CN112335887A - 一种膳食硅补充剂及其制备工艺 - Google Patents
一种膳食硅补充剂及其制备工艺 Download PDFInfo
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- CN112335887A CN112335887A CN202011362722.3A CN202011362722A CN112335887A CN 112335887 A CN112335887 A CN 112335887A CN 202011362722 A CN202011362722 A CN 202011362722A CN 112335887 A CN112335887 A CN 112335887A
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Abstract
本发明属于膳食补充剂制备应用技术领域,具体涉及一种膳食硅补充剂及其制备方法。该补充剂是由以下原料组成:聚γ‑谷氨酸,水溶性壳聚糖,硅酸盐水溶液,淀粉,木糖醇,硬脂酸镁,柠檬酸、水。本发明使用γ‑PGA的羧基与CS的氨基具有很高的配位系数,结构稳定,增加了硅酸盐的溶解性。具有适宜的甜度,以及不错的口感,使其成为饮食中硅摄入量的主要来源。本发明制备的膳食硅补充剂硅元素丰富,制造简单,安全无害。本发明中壳聚糖的加入使补充片有更强的人体亲和性,聚γ‑谷氨酸的加入与硅酸盐起到协同的作用,用于骨骼和结缔组织的生长,帮助抵抗骨质疏松症,减少骨质疏松症的风险。
Description
技术领域
本发明属于膳食补充剂制备应用技术领域,具体涉及一种膳食硅补充剂及其制备方法。
背景技术
骨质疏松症是由于多种原因导致的骨密度和骨质量下降,骨微结构破坏,造成骨脆性增加,从而容易发生骨折的全身性骨病。硅在结缔组织、软骨形成中是必须的,硅能将粘多糖互相连结,并将粘多糖结合到蛋白质上,形成纤维结构,从而增强结缔组织的弹性和强度,维持结构的完整性。硅参与骨的钙化作用,在钙化初始阶段起作用,食物中的硅能增加钙化的速度,尤其当钙摄入量低时效果更为明显,制备膳食硅补充剂就显得尤为重要。
γ-聚谷氨酸[Poly-γ-glutamic acid,(γ-PGA)]是一种典型的聚电解质,由D-谷氨酸和L-谷氨酸通过γ-谷氨酰胺键聚合而成的氨基聚合物,相对分子量一般在10万―100万。与其他聚合高分子化合物相比,γ-PGA在体内能降解为谷氨酸单体,为人体所必需,生物相容性优良,低免疫原性,无毒副作用,这是其它材料所不可比拟的。γ-PGA水溶液在粘度等诸方面表现出特殊的性质。
壳聚糖[Chitosan,(CS)]壳聚糖在食品工业中可作为黏结剂、保湿剂、澄清剂、填充剂、乳化剂、上光剂及增稠稳定剂,而作为功能性低聚糖,能降低胆固醇,提高机体免疫力,增强机体的抗病抗感染能力并且具有优异的生物相容性。
硅酸盐[Silicon]硅酸盐是由硅、氧和金属组成的化合物的总称,是一种良好的硅源选择。当与均衡饮食一起服用时,其有助于关节的恢复和软骨损伤。硅的摄入可用于骨骼和结缔组织的发育和生长,帮助抵抗骨质疏松症,减少骨质疏松症的风险。
中国专利CN101744789B公开了一种生物可降解纳米多孔聚L-谷氨酸/壳聚糖载药微胶囊及其制备方法,该方法制备的微胶囊具有显著的缓释作用及靶向性,但是,其作为日常的膳食补充剂并不适用。
发明内容
针对现有技术中存在的问题,本发明提供一种膳食硅补充剂,该膳食补充剂将硅酸盐、壳聚糖加入,增强了彼此的生物相容性使其更好地被机体吸收,生物利用度好,且具有良好的分散性。
本发明还提供了一种膳食硅补充剂的制备方法。
为实现上述目的,本发明涉及的具体技术方案如下:
本发明提供了一种膳食硅补充剂,是由以下重量份原料组成:聚γ-谷氨酸4-10份,水溶性壳聚糖5-8份,硅酸盐水溶液1-2份,淀粉15-20份,木糖醇10-15份,硬脂酸镁5-10份,柠檬酸0.5-0.6份、水40-50份。
本发明所使用的硅酸盐水溶液是由植物木贼中提取得到,所述提取的方法具体为:
(a)取新采集的木贼,洗净后沥干,112℃杀青10分钟,晒干,粉碎过筛,得到粒径为250~850μm的粒料;
(b)取木贼干粒料10.00g于250ml烧瓶中,加pH=2 的HCl水溶液100ml,加入聚乙二醇-甘油水溶液50ml,加入氯化胆碱1g,充分混匀后热 100℃回流提取2h,然后2500×g离心15min,取上清液,重复提取3次;
(c)合并3次上清液,旋转蒸发浓缩至原体积的1/3~1/4,最后蒸馏水定容至250ml,得硅酸盐水溶液。
进一步的,步骤(b)中,所述聚乙二醇-甘油水溶液中甘油的质量浓度为8%,聚乙二醇的质量浓度为2%;
进一步的,步骤(c)中,所述硅酸盐水溶液的浓度为0.44mg/ml。
本发明还提供了一种上述膳食硅补充剂的制备方法,包括以下步骤:
(1)室温下,将聚γ-谷氨酸溶液滴缓慢加至壳聚糖溶液中边加边搅拌;
(2)将聚γ-谷氨酸/壳聚糖溶液、硅酸盐溶液、柠檬酸混合,加水充分搅拌均匀;
(3)称取重量份的淀粉,加入酪朊酸钠及碳酸氢钠,搅拌均匀后加热充分溶解至透明溶液,然后加入木糖醇和硬脂酸镁充分搅拌,混合均匀;
(4)将步骤(3)中的混合溶液缓慢加入到(2)中的混合溶液中,边加边搅拌;
(5)将步骤(4)中所得的混合溶液喷雾干燥得固体颗粒,经压片机压制成膳食硅补充片。
进一步的,步骤(1)中,所述聚γ-谷氨酸溶液的浓度为2 g/L;所述壳聚糖溶液的质量分数为3~8%;所述壳聚糖的重均分子量为6×105g/mol,脱乙酰度大于90%。
进一步的,步骤(3)中,所述酪朊酸钠的加入量占淀粉重量的0.8-1.2%;所述碳酸氢钠和柠檬酸的重量比为0.1:1。
进一步的,步骤(5)中,所述喷雾干燥的工作参数为:最大水分蒸发量50kg/h,入口温度200℃,出口温度85℃,离心喷雾头机械转动,转速18000r/min。
本发明所使用的聚γ-谷氨酸是由地衣芽孢杆菌(bacillus licheniformis)发酵提取得到的,其发酵提取方法包括以下步骤:
1)称取基础培养基,溶解,得基础培养基溶液,然后称取优化培养基各成分加入至基础培养基溶液中,定容,固体NaOH调节pH至7.5;
2)将培养基分装至锥形瓶(50ml/瓶)中,经100-150℃灭菌,按2-10%的接种量将地衣芽孢杆菌接入培养基中,30-50℃摇床培养3-7天,得发酵液;
3)将发酵液离心,取上层清液加入2-7倍体积的乙醇沉淀10-24h,离心,所得上清液重新用2-6倍体积的乙醇沉淀,离心,旋转蒸发得残留固体;
4)将恒重样品溶于蒸馏水中,透析纯化,得纯化样品;
5)将纯化样品溶于蒸馏水中,喷雾干燥制得聚γ-谷氨酸粉末。
本发明所使用的基础培养基成分(g/L)为:葡萄糖10g,柠檬酸13.5g,L-谷氨酸23g,NH4Cl 6.8 g,K2HPO4· 3H2O 0.8 g,MgSO4· 7H2O 0.5g,FeCl3·6H2O 0.05 g,CaCl2·2H2O 0.17 g,(NH4)2Mo7O4 0.26g, pH7.5。本发明所使用的优化培养基成分(g/L)为: NaCl10-15、α-酮戊二酸1.0-2.5、Mn(Ⅱ)0.02-0.1、L-谷氨酰胺 0.2-1.0、甘油5-15。
本发明的有益效果为:
1、本发明使用的聚-γ谷氨酸和壳聚糖为无色无毒无味且易降解的微生物发酵提取物,γ-PGA 的羧基与CS的氨基具有很高的配位系数,结构稳定,增加了硅酸盐的溶解性。
2、本发明所述的膳食补充剂,具有适宜的甜度,以及不错的口感,使其成为饮食中硅摄入量的主要来源。
3、本发明制备的膳食硅补充剂硅元素丰富,制造简单,安全无害。
4、本发明在制备过程中,制备的补充剂原料均一无结块,喷雾干燥得率高,且使用后,崩解后分散性好,生物利用度高。
5、本发明中壳聚糖的加入使补充片有更强的人体亲和性,聚γ-谷氨酸的加入与硅酸盐起到协同的作用,用于骨骼和结缔组织的生长,帮助抵抗骨质疏松症,减少骨质疏松症的风险。
具体实施方式
以下通过具体实施方式对本发明作进一步的详细说明,但不应将此理解为本发明的范围仅限于以下的实例。在不脱离本发明上述方法思想的情况下,根据本领域普通技术知识和惯用手段做出的各种替换或变更,均应包含在本发明的范围内。
下述实施例中所使用的硅酸盐水溶液是由植物木贼中提取得到,所述提取的方法具体为:
(a)取新采集的木贼,洗净后沥干,112℃杀青10分钟,晒干,粉碎过筛,得到粒径为250~850μm的粒料;
(b)取木贼干粒料10.00g于250ml烧瓶中,加pH=2 的HCl水溶液100ml,加入聚乙二醇-甘油水溶液50ml,加入氯化胆碱1g,充分混匀后热 100℃回流提取2h,然后2500×g离心15min,取上清液,重复提取3次;
(c)合并3次上清液,旋转蒸发浓缩至原体积的1/3~1/4,最后蒸馏水定容至250ml,得浓度为0.48mg/ml的硅酸盐水溶液。
同时,通过过程优化试验发现,当仅采用聚乙二醇水溶液进行提取时,制备的硅酸盐水溶液其浓度为0.32mg/mL;当仅采用甘油水溶液进行提取时,制备的硅酸盐水溶的浓度为0.39mg/mL。
实施例1
一种膳食硅补充剂,配方为:聚γ-谷氨酸4份,水溶性壳聚糖7份,硅酸盐1份,淀粉17份,木糖醇13份,硬脂酸镁8份,柠檬酸0.5份,水50份。
具体制备方法如下:
(1)将聚γ-谷氨酸溶液滴加到壳聚糖溶液中,壳聚糖溶液中壳聚糖的质量分数为3%,溶剂为去离子水;所述壳聚糖的重均分子量为6×105 g/mol,脱乙酰度大于90%。在室温搅拌(600 r/min)下,将2g/L的γ-PGA 水溶液用微量注射泵按照 6 mL/h 的速率分别滴加到CS溶液中(pH=6)中,边加边搅拌并超声10min,透析1-3h除去未结合的小分子聚合物;
(2)将聚γ-谷氨酸/壳聚糖溶液、硅酸盐水溶液、柠檬酸混合,加水充分搅拌均匀;
(3)称取淀粉加热充分溶解至透明溶液,加入占淀粉重量1.0%的酪朊酸钠及占柠檬酸重量1/10的碳酸氢钠,搅拌均匀后加热充分溶解至透明溶液,然后加入木糖醇和硬脂酸镁充分搅拌,混合均匀;
(4)将步骤(3)中的混合溶液缓慢加入到(2)中的混合溶液中,边加边搅拌,使其充分混匀;
(5)将步骤(4)中所得的混合溶液喷雾干燥得固体颗粒,经压片机压制成膳食硅补充片。喷雾干燥的工作参数为:最大水分蒸发量50kg/h,入口温度200℃,出口温度85℃,离心喷雾头机械转动,转速18000r/min。
实施例2
一种膳食硅补充剂,配方为:聚γ-谷氨酸5份,水溶性壳聚糖6份,硅酸盐1份,淀粉16份,木糖醇15份,硬脂酸镁9份,水48份。
制备方法同实施例1。
实施例3
一种膳食硅补充剂,配方为:聚γ-谷氨酸5份,水溶性壳聚糖8份,硅酸盐2份,淀粉16份,木糖醇12份,硬脂酸镁7份,水50份。
制备方法同实施例1。
实施例4
一种膳食硅补充剂,配方为:聚γ-谷氨酸7份,水溶性壳聚糖6份,硅酸盐1份,淀粉18份,木糖醇11份,硬脂酸镁6份,水51份。
制备方法同实施例1。
实施例5
一种膳食硅补充剂,配方为:聚γ-谷氨酸10份,水溶性壳聚糖5份,硅酸盐2份,淀粉20份,木糖醇14份,硬脂酸镁9份,水40份。
制备方法同实施例1。
对比例1
一种膳食硅补充剂,配方为:聚γ-谷氨酸4份,水溶性壳聚糖7份,硅酸盐1份,淀粉17份,木糖醇13份,硬脂酸镁8份,水50份。
具体制备方法如下:
(1)将聚γ-谷氨酸溶液滴加到壳聚糖溶液中,壳聚糖溶液中壳聚糖的质量分数为3%,溶剂为去离子水;所述壳聚糖的重均分子量为6×105 g/mol,脱乙酰度大于90%。在室温搅拌(600 r/min)下,将2g/L的γ-PGA 水溶液用微量注射泵按照 6 mL/h 的速率分别滴加到CS溶液中(pH=6)中,边加边搅拌并超声10min,透析1-3h除去未结合的小分子聚合物;
(2)将聚γ-谷氨酸/壳聚糖溶液、硅酸盐水溶液混合,加水充分搅拌均匀;
(3)称取淀粉加热充分溶解至透明溶液,加入占淀粉重量1.0%的酪朊酸钠,搅拌均匀后加热充分溶解至透明溶液,然后加入木糖醇和硬脂酸镁充分搅拌,混合均匀;
(4)将步骤(3)中的混合溶液缓慢加入到(2)中的混合溶液中,边加边搅拌,使其充分混匀;
(5)将步骤(4)中所得的混合溶液喷雾干燥得固体颗粒,经压片机压制成膳食硅补充片。
对比例2
一种膳食硅补充剂,配方同实施例1。
具体制备方法如下:
(1)将聚γ-谷氨酸溶液滴加到壳聚糖溶液中,壳聚糖溶液中壳聚糖的质量分数为3%,溶剂为去离子水;所述壳聚糖的重均分子量为6×105 g/mol,脱乙酰度大于90%。在室温搅拌(600 r/min)下,将2g/L的γ-PGA 水溶液用微量注射泵按照 6 mL/h 的速率分别滴加到CS溶液中(pH=6)中,边加边搅拌并超声10min,透析1-3h除去未结合的小分子聚合物;
(2)将聚γ-谷氨酸/壳聚糖溶液、硅酸盐水溶液、柠檬酸混合,加水充分搅拌均匀;
(3)称取淀粉加热充分溶解至透明溶液,加入占柠檬酸重量1/10的碳酸氢钠,搅拌均匀后加热充分溶解至透明溶液,然后加入木糖醇和硬脂酸镁充分搅拌,混合均匀;
(4)将步骤(3)中的混合溶液缓慢加入到(2)中的混合溶液中,边加边搅拌,使其充分混匀;
(5)将步骤(4)中所得的混合溶液喷雾干燥得固体颗粒,经压片机压制成膳食硅补充片。喷雾干燥的工作参数为:最大水分蒸发量50kg/h,入口温度200℃,出口温度85℃,离心喷雾头机械转动,转速18000r/min。
该对比例中,喷雾干燥制备的固体颗粒较实施例1中产率降低了8.3%。
对比例3
一种膳食硅补充剂,配方为:水溶性壳聚糖13份,硅酸盐2份,淀粉16份,木糖醇12份,硬脂酸镁7份,水50份。
制备方法基本同实施例1,不同处在于不加入聚γ-谷氨酸。
(一)将实施例1及对比例1和2进行喷雾干燥后的固体颗粒进行产率的统计,对比例1中其出粉率较实施例1降低了5%,而对比例2中最终的出粉率较实施例1降低了4.3%,同时,对比例1制备的固体颗粒其流动性变差。
(二)配置人工胃液,并保持37℃温度下进行药片崩解试验:将实施例1及对比例1和2制备的片剂加入人工胃液中,均放置10min,然后将底部有细筛的吊笼取出,具体结果见表1。
表1
(二)本实验按自愿原则选择年龄为60-70岁之间,骨质疏松患者329名。
实验中设立对照组和试食组,其中按随机原则对照组选定47人,服用安慰剂,试食组又分为I、II、Ⅲ、Ⅳ、Ⅴ、Ⅵ五组,每组47人, 各组分别服用表中所示膳食补充片,每日1次,每次2片,连续服用35天,试验采用自身前后对照和组间对照如表2。
表2
其中,膳食片每片重量300mg,安慰剂的外观颜色、片剂重量与实验组膳食片完全一样。
各项指标于试食试验开始及结束进各测定一次,检测指标分为安全性指标和功效性指标。前者包括一般体格检查、血、尿、便常规检查,血生化指标检查,B超、胸部X线和心电图检查等其它相应的检查。后者包括腰背酸痛症状检查:详细询问病人疼痛症状。
实验结果:
由表3通过不同实验组比对,可以发现随着硅酸盐含量的增多,受试者腰背酸痛的症状的到改善的人数实验组相较于对照组出现明显改善的趋势,随着硅酸盐含量的升高,膳食补充剂的作用效果也相应提升。
表3
从上述实施例可以得出,本发明提供的技术方案,具有以下优点:
(1)本发明制备的聚γ-谷氨酸/壳聚糖/硅酸盐膳食硅补充剂,对于骨质疏松症的症状具有不错的缓解作用。
(2) 本发明制备的聚γ-谷氨酸/壳聚糖/硅酸盐膳食硅补充剂制备方法简单,原料成本较低。
(3)本发明制备的聚γ-谷氨酸/壳聚糖/硅酸盐具有很高的生物利用度,可用于帮助抵抗骨质疏松症,减少骨质疏松症的风险。
Claims (8)
1.一种膳食硅补充剂,其特征在于,是由以下重量份原料组成:聚γ-谷氨酸4-10份,水溶性壳聚糖5-8份,硅酸盐水溶液1-2份,淀粉15-20份,木糖醇10-15份,硬脂酸镁5-10份,柠檬酸0.5-0.6份、水40-50份。
2.根据权利要求1所述的膳食硅补充剂,其特征在于,所述硅酸盐水溶液是由植物木贼中提取得到,所述提取的方法具体为:
(a)取新采集的木贼,洗净后沥干,112℃杀青10分钟,晒干,粉碎过筛,得到粒径为250~850μm的粒料;
(b)取木贼干粒料10.00g于250ml烧瓶中,加pH=2 的HCl水溶液100ml,加入聚乙二醇-甘油水溶液50ml,加入氯化胆碱1g,充分混匀后热 100℃回流提取2h,然后2500×g离心15min,取上清液,重复提取3次;
(c)合并3次上清液,旋转蒸发浓缩至原体积的1/3~1/4,最后蒸馏水定容至250ml,得硅酸盐水溶液。
3.根据权利要求2所述的膳食硅补充剂,其特征在于,步骤(b)中,所述聚乙二醇-甘油水溶液中甘油的质量浓度为8%,聚乙二醇的质量浓度为2%。
4.根据权利要求2所述的膳食硅补充剂,其特征在于,步骤(c)中,所述硅酸盐水溶液的浓度为0.44mg/ml。
5.一种如权利要求1-4任一项所述的膳食硅补充剂的制备方法,其特征在于,包括以下步骤:
(1)室温下,将聚γ-谷氨酸溶液滴缓慢加至壳聚糖溶液中边加边搅拌;
(2)将聚γ-谷氨酸/壳聚糖溶液、硅酸盐溶液、柠檬酸混合,加水充分搅拌均匀;
(3)称取重量份的淀粉,加入酪朊酸钠及碳酸氢钠,搅拌均匀后加热充分溶解至透明溶液,然后加入木糖醇和硬脂酸镁充分搅拌,混合均匀;
(4)将步骤(3)中的混合溶液缓慢加入到(2)中的混合溶液中,边加边搅拌;
(5)将步骤(4)中所得的混合溶液喷雾干燥得固体颗粒,经压片机压制成膳食硅补充片。
6.根据权利要求5所述的制备方法,其特征在于,步骤(1)中,所述聚γ-谷氨酸溶液的浓度为2 g/L;所述壳聚糖溶液的质量分数为3~8%;所述壳聚糖的重均分子量为6×105g/mol,脱乙酰度大于90%。
7.根据权利要求5或6所述的制备方法,其特征在于,步骤(3)中,所述酪朊酸钠的加入量占淀粉重量的0.8-1.2%;所述碳酸氢钠和柠檬酸的重量比为0.1:1。
8.根据权利要求5所述的制备方法,其特征在于,步骤(5)中,所述喷雾干燥的工作参数为:最大水分蒸发量50kg/h,入口温度200℃,出口温度85℃,离心喷雾头机械转动,转速18000r/min。
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