CN114073314A - 一种预防或改善睡眠障碍的组合物 - Google Patents
一种预防或改善睡眠障碍的组合物 Download PDFInfo
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- CN114073314A CN114073314A CN202110925708.8A CN202110925708A CN114073314A CN 114073314 A CN114073314 A CN 114073314A CN 202110925708 A CN202110925708 A CN 202110925708A CN 114073314 A CN114073314 A CN 114073314A
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L21/00—Marmalades, jams, jellies or the like; Products from apiculture; Preparation or treatment thereof
- A23L21/10—Marmalades; Jams; Jellies; Other similar fruit or vegetable compositions; Simulated fruit products
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
本发明提供一种易于入睡、少醒、少梦,补益机体,调衡气血,改善睡眠障碍且成分简单、副作用小的组合物及其制备方法以及含有该组合物的保健品。该组合物含有短梗五加或者刺五加、酸枣仁、山楂、桑葚。
Description
技术领域
本发明涉及食品、保健品、药品领域,特别涉及一种口感合适、调衡气血、预防或改善睡眠的组合物及其制备方法。
背景技术
失眠是最常见的睡眠障碍,失眠症是指睡眠时间不足或睡得不深、不熟。多由于精神紧张、焦虑、恐惧等原因引起,常见于老年人高血压、动脉硬化、精神抑郁症患者,中医学称为“不寐”、“不得眠”、“目不瞑”等,凡以难于入睡、或睡而易醒、或彻夜不眠为主要临床表现者,均属于此范畴。中医学认为人的正常睡眠机理是阴阳之气自然而有规律的转化的结果,如果这种规律一旦被破坏,就可导致不寐的发生,失眠常因心神失养之为,与心、肝、脾关系最为密切,因心藏神,肝藏魂,脾输布精液,为气血生化之源,神、魂须赖气与血之寄托与滋养。气行心脉,阴血滋养心脉,气血运行脉中,则心得滋养,气虚则运血无力,阴虚则脉道涩滞,致血不达心,心失所养,且气阴虚弱则不能滋养脏腑、濡润经络,进而影响营血之运行,终致失眠形成。
目前在临床上,安定类药物为治疗失眠症的重要手段。但是,其改变了人体的正常睡眠模式,大脑实际未充分休息,次晨常出现嗜睡、头昏、乏力等现象,长期使用易引起成瘾、耐受、智力减退,记忆力下降、烦躁易怒等不良反应。另一方面,在已上市的治疗失眠的产品中,褪黑素受到大众青睐。然而,长期服用褪黑素往往导致过多副作用包括:犯困、头痛、恶心、头晕、抑郁情绪、轻微震颤、轻度焦虑、情绪易激惹、警觉性下降、意识混乱或定向力障碍,以及低血压,老年人还会出现血流减少和低体温症的副作用。
目前,需要一种能有效调衡气血、改善睡眠质量、缓解失眠且副作用小的组合物。
发明内容
基于上述现有技术存在的缺陷,本发明提供一种易于入睡、少醒、少梦,补益机体,调衡气血,改善睡眠,治疗失眠且成分简单、副作用小的组合物及其制备方法。
为了实现本发明的上述目的,特采用以下技术方案:
本发明提供一种预防或改善睡眠障碍的药物组合物,所述药物组合物由以下重量比的原料提取制备而成:短梗五加或者刺五加15%-60%、桑葚12%-31%、山楂12%-31%、酸枣仁7%-42%。更进一步所述药物组合物由以下重量份的原料提取制备而成:短梗五加或者刺五加30%-46%、桑葚18%-31%、山楂18%-31%份、酸枣仁7%-19%。更进一步所述药物组合物由以下重量份的原料提取制备而成:短梗五加或者刺五加31%-34%、桑葚18%-26%、山楂18%-26%、酸枣仁16%-19%。
进一步所述短梗五加或者刺五加:酸枣仁的重量比例为1:1-3:1。
进一步所述短梗五加或者刺五加:酸枣仁的重量比例为1.5:1-2:1。
更进一步所述药物组合物由以下重量份的原料提取制备而成:短梗五加31%、桑葚25%、山楂25%、酸枣仁19%。
更进一步所述药物组合物由以下重量份的原料提取制备而成:刺五加32%、桑葚26%、山楂26%、酸枣仁16%。
所述短梗五加选自于短梗五加果、短梗五加根、短梗五加茎、短梗五加叶或短梗五加树皮。
所述刺五加选自于刺五加果、刺五加根、刺五加茎、刺五加叶或刺五加树皮。
本发明进一步提供一种制备上述药物组合物的制备方法,所述制备方法包括将短梗五加或者刺五加、酸枣仁、山楂、桑葚进行混合,用水溶液进行提取、过滤得提取液;提取液适当浓缩、静置、离心得药物组合物。
本发明进一步提供一种制备上述药物组合物的制备方法,所述制备方法包括将短梗五加或者刺五加、酸枣仁、山楂、桑葚进行混合,加入10-30倍量水溶液文火煎煮进行提取、过滤得药物组合物。
本发明进一步提供一种制备上述药物组合物的制备方法,所述制备方法包括将短梗五加或者刺五加、酸枣仁、山楂、桑葚进行混合,加入10-30倍量水溶液文火煎煮进行提取、过滤得提取液;提取液在50-80℃,真空0.04-0.08MPa或者0.05-0.09MPa下加入适量乙醇,回收乙醇至相对密度1.004-1.008或者1.1-1.2适当浓缩,静置取上清液,离心(12000-16000r/min)得离心后的液体,得药物组合物。
进一步地,所述药物组合物可被制备为饮料、果冻、压片糖、膏或茶。
进一步,本发明提供一种上述药物组合物的新用途,即:
一种上述组合物在制备用于调衡气血、预防或改善睡眠的饮料、果冻、茶、压片糖或膏的应用。
本发明所用中药材解方如下:
短梗五加为五加科五加属植物,其干燥根及根茎、皮、茎、果实亦可供药。该药性温,味辛、无毒,平衡阴阳,入脾肾经,益气健脾,补肾安神。李时珍在《本草纲目》中记载:“五加,无毒。久服延年益老,功能近述。”
刺五加为五加科植物刺五加Acanthopanax senticosus(Rupr.et Maxim.)Harms的干燥根及根茎、树皮,叶、茎、果实亦可供药。该药性温,味辛、微苦,无毒,入脾肾经。能扶正固本、补肾健脾、益智安神。主治脾肾阳虚、腰膝酸软、体虚乏力、失眠多梦、食欲不振等病症。国外对人参及其近缘植物刺五加进行了较系统的研究,证明了刺五加和人参有相似的药理作用和临床疗效。
酸枣仁甘酸性平,归肝、胆、心经。能养心阴、益肝血而宁心安神。酸枣仁“疗不得眠”渊于其“安五脏”。尤宜于心肝阴血亏虚、心失所养之虚烦不眠、惊悸多梦;也可用于心脾两虚之心悸失眠,头晕体倦;或阴虚血少之心悸失眠,虚烦健忘。
桑椹,《本草从新》“甘酸而温。色黑入肾而补水。利五脏关节。安魂镇神。”甘、酸,寒。归心、肝、肾经,能养心并滋补肝肾阴血而安魂镇神。一方面,配合刺五加补养肝肾之阴,一方面配合酸枣仁滋养心肝之血;一方面滋阴降火,并以其寒佐制刺五加、山楂之微温,以防助火扰神。
山楂酸、甘,微温。入脾、胃、肝经。《药性解》谓之“主健脾消食,散结气,行滞血”,所以山楂一方面健胃消食,助复脾之运化水谷、化生气血、荣养心神之功;一方面入肝经,行气散结,助刺五加疏肝解郁,缓解抑郁、焦虑情绪,而复肝之职司疏泄、藏魂之功;还入肝经血分,通行气血,活血化瘀,使诸药无补而留瘀之弊。
本发明技术方案与现有技术相比,其组方简单,60-90%患者服用后睡眠问题得到有效改善,且皆未在使用产品之后的1周内发现不良反应。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述,但是本领域技术人员将会理解,下列实施例仅用于说明本发明,而不应视为限制本发明的范围。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
实施例1:
取以重量计的短梗五加625g、桑葚500g、山楂500g、酸枣仁375g,加入30倍量水溶液文火煎煮1h进行提取、用200目筛过滤得提取液;提取液在50-80℃,真空-0.05~-0.09MPa下加入适量乙醇,回收乙醇至相对密度1.004~1.008适当浓缩,静置12-20h取上清液,离心(16000r/min)得离心后的液体,得药物组合物。
实施例2:
取以重量计的短梗五加500g、桑葚375g、山楂375g、酸枣仁250g,加入10倍量水溶液文火煎煮1h进行提取、用150目筛过滤得提取液;提取液在60-90℃,真空-0.04~-0.08MPa下加入适量乙醇,回收乙醇至相对密度1.004~1.008适当浓缩,静置12-20h取上清液,离心(12000r/min)得离心后的液体,得药物组合物。
实施例3:
取以重量计的短梗五加5g、桑葚4g、山楂4g、酸枣仁3g,加入30倍量水溶液文火煎煮1h进行提取、用200目筛过滤得提取液;提取液在50-80℃,真空-0.05~-0.09MPa下加入适量乙醇,回收乙醇至相对密度1.004~1.008适当浓缩,静置12-20h取上清液,离心(16000r/min)得离心后的液体,得药物组合物。
实施例4:
取以重量计的短梗五加500g、桑葚400g、山楂400g、酸枣仁300g,加入30倍量水溶液文火煎煮1h进行提取、用200目筛过滤得提取液;提取液在50-80℃,真空-0.05~-0.09MPa下加入适量乙醇,回收乙醇至相对密度1.004~1.008适当浓缩,静置12-20h取上清液,离心(16000r/min)得离心后的液体,得药物组合物。
实施例5:
取以重量计的刺五加果20g、山楂16g、酸枣仁10g、桑葚16g,加水2000ml,文火煎煮半小时,200目过滤,得药物组合物。
实施例6:
取以重量计的山楂4g、酸枣仁1g、刺五加果4g、桑葚4g,加水500ml,煮沸后改使用文火煎制30min,200目过滤,得药物组合物。
实施例7:
取以重量计的山楂4g、酸枣仁2.5g、刺五加果5g、桑葚4g加水500ml,煮沸后改使用文火煎制30min后,200目过滤,得药物组合物。
实施例8:
取以重量计的山楂4g、酸枣仁2.5g、刺五加果5g、桑葚4g加水2000ml,煮沸后改使用文火煎制30min后,150目过滤,得药物组合物。
实施例9:
取以重量计的山楂16g、酸枣仁15g、刺五加果40g、桑葚16g加水2000ml,煮沸后改使用文火煎制30min后,200目过滤,得药物组合物。
实施例10:
取以重量计的山楂16g、酸枣仁10g、刺五加叶20g、桑葚16g,加水2000ml,文火煎煮半小时,取滤液,减压浓缩至相对密度1.1-1.2(70℃),得药物组合物。
实施例11:
取以重量计的山楂16g、酸枣仁10g、刺五加果20g、桑葚16g,加水2000ml,文火煎煮半小时,取滤液,减压浓缩至相对密度1.1-1.2(70℃),得药物组合物。
实施例12:
取以重量计的山楂16g、酸枣仁10g、刺五加茎20g、桑葚16g,加水2000ml,文火煎煮半小时,取滤液,减压浓缩至相对密度1.1-1.2(70℃),得药物组合物。
实施例13:
按照实施例3所述方法制备药物组合物,取制备好的药物组合物8g,加入0.12g甜菊糖苷、1g三氯蔗糖、0.55gDL-苹果酸、0.2g柠檬酸以及0.025g山梨酸钾混合,定容至500ml,得饮料,口感酸甜合适。
实施例14:
按照实施例3所述方法制备药物组合物,取制备好的药物组合物16g,加入0.1g甜菊糖苷、0.55g三氯蔗糖、0.315gDL-苹果酸、0.11g柠檬酸液以及0.025g山梨酸钾混合,定容至500ml,得饮料,口感酸甜合适。
实施例15:
按照实施例3所述方法制备药物组合物,取制备好的药物组合物40g,加入0.1g甜菊糖苷、0.235g三氯蔗糖、0.315gDL-苹果酸、0.11g柠檬酸、20g木糖醇、15g麦芽糊精、0.1375g食用盐、0.00025g山梨酸钾混合,定容至500ml,得饮料,口味酸甜,口感清凉。
实施例16:
按照实施例4所述方法制备药物组合物,取制备好的药物组合物400g,加入0.02g甜菊糖苷、0.05g三氯蔗糖、0.6gDL-苹果酸、0.2g柠檬酸、30g木糖醇、30g麦芽糊精、0.275g食用盐、0.5g山梨酸钾混合,定容至1000ml,得饮料,口味酸甜,口感清凉。
实施例17:
按照实施例5所述方法制备药物组合物12.4g,加入罗汉果甜苷0.5g,得原浆,取350ml水溶解80g吉利丁粉,混入上述原浆,凝结,得果冻。
实施例18:
按照实施例6所述方法制备药物组合物2.6g,取87.5ml水溶解20g吉利丁粉,混入上述中药提取物,凝结,得果冻。
实施例19:
按照实施例7所述方法制备药物组合物3.1g,取87.5ml水溶解20g吉利丁粉,混入上述中药提取物,凝结,得果冻。
实施例20:
按照实施例8所述方法制备药物组合物3.1g,取350ml水溶解80g吉利丁粉,混入上述中药提取物,凝结,得果冻。
实施例21:
按照实施例9所述方法制备药物组合物17.4g,取350ml水溶解80g吉利丁粉,混入上述中药提取物,凝结,得果冻。
实施例22:
(1)按照实施例10所述方法制备药物组合物15.5g,将柠檬酸溶解于药物组合物中,保温70-80℃;
(2)在适量纯化水中加入果冻粉、氯化钾、柠檬酸钾、山梨酸钾、罗汉果甜苷、乳酸钙,煮沸10-20min;
(3)将药物组合物加入(2)所得液体中,过滤、包装,冷却后在80-85℃温度下经过巴氏灭菌器灭菌15-25分钟,晾干水蒸气后包装入库。
实施例23:
(1)按照实施例11所述方法制备药物组合物12.4g;
(2)在药物组合物中加入麦芽糊精、环状糊精、卵磷脂、罗汉果甜苷、柠檬酸、柠檬酸钠,得原浆;
(3)将添加了辅料的原浆在室温下经高压均质机均质处理,使原浆呈细腻的状态;
(4)将处理后的原浆经喷雾干燥得到固体粉末;
(5)在干燥后的粉末中加入适量乙醇湿法制粒,整粒,包装,即得。
实施例24:
(1)按照实施例12所述方法制备药物组合物9.3g;
(2)药物组合物60份,微晶纤维素40份,罗汉果甜苷0.1份,柠檬酸0.2份,润滑剂1份,粘合剂适量;
(3)药物组合物与各辅料分别粉碎,过80目筛,按比例混合均匀,加入适量5%的PVP乙醇溶液制软材,过18目筛造粒,待颗粒干燥至水分在4%左右,粉碎,过16目筛整粒;
(4)压片:颗粒中加入1份硬脂酸镁,进行压片,得到压片糖果;
(5)灭菌:将片剂放在紫外线下照射25min,及时包装,得到成品。
实施例25:
1)研究对象:
本实验研究对象符合《中药新药临床研究指导原则》中睡眠障碍临床证候表现,即每周睡眠障碍最少发生3次,持续失眠时间>2周,无严重的身心疾病,具有较好的理解和沟通能力。其中排除过敏体质者;排除呼吸道疾病急性发作期;排除孕、产妇、儿童,有严重精神疾患、意识障碍者;排除由疼痛、发热、外伤、手术等其他因素引起的继发性失眠;排除合并有心脑血管、肺、肝、肾和造血系统严重原发性疾病者;排除酗酒或精神药物滥用和依赖所致失眠者。随机选取13例研究对象,其中男5例,女8例,年龄21-60岁。研究对象均签署知情同意书且自愿参与此次研究,采用自身前后对照实验来探究疗效。
2)研究过程
取按实施例17制备的果冻50g,由受试者分十日直接口服服用。
3)研究结果
结果显示,13例受试者睡眠问题均得到不同程度的改善,且皆未在使用产品之后的1周内发现不良反应。
实施例26:
1.1样品:
空白组:生理盐水
样品1:将短梗五加100g、山楂80g、桑葚80g、酸枣仁60g混合均匀,加入30倍重量的水,煎煮提取1次,提取时间为1小时,提取液200目过滤,提取液在50-80℃,真空-0.05~-0.09MPa下加入适量乙醇,回收乙醇至相对密度1.004~1.008适当浓缩,静置12-20h取上清液,离心(16000r/min)得离心后的液体。
样品2:将短梗五加120g、酸枣仁90g、大枣15g、茯苓45g、百合9g、人参21g混合,提取三次(第一次,加入10倍水提取3h;第二次,加入8倍水提取2h;第三次,加入6倍水提取1h)合并提取液,减压浓缩至相对密度1.30(80℃)的稠膏备用。加入稠膏重量2倍的葡糖糖,混合均匀,60℃干燥,粉碎,得粉末,取粉末0.3294g。
样品3:将酸枣仁140g、刺五加110g、远志45g、天麻55g饮片,混合均匀,加入11倍重量的水煎煮提取1次,提取时间为3小时,提取之前浸泡1小时,过滤,滤液减压回收至在70℃条件下相对密度为1.05的稠膏;在稠膏中添加加入制剂总量25%的蔗糖、搅拌溶解,加水至500ml,得浓缩液。
样品4:取刺五加干燥果实120g,加入1000ml水,用20%的硫酸调pH至2.0-3.5,浸泡10h后,超神提取1h后、煎煮2h,过滤,收集滤液,取滤渣再用1000ml pH为2.0-3.5的水煎煮2h。合并滤液,浓缩至100ml,加入95%的乙醇,使提取液的醇浓度至20%,静置48h后,过滤,滤液用氢氧化钠调pH至中性,减压浓缩至无乙醇,得浓缩液。
1.2实验动物:昆明小鼠,购置成都达硕试验动物有限公司,体重为18—22g,雌雄各半。将小鼠分为三组,第一组用于延长戊巴比妥钠睡眠时间实验,第二组用于戊巴比妥钠睡眠潜伏期实验,第三组用于戊巴比妥钠阈下剂量催眠实验,每组小鼠包含84只小鼠,雌雄各半,随机分为7组,分别为空白组、样品1低剂量组、样品1中剂量组、样品1高剂量组、样品2组、样品3组、样品4组。
其中样品2、样品3、样品4组给药剂量为0.656g生药/kg.d,样品1高剂量组、样品1中剂量组和样品1低剂量组给药剂量为1.312g生药/kg.d、0.656g生药/kg.d与0.328g生药/kg.d,灌胃给药体积为0.2ml/10g。空白组灌胃给予等体积的生理盐水。
1.3仪器与试剂:电子天平、戊巴比妥钠
1.4延长戊巴比妥钠睡眠时间实验:
动物实验样品处理:
称取样品1的0.9945g浓缩液,加入18.7ml生理盐水溶解,得低剂量组。
称取样品1的1.9923g浓缩液,加入18.7ml生理盐水溶解,得中剂量组。
称取样品1的4.0552g浓缩液,加入19ml生理盐水溶解,得高剂量组。
将样品2加入20ml生理盐水溶解。
称取样品3的浓缩液0.937ml,加入19.06ml生理盐水溶解。
称取样品4的浓缩液0.5913ml,加入4.0552g生理盐水溶解。
灌胃给药1次,给药后20min,每组小鼠腹腔注射戊巴比妥钠50mg/kg。以翻正反射消失为指标,记录小鼠的睡眠持续时间。
使用Excel软件收集数据,使用非配对t检验进行数据检验。
组别 | 剂量/(生药g/kg) | n | 睡眠时间/min |
空白组 | - | 12 | 21.98±4.06 |
样品1低剂量组 | 0.328g/kg | 12 | 30.11±3.81*** |
样品1中剂量组 | 0.656g/kg | 12 | 36.70±3.50*** |
样品1高剂量组 | 1.312g/kg | 12 | 40.52±3.29*** |
样品2 | 0.656g/kg | 12 | 28.06±7.07* |
样品3 | 0.656g/kg | 12 | 26.89±4.92* |
样品4 | 0.656g/kg | 12 | 29.21±4.68*** |
与空白组相比较:*p<0.05,有统计学差异,**p<0.01或***p<0.001有显著的统计学差异。
1.5戊巴比妥钠睡眠潜伏期实验
动物实验样品处理:
称取样品1的0.9945g浓缩液,加入18.7ml生理盐水溶解,得低剂量组。
称取样品1的1.9923g浓缩液,加入18.7ml生理盐水溶解,得中剂量组。
称取样品1的4.0552g浓缩液,加入19ml生理盐水溶解,得高剂量组。
将样品2加入20ml生理盐水溶解。
称取样品3的浓缩液0.937ml,加入19.06ml生理盐水溶解。
称取样品4的浓缩液0.5913ml,加入4.0552g生理盐水溶解。
灌胃给药1次,给药后20min,每组小鼠腹腔注射戊巴比妥钠300mg/kg。以翻正反射消失为指标,记录小鼠的睡眠潜伏期。
使用Excel软件收集数据,使用非配对t检验进行数据检验。
组别 | 剂量/(生药g/kg) | n | 睡眠时间/min |
空白组 | - | 12 | 4.09±0.35 |
样品1低剂量组 | 0.328g/kg | 12 | 3.76±0.37* |
样品1中剂量组 | 0.656g/kg | 12 | 2.93±0.50*** |
样品1高剂量组 | 1.312g/kg | 12 | 2.69±0.36*** |
样品2 | 0.656g/kg | 12 | 3.64±0.36** |
样品3 | 0.656g/kg | 12 | 3.71±0.38* |
样品4 | 0.656g/kg | 12 | 3.70±0.24** |
与对照组相比较:*p<0.05,有统计学差异;**p<0.01或***p<0.001有显著的统计学差异。
1.6戊巴比妥钠阈下剂量催眠实验
动物实验样品处理:
称取样品1的0.9945g浓缩液,加入18.7ml生理盐水溶解,得低剂量组。
称取样品1的1.9923g浓缩液,加入18.7ml生理盐水溶解,得中剂量组。
称取样品1的4.0552g浓缩液,加入19ml生理盐水溶解,得高剂量组。
将样品2加入20ml生理盐水溶解。
称取样品3的浓缩液0.937ml,加入19.06ml生理盐水溶解。
称取样品4的浓缩液0.5913ml,加入4.0552g生理盐水溶解。
灌胃给药1次,给药后20min,每组小鼠腹腔注射戊巴比妥钠30mg/kg。以翻正反射消失60秒以上者为入睡,记录各组的入睡动物数量。
使用Excel软件收集数据,使用X2检验进行数据检验。
与对照组相比较:***p<0.001有显著的统计学差异。
Claims (8)
1.一种预防或改善睡眠障碍的药物组合物,其特征在于所述药物组合物由以下重量比的原料提取制备而成:短梗五加或者刺五加、酸枣仁、山楂、桑葚。
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由以下重量比的原料提取制备而成:短梗五加或者刺五加15%-60%、桑葚12%-31%、山楂12%-31%、酸枣仁7%-42%,优选所述短梗五加或者刺五加30%-46%、桑葚18%-31%、山楂18%-31%份、酸枣仁7%-19%,优选所述短梗五加或者刺五加31%-34%、桑葚18%-26%、山楂18%-26%、酸枣仁16%-19%。
3.根据权利要求2所述的药物组合物,其特征在于所述短梗五加或者刺五加:酸枣仁的重量比例为1:1-3:1,优选所述短梗五加或者刺五加:酸枣仁的重量比例为1.5:1-2:1。
4.根据权利要求3所述的药物组合物,其特征在于所述药物组合物由以下重量份的原料提取制备而成:短梗五加31%、桑葚25%、山楂25%、酸枣仁19%。
5.根据权利要求4所述的药物组合物,其特征在于所述药物组合物由以下重量份的原料提取制备而成:刺五加32%、酸枣仁16%、山楂26%、桑葚26%。
6.一种制备上述权利要求1-5任一药物组合物的制备方法,其特征在于所述制备方法包括将短梗五加或者刺五加、酸枣仁、山楂、桑葚进行混合,用水溶液进行提取、过滤得提取液;
提取液适当浓缩、静置、离心得药物组合物。
7.根据权利要求6的制备方法,其特征在于所述制备方法包括将短梗五加或者刺五加、酸枣仁、山楂、桑葚进行混合,加入10-30倍量水溶液文火煎煮进行提取、过滤得药物组合物,优选所述制备方法包括将短梗五加或者刺五加、酸枣仁、山楂、桑葚进行混合,加入10-30倍量水溶液文火煎煮进行提取、过滤得提取液;提取液在50-80℃,真空0.04-0.08MPa或者0.05-0.09MPa下加入适量乙醇,回收乙醇至相对密度1.004-1.008或者1.1-1.2适当浓缩,静置取上清液,离心(12000-16000r/min)得离心后的液体,得药物组合物。
8.权利要求1-7的药物组合物在制备调衡气血、预防或改善睡眠的饮料、果冻、茶、压片糖或膏的用途。
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104173493A (zh) * | 2014-08-14 | 2014-12-03 | 漳州片仔癀药业股份有限公司 | 一种具有改善睡眠作用的药物组合物及其制备方法与应用 |
CN104435299A (zh) * | 2014-12-16 | 2015-03-25 | 天津中新药业集团股份有限公司达仁堂制药厂 | 一种改善睡眠的中药组合物及其制备方法 |
CN105250880A (zh) * | 2015-11-13 | 2016-01-20 | 谭惠娟 | 一种安神中药组合物及其制备方法和用途 |
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104173493A (zh) * | 2014-08-14 | 2014-12-03 | 漳州片仔癀药业股份有限公司 | 一种具有改善睡眠作用的药物组合物及其制备方法与应用 |
CN104435299A (zh) * | 2014-12-16 | 2015-03-25 | 天津中新药业集团股份有限公司达仁堂制药厂 | 一种改善睡眠的中药组合物及其制备方法 |
CN105250880A (zh) * | 2015-11-13 | 2016-01-20 | 谭惠娟 | 一种安神中药组合物及其制备方法和用途 |
Non-Patent Citations (1)
Title |
---|
乔铁,等: "桂北药用植物资源现代研究", vol. 1, 南京:河海大学出版社, pages: 358 * |
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