CN115444138B - 一种含有人参肽粉的温肾固元雾化组合物及其制备方法 - Google Patents
一种含有人参肽粉的温肾固元雾化组合物及其制备方法 Download PDFInfo
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- CN115444138B CN115444138B CN202210597331.2A CN202210597331A CN115444138B CN 115444138 B CN115444138 B CN 115444138B CN 202210597331 A CN202210597331 A CN 202210597331A CN 115444138 B CN115444138 B CN 115444138B
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Abstract
本发明公开了一种含有人参肽粉的温肾固元雾化组合物,碳单糖、酸性粘多糖、再生硅材料、肽粉、天然活性物质、微量有机物质、食用香精、极性溶剂的添加使制备得到的雾化组合物具有优异的温肾固元功效,能够促进男性性激素分泌,提高男性性功能,保持精力充沛;能够促进雌激素分泌,基础代谢提升,改善宫寒体寒;能够改善慢性疲劳感,提高身体运动技能;能够提高抗疲劳、抗运动乳酸堆积效果,提升运动耐力,进而提升人们的活力。此外,所得的雾化组合物表现出良好的热稳定性,同时能够维持多种活性成分在220℃下的活性。而且所得雾化组合物用料安全、无毒副作用、效果显著,而且雾化效率快、雾化饱和度高,极其适用于作为温肾固元的雾化原液使用。
Description
技术领域
本发明涉及的是温肾固元药剂的制备领域,A23L33/18,尤其涉及一种含有人参肽粉的温肾固元雾化组合物及其制备方法。
背景技术
在快节奏的时代,每个人都会处于多种工作、学习、生活的竞争及压力中,而且不规律的饮食、作息习惯等因素,均会导致人们的精神、身体的慢性疲劳,出现记忆力下降、注意力分散、身体机能下降等问题。而肾脏是人体津液系统的总阀门,通过对血液中的杂质的过滤作用、对体液和电解质的平衡调节作用、对内分泌系统的调节进而实现对血压的调节作用,肾脏中的精气的变化会直接导致人体呈现出生、长、壮、老、已的不同生理状况。因此,对于肾脏的保护作用至关重要。现在市面上温肾养肾的产品多为食用的药剂或者饮品,外出使用的方便性较低。
专利CN202010675242.6提供了一种补气安神、益精固肾的食品配方,包括海参肽粉、鸡内金低聚肽粉、人参低聚肽粉、核桃低聚肽粉、牦牛骨胶原蛋白肽粉、针叶樱桃粉、肉桂粉、聚葡萄糖、牛磺酸、维生素C,利用药食同源,具有补气安神、益精固肾,能够有效缓解中老年人脾胃虚弱、疲劳无力的症状。专利CN201810863972.1公开了一种养护改善肾功能的食品及其制备方法,将鹿鞭干粉与杜仲雄花粉、玛咖粉、牡蛎肽粉、透明质酸钠、ε-聚赖氨酸盐酸盐、辅料海藻糖结合,利于肾脏营养平衡,具有调节肾虚、平衡体质、补充营养、改善肾功能、改善宫冷不孕等优势。但是这些配方中含有的活性成分较多,且高温过程中容易失活,无法用于雾化原液。
发明内容
为了解决上述问题,本发明第一方面提供了一种含有人参肽粉的温肾固元雾化组合物,其制备原料包括:按重量百分比计,0.05~2%碳单糖、0.05~5%酸性粘多糖、1~10%再生硅材料、3~25%肽粉、0.1~2.5%天然活性物质、2~15%微量有机物质、0.5~4%食用香精、极性溶剂余量。
在一些优选的实施方式中,所述碳单糖选自6-脱氧己糖、D-葡糖糖胺、N-乙酰神经氨酸、D-木糖、D-葡萄糖、D-果糖、D-半乳糖醛酸中的至少一种;优选地,所述碳单糖为N-乙酰神经氨酸。
在一些优选的实施方式中,所述酸性粘多糖选自肝素、玻尿酸、芦荟多糖、海藻多糖、甲壳素、甲壳素衍生物、蛋白多糖中的至少一种;优选地,所述酸性粘多糖为玻尿酸。
在一些优选的实施方式中,所述玻尿酸选自高分子量玻尿酸、中等分子量玻尿酸、低分子量玻尿酸、超低分子量玻尿酸、寡聚玻尿酸中的至少一种;优选地,所述玻尿酸为寡聚玻尿酸。
在一些优选的实施方式中,所述寡聚玻尿酸分子量为500~3000Da;优选地,所述寡聚玻尿酸的分子量为776.6Da。
在一些优选的实施方式中,所述再生硅材料的分包括SiO2,Na2O,CaO,P2O5。
在一些优选的实施方式中,所述再生硅的比表面积为350~400m2/g,D50粒径为≤20μm;优选地,所述再生硅的比表面积为3790m2/g,D50粒径为5μm。
在一些优选的实施方式中,所述肽粉选自海洋鱼低聚肽粉、玉米(Zea mays L.)低聚肽粉、绿豆(Phaseolus radiatus L.)低聚肽粉、牡蛎(Ostrea gigas thunberg)低聚肽粉、海参(Holothuria sinica)低聚肽粉、核桃(Juglans regia L.)低聚肽粉、人参(Panaxginseng C.A.Meyer)肽粉、枸杞(Lycium barbarumL.)肽粉、鸡内金(Galli GigeriaeEndothelium Corneum)低聚肽粉、黑芝麻(Semen Sesami Nigrum)肽粉中的至少一种;优选地,所述肽粉为海参低聚肽粉和人参肽粉。
在一些优选的实施方式中,所述海参低聚肽粉和人参肽粉的质量比为(0.5~5):(3~7);优选地,所述海参低聚肽粉和人参肽粉的质量比为(0.8~2):(3.5~5);进一步优选地,所述海参低聚肽粉和人参肽粉的质量比为1:3.7。
在一些优选的实施方式中,所述海参低聚肽粉的分子量为500~1000Da,粒径为50~200目;优选地,所述海参低聚肽粉的分子量为800Da,粒径为80~120目。
在一些优选的实施方式中,所述人参肽粉的分子量为180~1000Da,粒径为50~300目;优选地,所述人参肽粉的分子量为180~500Da,粒径为80~100目。
人参肽粉是一种高营养价值的膳食补充剂,能够同时对男性和女性的肾脏表现出突出的温养作用。推测可能是因为人参肽粉中所含有的营养成分甘氨酸、组氨酸、精氨酸、苯丙氨酸、人参皂苷等能够促进皮肤胶原蛋白的生成,改善皮肤,对于女性能够改善内分泌失调,缓解气血两虚,延缓衰老。对于男性来讲人参肽粉在进入人体后能够增加血清中一氧化氮和睾酮的浓度,进而补充精子蛋白所需的营养元素,促进男性性激素的分泌,提高男性性功能,起到补肾、温肾的作用。特别是分子量为180~1000Da,粒径为50~300目的人参肽粉,其活性高,而且粒径小,极易被人体吸收,效果显著。但是人参性微温,人参肽粉用量过多会导致过于温补,出现上火、热疹的不良反应。
本申请人发现,在海参低聚肽粉的添加能够降低人参肽粉的含量,同时进一步改善温肾固元的功效。可能原因为海参性平,海参低聚肽粉中含有锌、酸性粘多糖、海参素等活性成分,有利于精氨酸的进一步补充,能有效提高男性精力,提高性生活质量,提高温肾固元作用。而且其能调节人体机能,增强人体免疫力,增加抗疲劳、抗病毒、抗肿瘤的功效,促使人体由亚健康状态想健康状态的转变。此外,其还能清楚体内自由基,使人体肌肤、身体维持年轻、活力状态。当其分子量为500~1000Da,粒径为50~200目时,其可进一步降低人参肽粉在雾化组合物中的含量,而且体系中相容性好。
本申请人发现,当海参低聚肽粉和人参肽粉的质量比为(0.5~5):(2~7)时,能够进一步增加体系的分散稳定性,促进人体对活性成分的吸收,同时还能维持人参肽粉中多种人参皂苷活性成分的含量,尤其是高温处理后的人参皂苷RE、人参皂苷RG1、人参皂苷RB1、人参皂苷RC、人参皂苷RB2、人参皂苷RD的活性含量,能够维持较小的降幅。
在一些优选的实施方式中,所述天然活性物质选自虫草多糖、虫草素、α-淀粉酶抑制剂、超氧化物歧化酶、虫草酸、氨基酸、冬虫夏草菌丝粉中的至少一种;优选地,所述天然活性物质为虫草素。
在一些优选的实施方式中,所述微量有机物质选自维生素A、维生素C、维生素B、维生素E中的至少一种;优选地,所述维生素为维生素B和维生素C。
在一些优选的实施方式中,所述维生素C和维生素B的质量比为(0.3~4):(2~10);优选地,所述维生素C和维生素B的质量比为1:3.6。
在一些优选的实施方式中,所述维生素B选自维生素B1、维生素B6、维生素B12中的一种或多种;优选地,所述维生素B为维生素B12。
在一些优选的实施方式中,所述极性溶剂选自去离子水、乙醇、三乙二醇、三甘醇、四乙二醇、1,2-丙二醇、1,3-丙二醇、1,2,3-丙三醇、丁二醇中的至少一种;优选地,所述极性溶剂为1,3-丙二醇和甘油。
在一些优选的实施方式中,所述1,3-丙二醇和1,2,3-丙三醇的重量比为(3.5~5):(4~7.5);优选地,所述1,3-丙二醇和1,2,3-丙三醇的重量比为4:6.4。
在一些优选的实施方式中,所述1,2,3-丙三醇选自水解1,2,3-丙三醇、皂化1,2,3-丙三醇、精炼1,2,3-丙三醇中的一种或多种;优选地,所述1,2,3-丙三醇为水解1,2,3-丙三醇。
在一些优选的实施方式中,所述水解1,2,3-丙三醇的表面张力为50~80mN/m,20℃时的粘度为1200~1600mPa·s;优选地,所述水解1,2,3-丙三醇的表面张力为63.3mN/m,20℃时的粘度为1412mPa·s。
雾化组合物需要通过压力雾化、转盘雾化、气体雾化、声波雾化等不同的方式被分散为微小液滴,进而发挥药效,实现其使用价值。在雾化分散的过程中产生的热量会影响雾化组合物的稳定性。而且体系中的包含的碳单糖、肽粉、天然活性物质等受温度影响严重,会随温度的升高而发生分解,导致活性成分的失活,进而降低药效。本申请人发现,采用1,3-丙二醇和1,2,3-丙三醇进行溶解时,有利于成分间的相容性增加,促使均一稳定体系的形成。特别是1,2,3-丙三醇为水解1,2,3-丙三醇时,其特定的粘合和表面张力,可以进一步促进体系中物质的稳定分散性性,同时可以保护肽粉、天然活性成分等组分在高温时发生变化,提高雾化组合物温肾固元的功效,此外,还能使所得的雾化原液可以快速雾化,具有较高的雾化饱和度,有效避免1,3-丙二醇在使用过程中会导致的肌肤刺激性等不良问题,有助于改善雾化液的气味,提升使用感受。
本发明的第二方面提供了一种含有人参肽粉的温肾固元雾化组合物的制备方法,其包括如下步骤:
S1.在极性溶剂中加入碳单糖、酸性粘多糖、微量有机物质、食用香精搅拌混合,即得混合物;
S2.在步骤S1所得混合物中继续加入再生硅材料、肽粉、天然活性物质继续搅拌,即得。
与现有技术相比,本发明具有以下有益效果:
(1)本申请中碳单糖、酸性粘多糖、再生硅材料、肽粉、天然活性物质、微量有机物质、食用香精、极性溶剂的添加使制备得到的雾化组合物具有优异的温肾固元功效,能够促进男性性激素分泌,提高男性性功能,保持精力充沛;能够促进雌激素分泌,基础代谢提升,改善宫寒体寒;能够改善慢性疲劳感,提高身体运动技能;能够提高抗疲劳、抗运动乳酸堆积效果,提升运动耐力,进而提升人们的活力。
(2)本申请中所得的雾化组合物表现出良好的热稳定性及高温下的活性,同时能够维持多种人参皂苷在220℃下的活性。
(3)本申请中所得雾化组合物用料安全、无毒副作用、效果显著,而且雾化效率快、雾化饱和度高。此外,本申请中雾化组合物的制备方法简单,适用范围广,使用方便,极其适用于作为温肾固元的雾化原液使用。
附图说明
图1人参皂苷RE的LC-MSMS标准曲线和处理前样品稀释后的LC-MSMS测试结果。
图2人参皂苷RG1的LC-MSMS标准曲线和处理前样品稀释后的LC-MSMS测试结果。
图3人参皂苷RB1的LC-MSMS标准曲线和处理前样品稀释后的LC-MSMS测试结果。
图4人参皂苷RC的LC-MSMS标准曲线和处理前样品稀释后的LC-MSMS测试结果。
图5人参皂苷RB2的LC-MSMS标准曲线和处理前样品稀释后的LC-MSMS测试结果。
图6人参皂苷RD的LC-MSMS标准曲线和处理前样品稀释后的LC-MSMS测试结果。
图7人参皂苷RE的LC-MSMS标准曲线和处理后样品稀释后的LC-MSMS测试结果。
图8人参皂苷RG1的LC-MSMS标准曲线和处理后样品稀释后的LC-MSMS测试结果。
图9人参皂苷RB1的LC-MSMS标准曲线和处理后样品稀释后的LC-MSMS测试结果。
图10人参皂苷RC的LC-MSMS标准曲线和处理后样品稀释后的LC-MSMS测试结果。
图11人参皂苷RB2的LC-MSMS标准曲线和处理后样品稀释后的LC-MSMS测试结果。
图12人参皂苷RD的LC-MSMS标准曲线和处理后样品稀释后的LC-MSMS测试结果。
具体实施方式
实施例1
1、一种含有人参肽粉的温肾固元雾化组合物,其制备原料包括:按重量百分比计,0.35%碳单糖、2.1%酸性粘多糖、4.8%再生硅材料、7%肽粉、0.9%天然活性物质、5%微量有机物质、1%食用香精、极性溶剂余量。
所述碳单糖为N-乙酰神经氨酸。
所述酸性粘多糖为玻尿酸。
所述玻尿酸为寡聚玻尿酸(江西华豫源生物科技有限公司)。
所述寡聚玻尿酸的分子量为776.6Da。
所述再生硅材料的分包括SiO2,Na2O,CaO,P2O5。
所述再生硅的比表面积为3790m2/g,D50粒径为5μm(RegeSi再生硅,购自北京幸福益生高新技术有限公司)。
所述肽粉为海参低聚肽粉和人参肽粉。
所述海参低聚肽粉和人参肽粉的质量比为1:3.7。
所述海参低聚肽粉的分子量为800Da,粒径为80~120目(西安全奥生物科技有限公司)。
所述人参肽粉的分子量为180~500Da,粒径为80~100目(西安诚泰生物技术有限公司)。
所述天然活性物质为虫草素。
所述维生素为维生素B和维生素C。
所述维生素C和维生素B的质量比为1:3.6。
所述维生素B为维生素B12。
所述极性溶剂为1,3-丙二醇和甘油。
所述1,3-丙二醇和1,2,3-丙三醇的重量比为4:6.4。
所述1,2,3-丙三醇为水解1,2,3-丙三醇。
所述水解1,2,3-丙三醇的表面张力为63.3mN/m,20℃时的粘度为1412mPa·s(印尼绿宝,购自广州叶互生化工有限公司)。
2、一种含有人参肽粉的温肾固元雾化组合物的制备方法,其包括如下步骤:
S1.在极性溶剂中加入碳单糖、酸性粘多糖、微量有机物质、食用香精搅拌混合,即得混合物;
S2.在步骤S1所得混合物中继续加入再生硅材料、肽粉、天然活性物质继续搅拌,即得。
实施例2
1、一种含有人参肽粉的温肾固元雾化组合物,与实施例1的不同之处在于:
所述海参低聚肽粉和人参肽粉的质量比为1:5。
2、一种含有人参肽粉的温肾固元雾化组合物的制备方法,同实施例1。
实施例3
1、一种含有人参肽粉的温肾固元雾化组合物,与实施例1的不同之处在于:
所述肽粉为人参-海参低聚肽双参肽(陕西夏州生物科技有限公司)。
2、一种含有人参肽粉的温肾固元雾化组合物的制备方法,同实施例1。
实施例4
1、一种含有人参肽粉的温肾固元雾化组合物,与实施例1的不同之处在于:
所述海参低聚肽粉和人参肽粉的质量比为1:1。
2、一种含有人参肽粉的温肾固元雾化组合物的制备方法,同实施例1。
实施例5
1、一种含有人参肽粉的温肾固元雾化组合物,与实施例1的不同之处在于:
所述1,3-丙二醇和1,2,3-丙三醇的重量比为1:0.5。
2、一种含有人参肽粉的温肾固元雾化组合物的制备方法,同实施例1。
性能测试
1、理化性能测试:依据标准Q/GHJK 002-2021《清咽润肺功能雾化原液》对实施例1所得组合物进行测试;
表1实施例1所得组合物理化性能测试结果
2、成分测试:
表2实施例1所得雾化原液成分含量测试结果
3、人参皂苷指定成分测定:对实施例1所得样品进行测定。
样品前处理:先在油浴锅里把玻璃皿加热5min,温度到达220℃,停止加热,马上取2mL样品,倒入玻璃容器中30s,用倒出来后的样品测试。
测试结果如表3和附图1-12所示。
表3实施例1中特定人参皂苷的测定结果
3、热稳定性测试:先在油浴锅里把玻璃皿加热5min,温度到达220℃,停止加热,马上取2mL实施例及对比例所得雾化液样品,倒入玻璃容器中30s,用倒出来后的样品测试。测试项目包括色泽、外观、透明质酸钠含量。
表4实施例及对比例所得雾化原液稳定性测试结果
Claims (6)
1.一种含有人参肽粉的温肾固元雾化组合物,其特征在于,其制备原料包括:按重量百分比计,0.05~2%碳单糖、0.05~5%酸性粘多糖、1~10%再生硅材料、3~25%肽粉、0.1~2.5%天然活性物质、2~15%微量有机物质、0.5~4%食用香精、极性溶剂余量;
所述肽粉为海参低聚肽粉和人参肽粉;所述海参低聚肽粉和人参肽粉的质量比为(0.5~5):(3~7);
所述天然活性物质选自虫草多糖、虫草素、α-淀粉酶抑制剂、超氧化物歧化酶、虫草酸、氨基酸、冬虫夏草菌丝粉中的至少一种;
所述极性溶剂为1,3-丙二醇和1 ,2 ,3-丙三醇,所述1,3-丙二醇和1 ,2 ,3-丙三醇的重量比为(3 .5~5):(4~7 .5)。
2.根据权利要求1所述的一种含有人参肽粉的温肾固元雾化组合物,其特征在于,所述碳单糖选自6-脱氧己糖、D-木糖、D-葡萄糖、D-果糖中的至少一种。
3.根据权利要求1所述的一种含有人参肽粉的温肾固元雾化组合物,其特征在于,所述酸性粘多糖选自肝素、玻尿酸、甲壳素、甲壳素衍生物中的至少一种。
4.根据权利要求3所述的一种含有人参肽粉的温肾固元雾化组合物,其特征在于,所述玻尿酸选自高分子量玻尿酸、中等分子量玻尿酸、低分子量玻尿酸、超低分子量玻尿酸、寡聚玻尿酸中的至少一种。
5.根据权利要求1所述的一种含有人参肽粉的温肾固元雾化组合物,其特征在于,所述海参低聚肽粉的分子量为500~1000Da,粒径为50~200目;所述人参肽粉的分子量为180~1000Da,粒径为50~300目。
6.一种根据权利要求1-5任一项所述的含有人参肽粉的温肾固元雾化组合物的制备方法,其特征在于,其包括如下步骤:
S1.在极性溶剂中加入碳单糖、酸性粘多糖、微量有机物质、食用香精搅拌混合,即得混合物;
S2.在步骤S1所得混合物中继续加入再生硅材料、肽粉、天然活性物质继续搅拌,即得。
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