CN112205561A - 一种益生菌泡腾微片及其制备方法 - Google Patents

一种益生菌泡腾微片及其制备方法 Download PDF

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CN112205561A
CN112205561A CN202011027868.2A CN202011027868A CN112205561A CN 112205561 A CN112205561 A CN 112205561A CN 202011027868 A CN202011027868 A CN 202011027868A CN 112205561 A CN112205561 A CN 112205561A
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tablet
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lactobacillus
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张耀华
许恒标
施苏倩
陈竣峰
张丽华
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Jiyuan Health Technology Jiangsu Co Ltd
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Abstract

本发明公开了一种益生菌泡腾微片及其制备方法,包括以下质量百分比的组份:益生菌粉末0.5%‑8%、益生元5%‑30%、崩解剂30%‑60%、填充剂0%‑50%、矫味剂0.5%‑5%、润滑剂0.5%‑5%、粘合剂0%‑5%、各组份的质量百分比总和为100%。本发明将益生菌做成泡腾微片制剂与传统泡腾片相比片剂直径由20mm以上改为微片尺寸2mm‑3mm,片重由5g左右减少为6mg‑30mg左右压片较小的压力就可以压制成型并不易破碎,降低了活菌因压片压力过大造成的较大损失率,本发明还将泡腾时间由传统泡腾片的5min降低到只有不到1min。

Description

一种益生菌泡腾微片及其制备方法
技术领域
本发明涉食品、医药技术领域,具体为一种益生菌泡腾微片及其制备方法。
背景技术
益生菌是通过定殖在人体内,改变宿主某一部位菌群组成的一类对宿主有益的活性微生物。益生菌最主要核心特征在于有益健康的功能属性,这是建立在科学严谨的临床试验评价和循证医学证据基础上的。目前有上万篇公开发表的学术论文研究了不同益生菌菌株的各种功能,已被证实益生菌的核心功能是改善人体胃肠道健康,如平衡肠道菌群、缓解肠道炎症、缓解肠易激综合征等。世界胃肠病学组织(WGO)在2011年指出益生菌在缓解腹泻、便秘等方面的功效有着“强有力的证据”,2017年再次指出益生菌可以有效防治消化道疾病。2016年中华预防医学会微生态学分会发布了《中国消化道微生态调节剂临床应用专家共识(2016版)》,指出作为微生态调节剂重要组成的益生菌具有广泛的生理功能。
近几年随着益生菌市场的普及,人们对益生菌的作用越来越关注,益生菌产业如雨后春笋般拔地而起,市面上的益生菌产品的种类也越来越多,其中大多数产品是以滴剂、片剂、粉剂形式为主。
益生菌片剂是将益生菌粉末与其他辅料混合压成片剂,服用时用水送服。此剂型片子在胃部崩解滞留时间较长通常需要半个小时以上时间,胃酸易对益生菌活菌造成较大破坏降低活菌含量。益生菌泡腾片可以很好解决这个问题,泡腾片体外崩解一般3-5分钟能崩解完溶于水中,口服后能快速通过胃部到达肠道起效。
益生菌活菌数是评价益生菌产品的重要指标,通常活性益生菌对外力较敏感,压片压力对益生菌泡腾片有较大影响。常规泡腾片尺寸都很大一般片子直径能到20mm以上,这样压片就需要很大压力才能将片子压成型并有一定硬度保证片子不会破碎,但是在很大的压力下活性益生菌损失很大,通过实验发现当压片压力达到40KN以上活菌损失率达到60%以上。另一方面泡腾片中通常含有大量酸碱泡腾剂,崩解过程中会有大量酸碱成分溶解在水中,在泡腾片崩解过程中如果崩解时间过长溶液会对活菌产生一些影响。
发明内容
本发明提供了一种益生菌泡腾微片及制备方法,能有效的降低活菌的损失率。
为了实现上述目的,本发明一方面提供了一种益生菌泡腾微片,包括以下重量百分比的组份:
Figure RE-GDA0002805336360000021
各组份的质量百分比总和为100%。
优选的,所述益生菌泡腾微片中益生菌粉末包括以下益生菌种类中的一种或多种的组合:青春双歧杆菌Bifidobacterium adolescentis、动物双歧杆菌(乳双歧杆菌)Bifidobacterium animalis(Bifidobacterium lactis)、两歧双歧杆菌Bifidobacteriumbifidum、短双歧杆菌Bifidobacterium breve、婴儿双歧杆菌Bifidobacterium infantis、长双歧杆菌Bifidobacterium longum、嗜酸乳杆菌Lactobacillus acidophilus、干酪乳杆菌Lactobacillus casei、卷曲乳杆菌Lactobacillus crispatus、德氏乳杆菌保加利亚亚种(保加利亚乳杆菌)Lactobacillus delbrueckii subsp. Bulgaricus(Lactobacillusbulgaricus)、德氏乳杆菌乳亚种Lactobacillus delbrueckii subsp.Lactis、发酵乳杆菌Lactobacillus fermentium、格氏乳杆菌
Lactobacillus gasseri、瑞士乳杆菌Lactobacillus helveticus、约氏乳杆菌
Lactobacillus johnsonii、副干酪乳杆菌Lactobacillus paracasei、植物乳杆菌
Lactobacillus plantarum、罗伊氏乳杆菌Lactobacillus reuteri、鼠李糖乳杆菌
Lactobacillus rhamnosus、唾液乳杆菌Lactobacillus salivarius、嗜热链球菌Streptococcus thermophilus、费氏丙酸杆菌谢氏亚种、乳酸乳球菌乳酸亚种、乳酸乳球菌乳脂亚种和乳酸乳球菌双乙酰亚种、肠膜明串珠菌肠膜亚种(Leuconostoc.mesenteroides subsp.mesenteroides)、小牛葡萄球菌(Staphylococcusvitulinus)、木糖葡萄球菌(Staphylococcus xylosus)、肉葡萄球菌(Staphylococcuscarnosus)、凝结芽孢杆菌(Bacillus coagulans)等国家相关部门批准允许使用的益生菌。
优选的,所述益生元包括菊粉、抗性糊精、低聚果糖、低聚半乳糖、低聚木糖、低聚异麦芽糖、大豆低聚糖、聚葡萄糖一种或多种的组合。
优选的,所述益生元为抗性糊精、低聚木糖一种或两种的组合。
优选的,所述崩解剂包括酸源、碱源、含有或不含有羧甲基淀粉钠、交联羧甲基纤维素钠、交联聚维酮中一种或多种的组合。
优选的,所述崩解剂中酸源包括柠檬酸、苹果酸、酒石酸、富马酸一种或多种的组合。
优选的,所述碱源包括碳酸氢钠、碳酸钠、碳酸氢钾、碳酸钾中一种或多种的组合;优选的,所述碱源包括碳酸氢钠、碳酸钠中一种或多种的组合。
优选的,所述填充剂包括微晶纤维素、木糖醇、山梨糖醇、淀粉、甘露糖醇、赤藓糖醇、蔗糖、葡萄糖、果糖、乳糖、异麦芽糖醇、麦芽糊精、麦芽糖醇中一种或多种的组合。
优选的,所述填充剂为木糖醇、甘露糖醇、异麦芽糖醇、蔗糖、麦芽糊精中一种或多种的组合。
优选的,所述矫味剂包括三氯蔗糖、甜菊糖苷、阿斯巴甜、AK糖、食用香精、食盐中一种或多种的组合。
优选的,所述润滑剂包括硬脂酸盐、硬脂酸、二氧化硅、牛油果油、亚麻籽油、橄榄油、甘油,聚乙二醇一种或多种的组合。
优选的,所述润滑剂为硬脂酸镁、牛油果油、二氧化硅、聚乙二醇中一种或多种的组合。
优选的,所述粘合剂包括粘合剂选自羟丙基甲基纤维素、聚乙烯吡咯烷酮、羧甲基淀粉钠、淀粉、预胶化淀粉、麦芽糊精、阿拉伯胶中一种或多种的组合。
优选的,所述粘合剂为羟丙基甲基纤维素、聚乙烯吡咯烷酮、麦芽糊精中一种或多种。
优选的,所述益生菌粉末的添加量以活菌数计含量为1×109-1×1011
本发明另一方面还提供了一种益生菌泡腾微片的制备方法,包括如下步骤:
步骤一:按照处方量称取益生菌泡腾微片所需原辅料,所有原辅料均需通过30目标准筛;
步骤二:根据原辅料性质,物料可以选择制粒或不制粒;制粒颗粒过30目标准筛;
步骤三:除润滑剂以外的物料混合均匀后再加入润滑剂混合得混合料;
步骤四:将步骤三所得的混合料压片得益生菌泡腾微片。
优选的,步骤一中,原辅料水活度要求≤0.2,如超过需烘干至符合。
优选的,步骤四中,压片模具为1mm-3mm的圆形模具,优选为2mm-3mm的圆形模具。
优选的,步骤四中,压片主压力≤20KN。
优选的,益生菌泡腾微片5g在20℃、200mL水中崩解时限≤1min。
本发明将益生菌做成泡腾微片制剂与传统泡腾片相比,片剂直径由20mm以上改为微片尺寸2mm-3mm,片重由5g左右减少为6mg-30mg左右,压片时候只需较小的压力就可以压制成型并不易破碎,降低了活菌因压片压力过大造成的较大损失率。我们知道有些活性益生菌在酸性或碱性溶液中不稳定,因此减少泡腾时间,尽快饮用很有必要。本发明将泡腾时间由传统泡腾片的5min降低到只有不到1min。
发明人通过实验来验证本发明技术效果。以下实验只是本发明众多实验中部分实验举例,并未涵盖本发明全部实验。
试验一:益生菌泡腾微片不同压片压力下益生菌活菌损失率
配方:异麦芽酮糖醇24.8g抗性糊精20g三氯蔗糖0.2g香精1g柠檬酸20g碳酸氢钠30g乳杆菌Lactobacillus rhamnosus 2g硬脂酸镁2g
Figure RE-GDA0002805336360000041
Figure RE-GDA0002805336360000051
从实验一可以看出益生菌泡腾微片压片主压力大大降低,活性益生菌损失率大幅度降低。
实验二:益生菌泡腾微片与传统泡腾片泡腾时间对比
配方:甘露糖醇24.3g抗性糊精20g阿斯巴甜0.2g香精1g柠檬酸20g碳酸氢钠30g双岐杆菌Bifidobacterium lactis 2.5g硬脂酸镁2g。
Figure RE-GDA0002805336360000052
从实验二可以看出益生菌泡腾微片泡腾时间明显小于传统益生菌泡腾片泡腾时间。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
应当说明的是,在本文中,诸如第一和第二等之类的关系术语仅仅用来将一个实体或操作与另一个实体或操作区分开来,而不一定要求或暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且,术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下,由语句“包括一个……”限定的要素,并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
实施例一
制备1000g益生菌泡腾微片,配方如下:
Figure RE-GDA0002805336360000061
制备方法:所有原料水活度控制0.2以下不符要求的干燥到符合要求过30目筛。乳双歧杆菌粉末、低聚木糖、柠檬酸、碳酸氢钠、木糖醇、甜橙香精、甜菊糖苷混合均匀加入硬脂酸镁混合均匀。选用3mm圆形模具压片,片重20mg、主压力15KN。得益生菌泡腾微片。所得益生菌泡腾微片相关指标如下:
Figure RE-GDA0002805336360000062
由上述实验数据可知,采用本实施例的配方能够制备得到尺寸明显小于传统泡腾片的益生菌泡腾微片制剂,并且崩解时间大大缩短,活性益生菌损失率大幅度降低。
实施例二
制备1000g益生菌泡腾微片,配方如下:
Figure RE-GDA0002805336360000063
Figure RE-GDA0002805336360000071
制备方法:所有原料水活度控制0.2以下不符要求的干燥到符合要求过30目筛。植物乳杆菌粉末、鼠李糖乳杆菌粉末、抗性糊精、柠檬酸、碳酸氢钠、直压蔗糖、交联聚维酮、甜橙香精、AK糖混合均匀得混粉1;牛油果油与二氧化硅混合过80目筛与混粉1混合均匀。选用2mm圆形模具压片,片重6mg、主压力10KN。得益生菌泡腾微片。所得益生菌泡腾微片相关指标如下:
Figure RE-GDA0002805336360000072
由上述实验数据可知,采用本实施例的配方能够制备得到尺寸明显小于传统泡腾片的益生菌泡腾微片制剂,并且崩解时间大大缩短,活性益生菌损失率大幅度降低。
对于本领域技术人员而言,显然本发明不限于上述示范性实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。因此,无论从哪一点来看,均应将实施例看作是示范性的,而且是非限制性的,本发明的范围由所附权利要求而不是上述说明限定,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。

Claims (16)

1.一种益生菌泡腾微片,其特征在于:包括以下质量百分比的组份:
Figure FDA0002702651710000011
各组份的质量百分比总和为100%。
2.根据权利要求1所述的益生菌泡腾微片,其特征在于:所述益生菌粉末包括以下益生菌种类中的一种或多种的组合:青春双歧杆菌Bifidobacterium adolescentis、动物双歧杆菌(乳双歧杆菌)Bifidobacterium animalis(Bifidobacterium lactis)、两歧双歧杆菌Bifidobacterium bifidum、短双歧杆菌Bifidobacterium breve、婴儿双歧杆菌Bifidobacterium infantis、长双歧杆菌Bifidobacterium longum、嗜酸乳杆菌Lactobacillus acidophilus、干酪乳杆菌Lactobacillus casei、卷曲乳杆菌Lactobacillus crispatus、德氏乳杆菌保加利亚亚种(保加利亚乳杆菌)Lactobacillusdelbrueckii subsp.Bulgaricus(Lactobacillus bulgaricus)、德氏乳杆菌乳亚种Lactobacillus delbrueckii subsp.Lactis、发酵乳杆菌Lactobacillus fermentium、格氏乳杆菌Lactobacillus gasseri、瑞士乳杆菌Lactobacillus helveticus、约氏乳杆菌Lactobacillus johnsonii、副干酪乳杆菌Lactobacillus paracasei、植物乳杆菌Lactobacillus plantarum、罗伊氏乳杆菌Lactobacillus reuteri、鼠李糖乳杆菌Lactobacillus rhamnosus、唾液乳杆菌Lactobacillus salivarius、嗜热链球菌Streptococcus thermophilus、费氏丙酸杆菌谢氏亚种、乳酸乳球菌乳酸亚种、乳酸乳球菌乳脂亚种和乳酸乳球菌双乙酰亚种、肠膜明串珠菌肠膜亚种(Leuconostoc.mesenteroidessubsp.mesenteroides)、小牛葡萄球菌(Staphylococcus vitulinus)、木糖葡萄球菌(Staphylococcus xylosus)、肉葡萄球菌(Staphylococcus carnosus)、凝结芽孢杆菌(Bacillus coagulans)。
3.根据权利要求1所述益生菌泡腾微片,其特征在于:所述益生元包括菊粉、抗性糊精、低聚果糖、低聚半乳糖、低聚木糖、低聚异麦芽糖、大豆低聚糖、聚葡萄糖中的一种或多种的组合。
4.根据权利要求1所述益生菌泡腾微片,其特征在于:所述崩解剂包括酸源、碱源、含有或不含有羧甲基淀粉钠、交联羧甲基纤维素钠、交联聚维酮中一种或多种的组合。
5.根据权利要求4所述益生菌泡腾微片,其特征在于:所述酸源包括柠檬酸、苹果酸、酒石酸、富马酸一种或多种的组合。
6.根据权利要求4所述益生菌泡腾微片,其特征在于:所述碱源包括碳酸氢钠、碳酸钠、碳酸氢钾、碳酸钾中一种或多种的组合;优选碳酸氢钠、碳酸钠中一种或多种的组合。
7.根据权利要求4所述益生菌泡腾微片,其特征在于:所述填充剂包括微晶纤维素、木糖醇、山梨糖醇、淀粉、甘露糖醇、赤藓糖醇、蔗糖、葡萄糖、果糖、乳糖、异麦芽糖醇、麦芽糊精、麦芽糖醇中一种或多种的组合。
8.根据权利要求1所述益生菌泡腾微片,其特征在于:所述矫味剂包括三氯蔗糖、甜菊糖苷、阿斯巴甜、AK糖、食用香精、食盐中一种或多种的组合。
9.根据权利要求1所述益生菌泡腾微片,其特征在于:所述润滑剂包括硬脂酸盐、硬脂酸、二氧化硅、牛油果油、亚麻籽油、橄榄油、甘油,聚乙二醇一种或多种的组合。
10.根据权利要求1所述益生菌泡腾微片,其特征在于:所述粘合剂包括羟丙基甲基纤维素、聚乙烯吡咯烷酮、羧甲基淀粉钠、淀粉、预胶化淀粉、麦芽糊精、阿拉伯胶中一种或多种的组合。
11.根据权利要求1或2所述益生菌泡腾微片,其特征在于:所述益生菌粉末的添加量以活菌数计含量为1×109-1×1011
12.一种益生菌泡腾微片的制备方法,其特征在于,包括如下步骤:
步骤一:按照处方量称取益生菌泡腾微片所需原辅料,所有原辅料均需通过30目标准筛;
步骤二:根据原辅料性质,物料可以选择制粒或不制粒;制粒颗粒过30目标准筛;
步骤三:除润滑剂以外的物料混合均匀后再加入润滑剂混合得混合料;
步骤四:将步骤三所得的混合料压片得益生菌泡腾微片。
13.根据权利要求12所述的制备方法,其特征在于:步骤一中,原辅料水活度≤0.2。
14.根据权利要求12所述的制备方法,其特征在于:步骤四中,压片模具为1mm-3mm的圆形模具。
15.根据权利要求12所述的制备方法,其特征在于:步骤四中,压片主压力为≤15KN。
16.根据权利要求12所述的制备方法,其特征在于:所述益生菌泡腾微片5g在20℃、200mL水中崩解时限≤1min。
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