CN115350260B - 一种用于皮肤具有助睡眠功能的日常护理生物制剂及其制备方法 - Google Patents
一种用于皮肤具有助睡眠功能的日常护理生物制剂及其制备方法 Download PDFInfo
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Abstract
本申请公开了一种用于皮肤具有助睡眠功能的日常护理生物制剂,其特征在于,方剂组分包括:贯叶连翘提取物、积雪草提取物、益母草提取物、紫苏叶提取物、姜根提取物、龙舌兰叶提取物、膜荚黄芪根提取物、黄芩根提取物、肌肽、没药油、薰衣草油、缬草油、维生素B1、维生素B6、维生素B12、氨基丁酸等。该组方结合日常护理改善睡眠状态,同时对提高机体的抗氧化、抗衰老能力,提高免疫力等起到积极作用。
Description
技术领域
本发明涉及睡眠改善的制剂领域,特别涉及一种用于皮肤具有助睡眠功能的日常护理生物制剂及其制备方法。
背景技术
觉醒-睡眠节律是人体基本的生命现象,正常人每24小时有一次觉醒与睡眠的节律性交替。睡眠是维持人体生命的极其重要的生理功能,与人体身心健康息息相关。睡眠可分为正相睡眠期(非快速眼动睡眠期NREM)和异相睡眠期(快速眼动睡眠期REM),健康人睡眠开始于正相睡眠期,维持70~100分钟后转入异相睡眠期,再维持20~30分钟后又转入正相睡眠期,每晚如此重复约4~6次。睡眠量常依年龄不同而异,新生儿需睡18~20小时,儿童12~14小时,成人7~9小时,老年人一般只需5~7小时。
我国古代医学家称睡眠是“养生之要务”,莎士比亚把睡眠比做是“生命筵席上的滋补品”,联合国教科文组织将每年的3月21日定为“世界睡眠日”,由此可见,睡眠对全人类的健康是何等重要。
然而,随着社会经济的发展和人们生活节奏的加快,越来越多的人受到睡眠障碍的困扰。睡眠障碍主要体现为两种:一种就是睡眠中出现梦游、梦呓、夜惊、梦魇、磨牙、肌肉或肢体不自主跳动等睡眠中发作性异常。另外一种就是睡眠量的不正常。包括睡眠过多,其中有因各种脑病、内分泌障碍、代谢异常导致的嗜睡或昏睡,也有睡眠量不足,整夜睡眠时间少于5小时的表现。最典型的睡眠障碍是入睡困难和失眠。失眠是中医学命名,是指人们对睡眠时间和/或质量不满足并影响日常社会功能的一种主观体验。常见的症状有入睡困难、睡眠断断续续不连贯、睡眠时间减少、睡眠浅表,容易过早地醒来,醒后不能再继续睡,记忆力和注意力下降以及不能消除疲劳、恢复体力与精力等。
目前,90后比老年人面临更严重的睡眠问题,有84%的90后深受各种各样的睡眠困扰,3/4的90后在晚上11点后入睡,1/3在凌晨1点入睡;还有睡不醒也是睡眠障碍,年轻人偏多。电子产品的普及、夜生活丰富令年轻人生活不规律,对他们的睡眠产生了很大影响,未来这种睡眠障碍年轻化的趋势可能还会加重。
睡眠障碍造成了相当一部分人群处于“亚健康”状态。短时间内的失眠,会产生体乏无力、头晕目眩、腰酸耳鸣、心慌气短等症状。如果长期性失眠(失眠症状超过一个月),将导致大脑疲劳,学习和工作效率大大下降,还会损坏记忆力、决策力及思想集中的能力;导致自身的情绪不安,忧虑焦急,免疫力降低,同时还容易引发各种躯体和精神疾病,如神经衰弱、胃肠疾病、心血管病、高血压、肥胖、糖尿病、癌症、抑郁症等,甚至造成猝死、恶性意外事故的发生。长期的失眠会导致人体内正常的内分泌发生失调,生物钟发生紊乱,使人体出现加速衰老的现象。男人长期失眠会出现精神疲惫,肾虚、体弱,性功能严重下降;女人长期失眠会导致更年期提早到来,皮肤灰暗,色斑、皱纹增多,身体特别是卵巢功能衰退显著。
中医将失眠称之为“不寐”,病位主要在心,并涉及肝、脾(胃)、肾三脏,其主要病机是机体脏腑阴阳失调、气血失和,以致心神不宁。主要由七情所伤,思虑太过或突变受惊吓引起,亦有禀赋不足,年迈体弱,气血、阴阳失衡,脏腑功能不调所致。中医学认为,心为君主之官,主神明,阴平阳秘,精神乃治。心气、心血、心阴充足,则心神得到润养,而神明有主,寤寐有时。
现代医学认为失眠是由于外界刺激、压力等导致的植物性神经功能紊乱造成的。造成失眠的原因主要有三个方面:心理因素、疾病与药物因素和环境因素,其中心理因素,如情绪困扰、心理压力是造成失眠的主要原因。疼痛、呼吸困难、哮喘、频繁咳嗽、心悸、腓肠肌痉挛等都能影响睡眠,服用中枢兴奋药物或长期服用镇静安眠药后突然停药也会出现失眠。睡眠环境的突然改变,如声音嘈杂,灯光太亮,室温过热过冷,湿度太大,床铺不舒服,房间太拥挤等都会影响睡眠,但环境因素引起的失眠往往是短暂性的。另外,由于个人的不良生活习惯如睡前饮茶、喝咖啡等也会影响睡眠。
目前,对于轻度失眠大多数人并不重视,持放之任之的态度,而对于中度或重度失眠者则选择药物和非药物治疗。非药物治疗有心理行为疗法、饮食疗法、芳香疗法、按摩、顺势疗法、光照疗法等,这些疗法在实际治疗过程中往往难于操作、起效缓慢。药物治疗仍占据失眠治疗的主导地位,包括化学合成类和天然药物(中成药)。现有的改善睡眠的中药制剂因条件限制很难达到理论上的治疗效果,有些治标不治本,且针对性较差,服用前需要对其进行繁琐的熬制过程。目前临床上使用的治疗失眠的药物普遍使用镇静剂、抗抑郁剂或安眠药,这些化学合成的药物,主要是通过药物降低神经系统兴奋性,强制使神经系统产生疲劳感达到使人入睡的目的,但长期服用会产生多种毒副作用,如脑细胞损伤、记忆力下降、血压升高、免疫力低下、性功能障碍及成瘾性、剂量不断增加等等,严重者(过量服用者)还会导致死亡。且这种睡眠是神经系统被强制抑制的结果,而不能达到通过睡眠使身心放松从而达到休息的目的。科学提高睡眠质量,是人们正常工作、学习和生活的保障。开发出安全有效的改善睡眠的制剂具有重大的社会意义。
发明内容
本发明的目的是提供一种用于皮肤具有助睡眠功能的日常护理生物制剂及其制备方法。
根据本申请的一方面,本发明公开了一种用于皮肤具有助睡眠功能的日常护理生物制剂,主要的组方包括:
贯叶连翘提取物、积雪草提取物、益母草提取物、紫苏叶提取物、姜根提取物、龙舌兰叶提取物、膜荚黄芪根提取物、黄芩根提取物、肌肽、没药油、薰衣草油、缬草油、维生素B1、维生素B6、维生素B12。
具体按重量百分数计,包括以下组分:
为了达到更好的具有助睡眠功能的效果,本申请在上述组方的基础上还具有以下更优的技术方案:
在一些实施例中添加基料A组分:
在一些实施例中添加基料B组分:
在一些实施例中添加基料C组分:
氨基丁酸 0.01-9.56%,
去离子水 0.01-12.26%。
在一些实施例中,添加按重量百分比计,具体为:
在一些实施例中,按重量百分比计,基料A组分:
在一些实施例中,按重量百分比计,基料B组分:
在一些实施例中,按重量百分比计,基料C组分:
氨基丁酸 0.01-6.56%,
去离子水 0.01-10.26%。
本发明还提供了一种用于皮肤具有助睡眠功能的日常护理生物制剂的制备方法,包括以下步骤:
(1)按重量百分比称量各相原料;
(2)将基料A混匀,加入水相锅中,加热至80-85℃,恒温灭菌,得到水相物料;
(3)将基料B混匀,加入乳化锅中,加热至75-80℃,恒温灭菌,得到油相物料;
(4)在真空搅拌状态下,将1/4-1/2体积的步骤(2)所得水相物料泵入乳化锅中与步骤(3)所得油相物料混合,再将剩余的水相物料泵入乳化锅中进行均质,并在70-80℃均质3-5min;
(5)待乳化锅中物料温度降至40-45℃,加入基料C,搅拌均匀;
(6)待乳化锅中物料温度降至32-38℃,加入贯叶连翘提取物、积雪草提取物、益母草提取物、紫苏叶提取物、姜根提取物、龙舌兰叶提取物、膜荚黄芪根提取物、黄芩根提取物、肌肽、没药油、薰衣草油、缬草油、维生素B1、维生素B6、维生素B12,搅拌均匀,出料;
其中,所述步骤(2)恒温灭菌25-30分钟;所述步骤(3)加热至固体油脂溶解完全,并恒温灭菌20-25分钟;所述步骤(4)恒温灭菌25-35分钟;
通过以上步骤获得的生物制剂,以水剂、乳剂、膏剂、油剂、块状、悬浮状、表面活性剂溶剂类、凝胶类、气溶胶、锭状制剂的形式通过皮肤给药。
前述一种用于皮肤具有助睡眠功能的日常护理生物制剂中的应用。
采用上述技术方案的生物制剂包括水剂、乳剂、膏剂、油剂、块状产品、悬浮状产品、表面活性剂溶剂类产品、凝胶类产品、气溶胶产品、锭状产品。
现在研究已经确认,昼夜节律的夹带受下丘脑中的视交叉上核(SCN)控制,已知的一种典型的调节昼夜节律的物质是褪黑素(N-乙酰-5甲氧基色胺)。内源性褪黑素分泌规律失调可能是导致睡眠障碍等昼夜节律失调的一个重要因素。
褪黑素(melatonin,MT),又称美拉酮宁、抑黑素、松果腺素,是由哺乳动物和人类脑部深处像松果般大小的“松果体”分泌的一种神经内分泌激素。褪黑素最初在动物中被发现,目前已在多种植物中检测到褪黑素的存在。褪黑素具有较广泛的生理活性,除具有抗氧化、调节生殖等广泛生物学效应外,可以调整内分泌功能,将内源性生物节律和周期、位相调整到与环境同期同步,即有催眠、镇静、调节睡眠、改善时差反应综合征的作用,对调节免疫功能、抗衰老等方面都显示出强大的保健潜力。褪黑素能缩短睡前觉醒时间和入睡时间,改善睡眠质量,延长深睡阶段,具有良好改善睡眠的功效。
褪黑素分泌节律由位于下丘脑视交叉上核(SCN)的内源生物钟引发,SCN接受视网膜感觉的输入,保持每日24小时内的褪黑素节律,褪黑素分泌是昼夜节律的同步因素,也是生物体与自然环境同步的重要环节。人类的褪黑素水平通常在凌晨2点到5点分泌达到高峰,正常年轻人在白天的血清褪黑素水平约为10pg/mL,到夜间可达到60pg/mL以上。人在婴幼儿期(1-3岁)夜间褪黑素水平最高,从儿童到青少年期平均褪黑素水平下降10%,尔后维持在这水平。至50岁以后,随年龄继续增加,褪黑素分泌减少。当褪黑素被分泌后,通过存在于视交叉上核的受体而调节昼夜节律,并且通过降体温作用或通过调节神经、内分泌功能而带来自然的睡眠。而当褪黑素分泌与昼夜循环不同步时,则可能发生睡眠失常。
由于外源性褪黑素在体内的半衰期较短,机体单纯依靠补充外源性褪黑素的生物作用有限,而且长期大量摄入褪黑素会进一步降低机体内源性褪黑素的分泌。另外,褪黑素系统功能是褪黑素通过褪黑素受体相互作用完成的,对于褪黑素受体功能下调和分泌匮乏引起的系统功能受损,仅是补充外源性褪黑素并不能达到预期功效。因此,需寻求能促进内源性褪黑素分泌,改善褪黑素受体功能的方法才能从根本上解决失眠问题。而机体气血阴阳的变化会影响褪黑素水平,而大多数中草药可介导脏腑功能,调节机体气血阴阳,进而影响褪黑素水平。
本组方的配伍思路为:以现代医学成果为辅助,以中医科学理论为基础,以温经通络祛风散寒为辩证用药原则,根据君、臣、佐、使的中药组方思想,通过“内病外治,内药外敷”使药效通过皮肤毛细孔以药物的归经作用到达病灶部位,从而达到保健和治疗的目的。
组方中,贯叶连翘提取物、积雪草提取物、益母草提取物、紫苏叶提取物、姜根提取物、龙舌兰叶提取物、膜荚黄芪根提取物、黄芩根提取物,方中对主证或主病起主要治疗作用的药物,为主攻方向,其药力居方中之首,因此为方中的君药。其中、肌肽、没药油、薰衣草油、缬草油、维生素B1、维生素B6、维生素B12,是辅助君药加强治疗主病和主症的药物,因此为方中的臣药。
基料A、基料B、基料C及具有辅助君药使其具有更好的保健效果,因此为方中的佐药。
方剂释义:
贯叶连翘提取物:贯叶连翘为我国传统中草药,味苦、辛,性平,国外俗称圣约翰草,是安全的神经营养品,具有疏肝解郁,清热利湿,消肿止痛的功效。贯叶连翅中,褪黑素的合成是由色氨酸在色氨酸轻化酶的作用下先生成5-羟色氨酸(5-HTP),5-HTP经色氨酸脱羧酶催化生成5-羟色胺,然后进一步修饰最终生成褪黑素。褪黑素作为贯叶连翘中一种重要的活性成分,是迄今发现的最强的内源性自由基清除剂之一,在机体内具有重要的生理作用,它能够改善人的睡眠状态,还能提高机体的抗氧化、抗衰老能力,提高免疫力等。
益母草提取物:具有疏通经血、增强机体的细胞免疫的作用。益母草有强烈的抗炎镇痛作用。益母草碱可通过与GABAA受体结合发挥显著的神经保护作用;益母草提取物还能通过抑制胆碱酯酶活性,发挥神经保护作用。
薰衣草油:具有一定的安神助眠功效。能够调节和舒缓人体的神经系统,从而减轻神经功能紊乱、日常生活压力大引起的过度紧张、思虑过多等引起的失眠、焦虑、多梦等不适症状。薰衣草精油作用于γ-氨基酸A型受体(GABAA),抑制大脑兴奋物质多巴胺的生成,从而具有抑制神经兴奋的作用。
缬草油:缬草有安心神、祛风湿、行气血、止痛的功效,主治心神不安,心悸失眠,癫狂,脏躁,风湿痹痛,脘腹胀痛,痛经,经闭,跌打损伤。缬草油的镇静活性与其能抑制γ-氨基丁酸(GABA)在脑内的酶解破坏有关。
氨基丁酸:又称γ-氨基丁酸(GABA),是哺乳动物中枢神经系统主要神经传递物,主要起抑制兴奋的作用。GABA水平在快动眼睡眠期高于觉醒时,GABA的水平升高,引起快动眼睡眠增加,在睡眠中起着重要的作用。具有镇静安神、调节心率、增强记忆力以及调节激素分泌等作用。
积雪草提取物:积雪草味苦、辛,性寒。归肝、脾、肾经。具有清热利湿、解毒消肿之功效。积雪草提取物具有抑制乙酰胆碱酯酶活性和促进空间记忆形成的神经保护作用。
紫苏叶提取物:紫苏叶味辛,性温,归肺、脾经,具有发表散寒、行气和胃的功效。有修复神经创伤、影响神经递质传递的效果,且具有抗氧化活性,对神经系统有一定的作用效果。
维生素B1:有助于神经系统的正常活动,它可促进神经系统脑细胞的正常发育和工作,促进大脑的生长和发育,能维持神经系统稳定和正常活动。
维生素B6:维持人体内分泌平衡,有助于维持人体内激素的相对比例平衡,可以间接性的起到维持内分泌平衡的作用。
维生素B12:具有营养神经,促进神经纤维修复的作用。
黄芩根提取物:黄芩黄酮能够保护线粒体的氧化损伤,黄芩素、黄芩苷、汉黄芩素和汉黄芩苷均对NADPH诱导的脑皮质线粒体氧化损伤和抗坏血酸-Fe2+诱发的线粒体肿胀、线粒体膜流动性降低有保护作用。
膜荚黄芪根提取物:能够减轻氧化应激时线粒体的裂解增加,促进线粒体融合,并且对线粒体自噬的过度激活具有抑制作用,通过减少PINK1和Parkin蛋白的表达,从而改善了线粒体功能。
肌肽:通过保护线粒体功能及减少ROS的产生延缓衰老;还能够激活端粒酶,抑制端粒缩短,进而延缓衰老。且与其它活性物一起使用,具有协同及扩大保护端粒的作用。
姜根提取物:姜根为姜科姜属的多年生草本植物的新鲜根茎,温中、散寒、祛风、活血,主风湿痹痛,跌打损伤。
没药油:有舒筋活血、祛瘀止痛、消肿生肌的功效。
龙舌兰叶提取物:具有平衡皮肤微生物组,重建微生物屏障保护,抵御防腐剂的破坏作用。
方剂中运用去离子水:是指除去了呈离子形式杂质后的纯水,可以起到保湿去油的作用;丙二醇:主要是起到亲水、保湿的作用;丁二醇:常用作保湿剂,具有吸附水分子式,清爽、无粘腻感;甘油:有保湿、滋润的作用,还可以在皮肤上形成一种保护膜。硫酸镁:收敛、抗炎、消肿、改善钾离子代谢;环五聚二甲基硅氧烷:主要的功效是能够使物体柔软,还能够起到抗静电的效果。环己硅氧烷:主要作用是柔润剂,成膜剂;聚二甲基硅氧烷:具有抑泡、消泡、防沫作用,防止涂抹产品时的“泛白"现象;辛基聚甲基硅氧烷:可调理剂和润滑剂使用,可以增加产品质感,使其清爽并易于涂抹;硬脂醇甘草亭酸酯:主要作用是皮肤调理剂,舒缓抗敏,止痒和保湿,具有抗菌、消炎、抗氧化、抗衰老、美白亮肤、祛斑等功能;生育酚乙酸酯:生育酚和生育三烯酚通过提供酚羟基的质子和电子,捕获自由基,是性能优良的天然抗氧化剂。其基本功能是抑制组织膜内围绕着细胞颗粒及红细胞的膜内多不饱和脂肪酸的氧化,稳定细胞的脂类,保护它们不受脂肪酸氧化而形成的有毒自由基的伤害,并能与过氧化物反应,使其转变成对细胞无害的物质。季戊四醇四(双-叔丁基羟基氢化肉桂酸)酯:具有抗氧化的作用,可防止衰老;PEG-10聚二甲基硅氧烷:主要作用是乳化剂。二硬脂二甲铵锂蒙脱石:主要作用是乳化稳定剂,悬浮剂,润滑剂、抗粘剂、助流剂。硬脂酰菊粉:具有优良的乳化、分散能力,可作为调理剂、润肤剂、乳化剂。羟苯甲酯:主要作为防腐剂,防止物品的腐败、分解。羟苯乙酯:用作抑菌防腐剂;泛醌:用作抗氧化剂、保湿剂和皮肤调理剂使用。泛醌已应用于化妆品中,它能抑制分解胶原蛋白的产生、起到维持肌肤丰润、弹性的作用,而且,它还能增加保湿成分透明质酸的含量,提高肌肤的保湿效果。此外,泛醌还能够促进新陈代谢,调节肌肤再生周期正常运行,使肌肤长保年轻,远离各种问题肌肤的同扰。
本发明将传统中草药特色和现代医学研究相结合,滋阴养心、健脾益气,主要通过促进内源性褪黑素分泌,增强褪黑素系统功能,使紊乱的睡眠节律规律化,调整和恢复昼夜节律,从根本上调理改善睡眠障碍。具有助睡安眠、提高生活质量,延缓衰老的作用,增强免疫力,改善整个身体的机能状态。
具体实施方式
下面对本发明作进一步详细的说明:
实施例:一种用于皮肤具有助睡眠功能的日常护理生物制剂,按以下要求准备物料:
再加入:
基料A:
基料B:
基料C:
氨基丁酸 0.01%或6.56%或9.56%;
去离子水 0.01%或10.26%或12.26%。
包括以下步骤:
将基料A混匀,加入水相锅中,加热至80-85℃,恒温灭菌25-30分钟,得到水相物料;将基料B混匀,加入乳化锅中,加热至75-80℃到固体油脂溶解完全,并恒温灭菌20-25分钟,得到油相物料;在真空搅拌状态下,将1/4-1/2体积的步骤(2)所得水相物料泵入乳化锅中与步骤(3)所得油相物料混合,再将剩余的水相物料泵入乳化锅中进行均质,并在70-80℃均质3-5min,恒温灭菌25-35分钟;待乳化锅中物料温度降至40-45℃,加入基料C,搅拌均匀;待乳化锅中物料温度降至32-38℃,加入贯叶连翘提取物、积雪草提取物、益母草提取物、紫苏叶提取物、姜根提取物、龙舌兰叶提取物、肌肽、没药油、薰衣草油、缬草油、维生素B1、维生素B6、维生素B12,搅拌均匀,出料。
最后可以根据需要,制成水剂、乳剂、膏剂、油剂、块状产品、悬浮状产品、表面活性剂溶剂类产品、凝胶类产品、气溶胶产品、锭状产品。
具体操作方法如下:
1.取适量精华均匀展至后颈部、脑后安眠区,点按风池、风府穴。
2.双手四指微握拳紧贴颈窝,双手拇指从风池穴推至大椎穴。
3.展霜,双手四指微握拳紧贴颈窝,双手拇指从风池穴推至大椎穴。拇指横拨膀胱经。
4.取适量精华从额头均匀展至翳风穴,从腋下排出。
5.点按印堂穴、太阳穴、神庭穴、头维穴、角孙穴、百会穴。
6.取适量霜在双手五指指腹,抓放整体头部。
注意事项:
①使用本产品10~30g,配合中医按摩手法来达到调节睡眠障碍的目的。
②每一个按摩步骤要重复30~40次,全程约90分钟。
③使用者在用本品做按摩护理前、后要注意补充适量水分,有助于体内毒素的排出。
④做按摩的过程中,要及时添加以上实施例的产品作为按摩介质,保证有足量产品被吸收的同时,增强疗效。
临床实施例1:
选择30例失眠或浅睡眠患者,平均年龄为28岁。都伴有不易入睡、睡后易醒、醒后不能再寐、容易被惊醒,对声音或灯光敏感,伴有日间精神不振、反应迟钝、体倦乏力、心烦的临床表现症状。分为三组,每组10例患者进行临床实验。
第一组患者使用实施例中最少的分量制备成的膏剂或油剂,每天2次,外用本发明的组合物并结合中医按摩手法进行临床治疗,治疗7天为1个疗程。孕妇禁用,严禁口服。
第二组患者使用实施例分量适中制备成的膏剂或油剂,每天2次,外用本发明的组合物并结合中医按摩手法进行临床治疗,治疗7天为1个疗程。孕妇禁用,严禁口服。
第三组患者使用实施例分量最多制备成的膏剂或油剂,每天2次,外用本发明的组合物并结合中医按摩手法进行临床治疗,治疗7天为1个疗程。孕妇禁用,严禁口服。
疗效判定:
有效:容易入睡、睡后不易醒、醒后能再寐、不易被惊醒,精神良好、思维敏捷。
好转:能入睡但容易被惊醒,其它症状减轻。
无效:不易入睡、睡后易醒、易被惊醒,精神不振、体倦乏力、心烦。
治疗结果:
经过一个疗程的观察,发现第一组患者中,有效6例,好转4例;第二组患者中,有效7例,好转2例,无效1例;第三组患者中,有效5例,好转3例,无效2例。
不良反应和毒副作用监管通过检测患者的血压、脉搏、是否出现恶心、呕吐、眩晕的临床症状来判断不良反应。发现三组共30例患者的收缩压在90-140mmHg之间,舒张压在60-90mmHg之间,脉搏为60-100次/分钟,血压和脉搏全部都在正常范围内,并且没有出现恶心、呕吐、眩晕的临床症状。没有明显的不良反应,进而证明三组药物都对于人体没有明显的毒副作用。本发明的预防和改善睡眠障碍的作用显著,其改善临床睡眠障碍症状有效率达90%以上。
临床实施例2:
选择30例失眠或浅睡眠患者,平均年龄为56岁。都伴有不易入睡、睡后易醒、醒后不能再寐、容易被惊醒,伴有日间精神不振、反应迟钝、体倦乏力、心烦的临床表现症状。分为三组,每组10例患者进行临床实验。
第一组患者使用实施例中最少的分量制备成的乳剂或块状制剂,每天2次,外用本发明的组合物并结合中医按摩手法进行临床治疗,治疗7天为1个疗程。孕妇禁用,严禁口服。
第二组患者使用实施例分量适中制备成的乳剂或块状剂,每天2次,外用本发明的组合物并结合中医按摩手法进行临床治疗,治疗7天为1个疗程。孕妇禁用,严禁口服。
第三组患者使用实施例分量最多制备成的乳剂或块状剂,每天2次,外用本发明的组合物并结合中医按摩手法进行临床治疗,治疗7天为1个疗程。孕妇禁用,严禁口服。
疗效判定:
有效:容易入睡、睡后不易醒、醒后能再寐、不易被惊醒,精神良好、思维敏捷。
好转:能入睡但容易被惊醒,其它症状减轻。
无效:不易入睡、睡后易醒、易被惊醒,精神不振、体倦乏力、心烦。
治疗结果:
经过一个疗程的观察,发现第一组患者中,有效4例,好转4例,无效2例;第二组患者中,有效6例,好转3例,无效1例;第三组患者中,有效5例,好转4例,无效1例。
不良反应和毒副作用监管通过检测患者的血压、脉搏、是否出现恶心、呕吐、眩晕的临床症状来判断不良反应。发现三组共30例患者的收缩压在90-130mmHg之间,舒张压在60-80mmHg之间,脉搏为60-90次/分钟,血压和脉搏全部都在正常范围内,并且没有出现恶心、呕吐、眩晕的临床症状。没有明显的不良反应,进而证明三组药物都对于人体没有明显的毒副作用。本发明的预防和改善睡眠障碍的作用显著,其改善临床睡眠障碍症状有效率达87%以上。
以上所述的仅是本发明的一些实施方式。对于本领域的普通技术人员来说,在不脱离本发明创造构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。
Claims (6)
1.一种用于皮肤具有助睡眠功能的日常护理生物制剂,其特征在于,由原料、基料A、基料B、基料C制成,所述原料按重量百分比为:
所述基料A按重量百分比为:
所述基料B按重量百分比为:
所述基料C按重量百分比为:
氨基丁酸0.01-9.56%,
去离子水0.01-12.26%。
2.根据权利要求1所述的一种用于皮肤具有助睡眠功能的日常护理生物制剂,其特征在于,按重量百分比计,包括以下组分:
3.根据权利要求1所述的一种用于皮肤具有助睡眠功能的日常护理生物制剂,其特征在于,按重量百分比计,包括以下基料A组分:
4.根据权利要求1所述的一种用于皮肤具有助睡眠功能的日常护理生物制剂,其特征在于,按重量百分比计,包括以下基料B组分:
5.根据权利要求1所述的一种用于皮肤具有助睡眠功能的日常护理生物制剂,其特征在于,按重量百分比计,包括以下基料C组分:
氨基丁酸0.01-6.56%,
去离子水0.01-10.26%。
6.根据权利要求1-5任一项所述的一种用于皮肤具有助睡眠功能的日常护理生物制剂的制备方法,其特征在于,包括以下步骤:
(1)按重量百分比称量各相原料;
(2)将基料A混匀,加入水相锅中,加热至80-85℃,恒温灭菌,得到水相物料;
(3)将基料B混匀,加入乳化锅中,加热至75-80℃,恒温灭菌,得到油相物料;
(4)在真空搅拌状态下,将1/4-1/2体积的步骤(2)所得水相物料泵入乳化锅中与步骤(3)所得油相物料混合,再将剩余的水相物料泵入乳化锅中进行均质,并在70-80℃均质3-5min;
(5)待乳化锅中物料温度降至40-45℃,加入基料C,搅拌均匀;
(6)待乳化锅中物料温度降至32-38℃,加入贯叶连翘提取物、积雪草提取物、益母草提取物、紫苏叶提取物、姜根提取物、龙舌兰叶提取物、膜荚黄芪根提取物、黄芩根提取物、肌肽、没药油、薰衣草油、缬草油、维生素B1、维生素B6、维生素B12,搅拌均匀,出料;
其中,所述步骤(2)恒温灭菌25-30分钟;所述步骤(3)加热至固体油脂溶解完全,并恒温灭菌20-25分钟;所述步骤(4)恒温灭菌25-35分钟。
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