CN1439377A - 一种改善骨质疏松的组合物 - Google Patents
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Abstract
本发明公开了一种新的改善骨质疏松的组合物,它是以天然白藜芦醇和/或白藜芦甙、类胡萝卜素、葡聚糖和吐温为原料制成的组合物。该组合物不仅具有雌激素样作用,改善人体因生理性雌激素缺乏所造成的骨质疏松,还具有抗氧化、抗辐射,结合金属及极性化合物以及促进肠道吸收的作用。
Description
技术领域
本发明涉及一种改善骨质疏松的组合物,具体地说是包括白藜芦醇和/或白藜芦甙,类胡萝卜素、葡聚糖和吐温为主要成分的组合物配方。
背景技术
由于生理性原因,很多中老年人都受到骨质疏松的困扰,尤其是中老年女性,由于体内雌激素分泌水平下降导致一系列内分泌功能的紊乱,骨质疏松是常见的并发症,临床上经常给这类患者补充类雌激素物质以改善症状。常用的类雌激素物质主要是经化学途径合成的化合物,但由于它是非天然产品,不可避免的对人体会产生一些毒副作用,所以症状较轻的患者因此不愿意服用。随着人们生活水平的提高,人们越来越渴望服用纯天然产品以改善由雌激素分泌水平下降引起的骨质疏松。
被誉为“植物雌激素”的白藜芦醇(Resveratrol,RV)或白藜芦甙(Polydatina,PD)是由乔治和左腾于1992年发现的,其化学结构分别为3,4’,5-三羟基二苯乙烯和3,4’,5-三羟基二苯乙烯-3-葡萄糖甙,最初自葡萄皮中提取获得,它是葡萄生长过程中为了抵抗灰葡萄孢霉菌(Botrytis.Sp)感染而自身产生的一种次生代谢产物。但葡萄果皮中白藜芦醇和白藜芦醇甙的含量很低,提取工艺复杂,成本高。美国、加拿大、日本等国家目前采用化学合成的方法合成高纯度的白藜芦醇,不仅价格昂贵,而且所有化学合成的RV产品的原料都采用苯,美国FDA(食品及药品管理局)均限制不得用于食品和药物。
所以,研究人员渴望从纯生物物质中获得高纯度的RV。随着研究的深入,人们发现在中药虎杖中有丰富的白藜芦醇的存在,这种来自纯天然植物虎杖的成分具有明显的雌激素作用,临床上使用可以改善因人体衰老造成的骨质疏松。但,由于白藜芦醇在化学性质上很不稳定,遇到光、热、金属、酸、碱、紫外线、溶液及其他化合物时均会被破坏或被结合,从而失去其应有的活性,因此在产品中保护白藜芦醇的稳定性是一个需要解决的问题。另外,白藜芦醇进入人体胃肠道后,易与其他食物中的大分子物质,极性物质及矿质元素结合,形成难以吸收的复合物质被排泄。所以保护白藜芦醇的稳定性也是一个需要解决的问题。
发明内容
本发明的目的在于提供一种保护白藜芦醇稳定性的含白藜芦醇或白藜芦甙的组合物,该组合物不仅保护了白藜芦醇在产品常温保存过程中的稳定性,同时也保护白藜芦醇在胃肠道中的稳定性,利于白藜芦醇在人体中的吸收,补充“植物雌激素”白藜芦醇,从而改善了由于人体衰老引起的骨质疏松。
本发明的组合物中主要包括:白藜芦醇或白藜芦醇甙,类胡萝卜素,葡聚糖,吐温或者Tritonx系列。其中按照该组合物的总重量计,各种组分的含量是0.01~10%天然白藜芦醇和/或白藜芦甙,0.05~10%类胡萝卜素,0.1~10%吐温或者Tritonx,葡聚糖70~98%。优选的是按照该组合物的重量计,0.05~8%天然白藜芦醇和/或白藜芦甙,0.1~6%类胡萝卜素,0.2~6%吐温或者Tritonx,葡聚糖80~95%。更优选的是按照该组合物的重量计,0.625~2.7白藜芦醇和/或白藜芦甙,2.7~5%萝卜素,0.25%~2%吐温或者Tritonx,葡聚糖85~90%。
其中所述的类胡萝卜素包括胡萝卜素,虾青素,番茄红素等。
其中所述的葡聚糖包括葡甘聚糖、葡果糖、果乳糖等。
其中所述的吐温可以选自吐温20,吐温40,吐温60,吐温65,吐温80,吐温86,或吐温86,优选为吐温20,
本发明的成分中可以选用Tritonx系列,例如Tritonx-100。
该组合物可以根据最后使用的药物剂型进行适当的修改,可以选用本领域技术人员公知的无药理活性的药物载体或者添加剂适当地调整,以便能够制成相应的剂型。
产品剂型包括片剂、胶囊如硬胶囊和软胶囊、口服液、冲剂及散粒剂等等。优选的是片剂、胶囊剂和冲剂,散粒剂可作为原材料用于药物、保健食品及食品的原料。
经测试,产品中的主要理化指标如下:
项 目 | 指标 | |
醇(RV)型 | 甙(PD)型 | |
干燥失重% | ≤10 | ≤10 |
砷% | ≤0.0002 | ≤0.0002 |
铅% | ≤0.0005 | ≤0.0005 |
重金属(以pb计)% | ≤0.002 | ≤0.002 |
白藜芦醇% | ≥0.2 | |
白藜芦醇甙% | ≥0.3 |
本发明组合物不仅含有白藜芦醇的雌激素样作用,从而改善因雌激素缺乏引起的骨质疏松,而且由于同时包含了类胡萝卜素、葡聚糖以及吐温等组分,从而使本组合物同时具有了类胡萝卜素的抗氧化、抗辐射,葡聚糖的结合金属及极性化合物的作用,含有的吐温则可以更好的利于白藜芦醇的肠道乳化吸收。
临床和实验都表明本发明组合物对改善骨质疏松具有明显的效果,这可能与白藜芦醇的雌激素样作用有关。对于老人,特别是妇女,尤其是绝经后的妇女发生的骨质疏松具有明显的效果。一般其口服有效剂量以组合物中的白藜芦醇计算为0.25~50mg/日/人,优选为20mg/日/人。
本发明组合物的制备方法可以采用公知的技术进行,本领域技术人员可以根据本发明的配方,进行配制。
具体实施方式
实施例一
选用白藜芦醇5公斤,1%β-胡萝卜素微囊10公斤,葡聚糖775公斤,吐温-60 2公斤。混合后制成约792公斤的混合物,即得到本发明所述的组合物。
在此基础上,可以加入80公斤的4%羟丙基+甲基纤维素溶液,3.8公斤的硬脂酸镁,再混合,经压片机压片,能够制得含有本发明组合物的片剂,其中每片重量为约800毫克。
实施例二
选用白藜芦醇10公斤,1%β-胡萝卜素微囊10公斤,葡甘聚糖350公斤,Tritonx-1006公斤。混合后制成约376公斤的混合物,即得到本发明所述的组合物。
在此基础上,可以加入3.8公斤的微粉硅胶,再混合,制得含有本发明组合物的胶囊颗粒,装胶囊成胶囊剂,其中每粒胶囊重量为约380毫克。
实施例三
选用白藜芦醇10斤,1%β-胡萝卜素微囊10斤,葡聚糖2200斤,Tritonx-100 6斤。混合后制成约2226斤的混合物,即得到本发明所述的组合物。
在此基础上,可以加入酒石酸100斤,甘露醇284斤,葡萄香精40斤,阿斯巴甜糖40斤,再混合,按照本领域公知的方法制得含有本发明组合物的冲剂。
Claims (10)
1.一种改善骨质疏松的组合物,其特征在于它包括按照该组合物的重量计,0.01~10%天然白藜芦醇和/或白藜芦甙,0.05~10%类胡萝卜素,0.1~10%吐温或者Tritonx,葡聚糖70~98%。
2.根据权利要求1所述的改善骨质疏松的组合物,其特征在于它包括按照该组合物的重量计,0.05~8%天然白藜芦醇和/或白藜芦甙,0.1~6%类胡萝卜素,0.2~6%吐温或者Tritonx,葡聚糖80~95%。
3.根据权利要求1所述的改善骨质疏松的组合物,其特征在于它包括按照该组合物的重量计,0.625~2.7藜芦醇和/或白藜芦甙,2.7~5%萝卜素,0.25%~2%吐温或者Tritonx,葡聚糖85~90%。
4.根据权利要求1、2或3的任一项所述的改善骨质疏松的组合物,其特征在于其中所述的类胡萝卜素包括胡萝卜素、虾青素和番茄红素。
5.根据权利要求1、2或3的任一项所述的改善骨质疏松的组合物,其特征在于其中所述的葡聚糖选自葡甘聚糖、聚果糖和果乳糖。
6.根据权利要求1、2或3的任一项所述的改善骨质疏松的组合物,其特征在于其中所述的吐温可以选自吐温20,吐温40,吐温60,吐温65,或吐温80和triton系列。
7.根据权利要求1、2或3的任一项所述的改善骨质疏松的组合物,其特征在于所述的剂型是任何一种药剂学上所说的剂型。
8.根据权利要求7所述的改善骨质疏松的组合物,其特征在于所述的剂型是片剂、胶囊、冲剂或散粒剂。
9.根据权利要求8所述的组合物,其特征在于其中所述的胶囊可以是硬胶囊或软胶囊。
10.根据权利要求8所述的组合物,其特征在于其中所述的散粒剂可作为原材料用于药物、保健食品及食品的原料。
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US20120136061A1 (en) * | 2009-05-14 | 2012-05-31 | Hsiehs Biotech (Singapore) Pte Ltd | Lycopene and resveratrol compositions for nk cell activation resulting in anti-neoplastic effect |
CN101433329B (zh) * | 2008-12-22 | 2012-06-27 | 南京大渊美容保健有限公司 | 一种用于保健功能的营养组合物 |
CN107028936A (zh) * | 2011-01-31 | 2017-08-11 | Ip科技有限公司 | 类胡萝卜素颗粒及其应用 |
IT201700079581A1 (it) * | 2017-07-14 | 2019-01-14 | Univ Degli Studi Di Foggia | Composizioni comprendenti o costituite da Polidatina per uso nel trattamento delle patologie ossee |
WO2022254316A1 (zh) * | 2021-05-30 | 2022-12-08 | 廖玉坤 | 皮膚外用治療關節退化及骨質疏鬆症的天然提取物與方法 |
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2002
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101433329B (zh) * | 2008-12-22 | 2012-06-27 | 南京大渊美容保健有限公司 | 一种用于保健功能的营养组合物 |
US20120136061A1 (en) * | 2009-05-14 | 2012-05-31 | Hsiehs Biotech (Singapore) Pte Ltd | Lycopene and resveratrol compositions for nk cell activation resulting in anti-neoplastic effect |
US8802732B2 (en) * | 2009-05-14 | 2014-08-12 | Hsiehs Biotech (Singapore) Pte Ltd | Lycopene and resveratrol compositions for NK cell activation resulting in anti-neoplastic effect |
CN107028936A (zh) * | 2011-01-31 | 2017-08-11 | Ip科技有限公司 | 类胡萝卜素颗粒及其应用 |
IT201700079581A1 (it) * | 2017-07-14 | 2019-01-14 | Univ Degli Studi Di Foggia | Composizioni comprendenti o costituite da Polidatina per uso nel trattamento delle patologie ossee |
WO2022254316A1 (zh) * | 2021-05-30 | 2022-12-08 | 廖玉坤 | 皮膚外用治療關節退化及骨質疏鬆症的天然提取物與方法 |
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