CN107156849A - 一种含姜黄素的关节保健组合物及其应用 - Google Patents
一种含姜黄素的关节保健组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种含姜黄素的关节保健组合物及其应用。按重量百分比，该组合物包括如下组分：姜黄素5‑20%，胶原低聚肽30‑50%，壳寡糖30‑50%，蘑菇粉1‑15%。本发明组合物对骨关节炎和关节老化状况具有良好的辅助治疗和预防保健作用，配合常规辅料，通过常规工艺可制备成各种剂型的保健食品、功能食品或特殊医学用途食品，适合作为关节保健群体的长期保健应用。
Description
技术领域
本发明涉及食品保健领域，具体涉及含姜黄素的保健组合物及其应用。
背景技术
骨关节炎(osteoarthritis,OA)是以关节软骨的变性、破坏及骨质增生为特征的常见慢性骨关节病，是一种缓慢、渐进的病理过程。近年来研究结果显示，我国OA患者以膝关节骨性关节炎的形式多见，流行病学调查表明中国人膝关节疼痛的患病率高于西方人群，中国60岁以上男、女膝关节骨关节炎(knee osteoarthritis,KOA)的临床患病率高达7％和15％，明显高于同龄的欧美男女(徐苓，Michael C，Nevitt YZ，等.北京城区老年人膝、髋和手骨关节炎的患病率及其与美国白人患病率的比较研究[J].中华医学杂志，2003(14):10-13.)；而随着老年化社会进程加快，KOA的发病率呈逐年递增趋势(Schuh A,Jezussek D,Fabijani R,et al.Conservative therapy of knee osteoarthritis[J].MMW Fortschr Med，2007，149(25—26):31—32.Higgs R.Osteoarthritis:Concentratedefforts to detect early OA[J].Nature Reviews Rheumatology，2010，6(11):616.)。有流行病学调查了中国6个城市(上海、成都、广州、哈尔滨、西安、石家庄)40岁以上的中老年人KOA的患病率高达15.6％(李宁华，张耀南，张毅，等.国内六大行政区域六城市中老年人群膝关节骨性关节炎患病危险因素比较[J].中国组织工程研究与临床康复，2007(,39)：7758—7760.)。此外，年龄因素与本病的发生呈正相关，荣杰生等研究表明，随着年龄的增高，膝关节骨性关节炎患病率呈逐年增高的趋势，其中在61～70岁这个年龄段的患病率最高(荣杰生，陶天遵，陶树清，等.高寒地区城市汉族人群膝骨关节炎情况调查[J].中国骨质疏松杂志，2007(10):723-726.)。由此可见，膝关节骨性关节炎是中老年人的常见病和多发病，其疼痛、关节活动度、肌力及步态异常是导致患者平地行走、上下楼梯等日常步行能力受限的主要原因。我国作为世界人口大国，老龄问题越来越突出，根据国家统计局第6次人口普查结果显示，2010年中国65岁及以上的老年人口达到1.2亿人，占全国总人口的8.9％，到2030年，中国65岁以上人口占比将超过日本，成为全球人口老龄化程度最高的国家。作为一种退行性病变，膝关节骨性关节炎的患病人数将持续上升。临床上，骨关节炎的治疗目标是控制疼痛、改善关节功能和生活质量，尽可能避免治疗的毒副作用(孙铁铮,吕厚山.骨关节炎的诊治与研究进展[J].继续医学教育,2005,10(7):7-22.)。目前，骨关节炎缺乏治愈的手段，因此延缓病程的进展是首选的策略。因而选用天然来源、安全的功能性成分来开发缓解骨关节炎发展的保健食品具有重要的价值。
姜黄素(curcumin)最早是从姜黄Curcuma longa L.中分离出来的一种低分子多酚化合物。随着现代医学对姜黄素研究的日益深入，发现姜黄素具有广泛的生理活性，比如心血管保护、抗肿瘤、抗氧化和抗炎(狄建彬,顾振纶,赵笑东,钱培刚,蒋小岗,郭次仪姜黄素的抗氧化和抗炎作用研究进展[J].中草药.2010.41(5):附18-21.罗廷顺,李洪文,刘正文,等.姜黄素的提取分离与药理作用研究进展[J].现代药物与临床,2011,26(2):102-107.)。有研究发现，姜黄素在抗炎方面的活性与甾体药物和非甾体类药物具有相当的水平，如吲哚美辛和保泰松(Aqqarwal B.B,Harikumar KB.Potential therapeutic effectof curucmin,the anti-infl-ammatory agent,against neurodegenerative,cardiovascular,pulmonary,metabolic,autoimmune and neoplastic diseases[J].IntJ Biochem Cell Biol,2009,41(1):40-59.)。
壳聚糖是2-氨基-2脱氧-D葡萄糖单体以β(1→4)苷键连接的直链多糖，是年产仅次于纤维素的生物资源-甲壳素部分脱乙酰基的产物。因其特殊的化学结构，使壳聚糖具有膳食纤维的功能、高分子性能、有成膜性、保湿性、吸附性、抑菌性、抗辐射性及生物相容性和对动植物的器官组织细胞有生物功能(平野茂博.Biotechnology Annual Review,1996,(2):237-238.)。壳寡糖是2～10个单体的壳聚糖的降解产物。由于其分子量大大小于壳聚糖，其水溶性强，使其对生命体的作用更特殊(赵玉清,郑兆艳,王冰,等.壳聚糖/壳寡糖系列功能食品的安全性评价[J].食品科学,2003,24(8):248-250.)。
胶原蛋白是具有独特结构的一族蛋白质，广泛存在于哺乳动物组织中，约占总蛋白质的30％以上。胶原蛋白为骨、皮肤、肌腔和韧带提供生物力学性能、控制发育中的细胞基因表型。胶原蛋白的结构呈三股螺旋结构，由三条多肤链组成(陈静涛,徐政,顾其胜.胶原蛋白研发的最新进展[J].生物医学工程学进展,2004,25(2):52-55.)。胶原蛋白是所有结缔组织的主要结构元素，几乎存在于所有的薄壁器官的间质组织中，作为细胞外基质纤维支架，起到稳定组织和器官并保持它们的完整。胶原低聚肽是胶原蛋白的水解物，常作为一种功能性成分应用于皮肤美容食品中。
研究含姜黄素、壳聚糖和胶原低聚肽的组合物，并应用于骨关节炎保健。
发明内容
本发明的目的在于提供一种含姜黄素的关节保健组合物，该组合物具有骨关节炎保健作用。
本发明目的还在于提供所述的一种含姜黄素的关节保健组合物的应用。
本发明通过如下技术方案实现。
一种含姜黄素的关节保健组合物，按重量百分比，包括如下组分：姜黄素5-20％，胶原低聚肽30-50％，壳寡糖30-50％，蘑菇粉1-15％。
优选的，姜黄素10-15％，胶原低聚肽30-45％，壳寡糖35-45％，蘑菇粉5-10％。
更优选的，姜黄素10％，胶原低聚肽40％，壳寡糖40％，蘑菇粉10％。
优选的，所述姜黄素的来源包括姜黄。
优选的，所述蘑菇粉中，维生素D的含量在100-10000IU/g。
优选的，所述蘑菇粉来自包括双孢菇或香菇。
所述的一种含姜黄素的关节保健组合物在制备骨关节炎辅助治疗及关节老化保健的保健食品、功能食品或特殊医学用途食品中的应用。
优选的，所述保健食品、功能食品或特殊医学用途食品的剂型是软胶囊剂、硬胶囊、片剂、粉剂、颗粒剂、口服液、饮料、果冻、糖果或软糖。
与现有技术相比，本发明具有如下优点和有益效果：
(1)本发明提供的组合物，多途径针对骨关节炎的保健策略，使用抑制炎症与营养补充相结合的方法，弥补单一方法的不足，从而提升关节保健效果；
(2)本发明提供的组合物来自于天然的食材，安全性好、无副作用，适合骨关节炎人群和关节老化人群长期保健服用；
(3)本发明的组合物配合常规辅料，通过常规工艺可制备成各种剂型的保健食品、功能食品或特殊医学用途食品，便于生产与推广、应用；
(4)利用本发明的组合物制成的保健食品、功能食品或特殊医学用途食品对骨关节炎、关节炎高风险、关节老化人群(中老年人群)具有良好的辅助治疗和预防保健作用。
具体实施方式
以下结合实施例来进一步解释本发明，但实施例并不对本发明做任何形式的限定。其他人根据本发明做出的一些非本质的修改和调整仍属于本发明的保护范围。
在未作说明的情况下，本发明涉及的原料与方法均为本领域的常规原料和方法。
实施例1
含姜黄素的关节保健组合物，按重量百分比，包括如下组分：姜黄素5％，胶原低聚肽49％，壳寡糖45％，蘑菇粉1％。
实施例2
含姜黄素的关节保健组合物，按重量百分比，包括如下组分：姜黄素10％，胶原低聚肽30％，壳寡糖50％，蘑菇粉10％。
实施例3
含姜黄素的关节保健组合物，按重量百分比，包括如下组分：姜黄素20％，胶原低聚肽35％，壳寡糖30％，蘑菇粉15％。
实施例4
含姜黄素的关节保健组合物，按重量百分比，包括如下组分：姜黄素15％，胶原低聚肽40％，壳寡糖35％，蘑菇粉10％。
实施例5
含姜黄素的关节保健组合物，按重量百分比，包括如下组分：姜黄素10％，胶原低聚肽40％，壳寡糖40％，蘑菇粉10％。
骨关节炎保健效果实验验证
采用实施例1-5的配比通过常规工艺制得含姜黄素的关节保健组合物，分别命名为S1、S2、S3、S4和S5，所得剂型为粉剂，进行了人体功效验证试验；利用同等重量的麦芽糊精作为空白对照。
试验方法：受试者60人，年龄在50-65岁之间，平均年龄59岁；把60人随机分成6组。
诊断标准：西医诊断标准符合2001美国风湿病协会制定的膝骨性关节炎的诊断标准，即：①前1月大多数时间膝痛；②关节活动时有骨响声；③晨僵＜30min；④年龄≥38岁；⑤膝检查示骨性肥大。具备①②③④项，或①②⑤项，或①④⑤项，即可诊断。
观察疗效评价采用膝womac(western Ontario and McMaster Universities)评分量表(陈蔚，郭燕梅，李晓英，等.西安大略和麦克马斯特大学骨关节炎指数的重测信度[J].中国康复理论与实践，2010，16(1):23-24.)，计算患者在治疗前、后的评分，依此判断治疗效果。
具体如下，显效：治疗前后womac积分减少≥80％；有效：治疗前后womac积分减少≥60％，但<80％；无效：治疗前后womac积分减少<60％。通过膝关节骨性关节量表来对患者进行日常生活的评定。
疼痛评分采用疼痛视觉模拟法(VAS)评分(陈蔚，郭燕梅，李晓英，等.西安大略和麦克马斯特大学骨关节炎指数的重测信度[J].中国康复理论与实践，2010，16(1):23-24.)。
食用剂量：4g/d，连用12周。实验组分别服用S1-S5，对照组服用麦芽糊精制备的安慰剂。
试用结果：实验结果如表1所示。
表1实验结果
与安慰剂组相比，*p<0.05；与治疗前相比，#p<0.05。
六组病例治疗后疼痛及日常生活评分，实施例组治疗前后比较明显降低，差异有统计学意义(P＜0.05)；安慰剂治疗后比较，治疗后疼痛及日常生活评分有降低的趋势，但无统计学差异(P>0.05)。
根据人体服用结果可知，实施例1-5组配方具有改善骨关节炎的作用。
Claims (8)
1.一种含姜黄素的关节保健组合物，其特征在于，按重量百分比，包括如下组分：姜黄素5-20%，胶原低聚肽30-50%，壳寡糖30-50%，蘑菇粉1-15%。
2.根据权利要求1所述的一种含姜黄素的关节保健组合物，其特征在于，按重量百分比，包括如下组分：姜黄素10-15%，胶原低聚肽30-45%，壳寡糖35-45%，蘑菇粉5-10%。
3.根据权利要求1所述的一种含姜黄素的关节保健组合物，其特征在于，按重量百分比，包括如下组分：姜黄素10%，胶原低聚肽40%，壳寡糖40%，蘑菇粉10%。
4.根据权利要求1~3任一项所述的一种含姜黄素的关节保健组合物，其特征在于，所述姜黄素的来源包括姜黄。
5.根据权利要求1~3任一项所述的一种含姜黄素的关节保健组合物，其特征在于，所述蘑菇粉中，维生素D的含量在100 -10000 IU/g。
6.根据权利要求1~3任一项所述的一种含姜黄素的关节保健组合物，其特征在于，所述蘑菇粉来自包括双孢菇或香菇。
7.权利要求1~3任一项所述的一种含姜黄素的关节保健组合物在制备骨关节炎辅助治疗及关节老化保健的保健食品、功能食品或特殊医学用途食品中的应用。
8.根据权利要求7所述的应用，其特征在于，所述保健食品、功能食品或特殊医学用途食品的剂型是软胶囊剂、硬胶囊、片剂、粉剂、颗粒剂、口服液、饮料、果冻、糖果或软糖。
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Application publication date: 20170915 |