CN111569052A - 一种增加更年期妇女骨密度的组合物及其保健品、应用 - Google Patents
一种增加更年期妇女骨密度的组合物及其保健品、应用 Download PDFInfo
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Classifications
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Abstract
本发明公开了一种增加更年期妇女骨密度的组合物及其保健品、应用。该组合物包括组分：乳矿物盐、大豆提取物、胶原蛋白粉、初乳碱性蛋白粉。本发明提供的增加更年期妇女骨密度的组合物是以乳矿物盐作为优质钙补剂来源，通过大豆提取物、胶原蛋白粉和初乳碱性蛋白粉配合应用。经试验研究证明，各组分之间具有协同增效作用，在达到增加骨密度，改善骨质疏松的同时，还能够调节更年期女性激素水平，降低血清丙二醛水平，提高血清超氧化物歧化酶水平，改善妇女更年期综合征症状。
Description
技术领域
本发明属于保健品领域，具体涉及一种增加更年期妇女骨密度的组合物及其保健品、应用。
背景技术
骨质疏松症（OP）是一种以低骨量和骨组织微细结构破坏为特征，导致骨骼脆性增加和易发生骨折的全身性代谢性疾病。随着人口老龄化，OP的发生呈上升趋势，OP以骨痛、易骨折、身高缩短为主要临床表现，在骨量减少期可出现全身骨骼疼痛，以腰背部常见，其次为膝关节、肩背部、手指、前臂等。骨折是骨质疏松的严重的并发症，髋部骨折危害最大，据报道其病死率达10%～20%，50%会致残，女性以椎体骨折为最常见，可引起驼背和身材变矮，主要见于绝经后的妇女。
而骨质疏松性骨折与骨密度相关，骨密度（Boneminaraldensity,BMD）指骨单位面积所含的骨矿物量，是反应人体骨骼代谢状况的一项重要指标。通过增加骨密度，能够有效防治骨质疏松症。
有研究表明，更年期女性卵巢功能逐渐减退，卵泡刺激素与雌二醇变化，使破骨细胞活性增生，成骨细胞活性下降，进而加速骨吸收，使骨生成减慢，骨重建障碍。同时雌激素水平下降增加甲状旁腺激素敏感性，加速骨质消融，致骨量减少，绝经后妇女骨质疏松发病率可高达20% - 50%。与此同时，由于妇女更年期卵巢功能减退，雌激素水平下降，导致内分泌功能失调而出现一系列的不适症状，如情绪易激动，易疲劳，焦虑或抑郁等。
因此，研究一种针对更年期妇女骨质疏松及更年期综合征症状的保健品非常有必要。
发明内容
鉴于此，本发明的首要目的在于提供一种增加更年期妇女骨密度的组合物，该组合物中各组分协同增效，在增加骨密度，改善骨质疏松的同时还能够改善妇女更年期综合征症状。
本发明是通过以下技术方案实现；
一种增加更年期妇女骨密度的组合物，其特征在于，由如下组分制成：乳矿物盐、大豆提取物、胶原蛋白粉、初乳碱性蛋白粉。
本发明中各原料如下报述：
乳矿物盐是以乳清为原料，经去除蛋白质、乳糖等成分而制成。乳矿物盐中含有70～78%的矿物质(其中含有23～28%的钙；10～14%的磷，如磷酸盐；9%的有机盐，如氯化钠、钾、镁、锌等)；6～1O%的乳糖；5%蛋白质；1%的脂肪和约5%的水分。其所含成分中，钙主要以磷酸钙、磷酸氢钙和磷酸三钙的形式存在。乳矿物盐是一种安全无毒的食品原料,其化学成分中钙磷比约2:1,接近母乳，其营养成分为人体所需。中华人民共和国卫生部2009年第18号“关于批准茶叶籽油等7种物品为新资源食品的公告”批准乳矿物盐为新资源食品。
大豆提取物的主要功能成分是大豆异黄酮。作为一种植物雌激素，主要存在于大豆及其制品中。目前认为它由染料木黄酮，大豆苷原，大豆黄素三种游离态苷原和九种葡萄糖结合态苷类成分组成。大豆异黄酮是典型的植物雌激素，具有弱雌激素活性，约相当于十万分之一的雌二醇活性，能够减轻女性更年期综合征症状，延迟女性细胞哀老，使皮肤保持弹性，减少骨丢失，促进骨生成，降血脂等双向调节平衡功能。
胶原蛋白粉是一种白色、不透明、无支链的纤维蛋白质，它主要存在于动物的皮、骨、软骨、牙齿、肌腱、韧带和血管中，是结缔组织极重要的结构蛋白质，起着支撑器官、保护机体的功能。是哺乳动物体内含量最多的蛋白质，占体内蛋白质总量的25%～30%，相当于体重的6%。胶原蛋白含有其它蛋白质所没有的羟基赖氨酸，因而营养特别丰富。胶原蛋白富含除色氨酸和半胱氨酸外的18种氨基酸，含有人体所必需的7种氨基酸，甘氨酸的含量为最高，约占总氨基酸的27%，脯氨酸和羟脯氨酸共占25%。胶原蛋白能促进钙的吸收，因为血浆中来自胶原蛋白的羟脯氨酸是将血浆中的钙运输到骨细胞的运载工具。
初乳碱性蛋白粉（CBP）是从牛初乳中使用一系列的超滤过程分离出来的，它以牛初乳为原料，经杀菌、脱脂、离心分离、去除酪蛋白、α－乳白蛋白、β－乳球蛋白，微滤、超滤、冷冻干燥等工艺而制成的。它含有促进骨形成和抑制骨吸收的成分有能力，直接作用于骨细胞，可抑制过度的骨吸收，同时激活成骨细胞促进骨形成。
根据更年期妇女骨质疏松的发病机理，本发明以乳矿物盐作为优质钙补剂来源，提高钙的有效吸收率，辅以大豆提取物，大豆提取物表现为弱雌激素作用，一方面与成骨细胞内的雌激素受体结合，加强成骨细胞的活性，促进骨基质的产生、分泌和骨矿化过程，抑制由于饮食中缺钙和缺 VD引起的骨钙含量降低，增加骨密度，另一方面增加女性雌激素的含量，能够减轻女性更年期综合征症状。再加入胶原蛋白粉促进钙的吸收，保证正常的钙质需要量，初乳碱性蛋白粉具有促进成骨细胞的增殖和调节骨代谢的功能。各组分协同增效，达到增加骨密度和改善妇女更年期综合征症状的双重功效。
作为一种优选的实施方式，所述增加更年期妇女骨密度的组合物，按重量份数计，由如下组分制成：乳矿物盐300-600份、大豆提取物60-80份、胶原蛋白粉30-60份、初乳碱性蛋白粉20-40份。
在一个优选的实施方式中，所述增加更年期妇女骨密度的组合物，按重量份数计，各组分用量为：乳矿物盐500份、大豆提取物70份、胶原蛋白粉50份、初乳碱性蛋白粉30份。
优选的，所述大豆提取物中大豆异黄酮的重量含量为10-50%。
优选的，所述初乳碱性蛋白粉的分子量为1-30kDa。
本发明还提供了上述的组合物在制备增加更年期妇女骨密度的保健品中的应用。
本发明还提供了一种增加更年期妇女骨密度的保健品，由本发明上述的组合物和保健品中可接受的辅料按本领域常规方法制成。
本发明所述的保健品的剂型可以为片剂、胶囊剂、粉剂、颗粒剂、丸剂或口服液等，优选为片剂。
合适的辅料可以为微晶纤维素、异麦芽酮糖醇、糊精、羟丙纤维素、聚维酮K30、硬脂酸镁等，其用量为本领域的常规用量。
本发明与现有技术相比，具有如下有益效果：
本发明提供的增加更年期妇女骨密度的组合物是以乳矿物盐作为优质钙补剂来源，通过大豆提取物、胶原蛋白粉和初乳碱性蛋白粉配合应用。经试验研究证明，各组分之间具有协同增效作用，在达到增加骨密度，改善骨质疏松的同时，还能够调节更年期女性激素水平，降低血清丙二醛水平，提高血清超氧化物歧化酶水平，改善妇女更年期综合征症状。
具体实施方式
下面通过具体实施方式来进一步说明本发明，以下实施例为本发明具体的实施方式，但本发明的实施方式并不受下述实施例的限制。
本发明实施例及对比例所采用的原料均来源于市购产品。
实施例1：人体试验
1、试验组别如表1所示：
表1 实施例和对比例组方
以上各组方按照产品功效成分核算为：
组合4（SI组20例，总黄酮60mg/天）；组合1（Ca组30例，总钙500mg/天）；组合5（CaSI组20例，总钙500mg/天，总黄酮60mg/天）。
效果试验
2.1试验方法
采用随机对照干预方法，招募围绝经期女性同时合并骨量减少或骨质疏松患者70例，随机分组，分为：①组合4（SI组204例，总黄酮60mg/天）；②组合1（Ca组30例，总钙500mg/天）；③组合5（CaSI组20例，总钙500mg/天，总黄酮60mg/天）。试验食用量：每天2次，每次2片。分别于研究前、干预后6个月进行骨密度测量、更年期自我综合评定、疲劳量评定和焦虑、抑郁评分等。
骨密度测量
采用超声骨密度仪对受试者腕部骨密度进行测定。
血清各项指标测定
更年期自我综合评定
采用《女性更年期综合征自我诊断评定表》进行评价，包括12项症状评分，每项所得评分×该项加权系数后之和，为总评分。结果分级：>35分为重度，20-35分为中度，＜20分为轻度。
疲劳量评定
采用“疲劳评定量表-14（FS-14）”对疲劳程度进行评价，通过14道问题的回答，赋予分值，了解患者疲劳症状的严重程度。结果评价：1-8反映躯体疲劳，9-14反映脑力疲劳，分值越高，反映疲劳越严重。
焦虑、抑郁评分
分别采用《GAD-7焦虑症筛查量表》和《PHQ-9抑郁症筛查量表》进行评分。
统计分析
采用SPSS18.0进行数据统计分析。计量资料中服从正态分布的以均值±标准差（`x±s）表示。多组间均数比较采用方差分析，双侧α=0.05作为检验水准，P<0.05为差异具有统计学意义。
试验结果
2.3.1各组血清激素水平的变化
干预6个月后CaSI组较Ca组促黄体生成激素显著降低（p<0.05），促卵泡激素水平未见统计学差异；见表2。
表2 各组血清激素水平的变化
# p<0.05 vs Ca组。
2.3.2各组更年期综合征、疲劳、焦虑及抑郁评分情况
研究干预6个月，受试者疲劳评定、PHQ-9抑郁症及GAD-7焦虑症评分未见统计学差异，且各组干预前后也未见统计学差异（p>0.05）；干预6个月时，SI组和CaSI组更年期综合征评分较Ca组显著降低（p<0.05），见表3。
表3各组更年期综合征、疲劳、焦虑及抑郁评分情况
# p<0.05 vs Ca组。
各组血清抗氧化指标水平的比较
干预6个月时，CaSI组血清丙二醛水平较较SI组、Ca组显著降低（p<0.05），CaSI组和Ca组血清超氧化物歧化酶水平较SI组显著增高（p<0.05），而谷胱甘肽过氧化酶活性各组之间未见统计学差异（p>0.05）。各组干预前后比较：SI组、Ca组及CaSI组干预6个月时较开始血清谷胱甘肽过氧化酶显著升高，CaSI组血清谷胱甘肽过氧化酶升高的更显著；Ca组和CaSI组干预6个月时较开始血清丙二醛显著降低，CaSI组血清丙二醛的降低更显著，见表4。
表4各组血清抗氧化水平的比较
*P<0.05 vs SI组；# p<0.05 vs Ca组；a P<0.05 vs 0个月。
各组骨密度情况比较
干预6个月时，CaSI组和Ca组骨密度SOS值较SI组显著增高（p<0.05），而且CaSI组骨密度T值也较SI组显著性增高（p<0.05）见表5。
表5 各组骨密度情况比较
*P<0.05 vs SI组。
实验结论
干预6个月，组合5长期干预能够降低促黄体生成激素水平，证明长期服用组合5较单独服用组合4能够调节更年期女性激素水平；并且长期服用组合5能够降低更年期综合征评分，改善了更年期女性的症状；组合5能够降低血清丙二醛水平，提高血清超氧化物歧化酶水平，改善受试者更年期症状。在骨质改善方面，组合5能改善骨质，并且组合5能够显著改善骨质疏松。
实施例2：动物功效试验
1.1试验组别如表6示：
表6实施例和对比例组方
1.2效果试验
1.2.1试验方法
按照《保健食品检验与评价技术规范》（2003版）“增加骨密度”中对动物的骨钙含量、骨密度测定、钙吸收率三方面进行试验。
1.2.1.1剂量选择
根据样品的人体推荐用量，1.05g/片，每天2次，每次2片，按照成人体重按60kg计算，折合剂量70mg/kg BW。设一个剂量组2.1g/kg BW(相当于人体推荐剂量的30倍)，设一个低钙对照组（150mg/100g饲料）和一个碳酸钙对照组（与2.1g/kg BW钙水平相同的碳酸钙对照组）。
将各组样品掺入低钙饲料中喂养，按体重的8%折算。另在低钙饲料的基础上掺入0.69%碳酸钙，制成碳酸钙对照组饲料。
将各组方给予动物自由摄食；低钙对照组动物给予低钙饲料（150mg/100g饲料）；在低钙饲料的基础上，掺入与2.1g/kg BW剂量组钙水平相同的碳酸钙（2.10×10.5%÷0.4=0.55%碳酸钙），给予碳酸钙对照组动物摄食。
1.2.1.2试验步骤
1.2.1.2.1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°C烤箱中烤至恒重，称量骨干重。
1.2.1.2.2股骨骨密度测定
用单光子骨密度仪测量股骨中点及股骨远心端的骨密度。
1.2.1.2.3骨钙含量及饲料含钙量测定
用原子吸收法测定。
1.2.1.2.4代谢实验
实验3周后进行3天钙代谢实验。记录3天进食量，收集72小时粪便，测定饲料及粪便中钙含量，计算钙的表观吸收率。饲料及粪便中改的测定方法：用原子吸收法测定。样品消化：同骨钙消化。测定按照原子吸收分光光度计仪器说明书的步骤进行。测定液、标准溶液和空白均用氧化镧溶液稀释。
摄入钙（mg/天）=饲料中钙含量（mg/g）×饲料消费量（g/天）；
粪钙（mg/天）=粪便中钙含量（mg/g）×粪便排出量（g/天）；
钙的表观消化率（%）=（摄入钙-粪钙）/摄入钙×100%。
1.2.1.3试验数据处理
试验数据处理用方差分析进行统计处理；但如果试验数据方差不齐，则改用秩和检验统计分析。
1.2.2 试验结果判定
受试样品钙的吸收率如与相同钙摄入水平的碳酸钙相近而无显著性差异，受试样品可以作为补钙剂。受试样品钙的吸收率若在两种钙摄入水平上均显著高于相同水平碳酸钙，则可以判定受试样品为“钙吸收率较高”。
骨钙含量或骨密度显著高于低钙对照组且不低于相应剂量碳酸钙对照组，钙的吸收率不低于碳酸钙对照组，可判定受试物具有增加骨密度功能的作用。
1.3试验结果
1.3.1样品对钙的表观吸收率的影响
从下表7可见，组合5和组合6钙的表观吸收率与相同水平的碳酸钙对照组比较，差异无显著性意义（P＞0.05），表明该受试样品可以作为补钙剂。
表7样品对钙的表观吸收率的影响
1.3.2样品对股骨重量、骨钙含量及骨密度的影响
从下表8可见，各实验组动物右侧股骨重量与低钙对照组比较增加，但骨钙含量与低钙对照组比较差异无统计学意义（P＞0.05）。各实验组动物左侧股骨中点及远端骨密度与低钙对照组比增加，其中组合5和组合6的中点及远端骨密度显著高于低钙对照组（P＜0.05）且不低于相应剂量的碳酸钙对照组，表明该样品的骨密度实验结果呈阳性。
表8样品对股骨重量、骨钙含量及骨密度的影响
*表示各组与低钙对照组比较 P＜0.05。
1.4结果评价
根据《保健食品检验与评价技术规范》（2003年版）中增加骨密度功能检验方法判定标准判断，组合5和组合6具有增加骨密度功能。
实施例3：片剂的制备
一种增加更年期妇女骨密度的片剂，按重量分数计，包括乳矿物盐500份、大豆提取物70份、胶原蛋白粉50份、初乳碱性蛋白粉30份、微晶纤维素30份、异麦芽酮糖醇20份、糊精15份、羟丙纤维素5份、聚维酮K30 5份、硬脂酸镁1份、包衣粉2份。
其制备方法为：将乳矿物盐、大豆提取物、异麦芽酮糖醇、糊精混合15分钟至物料色泽质地均匀，得混合物料1；将聚维酮K30与适量的纯化水配制成聚维酮K30溶液；将聚维酮K30溶液与混合物料1进行混合制软材，软材达到握之成团、搓之即散后，16目筛制粒，干燥，整粒，再将所有物料混合，得混合物料2，最后压片，包衣粉包衣即得。
Claims (8)
1.一种增加更年期妇女骨密度的组合物，其特征在于，由如下组分制成：乳矿物盐、大豆提取物、胶原蛋白粉、初乳碱性蛋白粉。
2.根据权利要求1所述的一种增加更年期妇女骨密度的组合物，其特征在于，按重量份数计，由如下组分制成：
乳矿物盐300-600份、大豆提取物60-80份、胶原蛋白粉30-60份、初乳碱性蛋白粉20-40份。
3.根据权利要求2所述的一种增加更年期妇女骨密度的组合物，其特征在于，按重量份数计，由如下组分制成：
乳矿物盐500份、大豆提取物70份、胶原蛋白粉50份、初乳碱性蛋白粉30份。
4.根据权利要求1～3任一项所述的一种增加更年期妇女骨密度的组合物，其特征在于，所述大豆提取物中大豆异黄酮的重量含量为10-50%。
5.根据权利要求1～3任一项所述的一种增加更年期妇女骨密度的组合物，其特征在于，所述初乳碱性蛋白粉的分子量为1-30kDa。
6.根据权利要求1～5任一项所述的组合物在制备增加更年期妇女骨密度的保健品中的应用。
7.一种增加更年期妇女骨密度的保健品，其特征在于，由权利要求1～5任一项所述的组合物和保健品中可接受的辅料制成。
8.根据权利要求7所述的保健品，其特征在于，所述保健品的剂型为片剂、胶囊剂、粉剂、颗粒剂、丸剂或口服液，优选为片剂。
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