201410542574A CN104306555B CN 104306555 B CN104306555 B CN 104306555B CN 201410542574 A CN201410542574 A CN 201410542574A CN 104306555 B CN104306555 B CN 104306555B
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供了一种治疗失眠的食品、保健品或药物组合物，其原料由如下重量配比的组分组成：雪菊8～15份，黑果枸杞5～15份，枸杞叶10～25份，红花12～15份，荞麦15～25份。本发明将各味原料进行科学合理的配伍，发挥了协同增效作用，能够有效改善睡眠情况，对失眠症有良好的治疗和预防作用，为临床使用提供了新的选择。
Description
技术领域
本发明提供了一种治疗失眠的食品、保健品或药物组合物。
背景技术
随着人们生活节奏的加快和工作压力的加大，人们正常的生物钟也会不时的发生改变，比如连续的加班加点、居住地周围的噪音干扰等，使得人们的生活习惯不得不接受改变，于是往往会产生睡眠不足的问题，即为失眠。失眠通常指患者对睡眠时间或质量不满足并影响白天社会功能的一种主观体验，包括入睡困难、时常觉醒及(或)晨醒过早。可引起人的疲劳感，不安、全身不适、无精打采，反应迟缓、头痛，记忆力不集中等症状，它的最大影响是精神方面的，严重一点会导致精神分裂，常见临床类型有：原发性睡眠障碍、继发性睡眠障碍、假性失眠。从病理上分析，失眠是由于情志、饮食内伤，或病后及年迈，禀赋不足，心虚胆怯等病因，引起心神失养或心神不安，从而导致经常不能获得正常睡眠为特征的一类病症。从中医理论认为，失眠症产生的诸多病因病机均与肝脾失调有关，中医如何全面诊断失眠症，调理失眠中药的选择，应在辨证论治的基础上，注重调理肝脾。
随着高节奏的现代生活方式和环境带来的变化，越来越多的人患上了失眠症，对于治疗失眠症的药物的需要日益增加。
发明内容
本发明的目的在于提供一种治疗失眠的食品、保健品或药物组合物。
具体地，本发明提供了一种治疗失眠的食品、保健品或药物组合物，其原料由如下重量配比的组分组成：
雪菊8～15份，黑果枸杞5～15份，枸杞叶10～25份，红花12～15份，荞麦15～25份。
本发明研究表明，将上述5味药材联合使用后，发挥了协同增效作用，其对失眠的改善活性明显优于其他中药配伍方式。
进一步地，其原料由如下重量配比的组分组成：
雪菊10～12份，黑果枸杞8～12份，枸杞叶15～20份，红花13～14份，荞麦18～23份。
更进一步地，其原料由如下重量配比的组分组成：
雪菊10份，黑果枸杞8份，枸杞叶18份，红花13份，荞麦20份。
雪菊属菊科，蛇目菊属。《本草经疏》中有记载：雪菊安肠胃，利五脉，调四肢，利气血者。雪菊含有对人体有益的18种氨基酸及15种微量元素，对高血压、高血脂、高血糖、冠心病等具有特殊疗效，并有杀菌、消炎、减肥、预防感冒和慢性肠炎的功效，对于失眠也有相当好的调理作用。
黑果枸杞味甘、性平，富含蛋白质、脂肪、糖类、游离氨基酸、有机酸、矿物质、微量元素、生物碱、维生素C、B1、B2、钙、镁、铜、锌、锰、铁、铅、镍、镉、钴、铬、钾、钠等各种营养成分，其维生素、矿物质等营养成分含量更丰富，尤其含具有清除自由基、抗氧化功能的天然花青素(Anthocyanosides)。花青素具有深入细胞保护细胞膜不被自由基氧化的作用，具有强力抗氧化和抗过敏功能，能穿越血脑屏障，可保护脑神经不被氧化，能稳定脑组织功能，保护大脑不受有害化学物质和毒素的伤害。食用黑枸杞中的花青素(Anthocyanosides)后，人们感觉头脑大为清醒，睡眠得到彻底改善。黑枸杞含有的花色甙素是最有效的天然自由基清除剂，延缓人体细胞组织衰老，保持年轻状态，延年益寿。
枸杞叶能补虚益精，清热，止渴，祛风明目。治虚劳发热，烦渴，目赤昏痛，障翳夜盲，崩漏带下，热毒疮肿。《口华子本草》记载，枸杞叶除烦益志，补五劳七伤，壮心气，去皮肤骨节间风，消热毒，散疮肿。
红花为菊科植物红花的干燥花，主要含有苷类和红花黄素。味辛，性温。归心，肝经。其具有活血化瘀，凉血解毒，解郁安神的作用。用于经闭症瘕，产后瘀阻，温毒发斑，忧郁痞闷，惊悸发狂。有研究表明一般长时间工作使人心情烦闷、思维迟钝，是人体内(尤其是大脑)缺氧的表现特别容易出现。红花茶能及时促进人体血液循环的血氧供给，让饮用者保持思维敏捷、心态平衡，充满自信。
荞麦又称为三角麦、乌麦、花荞，是蓼科荞麦属作物。荞麦功用主治开胃宽肠，下气消积。治绞肠痧，肠胃积滞，慢性泄泻，噤口痢疾，赤游丹毒，痈疽发背，瘰疬，汤火灼伤。中药典记载：“荞麦壳清脑、明目，对失眠、多梦、头晕、耳鸣等疾具适当效果”。据《本草纲目》记载，使用荞麦壳枕能至老明目，清热安神，促进睡眠等。
其中，它是由原料的粉末、原料药的水或/和有机溶剂提取物为活性成分制备而成的剂型。
所述有机溶剂可以选自乙醇、甲醇、正丁醇、乙酸乙酯、氯仿等。当然，为了保障安全性，可以仅选用乙醇，但是，若利用现有除有机残留技术，亦可采用其他有机溶剂。
进一步地，所述剂型为经胃肠道给药剂型。
其中，所述剂型为茶剂、颗粒剂、胶囊剂、散剂、片剂、丸剂或口服液。所述剂型中，还可以包括常规使用的辅料，如赋形剂、粘合剂、崩解剂、润滑剂、矫味剂等等。
若制备茶剂，则直接将药材粉碎至10～40目，包装即可。
本发明还提供了上述食品、保健品或药物组合物的制备方法，其特征在于：它包括如下操作步骤：
(1)按配比称取原料粉碎；
(2)将粉碎后的原料加水提取，所得水提物进行制剂即可。
本发明加水提取可以是温浸、水煎、超声、微波或回流提取。
本发明一个具体的实施方式中，采用水煎的方式进行提取，如水煎3次，每次5-15倍量水，每次煎煮0.5-2h。
本发明还提供了上述食品、保健品或药物组合物在制备预防或治疗失眠的食品、保健品或药物中的用途。
进一步地，所述失眠为非器质性失眠。
本发明将药食两用的多种中药材进行科学合理的配伍，能够有效改善睡眠情况，对失眠症有良好的治疗和预防作用，为临床使用提供了新的选择。
具体实施方式
实施例1
处方：雪菊100克，黑果枸杞80克，枸杞叶180克，红花130克，荞麦200克。
制备方法：按组方称取各药材，置于50～60℃烘箱中烘干粉碎，合并煎煮3次，第一次加12倍量水，浸泡1小时，加热煮沸1h以后每次分别加入10倍量水煎煮1h，过滤，合并滤液，减压浓缩，，加入适量淀粉、糊精和硬脂酸镁，按照常规方法制成片剂。
实施例2 本发明组合物的制备
处方：雪菊100克，黑果枸杞80克，枸杞叶200克，红花140克，荞麦230克。
制备方法：按组方称取各药材，置于50～60℃烘箱中烘干粉碎，合并煎煮2次，第一次加10倍量水，浸泡1小时，加热煮沸1.5h，第二次加入8倍量水煎煮1.5h，过滤，合并滤液，减压浓缩，加入适量糊精，按照常规方法制成颗粒剂。
实施例3 本发明组合物的制备
处方：雪菊120克，黑果枸杞10克，枸杞叶150克，红花130克，荞麦180克。
制备方法：按组方称取各药材，置于50～60℃烘箱中烘干粉碎，合并煎煮3次，第一次加8倍量水，浸泡0.5小时，加热煮沸0.5h以后加入10倍量水煎煮1h，第三次加6倍量水煎煮0.5h，过滤，合并滤液，减压浓缩，加入适量微晶纤维素，按照常规方法制成胶囊剂。
实施例4 本发明组合物的制备
处方：雪菊100克，黑果枸杞80克，枸杞叶180克，红花130克，荞麦200克。
制备方法：分别称取各组分干品，用淋水冲洗干净，分别测定水分，置于烘房中烘干或晒干，然后放置于粉碎机中分别进行粉碎，过筛，留用10-40目之间的合格粗粉，将所得合格粗粉再次进行烘干，将粗粉的含水量控制在5％以内，将不合格的粗粉再进行粉碎，过筛，留用10-40目之间的合格粗粉，按重量百分比称取各组分合格的粗粉，置于三维运动混合机中进行混合，用红外灭菌后，抽样检验，检验合格后，于袋泡茶包装机中进行包装成袋，再进行外层包装，即为成品。
以下通过实验例进一步阐述本发明一种明目中药复合制剂的有益效果。
实验例1
根据世界卫生组织有关精神与行为障碍分类中非器质性失眠及卫生部《中药新药临床研究指导原则》中失眠的诊断标准来选取患者。选取100例失眠症患者，男50例、女50例，平均年龄为36岁。表现为患者几乎以失眠为惟一的症状，包括难以入睡、睡眠不深、多梦、早醒，或醒后不易再睡、醒后不适感、疲乏，或白天困倦等；这种睡眠紊乱每周至少发生3次并持续1个月以上；睡眠紊乱造成患者明显的苦恼或影响了其日常生活。
疗效标准：按照国家中医药管理局制定的《中医病证诊断疗效标准》和国际通用睡眠效率值公式计算评价疗效。痊愈：症状完全或基本消失，睡眠率≥75％；显效：症状基本消失，睡眠率≥65％；有效：症状有改善或部分症状改善，睡眠率≥55％；无效：症状无变化或加重，睡眠率＜40％。
服药方法：服用本实施例1中的片剂，正常情况下一天一次，一次三粒(每粒相当于1g生药量)，病情较重时前3天～7天增加至每天六粒，睡前半小时服用。坚持服用2周为一个疗程。
一个疗程后有效率见下表1：
表1
由表1可知，服用本发明一种治疗失眠的中药复合制剂一个疗程后，失眠病人症状有明显好转，86.0％症状完全或基本消失。
实验例2
以下通过对比试验，说明本发明配方的合理性。
本发明一种治疗失眠的中药复合制剂由实施例1制备；
对比组A药物的制备方法如下：
分别按重量称取杭白菊100克，宁夏枸杞80克，枸杞叶180克，红花130克，荞麦200克置于50～60℃烘箱中烘干粉碎，合并煎煮3次，第一次加12倍量水，浸泡1小时，加热煮沸1h以后每次分别加入10倍量水煎煮1h，过滤，合并滤液，减压浓缩，，加入适量淀粉、糊精和硬脂酸镁，按照常规方法制成片剂，即得对比组A药物片剂。
对比组B药物的制备方法如下：
分别按重量称取枸杞叶180克，红花130克，荞麦200克置于50～60℃烘箱中烘干粉碎，合并煎煮3次，第一次加12倍量水，浸泡1小时，加热煮沸1h以后每次分别加入10倍量水煎煮1h，过滤，合并滤液，减压浓缩，，加入适量淀粉、糊精和硬脂酸镁，按照常规方法制成片剂，即得对比组B药物片剂。
对比组C药物的制备方法如下：
分别按重量称取雪菊100克，黑果枸杞80克，置于50～60℃烘箱中烘干粉碎，合并煎煮3次，第一次加12倍量水，浸泡1小时，加热煮沸1h以后每次分别加入10倍量水煎煮1h，过滤，合并滤液，减压浓缩，，加入适量淀粉、糊精和硬脂酸镁，按照常规方法制成片剂，即得对比组C药物片剂。
实验人群分为4个实验组：根据世界卫生组织有关精神与行为障碍分类中非器质性失眠及卫生部《中药新药临床研究指导原则》中失眠的诊断标准来选取患者。选取120例失眠症患者，男60例、女60例，普遍表现入睡浅，易惊易醒，醒后精神差，疲倦、记忆力减退，有的甚至影响生活自理能力，病情加重。按照男女一比一的比例将实验对象分为4组，每组30名，即分为本发明药物组、对比组A药物组、对比组B药物组和对比组C药物组。每日一次，分别每日服用实施例1制成的一种治疗失眠的中药复合制剂、对比组A药物片剂、对比组B药物片剂合对比组C药物片剂，一次三粒，病情较重时前3天～7天增加至每天六粒，睡前半小时服用。坚持服用2周为一个疗程。(三组的给药生药量相同)
疗效评定同实验例1；
临床试验结果对比，见表2：
表2
注：与本发明药物组相比，*为p＜0.05，**为p＜0.01。
由表2可知，本发明一种治疗失眠的中药复合制剂对于失眠症有较好的疗效，同时，与对比组A药物组对比，虽然药物成分相似，但是，本发明药物组合物在同等剂量下的药效活性明显优于对比组A药物组(p＜0.05)；与本发明药物组相比，在缺乏两味药材的情况下，对比组B药物组治疗失眠的功效很有限，与本发明药效有显著极差异(p＜0.01)。对比组C药物组虽然仅由两味药物黑果枸杞和雪菊组成，但相对于对比组B药物组在同等剂量下其明目效果稍强一些。上述试验表明，本发明组合物配伍精当，发挥了协同增效作用。
综合上述试验可见，本发明将药食两用的多种药材行科学合理的配伍，发挥了协同增效作用，能够有效改善睡眠情况，对失眠症有良好的治疗和预防作用，为临床使用提供了新的选择。
Claims (9)
1.一种治疗失眠的保健品或药物组合物，其特征在于：其原料由如下重量配比的组分组成：
雪菊8～15份，黑果枸杞5～15份，枸杞叶10～25份，红花12～15份，荞麦15～25份。
2.根据权利要求1所述的保健品或药物组合物，其特征在于：其原料由如下重量配比的组分组成：
雪菊10～12份，黑果枸杞8～12份，枸杞叶15～20份，红花13～14份，荞麦18～23份。
3.根据权利要求2所述的保健品或药物组合物，其特征在于：其原料由如下重量配比的组分组成：
雪菊10份，黑果枸杞8份，枸杞叶18份，红花13份，荞麦20份。
4.根据权利要求1~3任意一项所述的保健品或药物组合物，其特征在于：它是由原料的粉末、原料药的水或/和有机溶剂提取物为活性成分制备而成的剂型。
5.根据权利要求4所述的保健品或药物组合物，其特征在于：所述剂型为经胃肠道给药剂型。
6.根据权利要求4所述的保健品或药物组合物，其特征在于：所述剂型为茶剂、颗粒剂、胶囊剂、散剂、片剂、丸剂或口服液。
7.权利要求1-6任意一项所述保健品或药物组合物的制备方法，其特征在于：它包括如下操作步骤：
（1）按配比称取原料粉碎；
（2）将粉碎后的原料加水提取，所得水提物进行制剂即可。
8.权利要求1~6任意一项所述保健品或药物组合物在制备预防或治疗失眠的保健品或药物中的用途。
9.根据权利要求8所述的用途，其特征在于：所述失眠为非器质性失眠。
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| CN1456066A (zh) * | 2003-05-29 | 2003-11-19 | 刘元恒 | 枸杞叶茶的制备方法 |
| CN1895448A (zh) * | 2006-06-28 | 2007-01-17 | 王军 | 山楂荷菊冲剂 |
| CN102836264A (zh) * | 2012-09-10 | 2012-12-26 | 宁强县老羌寨生态农业发展有限责任公司 | 一种可降血糖及防治糖尿病并发症的药酒 |
| CN104055936A (zh) * | 2014-07-11 | 2014-09-24 | 郭海涛 | 枸杞片的制备方法 |
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| CN1456066A (zh) * | 2003-05-29 | 2003-11-19 | 刘元恒 | 枸杞叶茶的制备方法 |
| CN1895448A (zh) * | 2006-06-28 | 2007-01-17 | 王军 | 山楂荷菊冲剂 |
| CN102836264A (zh) * | 2012-09-10 | 2012-12-26 | 宁强县老羌寨生态农业发展有限责任公司 | 一种可降血糖及防治糖尿病并发症的药酒 |
| CN104055936A (zh) * | 2014-07-11 | 2014-09-24 | 郭海涛 | 枸杞片的制备方法 |
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| 新疆雪菊化学成分及研究进展;杨博等;《化学工程与装备》;20131130(第11期);第140页左栏第"1"节 * |
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