CN116672322A - 一种益生菌肠溶软胶囊及其制备方法和应用 - Google Patents
一种益生菌肠溶软胶囊及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种益生菌肠溶软胶囊及其制备方法和应用。所述肠溶益生菌软胶囊包括内容物以及植物囊皮；所述内容物以冻干益生菌为活性成分，食用油等油性液体为溶剂，蜂蜡为助悬剂；所述植物囊皮以水为溶剂，海藻酸钠为成膜材料和耐酸成分，卡拉胶、结冷胶为凝胶剂，甘油、麦芽糖醇等为增塑剂，并通过对制备的软胶囊进行钙化增强其耐酸性。油性混悬剂中水分含量非常低，可有效保证益生菌的稳定性；植物基囊皮水分含量低并能够隔绝外界空气和水分，有效延长产品货架期，另外囊皮中添加了耐酸成分，可保护益生菌不受胃酸的侵袭，显著提高了益生菌进入肠道的活菌数量。
Description
技术领域
本发明涉及口服益生菌技术领域，具体涉及一种益生菌肠溶软胶囊及其制备方法和应用。
背景技术
益生菌(Probiotics)是指一般口服后对宿主(如动物或人类)有正面效益的活性微生物，主要包括双歧杆菌和乳酸杆菌等。益生菌在人类中有许多有益的效果和治疗应用，例如维持正常的肠道菌群，改善便秘，治疗腹泻，增强免疫系统，降低乳糖不耐症，降低血清胆固醇水平，抗癌活性以及提高食物的营养价值等。益生菌可以作为营养补充剂、药品或食品在商业上应用。市场上有大量的益生菌产品，包括牛奶、饮料和冷冻酸奶、奶酪、发酵大豆产品等。此外，特殊的冻干制剂以颗粒剂、片剂、胶囊剂的形式提供。
随着人民群众对肠道健康意识的增强，益生菌产品得以快速发展。但想要确保摄入的益生菌有效，益生菌的活菌数和存活率都很重要。目前，市售的部分产品宣传添加大量益生菌，但益生菌出厂活菌检测结果通常显示，仅为每克10-50亿cfu之间，这很难保证益生菌进入胃肠道，能经受住胃酸、胆盐环境而存活，所以其活性难以保证，功效自然下降甚至微乎其微。
发明内容
为解决背景技术中所述的益生菌产品贮存过程中活菌数减少、货架期短及不耐胃酸的问题，本发明提供了一种益生菌肠溶软胶囊及其制备方法和应用。所述益生菌肠溶软胶囊的内容物为冻干益生菌均匀分散在油性液体中，以隔绝水分与氧气，解决益生菌怕水问题，以便在贮存过程中益生菌数量不变及延长货架期；外层为植物囊皮，并添加耐酸成分解决益生菌服用后不耐胃酸的缺点。
为实现上述发明目的，本发明采用以下技术方案予以实现：
本发明提供了一种益生菌肠溶软胶囊，其包括含益生菌的内容物以及植物囊皮；所述植物囊皮包括耐酸成分藻类植物多糖。
进一步的，所述内容物中还含有油性溶剂和助悬剂；所述植物囊皮还包括凝胶剂、增塑剂和溶剂。
进一步的，按重量百分数计，所述益生菌肠溶软胶囊的配方为：
内容物：益生菌5％～6％，助悬剂2％～3％，余量为油性溶剂；
植物囊皮：藻类植物多糖3％～4％，凝胶剂4％～6％，增塑剂3％，余量为溶剂水。
进一步的，所述油性溶剂为大豆油、花生油、玉米胚芽油、菜籽油、橄榄油、亚麻籽油、葡萄籽油、核桃油、沙棘籽油、EPA、DHA、共轭亚油酸、花生四烯酸中的至少一种。
进一步的，所述藻类植物多糖为海藻酸钠。
进一步的，所述助悬剂为甘油；所述凝胶剂为卡拉胶、结冷胶、琼胶、变性淀粉、KCl中的至少一种；所述增塑剂为甘油、麦芽糖醇中的至少一种。
进一步的，按重量百分数计，所述益生菌肠溶软胶囊的配方为：益生菌5％、蜂蜡2％、大豆油93％、海藻酸钠3％、琼胶3％、变性淀粉1.5％、甘油3％、水89.5％。
本发明还提供了所述的益生菌肠溶软胶囊的制备方法，其包括以下步骤：
(1)内容物配置：将助悬剂置于油性溶剂中，加热溶解，放置室温后，加入益生菌的冻干粉，充分搅拌均匀后备用；
(2)植物囊皮胶液制备：将藻类植物多糖、凝胶剂、增塑剂均溶于水中，高温加热溶胶，形成均一稳定的囊皮胶液，保温备用；
(3)益生菌肠溶软胶囊的制备：调整滴制设备参数，加入所述的内容物和植物囊皮胶液，开启设备，滴制得到的软胶囊进行钙化后，低温干燥并醇洗，挑选出合格品即为益生菌肠溶软胶囊。
进一步的，所述步骤(2)中的高温为90℃水浴加热溶胶30min-60min后，再于55-70℃下消除气泡；所述步骤(3)中的设备参数为胶液温度55-70℃，滴头温度55-70℃，制冷温度4-8℃。
进一步的，所述步骤(3)中钙化采用的是4％的CaCl2溶液；所述低温干燥的温度为16-22℃。
本发明还提供了所述的益生菌肠溶软胶囊在食品、营养保健食品和药品中的应用。
本发明与现有技术相比，具有以下优点和有益效果：
本发明制备了一种海藻基益生菌肠溶软胶囊，相比于其他粉剂、颗粒剂、片剂、胶囊剂益生菌产品。所述益生菌肠溶软胶囊密封性好，有效隔绝了外界空气、水分对内容益生菌的影响；冻干益生菌粉与油性液体共同作用，规避了益生菌怕水问题，协同保证了益生菌的活力。所述益生菌肠溶软胶囊为植物源多糖材料，含水量低，适用人群广，特别适用于素食主义者及特殊宗教人士，另外还添加了耐酸成分减少了益生菌产品过胃的损失。所述益生菌肠溶软胶囊以滴制法制备，工艺简单，适于工业大生产，无生产过程中压力、水分对益生菌失活的影响。该益生菌软胶囊外形美观，可制备以不同颜色标识的不同种类的益生菌复配产品，增加了益生菌多样性，可实现工业化生产。
附图说明
图1为益生菌软胶囊的产品图；其中A为湿的益生菌软胶囊，B为干的益生菌软胶囊。
图2为益生菌软胶囊的横切面。
图3为市售的益生菌晶球产品图；其中左侧为新希望活润酸奶中的益生菌晶球；右侧为森下仁丹的益生菌晶球。
图4为益生菌软胶囊(湿)连续三批产品。
图5为益生菌软胶囊(湿)的稳定性实验。
图6为益生菌软胶囊(干)连续三批产品。
图7为益生菌软胶囊的中试试制产品。
具体实施方式
结合以下具体实例对本发明的技术方案作进一步详细的说明。
下述实施例中，如无特殊说明，所使用的实验方法均为常规方法，所用材料、试剂等均可从生物或化学试剂公司购买。
本发明的益生菌软胶囊的内容物以益生菌冻干粉为活性物质，大豆油为溶剂，蜂蜡为助悬剂；囊皮辅料包括水为溶剂，海藻酸钠为成膜材料和耐酸成分，卡拉胶、结冷胶、琼胶等为凝胶剂，甘油、麦芽糖醇等为增塑剂。
内容物配置方法：称取处方量的蜂蜡置于大豆油中，加热溶解，放置室温后，加入处方量益生菌冻干粉，充分搅拌均匀后备用。
植物囊皮胶液制备：称取处方量材料溶于水中，于90℃水浴锅中加热溶胶30-60min，待充分溶胶后置于55-70℃水浴锅中保温除气泡，形成均一稳定的囊皮胶液，保温备用。
益生菌软胶囊产品制备工艺：内容物及胶液制备→开启设备→设置各项参数→加入内容物和胶液→滴制→钙化→低温干燥→洗丸→选丸→包装；
具体步骤：益生菌软胶囊的内容物和囊皮胶液制备完成后，开启设备，调整胶液温度(55-70℃)，滴头温度(55-70℃)，制冷温度(4-8℃)等参数，待参数达到要求后，加入胶液和内容物，开启胶液和内容物开关，调节合适的转速滴制即可，滴制完成的软胶囊倒入4％CaCl2溶液中进行钙化，取出进行低温(16-22℃)干燥一夜，干燥后的产品用95％乙醇进行清洗去油，挑选出合格产品即可。
实施例1
内容物配方：
益生菌5％
蜂蜡3％
大豆油92％
植物囊皮配方：
实施例1的配方制备的益生菌软胶囊外形圆整，质地较硬，不易破损，制备过程中软胶囊出现少量黄色混杂物，及制备完成后进行第二批实验时出现内容物堵塞管道问题，分析问题：1)益生菌用量问题，2)蜂蜡用量问题，通过不加蜂蜡后实验中堵塞更严重的现象，证明蜂蜡是非常必要的。堵塞问题解决方案如下：1)减少蜂蜡用量；2)菌粉进行粉粹过120目筛；3)实验完成后用加热的大豆油进行管道清洗，必要时进行管道拆解清洗；4)研制专用于软胶囊的益生菌冻干保护剂。
实施例2
内容物配方：
益生菌5％
蜂蜡2％
大豆油93％
植物囊皮配方：
实施例2的胶皮配方制备的胶液黏度降低，胶液流动性好，制备过程中滴制流畅，益生菌软胶囊外形圆整，大小适中，质地较硬，不易破损，在纯水及人工胃液中常温放置一夜不溶。
实施例3
内容物配方：
益生菌 5％
蜂蜡 2％
大豆油 93％
植物囊皮配方：
实施例3的胶皮配方制备的胶液黏度低，胶液流动性好，制备过程中滴制流畅，制冷温度在15℃时胶丸亦能凝固，制备的益生菌软胶囊外形圆整，大小适中，质地较硬，不易破损，放置在常温纯水及人工胃酸中一夜未出现内容物溶出现象，但胶液长时间保温放置时易凝固。
实施例4
内容物配方：
益生菌 5％
蜂蜡 2％
大豆油 93％
植物囊皮配方：
实施例4的胶皮配方制备的胶液黏度低，胶液流动性好，制备过程中滴制流畅，制冷温度可设置为15℃，制备的益生菌软胶囊外形圆整，大小适中，质地较硬，不易破损，在纯水及人工胃酸中常温放置一夜均不破碎溶解。
实施例5
内容物配方：
益生菌 5％
蜂蜡 2％
大豆油 93％
植物囊皮配方：
实施例5的胶皮配方制备的胶液黏度稍大，制备的益生菌软胶囊外形圆整，质地略软，在纯水及模拟胃酸中常温放置2h搅拌破碎溶解。
将实施例1-实施例5的益生菌软胶囊的制备情况总结如表1，可以看出，实施例4制备的益生菌软胶囊较好，确定最终胶皮配方材料为海藻酸钠3％、琼胶3％、变性淀粉1.5％、甘油3％，其余为水，并以此制备的益生菌软胶囊进行产品制备，并进行后续的分析。
表1实施例1-5制备的益生菌软胶囊的情况
| 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | |
| 滴制温度/℃ | 65 | 60 | 60 | 55 | 65 |
| 软胶囊性状 | 较好 | 较好 | 较好 | 较好 | 较好 |
| 溶解性 | 肠溶 | 肠溶 | 肠溶 | 肠溶 | 肠溶 |
| 活菌数/g | 80亿 | 110亿 | 95亿 | 130亿 | 70亿 |
实施例6：益生菌软胶囊的分析
1、产品对比
实施例4所制备的益生菌软胶囊的图片及其横切面简图参见图1和图2，市售的两种产品图片参见图3，在外观性状、材料、耐水性等方面进行对比，结果见表2和表3。
本发明的益生菌软胶囊(湿)相比于市售酸奶晶球产品，外形更加美观、圆整，采用原料均为植物源材料，载菌量更多，其耐水性和耐酸性均得到实验验证。而益生菌软胶囊(干)相比于市售产品，囊皮材料均为植物源多糖材料，测得的活菌数量更多。
表2益生菌软胶囊(湿)与市售产品对比
表3益生菌软胶囊(干)与市售产品对比
2、稳定性研究
(1)益生菌软胶囊(湿)稳定性
按照实施例4的配方制备了连续三批的益生菌软胶囊产品(图4)，将其加入纯水中置于4℃冰箱中(图5)，进行了28天的稳定性实验。结果如表4所示，影响益生菌制剂稳定性的因素有温度、水分、空气、制备工艺等，益生菌软胶囊(湿)置于水中会导致水慢慢进入软胶囊内部，影响活菌数量。
表4益生菌软胶囊(湿)稳定性实验结果
(2)益生菌软胶囊(干)稳定性
按照实施例4的配方制备了连续三批的益生菌软胶囊产品(图6)，放置于温度25℃下，进行了3个月的初期稳定性实验。
结果如表5所示，益生菌软胶囊(干)活菌数量会受到外界温度、空气等的影响，导致菌量出现轻微下降，但是相比于市售其他制剂的产品，其菌量数量级未变，稳定性显著提高。
表4实验所制益生菌软胶囊(干)稳定性实验结果
3、中试产品试制
内容物配方：
益生菌(过120目筛) 5％
蜂蜡 2％
大豆油 93％
植物囊皮配方：
工艺参数：溶胶温度：90℃，溶胶时间1-1.5h，保胶温度65℃，保胶时间2-3h，滴制温度60-65℃，制冷温度15℃。
采用以上配方工艺在软胶囊设备厂家进行了一次产品试制，产品图片如图7，各项参数见表6。
表6中试试制产品各项参数
| 分类 | 活菌数/g | 粒径 |
| 菌粉 | 3400亿 | 过120目筛 |
| 菌液 | 153亿 | 过80目筛 |
| 软胶囊(湿) | 71亿 | 3.5-4mm |
| 软胶囊(干) | 99亿 | 2.4-2.5mm |
以上实施例仅用以说明本发明的技术方案，而非对其进行限制；尽管参照前述实施例对本发明进行了详细的说明，对于本领域的普通技术人员来说，依然可以对前述实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或替换，并不使相应技术方案的本质脱离本发明所要求保护的技术方案的精神和范围。
Claims (10)
1.一种益生菌肠溶软胶囊，其特征在于，所述肠溶益生菌软胶囊包括含益生菌的内容物以及植物囊皮；所述植物囊皮包括耐酸成分藻类植物多糖。
2.根据权利要求1所述的益生菌肠溶软胶囊，其特征在于，所述内容物中还含有油性溶剂和助悬剂；所述植物囊皮还包括凝胶剂、增塑剂和溶剂。
3.根据权利要求2所述的益生菌肠溶软胶囊，其特征在于，按重量百分数计，所述益生菌肠溶软胶囊的配方为：
内容物：益生菌5％～6％，助悬剂2％～3％，余量为油性溶剂；
植物囊皮：藻类植物多糖3％～4％，凝胶剂4％～6％，增塑剂3％，余量为溶剂水。
4.根据权利要求3所述的益生菌肠溶软胶囊，其特征在于，所述油性溶剂为大豆油、花生油、玉米胚芽油、菜籽油、橄榄油、亚麻籽油、葡萄籽油、核桃油、沙棘籽油、EPA、DHA、共轭亚油酸、花生四烯酸中的至少一种。
5.根据权利要求3所述的益生菌肠溶软胶囊，其特征在于，所述藻类植物多糖为海藻酸钠。
6.根据权利要求3所述的益生菌肠溶软胶囊，其特征在于，所述助悬剂为甘油；所述凝胶剂为卡拉胶、结冷胶、琼胶、变性淀粉、KCl中的至少一种；所述增塑剂为甘油、麦芽糖醇中的至少一种。
7.权利要求1-6任一项所述的益生菌肠溶软胶囊的制备方法，其特征在于，包括以下步骤：
(1)内容物配置：将助悬剂置于油性溶剂中，加热溶解，放置室温后，加入益生菌的冻干粉，充分搅拌均匀后备用；
(2)植物囊皮胶液制备：将藻类植物多糖、凝胶剂、增塑剂均溶于水中，高温加热溶胶，形成均一稳定的囊皮胶液，保温备用；
(3)益生菌肠溶软胶囊的制备：调整滴制设备参数，加入所述的内容物和植物囊皮胶液，开启设备，滴制得到的软胶囊进行钙化后，低温干燥并醇洗，挑选出合格品即为益生菌肠溶软胶囊。
8.根据权利要求7所述的制备方法，其特征在于，所述步骤(2)中的高温为90℃水浴加热溶胶30min-60min后，再于55-70℃下消除气泡；所述步骤(3)中的设备参数为胶液温度55-70℃，滴头温度55-70℃，制冷温度4-8℃。
9.根据权利要求7所述的制备方法，其特征在于，所述步骤(3)中钙化采用的是4％的CaCl2溶液；所述低温干燥的温度为16-22℃。
10.权利要求1-6任一项所述的益生菌肠溶软胶囊在食品、营养保健食品和药品中的应用。
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