CN111631403B - 一种维生素c泡腾片及其制备方法 - Google Patents
一种维生素c泡腾片及其制备方法 Download PDFInfo
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- CN111631403B CN111631403B CN202010648023.9A CN202010648023A CN111631403B CN 111631403 B CN111631403 B CN 111631403B CN 202010648023 A CN202010648023 A CN 202010648023A CN 111631403 B CN111631403 B CN 111631403B
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- vitamin
- effervescent tablet
- tablet
- tabletting
- essence
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Classifications
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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Abstract
本发明公开了一种维生素C泡腾片及其制备方法。该维生素C泡腾片由包含以下按质量比计的成分制备得到:维生素C:填充剂:崩解剂:润滑剂:润湿剂=13~20:70~90:75~95:0.1~0.3:1~5。本发明通过一次湿法制粒,先将填充剂和润湿剂制备空白干颗粒,再与维生素C、崩解剂以及其他辅料进行混合压片,制得泡腾片,从而减少制备时间和成本;操作步骤少,工艺简单,质量可控,更适合产业化生产;在压片过程中,把润滑剂喷于压片机冲模表面,既保证压片过程不发生粘冲现象,又能有效解决泡腾片崩解后浮粉的技术问题,同时改善了泡腾片的硬度及外观。
Description
技术领域
本发明属于保健食品技术领域,特别涉及一种维生素C泡腾片及其制备方法。
背景技术
维生素C,又称抗坏血酸,是机体代谢不可或缺的物质之一。它能增强机体免疫力、抵御细菌与病毒的侵袭;促进钙、铁吸收;预防牙龈出血;同时具有美白祛斑,延缓衰老等功效。维生素C的缺失会造成厌食、营养不良、牙龈萎缩、出血、身体虚弱;严重缺失会导致坏血病、身体异常出血、动脉硬化等疾病的发生。
维生素C分子易溶于水,不溶于有机溶剂中,由于含有连二烯醇结构,极易被氧化。人体自身无法合成维生素C,只能通过进食食物如蔬菜、水果而摄入一定的量。中国营养学会建议成年人维生素C膳食摄入量为100mg/天。但食物烹饪过程中热度、铁离子、光和水洗等因素都会造成部分维生素C的损失;且由于生活节奏加快,工作繁忙等原因造成水果进食量减少,人们摄入的维生素C含量不足,使健康受影响。
泡腾片,一种以有机酸和碱式碳酸盐为崩解剂的药物剂型,置入水中后,即刻发生泡腾反应,产生大量二氧化碳,5min内崩解完成,溶出药物。该剂型存在如下优点:崩解时间短,服用方便,起效迅速,减少药物对胃肠道的刺激;口感好,患者依从性高;便于携带。
因此,将维生素C制备成泡腾片制剂,具有服用方便省时、剂量明确、口感良好、携带便捷的优点,有利于人们提高维生素C的摄入量,为身体健康筑造一道防线。
目前,制备维生素C泡腾片的方法主要有以下2种。方法一:酸碱单独制粒压片法,(如专利CN201410795147.4:一种D-核糖维生素C泡腾片及其制备方法、CN201410795033.X一种高锌低钠维生素C泡腾片及其制备方法、CN201310014979.3一种快速崩解的维生素C泡腾片及其制备方法),采用湿法制粒分别制备酸、碱干颗粒,再将两种颗粒混合、压片得泡腾片;该方法制备工艺繁琐,湿法制粒主要步骤包括:粉碎、混合、制软材、制粒、干燥、过筛等,使得制备时间与成本增加;在制备过程中分别制备酸、碱干颗粒再混合压片,则需要两次湿法制粒流程;而且在压片过程中容易出现粘冲。目前尚未见有维生素C泡腾片压片不粘冲的控制工艺。方法二:粉末直压法(如专利CN201810058646.3一种维生素C泡腾片)通过精选原辅料,称量、过筛,把主药与辅料混合均匀,压片即得。但该粉末直压法对粉末的流动性、可压性要求高,原辅料选择较严格;在将粉末直接压片时,需要加入适当的干燥粘合剂、助流剂等;压片过程中产生粉末飞扬较多,压片时容易产生裂片。因此寻找一种工艺稳定,不易产生裂片,口感佳的泡腾片制备工艺尤为重要。
发明内容
本发明的首要目的在于克服现有技术的缺点与不足,提供一种维生素C泡腾片。
本发明的另一目的在于提供上述维生素C泡腾片的制备方法。
本发明的上述目的通过以下技术方案实现:
一种维生素C泡腾片,由包含以下按质量比计的成分制备得到:维生素C:填充剂:崩解剂:润滑剂:润湿剂=13~20:70~90:75~95:0.1~0.3:1~5;优选由包含以下按质量比计的成分制备得到:维生素C:填充剂:崩解剂:润滑剂:润湿剂=14~17:70~90:85~95:0.1~0.2:3~4;更优选由包含以下按质量比计的成分制备得到:维生素C:填充剂:崩解剂:润滑剂:润湿剂=15:75~85:85~95:0.1~0.2:3~4;最优选由包含以下按质量比计的成分制备得到:维生素C:填充剂:崩解剂:润滑剂:润湿剂=15:80:90:0.1~0.15:3。
所述的维生素C泡腾片还包括色素和香精中的一种或两种。
所述的色素为食用色素,优选为甜菜红。
所述的色素的用量为符合食品行业的相关规定;其在所述的维生素C泡腾片的含量优选为质量百分比0.1~0.2%;更优选为0.15~0.16%。
所述的香精为食用香精,优选为香橙香精或蓝莓香精。
所述的香精的用量为符合食品行业的相关规定;其在所述的维生素C泡腾片的含量优选为质量百分比0.2~0.3%;更优选为0.26~0.27%。
所述的填充剂优选为白砂糖、乳糖、蔗糖、糊精、甘露醇和淀粉中的至少一种;更优选为白砂糖。
所述的崩解剂由酸性化合物和碱性化合物组成。该酸性化合物和碱性化合物搭配使用,在遇水的情况下能产生二氧化碳,发生崩解。
所述的酸性化合物优选为食用酸;更优选为柠檬酸、酒石酸和苹果酸中的至少一种。
所述的碱性化合物优选为食用碱;更优选为碳酸氢钠和碳酸钠中的一种或两种。
所述的酸性化合物和所述的碱性化合物优选为按质量比10:5~10配比;更优选为按质量比10:5~8配比混合;最优选为按质量比10:5配比。
所述的润滑剂优选为硬脂酸镁、滑石粉、微粉硅胶和氢化植物油中的至少一种;更优选为硬脂酸镁。
所述的润湿剂为纯化水、食用酒精和甜味剂中的至少一种;更优选为纯化水、食用酒精(折纯)和甜味剂按3:2~3:0.1~0.2配比;最优选为纯化水、食用酒精(折纯)和甜味剂按3:3:0.12配比。
所述的甜味剂优选为纽甜、阿斯巴甜、乳糖、三氯蔗糖和甜菊糖苷中的至少一种。
上述维生素C泡腾片的制备方法,包括以下步骤:
(1)粉碎:将填充剂粉碎过筛,得到处理后的填充剂;
(2)称量:根据处方量分别称取组成所述的维生素C泡腾片的成分,备用;
(3)制粒:将润湿剂和步骤(1)得到的处理后的填充剂混合均匀,得到湿颗粒;
(4)干燥、整粒:将步骤(3)制备得到的湿颗粒进行干燥,并过筛整粒,得到干颗粒;
(5)混合:将维生素C、崩解剂及干颗粒混合均匀,制得混合颗粒;如组成所述的维生素C泡腾片的成分含有色素和香精中的一种或两种时,色素和香精是在该步骤加入混合均匀;
(6)压片:取润滑剂喷于压片机冲模表面,喷粉,压片,即得维生素C泡腾片。
步骤(1)中所述的粉碎的程度优选为至少能过60目筛;更优选为能过80目筛。
步骤(4)中所述的干燥的程度是控制水分不超过1.0%为宜。
步骤(4)中所述的干燥的条件优选为于50~60℃干燥60~120分钟;优选为于55℃干燥80分钟。
步骤(4)中所述的过筛优选为能过30目筛。
步骤(5)中所述的混合的条件优选为于8~20转/分的转速下混合15~30min;优选为于15转/分的转速下混合15min。
步骤(6)中所述的润滑剂在压片过程中以喷粉形式加入。
步骤(6)中所述的喷粉速度是不能超过200g/h,更优选100~150g/h。
步骤(6)中所述的压片机的机速优选为(60~140)*1000片/小时。
与现有技术相比,本发明具有如下优点及有益效果:
(1)本发明中以维生素C作为主要功能成分;以白砂糖作为填充剂,同时也可作为粘合剂,以纯化水、食用酒精(折纯)和纽甜为润滑剂,优选合适配比混合,所制颗粒流动性好,压缩成形性强,使泡腾片硬度合适、不易疏松、碎裂;以硬脂酸镁为润滑剂,于压片过程中以喷粉形式加入,既保证压片过程不发生粘冲现象,又尽可能的减少了硬脂酸镁的用量;以柠檬酸和碳酸氢钠为崩解剂,优选柠檬酸和碳酸氢钠的投料比例,遇水后即刻产生二氧化碳,使泡腾片可快速崩解;对本发明的维生素C泡腾片进行溶解品尝,酸甜可口,味道佳。
(2)与现有维生素C泡腾片制备技术(酸碱单独制粒压片法、粉末直压片法)相比较,本发明减少制备工艺流程,工艺简单可控,操作方便。现有技术多采用两次湿法制粒流程制备泡腾片,而本发明只需一次湿法制粒流程,即先制备空白干颗粒,再将维生素C、酸碱化合物与其它辅料进行混合压片,制得泡腾片,从而减少制备时间和成本;操作步骤少,工艺简单,质量可控,更适合产业化生产。
(3)本发明提供的制备方法,在压片过程中,把硬脂酸镁按优选速度喷于压片机冲模表面,既保证压片过程不发生粘冲现象,又能有效解决泡腾片崩解后浮粉的技术问题,同时改善了泡腾片的硬度及外观。对比粉末直压法,本发明提供的制备方法稳定,质量易控,泡腾片外观整洁,没有出现裂片现象。
具体实施方式
下面结合实施例对本发明作进一步详细的描述,但本发明的实施方式不限于此。
实施例中所涉及的试剂、方法,如无特殊说明,均为本领域常用的试剂和方法,本领域的技术人员在本发明的基础上所做的任何非实质性的变化及替换均属于本发明所要求保护的范围。
处方一:维生素C泡腾片的各成分按质量比如下:维生素C:填充剂:崩解剂:润滑剂:润湿剂:色素:香精=15:80:90:2-5:4:0.3:0.5。
实施例1-3:制成1000片计算,维生素C(以L-抗坏血酸计)300mg,约3.7g/片;配方如表1所示。
表1 实施例1-3的配方表(单位:kg)
备注:润湿剂为纯化水、食用酒精(折纯)和纽甜,按2:3:0.1配比混合。食用酒精、纯化水在干燥过程中除去;崩解剂为柠檬酸与碳酸氢钠,按1:1比例投料。
实施例1-3按以下操作进行制备:
(1)粉碎:将白砂糖粉碎后过80目筛,备用;
(2)称量:根据处方量称取原辅料,备用;
(3)制粒:将纯化水、食用酒精和纽甜制成的润湿剂加入至粉碎处理的白砂糖粉中制备湿颗粒;
(4)干燥、整粒:将步骤(3)所得的湿颗粒在55℃下干燥,干燥时间80分钟,检测水分不超过1.0%,出料,并过30目筛整粒,得到干颗粒;
(5)混合:将维生素C、柠檬酸、碳酸氢钠、香精、甜菜红、硬脂酸镁及步骤(4)得到的干颗粒投入至固定料斗混合机,设定混合转速15转/分,混合时间15min,将物料混合均匀,制得混合颗粒;
(6)压片:取步骤(5)混合颗粒置于压片机加料斗,压片机以30*1000片/小时进行压片,即得维生素C泡腾片。
维生素C泡腾片检测结果如表2所示:
表2实施例1-3产品性能表
从表2的产品性能表可知,原处方工艺在试验中存在硬度不达标、粘冲、崩解后溶液表面浮着粉末的情况出现。从维生素C泡腾片的原辅料溶解性、物料性质、泡腾片性能等综合考虑,重点落在硬脂酸镁上,在实施例1-3处方中硬脂酸镁是一种润滑剂,它的质量占比分别为1.1%、1.6%、2.7%,可见,硬脂酸镁的使用量直接影响泡腾片的硬度,使用量大则降低泡腾片硬度,导致泡腾片易疏松、碎裂,使用量小则在压片过程中出现粘冲现象,导致生产效率低、片剂外观不整齐。此外,硬脂酸镁具有疏水性,崩解后的维生素C溶液表面浮着一层不溶性粉末,严重影响饮用者对产品的信心。
由上述实例1-3分析可知,为了克服硬脂酸镁加入量带来的技术问题,进行了考察研究,在泡腾片的制备中引入了喷粉机,改变了硬脂酸镁的投入方式,有效降低硬脂酸镁的使用量,同时在压片过程中不粘冲,详见实施例4-6。
处方二:维生素C泡腾片的各成分按质量比如下:维生素C:填充剂:崩解剂:润滑剂:润湿剂:色素:香精=15:75-85:85-95:0.1-0.2:4:0.3:0.5。
实施例4-6:制成10000片计算,维生素C(以L-抗坏血酸计)300mg,约3.7g/片;配方如表3所示。
表3实施例4-6的配方表(单位:kg)
备注:润湿剂为纯化水、食用酒精(折纯)和纽甜,按2:3:0.1配比混合。食用酒精、纯化水在干燥过程中除去;崩解剂为柠檬酸与碳酸氢钠,按1:1比例投入。
实施例4-6按以下操作进行制备:
(1)粉碎:将白砂糖粉碎后过80目筛,备用;
(2)称量:根据处方量称取原辅料,备用;
(3)制粒:将纯化水、食用酒精和纽甜制成的润湿剂加入至粉碎处理的白砂糖粉中制备湿颗粒;
(4)干燥、整粒:将步骤(3)所得的湿颗粒在55℃下干燥,干燥时间80分钟,检测水分不超过1.0%,出料,并过30目筛整粒,得到干颗粒;
(5)混合:将维生素C、柠檬酸、碳酸氢钠、香精、甜菜红及步骤(4)得到的干颗粒投入至固定料斗混合机,设定混合转速15转/分,混合时间15min,将物料混合均匀,制得混合颗粒;
(6)压片:取(5)混合颗粒置于压片机加料斗,硬脂酸镁加入喷粉机,调机后,压片机以60*1000片/小时,实施例4的喷粉速度为100g/小时,实施例5-6的喷粉速度为200g/小时,把硬脂酸镁喷于压片机冲模表面,压片,即得维生素C泡腾片。
实施例4-6维生素C泡腾片检测结果:
表4实施例4-6产品性能表
对比实施例1-3与实施例4-6,重点调整了硬脂酸镁的加入量及加入方式,从表4产品性能表可知:
(1)有效解决了泡腾片压片粘冲、崩解后溶液浮粉的技术问题。硬脂酸镁的喷粉速度不能超过200g/小时,对于喷粉速度控制硬脂酸镁的投入量,直接影响崩解后溶液面浮粉现象,还需进一步完善。
(2)改善了硬度不达标、片剂外观不合格的技术问题,但泡腾片偶尔碎裂现象,仍需进一步调整处方工艺,重点从步骤(3)湿法制粒进行研究考察,略提高硬度,使片剂完整性更好,不易碎裂。
(3)影响了泡腾片的崩解时间,从实施例1-3的约110s延长至约155s(实施例4-6),虽然是在崩解时间控制范围,但延长了饮用者的等待时间,重点调整崩解剂用量,筛选最优比例,使崩解时间控制约90s。
由上述实例4-6分析可知,为了改善泡腾片硬度、崩解时间技术性能,在湿法制粒的润湿剂、崩解剂影响因素进行研究考察,同时筛选喷粉机速的控制范围,更好控制维生素C泡腾片质量。详见实施例7-9。
处方三:维生素C泡腾片的各成分按质量比如下:维生素C:填充剂:崩解剂:润滑剂:润湿剂:色素:香精=15:80:90:0.1-0.15:3:0.3:0.5。
实施例7-9:制成10000片计算,维生素C(以L-抗坏血酸计)300mg,约3.7g/片;配方如表5所示。
表5实施例7-9的配方表(单位:kg)
备注:润湿剂为纯化水、食用酒精(折纯)和纽甜,实施例7按3:2:0.1配比混合,实施例8-9按1:1:0.04配比混合;食用酒精、纯化水在干燥过程中除去。崩解剂为柠檬酸与碳酸氢钠,实施例7-8按2:1比例投入,实施例9按5:4比例投入。
实施例7-9按以下操作进行制备:
(1)粉碎:将白砂糖粉碎后过80目筛,备用;
(2)称量:根据处方量称取原辅料,备用;
(3)制粒:将纯化水、食用酒精和纽甜制成的润湿剂加入至粉碎处理的白砂糖粉中制备湿颗粒;
(4)干燥、整粒:将步骤(3)所得的湿颗粒在55℃下干燥,干燥时间80分钟,检测水分不超过1.0%,出料,并过30目筛整粒,得到干颗粒;
(5)混合:将维生素C、柠檬酸、碳酸氢钠、香精、甜菜红及步骤(4)得到的干颗粒投入至固定料斗混合机,设定混合转速15转/分,混合时间15min,将物料混合均匀,制得混合颗粒;
(6)压片:取步骤(5)混合颗粒置于压片机加料斗,硬脂酸镁加入喷粉机,调机后,压片机以60*1000片/小时,实施例7喷粉速度为100g/小时,实施例8-9喷粉速度为150g/小时,把硬脂酸镁喷于压片机冲模表面,压片,即得维生素C泡腾片。
实施例7-9维生素C泡腾片检测结果:
表6实施例7-9产品性能表
经小试试验进行了润湿剂(纯化水、食用酒精(折纯)和纽甜)的混合配比、崩解剂(柠檬酸与碳酸氢钠)分配比例对泡腾片的硬度及崩解影响考察,筛选出润湿剂为纯化水、食用酒精(折纯)和纽甜按1:1:0.04及3:2:0.1比例混合,所制备干燥颗粒流动性好,压缩成形性强;柠檬酸与碳酸氢钠按2:1及5:4比例投料,崩解速度快,产气佳,稳定性好。针对润湿剂、崩解剂调整及硬脂酸镁喷粉速度调整进行了放大试验(实施例7-9),从表6产品性能表可知,实施例8的润湿剂为纯化水、食用酒精(折纯)和纽甜按1:1:0.04配比混合,崩解剂为柠檬酸与碳酸氢钠按2:1比例投料为最优配比,所得到的维生素C泡腾片的硬度合适,不易疏松、碎裂,崩解速度快,泡腾片外观整洁。同时也进行了硬脂酸镁喷粉速度的改善,喷粉速度控制在100-150g/小时,压片不粘冲,并且有效控制泡腾片崩解后的浮粉现象,浮粉不明显,可判断为无浮粉。此外,对实例8制备的泡腾片进行溶解品尝,酸甜可口,味道佳。
效果实施例1-9产品性能方法:
分别对实施例1~9制备得到的维生素C泡腾片的性能进行测试。其中:
硬度采用YD-Ⅱ型硬度计进行检测;
崩解时间采用置于200ml温度为20℃±5℃中崩解时限进行检测,浮粉现象采用目测;
粘冲情况采用目测进行测试;
片剂外观采用目测、轻力触压进行测试。
上述实施例为本发明较佳的实施方式,但本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (6)
1.一种维生素C泡腾片,其特征在于由以下按质量比计的成分制备得到:维生素C:填充剂:崩解剂:润滑剂:润湿剂=15:80:90:0.1~0.15:3;
所述的崩解剂由酸性化合物和碱性化合物组成;
所述的酸性化合物为柠檬酸;
所述的碱性化合物为碳酸氢钠;
所述的润滑剂为硬脂酸镁;
所述的填充剂为白砂糖;
所述的润湿剂为纯化水、食用酒精和甜味剂;
所述的酸性化合物和所述的碱性化合物按质量比10:5配比;
所述的润湿剂为纯化水、食用酒精和甜味剂按3:3:0.12配比;
所述的维生素C泡腾片还包括色素和香精中的一种或两种;
所述的维生素C泡腾片通过如下步骤制备得到:
(1)粉碎:将填充剂粉碎过筛,得到处理后的填充剂;
(2)称量:根据处方量分别称取组成所述的维生素C泡腾片的成分,备用;
(3)制粒:将润湿剂和步骤(1)得到的处理后的填充剂混合均匀,得到湿颗粒;
(4)干燥、整粒:将步骤(3)制备得到的湿颗粒进行干燥,并过筛整粒,得到干颗粒;
(5)混合:将维生素C、崩解剂及干颗粒混合均匀,制得混合颗粒;色素和香精是在该步骤加入混合均匀;
(6)压片:取润滑剂喷于压片机冲模表面,喷粉,压片,即得维生素C泡腾片;
步骤(6)中所述的润滑剂在压片过程中以喷粉形式加入;
步骤(6)中所述的喷粉速度为100~150 g/h;
步骤(6)中所述的压片机的机速为(60~140)×1000片/小时。
2.根据权利要求1所述的维生素C泡腾片,其特征在于:
所述的色素为甜菜红;
所述的香精为香橙香精或蓝莓香精。
3.根据权利要求1所述的维生素C泡腾片,其特征在于:
所述的色素在所述的维生素C泡腾片的含量为质量百分比0.1~0.2%;
所述的香精在所述的维生素C泡腾片的含量为质量百分比0.2~0.3%。
4.根据权利要求1所述的维生素C泡腾片,其特征在于:
所述的甜味剂为纽甜、阿斯巴甜、乳糖、三氯蔗糖和甜菊糖苷中的至少一种。
5.权利要求1~4任一项所述的维生素C泡腾片的制备方法,其特征在于通过如下步骤制备得到:
(1)粉碎:将填充剂粉碎过筛,得到处理后的填充剂;
(2)称量:根据处方量分别称取组成所述的维生素C泡腾片的成分,备用;
(3)制粒:将润湿剂和步骤(1)得到的处理后的填充剂混合均匀,得到湿颗粒;
(4)干燥、整粒:将步骤(3)制备得到的湿颗粒进行干燥,并过筛整粒,得到干颗粒;
(5)混合:将维生素C、崩解剂及干颗粒混合均匀,制得混合颗粒;色素和香精是在该步骤加入混合均匀;
(6)压片:取润滑剂喷于压片机冲模表面,喷粉,压片,即得维生素C泡腾片。
6.根据权利要求5所述的维生素C泡腾片的制备方法,其特征在于:
步骤(1)中所述的粉碎的程度为至少能过60目筛;
步骤(4)中所述的干燥的程度是控制水分不超过1.0%;
步骤(4)中所述的干燥的条件为于50~60℃干燥60~120分钟;
步骤(4)中所述的过筛为能过30目筛;
步骤(5)中所述的混合的条件为于8~20转/分的转速下混合15~30min。
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