CN112293747A - 一种补充铁和叶酸的片剂 - Google Patents
一种补充铁和叶酸的片剂 Download PDFInfo
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- CN112293747A CN112293747A CN201910698082.4A CN201910698082A CN112293747A CN 112293747 A CN112293747 A CN 112293747A CN 201910698082 A CN201910698082 A CN 201910698082A CN 112293747 A CN112293747 A CN 112293747A
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- folic acid
- tablet
- ferrous fumarate
- iron
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Abstract
本发明涉及保健食品技术领域,具体涉及一种补充铁和叶酸的片剂,所述补充铁和叶酸的片剂包括以下成份:富马酸亚铁和叶酸包覆物35.5%~47.0%、甜味剂20.0%~25.0%、填充剂25.0%~35.0%、色素1.0%~5.0%、润滑剂1.0%~4.5%,该片剂的制备工艺简单,原料易得,制得的片剂外观色泽佳,稳定性好,且满足成人补充足够的铁元素和叶酸。
Description
技术领域
本发明涉及保健食品技术领域,尤其涉及一种补充铁和叶酸的片剂。
背景技术
男性在现代社会工作压力大、饮食不均衡、熬夜、抽烟喝酒等不良生活习惯,造成缺铁的发病率也越来越高,相应地表现出:神经衰弱、记忆力减退、头昏脑涨、注意力不集中、反应迟钝、性功能障碍等问题,还常伴有腰膝酸软、手脚冰冷、失眠等症状。
女性缺铁的表现没有特异性,容易疲乏、注意力不集中、怕冷、抵抗力下降、月经量少、闭经或量多、痛经、皮肤易产生皱纹色斑、口腔易发溃疡、失眠多梦、阵发性头痛、易心慌等,缺铁发展到一定程度,就会发生缺铁性贫血,表现出萎黄、唇无血色、发无光泽等,同时前述的缺铁症状更加严重。
因此,对于成年人群,除了在日常的食物中补充铁元素,还要适当通过口服片剂进行增补,其中,成年人群的每日铁摄入量要保证在20mg以上。
叶酸是人体在利用糖分和氨基酸时的必要物质,是机体细胞生长和繁殖所必需的物质,可以帮助蛋白质的代谢,并与维生素B12共同促进红细胞的生成和成熟,是制造红血球不可缺少的物质。也作为干酪乳杆菌及其它微生物的促进增殖因子而起作用,对细胞的分裂生长及核酸、氨基酸、蛋白质的合成起着重要的作用。人体缺少叶酸可导致红血球的异常,未成熟细胞的增加,贫血以及白血球减少。同时,成年女性缺乏叶酸有可能导致胎儿在出生时出现低体重、唇腭裂、心脏缺陷。因此,准备怀孕的成年女性,可在怀孕前就开始每天服用200μg以上的叶酸量。
目前成年人群通过食用含富马酸亚铁和叶酸的片剂,同时补充铁元素和叶酸,可有效缓解上述症状,但在现有技术中,该类型片剂存在以下缺点:
(1)片剂外观色泽差,食用感官效果不佳;
(2)片剂中铁元素和叶酸的稳定性和有效性不足。
如曹机良、曹毅等关于“色素甜菜红的稳定性探讨实验研究”中发现,金属离子会和甜菜红色素形成一定络合结构的化合物,改变色素的外观颜色,例如加入Fe2+溶液后甜菜红变成橙色,加入Cu2+溶液后甜菜红变深紫色,加入Al3+溶液后甜菜红变成浅粉色,加入稀土溶液后甜菜红变成深粉色,因此,为了更好地改善含富马酸亚铁的片剂外观成色,提升食用感官效果,有必要对富马酸亚铁进行保护,避免铁元素与甜菜红结合形成络合物。
又如专利文献CN104906067A公开了一种稳定的叶酸包合物的亚铁组合物及其制备方法与制剂,该组合物由重量份30~40份叶酸包合物、50~500份亚铁盐、185~550份辅料组成。采用干法制粒的方式,利用泊洛沙姆F188(聚氧乙烯聚氧丙烯嵌段共聚物)对叶酸进行保护,使叶酸在生产和储存过程中,不被消耗分解。由于富马酸亚铁中的亚铁离子还原性强,极易和水、氧气发生氧化还原反应,使亚铁离子的稳定性和有效性下降,如果长时间存放,不及时保护处理,亚铁离子甚至会被氧化成氢氧化铁,导致生产的片剂会有铁锈味,降低了片剂的富马酸亚铁的含量,不满足特殊人群补充铁元素的需要。
因此,有必要提供一种制备成本低、外观色泽佳、稳定性好、用于补充铁和叶酸的片剂,保证成年人群每天补充足够的铁元素和叶酸。
发明内容
为了克服现有技术中,用于补充铁和叶酸的片剂性质不稳定、制备工艺复杂、成本高等问题,本发明提供一种补充铁和叶酸的片剂,通过合理的配方,简单的工艺制作,使片剂口感良好,可直接咀嚼食用,且有助于成年人群每天补充足够的铁元素和叶酸。
本发明提供的一种补充铁和叶酸的片剂,该片剂包括以下成份:富马酸亚铁和叶酸包覆物35.5%~47.0%、甜味剂20.0%~25.0%、填充剂25.0%~35.0%、色素1.0%~5.0%、润滑剂1.0%~4.5%。
进一步地,所述富马酸亚铁和叶酸包覆物包括以下成份:富马酸亚铁20.0%~25.0%、抗氧化剂2.0%~4.5%、叶叶酸0.07%~0.10%和明胶72.0%~77.0%;
进一步地,所述富马酸亚铁和叶酸包覆物的制备方法包括以下步骤:
a.将富马酸亚铁、抗氧化剂和叶酸等物质进行粉碎、混合均匀,得到混合物,备用;
b.将明胶于45℃水浴加热熔融,往明胶中加入步骤a所得混合物,搅拌均匀,得到混合熔融体;
c.将步骤b所得混合熔融体冷却固化后得到固体,将该固体过120目筛进行整粒,得到富马酸亚铁和叶酸包覆物。
进一步地,所述甜味剂为乳糖、三氯蔗糖、D-甘露糖醇、葡萄糖、果糖、麦芽糖和淀粉糖中的一种或多种。
进一步地,所述填充剂为微晶纤维素、淀粉、硫酸钙和磷酸氢钙中的一种或多种。
进一步地,所述色素为叶黄素、甜菜红和番茄红素中的一种或多种。
进一步地,所述抗氧化剂为柠檬酸、醋酸、酒石酸、苹果酸中的一种或多种。
进一步地,所述润滑剂为硬脂酸镁、聚乙二醇4000、滑石粉和二氧化硅中的一种或多种。
上述的补充铁和叶酸的片剂,其制备方法如下:1)将配方量的富马酸亚铁和叶酸包覆物、填充剂进行混合,得到混合物A,将配方量的色素溶液均匀喷入混合物A,得到混合物B;2)将混合物B置干法制粒机,制颗粒,过60目筛整粒,得干颗粒C;3)将配方量的润滑剂、甜味剂与干颗粒C置混合机混合均匀,得总混合颗粒D;4)将总混合颗粒D置压片机,调节片重为0.8g/片,进行压片,即得片剂。
本发明的片剂以食品级原料富马酸亚铁(含量超过99%)作为铁补充剂,含铁量高,人体吸收、利用率高;以合成叶酸作为叶酸补充剂,合成叶酸的纯度高达98%,保证补充足够的铁元素和叶酸;以微晶纤维素做填充剂,能够增加主料的体积,改善主料性能;以甜菜红作为色素,直接混合到压片粉中,能够有助于掩盖产品存放过程中因光、热引起的氧化变色问题,且使用天然色素更加健康;以乳糖作为甜味剂,搭配出清甜可口的味道,使片剂口感更佳,同时避免过多摄入糖分;以硬脂酸镁作为润滑剂,来提高主料的润滑分散程度,使主料具有成片、脱模必需的特性,符合硬度和脆碎度的要求,保有良好的咀嚼性,便于食用。
现有技术中,片剂生产时如果采用无包衣方式,富马酸亚铁和叶酸在无包衣条件下容易被氧化,同时,Fe2+或Fe3+会对甜菜红产生不利影响,造成生产的片剂成色不佳,影响片剂产品的食用美观。因此,本发明采用明胶包覆技术,利用食品级明胶包覆富马酸亚铁,防止其因为与氧气接触而被氧化成氢氧化铁,降低药物中的铁锈味,也避免了亚铁离子与甜菜红形成络合物,对甜菜红色泽产生不利影响;同时,可以避免叶酸被光、热等条件引发氧化降解,保证片剂中叶酸的含量。但明胶的添加量过少会影响对富马酸亚铁和叶酸的保护效果,添加量过多不利于人体对富马酸亚铁和叶酸的消化吸收。在制备富马酸亚铁和叶酸包覆物过程中,进行搅拌步骤时,亚铁离子容易被氧化,需要提前加入抗氧化剂柠檬酸对富马酸亚铁进行保护,其作用是使富马酸亚铁中的亚铁离子处于酸性条件下,氢离子有助于抑制亚铁离子与水中的氢氧根离子结合,防止亚铁离子转化成成氢氧化铁。在这过程中,只能采用少量的柠檬酸,因为过量的柠檬酸会导致明胶包覆膜的性质不稳定,降低对富马酸亚铁和叶酸的包覆效果。
因此,与现有技术相比,本发明的优势在于:
该片剂是采用直接混合、直接压片的方式制成,不经过包衣,原料易得,且采用明胶包覆富马酸亚铁和叶酸的方式,有效避免叶酸和富马酸亚铁在生产和储存过程中被氧化降解,提高了片剂的稳定性,可满足成年人群补充足够的铁元素和叶酸。
具体实施方式
下面将结合具体实施例来详细说明本发明,在此本发明的示意性实施例以及说明用来解释本发明,但并不作为对本发明的限定。
实施例1、本发明补充铁和叶酸的片剂
该片剂包括以下成份:富马酸亚铁和叶酸包覆物35.5%、乳糖20.0%、微晶纤维素35.0%、甜菜红5.0%、硬脂酸镁4.5%;
其中,所述富马酸亚铁和叶酸包覆物包括以下成份:富马酸亚铁25.0%、抗氧化剂4.5%、叶酸0.10%和明胶72.0%,该包覆物的制备方法包括以下步骤:
a.将富马酸亚铁、柠檬酸和叶酸等物质进行粉碎、混合均匀,得到混合物,备用;
b.将明胶于45℃水浴加热熔融,往明胶中加入步骤a所得混合物,搅拌均匀,得到混合熔融体;
c.将步骤b所得混合熔融体冷却固化后得到固体,将该固体过120目筛进行整粒,得到富马酸亚铁和叶酸包覆物;
该片剂的制备方法如下:1)将配方量的富马酸亚铁和叶酸包覆物、微晶纤维素进预混合,得到混合物A,将配方量的甜菜红溶液均匀喷入混合物A,得到混合物B;2)将混合物B置干法制粒机,制颗粒,过60目筛整粒,得干颗粒C;3)将配方量的硬脂酸镁、乳糖与干颗粒C置混合机混合均匀,得总混合颗粒D;4)将总混合颗粒D置压片机,调节片重为0.8g/片,进行压片,即得片剂。
实施例2、本发明补充铁和叶酸的片剂
该片剂包括以下成份:富马酸亚铁和叶酸包覆物47.0%、乳糖25.0%、微晶纤维素25.0%、甜菜红2.0%、硬脂酸镁1.0%;
其中,所述富马酸亚铁和叶酸包覆物包括以下成份:富马酸亚铁20.0%、抗氧化剂2.0%、叶酸0.07%明胶77.0%,该包覆物的制备方法包括以下步骤:
a.将富马酸亚铁、柠檬酸和叶酸等物质进行粉碎、混合均匀,得到混合物,备用;
b.将明胶于45℃水浴加热熔融,往明胶中加入步骤a所得混合物,搅拌均匀,得到混合熔融体;
c.将步骤b所得混合熔融体冷却固化后得到固体,将该固体过120目筛进行整粒,得到富马酸亚铁和叶酸包覆物;
该片剂的制备方法与实施例1的片剂制备方法相同。
实施例3、本发明补充铁和叶酸的片剂
该片剂包括以下成份:富马酸亚铁和叶酸包覆物40.0%、乳糖22.0%、微晶纤维素30.0%、甜菜红3.5%、硬脂酸镁4.5%;
其中,所述富马酸亚铁和叶酸包覆物包括以下成份:富马酸亚铁22.0%、抗氧化剂3.0%、叶酸0.08%和明胶75.0%,该包覆物的制备方法包括以下步骤:
a.将富马酸亚铁、柠檬酸和叶酸等物质进行粉碎、混合均匀,得到混合物,备用;
b.将明胶于45℃水浴加热熔融,往明胶中加入步骤a所得混合物,搅拌均匀,得到混合熔融体;
c.将步骤b所得混合熔融体冷却固化后得到固体,将该固体过120目筛进行整粒,得到富马酸亚铁和叶酸包覆物;
该片剂的制备方法与实施例1的片剂制备方法相同。
实施例4、本发明补充铁和叶酸的片剂
该片剂包括以下成份:富马酸亚铁和叶酸包覆物45.0%、乳糖24.0%、微晶纤维素27.0%、甜菜红1.0%、硬脂酸镁3.0%;
其中,所述富马酸亚铁和叶酸包覆物包括以下成份:富马酸亚铁24.0%、抗氧化剂4.0%、叶酸0.09%和明胶74.0%,该包覆物的制备方法包括以下步骤:
a.将富马酸亚铁、柠檬酸和叶酸等物质进行粉碎、混合均匀,得到混合物,备用;
b.将明胶于45℃水浴加热熔融,往明胶中加入步骤a所得混合物,搅拌均匀,得到混合熔融体;
c.将步骤b所得混合熔融体冷却固化后得到固体,将该固体过120目筛进行整粒,得到富马酸亚铁和叶酸包覆物;
该片剂的制备方法与实施例1的片剂制备方法相同。
对比例1
与实施例3相比,本对比例的区别在于,在制备富马酸亚铁和叶酸包覆物过程中,不添加柠檬酸,其他参数和操作同实施例3。
对比例2
与实施例3相比,本对比例的区别在于,在制备富马酸亚铁和叶酸包覆物过程中,不添加明胶,其他参数和操作同实施例3。
对比例3
与实施例3相比,本对比例的区别在于,在制备富马酸亚铁和叶酸包覆物过程中,柠檬酸的添加量为5.5%,其他参数和操作同实施例3。
对比例4
与实施例3相比,本对比例的区别在于,在制备富马酸亚铁和叶酸包覆物过程中,明胶的添加量为87.0%,其他参数和操作同实施例3。
试验例一、本发明补充铁和叶酸的片剂的性能检测
取本发明的实施例1~4和对比例1~4制得的片剂各一批次,每批次各50片。对本发明的实施例1~4制得的片剂批次进行外观、片重差异、硬度、脆碎度检测分析,测试结果如表1所示。
表1实施例1~4和对比例1~4片剂的性能检测结果
由上表1可知:
(1)采用本发明实施例1~4制备方法,制得的片剂中外观为紫红色,色泽均一,片重差异满足规定要求的5%以内,硬度满足要求的3~5kg/mm范围内,脆碎度满足要求的1%以内。证明采用该原料配方制得的片剂从外观差异、片重差异、硬度、脆碎度方面都符合制备常规片剂的要求;
(2)与实施例3相比,对比例1~3改变的参数分别是:不添加柠檬酸、不添加明胶、柠檬酸的添加量为5.5%,制得的片剂外观色泽均不佳,出现干扰性杂色,降低了片剂的稳定性和食用效果,其中,对比例2的片剂颜色变化更加明显,且硬度和脆碎度受到了一定的影响;
(3)与实施例3相比,对比例4设定明胶的添加量为87.0%,得到的片剂表面粗糙,呈紫红色,片重差异与实施例3的相差较大,在优选的配方情况下,该对比例不能满足片剂的制备要求。
试验例二、本发明补充铁和叶酸的片剂的含量检测
取本发明的实施例1~4和对比例1~4制得的片剂各三批次,每批次各50片进行下列物质含量检测。
(1)铁元素含量的测定
根据《中国药典2015年版》测试富马酸亚铁含量的测试方法,每次精密称取上述三批次的适量片剂(约相当于富马酸亚铁为60mg),精密称定,加稀硫酸15ml,加热溶解后,放冷,加新沸过的冷水50ml与邻二氮菲指示液2滴,立即用硫酸铈滴定液(0.1mol/L)滴定,每1ml硫酸铈滴定液(0.1mol/L)相当于16.99mg的C4H2FeO4(约相当于亚铁含量为5.6mg)。在温度为18~26℃,相对湿度为45%~65%的条件下放置六个月后,重复上述检测方案,测试结果如下表2所示。
(2)叶酸含量的测定
根据《中国药典2015年版》测试叶酸含量的测试方法,避光操作。每次精密称取三批次的适量片剂(约相当于叶酸200μg),将片剂置25ml量瓶中,加0.5%氨溶液约15ml,置热水浴中加热20分钟,边加热边振摇使叶酸溶解,放冷,用水稀释至刻度,摇匀,滤过,取续滤液作为供试品溶液;用十八烷基硅烷键合硅胶为填充剂,以磷酸盐缓冲液(pH 5.0)(取磷酸二氢钾2.0g,加水约650ml溶解,加0.5mol/L四丁基氢氧化铵的甲醇溶液15ml、1mol/L磷酸溶液7ml与甲醇270ml,放冷,用1mol/L磷酸溶液或氨试液调节pH值至5.0,用水稀释至1000ml)为流动相>检测波长为280nm;流速为1.2ml/min。其按外标法以峰面积计算叶酸含量,在温度为18~26℃,相对湿度为45%~65%的条件下放置六个月后,重复上述检测方案,结果如下表3所示。
表2各批次片剂中铁元素含量检测结果
表3实施例1~4和对比例1~2的叶酸含量检测结果
由上表2和3可知:
(1)采用本发明实施例1~4制备方法,制得的片剂中铁元素平均含量≥20.5mg,叶酸含量为210~240μg;片剂存放6个月后,再次检测铁元素平均含量>20.0mg,叶酸含量为210~240μg。证明该片剂的原料配方可以提高亚铁离子和叶酸的稳定性和有效性,同时添加的明胶量适合成年人群对富马酸亚铁的消化吸收,满足补充铁元素和叶酸的需求,该方法工艺简单,原料易得,在市场上将具有良好的应用前景;
(2)对比例1在富马酸亚铁和叶酸包覆物制备过程中,不添加柠檬酸,部分Fe2+被氧化成Fe3+,导致制成的片剂中Fe2+含量偏低,6个月后Fe2+含量明显低于标准含量,不满足成年人群补充足够的铁元素,生成的Fe3+会对人体产生损害;
(3)对比例2在富马酸亚铁和叶酸包覆物制备过程中,不添加明胶做囊膜,亚铁离子容易对甜菜红产生影响,影响了片剂外观色泽,同时,部分富马酸亚铁和叶酸被氧化降解,制成的片剂中Fe2+和叶酸的含量偏低,6个月后Fe2+和叶酸的含量都明显低于标准含量,不利于成年人群补充铁元素和叶酸;
(4)对比例3在富马酸亚铁和叶酸包覆物制备过程中,柠檬酸的添加比例为5.5%,过量的酸性物质破坏明胶中的蛋白质层,使部分富马酸亚铁失去明胶的保护,Fe2+被氧化成Fe3+,导致片剂中Fe2+含量低于标准含量,且亚铁离子容易对甜菜红产生影响,影响片剂稳定性,不利于成年人群补充铁元素,生成的Fe3+也会对人体产生损害;
综上所述,为防止富马酸亚铁与氧气、水等物质接触而被氧化成氢氧化铁,同时,避免叶酸被光、热等条件引发氧化降解,保证片剂的稳定性,本发明将富马酸亚铁、柠檬酸、叶酸和明胶制备成富马酸亚铁和叶酸包覆物,其作用是使富马酸亚铁中的亚铁离子处于柠檬酸的酸性环境下,氢离子有助于抑制亚铁离子与水中的氢氧根离子结合,防止亚铁离子转化成氢氧化铁,同时,明胶对富马酸亚铁和叶酸进行保护,避免了富马酸亚铁中的亚铁离子对甜菜红的色泽产生不利影响,也保证了叶酸的性质稳定。通过筛选原料配比和工艺参数,得到的片剂中铁元素平均含量≥20.5mg,叶酸平均含量为210~240μg;片剂存放6个月后,再次检测铁元素平均含量
≥20.0mg,叶酸平均含量为210~240μg,该片剂制备工艺简单,性质稳定,满足成年人群每天补充足够铁元素和叶酸的需求,在市场上将具有良好的应用前景。
上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。
Claims (9)
1.一种补充铁和叶酸的片剂,其特征在于,所述补充铁和叶酸的片剂包括以下成份:富马酸亚铁和叶酸包覆物35.5%~47.0%、甜味剂20.0%~25.0%、填充剂25.0%~35.0%、色素1.0%~5.0%、润滑剂1.0%~4.5%。
2.根据权利要求1所述的补充铁和叶酸的片剂,其特征在于,所述富马酸亚铁和叶酸包覆物包括以下成份:富马酸亚铁20.0%~25.0%、抗氧化剂2.0%~4.5%、叶酸0.07%~0.10%和明胶72.0%~77.0%。
3.根据权利要求1所述的补充铁和叶酸的片剂,其特征在于,所述富马酸亚铁和叶酸包覆物的制备方法包括以下步骤:
a.将配方量的富马酸亚铁、抗氧化剂和叶酸进行粉碎、混合均匀,得到混合物,备用;
b.将配方量的明胶于45℃水浴加热熔融,往明胶中加入步骤a所得混合物,搅拌均匀,得到混合熔融体;
c.将步骤b所得混合熔融体冷却固化后得到固体,将该固体过120目筛进行整粒,得到富马酸亚铁和叶酸包覆物。
4.根据权利要求1所述的补充铁和叶酸的片剂,其特征在于,所述甜味剂为乳糖、三氯蔗糖、D-甘露糖醇、葡萄糖、果糖、麦芽糖和淀粉糖中的一种或多种。
5.根据权利要求1所述的补充铁和叶酸的片剂,其特征在于,所述填充剂为微晶纤维素、淀粉、硫酸钙和磷酸氢钙中的一种或多种。
6.根据权利要求1所述的补充铁和叶酸的片剂,其特征在于,所述色素为叶黄素、甜菜红和番茄红素中的一种或多种。
7.根据权利要求1所述的补充铁和叶酸的片剂,其特征在于,所述润滑剂为硬脂酸镁、聚乙二醇4000、滑石粉和二氧化硅中的一种或多种。
8.根据权利要求2所述的富马酸亚铁和叶酸包覆物,其特征在于,所述抗氧化剂为柠檬酸、醋酸、酒石酸、苹果酸中的一种或多种。
9.根据权利要求1~8任一项所述的补充铁和叶酸的片剂,其特征在于,该片剂的制备方法包括以下步骤:
1)预混合:将配方量的富马酸亚铁和叶酸包覆物、填充剂进行混合,得到混合物A,将配方量的色素溶液均匀喷入混合物A,得到混合物B;
2)制粒:将混合物B置干法制粒机,制颗粒,过60目筛整粒,得干颗粒C;
3)总混合:将配方量的润滑剂、甜味剂与干颗粒C置混合机混合均匀,得总混合颗粒D;
4)压片:将总混合颗粒D置压片机,调节片重为0.8g/片,进行压片,即得片剂。
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