CN108378374A - 一种预防骨质疏松、促进骨健康的组合物 - Google Patents
一种预防骨质疏松、促进骨健康的组合物 Download PDFInfo
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- CN108378374A CN108378374A CN201810125823.5A CN201810125823A CN108378374A CN 108378374 A CN108378374 A CN 108378374A CN 201810125823 A CN201810125823 A CN 201810125823A CN 108378374 A CN108378374 A CN 108378374A
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Abstract
本发明公开了一种预防骨质疏松、促进骨健康的组合物，该组合物按重量份，包括以下组分：Ⅱ型胶原肽35～68份；海藻粉0.6～15份；钙源0.65～5份；酪蛋白磷酸肽0.16～2.8份；辅料 8.2～50份。本发明的组合物吸收率非常高，针对性强，促进消化吸收功能较弱的中老年人的吸收与利用，加快退化骨骼的修复。
Description
技术领域
本发明涉及一种预防骨质疏松、促进骨健康的组合物，属于食品/保健食品领域。
背景技术
骨质疏松症是一个世界范围的、越来越引起人们重视的健康问题。目前全世界约2亿人患有骨质疏松，其发病率已跃居常见病、多发病的第七位。最新研究表明，在我国一直被认为是老年人特有疾病的骨质疏松症，我国骨质疏松症患者有6000万～8000万，随着人口老龄化日趋明显，骨质疏松症以其高发病率、高致残率、高死亡率而严重影响着居民的生命健康，逐渐成为一个严重的公共健康问题。
现代研究表明老年人由于牙齿脱落及胃酸分泌不足或胃酸缺失，消化功能降低，纳骨的能力较差，营养的摄取降低，多有营养的缺乏，致使钙、维生素、微量元素摄入不足。而我国习惯膳食属低钙食谱，钙来源主要依靠谷物及蔬菜，老年人缺失较多，蔬菜、水果、瘦肉不易咀嚼，摄入量减少，呈现“负钙平衡”。近年来市场上，出现大量预防、改善或辅助治疗骨质疏松症的保健食品或药物制剂，但没有针对老年人的特征，普遍吸收率不高或副作用较大，并且过多摄取的钙质由于不能被充分吸收可能与摄入的蔬菜等含草酸类物质结合形成醋酸钙结石，对人体危害较大。市场上的增强高密度产品，一类是以直接补钙成分来强化人体对钙质的吸收，吸收率普遍都较低，此类产品相当部分采用碳酸钙等需要消耗胃酸、水溶性差的钙质，不利于吸收，并且会使老年人的胃酸更加缺乏；一类是补充钙质，同时补充吸收促进剂，钙吸收率较高，但是由于未针对老年人的特征选择合适的钙源和钙吸收促进剂，如水溶性差的碳酸钙，如采用维生素D作为钙吸收促进剂，由于维生素D在人体内的代谢时间较长，而很多老年人代谢功能相对较差，容易在体内蓄积，导致中毒。
因此，开发一款针对性强、吸收率高、无副作用、适合老年人服用的，对预防骨质疏松和促进骨健康的保健食品，不仅可减轻患者的痛苦和家庭负担，而且可避免产生并发症，将是一种理想途径。
发明内容
本发明所解决的技术问题是克服现有增加骨密度产品的缺陷，将Ⅱ型胶原肽与天然有机海洋植物钙源-红海藻粉与其它具有增加骨密度功能的原料科学复配，制备一种安全、营养、高效、稳定的促进骨健康的组合物。
本发明的技术方案是，提供一种预防骨质疏松、促进骨健康的组合物，按重量份，包括以下组分：
优选地，按重量份，包括以下组分：
优选地，Ⅱ型胶原肽中，相对分子量小于1000的低聚肽占Ⅱ型胶原肽总质量的80％以上。
优选地，所述钙源为骨粉、天门冬氨酸钙、乳酸钙、L-乳酸钙、柠檬酸钙、碳酸钙中的一种或几种。更优选地，碳酸钙为生物碳酸钙。
优选地，所述Ⅱ型胶原肽是Ⅱ型胶原蛋白经酶水解后的产物。选用II型胶原蛋白水解酶水解Ⅱ型胶原蛋白，得到Ⅱ型胶原肽，即Ⅱ型胶原蛋白多肽。
优选地，所述Ⅱ型胶原肽的制备方法是：将Ⅱ型胶原蛋白经酶水解，再将酶灭活，离心，喷雾干燥，得到Ⅱ型胶原肽粉末。
优选地，所述辅料为填充剂、甜味剂、食用香精和润滑剂中的一种或几种。
优选地，所述润滑剂选自硬脂酸镁、二氧化硅和滑石粉的一种或几种。
优选地，所述食用香精选自橙香精、柠檬香精、草莓香精、蓝莓香精、苹果香精、凤梨香精和牛奶香精一种或几种。
优选地，所述甜味剂选自甜菊糖苷、罗汉果甜苷、三氯蔗糖和阿斯巴甜一种或几种。
优选地，所述将辅料与海藻粉、钙源、酪蛋白磷酸肽混匀，再加入Ⅱ型胶原肽，混合均匀后得到所述预防骨质疏松、促进骨健康的组合物。
上述组合物应用于预防骨质疏松、促进骨健康中，具有非常好的效果。
海藻粉优选红海藻粉，是一种天然有机海洋植物钙源，其原料是生长在海岸海床里的红色海藻，经萃取精制后的海藻粉含钙量高，富含其它微量矿物质，包括镁、锌、铁、磷、硼等。
上述一种预防骨质疏松、促进骨健康的组合物可以制备成固体制剂。所述的固体制剂优选为粉剂、颗粒剂、胶囊剂、片剂。
上述一种预防骨质疏松、促进骨健康的组合物制备方法包括以下步骤：
1)Ⅱ型胶原肽原料加工工艺：Ⅱ型胶原蛋白---酶水解---灭活---离心---喷雾干燥---Ⅱ型胶原肽粉末；
2)按产品配方称取各原料；
3)混合：将甜味剂、香精与填充剂充分混匀后，再加入红海藻粉、钙源、酪蛋白磷酸肽混合均匀，最后加入Ⅱ型胶原肽与其他剩余辅料混合均匀；
4)分装：按包装规格装袋。
本产品的关键创新点是本发明产品吸收率非常高，针对性强。
本发明的有益效果是：
1、Ⅱ型胶原肽，肽链短，分子量小，易吸收，促进消化吸收功能较弱的中老年人的吸收与利用，加快退化骨骼的修复；
2、红海藻粉-天然有机海洋植物钙源，安全性高，吸收率高，同时富含镁、磷、硼及其他微量元素，协同促进钙吸收，补钙的同时补充了人体所需的其他微量元素；
3、通过加入特定配比的酪蛋白磷酸肽(CPP)，来促进人体对钙的吸收，酪蛋白磷酸肽水溶性好，热稳定性好，易于人体吸收，能增强中老年人对钙的结合、吸收；
4、Ⅱ型胶原肽搭配钙源，促进骨骼修复，钙离子附着在修复的骨骼支架，进而合理利用，增强骨密度的效果。
具体实施方式
下面列举一部分具体实施例对本发明进行说明，有必要在此指出的是以下具体实施例只用于对本发明作进一步说明，不代表对本发明保护范围的限制。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。
Ⅱ型胶原肽原料处理：
步骤1：将Ⅱ型胶原蛋白用2倍量的纯化水溶解，在液温50℃的条件下，加入胶原蛋白水解酶，恒温水解4小时；
步骤2：升温至95℃并保持10分钟，进行灭酶处理；
步骤3：5000r/min，离心处理；
步骤4：喷雾干燥，得Ⅱ型胶原肽粉末
将上述工艺得到的Ⅱ型胶原肽粉末进行检测，低聚肽含量是88.2％，其中相对分子量小于1000u的蛋白质水解物所占比例是85.1％。
本发明采用的海藻粉，是通过市售购得的海藻粉，比如上海诚一食品原料有限公司。
实施例1
本发明实施例1提供的具有预防骨质疏松、促进骨健康的组合物由下述重量配比制备而成：
1)按配方称取各原料；
2)混合：将甜菊糖苷、甜橙香精与麦芽糊精充分混匀后，再加入Ⅱ型胶原肽、海藻粉、天门冬氨酸钙、酪蛋白磷酸肽、山梨糖醇混合均匀，最后加入硬脂酸镁混合均匀，得总混物料；
3)压片：将总混物料压片，获得素片；
4)包衣：将羟丙甲纤维素与聚乙二醇1000配成10％(w/v)的薄膜包衣液，再将素片在包衣锅中用包衣液进行包衣，即得成品。
实施例2
本发明实施例2提供的具有预防骨质疏松、促进骨健康的组合物由下述重量配比制备而成：
1)按配方称取各原料；
2)混合：将酪蛋白磷酸肽、生物碳酸钙与淀粉充分混匀后，再加入Ⅱ型胶原肽、海藻粉、果糖(60目)混合均匀；
3)制粒：75％的乙醇做湿润剂，用量10％，18目筛制粒；
4)干燥：干燥温度60℃，颗粒水分控制在3％～4.5％；
5)整粒：将干燥后的颗粒过16目筛整粒；
6)总混：将整粒后的颗粒与二氧化硅混合均匀；
7)灌胶囊：按规格灌装。
实施例3
本发明实施例3提供的具有预防骨质疏松、促进骨健康的组合物由下述重量配比制备而成：
1)按配方称取各原料；
2)混合：将三氯蔗糖、海藻粉、乳酸钙与淀粉充分混匀后，再加入Ⅱ型胶原肽、酪蛋白磷酸肽、脱脂奶粉、菊粉混合均匀；
3)制粒：60％的乙醇做湿润剂，用量8％，18目筛制粒；
4)干燥：干燥温度60℃，颗粒水分控制在3％～4.5％；
5)整粒：将干燥后的颗粒过16目筛整粒；
6)总混：先将整粒后的部分颗粒与凤梨香精等量递增混合，再加入剩余颗粒与滑石粉混合均匀；
7)分装：按包装规格分装。
实施例4
本发明实施例4提供的具有预防骨质疏松、促进骨健康的组合物由下述重量配比制备而成：
1)按配方称取各原料；
2)混合：将阿斯巴甜、蓝莓香精与糊精充分混匀后，再加入海藻粉、骨粉、酪蛋白磷酸肽混合均匀，最后加入Ⅱ型胶原肽、二氧化硅混合均匀；
3)分装：按包装规格分装。
应用例一、通过以下试验验证本发明具有增加骨密度功能：
动物试验
1.实验目的
研究本发明具有预防骨质疏松、促进骨健康的作用
2.实验药物
对比1组(Ⅱ型胶原肽68％、辅料32％)、对比2组(海藻粉15％、骨粉2.5％、酪蛋白磷酸肽2.7％、辅料79.8％)，对比3组(Ⅱ型胶原肽30％、海藻粉0.5％、生物碳酸钙1.55％、酪蛋白磷酸肽0.25％、辅料,67.7％)，具体实施例4。
3.实验动物
SPF级SD种大鼠，共50只，雌性，每组10只，体质量60～75g，实验动物生产许可证号:SCXK(京)2014-0013，由中国食品药品检定研究院实验动物资源中心提供。
4.实验方法和结果
4.1饲料配制：(1)低钙基础饲料配方:参照《保健食品检验与评价技术规范》2003年版第111页。(2)用低钙基础饲料配制各剂量组:剂量组按8g/天/设计扩大10倍剂掺入。
4.2将大鼠随机进行分成5组，分别为低钙对照组、对比1组、对比2组、对比3组、具体实施例4组。经口给予受试样品3个月，并记录每只动物的体质量及饲料摄入量。
4.3体质量测定禁食12h后，测定体质量。每周1次。
4.4股骨重量测定动物喂养3个月后处死，剥离出右侧股骨，于105℃烤箱中烤至恒重，称量骨干重。
4.5骨钙含量及饲料含钙量测定按原子吸收分光光度法测定。
4.6股骨骨密度测定用骨密度仪(DISCOVEY WI AAL286)测量股骨中点及股骨远心端的骨密度。
5.统计学分析：采用SPSS软件进行各受试组与低钙对照组的方差分析。
表1.具有预防骨质疏松、促进骨健康粉剂对大鼠骨健康的影响
注：*代表与低钙对照组比较，P＜0.05
结论：由表1可见，骨钙含量项除对比组1与低钙对照组差异没有统计学意义，其它项，各受试组与低钙对照组差异均有统计学意义，同时实施例4组均比对比组1、2、3组各项指标效果好。
应用例二、本发明食用效果，对中老年人骨密度增加作用
1、一般资料：观察例数16例。男6例，女10例。年龄50-75岁，骨密度T≤—2.5。
2、测试仪器：超声波骨密度分析仪。X-36R型双能X线骨密度仪，美国NORLAND公司。
3、检测部位：桡骨远端三分之一处。
4、观察指标：骨密度T值。
5、观察方法：0月，食用前1天；3个月，食用3个月次日；6个月，食用6个月次日；各检测1次。
6、食用方法：8g/次，1次/天。
7、观测单位：长沙市第四医院。
8、观测结果：食用本发明产品3个月，骨质疏松者骨密度值接近正常，6个月后骨质疏松者骨密度值完全正常，结果详见表2。
9、结论：本发明具有明显增加骨密度的作用
表2.产品对骨质疏松中老年人骨密度的影响
本发明食用效果，对中老年人骨质疏松患者关节疼痛的作用
1、研究对象随机选取长沙市第四医院门诊113例主诉为关节疼痛、50～70岁中老年骨质疏松患者为研究对象。实验前对其健康状况进行评估，血常规、尿常规、肝肾功能、血尿酸正常者90例进入实验。男34例，女56例。按随机数字表法分为A、B、C 3组，每组30例。
2、方法疼痛评定采用视觉模拟评分法(VAS)对入选患者疼痛程度进行评定，以0～10分表示，要求患者根据自身疼痛情况进行评分。即用一条长约10cm游动标尺两端分别为“0”分端和“10”分端，“0”代表无痛，“10”代表难以忍受的最剧烈疼痛，临床使用时将有刻度的一面背向患者，让患者在直尺上标出能代表自己疼痛的相应位置，记录者根据患者标出的位置评出分数。临床评定以0～2为“优”，3～5分为“良”，6～8分为“可”，＞8分为“差”。随机分配的3组中A组为空白对照组；B组为补充某厂家氨糖软骨素胶囊(0.5g/粒，含氨基葡萄糖盐酸盐230mg、碳酸钙180mg、硫酸软骨素80mg，其他辅料10mg)组；C组为本发明实施例4组，按8g/d服用。观察不同时点各组的VAS评分。
3、统计学分析多组比较采用方差分析，其两两间的多重比较使用Bonferroni法t检验。数据运算采用统计软件SAS8.02。P＜0.05为差异有统计学意义。
表3.3组患者不同时点的VAS评分比较(n＝30，)
| 组别 | 10d | 20d | 30d | 60d |
| A组 | 8.09±1.57 | 8.06±1.47 | 7.65±1.99 | 7.99±1.76 |
| B组 | 7.88±1.62 | 5.96±1.33 | 4.67±1.51▲ | 4.15±1.29▲ |
| C组 | 6.23±1.28 | 4.61±0.76▲ | 3.82±0.75▲ | 2.94±1.05▲ |
注：与A组比较，▲P＜0.05
结果显示，对骨质疏松引起的骨关节疼痛，本发明组缓解骨关节疼痛效果优于氨糖软骨素胶囊组。20d时本发明实施例4组VAS评分与A组相比有统计学差异(P＜0.05)，且患者的关节疼痛均分别在第30天、第60天均有明显改善(P＜0.05)。氨糖软骨素胶囊组在第30天和第60天有明显改善(P＜0.05)。
Claims (10)
1.一种预防骨质疏松、促进骨健康的组合物，其特征在于，按重量份，包括以下组分：
Ⅱ型胶原肽 35～68份；
海藻粉 0.6～15份；
钙源 0.65～5份；
酪蛋白磷酸肽 0.16～2.8份；
辅料 8.2～50份。
2.如权利要求1所述的组合物，其特征在于，按重量份，包括以下组分：
Ⅱ型胶原肽 48～58份；
海藻粉 2～15份；
钙源 0.8～5份；
酪蛋白磷酸肽 0.7～2.5份；
辅料 8.2～39份。
3.如权利要求1所述的组合物，其特征在于，所述Ⅱ型胶原肽中，相对分子量小于1000的低聚肽占Ⅱ型胶原肽总质量的80%以上。
4.如权利要求1所述的组合物，其特征在于，所述Ⅱ型胶原肽是Ⅱ型胶原蛋白经酶水解后的产物。
5.如权利要求1所述的组合物，其特征在于，所述Ⅱ型胶原肽的制备方法是：将Ⅱ型胶原蛋白经酶水解，再将酶灭活，离心，喷雾干燥，得到Ⅱ型胶原肽粉末。
6.如权利要求1所述的组合物，其特征在于，所述辅料为填充剂、甜味剂、食用香精和润滑剂中的一种或几种。
7.如权利要求6所述的组合物，其特征在于，所述润滑剂选自硬脂酸镁、二氧化硅和滑石粉的一种或几种；所述食用香精选自橙香精、柠檬香精、草莓香精、蓝莓香精、苹果香精、凤梨香精和牛奶香精一种或几种；所述甜味剂选自甜菊糖苷、罗汉果甜苷、三氯蔗糖和阿斯巴甜一种或几种。
8.如权利要求1所述的组合物，其特征在于，所述钙源为骨粉、天门冬氨酸钙、乳酸钙、L-乳酸钙、柠檬酸钙、碳酸钙中的一种或几种。
9.如权利要求8所述的组合物，其特征在于，所述碳酸钙为生物碳酸钙。
10.如权利要求1所述的组合物，其特征在于，将辅料与海藻粉、钙源、酪蛋白磷酸肽混匀，再加入Ⅱ型胶原肽，混合均匀后得到所述预防骨质疏松、促进骨健康的组合物。
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