CN108523133A - 一种益生菌复合微粒及其制备方法 - Google Patents
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Abstract
本发明公开了一种益生菌复合微粒，所述复合微粒包含益生菌、鞣酸蛋白及低聚果糖。本发明所公开的益生菌复合微粒，成分工艺简单，添加少、应用于治疗腹泻及肠粘膜修复低剂量即有极好的效果，并可在常温下较长期存放。
Description
技术领域
本发明涉及一种益生菌复合微粒及其制备方法。
背景技术
研究表明，益生菌对机体有重要的生理功能，包括整肠作用，维持肠道菌群平衡，防治腹泻；缓解乳糖不耐症，促进机体营养吸收；增强免疫力；降低高血压；降低胆固醇；预防癌症，抑制肿瘤生长等等作用，因而益生菌产品已被广泛用于保健、医药等领域。但由于益生菌的耐受性较差，活菌制剂进入消化道后难以经受低pH值的胃酸、胆汁酸，消化酶等的作用，使之难以有足够的活菌数量到达肠道、进行增殖并发挥作用。
目前，对益生菌的保护方法主要是将益生菌用载体包埋，利用载体材料自身的传质阻力以阻止胃酸等与益生菌相接触而起到保护作用，提升了到达肠道的活菌数量，但存在壁材组成成分复杂，占比高，工艺复杂，效果不佳等问题，对于益生菌的应用存在一定的不利影响。
发明内容
本发明要解决的技术问题是提供一种成分工艺简单、添加少、效果好的益生菌复合微粒。
为解决上述技术问题，本发明公开了一种益生菌复合微粒，所述复合微粒包含益生菌、鞣酸蛋白及低聚果糖。
所述益生菌优选为鼠李糖乳杆菌、乳酸双歧杆菌或干酪乳杆菌，优选为冻干菌粉，活菌数1×1010～1×1013cfu/g。所述鞣酸蛋白与低聚果糖的重量比优选为1:2～4，更优选为1:3。
本发明所公开的益生菌复合微粒，可通过如下步骤制备：a)低聚果糖置于水中，溶解得澄清水溶液；b)步骤a)水溶液中加入鞣酸蛋白，混合均匀后除菌；c)步骤b)溶液中加入益生菌，均质后干燥。
本发明所公开的益生菌复合微粒适用于治疗腹泻及肠粘膜修复。
鞣酸蛋白由鸡蛋白的稀溶液与鞣酸作用制得，临床上常作为止泻药，适用于急性胃肠炎及各种非细菌性腹泻、小儿消化不良等，需较大剂量才能发挥作用(成人:每天3次，每次1～2g，空腹服)，并有便秘等副作用，本发明的研究人员意外发现，将益生菌、鞣酸蛋白及低聚果糖制备成复合微粒，可能是由于低聚果糖的传质阻力，及鞣酸蛋白在胃内不分解，及对胃蛋白酶、胰酶、乳酶生等消化酶类活性的抑制，使益生菌可以以较高的活性状态到达肠道顺利定殖，发挥作用，且与鞣酸蛋白的止泻有较好的协同作用，本发明所公开的益生菌复合微粒应用于治疗腹泻及肠粘膜修复，低剂量即有极好的效果，并可在常温下较长期存放。
具体实施方式
以下通过具体实施例再对本发明的上述内容作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅局限于以下的实施例。在不脱离本发明上述技术思想的情况下，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，均应包括在本发明的范围内。
实施例1
处方：
| 物料组成 | 处方配比 |
| 益生菌 | 3.4×1010cfu |
| 鞣酸蛋白 | 1.0g |
| 低聚果糖 | 2.0g |
制备方法：
1)低聚果糖置于水中，溶解得澄清水溶液；
2)步骤1)水溶液中加入鞣酸蛋白，混合均匀后除菌；
3)步骤2)溶液中加入益生菌，均质后冷冻干燥。
实施例2
处方：
| 物料组成 | 处方配比 |
| 益生菌 | 5.4×1011cfu |
| 鞣酸蛋白 | 1.0g |
| 低聚果糖 | 4.0g |
制备方法：
1)低聚果糖置于水中，溶解得澄清水溶液；
2)步骤2)水溶液中加入鞣酸蛋白，混合均匀后除菌；
3)步骤3)溶液中加入益生菌，均质后冷冻干燥。
实施例3
处方：
| 物料组成 | 处方配比 |
| 益生菌 | 5.4×1011cfu |
| 鞣酸蛋白 | 1.0g |
| 低聚果糖 | 4.0g |
制备方法：
1)鞣酸蛋白粉碎至粒径D90约20μm，(使用Micros超细粉碎机粉碎，粒径应用马尔文2000激光粒度仪检测)
2)低聚果糖置于水中，溶解得澄清水溶液；
3)步骤2)水溶液中加入鞣酸蛋白，混合均匀后除菌；
4)步骤3)溶液中加入益生菌，均质后冷冻干燥。
实施例4
处方：
| 物料组成 | 处方配比 |
| 益生菌 | 5.4×1012cfu |
| 鞣酸蛋白 | 1.0g |
| 低聚果糖 | 3.0g |
制备方法：
1)鞣酸蛋白粉碎至粒径D90约10μm，(使用Micros超细粉碎机粉碎，粒径应用马尔文2000激光粒度仪检测)
2)低聚果糖置于水中，溶解得澄清水溶液；
3)步骤2)水溶液中加入鞣酸蛋白，混合均匀后除菌；
4)步骤3)溶液中加入益生菌，均质后冷冻干燥。
实施例5
处方：
| 物料组成 | 处方配比 |
| 益生菌 | 2.1×1013cfu |
| 鞣酸蛋白 | 1.0g |
| 低聚果糖 | 3.0g |
制备方法：
1)鞣酸蛋白粉碎至粒径D90约1μm，(使用Micros超细粉碎机粉碎，粒径应用马尔文2000激光粒度仪检测)
2)低聚果糖置于水中，溶解得澄清水溶液；
3)步骤2)水溶液中加入鞣酸蛋白，混合均匀后除菌；
4)步骤3)溶液中加入益生菌，均质后冷冻干燥。
本发明以上实施例所制备的益生菌复合微粒的试验测试结果如下：
1)以上实施例所得到的益生菌复合微粒为白色粉末，电子显微镜扫描结果显示各实施例样品分散均均匀，基元为直径约60-80微米的微球。
2)以上实施例制备的益生菌复合微粒各1g置于100mL的人工胃液中，人工胃液pH值为2.0，37℃厌氧处理，分别于0、0.5、1、2、3小时后收集复合微粒，并进行活菌计数，分析复合微粒对人工胃液的耐受情况，结果显示实施例制得的益生菌复合微粒在人工胃液中性质较稳定，可以较好的保护菌体免受胃酸的伤害，能以较高的活性状态到达肠道顺利定殖。具体结果见下表1：
表1
3)实施例所制备的益生菌复合微粒治疗腹泻及肠粘膜修复的疗效验证：采用出生后21天大鼠，制备刺激性腹泻模型，造模成功后，给予治疗，每组10只，阴性对照组给予生理盐水灌胃，阳性对照组给予鞣酸蛋白，实施例组给予益生菌复合微粒0.02g/kg(按鞣酸蛋白计)，分两次灌胃给予，连续5天。观察每日给药后5h内稀便率(动物排稀便次数/动物排便总次数×100％)，每日记录腹泻率(腹泻的动物数/该组动物总数×100％)，第6天处死实验动物，各取1.5cm左右长的空肠进行组织病理学研究，按chiu标准对小肠黏膜损伤进行分级。结果显示实施例制得的益生菌复合微粒对于腹泻及肠粘膜修复有良好的作用，疗效远优于同等剂量的鞣酸蛋白。具体结果见下表2
表2
4)实施例所制备的益生菌复合微粒,于25℃、60％RH条件下放置考察其稳定性，实施例1～5的稳定性皆较好，可长期存放至12个月以上。具体结果见下表3：
表3
Claims (9)
1.一种益生菌复合微粒，其特征在于：所述复合微粒包含益生菌、鞣酸蛋白及低聚果糖。
2.如权利要求1所述益生菌复合微粒，其特征在于：所述益生菌为鼠李糖乳杆菌、乳酸双歧杆菌或干酪乳杆菌。
3.如权利要求1所述益生菌复合微粒，其特征在于：所述鞣酸蛋白与低聚果糖的重量比为1:2～4。
4.如权利要求1所述益生菌复合微粒，其特征在于：所述鞣酸蛋白与低聚果糖的重量比为1:3。
5.如权利要求1所述益生菌复合微粒，其特征在于：所述益生菌为冻干菌粉。
6.如权利要求1所述益生菌复合微粒，其特征在于：所述益生菌的活菌数1×1010～1×1013cfu/g。
7.如权利要求1所述益生菌复合微粒的制备方法，其特征在于：包含如下步骤：
a)低聚果糖置于水中，溶解得澄清水溶液；
b)步骤a)水溶液中加入鞣酸蛋白，混合均匀后除菌；
c)步骤b)溶液中加入益生菌，均质后干燥。
8.如权利要求7所述的益生菌复合微粒的制备方法，其特征在于：所述步骤b)中鞣酸蛋白的粒径小于20μm。
9.如权利要求1所述的益生菌复合微粒在治疗腹泻及肠粘膜修复中的应用。
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