CN103520133A - 一种淀粉基软胶囊的制备方法 - Google Patents
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Abstract
本发明公开了一种淀粉基胶囊的制备方法,具体是将淀粉预混物料挤出成淀粉挤出膜,再将凝胶剂涂覆在膜上制成复合淀粉膜,再将所述复合淀粉膜经旋转冲膜法制成淀粉基软胶囊。
Description
技术领域
本发明涉及到软胶囊的制备方法,具体是一种非明胶软胶囊的制备方法。
背景技术
胶囊一般用于包裹不宜直接与食道接触,需要在胃或肠道中再崩解作用的药物。目前大部分药用或保健食品的胶囊是由明胶制成,明胶来自于动物的皮或骨,经酸或碱处理,熬制而得。其生产过程中,不可避免的会有动物蛋白残留,会和内容药物产生相互作用,从而导致药物变质等不良后果。
此外,动物来源的明胶,对于素食主义者以及持有伊斯兰、犹太等宗教信仰的人士是无法接受的。同样的,对于过敏体质的人群,也是应当避免摄入明胶制品。
淀粉是植物来源,其来源广泛且量大,价格要远低于明胶。经改性的淀粉将获得更好的凝胶能力和机械强度,使其接近明胶的性质。利用淀粉制作软胶囊,将克服现有明胶胶囊的种种缺陷,同时具有成本低廉的优势,值得推广应用。
现有技术中,软胶囊是将制好的凝胶液涂在辊筒上,待蒸发掉部分水形成具有粘性的胶膜后,送入胶丸机灌装压制成型。这类技术的缺陷是:胶膜容易与辊筒粘连难于剥落,需要在辊筒和模具上预先涂抹脱模剂(如聚硅氧烷、甲基硅油等),或是将脱模剂添加到凝胶液的配方中,进而会有部分脱模剂进入成品软胶囊内。这对制药来说引入了不必要的杂质。
胶囊套壳必须在必要时迅速溶解在胃和肠道中以便能够释放活性物质。为贮存药物,胶囊套壳材料必须可焊接,从而确保接缝处具有足够的稳定性。另一方面,淀粉膜的弹性不足,在制造时容易被撕裂尤其是在脱模过程中,或使最终的胶囊撕裂。
发明内容
本发明方案中,公开了一种新的涂覆制备淀粉软胶囊方式。这种方式的创新处在于,将凝胶剂涂覆在构成淀粉胶囊基础骨架的淀粉基挤出膜上,确切的是涂在需要包封的一侧。与辊筒直接接触的淀粉基挤出膜不与辊筒粘连,无需使用脱模剂即可将淀粉膜与辊筒分离。应用此法制备的软胶囊,没有脱模剂残留,大大提高了安全性。
本发明公开了一种淀粉软胶囊的制备方法,包含如下步骤:
(a)复合淀粉膜的制备:将淀粉基预混物料经挤出机制成淀粉基挤出膜,再将凝胶剂糊液涂覆于淀粉基挤出膜上制成复合淀粉膜,
(b)淀粉基软胶囊的制备:将两张复合淀粉膜,经旋转冲模法制成淀粉基胶囊。
其中淀粉基挤出膜的制备方法包括以下步骤,先使用双螺杆挤出机把淀粉基预混物料挤出造粒得到淀粉基粒料,再使用单螺杆挤出机把淀粉基粒料制成膜,得到淀粉基挤出膜;
其中淀粉基预混物料由淀粉、抗结剂和糊化剂预混制成;
其中涂覆的方法是,将凝胶剂、水分保持剂和乳化剂溶于水制成凝胶剂糊液,将凝胶剂糊液涂覆在淀粉挤出膜上制成复合淀粉膜。
具体包括如下步骤:
(1)将淀粉和抗结剂放入高速混合机下以1500-2000rpm的转速,60℃下混合5min后搅拌混合,再将糊化剂在搅拌下缓缓加入高速混合机中,继续混合5min得淀粉基预混物料;
(2)将淀粉基预混物料投入双螺杆挤出机,挤出造粒得到淀粉基粒料,再使用单螺杆挤出机把淀粉基粒料制成膜,得到淀粉基挤出膜;
(3)将凝胶剂、水分保持剂和乳化剂溶于去离子水制成凝胶剂糊液,将凝胶剂糊液涂在淀粉挤出膜需要包封的内侧制成复合淀粉膜。
在上述步骤(1)中,所述淀粉为各种天然来源的淀粉,或经物理、化学手段改性的天然来源淀粉。
在上述步骤(1)中,所述抗结剂为药用级硬脂酸或脂肪酸甘油酯,所述糊化剂为去离子水。
在上述步骤(2)中,所述双螺杆挤出参数为:物料温度在25-160℃之间,螺杆转速60-400转/分钟,优选为50-150℃,60-140℃,70-130℃,80-140℃,90-120℃,100-140℃。
在上述步骤(2)中,所述单螺杆挤出参数为:物料温度在25-160℃之间,螺杆转速60-400转/分钟。
在上述步骤(3)中,所述凝胶剂,为支链淀粉、结冷胶、卡拉胶、黄原胶、瓜尔胶、海藻胶、刺槐豆胶、叉角菜胶或各种植物胶的一种或多种组合。优选黄原胶、瓜尔胶。
在上述步骤(3)中,所述水分保持剂为药用级甘油或药用级山梨糖醇。
在上述步骤(3)中,所述乳化剂为离子型乳化剂,优选药用级十二烷基硫酸的碱金属盐或十二烷基磺酸的碱金属盐,如药用级十二烷基硫酸钠或十二烷基磺酸钠。
其中凝胶剂糊液的组成如下:
凝胶剂:占凝胶剂糊液重量的15%-25%;
水分保持剂:占凝胶剂糊液重量的1-5%;
乳化剂:占凝胶剂糊液重量的0.02-1%;
以及去离子水。
其中凝胶剂的涂覆程度为每平方米淀粉基挤出膜涂覆0.2-0.5升的凝胶剂糊液。
上述淀粉基软胶囊的制备
淀粉基软胶囊采用旋转冲模法制备,具体如下:
将两张复合淀粉膜,各自经辊筒送入旋转冲模机的两个紧挨的圆筒模具,调节模具温度为40-90℃,开动机器,两个圆筒模具异向向内带动两张复合淀粉膜转动,模具上的凹槽可抽真空,使贴合在模具上的复合淀粉膜因真空而形成凹陷,再模具的挤压形成具有空腔的软胶囊。在软胶囊成型同时,从两个圆筒模具结合处的正上方添加胶囊内容物。
根据本发明所述方法制备的淀粉基软胶囊可以用于制备药品、保健品和功能食品。
具体实施例
以下将列举数个实施实例,来进一步说明本发明内容及依据本发明方案生产的产品性质。
实施例1
淀粉基挤出膜所用原料与重量比例如下:
淀粉:玉米淀粉,75%;
抗结剂:药用级硬脂酸,1.2%;
糊化剂:去离子水,23.8%;
凝胶剂糊液所用原料与重量比例如下:
凝胶剂:叉角菜胶,25%
水分保持剂:药用级甘油,1%
乳化剂:药用级十二烷基硫酸钠,0.2%
去离子水:73.8%
双螺杆挤出机参数如下:
在螺杆的转动速度为350转/分钟的条件下挤出,其中各滑块设定的温度为:
滑块1: 25℃
滑块2-3: 110℃
滑块4-6: 145℃
滑块7-9: 165℃
滑块10-12: 160℃
喷嘴: 160℃
单螺杆挤出机的参数如下:
螺杆的转动速度为350转/分钟的,设定的温度为150℃
操作步骤如下:
(a)将淀粉和抗结剂放入高速混合机下以1500-2000rpm的转速,60℃下混合2min后搅拌混合,再将糊化剂在搅拌下缓缓加入高速混合机中,继续混合5min得淀粉基预混物料;
(b)将淀粉基预混物料投入双螺杆挤出机,挤出造粒得到淀粉基粒料,再使用单螺杆挤出机把淀粉基粒料制成膜,得到淀粉基挤出膜;
(c)将凝胶剂、水分保持剂和乳化剂溶于去离子水制成凝胶剂糊液,将凝胶剂糊液涂在淀粉挤出膜需要包封的内侧制成复合淀粉膜。
淀粉基胶囊制备步骤为:将共混膜放入加有温控的旋转冲模中制备出淀粉基胶囊,模具温度60℃。
上述制备过程中未加入任何脱模剂。
实施例2
淀粉基挤出膜所用原料与重量比例如下:
淀粉:木薯淀粉,75%;
抗结剂:药用级硬脂酸,1.2%;
糊化剂:去离子水,23.8%;
凝胶剂糊液所用原料与重量比例如下:
凝胶剂:交联木薯淀粉,25%
水分保持剂:药用级甘油,1%
乳化剂:药用级十二烷基硫酸钠,0.2%
去离子水:73.8%
其余同实施例1。
实施例3
淀粉基挤出膜所用原料与重量比例如下:
淀粉:玉米淀粉,75%;
抗结剂:药用级硬脂酸,1.2%;
糊化剂:去离子水,23.8%;
凝胶剂糊液所用原料与重量比例如下:
凝胶剂:瓜尔胶,25%
水分保持剂:药用级山梨糖醇,1%
乳化剂:药用级十二烷基硫酸钠,0.2%
去离子水:73.8%
其余同实施例1。
实施例4
淀粉基挤出膜所用原料与重量比例如下:
淀粉:酯化木薯淀粉,75%;
抗结剂:药用级硬脂酸,1.2%;
糊化剂:去离子水,23.8%;
凝胶剂糊液所用原料与重量比例如下:
凝胶剂:卡拉胶,20%
水分保持剂:药用级甘油,3%
乳化剂:药用级十二烷基硫酸钠,0.2%
去离子水:76.8%
其余同实施例1。
实施例5
淀粉基挤出膜所用原料与重量比例如下:
淀粉:绿豆淀粉,75%;
抗结剂:药用级硬脂酸,1.2%;
糊化剂:去离子水,23.8%;
凝胶剂糊液所用原料与重量比例如下:
凝胶剂:黄原胶,25%
水分保持剂:药用级甘油,1%
乳化剂:药用级十二烷基硫酸钠,0.2%
去离子水:73.8%
其余同实施例1
实施例6
淀粉基挤出膜所用原料与重量比例如下:
淀粉:玉米淀粉,75%;
抗结剂:药用级硬脂酸,2.2%;
糊化剂:去离子水,22.8%;
凝胶剂糊液所用原料与重量比例如下:
凝胶剂:结冷胶,25%
水分保持剂:药用级山梨糖醇,1%
乳化剂:药用级十二烷基硫酸钠,0.2%
去离子水:73.8%
其余同实施例1。
实施例7
淀粉基挤出膜所用原料与重量比例如下:
淀粉:玉米淀粉,75%;
抗结剂:药用级硬脂酸,2.2%;
糊化剂:去离子水,22.8%;
凝胶剂糊液所用原料与重量比例如下:
凝胶剂:刺槐豆胶,25%;
水分保持剂:药用级山梨糖醇,1%;
乳化剂:药用级十二烷基硫酸钠,0.2%;
去离子水:73.8%;
其余同实施例1。
对比实施例
所使用的原料及各组分的重量与实施例3的原料及用量相同,但采用下述方法制备:
将上述原料投入夹套釜中,再投入去离子水,升温至60℃,搅拌混合使充分溶胀和溶解,保温1-2h,形成胶液备用,将上述预混物料投入双螺杆挤出机,挤出造粒得到淀粉基粒料,再使用单螺杆挤出机把淀粉基粒料制成膜,得到淀粉基挤出膜;
淀粉基胶囊制备步骤为:将共混膜放入加有温控的旋转冲模中制备出淀粉基胶囊,模具温度60℃。
制备过程中加入常规的脱模剂如聚硅氧烷、甲基硅油。
各取上述6个实施例制备的软胶囊,对胶膜的成品率、软胶囊破损进行检测,结果见表1。
胶膜成品率考查:按常规相同方法脱模1000张胶膜,考查撕裂、破损的胶膜数。
破损检查:取软胶囊100粒,置于脆碎度检查仪中,转动100次,对出现破损的胶囊计数。
根据以上实施例,表明本发明方案所生产的软胶囊性能优越,符合药典标准,在不使用脱模剂时,采用本发明的方法制备的产品仍能保持较高的成品率,在使用某些凝胶剂糊液如含瓜尔胶、黄原胶时,还意外的发现,其破损率远远低于使用脱模剂时的破损率。胶囊套壳焊接处的焊接材料,直接影响到焊接的稳定性,从而使软胶囊在贮存、运输中不易因焊接的不稳定导致泄漏出现破损的情况,在淀粉膜骨架上涂覆凝胶剂糊液后,使压制焊接处更佳牢固,不易破损。
表1不同制备方式制得软胶囊的性能参数
表1
按照中国药典第二部附录XA的检查规定,上述实施例1-7的软胶囊崩解时限均在1小时内。
Claims (8)
1.一种淀粉基软胶囊的制备方法,其特征在于包含以下步骤:
(a)复合淀粉膜的制备:将淀粉基预混物料经挤出机制成淀粉基挤出膜,再将凝胶剂糊液涂覆于淀粉基挤出膜上制成复合淀粉膜,
(b)淀粉基软胶囊的制备:将两张复合淀粉膜,经旋转冲模法制成淀粉基胶囊。
2.根据权利要求1所述的制备方法,所述淀粉基挤出膜的制备,先使用双螺杆挤出机把淀粉基预混物料挤出造粒得到淀粉基粒料,再使用单螺杆挤出机把淀粉基粒料制成膜,得到淀粉基挤出膜。
3.根据权利要求2所述的制备方法,所述的淀粉基预混物料由淀粉、抗结剂和糊化剂预混制成,所述淀粉选自各种天然来源的淀粉,或经物理、化学手段改性的淀粉;所述抗结剂为药用级硬脂酸或脂肪酸甘油酯;所述糊化剂为去离子水。
4.根据权利要求1所述的制备方法,其中涂覆的方法,将凝胶剂、水分保持剂和乳化剂溶于水制成凝胶剂糊液,将凝胶剂糊液涂覆在淀粉挤出膜上制成复合淀粉膜。
5.根据权利要求4所述的制备方法,所述凝胶剂的涂覆程度,其特征为每平方米的淀粉挤出膜上涂覆糊液0.2-0.5升。
6.根据权利要求4所述的制备方法,所述凝胶剂选自支链淀粉、结冷胶、卡拉胶、黄原胶、瓜尔胶、海藻胶、刺槐豆胶、叉角菜胶或各种植物胶的一种或多种组合,所述水分保持剂为多元脂肪醇,优选为药用级甘油或药用级山梨糖醇;所述乳化剂为离子型乳化剂,优选为药用级十二烷基硫酸的碱金属盐或十二烷基磺酸的碱金属盐。
7.根据权利要求4所述的制备方法,所述凝胶剂糊液由下列组分组成:
凝胶剂:占凝胶剂糊液重量的15%-25%;
水分保持剂:占凝胶剂糊液重量的1-5%;
乳化剂:占凝胶剂糊液重量的0.02-1%;
其余为去离子水。
8.根据权利要求1所述方法制备的淀粉基软胶囊在药品、保健品和功能食品中的用途。
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