CN108186717A - 具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物及其制备方法和应用 - Google Patents
具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物及其制备方法和应用 Download PDFInfo
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Abstract
具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物及其制备方法和应用，属于医药和食品技术领域，本发明按照重量份数计包括以下组份：梅花鹿鹿茸粉300～400份；补骨脂醇提取物100～200份；葛根醇提取物100～200份；黄瓜籽提取物50～150份。本发明对改善中老年人，特别是女性绝经后体内钙、磷平衡有促进作用，能补肾、续筋骨、调血脉，能改善腰背酸痛、足膝无力的症状。本发明具有纯天然、疗效确切、无毒副作用、服用方便、配方明确、成分清楚、质量易控制、对其他器官组织毒副作用小、可长期服用等特点，同时具有强身、健骨功能，对骨质疏松、骨折等疾病均有显著疗效。
Description
技术领域
本发明属于医药和食品技术领域，具体涉及一种具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物及其制备方法和应用。
背景技术
骨质疏松系多种原因引起的一种全身骨代谢障碍的疾病，以骨组织显微结构受损、骨矿成分和骨基质等比例不断减少、骨质变薄、骨小梁数量减少、骨脆性增加和骨折危险度升高为特点，最明显的特征即为骨密度降低。全球有相当大比例的人群被骨质疏松症所困扰，多发于绝经后女性和中老年人群。随着当代疾病谱的改变，世界卫生组织把骨质疏松症列为中老年三大疾病之一，在常见病中居第七位。引起此症的原因有多个方面，如年龄老化、器官生理功能退行性改变、性激素分泌减少、内分泌性的包括甲状腺素、胰岛素、胰岛素样生长因子(IGF)等分泌异常、营养性的包括蛋白质、维生素D等的缺乏以及肾脏功能损伤导致的骨质疏松等。目前，国内外治疗骨质疏松症的药物主要分为钙制剂、化学药和中成药三大类。钙制剂主要有葡萄糖酸钙、碳酸钙、氨基酸螯合钙等；化学药则包括维生素D类的骨化三醇、α-骨化醇等，雌激素类的乙烯雌酚、尼尔雌醇、甲基炔诺酮等，降钙素类的鲑鱼降钙素、鳗鱼降钙素等，二膦酸盐类的阿仑膦酸盐、唑来膦酸盐、帕米膦酸二钠、伊班膦酸盐等，以及其他选择性雌激素受体调节剂或激素替代疗法；中成药主要有仙灵骨葆胶。钙制剂和化学药虽然可以治疗骨质疏松，但具有一定的副作用，同时治标不治本，不能消除引起骨质疏松的因素。如补充维生素D时，当25-羟维生素D>150μg/L时可能会出现维生素D中毒，引起血钙过高，出现便秘、呕吐、头痛等症状，重者可致心律失常、肾衰竭等。再比如雌激素类药在有效抑制骨吸收,降低骨转换,增加骨密度的同时,还强烈的刺激乳房、子宫等其他组织，引起乳房癌和子宫出血。此外,服药后常见恶心,食欲不振等。因此,在美国等国家，已限制了雌激素治疗骨质疏松的长期应用。
随着社会经济的发展、人们生活水平的提高，食物消费正从温饱型向小康型过渡，人们对食品的数量和质量提出了更高的要求，保健食品应运而生。中国是一个文明古国，有着食疗和食养的悠久历史和传统，经过几千年的实践，积累了大量的养生保健经验，形成了大量的养生保健药方，建立了独特的保健食品科学。中医中药作为传统的医药卫生和养生文化，是我国保健食品研制的重要理论基础和有效的物质来源，同时，开发符合我国国情、具有中国特色的保健食品促进了民族产业和中医药现代化的不断发展。
国内医药专家普遍认为：与西药制剂相比，中药制剂和保健食品具有“多靶点、多效应”作用，适合长期服用，故中药类制剂和保健食品与作用单一的西药制剂相比更具优势。因此，开发安全性高、毒性低、功效确切的保健食品是十分必要的。
在本发明申请之前，未见由梅花鹿鹿茸粉、补骨脂醇提取物、葛根醇提取物、黄瓜籽提取物组成的组合物具有防治骨质疏松症的报道。
发明内容
为了得到活性成分明确的产品，本发明提供一种具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物及其制备方法和应用。
本发明为解决技术问题所采用的技术方案如下：
本发明的具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物，按照重量份数计包括以下组份：
梅花鹿鹿茸粉300～400份；
补骨脂醇提取物100～200份；
葛根醇提取物100～200份；
黄瓜籽提取物50～150份。
作为优选的实施方式，将该鹿茸补骨脂组合物与药用辅料混合后制成口服制剂，所述口服制剂为硬胶囊、软胶囊、片剂、颗粒剂、散剂或丸剂。
作为优选的实施方式，本发明的具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物，按照重量份数计包括以下组份：
梅花鹿鹿茸粉350份；
补骨脂醇提取物150份；
葛根醇提取物150份；
黄瓜籽提取物100份。
本发明还提供了一种具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物的制备方法，包括以下步骤：
步骤一、梅花鹿鹿茸，锯茸后，经煮炸干燥、粉碎后即得鹿茸粉；
步骤二、补骨脂用6～10倍量、40～70％乙醇提取2～3次，每次提取1～2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得补骨脂醇提取物；
步骤三、葛根用6～10倍量、60～80％乙醇提取2～3次，每次提取1～2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得葛根醇提取物；
步骤四、黄瓜籽用水煎煮提取2～3次，每次提取1～3小时，经过滤后将滤液浓缩、干燥、粉碎成细粉后即得黄瓜籽提取物；
步骤五、按照重量份将鹿茸粉、补骨脂醇提取物、葛根醇提取物、黄瓜籽提取物混合均匀即得鹿茸补骨脂组合物。
作为优选的实施方式，步骤二中，补骨脂用8倍量、50％乙醇提取。
作为优选的实施方式，步骤三中，葛根用8倍量、70％乙醇提取。
本发明的鹿茸补骨脂组合物可以应用在制备具有增加骨密度、防治骨质疏松症的产品上，所说的产品可以是药品或者保健食品。
本发明的有益效果是：
1、本发明对改善中老年人，特别是女性绝经后体内钙、磷平衡有促进作用，能补肾、续筋骨、调血脉，能改善腰背酸痛、足膝无力的症状。
2、本发明能显著提高骨密度和骨矿物质含量，具有显著的治疗骨质疏松的疗效。
3、本发明具有纯天然、疗效确切、无毒副作用、服用方便、配方明确、成分清楚、质量易控制、对其他器官组织毒副作用小、可长期服用等特点，同时具有强身、健骨功能，对骨质疏松、骨折等疾病均有显著疗效。
4、本发明以补肾为主，兼顾益肾阳滋肾阴，阴而不腻，阳而不燥，又合增益通达肌表筋骨气血之品，使补益肝肾达于病所，奏强筋壮骨之功。本病病起缓缓，治疗亦难图速效。
具体实施方式
本发明以骨质疏松症属肾虚、当以补肾为治则作基点，复查了文献上各补肾经典方，从中医补肾、强筋骨，西医补钙、补充胶原蛋白等不同的作用机制出发，结合近代对骨质疏松症的治疗经验，经拆方实验，几经筛选调整而成。本发明综合作用于机体，体现了联合用药的优势，达到了较好的预防和治疗骨质疏松症的效果。
本发明的一种具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物，按照重量份数计包括以下组份：
梅花鹿鹿茸粉300～400份；
补骨脂醇提取物100～200份；
葛根醇提取物100～200份；
黄瓜籽提取物50～150份。
本发明由梅花鹿鹿茸粉、补骨脂醇提取物、葛根醇提取物、黄瓜籽提取物经加工工艺制备而成，本发明诸药药性平和、从容，取效而缓图亦符合本病当长期用药才能评价疗效的原则，充分利用了其中各成份的相互协同作用。本发明的鹿茸补骨脂组合物与药用辅料混合后可以制成口服制剂，如硬胶囊、软胶囊、片剂、颗粒剂、散剂、丸剂、袋泡茶、药酒。本发明的鹿茸补骨脂组合物可应用在制备具有增加骨密度、防治骨质疏松症产品上，例如药品或保健食品，具有防治骨质疏松的作用。
本发明鹿茸补骨脂组合物中，不同的药物作用机理不同，而且又相互协同，增强了疗效，具有突出的实质性特点和显著的进步。
本发明鹿茸补骨脂组合物中，鹿茸味甘、咸，性温，归肾、肝经，具有壮肾阳、益精血、强筋骨的功效，用于治疗虚劳羸瘦、精神倦乏、腰膝酸痛、阳痿滑精、子宫虚冷等症。
本发明鹿茸补骨脂组合物中，补骨脂为豆科植物补骨脂的干燥成熟果实，味辛、苦，性温，归肾、脾经，具有温肾助阳，纳气止泻的功效，用于阳痿遗精、腰膝冷痛、肾虚作喘、五更泄泻。
本发明鹿茸补骨脂组合物中，葛根，为豆科植物野葛或甘葛藤的干燥根，味甘、辛，性凉，归脾、胃经，具有解肌退热，生津透疹，升阳止泻的功效，用于外感发热头痛、项背强痛、消渴，麻疹不透，热痢泄泻等症。
本发明鹿茸补骨脂组合物中，黄瓜籽，为葫芦科植物黄瓜的种子，味甘，性平，具有续筋接骨、祛风消痰、舒筋活络的功效，用于骨折筋伤、风湿痹痛、老年痰喘。诸药合用，共奏温补肾阳、填精益髓、强筋壮骨之功效。
本发明鹿茸补骨脂组合物的一个重要特点是组合物中蕴涵了大量促进成骨细胞增殖、抑制破骨细胞、抑制骨吸收、提高骨密度、调节骨重建、提高机体免疫水平、抗疲劳、抗氧化和消除氧自由基等的化学成分。通过梅花鹿鹿茸中的胶原蛋白、多肽和钙质，黄瓜籽中的多肽和多种矿质元素，葛根中的葛根素等黄酮类以及补骨脂中的补骨脂素类等活性成分的相互协同、多靶点、多途径作用，从根本上全面调节骨质疏松人群的机体，改善其骨质疏松症状。
本发明还提供了一种具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物的制备方法，具体包括以下步骤：
步骤一、梅花鹿鹿茸，锯茸后，经煮炸干燥、粉碎后即得鹿茸粉；
步骤二、补骨脂用6～10倍量、40～70％乙醇提取2～3次，每次提取1～2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得补骨脂醇提取物；
步骤三、葛根用6～10倍量、60～80％乙醇提取2～3次，每次提取1～2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得葛根醇提取物；
步骤四、黄瓜籽用水煎煮提取2～3次，每次提取1～3小时，经过滤后将滤液浓缩、干燥、粉碎成细粉后即得黄瓜籽提取物；
步骤五、按照重量份将鹿茸粉、补骨脂醇提取物、葛根醇提取物、黄瓜籽提取物混合均匀即得鹿茸补骨脂组合物。
以下结合实施例对本发明作进一步详细说明。
实施例1鹿茸补骨脂组合物的制备
(1)梅花鹿鹿茸，锯茸后，经煮炸干燥、粉碎后即得鹿茸粉；
(2)补骨脂用8倍量、50％乙醇提取2次，每次提取1小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得补骨脂醇提取物；
(3)葛根用8倍量、70％乙醇提取3次，每次提取2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得葛根醇提取物；
(4)黄瓜籽用水煎煮提取2次，每次提取2小时，经过滤后将滤液浓缩、干燥、粉碎成细粉后即得黄瓜籽提取物；
(5)按照重量份，将350份鹿茸粉、150份补骨脂醇提取物、150份葛根醇提取物、100份黄瓜籽提取物混合均匀即得鹿茸补骨脂组合物。
实施例2鹿茸补骨脂组合物的制备
(1)梅花鹿鹿茸，锯茸后，经煮炸干燥、粉碎后即得鹿茸粉；
(2)补骨脂用6倍量、40％乙醇提取3次，每次提取2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得补骨脂醇提取物；
(3)葛根用10倍量、60％乙醇提取2次，每次提取1小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得葛根醇提取物；
(4)黄瓜籽用水煎煮提取3次，每次提取1小时，经过滤后将滤液浓缩、干燥、粉碎成细粉后即得黄瓜籽提取物；
(5)按照重量份，将300份鹿茸粉、100份补骨脂醇提取物、200份葛根醇提取物、50份黄瓜籽提取物混合均匀即得鹿茸补骨脂组合物。
实施例3鹿茸补骨脂组合物的制备
(1)梅花鹿鹿茸，锯茸后，经煮炸干燥、粉碎后即得鹿茸粉；
(2)补骨脂用10倍量、70％乙醇提取3次，每次提取1.5小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得补骨脂醇提取物；
(3)葛根用6倍量、80％乙醇提取2次，每次提取1.5小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得葛根醇提取物；
(4)黄瓜籽用水煎煮提取3次，每次提取2小时，经过滤后将滤液浓缩、干燥、粉碎成细粉后即得黄瓜籽提取物；
(5)按照重量份，将400份鹿茸粉、200份补骨脂醇提取物、100份葛根醇提取物、150份黄瓜籽提取物混合均匀即得鹿茸补骨脂组合物。
实施例4药效学实验
对缺钙大鼠抗骨质疏松症的治疗作用：主要考察本发明鹿茸补骨脂组合物对大鼠股骨骨指数及大鼠股骨骨密度的影响，对大鼠血清磷、血清钙的影响，对大鼠股骨骨灰分、骨钙、骨磷的影响。
本药效学实验主要是根据《保健食品功能学评价程序和检验方法规范》中增加骨密度功能检验方法中方案一进行。具体的实验过程如下：
将雌性大鼠(体重260～280g)随机分为6组，分别为对照组、模型组、阳性对照组和组合物给药组(设高、中、低三个组合物给药组)，每组10只。整个试验期，对照组均饲喂大鼠维持日粮。其余各组试验初始30天，均饲喂大鼠维持日粮，从31天开始饲喂低钙日粮(日粮中钙为40mg/100g饲料)。饲喂低钙日粮的同时，每隔3天肌肉注射地塞米松(1mg/Kg体重)1次。组合物给药组按400mg/kg，200mg/kg，100mg/kg高、中、低三个给药组给药(实施例1所得鹿茸补骨脂组合物)，每日一次，连续90天；阳性对照选用葡萄糖酸钙0.13mg/kg，每日一次，连续90天；对照组及模型组给与相应溶剂。试验期间，饮用去离子水以避免从饮水中获得钙。观察指标：给药结束处死动物，取血分离血清，按试剂盒方法测定S/Ca、S/P含量，取大鼠双侧股骨剥净肉及其他组织，其中一侧股骨在双能X线骨密度仪上做骨密度扫描，测出骨密度(g/cm2)，称股骨重(W)，测骨长(L)，110℃烘干1小时，再置马弗炉内200℃、400℃、600℃、800℃各灰化两小时，灰化结束，冷却称灰重(Wash)，用6N HNO3提取后，以原子吸收分光光度法测骨灰中Ca、P含量，以100g骨灰含钙离子或P的克数表示。以上结果均以给药组和模型组比较，模型组和对照组比较。实验结果见表1、2、3。
表1本组合物对大鼠股骨骨密度及大鼠股骨骨指数的影响
表2本组合物对大鼠血清钙、血清磷的影响
表3本组合物对大鼠股骨骨灰分、骨钙、骨磷的影响
通过上述实验证实，本发明的鹿茸补骨脂组合物对缺钙大鼠股骨骨密度、骨重、骨灰重、骨钙、骨磷均有显著影响，使其增加，而对骨长度没有影响，使血清钙有所提高，对血清磷影响较小。综上所述，本发明的天然产物鹿茸补骨脂组合物具有增加骨密度，防治骨质疏松等功能。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (8)
1.具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物，其特征在于，按照重量份数计包括以下组份：
梅花鹿鹿茸粉 300～400份；
补骨脂醇提取物 100～200份；
葛根醇提取物 100～200份；
黄瓜籽提取物 50～150份。
2.根据权利要求1所述的具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物，其特征在于，将该鹿茸补骨脂组合物与药用辅料混合后制成口服制剂，所述口服制剂为硬胶囊、软胶囊、片剂、颗粒剂、散剂或丸剂。
3.根据权利要求1所述的具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物，其特征在于，按照重量份数计包括以下组份：
梅花鹿鹿茸粉 350份；
补骨脂醇提取物 150份；
葛根醇提取物 150份；
黄瓜籽提取物 100份。
4.制备权利要求1至3中任意一项所述的具有增加骨密度、防治骨质疏松功能的鹿茸补骨脂组合物的方法，其特征在于，包括以下步骤：
步骤一、梅花鹿鹿茸，锯茸后，经煮炸干燥、粉碎后即得鹿茸粉；
步骤二、补骨脂用6～10倍量、40～70％乙醇提取2～3次，每次提取1～2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得补骨脂醇提取物；
步骤三、葛根用6～10倍量、60～80％乙醇提取2～3次，每次提取1～2小时，经过滤后将滤液浓缩至无乙醇味，再经干燥、粉碎后即得葛根醇提取物；
步骤四、黄瓜籽用水煎煮提取2～3次，每次提取1～3小时，经过滤后将滤液浓缩、干燥、粉碎成细粉后即得黄瓜籽提取物；
步骤五、按照重量份将鹿茸粉、补骨脂醇提取物、葛根醇提取物、黄瓜籽提取物混合均匀即得鹿茸补骨脂组合物。
5.根据权利要求4所述的制备方法，其特征在于，步骤二中，补骨脂用8倍量、50％乙醇提取。
6.根据权利要求4所述的制备方法，其特征在于，步骤三中，葛根用8倍量、70％乙醇提取。
7.如权利要求1至3中任意一项所述的鹿茸补骨脂组合物在制备具有增加骨密度、防治骨质疏松症产品中的应用。
8.根据权利要求7所述的应用，其特征在于，所述产品为药品或保健食品。
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