CN109078089A - 一种抗衰老、防治骨质疏松的中药组合物及其制剂 - Google Patents
一种抗衰老、防治骨质疏松的中药组合物及其制剂 Download PDFInfo
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Abstract
本发明公开一种抗衰老、防治骨质疏松的中药组合物,由海洋生物废弃物、牡蛎肉、金花茶叶、金银花或山银花、菊花、槐花、玳玳花、茉莉花、葛根等制备而成;本发明的中药组合物发挥健肾益脾、滋阴助阳、宁心安神、清肝明目、通脉排毒、扶正驱邪等功效,可用于润肤养颜、强体补虚、延缓衰老;还可用于防治性功能低下、肠胃功能减退、骨质疏松等。本发明的中药组合物作用平和,安全性和稳定性较高,对人体无毒副作用和无不良反应;本发明的中药组合物还可制成胶囊剂、颗粒剂、片剂、口服液,功能性保健饮料等,满足不同病况的病患携带和服用,尤其利于养颜、养骨、养生和防治老年疾病,积极维护广大人们健康。
Description
技术领域
本发明涉及医药领域,具体涉及一种抗衰老、防治骨质疏松的中药组合物及其制剂。
背景技术
衰老是一种自然的过程,生物分子自然交联学说对此作过比较系统的阐述。该学说在论证生物体衰老的分子机制时指出:生物体是一个不稳定的化学体系,属于耗散结构。体系中各种生物分子具有大量的活泼基团,它们必然相互作用发生化学反应使生物分子缓慢交联以趋向化学活性的稳定。随着时间的推移,交联程度不断增加,生物分子的活泼基团不断消耗减少,原有的分子结构逐渐改变,这些变化的积累会使生物组织逐渐出现衰老现象。从生物学上讲,衰老是生物随着时间的推移,自发的必然过程,它是复杂的自然现象,表现为结构和机能衰退,适应性和抵抗力减退。在生理学上,把衰老看作是从受精卵开始一直进行到老年的个体发育史。从病理学上,衰老是应激和劳损,损伤和感染,免疫反应衰退,营养不足,代谢障碍以及疏忽和滥用积累的结果。
衰老的原因主要有:1、荷尔蒙的缺失,荷尔蒙对人体新陈代谢内环境的恒定,器官之间的协调以及生长发育、生殖等起调节作用。荷尔蒙维持着人体生理机能的正常运作,若荷尔蒙分泌失调时,就会使生理机能衰退老化并出现各种不适应症状。例如:暴躁易怒、情绪起伏不定、失眠、记忆力衰退、疼痛、出现皱纹、色斑等等。荷尔蒙的流失、生理的痛苦加速了人体的衰老!另外,自体中毒、营养不良都会导致人的衰老。2、过度氧化,人体过度氧化的危害会加速衰老、疾病、死亡;导致肿瘤迅速生长;引发炎症、自身免疫反应而使身体健康遭受破坏;产生色素沉着,色斑出现。3、细胞的寿命,细胞的间隙被代谢废物充填也会导致细胞衰老;细胞突变,染色体畸变也会诱发衰老,常见原因包括电离辐射、放射线危害等。4、衰则全身衰,精神打击,让人突然衰老,说明大脑中枢对衰老有着巨大的影响。有的人在相濡以沫的老伴去世后,不久也会悄然而去,这就是衰老受中枢神经影响的典型例子。5、蛋白质的老化,其可能途径有:蛋白质合成出现差错;核蛋白老化;异常基因导致蛋白质合成障碍,从而引起生命的衰老。6、内分泌系统功能减退,有学者认为,性腺、甲状腺、肾上腺、脑垂体等功能的减退,会诱导人体迅速衰老。比如说有甲状腺疾病的病人就很容易出现早衰。近年来,因胸腺萎缩而促使衰老加剧的观点,也越来越引起专家学者们的注意。7、微循环障碍,由于人体大量代谢废物的沉积和病理性代谢渣滓的黏着,破坏了许多微血管系统,从而导致血管的管腔狭窄,甚至封闭,导致微循环、循环发生障碍,使生命代谢的交换活动受到限制,从而导致了细胞的衰老。
抗衰老常用的药物治疗有维生素C,它是水溶性物质,能够重建真皮与表皮的结合部,促进胶原纤维生成。此外还具有很强的清除自由基能力,同时也是增强身体免疫力不可缺少的成分。研究证明,经常补充维生素C的人比其他人的寿命更长。而维生素E它是被研究和应用最多的抗老成分之一,属于人体主要的脂溶性抗氧化物,可以清除体内自由基以阻断氧化反应的生成,并减轻和修复细胞膜损伤,达到抵抗衰老的作用。然而,过量服用维生素C的副作用:维生素C是水溶性,这意味着身体能将多余部分通过尿液排泄掉,因此达到中毒水平是很困难的。但摄入太多维生素C仍然有可能带来不良后果。比如具有以下副作用:1、短期内服用VC补充品过量,会产生多尿、下痢、皮肤发疹等副作用;2、长期服用过量VC补充品,可能导致草酸及尿酸结石,有过肾结石病史的人应该避免服用维生素C营养品,只通过天然食物获得这种营养素;3、小儿生长时期过量服用,容易产生骨骼疾病;4、一次性摄入VC2500-5000毫克以上时,可能会导致红细胞大量破裂,出现溶血等危重现象。且滥用维生素C会削弱人体免疫力,可能会加快动脉硬化。
骨质疏松症(osteoporosis,OP)是一种以全身性骨量减少、骨密度损失及骨微结构破坏为特征,导致骨脆性增加和骨强度降低易于骨折的代谢性骨病,该病以疼痛,身高变短,甚至脊柱畸形,或出现骨折为临床表现,以疼痛症状为主,腰背部常见。根据骨质疏松症的发病原因,可分为原发性、继发性和特发性骨质疏松症3大类。其中原发性骨质疏松症占90%,分为绝经后骨质疏松症和老年性骨质疏松症。据统计,全世界有超过2亿人患有骨质疏松症,其发病率已跃居世界各种常见疾病的第7位。伴随我国人口老龄化进程,骨质疏松症已成为危害我国人口公共健康最严重的问题之一。我国现有老龄人口约1.3亿,骨质疏松症患者达8400万人,占总人口数量的6.6%,预计到2050年,我国老龄人口将达到2.5亿,其中25%-70%可能患有骨质疏松症。因此,防治骨质疏松症已经成为中老年人群的重要问题。
中国历代医书中并无骨质疏松病名的记载,但对骨瘘、骨痹、骨枯等的临床症状的描述与骨质疏松症颇为相似。多数学者认为,原发性骨质疏松症应属骨瘘。历代中医学家经过对骨瘘、骨痹的发病机制和临床表现的全面研究,认为本病源于肾虚,此外,脾虚、肝郁、血瘀也是骨质疏松症发病的重要病机。
目前,该病的主要治疗药物有基础药物(钙剂、维生素D)、抑制骨转换剂(二磷酸盐类、降钙素、雌激素等)、骨形成促进剂(甲状旁腺激素、氟化物)和解偶联剂(锶盐)。其中雌激素服药时间较长,同时可能引发乳腺癌及子宫内膜癌,长期应用毒副作用较大。降钙素对骨质疏松症有一定疗效,但价格昂贵,难以为广大患者接受。维生素D有不良反应:1..便秘、腹泻、持续性头痛、食欲减退、口内有金属味、恶心呕吐、口渴、疲乏、无力;2.骨痛、尿混浊、惊厥、高血压、眼对光刺激敏感度增加、心律失常、偶有精神异常、皮肤瘙痒、肌痛、严重腹痛(有时误诊为胰腺炎)、夜间多尿、体重下降。
我国拥有丰富的海洋生物资源,其中,贝类、虾、蟹以及鱼类在直接食用或海产品加工后产生大量的废弃物,如贝壳、虾蟹壳、鱼皮等。这些废弃物由于缺乏有效的利用从而形成了一定的资源浪费;另外,废弃物在存放过程中会占用大量土地空间,其产生的降解物会造成(包括土壤和水体)严重的环境污染。如何实现这些废弃物的再利用,保护海洋生态环境、维护海洋资源的可持续发展是当今世界亟待解决的现实问题。
大量研究表明,这些海洋生物废弃物中含有种类丰富的生物活性成分,在生物材料、化工、食品、化妆品以及医药保健等领域具有较大的利用价值,分述如下:
一、贝类,例如牡蛎壳,其主要成分为碳酸钙(约占总重量的80-85%),另外含有少量的镁、铁、锌、铜、锶、硒等无机元素,以及微量的蛋白质、氨基酸、牛磺酸及多糖类等有机成分,具有补钙、保护胃粘膜,提高机体免疫力等保健功能。特别地,由于这种来自海洋生物的碳酸钙具有良好的生物相容性,能促进干细胞成骨分化,并能诱导新骨生成,因此一直都是骨骼仿生材料研究方面的热点。MountA.S.等科研人员于2004年在世界权威学术杂志Science上发表研究论文指出:牡蛎壳的形成与人体骨盐的沉积有高度相似性,且目前的研究也已证实牡蛎壳粉末对机体没有明显的细胞毒性和遗传毒性,从而为其作为骨替代材料的研发提供了可靠的科学依据。除此,传统中医药对牡蛎壳也有一定的认识和利用,《神农本草经》记载:牡蛎壳味咸、涩,性微寒,具有镇惊安神、收敛固涩的作用,可减轻表卫不固引起的自汗、盗汗现象。明代《普济方》也载:“蛎壳研粉水飞,蜜丸服,并食蛎肉,治面色黧黑,洁肤美容”,因此美容、护肤相关产品研发的市场潜力巨大。
二、虾、蟹壳,与牡蛎壳相似的是同样含有丰富的矿物质、多聚糖、蛋白质和脂肪酸。虾壳中的虾青素是一种天然的色素,具有极强的抗氧化作用,可清除体内自由基,因此具有一定的保健功能;而虾、蟹壳中的甲壳素则具有抗肿瘤、抗感染、降压和降糖等功效。目前,含有虾青素和壳聚糖成分的功能保健食品已获得较好的市场认同,但虾、蟹壳废弃物相关附加值产品仍有广泛的开发前景和市场需求。
三、鱼皮,其所含胶原蛋白在食品、美容化妆品和生物材料等行业应用广泛。胶原蛋白具有多种生物活性,包括降低血压,抗氧化、促进皮肤代谢、降低胆固醇,延缓衰老和预防骨质疏松症等。另外,鱼皮胶原蛋白具有一定的凝胶性、高度分散性、低粘度性、吸水性及乳化性等特点,胶原结合间充质干细胞用于软骨缺损修复则可实现透明软骨修复。相比牛皮胶原水凝胶在安全性和力学性方面尚存在一定的不确定性,鱼皮胶原水凝胶则有可能成为实用性更强的软骨修复材料。
基于上述分析,本申请人将以贝壳、虾蟹壳、鱼皮等大宗海洋生物废弃物为原材料,通过现代化的材料制备技术、先进的食品医药研究方法和化学工艺,对其天然有效成分进行分离、纯化和鉴定;通过技术革新和工艺优化,使海洋生物废弃物“变废为宝”,最终实现产品开发和产业化输出,并在终端市场形成核心竞争力。既能提高我国大宗海洋生物废弃物的产品附加值;还能降低海洋生物废弃物的环境污染风险。进一步地,以国家新型战略产业——生物制造业的创制为契机,通过提升海洋生物废弃物综合利用的关键技术,实现“废弃物”资源合理以及高值化的利用,并形成新的经济增长点,从而促进我国水产品加工产业链的可持续性发展。
另外,广西中药和民族药资源优势显著,广大人们对新的抗衰老又抗骨质疏松的医药产品和健康产品的需求十分迫切,而将海洋资源和大宗海洋生物废弃物结合广西中药和民族药资源来开发新的抗衰老又抗骨质疏松的医药和健康产品又十分缺乏。
发明内容
本发明的目的在于克服现有技术存在的缺陷,提供一种抗衰老、防治骨质疏松的中药组合物及其制剂。
为了实现上述目的,本发明采用的技术方案如下:
本发明的抗衰老、防治骨质疏松的中药组合物,由如下重量份的原料制备而成的:海洋生物废弃物30-90份、牡蛎肉20-60份、葛根50-150份、金花茶叶25-75份、金银花或山银花25-70份、菊花10-30份、玳玳花10-30份、槐花10-30份、茉莉花15-45份;所述的海洋生物废弃物为贝壳、虾壳、蟹壳、龟壳、鱼骨、鱼皮中的两种或两种以上的混合物。
优选地,由如下重量份的原料制备而成的:牡蛎肉30-40份、海洋生物废弃物65-80份、葛根75-100份、金花茶叶40-55份、金银花或山银花45-60份、菊花15-20份、玳玳花15-20份、槐花15-20份、茉莉花25-35份;所述的海洋生物废弃物为贝壳和鱼皮的混合物。
优选地,由如下重量份的原料制备而成的:海洋生物废弃物60份、牡蛎肉40份、金花茶叶50份、金银花或山银花50份、菊花20份、槐花20份、葛根100份;所述的海洋生物废弃物为贝壳。
以下是本发明中药组合物的药材来源:
牡蛎壳,为牡蛎科动物长牡蛎Ostrea gigas Thunberg、大连湾牡蛎Ostreatalienwhanensis Crosse或近江牡蛎Ostrea rivularis Gould的贝壳。咸,微寒。重镇安神,潜阳补阴,软坚散结。用于惊悸失眠,眩晕耳鸣,瘰疬痰核,症瘕痞块。煅牡蛎收敛固涩。用于自汗盗汗,遗精崩带,胃痛吞酸。
牡蛎肉,为牡蛎科动物近江牡蛎、长牡蛎、大连湾牡蛎、密鳞牡蛎等的肉。味甘、咸;性平。可养血安神,软坚消肿。用于烦热失眠,悯神不安,瘰疬。
金花茶叶,为金花茶Camellia nitidissima C.W.Chi的叶子,微苦;涩;平。可清热解毒,止痢。用于痢疾;疮疡。
金银花,为忍冬科植物忍冬Lonicerajaponica Thunb.、红腺忍冬Lonicerahypoglauca Miq.或毛花柱忍冬Lonicera dasystyla Rehd.的干燥花蕾或带初开的花。甘,寒。可清热解毒,凉散风热。用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
山银花,为忍冬科植物灰毡毛忍冬Lonicera macranthoidesHand.-Mazz.、红腺忍冬Lonicera hypoglauca Miq.、华南忍冬Lonicera con fusa DC.成黄褐毛忍冬Lonicerafulv。tome"tosa Hsu et S.C.Cheng的干燥花蕾或带初开的花。甘,寒。清热解毒,疏散风热。用于痈肿疗疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
菊花,为菊科植物菊Chrysanthemum morifolium Ramat.的干燥头状花序。甘、苦,微寒。可散风清热,平肝明目。用于风热感冒,头痛眩晕,目赤肿痛,眼目昏花。
玳玳花,为芸香利植物玳玳花的花蕾。拉丁名为Citrus aurantium L.var.amaraEngl.[C.aurantium‘Daidai’],别名枳壳花,代代花,酸橙花等。甘,微苦。可理气宽胸,和胃止呕,用于胸中痞闷,脘腹胀痛,不思饮食,恶心呕吐,少食。
槐花,拉丁名为Sophorajaponica Linn,又名洋槐花,槐属,苦,平,无毒。可清热、凉血、止血、降压的功效,用于吐血、尿血、痔疮出血、风热目赤、高血压病、高脂血症、颈淋巴结核、血管硬化、大便带血、糖尿病、视网膜炎、银屑病;还可以驱虫、治咽炎。槐花能增强毛细血管的抵抗力,减少血管通透性,可使脆性血管恢复弹性的功能,从而降血脂和防止血管硬化。
茉莉花,为木犀科植物茉莉的花。辛甘,温。可理气,开郁,辟秽,和中。治下痢腹痛,结膜炎,疮毒。
葛根,为豆科植物野葛Pueraria lobata(Willd.)Ohwi或甘葛藤Puerariathomsonii Benth.的干燥根。甘、辛,凉。可解肌退热,生津,透疹,升阳止泻。用于外感发热头痛、项背强痛,口渴,消渴,麻疹不透,热痢,泄泻;高血压颈项强痛。
本发明的另一目的是提供本发明中药组合物的活性成分的制备方法,该方法是将葛根、金花茶叶、金银花或山银花、菊花、玳玳花、槐花和茉莉花采用水提或40-70%体积百分浓度的乙醇提取后,再与海洋生物废弃物和牡蛎肉的粉末混合制备而成。具体制备方法如下:
方案一:将原料中的植物原料混合后加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.10-1.20的清膏;将牡蛎肉和海洋生物废弃物磨成粉末,过300-800目筛,与清膏混合均匀,即得活性成分。
方案二:将原料中的植物原料混合后用40-70%乙醇回流提取2-3次,每次乙醇用量为药材总量的4-10倍,提取时间为1-4小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.05-1.20的清膏;将牡蛎肉和海洋生物废弃物磨成粉末,过300-800目筛,与清膏混合均匀,即得活性成分。
方案三:将原料中的植物原料混合后用40-70%乙醇回流提取2-3次,每次乙醇用量为药材总量的4-10倍,提取时间为1-4小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.05-1.20的清膏;将牡蛎肉和海洋生物废弃物磨成粉末,过300-800目筛,与清膏混合均匀,即得活性成分。
本发明所述的抗衰老、防治骨质疏松的中药组合物,还可以与医药学上可接受的载体配合,制成各种制剂,如片剂、胶囊剂、口服液、糖浆剂、合剂、颗粒剂、散剂等。此外,还可与食品工程上可接受的载体配合,制成功能性保健饮料。
本发明的药学上可接受的载体包括但不限于以下:
稀释剂:淀粉、糖粉、乳糖、糊精、微晶纤维素、无机盐、糖醇类等。
润湿剂与粘合剂:纯化水、乙醇、明胶、聚乙二醇、纤维素衍生物等。
崩解剂:淀粉、羧甲基淀粉钠、纤维素衍生物、交联聚维酮等。
润滑剂:硬脂酸镁、微粉硅胶、滑石粉、聚乙二醇等。
助溶剂:水、乙醇、甘油、丙二醇、液状石蜡、植物油等。
矫味剂:蔗糖、单糖、芳香剂等。
防腐剂:苯甲酸、山梨酸、甲酯、乙酯、丙酯等。
本发明的食品工程上可接受的载体包括但不限于以下:
助溶剂:水、乙醇、甘油、丙二醇、液状石蜡、植物油等。
矫味剂:蔗糖、单糖、芳香剂等。
防腐剂:苯甲酸、山梨酸、甲酯、乙酯、丙酯等。
方法1:片剂
取方案一至方案三所得活性成分之一,加入片剂常用辅料,按常规生产方法制备得本发明片剂。
上述片剂常用辅料包括稀释剂、润湿剂、粘合剂、崩解剂、润滑剂之一或全部。
方法2:胶囊剂
取方案一至方案三所得活性成分之一,加入胶囊剂常用辅料,按常规生产方法制备得本发明胶囊剂。
上述胶囊剂常用辅料包括稀释剂、润湿剂、粘合剂、崩解剂、润滑剂之一或全部。
方法3:糖浆剂
取方案一至方案三所得活性成分之一,加入糖浆剂常用辅料,按常规生产方法制备得本发明糖浆剂。
上述糖浆剂常用辅料包括矫味剂、防腐剂、助溶剂之一或全部。
方法4:合剂
取方案一至方案三所得活性成分之一,加入合剂常用辅料,按常规生产方法制备得本发明合剂。
上述合剂常用辅料包括矫味剂、防腐剂之一或全部。
方法5:口服液
取方案一至方案三所得活性成分之一,溶解后净化、浓缩,加入口服液常用辅料,按常规生产方法制备得本发明口服液。
上述口服液常用辅料包括矫味剂、防腐剂、助溶剂之一或全部。
方法6:颗粒剂
取方案一至方案三所得活性成分之一,加入颗粒剂常用辅料,按常规生产方法制备得本发明颗粒剂。
上述颗粒剂常用辅料包括稀释剂、润湿剂、粘合剂、崩解剂、润滑剂之一或全部。
方法7:功能性保健饮料
取方案一至方案三所得活性成分之一,加入保健饮料的常用辅料,按常规生产方法制备得本发明的功能性保健饮料。
上述保健饮料常用辅料包括助溶剂、矫味剂、防腐剂之一或全部。
方法8:散剂
将全部原材料分别烘干后磨成粒径为500-1000目的颗粒,混合均匀,得到抗衰老、防治骨质疏松的散剂。
本申请人结合传统中医辨证治疗和现代药理研究成果,其一,遵循中医药的君臣佐使理论,结合壮医药的排毒理论,针对海洋生物废弃物,精选金花茶叶、金银花(或者山银花)、菊花、玳玳花、槐花、茉莉花和葛根等配伍,经现代工艺制备而成。牡蛎壳等贝类、蟹壳、虾壳等海洋生物废弃物中的生物活性钙、矿物质、生物活性多糖和多肽等,强壮和补虚,为君药;金花茶叶、金银花、菊花、玳玳花、槐花、茉莉花等清热解毒,强心活血,逐瘀通脉,利尿排汗等功效,牡蛎肉养血安神,软坚消肿,为臣药;葛根富含葛根黄酮、葛根多糖等,促进人体吸收钙和矿物质等,又养心脉,调和诸药药性和偏性,为佐使药。其二,本发明的中药组合物还包含壮医排毒、解毒、调补三重含义,遵循“补泄兼施,通补结合”的原则,在补的基础上解毒和排毒,使三道两路排毒管道通畅,毒有出路,打通人体的各路排毒管道,通过“通补结合”等升降得宜的精妙处方之间的配伍,调理人体紊乱的代谢和失调的内分泌,调节机体状态平衡,使脏腑功能活动正常,气血流畅,排出陈毒。其三,现代药理学研究表明,该组合物富含生物活性钙、微量元素及矿物质、活性多糖、活性多肽、氨基酸等,还有虾青素、甲壳素、胶原蛋白、菊花苷、绿原酸、多酚黄酮类等生物活性成分,有补钙,补充微量元素及矿物质,促进干细胞成骨分化、诱导新骨生成、增强骨密度;促进皮肤代谢,改善心脑血管功能,改善胃肠道功能,排汗,利尿,提高免疫力,抗氧化,清除体内自由基及毒素,抗疲劳,抗肿瘤,抗菌抗病毒抗炎,降压降糖控脂等作用。
本发明由于采用了上述技术方案,具有以下有益效果:
1、本发明的中药组合物通过上述多成分多靶点协同机制,发挥健肾益脾、滋阴助阳、宁心安神、清肝明目、通脉排毒、调和脏腑、扶正驱邪等功效,可用于润肤养颜,强体补虚,延缓衰老;还可用于防治性功能低下、肠胃功能减退、骨质疏松等患者,标本兼治,作用平和,对人体无毒副作用和不良反应,安全。
2、本发明的中药组合物及其制剂经临床试验证明,对因早衰出现的各种症状的治愈率为23.33%,总有效率达到88.33%;对各类常见骨质疏松症的治愈率为22.06%,总有效率88.24%,治疗效果显著。且停药后病情不出现“反弹”,临床服用安全可靠,对于较低年龄段的人群同样适用。
3、本发明的中药组合物可制成多种制剂,易吸收,生物利用度高,方便满足不同病况的病患携带和服用。本发明的中药组合物把养颜、养骨和养心脑肾、养胃肝脾等结合,改善机体内环境,对于亚健康人群和健康人群也适用,四季皆宜,适用于各种体质的人群,也可用于运动职业者提高运动体力和耐力,脑力职业者改善或提高脑力和智力。且本发明的中药组合物及其制剂还可以促进胃肠道功能吸收,服用后不会便秘,对于胃肠道功能较弱的人群有较好的适应性。
4、本发明的中药组合物还适用于长期饮用纯净水的人群和偏食人群,改善其体质和内环境。纯净水进入人体后,因为它不含各种正负离子,所以溶解性能很强,这样不仅可以把各种有害废物和有害微量元素溶解,并排出体外。同时,也可以溶解人体非常需要的各种必需微量元素,而被排出体外。纯净水的分子结构,经过净水器处理后会发生重排现象,使纯水分子的结构变为极度串联和线团化,这种水分子,不易通过细胞膜,会导致身体内有益的生命相关元素向体外流失。有些敏感的人感觉越喝越渴,越渴越想喝。长期喝纯净水会感觉无力。这对正在长身体的青少年有比较突出的副作用。随着大量的水处理系统设备进入千家万户,本发明的中药组合物将给人们身体健康带来不可忽视的有益保护和帮助,减少骨质疏松发生,防止体质下降。
5、本发明的中药组合物及制剂有利于中老年人,尤其女性,保护和保持健康皮肤和容颜及机体活力。胶原蛋白缺乏症是指由于体内胶原蛋白流失造成人体组织器官衰老的一系列症状的总称。由于人体胶原蛋白流失造成的骨骼、关节、皮肤、血管、肠胃、眼睛、指甲和肌肉等组织器官的衰老的症状。本发明的中药组合物及制剂为人们提供了一种较安全、成效较高、不引起发胖等的补充胶原蛋白的方式。本发明的中药组合物及制剂可对抗中年人代谢缓慢,脂肪堆积、呈酸性体质、而容易疲惫、饮酒后不适、易发糖尿病、高血压、导致肝脏、肾脏衰弱等趋势。本发明的中药组合物及制剂可预防颈椎肌肉硬桔,颈椎病,脑供血不足,腰酸背痛,肩部酸麻,结缔块,乳酸堆积后,压迫神经系统,阻碍神经反射区,肌肉收缩差,失去活力,肌肉无提拉力,肌肉张力下降,呈八字下垂趋势;预防人体腹腔压力下降,脏器下垂,胃下垂,心肌泵血不足,避免出现腰腹部增大,胀气等,肝脏排毒出现异常,胆结石,口苦,分泌吸收能力差,糖尿病,刢造血功能弱,不平衡时出现恶性贫血,身体机能下降等现象;可预防淋巴循环缓慢而导致免疫下降,易感染流行疾病,肌肉酸疼,减体乏无力等症状;可预防体能特征变得不明显,闭经,月经量少,月经紊乱,提前进入更年期,发育不良,乳房松弛下垂,乳腺增生,易引起乳腺癌,易引起男性化,男性阳痿,早泄,男性特征不明显;可预防子宫脱垂,尿失禁、卵巢萎缩;生殖系统免疫力低、习惯性流失等。由于女性阴道条锁状肌肉组织、子宫的肌肉组织、卵巢的包膜都含有大量的胶原蛋白。女性经期子宫内膜脱落使胶原蛋白大量流失,40岁的女性胶原蛋白流失比率是男性的2.5倍;可预防绝经后骨质疏松。骨密度(BMD)是诊断骨质疏松的标准,BMD低于绝经前女性绝对值2.5个标准差或以上称之,由其所致的严重并发症中,在髋部骨折中有12%~14%的人于骨折后1年内死于循环、呼吸、消化等系统的各种并发症,存活者中50%行动不便。本发明的中药组合物及制剂不仅给中老年人,且给各年龄段的广大女性维护和保持年轻态和健康提供了极佳的帮助和选择。
6、本发明的中药组合物及其制剂配方科学合理,原料来源广泛,制备方法易行,制备成本较低,品质稳定性较高,可大大减轻患者的身体和经济负担,成为我国应对老龄化社会,给人们治未病,抗衰老同时防治骨质疏松提供又一种良佳选择,经济前景可观,具有很大的推广价值。
7、本发明利用贝壳、虾壳、蟹壳、龟壳、鱼骨、鱼皮等海洋生物废弃物进行废物利用,既有效利用了海洋资源,又解决了此类废弃物的存放问题,避免废弃物在降解过程产生的降解物对土壤、水体的污染,本发明对保护海洋生态环境、维护海洋资源的可持续发展、提高我国在海洋生物废弃物应用领域在国际上的影响力有着深远的意义。
具体实施方式
为使本发明的目的、技术方案及优点更加清楚明白,以下举出优选实施例,对本发明进一步详细说明。然而,需要说明的是,说明书中列出的许多细节仅仅是为了使读者对本发明的一个或多个方面有一个透彻的理解,即便没有这些特定的细节也可以实现本发明的这些方面。除非另有说明,本发明中的乙醇量的百分数是体积百分数,v/v表示溶液的体积比。
实施例1片剂
取牡蛎肉20kg、牡蛎壳10kg、鱼皮10kg、葛根50kg、金花茶叶25kg、金银花25kg、菊花10kg、玳玳花10kg、槐花10kg、茉莉花15kg;
将葛根、金花茶叶、金银花、菊花、玳玳花、槐花和茉莉花混合后加水提取2次,每次加水量相当于药材总重量的12倍、10倍,两次提取时间分别为3小时、2小时,合并提取液,过滤,滤液浓缩70℃时相对密度为1.10的清膏,备用;将牡蛎肉、牡蛎壳和鱼皮磨成粉末,过300目筛,与清膏混合均匀,再加入片剂辅料糊精、滑石粉、羧甲基淀粉钠、纤维素衍生物,按常规方案制得片剂。
实施例2片剂
取牡蛎肉23kg、虾壳12kg、蟹壳22kg、葛根55kg、金花茶叶30kg、金银花38kg、菊花12kg、玳玳花11kg、槐花12kg、茉莉花18kg;
将葛根、金花茶叶、金银花、菊花、玳玳花、槐花和茉莉花混合后用40%乙醇回流提取3次,每次乙醇用量为药材总量的10倍、8倍、6倍,三次提取时间分别为4小时、2小时、1小时,合并提取液,过滤,滤液浓缩至70℃时相对密度为1.05的清膏;将牡蛎肉、虾壳和蟹壳磨成粉末,过300目筛,与清膏混合均匀,再加入片剂辅料糖粉、淀粉、聚乙二醇、滑石粉、纤维素衍生物,按常规方案制得片剂。
实施例3胶囊剂
取牡蛎肉26kg、龟壳10kg、鱼皮17kg、鱼骨12kg、葛根60kg、金花茶叶45kg、金银花35kg、菊花14kg、玳玳花12kg、槐花13kg、茉莉花20kg;
将葛根、金花茶叶、金银花、菊花、玳玳花、槐花和茉莉花混合后加水提取2次,每次加水量相当于药材总重量的12倍、8倍,每次提取时间分别为3小时、2小时,合并提取液,过滤,滤液浓缩至70℃时相对密度为1.10的清膏,加入乙醇,使含醇量为40%,静置12小时,过滤,滤液浓缩至70℃时相对密度为1.05的浸膏;将牡蛎肉、龟壳、鱼皮和鱼骨磨成粉末,过300目筛,与浸膏混合均匀,再加入胶囊剂辅料淀粉、乙醇、硬脂酸镁,按常规方案制得胶囊剂。
实施例4胶囊剂
取牡蛎肉28kg、牡蛎壳15kg、蟹壳14kg、鱼骨14kg、葛根68kg、金花茶叶37kg、金银花53kg、菊花15kg、玳玳花14kg、槐花14kg、茉莉花23kg;
将葛根、金花茶叶、金银花、菊花、玳玳花、槐花和茉莉花混合后加水提取3次,每次加水量相当于药材总重量的10倍、8倍、6倍,每次提取时间分别为3小时、2小时、1小时,合并提取液,过滤,滤液浓缩74℃时相对密度为1.15的清膏;将牡蛎肉、牡蛎壳、蟹壳和鱼骨磨成粉末,过600目筛,与清膏混合均匀,再加入胶囊剂辅料羧甲基淀粉钠、微晶纤维素、微粉硅胶、聚乙二醇,按常规方案制得胶囊剂。
实施例5糖浆剂
取牡蛎肉30kg、虾壳20kg、蟹壳14kg、龟壳7kg、鱼皮14kg、葛根75kg、金花茶叶40kg、金银花61kg、菊花15kg、玳玳花15kg、槐花15kg、茉莉花25kg;
将葛根、金花茶叶、金银花、菊花、玳玳花、槐花和茉莉花混合后用50%乙醇回流提取3次,每次乙醇用量为药材总量的8倍、6倍、4倍,每次提取时间分别为3小时、2小时、1小时,合并提取液,过滤,滤液浓缩至77℃时相对密度为1.10的清膏;将牡蛎肉、虾壳、蟹壳、龟壳和鱼皮磨成粉末,过500目筛,与清膏混合均匀,再加入糖浆剂辅料单糖、山梨酸及水搅拌均匀,制得糖浆剂。
实施例6合剂
取牡蛎肉33kg、虾壳26kg、蟹壳26kg、葛根83kg、金花茶叶45kg、金银花68kg、菊花16kg、玳玳花17kg、槐花17kg、茉莉花28kg;
将葛根、金花茶叶、金银花、菊花、玳玳花、槐花和茉莉花混合后加水提取3次,每次加水量相当于药材总重量的10倍、8倍、6倍,每次提取时间分别为3小时、2小时、1小时,合并提取液,过滤,滤液浓缩至75℃时相对密度为1.15的清膏,加入乙醇,使含醇量为55%,静置18小时,过滤,滤液浓缩至74℃时相对密度为1.10的浸膏;将牡蛎肉、虾壳和蟹壳磨成粉末,过600目筛,与浸膏混合均匀,再加入合剂辅料蔗糖、苯甲酸,搅拌均匀,制得合剂。
实施例7口服液
取牡蛎肉37kg、龟壳30kg、鱼皮27kg、葛根90kg、金花茶叶48kg、金银花75kg、菊花18kg、玳玳花18kg、槐花19kg、茉莉花30kg;
将葛根、金花茶叶、金银花、菊花、玳玳花、槐花和茉莉花混合后加水提取3次,每次加水量相当于药材总重量的10倍、7倍、6倍,每次提取时间分别为3小时、1小时、1小时,合并提取液,过滤,滤液浓缩80℃时相对密度为1.20的清膏;将牡蛎肉、龟壳和鱼皮磨成粉末,过800目筛,与清膏混合均匀,再加入口服液辅料山梨酸、甲酯、水搅拌均匀,分装,制得口服液。
实施例8颗粒剂
取牡蛎肉38kg、鱼骨25kg、鱼皮27kg、牡蛎壳10kg、葛根96kg、金花茶叶53kg、山银花25kg、菊花19kg、玳玳花20kg、槐花19kg、茉莉花33kg;
将葛根、金花茶叶、山银花、菊花、玳玳花、槐花和茉莉花混合后用70%乙醇回流提取2次,每次乙醇用量为药材总量的6倍、4倍,提取时间分别为2小时、1小时,合并提取液,过滤,滤液浓缩至80℃时相对密度为1.20的清膏;将牡蛎肉、鱼骨、鱼皮和牡蛎壳磨成粉末,过800目筛,与清膏混合均匀,再加入辅料乳糖、明胶、淀粉、微晶纤维素,制粒、干燥、整粒,制得颗粒剂。
实施例9颗粒剂
取牡蛎肉40kg、鱼骨16kg、龟壳30kg、牡蛎壳29kg、葛根100kg、金花茶叶55kg、山银花32kg、菊花20kg、玳玳花20kg、槐花20kg、茉莉花35kg;
将葛根、金花茶叶、山银花、菊花、玳玳花、槐花和茉莉花混合后加水提取2次,每次加水量相当于药材总重量的12倍、6倍,每次提取时间为3小时、2小时,合并提取液,过滤,滤液浓缩至80℃时相对密度为1.20的清膏,加入乙醇,使含醇量为70%,静置24小时,过滤,滤液浓缩至80℃时相对密度为1.20的浸膏;将牡蛎肉、鱼骨、龟壳和牡蛎壳磨成粉末,过800目筛,与浸膏混合均匀,再加入辅料糊精、水、聚乙二醇、交联聚维酮,制粒、干燥、整粒,制得颗粒剂。
实施例10
取牡蛎肉45kg、鱼骨15kg、虾壳42kg、鱼皮15kg、葛根110kg、金花茶叶57kg、山银花40kg、菊花22kg、玳玳花21kg、槐花23kg、茉莉花38kg;
将葛根、金花茶叶、山银花、菊花、玳玳花、槐花和茉莉花混合后加水提取3次,每次加水量相当于药材总重量的10倍、8倍、7倍,每次提取时间分别为3小时、1小时、1小时,合并提取液,过滤,滤液浓缩78℃时相对密度为1.18的清膏;将牡蛎肉、鱼骨、虾壳和鱼皮磨成粉末,过800目筛,与清膏混合均匀,再加入饮料辅料水、蔗糖、苯甲酸,搅拌均匀,分装,制得抗衰老、防治骨质疏松的功能性保健饮料。
实施例11
取牡蛎肉50kg、龟壳30kg、鱼皮45kg、葛根122kg、金花茶叶60kg、山银花48kg、菊花24kg、玳玳花23kg、槐花25kg、茉莉花40kg;
将葛根、金花茶叶、山银花、菊花、玳玳花、槐花和茉莉花混合后用65%乙醇回流提取2次,每次乙醇用量为药材总量的6倍、5倍,提取时间分别为2小时、1.5小时,合并提取液,过滤,滤液浓缩至78℃时相对密度为1.15的清膏;将牡蛎肉、龟壳和鱼皮磨成粉末,过600目筛,与清膏混合均匀,再加入饮料辅料水、芳香剂、山梨酸,搅拌均匀,分装,制得抗衰老、防治骨质疏松的功能性保健饮料。
实施例12
取牡蛎肉55kg、鱼骨40kg、鱼皮40kg、葛根135kg、金花茶叶66kg、山银花56kg、菊花26kg、玳玳花25kg、槐花27kg、茉莉花42kg;
将葛根、金花茶叶、山银花、菊花、玳玳花、槐花和茉莉花混合后加水提取2次,每次加水量相当于药材总重量的12倍、10倍,每次提取时间为2小时、2小时,合并提取液,过滤,滤液浓缩至80℃时相对密度为1.20的清膏,加入乙醇,使含醇量为70%,静置24小时,过滤,滤液浓缩至80℃时相对密度为1.20的浸膏;将牡蛎肉、鱼骨和鱼皮磨成粉末,过700目筛,与浸膏混合均匀,再加入饮料辅料水、单糖、甲酯,搅拌均匀,分装,制得抗衰老、防治骨质疏松的功能性保健饮料。
实施例13散剂
取牡蛎肉60kg、鱼骨43kg、虾壳41kg、葛根140kg、金花茶叶71kg、山银花62kg、菊花28kg、玳玳花27kg、槐花28kg、茉莉花43kg;将上述材料分别烘干后磨成粒径为500目的颗粒,混合均匀,得到抗衰老、防治骨质疏松的散剂。
实施例14散剂
取牡蛎肉53kg、牡蛎壳45kg、虾壳25kg、鱼皮18kg、葛根146kg、金花茶叶73kg、山银花70kg、菊花29kg、玳玳花28kg、槐花29kg、茉莉花45kg;将上述材料分别烘干后磨成粒径为700目的颗粒,混合均匀,得到抗衰老、防治骨质疏松的散剂。
实施例15
取牡蛎肉60kg、牡蛎壳40kg、葛根100kg、金花茶叶50kg、山银花75kg、菊花20kg、槐花20kg;将上述材料分别烘干后磨成粒径为700目的颗粒,混合均匀,得到抗衰老、防治骨质疏松的散剂。
临床试验总结一
1、基本资料
选择60例具有牙齿动摇、听力明显下降、面憔无华、腰膝酸软、疲倦乏力、动作反应迟缓、头晕眼花、盗汗、口干咽燥、老年斑等症状的中老年,其中男性34人,女性26人,年龄最大78岁,最小50岁。排除妊娠及哺乳期妇女,对本药过敏者、严重心肺功能障碍、非冠心病性心脏病、肾脏疾病、高血压、胃病者。
2、诊断标准
参照临床诊断标准,并以症状分轻、中、重度。
3、治疗方法
使用本发明实施例4的胶囊剂给予治疗,每天2次,每次5g,30天为一疗程。
4、疗效判断标准
治愈:症状消失。
显效:症状基本消失。
有效:主要症状有所缓解。
无效:症状无任何改善,基本与治疗前相同,或者症状程度及持续时间有所加重。
5、结果
经过三个疗程的治疗,临床疗效见表1。
表1治疗效果
治愈/例 | 显效/例 | 有效/例 | 无效/例 | 治愈率/% | 总有效率/% |
14 | 23 | 16 | 7 | 23.33 | 88.33 |
从表1可以看出,60例中老年经过三个疗程的治疗,治愈14例,治愈率为23.33%,显效23例,有效16例,总有效率达到88.33%,说明本发明实施例提供的抗衰老、防治骨质疏松的中药组合物能有效延缓衰老,改善因衰老产生的牙齿动摇、头发斑白、听力下降、面憔无华、腰膝酸软、疲倦乏力、动作反应迟缓、头晕眼花、盗汗、口干咽燥、精神不振、性欲减退、老年斑等衰老症状。
临床试验总结二
1、基本资料
选择68例骨质疏松者,其中男性30人,女性38人,年龄最大72岁,最小45岁,老年期年龄≥60岁,老年前期45-59岁。排除妊娠及哺乳期妇女,对本药过敏者、严重心肺功能障碍、非冠心病性心脏病、肾脏疾病、高血压、胃病、甲状腺功能亢进、糖尿病、类风湿、多发性骨髓瘤等继发性骨质疏松患者。
2诊断标准
参照卫生部药政局1993年颁布的《新药(中药)临床研究技术指导原则》及1986年郑州会议制定的《中医虚证辩证参考标准》制定。
3治疗方法
使用本发明实施例9的颗粒剂给予治疗,每天2次,每次5g,30天为一疗程。
4疗效判断标准
治愈:腰脊酸疼等症状消失,骨密度检查显示桡骨(尺骨)骨密度值上升0.059/cm2以上。
显效:腰脊酸疼等症状基本消失,骨密度检查显示桡骨(尺骨)骨密度值上升<0.059/cm2。
有效:腰脊酸疼等症状明显好转,骨密度检查显示桡骨(尺骨)骨密度增加。
无效:腰脊酸疼等症状无好转,骨密度检查无改变或继续下降。
5结果
经过三个疗程的治疗,临床疗效见表2。
表2治疗效果
治愈/例 | 显效/例 | 有效/例 | 无效/例 | 治愈率/% | 总有效率/% |
15 | 28 | 17 | 8 | 22.06 | 88.24 |
从表2可以看出,68例患者经过三个疗程的治疗,治愈15例,治愈率为22.06%,显效28例,有效17例,总有效率88.24%,可见本发明实施例提供的抗衰老、防治骨质疏松的中药组合物能有效防治骨质疏松症,提高人体骨密度。
典型病例
病例1:张XX,女,55岁。
患者近一年来常出现腰膝酸软,疲倦乏力,头晕眼花,盗汗等现象,夜间少眠多醒,睡眠质量差。服用本发明实施例1的片剂两个月余,上述症状消失,停药半年后未复发。
病例2:何X,男,62岁。
患者于五年前开始感觉牙齿动摇,腰膝酸软,夜间多盗汗,白天精神不振,服用本发明实施例5糖浆剂3个月,诸症减轻;再连服2个月巩固疗效,上述症状已消失,停药一年后未复发。
病例3:陈XX,男,65岁。
患者3年前体检时骨密度检查提示骨量低,无明显骨痛、骨折等症状,确诊为骨质疏松症。近期进行性加重,出现明显骨痛现象。服用本发明实施例7的口服液两个月,骨痛减轻;再连服三个月巩固疗效,骨痛消失,复检显示骨密度明显上升,停药18个月后骨痛未复发。
病例4:钱X,女,54岁。
患者主诉8年前出现间断性腰背痛,绝经八年,两年前因摔倒导致右尺骨骨折,骨科处理,一年前再次摔倒导致左腕骨骨折,骨科处理。经诊断确诊为绝经后骨质疏松症。服用本发明实施例6的合剂三个月,腰背痛症状显著缓解,复检骨密度上升,停药1年后腰背痛未复发。
Claims (10)
1.一种抗衰老、防治骨质疏松的中药组合物,其特征在于,由如下重量份的原料制备而成的:海洋生物废弃物30-90份、牡蛎肉20-60份、金花茶叶25-75份、金银花或山银花25-70份、菊花10-30份、玳玳花10-30份、槐花10-30份、茉莉花15-45份、葛根50-150份;所述的海洋生物废弃物为贝壳、虾壳、蟹壳、龟壳、鱼骨、鱼皮中的两种或两种以上的混合物。
2.根据权利要求1所述的抗衰老、防治骨质疏松的中药组合物,其特征在于,由如下重量份的原料制备而成的:海洋生物废弃物65-80份、牡蛎肉30-40份、金花茶叶40-55份、金银花或山银花45-60份、菊花15-20份、玳玳花15-20份、槐花15-20份、茉莉花25-35份、葛根75-100份;所述的海洋生物废弃物为贝壳和鱼皮的混合物。
3.根据权利要求2所述的抗衰老、防治骨质疏松的中药组合物,其特征在于,由如下重量份的原料制备而成的:海洋生物废弃物60份、牡蛎肉40份、金花茶叶50份、金银花或山银花50份、菊花20份、槐花20份、葛根100份;所述的海洋生物废弃物为贝壳。
4.根据权利要求1-3任一项所述的抗衰老、防治骨质疏松的中药组合物,其特征在于:它的活性成分是将原料中的植物原料混合,采用水提或40-70%体积百分浓度的乙醇提取后,再与牡蛎肉和海洋生物废弃物的粉末混合制备而成。
5.根据权利要求4所述的抗衰老、防治骨质疏松的中药组合物,其特征在于,它的活性成分是通过以下方法制备而成的:将原料中的植物原料混合后加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.10-1.20的清膏,将牡蛎肉和海洋生物废弃物混合后磨成粉末,过300-800目筛,与清膏混合均匀,即得活性成分。
6.根据权利要求4所述的抗衰老、防治骨质疏松的中药组合物,其特征在于,它的活性成分是通过以下方法制备而成的:将原料中的植物原料混合后用40-70%乙醇回流提取2-3次,每次乙醇用量为药材总量的4-10倍,提取时间为1-4小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.05-1.20的清膏,将牡蛎肉和海洋生物废弃物混合后磨成粉末,过300-800目筛,与清膏混合均匀,即得活性成分。
7.根据权利要求4所述的抗衰老、防治骨质疏松的中药组合物,其特征在于,它的活性成分是通过以下方法制备而成的:将原料中的植物原料混合后加水提取2-3次,每次加水量相当于药材总重量的6-12倍,每次提取时间为1-3小时,合并提取液,过滤,滤液浓缩至70-80℃时相对密度为1.10-1.20的清膏,加入乙醇,使含醇量为40-70%,静置12-24小时,过滤,滤液浓缩至70-80℃时相对密度为1.05-1.20的浸膏,将牡蛎肉和海洋生物废弃物混合后磨成粉末,过300-800目筛,与浸膏混合均匀,即得活性成分。
8.一种抗衰老、防治骨质疏松的中药制剂,根据权利要求1-3任一项所述的抗衰老、防治骨质疏松的中药组合物与医药学上可接受的载体配合制备而成。
9.一种抗衰老、防治骨质疏松的功能性保健饮料,根据权利要求1-3任一项所述的抗衰老、防治骨质疏松的中药组合物与食品工程上可接受的载体配合制备而成。
10.根据权利要求1-3任一项所述的抗衰老、防治骨质疏松的中药组合物,其特征在于,其制备方法包括如下步骤:将全部原材料分别烘干后磨成粒径为500-1000目的颗粒,混合均匀,得到抗衰老、防治骨质疏松的散剂。
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