CN110338426A - 一种补血泡腾片剂及其制备方法 - Google Patents
一种补血泡腾片剂及其制备方法 Download PDFInfo
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- CN110338426A CN110338426A CN201910683314.9A CN201910683314A CN110338426A CN 110338426 A CN110338426 A CN 110338426A CN 201910683314 A CN201910683314 A CN 201910683314A CN 110338426 A CN110338426 A CN 110338426A
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- effervescent tablet
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- ferrous lactate
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Abstract
本发明提供了一种补血泡腾片剂,包括以下质量份的原料制备而成:微胶囊化乳酸亚铁1~5份、VC 1~5份、柠檬酸15~30份、碳酸氢钠15~30份、PEG6000 2‑10份、乳糖15~30份、甜菊糖苷0.5~1.5份、香橙果粉5~10份;所述微胶囊化乳酸亚铁包埋率为92%~94%,有效铁含量为14%~16%。本发明补血泡腾片剂配方通过合理选择,可在饮水中快速崩解,直接方便使用且经济有效,满足不同人群的需要,特别是孩童及吞咽困难人群。本发明配方可采用粉末直压工艺,成本低,工艺简单,成品可作为改善贫血的营养补充剂。
Description
技术领域
本发明属于食品加工技术领域,具体涉及一种补血泡腾片剂及其制备方法。
背景技术
据统计,我国有约15~20%的人群存在铁缺乏或缺铁性贫血症,儿童贫血比率更高达25%,世界卫生组织将缺铁性贫血列为全球四大营养性疾病之一。铁是人体内不可缺少的一种微量元素,人体中的铁主要是Fe2+在起作用,但Fe2+极不稳定,易氧化变色,在食品中不仅影响感官性状及货架期,且可能对机体造成不良反应,如胃肠道的刺激及毒副作用等。进行铁强化,是改善居民膳食中铁缺乏最简便有效的方法之一,如铁强化酱油、铁强化食盐等。
泡腾片作为近年来的一种新颖片剂,其中含有的泡腾崩解剂,使泡腾片剂放入饮水之中后产生大量气泡,加速崩解和融化,经调味后的泡腾片不仅乐趣无穷、口味更佳,且具有携带方便、服用方便、生物利用度高等特点,尤其适用于孩童及老人。泡腾片剂常规制备方法有湿法制粒、干法制粒、直接压片三种。湿法制粒:当粘合剂为含水溶液时,为避免制粒过程中发生酸碱反应,宜将泡腾崩解剂的酸源和碱源分开制粒,干燥,混合均匀后压片。从理论上说,使用无水乙醇等有机溶剂制粒有利于制剂的稳定,但很难保证它们完全无水,从而可能影响制剂的稳定性和增加成本。干法制粒:干法制粒可连续操作、耗能低、产量高。最大的优点是在制粒过程中,不需要加入粘合剂,从而最大限度地避免了泡腾崩解剂的酸源和碱源与水接触,非常有利于提高泡腾片的稳定性。直接粉末压片:选择适当的药物组分和辅料,不经过制粒直接进行压片,具有省时节能、工艺简单、可以避免与水接触而降低泡腾片稳定性等优点。但该法对物料的流动性和压缩成形性要求较高,所以在实际应用过程中受到一定限制。因此,如何将铁剂巧妙地制备成泡腾片,改善其口感利于吸收,且能够直接压片制备,降低生产成本,对于补铁的推广具有重要的实践意义。
发明内容
本发明的目的是提供一种补血泡腾片剂,所述补血泡腾片剂利用微胶囊化乳酸亚铁与其他营养成分复配,可直接压片成型,具有明显的改善贫血及缺铁综合症的营养保健功能。
为达到上述目的,本发明采用下述技术方案:
一种补血泡腾片剂,包括以下质量份的原料制备而成:微胶囊化乳酸亚铁1~5份、VC 1~5份、柠檬酸15~30份、碳酸氢钠15~30份、PEG6000 2-10份、乳糖15~30份、甜菊糖苷0.5~1.5份、香橙果粉5~10份;所述微胶囊化乳酸亚铁包埋率为92%~94%,有效铁含量为14%~16%;
所述微胶囊化乳酸亚铁的制备包括以下步骤:
S1.将麦芽糊精溶解于蒸馏水中充分搅拌得溶液A,将黄原胶加热溶于水中制得质量分数5%的黄原胶溶液B,A与B混合均匀得溶液C;
S2.将单硬脂酸甘油酯溶于乙醇中,加热充分搅拌溶解,冷却后再加入乳酸亚铁,得溶液D;
S3.将溶液C与溶液D充分混合,在-18℃预冻12h后,冷冻干燥,粉碎过筛得微胶囊化乳酸亚铁。
本发明首先通过微胶囊技术制备微胶囊化乳酸亚铁,通过包膜材料的选择和质量比例复配,并且优化制备工艺,得到的微胶囊化乳酸亚铁包埋率和有效铁含量高,在泡腾片剂中不仅可以提高二价铁的稳定性,保护二价铁免受环境的影响,而且能够改善铁剂口感,同时微胶囊化乳酸亚铁为颗粒状,有利于进行压片成型。其次使用柠檬酸和碳酸氢钠作为崩解剂,并通过调整两者的重量比,使泡腾片的崩解性能良好。最后加入功能成分VC以及调味剂甜菊糖苷、香橙果粉,与微胶囊化乳酸亚铁结合使用,可快速有效的改善贫血症状。香橙富含多种活性物质,如维生素C、胡萝卜素等,且口感色泽良好,可替代色素带来愉快的色泽。甜菊糖苷与柠檬酸配合使用,味道良好,且甜菊糖苷食用后不被人体吸收,不影响血糖水平。本发明泡腾片剂所采用的配方组分和含量选择合理,能够采用粉末直压工艺,成本低,工艺简单,补血效果显著。
优选地,所述麦芽糊精、黄原胶、单硬脂酸甘油酯、乳酸亚铁的质量比为5~40:1~5:1~2:1~5。在上述原料的选择和质量比条件下,所述微胶囊化乳酸亚铁包埋率高,有效铁含量高,且得到的微胶囊适宜压片成型。更优选地,所述麦芽糊精、黄原胶、单硬脂酸甘油酯、乳酸亚铁的质量比为35:4:1.2:2。
优选地,S3所述冷冻干燥为在冷冻干燥机中于-20℃冷冻15h。在上述冷冻干燥条件下,可最大程度的保留乳酸亚铁活性成分以及微胶囊化乳酸亚铁的完整性。
优选地,所述补血泡腾片剂由以下质量份的原料制备而成:微胶囊化乳酸亚铁1~5份、VC 1~5份、柠檬酸15~30份、碳酸氢钠15~30份、PEG6000 2-10份、乳糖15~30份、甜菊糖苷0.5~1.5份、香橙果粉5~10份。
进一步优选地,所述补血泡腾片剂由以下质量份的原料制备而成:微胶囊化乳酸亚铁3份、VC 3份、柠檬酸20份、碳酸氢钠25份、PEG6000 6份、乳糖20份、甜菊糖苷1.0份、香橙果粉8份。
优选地,所述甜菊糖苷是由甜叶菊干叶经水回流提取,所得提取液再经体积浓度80%的乙醇溶液沉淀除杂,最后经大孔吸附树脂纯化后制得。
优选地,所述香橙果粉是由新鲜香橙清洗干净后,去皮搅拌匀浆,然后添加麦芽糊精,经真空冷冻干燥后粉碎过100目筛制得。进一步优选地,所述真空冷冻干燥条件为压强10Pa,于-55℃下处理24h。在上述真空冷冻干燥条件下,可最大程度的保留香橙的活性成分,如维生素C、胡萝卜素等。
所述一种补血泡腾片剂的制备方法,包括如下步骤:
S1.将微胶囊化乳酸亚铁、VC、柠檬酸、碳酸氢钠、PEG6000、乳糖、甜菊糖苷、香橙果粉所有原料过80目筛,按质量比充分混合均匀;
S2.将上述粉末采用粉末直压工艺,加入压片机,调节上冲及下冲压力,制成片重差异合格,硬度及脆碎度合格的片剂。
优选地,本发明所述的片剂为水溶性可口服泡腾片,每片质量为6g~8g。
与现有技术相比,本发明的有益效果:
(1)本发明所用微胶囊化乳酸亚铁作为一种优良的补铁营养强化剂,不仅改善了片剂的感官性状,保护乳酸亚铁中二价铁的生物活性,提高了生物利用度,且安全高效,无刺激、无不良作用。片剂整体易吸收且对胃肠道无刺激,使用方便,特别的,可让孩童及吞咽困难病人在饮水中达到补血目的。
(2)本发明所用甜菊糖苷与柠檬酸配合使用,味道良好,且甜菊糖苷食用后不被人体吸收,不影响血糖水平;本发明所采用的香橙果粉,制备方法简单,经真空冷冻干燥可最大程度的保留活性成分,如维生素C、胡萝卜素等,与微胶囊化乳酸亚铁结合使用,可快速有效的改善贫血症状。
(3)本发明配方通过合理选择,可在饮水中快速崩解,直接方便使用且经济有效,满足不同人群的需要,特别是孩童及吞咽困难人群。本发明配方可采用粉末直压工艺,成本低,工艺简单,成品可作为改善贫血的营养补充剂。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合具体实施例,对本发明进一步详细说明,但本发明要求的保护范围并不局限于实施例。
下述实施例和对比例所采用的甜菊糖苷是由甜叶菊干叶经水回流提取,所得提取液再经体积浓度80%的乙醇溶液沉淀除杂,最后经大孔吸附树脂纯化后制得。所采用的香橙果粉是由新鲜香橙清洗干净后,去皮搅拌匀浆,然后添加麦芽糊精,经真空冷冻干燥后粉碎过100目筛制得。其他原料为市售。
实施例1:
补血泡腾片剂的制备
(1)微胶囊化乳酸亚铁的制备:
S1.将5Kg麦芽糊精溶解于50Kg蒸馏水中充分搅拌得溶液A,质量浓度为9.1%,将1Kg黄原胶加热溶于水中制得质量分数为5%的黄原胶溶液B,A与B混合均匀得溶液C。
S2.将1Kg单硬脂酸甘油酯溶于99Kg乙醇中,加热充分搅拌溶解,冷却后再加入1Kg乳酸亚铁,得溶液D。
S3.将溶液C与溶液D充分混合,在-18℃预冻12h后,于冷冻干燥机中进行冷冻干燥,干燥样品粉碎,过80目筛得微胶囊化乳酸亚铁。微胶囊化乳酸亚铁的包埋率为92.02%,有效铁含量为14.12%。
(2)将微胶囊化乳酸亚铁1Kg、VC 1Kg、柠檬酸15Kg、碳酸氢钠15Kg、PEG6000 2Kg、乳糖15Kg、甜菊糖苷0.5Kg、香橙果粉5Kg,所有原料过80目筛,按质量比充分混合均匀;
(3)将上述粉末采用粉末直压工艺,加入压片机,调节上冲及下冲压力,制成片重差异合格,硬度及脆碎度合格的片剂。
实施例2:
补血泡腾片剂的制备
(1)微胶囊化乳酸亚铁的制备:
S1.将40Kg麦芽糊精溶解于50Kg蒸馏水中充分搅拌得溶液A,质量浓度为44.4%,将5Kg黄原胶加热溶于水中制得质量分数为5%黄原胶溶液B,A与B混合均匀得溶液C。
S2.将2Kg单硬脂酸甘油酯溶于98Kg乙醇中,加热充分搅拌溶解,冷却后再加入5Kg乳酸亚铁,得溶液D。
S3.将溶液C与溶液D充分混合,在-18℃预冻12h后,于冷冻干燥机中进行冷冻干燥,干燥样品粉碎,过80目筛得微胶囊化乳酸亚铁。微胶囊化乳酸亚铁的包埋率为93.12%,有效铁含量为14.35%。
(2)将微胶囊化乳酸亚铁3Kg、VC 3Kg、柠檬酸22.5Kg、碳酸氢钠22.5Kg、PEG60006Kg、乳糖22.5Kg、甜菊糖苷1Kg、香橙果粉7.5Kg,所有原料过80目筛,按质量比充分混合均匀;
(3)将上述粉末采用粉末直压工艺,加入压片机,调节上冲及下冲压力,制成片重差异合格,硬度及脆碎度合格的片剂。
实施例3:
补血泡腾片剂的制备
(1)微胶囊化乳酸亚铁的制备:
S1.将20Kg麦芽糊精溶解于50Kg蒸馏水中充分搅拌得溶液A,质量浓度为28.6%,将3Kg黄原胶加热溶于水中制得质量分数为5%黄原胶溶液B,A与B混合均匀得溶液C。
S2.将1.5Kg单硬脂酸甘油酯溶于98.5Kg乙醇中,加热充分搅拌溶解,冷却后再加入2Kg乳酸亚铁,得溶液D。
S3.将溶液C与溶液D充分混合,在-18℃预冻12h后,于冷冻干燥机中进行冷冻干燥,干燥样品粉碎,过80目筛得微胶囊化乳酸亚铁。微胶囊化乳酸亚铁的包埋率为93.56%,有效铁含量为15.06%。
(2)将微胶囊化乳酸亚铁3Kg、VC 3Kg、柠檬酸20Kg、碳酸氢钠25Kg、PEG6000 6Kg、乳糖20Kg、甜菊糖苷1.0Kg、香橙果粉8Kg,所有原料过80目筛,按质量比充分混合均匀;
(3)将上述粉末采用粉末直压工艺,加入压片机,调节上冲及下冲压力,制成片重差异合格,硬度及脆碎度合格的片剂。
实施例4:
补血泡腾片剂的制备
(1)微胶囊化乳酸亚铁的制备:
S1.将35Kg麦芽糊精溶解于50Kg蒸馏水中充分搅拌得溶液A,质量浓度为70%,将4Kg黄原胶加热溶于水中制得质量分数为5%黄原胶溶液B,A与B混合均匀得溶液C。
S2.将1.2Kg单硬脂酸甘油酯溶于98.8Kg95%乙醇中,加热充分搅拌溶解,冷却后再加入2Kg乳酸亚铁,得溶液D。
S3.将溶液C与溶液D充分混合,在-18℃预冻12h后,于冷冻干燥机中进行冷冻干燥,干燥样品粉碎,过80目筛得微胶囊化乳酸亚铁。微胶囊化乳酸亚铁的包埋率为93.96%,有效铁含量为15.89%。
(2)将微胶囊化乳酸亚铁3Kg、VC 3Kg、柠檬酸20Kg、碳酸氢钠25Kg、PEG6000 6Kg、乳糖20Kg、甜菊糖苷1.0Kg、香橙果粉8Kg,所有原料过80目筛,按质量比充分混合均匀。
(3)将上述粉末采用粉末直压工艺,加入压片机,调节上冲及下冲压力,制成片重差异合格,硬度及脆碎度合格的片剂。
对比例1:
与实施例1相比,制备微胶囊化乳酸亚铁时不含有麦芽糊精,而黄原胶的用量为6Kg,其它操作与实施例1相同。具体制备获得的微胶囊化乳酸亚铁的包埋率为78.68%,有效铁含量为8.9%。
对比例2:
与实施例1相比,制备微胶囊化乳酸亚铁时麦芽糊精、黄原胶、单硬脂酸甘油酯、乳酸亚铁的质量比为4:5:1:1,其它操作与实施例1相同。具体制备获得的微胶囊化乳酸亚铁的包埋率为80.10%,有效铁含量为10%。
对比例3:
与实施例1相比,不含有甜菊糖苷,其它操作与实施例1相同。
对比例4:
与实施例1相比,不含有香橙果粉,其它操作与实施例1相同。
对比例5:
与实施例1相比,补血泡腾片剂的成分相同,但各成分含量不同于实施例1,其它操作与实施例1相同。本对比例的成分含量如下:
将微胶囊化乳酸亚铁0.8Kg、VC 0.8Kg、柠檬酸10Kg、碳酸氢钠10Kg、PEG6000 1Kg、乳糖10Kg、甜菊糖苷0.3Kg、香橙果粉3Kg,所有原料过80目筛,按质量比充分混合均匀,得粉末。
性能测试
微胶囊化乳酸亚铁对感官性状的影响
选用市售的葡萄糖酸亚铁、乳酸亚铁、实施例1制备的微胶囊化乳酸亚铁,并按实施例1所述制备方法分别制成铁含量为200mg/Kg的重量形状相同的泡腾片剂样品,每片泡腾片剂溶于300mL饮用水中,对其进行颜色、气味等感官性状的评价,结果如下表1所示:
表1铁强化剂对泡腾片剂感官性状的影响
铁强化剂 | 色泽 | 气味 |
葡萄糖酸亚铁 | 带灰色的橙黄色 | 焦糖样气味 |
乳酸亚铁 | 灰黄色 | 铁腥味较浓 |
微胶囊化乳酸亚铁 | 橙黄色 | 无异味,香橙香味 |
补血效果测试
测试方法:以血红蛋白浓度:男性<120g/L,女性<110g/L,判定为贫血。选取140例成年男、女性为研究对象,年龄18~45岁,其中男性73人,女性67人,按性别和年龄将研究对象进行随机分为7组,研究对象随机进入其中之一组,再将7组随机分为实施例1组、实施例2组、实施例3组、实施例4组和对比例3组、对比例4组、对比例5组,每组20人,分别按上述实施例1-4和对比例3-5方法制备得到的补血泡腾片剂进行试用,每日2片,一次1片溶解于300mL饮用水中,现泡现饮。分别于使用后1个月、2个月、3个月进行血红蛋白测定,每组按男女进行统计,并计算平均值,结果如下表:
表2泡腾片剂对血红蛋白的影响
上述结果显示,本发明实施例1-4制备的补血泡腾片剂能够明显提高血红蛋白浓度,从而达到补血效果,尤其是实施例4制备的补血泡腾片剂。而当缺少本发明中某成分或者各成分含量不同于本发明时,其提高血红蛋白浓度的效果明显降低,说明本发明通过各成分的选择和含量配比,获得的泡腾片剂能够达到显著提高血红蛋白浓度,达到补血的效果。
根据上述说明书的揭示和教导,本发明所属领域的技术人员还可以对上述实施方式进行变更和修改。因此,本发明并不局限于上面揭示和描述的具体实施方式,对发明的一些修改和变更也应当落入本发明的权利要求的保护范围内。此外,尽管本说明书中使用了一些特定的术语,但这些术语只是为了方便说明,并不对本发明构成任何限制。
Claims (10)
1.一种补血泡腾片剂,其特征在于,包括以下质量份的原料制备而成:微胶囊化乳酸亚铁1~5份、VC1~5份、柠檬酸15~30份、碳酸氢钠15~30份、PEG6000 2-10份、乳糖15~30份、甜菊糖苷0.5~1.5份、香橙果粉5~10份;所述微胶囊化乳酸亚铁包埋率为92%~94%,有效铁含量为14%~16%;
所述微胶囊化乳酸亚铁的制备包括以下步骤:
S1.将麦芽糊精溶解于蒸馏水中充分搅拌得溶液A,将黄原胶加热溶于水中制得质量分数5%的黄原胶溶液B,A与B混合均匀得溶液C;
S2.将单硬脂酸甘油酯溶于乙醇中,加热充分搅拌溶解,冷却后再加入乳酸亚铁,得溶液D;
S3.将溶液C与溶液D充分混合,在-18℃预冻12h后,冷冻干燥,粉碎过筛得微胶囊化乳酸亚铁。
2.根据权利要求1所述一种补血泡腾片剂,其特征在于,所述麦芽糊精、黄原胶、单硬脂酸甘油酯、乳酸亚铁的质量比为5~40:1~5:1~2:1~5。
3.根据权利要求2所述一种补血泡腾片剂,其特征在于,S3所述冷冻干燥为在冷冻干燥机中于-20℃冷冻15h。
4.根据权利要求1所述一种补血泡腾片剂,其特征在于,由以下质量份的原料制备而成:微胶囊化乳酸亚铁1~5份、VC1~5份、柠檬酸15~30份、碳酸氢钠15~30份、PEG60002-10份、乳糖15~30份、甜菊糖苷0.5~1.5份、香橙果粉5~10份。
5.根据权利要求4所述一种补血泡腾片剂,其特征在于,由以下质量份的原料制备而成:微胶囊化乳酸亚铁3份、VC3份、柠檬酸20份、碳酸氢钠25份、PEG6000 6份、乳糖20份、甜菊糖苷1.0份、香橙果粉8份。
6.根据权利要求1或2所述一种补血泡腾片剂,其特征在于,所述香橙果粉是由新鲜香橙清洗干净后,去皮搅拌匀浆,然后添加麦芽糊精,经真空冷冻干燥后粉碎过100目筛制得。
7.根据权利要求6所述一种补血泡腾片剂,其特征在于,所述真空冷冻干燥条件为压强10 Pa,于-55℃下处理24h。
8.根据权利要求1或2所述一种补血泡腾片剂,其特征在于,所述甜菊糖苷是由甜叶菊干叶经水回流提取,所得提取液再经体积浓度80%的乙醇溶液沉淀除杂,最后经大孔吸附树脂纯化后制得。
9.权利要求1-8任一所述一种补血泡腾片剂的制备方法,其特征在于,包括如下步骤:
S1.将微胶囊化乳酸亚铁、VC、柠檬酸、碳酸氢钠、PEG6000、乳糖、甜菊糖苷、香橙果粉所有原料过80目筛,按质量比充分混合均匀;
S2.将上述粉末采用粉末直压工艺,加入压片机,调节上冲及下冲压力,制成片重差异合格,硬度及脆碎度合格的片剂。
10.根据权利要求9所述一种补血泡腾片的制备方法,其特征在于,所述的片剂为水溶性可口服泡腾片,每片质量为6g~8g。
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