CN109568349A - 一种复合靶向肠溶多种物质包埋真空冷冻干燥技术 - Google Patents
一种复合靶向肠溶多种物质包埋真空冷冻干燥技术 Download PDFInfo
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Abstract
本发明公开了一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,属于生物制剂包埋领域,本发明提供肠溶多层包埋,以α‑环糊精与麦芽糊精为第一层包埋,经冷冻干燥后粉碎170目,瓜尔胶,海藻酸钠与氯化钙,经冷冻干燥后粉碎120目为第二层包埋,最后以可溶性大豆多糖,微晶纤维素与壳聚糖,经冷冻干燥后粉碎80‑100目,成为第三层包埋,利用三层壁材,使内包裹的益生菌、活性酶物质等穿过胃酸环境,到达肠道中定植,做到靶向释放出益生菌、活性酶物质。
Description
技术领域
本发明涉及生物制剂包埋领域,具体是指一种复合靶向肠溶多种物质包埋真空冷冻干燥技术。
背景技术
益生菌在人身体内十分重要,菌群平衡构成了我们肠道健康,菌群失衡导致腹泻、便秘等,一旦菌群失衡,额外补充益生菌就尤为重要,通过口服益生菌补充菌群效果直接明显,但胃部酸性环境对活性益生菌伤害明显,酶是一种具有活性功能的蛋白质,它是由活细胞形成并且帮助执行生命中无数的生物化学反应和过程的一些复杂结构物质,在人体内有无数各种各样酶系去完成人体新陈代谢过程,包埋技术可以很好的保护菌种到达肠胃,提高效率和效果。
发明内容
本发明要解决的技术问题是,针对以上问题提供一种提供益生菌穿过胃酸环境,到达肠道定植的方法。
为解决上述技术问题,本发明提供的技术方案为:一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,所述复合靶向肠溶包埋真空冷冻干燥技术,包括以下步骤:
1)将益生菌或活性酶物质粉充分混合,粉碎200目;
2)配置灭菌α-环状糊精溶液;
3)配置灭菌麦芽糊精溶液;
4)将步骤2)和步骤3)溶液充分混合;
5)将步骤4)混合溶液与益生菌粉或活性酶粉混合,通过高压均质机形成悬浊液;
6)将步骤5)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎170目,得到第一层包埋益生菌、活性酶物质粉;
7)将步骤6)所得菌粉与瓜尔胶粉以(600-800):1比例混合均匀;
8)配置灭菌海藻酸钠溶液;
9)配置灭菌氯化钙溶液;
10)将步骤7)与步骤8)以1:(5-15)比例混合形成悬浊液;
11)将步骤9)溶液倒入步骤10)溶液,通过高压均质机获得悬浊液;
12)将步骤11)经真空冷冻干燥冻干,水分≤10%,粉碎120目,得到第二层包埋益生菌、活性酶物质粉;
13)配置灭菌可溶性大豆多糖溶液;
14)配置灭菌微晶纤维素溶液;
15)配置灭菌壳聚糖溶液;
16)将步骤13)、14)和15)均匀混合液以(20-50):1与步骤12)混合,通过高压均质机获得悬浊液;
17)将步骤16)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎80-100目,得到第三层包埋益生菌、活性酶物质粉。
进一步的,所述灭菌α-环状糊精溶液为α-环状糊精8%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌麦芽糊精溶液为麦芽糊精6%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌海藻酸钠溶液为海藻酸钠(7-10)%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌氯化钙溶液为氯化钙5-8%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌可溶性大豆多糖溶液为可溶性大豆多糖5%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌微晶纤维素溶液为微晶纤维素5%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌壳聚糖溶液为壳聚糖3%溶液,经121℃灭菌25分钟制备而成。
本发明与现有技术相比的优点在于:利用三层壁材,使内包裹的益生菌、活性酶物质等穿过胃酸环境,到达肠道中定植,做到靶向释放出益生菌、活性酶物质,能够让益生菌穿过胃酸环境,到达肠道定植,菌种为活性菌种、真空冷冻干燥最大程度保留菌种活,三层包埋、三次冻干,利用三次粉碎目数的不同,物理上最大程度保证包埋效果。
具体实施方式
本发明在具体实施时,一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,所述复合靶向肠溶包埋真空冷冻干燥技术,包括以下步骤:
1)将益生菌或活性酶物质粉充分混合,粉碎200目;
2)配置灭菌α-环状糊精溶液;
3)配置灭菌麦芽糊精溶液;
4)将步骤2)和步骤3)溶液充分混合;
5)将步骤4)混合溶液与益生菌粉或活性酶粉混合,通过高压均质机形成悬浊液;
6)将步骤5)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎170目,得到第一层包埋益生菌、活性酶物质粉;
7)将步骤6)所得菌粉与瓜尔胶粉以(600-800):1比例混合均匀;
8)配置灭菌海藻酸钠溶液;
9)配置灭菌氯化钙溶液;
10)将步骤7)与步骤8)以1:(5-15)比例混合形成悬浊液;
11)将步骤9)溶液倒入步骤10)溶液,通过高压均质机获得悬浊液;
12)将步骤11)经真空冷冻干燥冻干,水分≤10%,粉碎120目,得到第二层包埋益生菌、活性酶物质粉;
13)配置灭菌可溶性大豆多糖溶液;
14)配置灭菌微晶纤维素溶液;
15)配置灭菌壳聚糖溶液;
16)将步骤13)、14)和15)均匀混合液以(20-50):1与步骤12)混合,通过高压均质机获得悬浊液;
17)将步骤16)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎80-100目,得到第三层包埋益生菌、活性酶物质粉。
进一步的,所述灭菌α-环状糊精溶液为α-环状糊精8%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌麦芽糊精溶液为麦芽糊精6%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌海藻酸钠溶液为海藻酸钠(7-10)%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌氯化钙溶液为氯化钙5-8%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌可溶性大豆多糖溶液为可溶性大豆多糖5%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌微晶纤维素溶液为微晶纤维素5%溶液,经121℃灭菌25分钟制备而成。
进一步的,所述灭菌壳聚糖溶液为壳聚糖3%溶液,经121℃灭菌25分钟制备而成。
本发明的工作原理:一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,属于生物制剂包埋领域,本发明提供肠溶多层包埋,以α-环糊精与麦芽糊精为第一层包埋,经冷冻干燥后粉碎170目,瓜尔胶,海藻酸钠与氯化钙,经冷冻干燥后粉碎120目为第二层包埋,最后以可溶性大豆多糖,微晶纤维素与壳聚糖,经冷冻干燥后粉碎80-100目,成为第三层包埋,利用三层壁材,使内包裹的益生菌、活性酶物质、活性酶物质等穿过胃酸环境,到达肠道中定植,做到靶向释放出益生菌、活性酶物质。
实施例:
实施例一:1)将益生菌或活性酶物质粉充分混合,粉碎200目;
2)配置α-环状糊精8%溶液,经121℃灭菌25分钟,得到灭菌α-环状糊精溶液;
3)配置麦芽糊精6%溶液,经121℃灭菌25分钟,得到灭菌麦芽糊精溶液;
4)将步骤2)和步骤3)溶液充分混合;
5)将步骤4)混合溶液与益生菌粉或活性酶粉混合,通过高压均质机形成悬浊液;
6)将步骤5)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎170目,得到第一层包埋益生菌、活性酶物质粉;
7)将步骤6)所得菌粉与瓜尔胶粉以600:1比例混合均匀;
8)配置海藻酸钠7%溶液,经121℃灭菌25分钟,得到灭菌海藻酸钠溶液;
9)配置氯化钙5-8%溶液,经121℃灭菌25分钟,得到灭菌氯化钙溶液;
10)将步骤7)与步骤8)以1:5比例混合形成悬浊液;
11)将步骤9)溶液倒入步骤10)溶液,通过高压均质机获得悬浊液;
12)将步骤11)经真空冷冻干燥冻干,水分≤10%,粉碎120目,得到第二层包埋益生菌、活性酶物质粉;
13)配置可溶性大豆多糖5%溶液,经121℃灭菌25分钟,得到灭菌可溶性大豆多糖溶液;
14)配置微晶纤维素5%溶液,经121℃灭菌25分钟,得到灭菌微晶纤维素溶液;
15)配置壳聚糖3%溶液,经121℃灭菌25分钟,得到灭菌壳聚糖溶液;
16)将步骤13)、14)和15)均匀混合液以20:1与步骤12)混合,通过高压均质机获得悬浊液;
17)将步骤16)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎80-100目,得到第三层包埋益生菌、活性酶物质粉。
实施例二:1)将益生菌或活性酶物质粉充分混合,粉碎200目;
2)配置α-环状糊精8%溶液,经121℃灭菌25分钟,得到灭菌α-环状糊精溶液;
3)配置麦芽糊精6%溶液,经121℃灭菌25分钟,得到灭菌麦芽糊精溶液;
4)将步骤2)和步骤3)溶液充分混合;
5)将步骤4)混合溶液与益生菌粉或活性酶粉混合,通过高压均质机形成悬浊液;
6)将步骤5)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎170目,得到第一层包埋益生菌、活性酶物质粉;
7)将步骤6)所得菌粉与瓜尔胶粉以800:1比例混合均匀;
8)配置海藻酸钠10%溶液,经121℃灭菌25分钟,得到灭菌海藻酸钠溶液;
9)配置氯化钙5-8%溶液,经121℃灭菌25分钟,得到灭菌氯化钙溶液;
10)将步骤7)与步骤8)以1:15比例混合形成悬浊液;
11)将步骤9)溶液倒入步骤10)溶液,通过高压均质机获得悬浊液;
12)将步骤11)经真空冷冻干燥冻干,水分≤10%,粉碎120目,得到第二层包埋益生菌、活性酶物质粉;
13)配置可溶性大豆多糖5%溶液,经121℃灭菌25分钟,得到灭菌可溶性大豆多糖溶液;
14)配置微晶纤维素5%溶液,经121℃灭菌25分钟,得到灭菌微晶纤维素溶液;
15)配置壳聚糖3%溶液,经121℃灭菌25分钟,得到灭菌壳聚糖溶液;
16)将步骤13)、14)和15)均匀混合液以50:1与步骤12)混合,通过高压均质机获得悬浊液;
17)将步骤16)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎80-100目,得到第三层包埋益生菌、活性酶物质粉。
实施例三:1)将益生菌或活性酶物质粉充分混合,粉碎200目;
2)配置α-环状糊精8%溶液,经121℃灭菌25分钟,得到灭菌α-环状糊精溶液;
3)配置麦芽糊精6%溶液,经121℃灭菌25分钟,得到灭菌麦芽糊精溶液;
4)将步骤2)和步骤3)溶液充分混合;
5)将步骤4)混合溶液与益生菌粉或活性酶粉混合,通过高压均质机形成悬浊液;
6)将步骤5)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎170目,得到第一层包埋益生菌、活性酶物质粉;
7)将步骤6)所得菌粉与瓜尔胶粉以720:1比例混合均匀;
8)配置海藻酸钠8%溶液,经121℃灭菌25分钟,得到灭菌海藻酸钠溶液;
9)配置氯化钙5-8%溶液,经121℃灭菌25分钟,得到灭菌氯化钙溶液;
10)将步骤7)与步骤8)以1:11比例混合形成悬浊液;
11)将步骤9)溶液倒入步骤10)溶液,通过高压均质机获得悬浊液;
12)将步骤11)经真空冷冻干燥冻干,水分≤10%,粉碎120目,得到第二层包埋益生菌、活性酶物质粉;
13)配置可溶性大豆多糖5%溶液,经121℃灭菌25分钟,得到灭菌可溶性大豆多糖溶液;
14)配置微晶纤维素5%溶液,经121℃灭菌25分钟,得到灭菌微晶纤维素溶液;
15)配置壳聚糖3%溶液,经121℃灭菌25分钟,得到灭菌壳聚糖溶液;
16)将步骤13)、14)和15)均匀混合液以37:1与步骤12)混合,通过高压均质机获得悬浊液;
17)将步骤16)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎80-100目,得到第三层包埋益生菌、活性酶物质粉。
以上对本发明及其实施方式进行了描述,这种描述没有限制性,以上所示的也只是本发明的实施方式之一,实际的结构并不局限于此。总而言之如果本领域的普通技术人员受其启示,在不脱离本发明创造宗旨的情况下,不经创造性的设计出与该技术方案相似的结构方式及实施例,均应属于本发明的保护范围。
Claims (8)
1.一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述复合靶向肠溶包埋真空冷冻干燥技术,包括以下步骤:
1)将益生菌或活性酶物质粉充分混合,粉碎200目;
2)配置灭菌α-环状糊精溶液;
3)配置灭菌麦芽糊精溶液;
4)将步骤2)和步骤3)溶液充分混合;
5)将步骤4)混合溶液与益生菌粉或活性酶粉混合,通过高压均质机形成悬浊液;
6)将步骤5)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎170目,得到第一层包埋益生菌、活性酶物质粉;
7)将步骤6)所得菌粉与瓜尔胶粉以(600-800):1比例混合均匀;
8)配置灭菌海藻酸钠溶液;
9)配置灭菌氯化钙溶液;
10)将步骤7)与步骤8)以1:(5-15)比例混合形成悬浊液;
11)将步骤9)溶液倒入步骤10)溶液,通过高压均质机获得悬浊液;
12)将步骤11)经真空冷冻干燥冻干,水分≤10%,粉碎120目,得到第二层包埋益生菌、活性酶物质粉;
13)配置灭菌可溶性大豆多糖溶液;
14)配置灭菌微晶纤维素溶液;
15)配置灭菌壳聚糖溶液;
16)将步骤13)、14)和15)均匀混合液以(20-50):1与步骤12)混合,通过高压均质机获得悬浊液;
17)将步骤16)悬浊液经真空冷冻干燥冻干,水分≤10%,粉碎80-100目,得到第三层包埋益生菌、活性酶物质粉。
2.根据权利要求1所述的一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述灭菌α-环状糊精溶液为α-环状糊精8%溶液,经121℃灭菌25分钟制备而成。
3.根据权利要求1所述的一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述灭菌麦芽糊精溶液为麦芽糊精6%溶液,经121℃灭菌25分钟制备而成。
4.根据权利要求1所述的一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述灭菌海藻酸钠溶液为海藻酸钠(7-10)%溶液,经121℃灭菌25分钟制备而成。
5.根据权利要求1所述的一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述灭菌氯化钙溶液为氯化钙5-8%溶液,经121℃灭菌25分钟制备而成。
6.根据权利要求1所述的一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述灭菌可溶性大豆多糖溶液为可溶性大豆多糖5%溶液,经121℃灭菌25分钟制备而成。
7.根据权利要求1所述的一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述灭菌微晶纤维素溶液为微晶纤维素5%溶液,经121℃灭菌25分钟制备而成。
8.根据权利要求1所述的一种复合靶向肠溶多种物质包埋真空冷冻干燥技术,其特征在于:所述灭菌壳聚糖溶液为壳聚糖3%溶液,经121℃灭菌25分钟制备而成。
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