CN104435299B - 一种改善睡眠的中药组合物及其制备方法 - Google Patents
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Abstract
本发明涉及中医药领域,具体公开了一种改善睡眠的中药组合物,其原料以重量份计包含:酸枣仁15‑25份;灵芝15‑25份;刺五加15‑20份;五味子5‑15份。本发明所述中药组合物能延长戊巴比妥钠催眠小鼠的睡眠时间;缩短巴比妥钠催眠小鼠的入睡潜伏期;且无明显的直接睡眠作用,并对小鼠体重无不良影响。本发明还提供了所述中药组合物的制备方法,本发明所述中药组合物为纯中药制剂,无毒副作用,能够有效改善睡眠,具有良好的应用前景。
Description
技术领域
本发明涉及中药领域,尤其涉及一种能改善睡眠的中药组合物及其制备方法。
背景技术
失眠即睡眠失常。表现为入睡困难,断断续续不连贯,而过早地醒来,醒后不能再继续睡,有睡眠不足,全身乏力,倦怠感觉,多因健康情况不佳,疼痛.感觉不适,生理节奏被打乱,睡眠环境影响等。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。随着人们生活节奏的加快,以及社会、家庭等方面的压力,现在越来越多的人们患有失眠、头晕、头疼、健忘、乏力等症状,给患者带来了巨大的身体和精神上的痛苦。西药治疗失眠效果快,但是毒副作用大,容易形成依赖,而且不能提高睡眠质量。顽固性的失眠,给病人带来长期的痛苦,甚至形成对***物的依赖,而长期服用***物又可引起医源性疾病。中药调理,没有依赖性,是首选治疗方式,但是疗程较长,对于长期顽固的失眠患者,采用中药治疗的时候,极易着急,而放弃治疗或采用西药治疗,需要改进。
发明内容
本发明目的在于克服现有技术的不足之处,提供一种无毒副作用,效果明显的中药组合物及其制备方法。
为了实现上述发明目的,本发明提供了一种中药组合物,所述组合物,其原料以重量份计包含:酸枣仁15-25份;灵芝15-25份;刺五加15-20份;五味子5-15份。
优选的,其原料以重量份计包含:酸枣仁25份;灵芝15份;刺五加20份;五味子10份。
本发明中各原料药的药性如下:
酸枣仁:甘、酸,平。归肝、胆、心经。功能主治:补肝,宁心,敛汗,生津。用于虚烦不眠,惊悸多梦,体虚多汗,津伤口渴。
灵芝:性温,味淡。主治心神不宁,失眠,惊悸,咳喘痰多,虚劳症。
刺五加:味辛、微苦、性微温。归脾、肾、心经。具有调节机体紊乱,使之趋于正常的功能。有良好的抗疲劳作用,较人参显著,并能明显的提高耐缺氧能力。补中、益精、强意志、祛风湿、壮筋骨、活血去瘀、健胃利尿等功能。
五味子:主治敛肺,滋肾,生津,收汗,涩精。治肺虚喘咳,口干作渴,自汗,盗汗,劳伤羸瘦,梦遗滑精,久泻久痢。
在小鼠上进行本发明所述中药组合物对其睡眠的影响试验,发现本发明能延长戊巴比妥钠催眠小鼠的睡眠时间;缩短巴比妥钠催眠小鼠的入睡潜伏期;且无明显的直接睡眠作用,并对小鼠体重无不良影响。说明本发明所述中药组合物具有改善睡眠作用,同时经过急性毒性试验和30天喂养试验判断本发明中药组合物无毒副作用,适合长期服用。
优选的,可将本发明中药组合物与药学上可接受的赋形剂一起制成各种常规的剂型,包括片剂、丸剂、胶囊剂、颗粒剂、膏滋剂或口服液。
进一步,本发明还提供了一种本发明中药组合物与微晶纤维素、淀粉和硬脂酸镁混合制成的胶囊剂。
本发明还提供了所述中药组合物的制备方法,包含以下步骤:
(1)取配方比例的酸枣仁、五味子,加70%-90%乙醇提取,滤过,回收乙醇;
(2)取配方比例的灵芝、刺五加,加水煎煮,滤过,取滤液备用;
(3)将步骤(1)回收乙醇后的浓缩液与步骤(2)所得的滤液合并,浓缩至70℃相对密度为1.05~1.15的浸膏。
作为优选,所述步骤(1)具体为取配方比例的酸枣仁、五味子,加入8-10倍量的70%-90%乙醇提取2-3次,每次1-2小时,滤过,回收乙醇。
更优选的,取配方比例的酸枣仁、五味子,加入8倍量的70%乙醇提取2次,每次2小时,滤过,回收乙醇。
作为优选,所述步骤(2)具体为取配方比例的灵芝、刺五加,加8-10倍量水煎煮2-3次,每次1-2小时,滤过,合并滤液备用。
更优选的,取配方比例的灵芝、刺五加,加10倍量水煎煮2次,每次2小时,滤过,合并滤液备用。
作为优选,所述步骤(3)采用70~80℃,-0.06~-0.1Mpa的减压浓缩。
本发明的制备方法,工艺成熟合理,充分考虑到组合物中各种药物成分的充分提取,可以使原料药充分发挥治疗作用和滋补作用。
本发明中药组合物可以应用在制备改善失眠的药物或保健品中。
具体实施方式
本发明公开了一种改善失眠的中药组合物及其制备方法,本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,他们都被视为包括在本发明。本发明的产品、方法及应用已经通过较佳的实施例进行了面述,相关人员明显能再不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合,来实现和应用本发明。
实施例1制备本发明所述中药组合物
所述中药组合物由下列份的原料药制成:
酸枣仁20份;灵芝25份;刺五加15份;五味子15份。
取配方比例的酸枣仁、五味子加10倍量90%乙醇提取2次,每次1小时,滤过,回收乙醇,备用;取灵芝、刺五加,加8倍量水煎煮3次,每次1小时,滤过,合并滤液与上述回收乙醇后的浓缩液合并,浓缩至相对密度1.05~1.15(70℃)的浸膏。
实施例2制备本发明所述中药组合物
所述中药组合物由下列份的原料药制成:
酸枣仁15份;灵芝25份;刺五加20份;五味子5份。
取配方比例的酸枣仁、五味子,加8倍量70%乙醇提取3次,每次1小时,滤过,回收乙醇,备用;取灵芝、刺五加,加10倍量水煎煮2次,每次2小时,滤过,合并滤液与上述回收乙醇后的浓缩液合并,减压浓缩(70~80℃,-0.06~-0.1Mpa)至相对密度1.05~1.15(70℃)的浸膏。
实施例3制备本发明所述中药组合物的胶囊剂
原料以重量份数计:
酸枣仁25份;灵芝15份;刺五加20份;五味子10份。
取配方比例的酸枣仁、五味子,加8倍量70%乙醇提取2次,每次2小时,滤过,回收乙醇,备用;取灵芝、刺五加,加10倍量水煎煮2次,每次2小时,滤过,合并滤液与上述回收乙醇后的浓缩液合并,减压浓缩(70~80℃,-0.06~-0.1Mpa)至相对密度1.05~1.15(70℃)的浸膏。取浸膏干燥,粉碎,过80目筛,得浸膏粉。取浸膏粉加入淀粉、微晶纤维素、硬脂酸镁混合30分钟,(以重量份数计,浸膏粉:淀粉:微晶纤维素:硬脂酸镁=154:122:120:4),得到混合粉,将混合粉加入适量85%乙醇混合均匀,制粒,50℃干燥至水分5%以下,30目整粒,得干颗粒,装胶囊,0.4g/粒。
本胶囊剂的食用方法及食用量:每日2次,每次4粒。
实施例4本发明所述中药组合物的改善睡眠功能的动物实验
1.材料和方法
1.1样品:实施例3制备的胶囊剂的内容物,每次称取6.4g样品,加蒸馏水至80mL搅拌均匀,配成高剂量组受试物;量取20mL高剂量组受试物加蒸馏水至60mL搅拌均匀,配成中剂量组受试物;量取20mL中剂量组受试物加蒸馏水至40mL搅拌均匀,配成低剂量组受试物。
1.2实验动物及饲料:均购于上海斯莱克实验动物有限责任公司,许可证号:SCXK(沪)2012-0002,所购动物为清洁级ICR健康雄性小鼠120只,体重18~22g。本实验将动物分为3个实验组,第1组进行直接睡眠实验和延长戊巴比妥钠睡眠时间实验、第2组进行戊巴比妥钠阈下剂量催眠实验、第3组进行巴比妥钠睡眠潜伏期实验。每个实验组将40只小鼠按体重随机分成4个小组,每组10只动物。
1.3饲养环境:福建省疾控中心SPF级动物实验室,许可证号:SYXK(闽)2012-0008。
1.4剂量选择:该样品成人日推荐量为3.2g,即相当于0.0533g/kg BW(成人体重以60kg计),按推荐量的5倍、10倍、30倍设三个剂量组:0.267g/kg BW、0.533g/kgBW和1.60g/kgBW,另设蒸馏水为溶剂对照组。
l.5给药途径:各组动物每日称重,并按2.0mL/l00g体重经口灌胃给予不同浓度的受试物及蒸馏水,连续30天。
1.6仪器与试剂:电子天平、秒表、戊巴比妥钠、巴比妥钠。
1.7实验数据统计方法:实验数据用SPSS1O.0软件统计,计量资料用单因素方差分析,经方差齐性检验,方差齐的实验数据采用LSD法进行统计分析,对方差不齐或非正态的实验数据先进行变量转换再进行统计;计数资料用X2检验。
1.8实验方法:
1.8.1直接睡眠实验
末次灌胃后,观察是否出现睡眠现象,睡眠以翻正反射消失为指标。当小鼠置于背卧位时,能立即翻正身位,如超过60秒不能翻正者,即认为翻正反射消失,进入睡眠。翻正反射恢复即为动物觉醒,翻正反射消失至恢复这段时间为动物睡眠时间,记录对照组与各剂量组入睡动物数及睡眠时间。
1.8.2延长戊巴比妥钠睡眠时间实验
于末次灌胃15分钟后,给各组动物腹腔注射45mg/kg BW戊巴比妥钠,注射量为0.2mL/20g BW,以翻正反射消失为入睡判断标准,观察受试样品是否延长戊巴比妥钠睡眠时间。
1.8.3戊巴比妥钠阈下剂量催眠实验
于末次灌胃15分钟后,给各组动物腹腔注射30mg/kg BW戊巴比妥钠,注射量为0.2mL/20g BW,以翻正反射消失达1分钟以上为入睡判断标准,记录30分钟内入睡动物数。
1.8.4巴比妥钠睡眠潜伏期实验
于末次灌胃15分钟后,给各组动物腹腔注射280mg/kg BW巴比妥钠,注射量为0.2mL/20g BW,以翻正反射消失为指标,观察受试样品对巴比妥钠睡眠潜伏期的影响。
2结果
2.1该样品对小鼠直接睡眠作用观察结果:
由表1可见,各剂量组入睡动物数及睡眠时间均为0,与对照组比较差异均无统计学意义(P>0.05)。
表1 样品对小鼠直接睡眠作用的观察结果
2.2该样品对戊巴比妥钠诱导小鼠睡眠时间的影响:
由表2可见,该样品可延长戊巴比妥钠催眠的中、高剂量组小鼠的睡眠时间,与对照组比较差异均有统计学意义(P<0.05)。
表2 样品对戊巴比妥钠诱导小鼠睡眠时间的影响
注:*与对照组比较,P<0.05
2.3该样品对戊巴比妥钠阈下剂量催眠作用的影响:
由表3可见,各剂量组动物入睡数与对照组比较,差异均无统计学意义(P>0.05)。
表3 样品对小鼠戊巴比妥钠阈下剂量催眠作用的影响
2.4该样品对巴比妥钠诱导小鼠入睡潜伏期的影响:
由表4可见,该样品可缩短巴比妥钠催眠的高剂量组小鼠的入睡潜伏期,与对照组比较差异有统计学意义(P<0.05)。
表4 样品巴比妥钠诱导小鼠入睡潜伏期的影响
2.5该样品对小鼠体重的影响:
该样品各组小鼠的初始体重经方差分析差异均无统计学意义(P>O.05),即小鼠的初始体重在各组间较为均衡;实验结束时,各组小鼠的末重经统计,差异均无统计学意义(P>0.05),即该样品对小鼠的体重增长无影响。结果见表1-4。
3小结
经口灌胃给予小鼠不同剂量的实施例3制备的胶囊剂的内容物30天后,结果能延长戊巴比妥钠催眠小鼠的睡眠时间;缩短巴比妥钠催眠小鼠的入睡潜伏期;且无明显的直接睡眠作用,并对小鼠体重无不良影响。说明该样品具有改善睡眠作用。
实施例5本发明所述中药组合物的急性毒性试验
样品:实施例3制备的胶囊剂的内容物,成人推荐量为3.2g,相当于0.0533g/kg BW(成人体重以60kg计)。
选取18~22g健康ICR小鼠20只,雌雄各半。试验前小鼠隔夜禁食16小时,不禁水。称取实施例3制备的胶囊剂的内容物10g加蒸馏水至30mL,搅拌均匀,间隔4h经口灌胃3次,灌胃容量为0.02mL/g BW,试验剂量为20g/kgBW。灌胃后,连续观察14天,观察并记录动物中毒的表现和死亡情况如下:
表5 样品急性经口毒性试验
由上表可知试验期间动物未见异常,观察期结束存活动物进行大体解剖未见异常,该样品急性毒性试验结果为MTD>20/kg BW,相当于成人日推荐量的375倍,根据急性毒性分级属无毒级。
实施例6本发明所述中药组合物的30天喂养试验
将本发明实施例3制备的胶囊剂的内容物的各剂量组给予大鼠喂养30天,将大鼠平均分为雄性组和雌性组,又分别根据给药剂量的高低,将雄性组和雌性组分为对照组、低剂量组、中剂量组和高剂量组。
试验期间,各组动物生长活动正常。各剂量组大鼠每周体重、进食量、食物利用率及试验结束时各剂量组体重、体重增重、总进食量、总食物利用率、脏体比与对照组比较,差异均无统计学意义(P>O.05)。雄性中剂量组的嗜酸性粒细胞;雌性低剂量组谷丙转氨酶、尿素,中剂量组谷草转氨酶、血糖、红细胞计数与对照组相比,差异有统计学意义(P<0.05),但均在本实验室正常值范围内,本实验室认为无生物学意义。其余各剂量组大鼠的血清谷丙转氨酶、谷草转氨酶、尿素、肌酐、血糖、总胆固醇、甘油三酯、总蛋白、白蛋白测定值、血红蛋白、红细胞计数、白细胞计数和白细胞分类与对照组相比差异均无统计学意义(P>0.05)。对受检脏器作组织病理学检查,未见特异性病变。
以上对本发明的较佳实施例进行了详细说明,但所述内容仅为本发明的较佳实施例,不能被认为用于限定本发明的实施范围。凡依本发明申请范围所作的均等变化与改进等,均应仍归属于本发明的专利涵盖范围之内。
Claims (7)
1.一种改善睡眠的中药组合物,其特征在于,其原料以重量份计由以下组分组成:
酸枣仁25份;灵芝15份;刺五加20份;五味子10份;
其制备方法,包含以下步骤:
(1)取配方比例的酸枣仁、五味子,加70%-90%乙醇提取,滤过,回收乙醇;
(2)取配方比例的灵芝、刺五加,加水煎煮,滤过,取滤液备用;
(3)将步骤(1)回收乙醇后的浓缩液与步骤(2)所得的滤液合并,浓缩至70℃相对密度为1.05~1.15的浸膏。
2.由权利要求1所述的中药组合物与药学上可接受的赋形剂制成的制剂。
3.一种改善睡眠的胶囊剂,其特征在于:由权利要求1所述的组合物,微晶纤维素、淀粉和硬脂酸镁制成。
4.根据权利要求1所述的中药组合物,其特征在于:所述步骤(1)具体为取配方比例的酸枣仁、五味子,加入8-10倍量的70%-90%乙醇提取2-3次,每次1-2小时,滤过,回收乙醇。
5.根据权利要求1所述的中药组合物,其特征在于:所述步骤(2)具体为取配方比例的灵芝、刺五加,加8-10倍量水煎煮2-3次,每次1-2小时,滤过,合并滤液备用。
6.根据权利要求1所述的中药组合物,其特征在于:所述步骤(3)采用70~80℃,-0.06~-0.1Mpa的减压浓缩。
7.权利要求1所述中药组合物在制备改善失眠药物或保健品中的应用。
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