CN110946994A - 一种增加骨密度的组合物及其制备方法 - Google Patents
一种增加骨密度的组合物及其制备方法 Download PDFInfo
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- CN110946994A CN110946994A CN201911394861.1A CN201911394861A CN110946994A CN 110946994 A CN110946994 A CN 110946994A CN 201911394861 A CN201911394861 A CN 201911394861A CN 110946994 A CN110946994 A CN 110946994A
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Abstract
本发明属于保健食品技术领域,具体地涉及一种增加骨密度的组合物及其制备方法;其原料包括胶原蛋白肽、碳酸钙、D‑氨基葡萄糖盐酸盐、硫酸软骨素、微晶纤维素、聚维酮K30、硬脂酸镁、香精和三氯蔗糖;所制备的组合物主要功效成分为维生素D3、硫酸软骨素、氨基葡萄糖盐酸盐和钙,本产品能够促进软骨再生,修复损伤的关节软骨,合成、补充关节滑液,润滑关节软骨表面,抑制各种破坏软骨的酶的活性,清除关节腔内的有害物质,提高关节和机体免疫能力。
Description
技术领域
本发明属于保健食品技术领域,具体地涉及一种增加骨密度的组合物及其制备方法。
背景技术
骨质疏松是全身骨质减少的一种现象,主要表现为骨骼中基质的含量明显减少,而骨骼中矿物质(主要是钙、磷)的成分基本正常。骨质疏松时,骨骼中蛋白质等有机类物质及水分的含量减少而钙、磷等矿物质含量相对保持在正常水平。由于骨基质在钙、磷等矿物质之间起支持和连接作用,所以如果骨基质减少,则矿物质之间的间隙就增大,表现为骨质疏松。随着骨质疏松的进展,骨骼中钙、磷等矿物质也会不断丢失及减少,从而造成骨骼中骨基质和矿物质都减少的现象。
骨质疏松症(Osteoporosis,OP)是一种常见的老年退行性疾病。据报道,全世界约2亿人患有骨质疏松,其发病率跃居老年人常见病、多发病的第七位。随着社会人口的老龄化,该病的发病率正日益上升,成为严重影响我国老年人健康的重要疾病。因此,有必要设计一种增加骨密度的组合物及其制备方法,以解决上述问题。
发明内容
本发明的目的在于提供一种增加骨密度的组合物及其制备方法。
本发明解决其技术问题所采取的技术方案是:
一种增加骨密度的组合物,其各原料重量组份为:胶原蛋白肽0-600份、碳酸钙250-450份、D-氨基葡萄糖盐酸盐100-475份、硫酸软骨素0-245份、维生素D3 0.0001-0.004份、聚维酮K3016-84份、微晶纤维素0-270份、硬脂酸镁3-15.6份、香精0-8份、三氯蔗糖0-13份。
优选的,所述增加骨密度的组合物,其各原料重量组份为:胶原蛋白肽200份、碳酸钙320份、D-氨基葡萄糖盐酸盐150份、硫酸软骨素136份、维生素D30.0025份、聚维酮K3020份、微晶纤维素169.5份、硬脂酸镁4份、香精6份、三氯蔗糖10份。
一种增加骨密度的组合物的制备方法,包括以下工艺步骤:
(1)原料制备:按重量组分称取胶原蛋白肽、碳酸钙、D-氨基葡萄糖盐酸盐、硫酸软骨素、微晶纤维素、聚维酮K30、硬脂酸镁、香精和三氯蔗糖,分别过80目筛,备用;按重量组分称取维生素D3,过60目筛,备用;
(2)碳酸钙制粒:
S1、制软材:将步骤(1)过筛后的碳酸钙与聚维酮K30、纯化水混合进行搅拌软化,以手轻握成团,捏之即散为度,备用;
S2、制粒:利用高效湿法混合制粒机,将步骤S1制得的物料,制成粒并过16目筛,得湿粒备用;
S3、干燥:将步骤S2制得湿颗粒物放入高效沸腾制粒干燥机内干燥,在温度为75-85℃下干燥,使得物料颗粒的含水量<2%时,过18目筛整粒,得碳酸钙颗粒,备用;
(3)硫酸软骨素制粒:
L1、制软材:将步骤(1)过筛后的硫酸软骨素、聚维酮K30、微晶纤维素、体积分数为50%的乙醇溶液混合进行搅拌软化,以手轻握成团,捏之即散为度,备用;
L2、制粒:利用高效湿法混合制粒机,将步骤L1制得的物料,制成粒并过16目筛,得湿粒备用;
L3、干燥:将步骤L2制得湿颗粒物放入热风循环烘箱内干燥,在温度为60-70℃下干燥,使得物料颗粒的含水量<5%时,过18目筛整粒,得硫酸软骨素颗粒,备用;
(4)混合:将质量分数为1.5-2.5%的微晶纤维素与维生素D3等量递增进行混合,搅拌均匀,得混合粉A,备用。
(5)总混:D-氨基葡萄糖盐酸盐、碳酸钙颗粒、剩余质量分数约84%的微晶纤维素、硫酸软骨素颗粒、胶原蛋白肽与混合粉A混合30分钟,混合均匀,得总混合粉A,备用;总混合粉A与硬脂酸镁、三氯蔗糖混合10分钟,混合均匀,得总混合粉B,备用;
(6)成型:将总混合粉B制成片剂或颗粒剂;
(7)包装:进行内包装和外包装。
优选的,所述步骤(7)采用的包装材料为口服固体药用高密度聚乙烯瓶(质量标准符合:YBB00122002的要求)或聚酯/镀铝聚酯/聚乙烯药品包装用复合膜(质量标准执行YBB00172002的要求)或包装材料标准符合“GB4806.7食品安全国家标准食品接触用塑料材料及制品”。
优选的,所述步骤S1中各组分重量比如下,碳酸钙:聚维酮K30:纯化水=100:1.84:15.96。
优选的,所述步骤L1中各组分重量比如下,硫酸软骨素:聚维酮K30:微晶纤维素:体积分数为50%的乙醇溶液=100:3:17:49。
本发明所述步骤(2)和步骤(3)的执行顺序不进行限制,可以先执行步骤(2),再执行步骤(3),或先执行步骤(3),再执行步骤(4),或同时执行步骤(2)和步骤(3)。
碳酸钙:钙是人体的生命之源,是人体含量最丰富的无机元素,总量超过1千克,有人体“生命元素”的美誉,同时又是一种非常重要的电解质,对骨质形成、维持神经与肌肉的正常兴奋性、降低毛细血管的通透性具有相当重要的作用。
D-氨基葡萄糖盐酸盐:氨基葡萄糖盐酸盐是甲壳素在盐酸中经充分降解得到的壳寡糖衍生物,是一种在人体内具有重要生理意义的海洋生物制剂。它具有重要的生理功能,能促进人体黏多糖合成,提高关节滑液黏性,有利于关节软骨的代谢和修复,并有明显的消炎镇痛作用。具有抗炎、抗肿瘤、免疫调节、增加骨密度、防腐抗菌等药理作用。
硫酸软骨素:硫酸软骨素是从动物的喉骨、鼻中隔、气管等软骨组织中提取、纯化所得到的黏性多糖,具多种异构体,主要有硫酸软骨素A和硫酸软骨素C两种。硫酸软骨素临床多用于神经性头痛、神经痛、关节炎、冠心病、偏头痛和动脉粥样硬化的辅助治疗,具有抗凝血、调节细胞黏附、调节炎症、调节免疫、阻碍血管生成、抗氧化等多种药理活性,国内除药用外,还大量应用于保健食品中。
维生素D3:促进肠道钙吸收,诱导骨质钙磷沉着和防止佝偻病。
胶原蛋白肽:胶原蛋白肽是一种细胞外蛋白质,它是曲3条肽链拧成螺旋形的纤维状蛋白质,胶原蛋白是人体内含量最丰富的蛋白质,占全身总蛋白质的1/3。胶原蛋白肽可促进骨的形成,增强低钙水平下的骨胶原结构,从而提高了骨强度,即达到了预防骨质疏松症的作用。
产品以现代医学理论为基础,以碳酸钙、D-氨基葡萄糖盐酸盐、硫酸软骨素、维生素D3、胶原蛋白肽等为主要原料组方制成。产品氨糖和硫酸软骨素、钙、维生素D相互配合可刺激新软骨的合成,强化软骨细胞分子、透明质酸的合成(粘多糖、粘多蛋白、胶原蛋白、核糖核酸和脱氧核糖核酸),同时抑制噬软骨酶的活动,加强软骨修复,消除骨关节炎症,减缓关节疼痛,改善关节功能,补充钙质和营养,加强骨关节抵抗力,为骨骼关节营造一个健康环境。
本发明的技术效果:与现有技术相比,本发明的一种增加骨密度的组合物,碳酸钙比重大、力度小,混料过程易出现混料不均匀,压片过程易造成裂片,制粒工艺后有效解决的混料难、裂片现象;硫酸软骨素具有极强的吸水性,直接添加遇水吸湿抱团,易出现崩解难的情况,制粒以后可有效防止该情况的发生,改善崩解情况,同时防止吸水裂片、质量不合格现象。同时,还具有以下有益效果:
修:促进软骨再生,修复损伤的关节软骨,使软骨表面变得平滑、厚实有弹性,恢复关节正常的生理和运动功能;
补:合成、补充关节滑液,润滑关节软骨表面,减少骨关节间的摩擦及震动,从而减缓软骨退化;
清:抑制各种破坏软骨的酶的活性,清除关节腔内的有害物质,减轻软骨和周围软组织损伤;
提:提高关节和机体免疫能力防止有害因子增多损伤关节软骨及周围软组织;防止软组织退化引发的各种疾病及症状,如腰酸腿软、关节炎等。
具体实施方式
下面通过具体实施例对本发明作进一步说明。
实施例1:
本实施例制备的增加骨密度的组合物,其各原料重量组份为:碳酸钙320份、D-氨基葡萄糖盐酸盐150份、硫酸软骨素136份、维生素D30.0025份、聚维酮K3020份、微晶纤维素169.5份、硬脂酸镁4份。
一种增加骨密度的组合物的制备方法,包括以下工艺步骤:
(1)原料制备:按重量组分称取胶原蛋白肽、碳酸钙、D-氨基葡萄糖盐酸盐、硫酸软骨素、微晶纤维素、聚维酮K30、硬脂酸镁、香精和三氯蔗糖,分别过80目筛,备用;按重量组分称取维生素D3,过60目筛,备用;
(2)碳酸钙制粒:
S1、制软材:将步骤(1)过筛后的碳酸钙与聚维酮K30、纯化水混合进行搅拌软化,以手轻握成团,捏之即散为度,备用;
S2、制粒:利用高效湿法混合制粒机,将步骤S1制得的物料,制成粒并过16目筛,得湿粒备用;
S3、干燥:将步骤S2制得湿颗粒物放入高效沸腾制粒干燥机内干燥,在温度为75-85℃下干燥,使得物料颗粒的含水量<2%时,过18目筛整粒,得碳酸钙颗粒,备用;
(3)硫酸软骨素制粒:
L1、制软材:将步骤(1)过筛后的硫酸软骨素、聚维酮K30、微晶纤维素、体积分数为50%的乙醇溶液混合进行搅拌软化,以手轻握成团,捏之即散为度,备用;
L2、制粒:利用高效湿法混合制粒机,将步骤L1制得的物料,制成粒并过16目筛,得湿粒备用;
L3、干燥:将步骤L2制得湿颗粒物放入热风循环烘箱内干燥,在温度为60-70℃下干燥,使得物料颗粒的含水量<5%时,过18目筛整粒,得硫酸软骨素颗粒,备用;
(4)混合:将质量分数为1.5-2.5%的微晶纤维素与维生素D3等量递增进行混合,搅拌均匀,得混合粉A,备用。
(5)总混:D-氨基葡萄糖盐酸盐、碳酸钙颗粒、剩余质量分数约84%的微晶纤维素、硫酸软骨素颗粒、胶原蛋白肽与混合粉A混合30分钟,混合均匀,得总混合粉A,备用;总混合粉A与硬脂酸镁、三氯蔗糖混合10分钟,混合均匀,得总混合粉B,备用;
(6)成型:将总混合粉B制成片剂或颗粒剂;
(7)包装:进行内包装和外包装。
优选的,所述步骤(7)采用的包装材料为口服固体药用高密度聚乙烯瓶(质量标准符合:YBB00122002的要求)或聚酯/镀铝聚酯/聚乙烯药品包装用复合膜(质量标准执行YBB00172002的要求)或包装材料标准符合“GB4806.7食品安全国家标准食品接触用塑料材料及制品”。
优选的,所述步骤S1中各组分重量比如下,碳酸钙:聚维酮K30:纯化水=100:1.84:15.96。
优选的,所述步骤L1中各组分重量比如下,硫酸软骨素:聚维酮K30:微晶纤维素:体积分数为50%的乙醇溶液=100:3:17:49。
优选的,所述步骤(6)将总混合粉B加入香精放入高速压片机中压片,制成片剂,片剂含水量不大于2.5%,规格为0.80g/片或1.25g/片。
优选的,所述步骤(6)将总混合粉B加入香精放入沸腾制粒机中制成颗粒剂,颗粒剂含水量不大于2.5%,规格为3.0g/袋或6.0g/袋。
本发明所述步骤(2)和步骤(3)的执行顺序不进行限制,可以先执行步骤(2),再执行步骤(3),或先执行步骤(3),再执行步骤(4),或同时执行步骤(2)和步骤(3)。
本实施例制备的增加骨密度的组合物,其主要功效成分如表1所示:
表1主要功效成分表
从表1中可以看出,主要功效成分为维生素D3、硫酸软骨素、氨基葡萄糖盐酸盐和钙,本产品能够促进软骨再生,修复损伤的关节软骨,合成、补充关节滑液,润滑关节软骨表面,抑制各种破坏软骨的酶的活性,清除关节腔内的有害物质,提高关节和机体免疫能力。
毒理性实验:
样品:样品为片剂,由东营广元生物工程有限公司提供,白色,0.8g/片,人体每日推荐用量为3.2g/60kg.bw。
试验动物:选用山东大学实验动物中心提供的健康SPF级昆明种小鼠,实验环境温度22'C土2C,相对湿度50%土10%。
小鼠急性毒性试验:采用最大耐受量(MTD)试验。健康昆明种小鼠20只,雌雄各半,体重为18g~22g。称取受试物20g,用蒸馏水溶解并定容至40ml,小鼠空腹16h后,间隔4h,以0.20m1/10g.bw容量灌胃2次,总剂量为20.0g/kg.bw灌胃,连续观察14天,记录中毒表现及死亡情况。
结果:急性毒性试验由表2可见,将受试样品以20.0g/kg.bw的剂量给小鼠灌胃后,观察14天,两种性别的小鼠均未见明显的中毒症状,也无死亡。将受试动物处死后进行解剖检查,肝脏、脾脏、肾脏、心脏、肺、胃、肠等主要器官,均未见明显异常改变。受试样品对两种性别小鼠的最大耐受剂量(MTD)均大于20.0g/kg.bw,符合《保健食品检验与评价技术规范》中的急性毒性分级标准,属无毒级。
表2对小鼠的急性毒性试验结果
功能试验:
样品:样品白色片剂,由东营广元生物工程有限公司提供。人体推荐剂量为3.2g/60kg.bw,其中钙摄入量为544mg/d。
实验动物:选用山东大学实验动物中心提供的SPF级出生4周左右的断乳Wistar雄性大鼠,体重约60-75克。实验环境温度22C+2C,相对湿度50%+10%。经适应期一周后,禁食12小时,称体重,根据体重随机分为对低钙对照组、碳酸钙对照组、低、中、高剂量组,每组9只大鼠。
剂量设置与受试物给予方式:推荐摄入量为每人每日3200mg(稳定性试验实测钙含量为17%),每人按60kg体重计,相当于每日53.3mg/kg.bw。按相当于人体推荐量的5倍、10倍、30倍确定大鼠的低、中、高剂量,即各组大鼠每日食用量分别为267mg/kg.bw、533mg/kg.bw、1600mg/kg bw。各组均喂低钙基础饲料,饮用去离子水。经口每日一次灌胃给予大鼠受试物,灌胃体积按1mL100g.bw计,低、中、高剂量组受试物溶液的浓度分别为26.7mg/mL.533mg/mL和160mg/mL;碳酸钙对照组的每日碳酸钙(其中钙含量为40%)食用量确定为680mg/kg.bw(含钙量与高剂量组相同,即272m/kgbw),灌胃碳酸钙溶液浓度为68mg/mL:低钙对照组以等体积的去离子水代替受试物溶液灌胃。连续给予3个月后测试增加骨密度功能的各项指标。
低钙基础饲料配方如表3所示:
表3
低钙基础饲料配方(Ca2+计,150mg/100g饲料)
主要仪器与试剂:美国NORLAND-Stratec周围型双能X线骨密度仪(pDEXA)、动物解剖器械、动物天平、105C烘箱、碳酸钙标准溶液、氢氧化钾、EDTA溶液。
实验方法:
体重测定:禁食12小时后,测定体重。每周测定动物体重一次。
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。
骨钙含量及饲料中钙含量测定:低钙基础饲料样品经均匀混合,在烘箱中烘干,置干燥器中冷却,取出研磨。取大鼠右侧股骨在105'C烘箱中烘干至恒重,称量骨干重,然后粉碎、研磨、消化。用EDTA滴定法测定低钙基础饲料和股骨样品中钙含量。低钙基础饲料中钙含量为146.0mg/100g,符合实验要求。
股骨骨密度测定:用美国产NORLAND STRATEC周围型双能X线骨密度仪测量股骨中点及股骨远心端的骨密度。
验数据统计:采用SPSS统计软件进行各实验组与对照组的单因素方差分析和组间比较。
结果:
表4各组动物股骨重量
与低钙对照组比较*P<0.05,**P<0.01
由表4可见,与低钙对照组相比,中、高剂量组和碳酸钙组股骨重量差异均有统计学意义(P<0.05,P<0.01)。高剂量组股骨重量不低于同剂量碳酸钙对照组。
表5各组动物股骨钙含量
与低钙对照组比较*P<0.05,**P<0.01
由表5可见,与低钙对照组相比,中、高剂量组和碳酸钙组股骨钙含量差异有统计学意义(P<0.05,P<0.01)。高剂量组股骨钙含量不低于同剂量碳酸钙对照组。
表6各组动物股骨中点骨密度
与低钙对照组比较*P<0.05,**P<0.01
由6可见,与低钙对照组相比,中、高剂量组和碳酸钙组股骨中点骨密度差异均有统计学意义(P<0.05,P<0.01)。高剂量组股骨中点骨密度不低于碳酸钙组。
表7各组动物股骨远心端骨密度
与低钙对照组比较*P<0.05,**p<0.01
由表7可见,与低钙对照组相比,碳酸钙组、中、高剂量组股骨远心端骨密度差异均有统计学意义(P<0.05,P<0.01)。高剂量组股骨远心端骨密度不低于碳酸钙组。
本实验表明,经口给予大鼠不同剂量的增加骨密度的组合物白色片剂样品,中、高剂量能显著提高大鼠的骨重、骨钙含量、股骨中点及远心端骨密度,且不低于碳酸钙对照组,具有较好的增加骨密度功能。
上述具体实施方式仅是本发明的具体个案,本发明的专利保护范围包括但不限于上述具体实施方式的产品形态和式样,任何符合本发明权利要求书且任何所属技术领域的普通技术人员对其所做的适当变化或修饰,皆应落入本发明的专利保护范围。
Claims (9)
1.一种增加骨密度的组合物,其特征在于:其各原料重量组份为:胶原蛋白肽0-600份、碳酸钙250-450份、D-氨基葡萄糖盐酸盐100-475份、硫酸软骨素0-245份、维生素D30.0001-0.004份、聚维酮K30 16-84份、微晶纤维素0-270份、硬脂酸镁3-15.6份、香精0-8份、三氯蔗糖0-13份。
2.根据权利要求1所述的增加骨密度的组合物,其特征在于:所述增加骨密度的组合物的制备方法包括:
(1)原料制备:按重量组分称取胶原蛋白肽、碳酸钙、D-氨基葡萄糖盐酸盐、硫酸软骨素、微晶纤维素、聚维酮K30、硬脂酸镁、香精和三氯蔗糖,分别过80目筛,备用;按重量组分称取维生素D3,过60目筛,备用;
(2)碳酸钙制粒;
(3)硫酸软骨素制粒;
(4)混合:将质量分数为1.5-2.5%的微晶纤维素与维生素D3等量递增进行混合,搅拌均匀,得混合粉A,备用。
(5)总混:D-氨基葡萄糖盐酸盐、碳酸钙颗粒、剩余质量分数约84%的微晶纤维素、硫酸软骨素颗粒、胶原蛋白肽与混合粉A混合30分钟,混合均匀,得总混合粉A,备用;总混合粉A与硬脂酸镁、三氯蔗糖混合10分钟,混合均匀,得总混合粉B,备用;
(6)成型:将总混合粉B制成片剂或颗粒剂;
(7)包装:进行内包装和外包装。
3.根据权利要求2所述的增加骨密度的组合物,其特征在于:所述步骤(2)包括:
S1、制软材:将步骤(1)过筛后的碳酸钙与聚维酮K30、纯化水混合进行搅拌软化,以手轻握成团,捏之即散为度,备用;
S2、制粒:利用高效湿法混合制粒机,将步骤S1制得的物料,制成粒并过16目筛,得湿粒备用;
S3、干燥:将步骤S2制得湿颗粒物放入高效沸腾制粒干燥机内干燥,在温度为75-85℃下干燥,使得物料颗粒的含水量<2%时,过18目筛整粒,得碳酸钙颗粒,备用。
4.根据权利要求3所述的增加骨密度的组合物,其特征在于:所述步骤(3)包括:
L1、制软材:将步骤(1)过筛后的硫酸软骨素、聚维酮K30、微晶纤维素、体积分数为50%的乙醇溶液混合进行搅拌软化,以手轻握成团,捏之即散为度,备用;
L2、制粒:利用高效湿法混合制粒机,将步骤L1制得的物料,制成粒并过16目筛,得湿粒备用;
L3、干燥:将步骤L2制得湿颗粒物放入热风循环烘箱内干燥,在温度为60-70℃下干燥,使得物料颗粒的含水量<5%时,过18目筛整粒,得硫酸软骨素颗粒,备用。
5.根据权利要求3所述的增加骨密度的组合物,其特征在于:所述步骤S1中各组分重量比如下,碳酸钙:聚维酮K30:纯化水=100:1.84:15.96。
6.根据权利要求4所述的增加骨密度的组合物,其特征在于:所述步骤L1中各组分重量比如下,硫酸软骨素:聚维酮K30:微晶纤维素:体积分数为50%的乙醇溶液=100:3:17:49。
7.根据权利要求2所述的增加骨密度的组合物,其特征在于:先执行步骤(2),再执行步骤(3),或先执行步骤(3),再执行步骤(4),或同时执行步骤(2)和步骤(3)。
8.根据权利要求2所述的增加骨密度的组合物,其特征在于:所述步骤(6)将总混合粉B加入香精放入高速压片机中压片,制成片剂,片剂含水量不大于2.5%。
9.根据权利要求2所述的增加骨密度的组合物,其特征在于:所述步骤(6)将总混合粉B加入香精放入沸腾制粒机中制成颗粒剂,颗粒剂含水量不大于2.5%。
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