CN114028535B - 一种促进骨折愈合的富硒地龙蛋白组合物及其制备方法 - Google Patents
一种促进骨折愈合的富硒地龙蛋白组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开一种促进骨折愈合的富硒地龙蛋白组合物及其制备方法,由下列重量份的原料制成:地龙蛋白95~110份、富硒麦芽粉17~32份、牛骨胶原蛋白肽粉18~22份、南极磷虾肽20~35份、小麦低聚肽15~25份、黄精提取物10~20份、桃仁提取物10~25份、枸杞提取物10~20份、木糖醇60~70份、预胶化淀粉80~130份、食品添加剂88~133份。本发明采用多种蛋白肽协同,经富硒成分强化,辅以祛瘀补益药食两用活性成分,有利于促进骨痂重塑,具有促进软骨基质合成、软骨细胞分化成熟的作用,使其提前度过软骨基质合成高峰期,向软骨细胞成熟与矿化迈进,对促进骨折愈合具有显著疗效。
Description
技术领域
本发明涉及食品技术领域,更具体地,涉及一种促进骨折愈合的富硒地龙蛋白组合物及其制备方法。
背景技术
骨折是由外力作用、骨骼疾病等引起的骨或骨小梁的连续性中断,容易造成骨折延迟愈合或不愈合的现象。治疗骨折的方法主要有中医治疗和西医治疗。骨折的愈合是一个极其复杂的过程,需要经过“瘀去、新生、骨合”的过程,一般分为炎症反应期、修复期和塑型期三个阶段。有统计数据显示,长骨开放性骨折后出现骨不连现象的患者占17%,骨骼出现延迟愈合的患者占8%,严重影响患者健康及日常生活。骨折延迟愈合引起的高致残率与I型糖尿病、中风或获得性免疫缺陷征对患者产生的影响相当。
目前还没有被批准的药物用于加速骨折愈合或治疗骨不连。当下治疗骨折的方法主要有中医治疗和西医治疗。西医治疗骨折的主要方法有开刀手术、上钢板钢钉固定、石膏固定、打针吊水、在家静养等,这样的治疗方法非常缓慢,用于骨折治疗的西药主要有生长激素、骨生长因子、类固醇激素等药物,具有副作用,大多数患者难以接受。中医治疗骨折的方法有内敷、外服、外洗等,传统的中医疗法虽然对骨折愈合具有一定的疗效,但控制症状收效缓慢,愈合只能等到生理自然愈合期,并没有缩短患者的病程和痛苦期。所以人们期望采取膳食治疗的方法辅助临床治疗,加快患者骨折愈合速度;因此,通过膳食治疗来加快骨折愈合成为迫切需求。针对现有技术存在的问题,迫切需要一种从天然无副作用的功能食品出发,研发出既可有效促进骨折愈合,同时又具有携带方便、口感好的组合物。
发明内容
有鉴于此,本发明的目的之一在于提供一种促进骨折愈合的富硒地龙蛋白组合物,以解决现有技术中存在的问题。
为实现上述目的,本发明的技术方案为:
一种促进骨折愈合的富硒地龙蛋白组合物,由下列重量份的原料制成:地龙蛋白95~110份、富硒麦芽粉17~32份、牛骨胶原蛋白肽粉18~22份、南极磷虾肽20~35份、小麦低聚肽15~25份、黄精提取物10~20份、桃仁提取物10~25份、枸杞提取物10~20份、木糖醇60~70份、预胶化淀粉80~130份、食品添加剂88~133份。
优选的,所述食品添加剂包括:微晶纤维素80~120份、柠檬酸钠2~5份、硬脂酸镁6~8份。
优选的,一种促进骨折愈合的富硒地龙蛋白组合物,由下列重量份的原料制成:地龙蛋白95~105份、富硒麦芽粉23~27份、牛骨胶原蛋白肽19~21份、南极磷虾肽23~27份、小麦低聚肽18~22份、黄精提取物13~17份、桃仁提取物12~18份、枸杞提取物12~18份、木糖醇62~68份、预胶化淀粉90~110份、微晶纤维素90~110份、柠檬酸钠2~3份、硬脂酸镁7~8份。
优选的,一种促进骨折愈合的富硒地龙蛋白组合物,由下列重量份的原料制成:地龙蛋白100份、富硒麦芽粉25份、牛骨胶原蛋白肽粉20份、南极磷虾肽25份、小麦低聚肽20份、黄精提取物15份、桃仁提取物15份、枸杞提取物15份、木糖醇65份、预胶化淀粉100份、微晶纤维素100份、柠檬酸钠2.5份、硬脂酸镁7.5份。
本发明的目的之二在于提供一种上述促进骨折愈合的富硒地龙蛋白组合物的制备方法,包括以下步骤:
1)配料:按照以下原料重量比例:地龙蛋白95~110份、富硒麦芽粉17~32份、牛骨胶原蛋白肽粉18~22份、南极磷虾肽20~35份、小麦低聚肽15~25份、黄精提取物10~20份、桃仁提取物10~25份、枸杞提取物10~20份、木糖醇60~70份、预胶化淀粉80~130份、微晶纤维素80~120份、柠檬酸钠2~5份、硬脂酸镁6~8份,称取每种原料;
2)粉碎过筛:将木糖醇、柠檬酸钠分别经粉碎机粉碎后过80目筛;将地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、黄精提取物提取物、桃仁提取物提取物、枸杞提取物提取物分别过60目筛,备用;
3)预混:将称量好的柠檬酸钠、硬脂酸镁于聚乙烯袋中手工预混2~5分钟,得预混料;
4)总混:将预混物料与地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、木糖醇、黄精提取物、桃仁提取物、枸杞提取物、预胶化淀粉、微晶纤维素分别置于混合机中混合,混合时间为10min~20min,出料,得到总混物;
5)压片、包衣:将步骤4)所得总混物经压片和包衣后得成品。
优选的,步骤4)中,还包括将所得总混物经60目筛过筛处理。
优选的,步骤5)中,压片时,设置冲模直径12.0mm,理论片重0.5g,片剂硬度控制为80N~150N;包衣时,控制薄膜包衣浆浓度14%,高效包衣机进风温度设定为60℃。
本发明的有益效果在于:本发明提供的促进骨折愈合的富硒地龙蛋白组合物,采用多种蛋白肽协同,经富硒成分强化,辅以祛瘀补益药食两用活性成分,有利于促进骨痂重塑,具有促进软骨基质合成、软骨细胞分化成熟的作用,使其提前度过软骨基质合成高峰期,向软骨细胞成熟与矿化迈进,对促进骨折愈合具有显著疗效。
具体实施方式
在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施的限制。
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的,不是旨在于限制本发明。
本发明提供一种促进骨折愈合的富硒地龙蛋白组合物,由下列重量份的原料制成:地龙蛋白95~110份、富硒麦芽粉17~32份、牛骨胶原蛋白肽粉18~22份、南极磷虾肽20~35份、小麦低聚肽15~25份、黄精提取物10~20份、桃仁提取物10~25份、枸杞提取物10~20份、木糖醇60~70份、预胶化淀粉80~130份、食品添加剂88~133份。
其中,地龙蛋白,即地龙中提取的蛋白,可增强组织细胞增殖和修复胶原蛋白,在创伤愈合和修复神经系统损伤方面具有非常好的疗效。
牛骨胶原蛋白肽:胶原蛋白肽能为表皮细胞的迁移、增殖铺垫支架,提供良好的营养支持,诱导生长因子,促进皮肤及神经增长,利于上皮细胞的增生修复,促进创面的愈合;同时可显著促进人成骨细胞的增值,具有良好的促进骨合成及代谢功效,预防骨质疏松。
南极磷虾肽:南极磷虾蛋白是一类生物价优于肉类蛋白和牛奶蛋白的优质蛋白,研究表明,南极磷虾肽可促进软骨形成及其肥大、促进软骨基质降解、血管入侵以及后期新骨生成来促进软骨内成骨进程,从而加速正常生长的开放性骨折模型小鼠的骨折愈合。
小麦低聚肽:是以谷朊粉为原料、经过定向酶切及特定的小肽分离技术获得的小分子多肽类混合物,主要成分是由2~6个氨基酸分子构成的小肽,味苦、水溶性好、分散稳定、易吸收、生物活性强等。小麦低聚肽中丰富的谷氨酰胺,是优良的谷氨酰胺补充剂,可调节机体骨骼肌细胞中蛋白质的含量,具有增强免疫力、抗氧化、降血压、降血脂、降血糖等生理活性功能。
富硒麦芽粉:是以小麦作为硒转化的活性载体,是一种富含天然有机硒的补硒产品,具有增强免疫、保护修复细胞、防癌抗癌以及防治心脑血管疾病等功能。硒元素缺乏,可引起骨代谢减缓、骨量减少和血钙含量降低等风险。
中医骨折三期辩证包括活血化瘀、接骨续筋、补骨壮骨。组方中桃仁,活血祛瘀、通络消肿;黄精,补气养阴,健脾益肾;枸杞,滋补肝肾,益精明目:组方祛瘀不伤正,补益而不壅滞。
木糖醇:骨折后的修复过程需要多量的钙质,骨折病人过多摄取白糖后会产生丙酮酸、乳酸等代谢产物,使机体呈酸性状态。机体就会动员钙、镁、钠等离子去参加对酸性产物的中和作用。这样势必会消耗较多的钙质,对骨折的修复不利。故而本组方选用木糖醇,口感好,在体内新陈代谢不需要胰岛素参与,不使血糖值升高,适用于老年人及糖尿病人食用。
以下通过具体实施例对本发明提出的促进骨折愈合的富硒地龙蛋白组合物及其制备方法进行具体说明:
实施例1
一种促进骨折愈合的富硒地龙蛋白组合物,由下列重量份的原料制成:地龙蛋白100份、富硒麦芽粉25份、牛骨胶原蛋白肽粉20份、南极磷虾肽25份、小麦低聚肽20份、黄精提取物15份、桃仁提取物15份、枸杞提取物15份、木糖醇65份、预胶化淀粉100份、微晶纤维素100份、柠檬酸钠2.5份、硬脂酸镁7.5份。
该促进骨折愈合的富硒地龙蛋白组合物的制备方法包括以下步骤:
1)配料:按照原理重量比准确称取每种原料,复核无误后,方可投料;
2)粉碎过筛:将木糖醇、柠檬酸钠分别经粉碎机粉碎后过80目筛;将地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、黄精提取物提取物、桃仁提取物提取物、枸杞提取物提取物分别过60目筛,备用;
3)预混:将称量好的柠檬酸钠、硬脂酸镁于聚乙烯袋中手工预混4分钟,得预混料;
4)总混:将预混物料与地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、木糖醇、黄精提取物、桃仁提取物、枸杞提取物、预胶化淀粉、微晶纤维素分别置于混合机中混合,混合时间为18min,出料,得到总混物;
将所得总混物经60目筛过筛处理;
5)压片、包衣:将步骤4)所得总混物经压片和包衣后得成品A;其中,压片时,设置冲模直径12.0mm,理论片重0.5g,片剂硬度控制为80N~150N;包衣时,控制薄膜包衣浆浓度14%,高效包衣机进风温度设定为60℃。
实施例2
一种促进骨折愈合的富硒地龙蛋白组合物,由下列重量份的原料制成:地龙蛋白95份、富硒麦芽粉17份、牛骨胶原蛋白肽粉18份、南极磷虾肽20份、小麦低聚肽15份、黄精提取物10份、桃仁提取物10份、枸杞提取物10份、木糖醇60份、预胶化淀粉80份、微晶纤维素80份、柠檬酸钠2份、硬脂酸镁8份。
该促进骨折愈合的富硒地龙蛋白组合物的制备方法包括以下步骤:
1)配料:按照原理重量比准确称取每种原料,复核无误后,方可投料;
2)粉碎过筛:将木糖醇、柠檬酸钠分别经粉碎机粉碎后过80目筛;将地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、黄精提取物提取物、桃仁提取物提取物、枸杞提取物提取物分别过60目筛,备用;
3)预混:将称量好的柠檬酸钠、硬脂酸镁于聚乙烯袋中手工预混3分钟,得预混料;
4)总混:将预混物料与地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、木糖醇、黄精提取物、桃仁提取物、枸杞提取物、预胶化淀粉、微晶纤维素分别置于混合机中混合,混合时间为12min,出料,得到总混物;
将所得总混物经60目筛过筛处理;
5)压片、包衣:将步骤4)所得总混物经压片和包衣后得成品B;其中,压片时,设置冲模直径12.0mm,理论片重0.5g,片剂硬度控制为80N~150N;包衣时,控制薄膜包衣浆浓度14%,高效包衣机进风温度设定为60℃。
实施例3
一种促进骨折愈合的富硒地龙蛋白组合物,由下列重量份的原料制成:地龙蛋白110份、富硒麦芽粉32份、牛骨胶原蛋白肽粉22份、南极磷虾肽35份、小麦低聚肽25份、黄精提取物20份、桃仁提取物25份、枸杞提取物20份、木糖醇70份、预胶化淀粉130份、微晶纤维素120份、柠檬酸钠5份、硬脂酸镁6份。
该促进骨折愈合的富硒地龙蛋白组合物的制备方法包括以下步骤:
1)配料:按照原理重量比准确称取每种原料,复核无误后,方可投料;
2)粉碎过筛:将木糖醇、柠檬酸钠分别经粉碎机粉碎后过80目筛;将地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、黄精提取物提取物、桃仁提取物提取物、枸杞提取物提取物分别过60目筛,备用;
3)预混:将称量好的柠檬酸钠、硬脂酸镁于聚乙烯袋中手工预混5分钟,得预混料;
4)总混:将预混物料与地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、木糖醇、黄精提取物、桃仁提取物、枸杞提取物、预胶化淀粉、微晶纤维素分别置于混合机中混合,混合时间为20min,出料,得到总混物;
将所得总混物经60目筛过筛处理;
5)压片、包衣:将步骤4)所得总混物经压片和包衣后得成品A;其中,压片时,设置冲模直径12.0mm,理论片重0.5g,片剂硬度控制为80N~150N;包衣时,控制薄膜包衣浆浓度14%,高效包衣机进风温度设定为60℃。
实施例4疗效试验
为了证实本发明具有促进骨折愈合的功效,用按实施例1方法制成的压片糖果,进行了以下动物实验研究:
取70只健康小鼠适应性饲养一周后,体积分数4%水合氯醛麻醉,于右胫中上1/3处进行胫骨开放性骨折手术。术后存活小鼠随机分为:骨折模型组(Model,生理盐水)、地龙蛋白压片糖果低剂量组(166.5mg/kg mb)、高剂量组(333.3mg/kg mb),每组21只。骨折术后第一天立即灌胃受试动物,每天一次,灌胃量均为10mL/kg mb。
1、对骨小梁数、骨体积/组织体积和骨小梁间距的影响试验
骨折术后21d,取下髓内针,用微型CT系统以70kV的电压和114μA的电流扫描小鼠右胫骨,扫描区域为骨折线近端3mm和远端3mm之间。使用匹配软件中的骨骼分析库功能计算形态参数(骨小梁数、骨体积/组织体积和骨小梁间距)。结果如表1所示,相比于模型组,低剂量的的骨体积/组织体积和骨小梁数极显著增加(P<0.01),骨小梁间距显著减少(P<0.05);高剂量组骨体积/组织体积和骨小梁数极显著增加(P<0.01),骨小梁间距极显著减少(P<0.01),即压片糖果干预有利于促进骨痂重塑。
表1:骨小梁数、骨体积/组织体积和骨小梁间距
分组 | 骨体积/组织体积 | 骨小梁数(mm2/mm3) | 骨小梁间距/mm |
模型组 | 0.32±0.37 | 3.81±0.85 | 0.28±0.44 |
低剂量组 | 0.37±0.76** | 4.15±1.13** | 0.26±0.37* |
高剂量组 | 0.45±0.43**## | 4.52±0.58**# | 0.25±0.22**# |
注:与模型组比,*P<0.05,**P<0.01,与低剂量组比,#P<0.05,##P<0.01。
2、对骨折愈合血清指标的影响
分别在术后5、10、21d,每组取7只小鼠禁食不禁水8h后摘眼球取血,分离血清用于相关指标的测定。Aggrecan标志着软骨基质的形成;VEGF是血管生成诱导因子,TGF-β是转化生长因子超家族中的一员,在软骨形成过程中具有促进软骨细胞分化和成熟的作用。
结果如表2-4所示,骨折术后第10天,与模型组相比,压片糖果干预显著降低了血清Aggrecan质量浓度(P<0.05);术后第21天,与模型组相比,压片糖果干预显著降低了血清Aggrecan质量浓度(P<0.05);血清TGF-β的质量浓度极显著升高(P<0.01);各组VEGF质量浓度均在术后第10天达到最高水平;术后第21天,高剂量组血清VEGF质量浓度较模型组极显著降低(P<0.01)。结果表明,压片糖果干预有促进软骨基质合成、软骨细胞分化成熟的作用,使其提前度过软骨基质合成高峰期,向软骨细胞成熟与矿化迈进。在愈合中后期较模型组可更早地进行血管重建从而促新骨生成,且高剂量效果优于低剂量。
表2:血清Aggrecan质量浓度(n=7,ng/ml)
分组 | 第5天 | 第10天 | 第21天 |
模型组 | 18.72±0.32 | 24.37±0.65 | 28.21±0.77 |
低剂量组 | 20.16±0.17* | 17.28±0.23* | 15.64±0.53* |
高剂量组 | 19.31±0.42* | 17.03±0.46* | 14.91±0.41* |
表3血清VEGF质量浓度(n=7,ng/ml)
分组 | 第5天 | 第10天 | 第21天 |
模型组 | 221.32±0.22 | 313.47±0.35 | 220.18±0.31 |
低剂量组 | 223.56±0.58 | 353.61±0.24 | 222.37±0.68 |
高剂量组 | 220.82±0.75 | 378.45±0.26* | 185.93±0.27**## |
表4血清TGF-β质量浓度(n=7,pg/ml)
分组 | 第5天 | 第10天 |
模型组 | 212.48±0.26 | 472..61±0.93 |
低剂量组 | 244.56±0.57 | 486.84±0.62** |
高剂量组 | 303.82±0.47**## | 500.27±0.26**# |
注:与模型组比,*P<0.05,**P<0.01,与低剂量组比,#P<0.05,##P<0.01。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (7)
1.一种促进骨折愈合的富硒地龙蛋白组合物,其特征在于,由下列重量份的原料制成:地龙蛋白95~110份、富硒麦芽粉17~32份、牛骨胶原蛋白肽粉18~22份、南极磷虾肽20~35份、小麦低聚肽15~25份、黄精提取物10~20份、桃仁提取物10~25份、枸杞提取物10~20份、木糖醇60~70份、预胶化淀粉80~130份、食品添加剂88~133份。
2.根据权利要求1所述的一种促进骨折愈合的富硒地龙蛋白组合物,其特征在于,所述食品添加剂包括:微晶纤维素80~120份、柠檬酸钠2~5份、硬脂酸镁6~8份。
3.根据权利要求2所述的一种促进骨折愈合的富硒地龙蛋白组合物,其特征在于,由下列重量份的原料制成:地龙蛋白95~105份、富硒麦芽粉23~27份、牛骨胶原蛋白肽粉19~21份、南极磷虾肽23~27份、小麦低聚肽18~22份、黄精提取物13~17份、桃仁提取物12~18份、枸杞提取物12~18份、木糖醇62~68份、预胶化淀粉90~110份、微晶纤维素90~110份、柠檬酸钠2~3份、硬脂酸镁7~8份。
4.根据权利要求3所述的一种促进骨折愈合的富硒地龙蛋白组合物,其特征在于,由下列重量份的原料制成:地龙蛋白100份、富硒麦芽粉25份、牛骨胶原蛋白肽粉20份、南极磷虾肽25份、小麦低聚肽20份、黄精提取物15份、桃仁提取物15份、枸杞提取物15份、木糖醇65份、预胶化淀粉100份、微晶纤维素100份、柠檬酸钠2.5份、硬脂酸镁7.5份。
5.一种促进骨折愈合的富硒地龙蛋白组合物的制备方法,其特征在于,包括以下步骤:
1)配料:按照以下原料重量比例:地龙蛋白95~110份、富硒麦芽粉17~32份、牛骨胶原蛋白肽粉18~22份、南极磷虾肽20~35份、小麦低聚肽15~25份、黄精提取物10~20份、桃仁提取物10~25份、枸杞提取物10~20份、木糖醇60~70份、预胶化淀粉80~130份、微晶纤维素80~120份、柠檬酸钠2~5份、硬脂酸镁6~8份,称取每种原料;
2)粉碎过筛:将木糖醇、柠檬酸钠分别经粉碎机粉碎后过80目筛;将地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、黄精提取物、桃仁提取物、枸杞提取物分别过60目筛,备用;
3)预混:将称量好的柠檬酸钠、硬脂酸镁于聚乙烯袋中手工预混2~5分钟,得预混料;
4)总混:将预混物料与地龙蛋白、富硒麦芽粉、牛骨胶原蛋白肽粉、南极磷虾肽、小麦低聚肽、木糖醇、黄精提取物、桃仁提取物、枸杞提取物、预胶化淀粉、微晶纤维素分别置于混合机中混合,混合时间为10min~20min,出料,得到总混物;
5)压片、包衣:将步骤4)所得总混物经压片和包衣后得成品。
6.根据权利要求5所述的一种促进骨折愈合的富硒地龙蛋白组合物的制备方法,其特征在于,步骤4)中,还包括将所得总混物经60目筛过筛处理。
7.根据权利要求5所述的一种促进骨折愈合的富硒地龙蛋白组合物的制备方法,其特征在于,步骤5)中,压片时,设置冲模直径12.0mm,理论片重0.5g,片剂硬度控制为80N~150N;包衣时,控制薄膜包衣浆浓度14%,高效包衣机进风温度设定为60℃。
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