CN111803480A - 一种固体制剂及其制备方法和用途 - Google Patents
一种固体制剂及其制备方法和用途 Download PDFInfo
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- CN111803480A CN111803480A CN202010707829.0A CN202010707829A CN111803480A CN 111803480 A CN111803480 A CN 111803480A CN 202010707829 A CN202010707829 A CN 202010707829A CN 111803480 A CN111803480 A CN 111803480A
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Images
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
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Abstract
本发明涉及一种固体制剂及其制备方法和用途。所述固体制剂包含第一部分和第二部分,其中所述第一部分包含茶氨酸且不含氨基丁酸,所述第二部分包含氨基丁酸且不含茶氨酸。
Description
技术领域
本发明涉及一种固体制剂及其制备方法和用途。
背景技术
γ-氨基丁酸(简称GABA)是一种天然存在的非蛋白质功能性氨基酸,是中枢神经系统的抑制性神经递质。作为脑组织最重要的神经递质之一,其能够降低神经细胞活性,防止神经细胞过热,因而具有安神和消除抑郁的作用。GABA能结合抗焦虑脑受体并使之激活,然后与另外一些物质协同作用,阻止与焦虑相关的信息抵达脑指示中枢。因此,在对抗抑郁焦虑,改善情绪,缓解压力,促进睡眠,提高记忆力等方面作用明显。茶氨酸(L-Theanine)是茶叶中特有的游离氨基酸,茶氨酸是谷氨酸γ-乙基酰胺,有甜味。茶氨酸可以明显促进脑中枢多巴胺释放,提高脑内多巴胺生理活性。因此,可以起到解消疲劳、降低血压和提高学习记忆能力等作用。
目前,对于促进睡眠的相关研究较多,其中下-氨基丁酸和茶氨酸常作为促进睡眠的功效组分。
然而将γ-氨基丁酸、茶氨酸用于软糖的研究较少,且未提到茶氨酸和氨基丁酸组合,例如在低糖/无糖软糖中,会出现明显的出水问题,进而影响制剂的稳定性。
仍需要具有改善的稳定性的包含γ-氨基丁酸和茶氨酸的制剂。
发明内容
本发明的目的是提供具有改善的稳定性的包含γ-氨基丁酸和茶氨酸的制剂。
本发明涉及一种固体制剂,包含第一部分和第二部分,其中所述第一部分包含茶氨酸且不含氨基丁酸,所述第二部分包含氨基丁酸且不含茶氨酸。
所述固体制剂包含γ-氨基丁酸和茶氨酸,且改善了出水现象,从而减轻了在存储期间发生的粘连问题,提高了稳定性。
附图说明
图1是TPA实验典型测试图形。
具体实施方式
除非另外定义,本文所用的所有技术和科学术语具有本领域技术人员通常理解的相同含义。在冲突的情况下,以包括定义在内的本文件为准。下面描述优选的方法和材料,但是与本文所述那些类似或等同的方法和材料可用于实施或测试本发明。本文公开的材料、方法和实例仅是说明性的,而非旨在限制。
对于本公开内容涉及的所有数值范围,应理解为公开了该范围内所有具体数值,以及该范围内任意两个数值限定的子范围。例如,对于1-20重量份,应理解为公开了1、2、3、3.5、4.5、10、12、15、20重量份等具体数值,以及1-5,2-6,3.5-7.5,15-20重量份等子范围。
在一个方面,本发明涉及一种固体制剂,包含第一部分和第二部分,其中所述第一部分包含茶氨酸且不含氨基丁酸,所述第二部分包含氨基丁酸且不含茶氨酸。
在一个方面,所述第一部分和第二部分呈分层、扭花或芯皮的形式。
在一个方面,所述第一部分和第二部分包含甜味剂,例如糖醇。
在一个方面,所述甜味剂选自:山梨糖醇、甘露醇、麦芽糖醇、异麦芽糖醇、赤藓糖醇、木糖醇或其两种或更多种的组合。
在一个方面,所述第一部分和第二部分包含凝胶剂。
在一个方面,所述凝胶剂选自:果胶、明胶、琼脂、淀粉、变性淀粉、阿拉伯胶、卡拉胶、结冷胶、黄原胶、海藻酸钠、槐豆胶或其两种或更多种的组合。
在一个方面,所述第一部分包含茶氨酸1-20重量份,甜味剂200-900重量份和凝胶剂10-80重量份;所述第二部分包含氨基丁酸1-40份,甜味剂200-900份和凝胶剂10-80份。
在一个方面,所述第一部分和第二部分可包含酸味剂,所述酸味剂例如柠檬酸、苹果酸、柠檬酸钠、乳酸、酒石酸、富马酸或其两种或更多种的组合。
在一个方面,所述第一部分和第二部分可包含浓缩果汁,例如草莓、苹果、葡萄、甜橙、菠萝、芒果、桃子、梨、西瓜、石榴、榴莲、西柚等浓缩果汁或其两种或更多种的组合。果蔬汁类可为《GB/T 31121果蔬汁类及其饮料》中规定的果蔬汁类饮料产品。
在一个方面,所述第一部分和第二部分可包含营养强化剂,例如GB14880现行营养强化剂使用标准中允许使用的营养强化剂,例如矿物质类,如钙、铁、锌、硒、镁、钾、钠、铜等;维生素类,如维生素A、维生素D、维生素E、维生素C、B族维生素、叶酸、生物素等;氨基酸类,如牛磺酸、赖氨酸等;其他营养素类,如二十二碳六烯酸(DHA)、膳食纤维、卵磷脂等;或其两种或更多种的组合。
在一个方面,所述第一部分和第二部分可包含食用香精,例如食品香精。
在一个方面,所述第一部分和第二部分可包含食用色素,例如食品色素。
在一个方面,所述第一部分和第二部分可包含其他促睡眠物质,例如蜜蜂花提取物,褪黑素等食品/原料或者药食两用原料。
在一个方面,所述固体制剂是软糖。
在一个方面,所述固体制剂是多层软糖形式,优选为两层。例如,上层中包含甜味剂200-900份,凝胶剂10-80份,浓缩果汁0-60份,果蔬汁类0-50份,酸味剂0-30份,营养强化剂0-300份,茶氨酸1-20份,食用香精0-10份,食用色素0-5份,其他促睡眠物质等;下层中包含甜味剂200-900份,凝胶剂10-80份,浓缩果汁0-60份,果蔬汁类0-50份,酸味剂0-30份,营养强化剂0-300份,氨基丁酸1-40份,食用香精0-10份,食用色素0-5份,其他促睡眠物质等。
本发明还涉及一种制备分层软糖的方法,所述分层软糖包括第一层和第二层,所述第一层包含茶氨酸且不含氨基丁酸,所述第二层包含氨基丁酸且不含茶氨酸,所述方法包括制备第一层凝胶料液,其包含茶氨酸且不含氨基丁酸;制备第二层凝胶料液,其包含氨基丁酸且不含茶氨酸;将第一层凝胶料液和第二层凝胶料液浇铸成型,得到所述分层软糖。
本发明还涉及所述的固体制剂在制备用于促进人体睡眠的食品或药品中的用途。
本发明所用的材料可购买得到,或用本领域技术人员公知的方法得到。
实施例
一、实施例和对比例参照下面的表格,其中制备工艺如下所述:
1、制备凝胶料液
1.1胶液的制备
将上述凝胶剂与热水混合均匀,使其充分溶解,得到胶液;
1.2糖液的制备
将上述甜味剂与适量纯化水混合,加热,使其完全溶解,熬煮浓缩至固形物含量为70%-90%,所得糖液保温备用;
2、调配
将糖液和胶液混合均匀,称取好的食用香精、浓缩果汁、营养强化剂、食用色素、酸味剂分别倒入,一起混合均匀,得到料液;
3、浇铸成型
将制备好的胶料液放到浇注机的储备箱中,60℃-120℃保温,调试设备使夹心容量在5%-35%,成型工艺采用淀粉压模成型;
4、干燥、抛光:
将得到的软糖干燥温度为10-60℃,相对湿度为10%-70%RH条件下进行干燥。
干燥后的软糖进行脱模,抛光或拌砂后得到软糖。
二、实施例1-19
表1.实施例1-5配方(单位:重量份)
表2.实施例6-10配方(单位:重量份)
表3.实施例11-15配方(单位:重量份)
表4.实施例16-19配方(单位:重量份)
表5.实施例20-22配方(单位:重量份)
表6.实施例23-25配方(单位:重量份)
三、对比实施例1-4
表7.对比实施例1-4配方(单位:重量份)
四、实验和结果
(1)软糖出水程度测试
将加速后的软糖50g左右置于25℃,湿度20-30%的干燥室中均匀铺开,干燥24h,干燥失重/%=(M1-M2)/M1,当软糖表面出现出水现象时,干燥失重>2%。
备注:M1表示干燥前重量,M2表示干燥后重量。重复3次,取平均值。
表8.干燥失重测试结果
分析:
由实施例1-25的结果可知,茶氨酸和氨基丁酸分别置于上下层时,出水量显著降低,能明显避免出水现象。在制备软糖过程中,所用的氨基丁酸含量在0.9‰-70‰范围内,茶氨酸在0.9‰-36‰范围内。
由对比实施例1的结果可知,在制备软糖过程中,茶氨酸、氨基丁酸占比各0.9‰时会出现轻微出水现象,出水量3.4%,其造成出水问题的原因可能在于茶氨酸和氨基丁酸混合会破坏胶体,影响凝胶,而无法固定水分。如果把氨基丁酸和茶氨酸分别置于上下层(实施例19),干燥失重为1.3%,出水现象得到明显改善。对比实施例2、3提高茶氨酸、氨基丁酸占比,出水量明显增加,分别为4.4%、5.4%,说明提高氨基丁酸和茶氨酸含量会导致出水更为严重。
而对比实施例4表明,当所采用的氨基丁酸为45‰,茶氨酸为78‰时,尽管将两者分别置于软糖的上下两层时,干燥失重为6.7%,依然无法避免出水。
(2)质构测试
使用SMS TA XT plus质构仪通过TPA测试模式测试前速度:1mm/s,测试速度:1mm/s,测试后速度:1mm/s,触发力:8g,目标模式:形变量50%,分别取实施例和对比实施例的软糖产品测试(控制成品规格及形状一致,圆柱形,4.0g/粒),每组样品平行测试6次,粘性结果见图1。
表9.实施例和对比实施例的质构评分表
实施例 | 粘度 |
实施例1 | -0.12 |
实施例2 | -0.20 |
实施例3 | -0.10 |
实施例4 | -0.24 |
实施例5 | -0.21 |
实施例6 | -0.12 |
实施例7 | -0.12 |
实施例8 | -0.20 |
实施例9 | -0.10 |
实施例10 | -0.24 |
实施例11 | -0.21 |
实施例12 | -0.12 |
实施例13 | -0.12 |
实施例14 | -0.20 |
实施例15 | -0.10 |
实施例16 | -0.24 |
实施例17 | -0.21 |
实施例18 | -0.12 |
实施例19 | -0.21 |
实施例20 | -0.21 |
实施例21 | -0.18 |
实施例22 | -0.11 |
实施例23 | -0.20 |
实施例24 | -0.19 |
实施例25 | -0.11 |
对比实施例1 | -0.76 |
对比实施例2 | -1.97 |
对比实施例3 | -1.88 |
对比实施例4 | -1.97 |
分析:
图1中,Area 3面积表示探头与样品完全脱离做的功,即粘性(adhesiveness)值越小,即表示粘性越大。
表7对比实施例1、2、3和4质构数据表明软糖由于出水导致质构变粘,且出水量与粘度正相关,即对比实施例4出水量最大,粘度最大。
表7实施例1-25质构表明,不出水软糖的样品,粘度较低。
虽然本发明某些特征已经在本文中阐释和描述,但本领域技术人员将想到许多修改、替代、变更和等同。因此,应理解的是,所附权利要求书意在涵盖落入本发明真实精神范围之内的所有此类修改和变更。
Claims (10)
1.一种固体制剂,包含第一部分和第二部分,其中所述第一部分包含茶氨酸且不含氨基丁酸,所述第二部分包含氨基丁酸且不含茶氨酸。
2.根据权利要求1所述的固体制剂,其中所述第一部分和第二部分呈分层、扭花或芯皮的形式。
3.根据权利要求1所述的固体制剂,其中所述第一部分和第二部分包含甜味剂,例如糖醇。
4.根据权利要求3所述的固体制剂,其中所述甜味剂选自:山梨糖醇、甘露醇、麦芽糖醇、异麦芽糖醇、赤藓糖醇、木糖醇或其两种或更多种的组合。
5.根据权利要求1所述的固体制剂,其中所述第一部分和第二部分包含凝胶剂。
6.根据权利要求5所述的固体制剂,其中所述凝胶剂选自:果胶、明胶、琼脂、淀粉、变性淀粉、阿拉伯胶、卡拉胶、结冷胶、黄原胶、海藻酸钠、槐豆胶或其两种或更多种的组合。
7.根据权利要求1所述的固体制剂,其中所述第一部分包含茶氨酸1-20重量份,甜味剂200-900重量份和凝胶剂10-80重量份;所述第二部分包含氨基丁酸1-40份,甜味剂200-900份和凝胶剂10-80份。
8.根据权利要求1所述的固体制剂,其中所述固体制剂是软糖。
9.一种制备分层软糖的方法,所述分层软糖包括第一层和第二层,所述第一层包含茶氨酸且不含氨基丁酸,所述第二层包含氨基丁酸且不含茶氨酸,所述方法包括制备第一层凝胶料液,其包含茶氨酸且不含氨基丁酸;制备第二层凝胶料液,其包含氨基丁酸且不含茶氨酸;将第一层凝胶料液和第二层凝胶料液浇铸成型,得到所述分层软糖。
10.根据权利要求1-8中任一项所述的固体制剂在制备用于促进人体睡眠的食品或药品中的用途。
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