CN116196375B - 一种用于预防和/或治疗失眠的复方精油 - Google Patents
一种用于预防和/或治疗失眠的复方精油 Download PDFInfo
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- CN116196375B CN116196375B CN202310056735.5A CN202310056735A CN116196375B CN 116196375 B CN116196375 B CN 116196375B CN 202310056735 A CN202310056735 A CN 202310056735A CN 116196375 B CN116196375 B CN 116196375B
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Abstract
本发明属于中药技术领域,具体涉及一种用于预防和/或治疗失眠的复方精油及其组合物。所述复方精油由包括如下重量份组分的原料制成的:乳香精油1~2份、木香精油0.5~1份、薰衣草精油1~2份、岩兰草根精油0.5~1份、白花春黄菊花精油0.25~0.5份、降香精油0.5~1份、雪松木精油1~2份、甜橙精油0.25~0.5份;或,乳香精油1~2份、木香精油0.5~1份、薰衣草精油1~2份、岩兰草根精油0.5~1份、白花春黄菊花精油0.25~0.5份、沉香精油0.5~1份、甘松精油1~2份、天竺葵精油1~2份。本发明提供了新的复方精油,对失眠症具有良好的防治效果,为临床应用提供了新的选择,具有很好的应用前景。
Description
技术领域
本发明属于中药技术领域,具体涉及一种用于预防和/或治疗失眠的复方精油及其组合物。
背景技术
失眠是一种由环境因素、生理因素、心理因素、药物因素、精神刺激、生活习惯、情绪因素等所引起的睡眠病症,主要表现难以入睡、睡眠不深、易醒、多梦、早醒、醒后不易再睡、醒后不适感、疲乏,或白天困倦等临床症状,在各个年龄阶段均有发病,是临床上常见的多发病、慢性病。失眠可引起病人焦虑、抑郁、或恐惧心理,并导致精神活动效率下降,妨碍社会功能;严重危害患者身心健康,影响其正常的工作、生活、学习。
目前国内外防治失眠的主要采用药物法、穴位按压法、针刺法、心理干预法、及联合治疗法,疗效并不显著。西药常用苯二氮卓类、非苯二氮卓类、褪黑素、抗焦虑抗抑郁等控制病情,但无法根治,易反复,反复用药易引起全身副作用及依赖性;中医治疗作用缓慢,治疗周期长,疗效不佳;心理干预等因人而异,只作为辅助疗法。
芳香疗法是采用天然植物香精或提取出的芳香精油用于减轻、预防、治疗人体某些疾病的一种辅助方法。芳香精油可通过口服、局部皮肤外用,经鼻、口腔黏膜等途径作用于身体特定部位。随着研究的开展(例如:陈冬晶.芳香植物精油对改善青年人睡眠质量的功能性研究[D].上海交通大学,2015.),发现芳香精油具有镇静、安抚人情绪等作用,可用于各种失眠症状的缓解和治疗,减轻患者的紧张情绪和消极感,使患者心身得以放松,舒缓心情,提高睡眠质量。因此可利用芳香精油来失眠症。
然而,由于患者个人对药物耐受性的差异等因素,可能对不同的药物有这不同的反应。因此,开发新的用于防治失眠症的芳香精油依然是本领域重要的课题。
发明内容
针对现有技术的缺陷,本发明提供一种用于预防和/或治疗失眠的复方精油,目的在于提供新的能够用于防治失眠症的芳香精油配方,为临床应用提供更多的选择。
一种用于预防和/或治疗失眠的组合物,它是由包括如下重量份组分的原料制成的:
乳香精油1~2份、
木香精油0.5~1份、
薰衣草精油1~2份、
岩兰草根精油0.5~1份、
白花春黄菊花精油0.25~0.5份。
优选的,它的原料还包括:
降香精油0.5~1份、
雪松木精油1~2份、
甜橙精油0.25~0.5份。
优选的,它是由如下重量份组分的原料制成的:
乳香精油1份、
木香精油0.5份、
降香精油0.5份、
薰衣草精油2份、
岩兰草根精油0.5份、
雪松木精油1份、
甜橙精油0.5份、
白花春黄菊花精油0.5份。
优选的,它的原料还包括:
沉香精油0.5~1份、
甘松精油1~2份、
天竺葵精油1~2份。
优选的,它是由如下重量份组分的原料制成的:
乳香精油1份、
木香精油1份、
沉香精油1份、
薰衣草精油1份、
岩兰草根精油0.5份、
甘松精油1份、
天竺葵精油1份、
白花春黄菊花精油0.5份。
优选的,所述原料中的精油和提取物分别采用如下方法制备:超临界CO2提取法、水蒸气蒸馏法、浸泡法或压榨法。
本发明还提供上述组合物用于制备预防和/或治疗失眠的产品中的用途。
本发明还提供一种用于预防和/或治疗失眠的产品,它是以上述组合物作为活性成分,加入药学上可接受的辅料或辅助性成分制成的,优选的,所述产品的剂型为精油。
乳香(Boswelliacarterii)精油主要活性成分为乙酸辛酯和芳樟醇等;具有具有抗炎、抗肿瘤、抗溃疡、抗哮喘、抗氧化、抗抑郁等药理活性药理作用;临床主要用来治疗治疗痛经和缓解经前期综合症、风湿关节炎、肌肉酸痛、老化皮肤活化、促进结疤、月经不顺、产后忧郁、子宫出血等症状;能净化心灵,帮助舒缓急躁、受挫、哀伤等负面情绪;可安抚躁动的心灵,使人心情平和,并有助冥想。
木香(Aucklandialappa)精油主要化学成分为去氢木香烃内酯和木香烃内酯等;具有健胃、抗溃疡、解痉、抗菌、肌松、扩张血管、降血压等功效,传统主要治疗脾胃气滞证、泻痢、里急后重、食积不消、食少吐泻等肠胃疾病。能舒缓痉挛,平复紧张情绪。除此之外,现代药理学研究发现其在抗肿瘤、抗炎、保肝、保护心肌损伤、抗氧化等方面也有相关作用。
降香(Dalbergiaodorifera)精油主要化学成分为β-没药烯和橙花叔醇等;现代药理学研究发现其有抗心肌缺血,抗凝血,镇痛抗炎等作用。
沉香(Aquilariaagallocha(Lour.)Roxb)精油主要化学成分为γ-桉叶醇、沉香螺醇、α-愈创木烯;具有抗氧化、抑菌、镇痛、镇静、抗炎、抗癌、抗心肌缺血、降血糖等作用。
薰衣草(Lavandulaangustifolia)精油主要化学成分为芳樟醇和乙酸芳樟醇;可以明显提高睡眠质量并有舒缓情绪,减轻焦虑抑郁的作用,且暂未发现明显的不良反应。
岩兰草(Andropogonmuricatus)精油主要成分为异长叶烯和异雪松醇;能抗敏消炎、镇静、安抚情绪。
雪松木(Cedrusdeodara(Roxb.)G.Don)精油主要化学成分为α-顺式-雪松烯和β-雪松烯;具有抗炎、镇痛和抗疟等多种药理活。
甘松(Nardostachysjatamansi)精油主要化学成分为缬草酮、白菖烯;具有镇静安抚、解痉、降血压、抗心律失常、增加耐氧力、抗心肌缺血、抑菌等作用。
天竺葵(Pelargonium hortorum Bailey)精油主要化学成分为香叶醇、芳樟醇和香茅醇;具有清除自由基、抗氧化、抗肿瘤、抑菌、缓解压力等作用。
甜橙(Citrus sinensis(L.)Osbeck)精油主要化学成分为水芹烯和柠檬烯;具有镇静安抚、抗菌抗炎等作用。
白花春黄菊(Anthemisnobilis)精油主要化学成分为异丁酸异丁酯和α-蒎烯等;具有抗菌抗炎、止痛、抗抑郁等作用。
以上精油按比例和药味组成本发明的复方精油,可用于失眠症状的治疗。配伍后的复方精油气味更芳香,层次更丰富,镇静舒缓效果更好。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
以下实施例和实验例中,所用的试剂和材料无具体说明的均为市售品。
实施例1
采用超临界CO2提取法、水蒸气蒸馏法、浸泡法、压榨法等常用芳香精油的提取方法提取精油。
具体的:
乳香精油采用超临界CO2提取法提取,萃取压力35mpa,萃取温度40℃,萃取时间60-90min;CO2流速250kg/hr;分离釜i的压力为10mpa,萃取温度45℃,分离釜ⅱ的压力为5mpa,萃取温度40℃。沉香精油提取方法同乳香精油。
木香采用水蒸气蒸馏法提取,将木香置于挥发油提取罐中,水蒸气蒸馏2~4h,静置一段时间待油水分离器中油和水分离完全后,分离出木香精油。薰衣草精油、岩兰草精油、降香精油、雪松木精油、白花春黄菊花精油、天竺葵精油、甘松精油提取方法同木香精油。
甜橙精油采用采用冷榨法提取,直接利用榨油机进行压榨,经分离后制取的甜橙精油含有浓郁的果香味。
按照如下配方制成复方精油:
乳香精油1g,木香精油0.5g,降香精油0.5g,薰衣草精油2g,岩兰草根精油0.5g,雪松木精油1g,甜橙精油0.5g,白花春黄菊花精油0.5g。
实施例2
本实施例的单方精油制备方法与实施例1一样。
按照如下配方制成复方精油:
乳香精油2g,木香精油1g,降香精油1g,薰衣草精油1g,岩兰草根精油1g,雪松木精油2g,甜橙精油0.25g,白花春黄菊花精油0.25g。
实施例3
本实施例的单方精油制备方法与实施例1一样。
按照如下配方制成复方精油:
乳香精油1g,木香精油1g,沉香精油1g,薰衣草精油1g,岩兰草根精油0.5g,甘松精油1g,天竺葵精油1g,白花春黄菊花精油0.5g。
实施例4
本实施例的单方精油制备方法与实施例1一样。
按照如下配方制成复方精油:
乳香精油2g,木香精油0.5g,沉香精油0.5g,薰衣草精油2g,岩兰草根精油1g,甘松精油2g,天竺葵精油2g,白花春黄菊花精油0.25g。
下面通过实验对本发明的技术方案做进一步的说明。
实验例1复方精油功效验证实验
一、实验方法
1、功效验证试验
1.1优选处方比例
处方1:实施例1的复方精油。
处方2:实施例3的复方精油。
1.2大鼠在体试验
采用PCPA法制造大鼠失眠模型,考察精油对大鼠睡眠潜伏期、睡眠持续时间的影响;采用ELISA法测定下丘脑和海马部位5-HT的含量;用大鼠DA酶联免疫测定下丘脑及纹状体部位DA的含量。
1.2.1复制大鼠失眠模型
取PCPA适量,用生理盐水配置成100mg/ml的溶液。大鼠适应性喂养一周,实验室条件:温度20-22℃,相对湿度45%-65%,自然光照,自由饮水、摄食。于第八、第九天9:00am-10:00am之间按照400mg/kg剂量给予大鼠腹腔注射PCPA。于第二次腹腔注射PCPA12小时之后,利用戊巴比妥钠睡眠实验(使所有大鼠发生睡眠且睡眠时间适当的剂量,经过预实验戊巴比妥钠剂量为35mg/kg,戊巴比妥钠按0.05g/ml溶解于生理盐水备用)对空白组大鼠与模型组大鼠之间睡眠潜伏期和睡眠持续时间进行统计分析,评价造模成功与否。
1.2.2精油对PCPA致失眠模型大鼠疗效观察
取90只Wistar大鼠,雄性,8-9周龄,体重180-220g。随机分为空白组、模型组、单方沉香精油(0.05g、0.15g、0.3g)剂量组、单方薰衣草精油(0.05g、0.15g、0.3g)剂量组、复方精油处方1(0.05g、0.15g、0.3g)剂量组、复方精油处方2(0.05g、0.15g、0.3g)剂量组、安定阳性药组,每组6只。空白组大鼠不进行处理,模型组、实验组的大鼠按照“2.2.1”中方法复制大鼠失眠模型。造模后,模型组和各精油组将扩香木放入改造的相对密闭但透气型性良好(不影响小鼠呼吸)的饲养盒内固定,精油组滴入精油扩香,模型组滴入水、每天三滴。阳性组灌胃的1.5mg/kg浓度的安定溶液。连续给药7天,于第七次给药结束之后12小时进行戊巴比妥钠睡眠实验,腹膜内注射阈值剂量的戊巴比妥钠35mg/kg(预实验结果表明该浓度下实验动物100%入睡),观察记录治疗后各组间睡眠潜伏期及睡眠时间差异;戊巴比妥钠睡眠实验结束后,各组大鼠在冰台上断头取脑,取下丘脑及海马组织,ELISA法测定下丘脑和海马部位5-HT的含量,下丘脑及纹状体部位DA的含量。
2、临床试验
按照复方精油处方1、复方精油处方2制备香薰精油,对精油临床应用效果进行评价。
2.1选取成都市某三甲医院2020年5月至2022年5月接诊的250例失眠患者,随机分为沉香组、薰衣草组、复方精油处方1组、复方精油处方2组,每组50例。各组患者性别、年龄、病程及病情比较,差异无统计学意义(P>0.05),具有可比性。
2.2诊断标准:参照2017年国内最新版“中国成人失眠诊断和治疗指南中制定的成人失眠诊断标准”拟定:
2.2.1慢性失眠的诊断标准(必须同时符合1~6项标准)
2.2.1.1.存在以下一种或者多种睡眠异常症状(患者自述,或者照料者观察到)(1)入睡困难;(2)睡眠维持困难;(3)比期望的起床时间更早醒来;(4)在适当的时间不愿意上床睡觉。
2.2.1.2.存在以下一种或者多种与失眠相关的日间症状(患者自述,或者照料者观察到)∶(1)疲劳或全身不适感;(2)注意力不集中或记忆障碍;(3)社交、家庭、职业或学业等功能损害(4)情绪易烦躁或易激动;(5)日间思睡;(6)行为问题(比如:多动、冲动或攻击性);(7)精力和体力下降;(8)易发生错误与事故;(9)过度关注睡眠问题或对睡眠质量不满意。
2.2.1.3.睡眠异常症状和相关的日间症状不能单纯用没有合适的睡眠时间或不恰当的睡眠环境来解释。
2.2.1.4.睡眠异常症状和相关的日间症状至少每周出现3次。
2.2.1.5.睡眠异常症状和相关的日间症状持续至少3个月。
2.2.1.6.睡眠和觉醒困难不能被其他类型的睡眠障碍更好地解释。
2.2.2短期失眠的诊断标准
符合慢性失眠第1~3、6条标准,但病程不足3个月和(或)相关症状出现的频率未达到每周3次。
2.2.3失眠的鉴别诊断
失眠需要与精神障碍、躯体疾病、药物或物质滥用,以及其他类型的睡眠障碍相鉴别。需要鉴别的其他睡眠障碍类型包括呼吸相关性睡眠障碍、不宁腿综合征、周期性肢体运动障碍、CRSWDs、环境性睡眠困难、睡眠不足综合征、短睡眠者等。确定失眠诊断时还应针对可以确定的精神或躯体障碍给予相应的诊断。
推荐意见∶(1)如有可能,在首次系统评估前最好记录睡眠日记(Ⅰ级推荐);(2)诊断失眠时应关注共存的其他疾病和症状,并给予相应的诊断(Ⅰ级推荐);(3)鉴别其他睡眠障碍如呼吸性睡眠障碍、周期性肢体运动障碍时应进行PSG检查(I级推荐);(4)失眠患者伴随日间过度思睡,特别是在需要鉴别发作性睡病时,应当同时进行PSG和MSLT检查(Ⅱ级推荐);(5)失眠患者接受合理干预后疗效反应不理想时,应进行PSG检查排除其他类型睡眠障碍(Ⅱ级推荐)。
2.3纳入标准:(1)符合失眠的诊断标准且处于发作期;(2)年龄18~70岁;(3)能够正确描述本人意愿,自愿填写知情同意书,同意参加临床受试者。同时符合以上3条者方可纳入。
2.4排除标准:(1)不符合失眠诊断标准;(2)妊娠或哺乳期妇女或准备妊娠的妇女;(3)伴恶性肿瘤患者、精神病患者;(4)精油不适应患者或不合作的患者;(5)不愿意签署知情同意书者;(6)已接受其他有关治疗,可能影响该研究的效应指标观测者。
2.5剔除标准:(1)试验过程中发现受试者符合排除标准或不符合纳入标准;(2)试验过程中自行接受其他可能对实验结果产生影响的治疗;(3)各种不能配合治疗的患者。
2.6治疗方法
实验组分别使用处方1至2制备得到的复方精油与沉香、天竺葵精油,即实验组1的患者使用处方1,实验组2的患者使用处方2,实验组3的患者使用沉香单方精油,实验组4的患者使用天竺葵单方精油;使用时各组均一天使用3次,每次香薰60min(每日0.5g左右),各组均连续使用30天,为一个疗程。
2.7评价方法
临床志愿者采用国际通用PSQI睡眠评测法进行睡眠评价,得出评价结果。对志愿者进行用药30天,再进行PSQI睡眠质量评价。对比用药前后的评价结果,得出治愈率、显效率及好转率。
二、实验结果
1、大鼠实验结果及结论
1.1复方精油与单方精油的功效对比
由实验结果可知,模型组与空白组比较,大鼠睡眠潜伏期显著增加,睡眠持续时间显著减少,二者差异有统计学意义(P<0.01),表明造模成功;沉香组、薰衣草组、复方精油处方1组、复方精油处方2组、阳性药物安定组与模型组比较,睡眠潜伏期降低(P<0.05),睡眠持续时间增加(P<0.05),说明沉香、薰衣草、复方精油处方1、复方精油处方2可显著改善失眠大鼠睡眠状况;复方精油处方1、复方精油处方2高剂量组药效与安定组相仿。结果见表一:
表一精油对PCPA造模对大鼠睡眠潜伏期和睡眠时间的影响(治疗后)(n=6)
(注:与模型组相比,*P<0.05,**P<0.01;与空白组相比,#P<0.05,##P<0.01;与阳性药安定组相比,▲P<0.05,▲▲P<0.01)
1.2精油对失眠大鼠5-HT、DA含量的影响
由实验结果可知,模型组与空白组比较,大鼠下丘脑和海马部位5-HT的含量显著降低、下丘脑及纹状体部位DA的含量显著增加,差异有统计学意义(P<0.01);沉香组、薰衣草组、复方精油处方1组、复方精油处方2组、阳性药物安定组与模型组比较,大鼠下丘脑和海马部位5HT的含量降低、下丘脑及纹状体部位DA的含量增加(P<0.05);沉香组、薰衣草组、复方精油处方1组、复方精油处方2组、阳性药物安定组与模型组比较,大鼠下丘脑和海马部位5HT的含量降低、下丘脑及纹状体部位DA的含量增加(P<0.05),说明沉香、薰衣草、复方精油处方1、复方精油处方2可降低大鼠下丘脑和海马部位5-HT的含量、增加下丘脑及纹状体部位DA的含量;复方精油处方1、复方精油处方2药效与安定组相仿。结果见表二:
表二治疗后大鼠体内5-HT、DA含量(ng/g)(n=6)
(注:与模型组相比,*P<0.05,**P<0.01;与空白组相比,#P<0.05,##P<0.01;与阳性药安定组相比:▲P<0.05,▲▲P<0.01)
2、临床结果及讨论
对志愿者进行用药30天,在进行PSQI睡眠质量评价。对比用药前后的评价结果。结果见表三
表三精油对失眠志愿者治疗效果分析表
从上述实验数据可以看到,本发明提供的复方精油对失眠症具有良好的治疗效果,且其治疗效果优于沉香和薰衣草等单方精油的治疗效果。
通过上述实施例和实验例可以看到,本发明提供了新的复方精油,对失眠症具有良好的治疗效果,为临床应用提供了新的选择,具有很好的应用前景。
Claims (7)
1.一种用于预防和/或治疗失眠的组合物,其特征在于,它是由如下重量份的原料制成的:
乳香精油 1份、
木香精油0.5份、
降香精油0.5份、
薰衣草精油2份、
岩兰草根精油0.5份、
雪松木精油1份、
甜橙精油0.5份、
白花春黄菊花精油0.5份。
2.按照权利要求1所述的组合物,其特征在于:所述原料中的精油分别采用如下方法制备:超临界CO2提取法、水蒸气蒸馏法、浸泡法或压榨法。
3.一种用于预防和/或治疗失眠的组合物,其特征在于,它是由如下重量份的原料制成的:
乳香精油 1份、
木香精油1份、
沉香精油1份、
薰衣草精油1份、
岩兰草根精油0.5份、
甘松精油1份、
天竺葵精油1份、
白花春黄菊花精油0.5份。
4.按照权利要求3所述的组合物,其特征在于:所述原料中的精油分别采用如下方法制备:超临界CO2提取法、水蒸气蒸馏法、浸泡法或压榨法。
5.权利要求1-4任一项所述的组合物在用于制备预防和/或治疗失眠的药物中的用途。
6.一种用于预防和/或治疗失眠的药物,其特征在于:它是以权利要求1-4任一项所述的组合物作为活性成分,加入药学上可接受的辅料或辅助性成分制成的。
7.按照权利要求6所述的药物,其特征在于:所述药物的剂型为吸入剂。
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