CN106552105A - 一种增强免疫力的泡腾片及其制备方法 - Google Patents
一种增强免疫力的泡腾片及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种增强免疫力的泡腾片,该泡腾片包括以下重量份的组分:维生素C钠50‑200份、牛磺酸10‑30份、葡萄糖酸锌10‑30份、花果提取物10‑20份。本发明针对现有含维生素C泡腾片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用,及存储过程中维生素C容易氧化失效,泡腾片易受潮吸湿等问题,提供一种具有增强免疫力、清热解毒、补肾健脾、美容养颜等功效,还可以补充人体所需的营养、缓解疲劳、延缓衰老的泡腾片。
Description
技术领域
本发明属于药品、保健食品、食品领域,涉及一种组合物制剂及其制备方法,特别是涉及一种增强免疫力的泡腾片及其制备方法。
背景技术
现代人由于工作繁忙、平时饮食的不注意等原因,导致很多人的免疫力低下,身体都处于亚健康状态,如不注意将会发展为疾病甚至危及生命。随着生活水平的提高,人们对健康也日益重视,故希望使用的产品也是安全有效的,而“药食同源”类中药以及一些具有保健作用的瓜果符合人们的治疗疾病、保健需求。本发明在西药的基础上加入合适的“药食同源”类中药以及保健作用极佳的水果,制成一种增强免疫力的泡腾片,此泡腾片含有丰富的营养物质及改善人体健康的有效成分,具有增强免疫力、清热解毒、补肾健脾、美容养颜等功效,还可以补充人体所需的营养、缓解疲劳、延缓衰老,特别针对中老年人的健体美颜、抗衰老以及免疫力低下的癌症患者的康复。
维生素C是临床基本常用药物或营养补充剂,是抗氧化维生素当中的一种,它参与体内羟化反应,为形成骨骼、牙齿、结缔组织及非上皮组织细胞间粘物所必需,可维持牙齿、骨骼、血管的正常功能,增加对疾病的抵抗能力,为人体必需的营养元素之一,广泛应用于多种疾病预防和治疗。维生素C钠是维生素C的钠盐,水溶液pH值接近中性,它的作用与维生素C相同,但由于是钠盐,所以性能更稳定,同时不再有维生素C的强酸性,可以长期与多种药物同时服用,更优于维生素C。
泡腾片是近年来国外开发应用的一种新颖片剂。它与普通片剂的不同之处,就在于它还含有泡腾崩解剂,当泡腾片放入饮水中之后,在泡腾崩解剂的作用下,即刻产生大量气泡,使片剂迅速崩解和融化,有时崩解产生的气泡还会使药片在水中上下翻滚,加速其崩解和融化。片剂崩解时产生的气体部分溶解于饮水中,使饮水喝入口中时有汽水般的美感。泡腾片有如下的优点:便于保存和携带;崩解快速、服用方便、起效迅速;生物利用度高,能提高临床疗效;特别适用于儿童、老年人以及吞服药丸困难的患者;经过调味后的泡腾片,口味更佳,良药不再苦口,使消费者或病人更乐于接受。
发明内容
本发明针对现有含维生素C泡腾片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用,及存储过程中维生素C容易氧化失效、泡腾片易吸湿导致片剂崩解不良等问题,提供一种增强免疫力同时具有清热解毒、补肾健脾、美容养颜等功效的泡腾片及其制备方法,解决了临床上应用维生素C存在的质量不稳定、不易长期服用的等问题。本发明增强免疫力的泡腾片,安全、无毒副作用,可长期用于改善免疫力低下以及中老年人的健体美颜、抗衰老;或作为营养补充剂长期服用。
为解决上述技术问题,本发明是通过以下技术方案实现的:
一种增强免疫力的泡腾片,包括以下重量份的组分:维生素C钠50-200份、牛磺酸10-30份、葡萄糖酸锌10-30份、花果提取物10-20份。
以上所述花果提取物由以下重量份的原料制成:密蒙花30-50份、鲜桑葚30-60份、鲜葡萄5-10。
以上所述花果提取物的制备方法为:
S1:按以下重量份称取原料:密蒙花30-50份、鲜桑葚30-60份、鲜葡萄5-10份;
S2:取称量好的密蒙花,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花提取液;
S3:取称量好的鲜桑葚、鲜葡萄,洗净,榨取原汁,滤过,得果汁;
S4:将花提取液与果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18-1.22的流浸膏,将流浸膏进行干燥,控制干燥温度为65-80℃,得花果提取物。
所述步骤S2项下提取方法优选为加热回流提取、超声提取。
所述步骤S4项下干燥方法优选为烘箱加热干燥、喷雾干燥。
以上所述的增强免疫力的泡腾片,优选还包括以下重量份的组分:酒石酸50-120份、碳酸氢钠50-130份、阿斯巴甜10-30份。
以上所述的增强免疫力的泡腾片,进一步优选还包括占以上所述组分总重量0.5-1.0%的海藻糖及占以上所述组分总重量0.3-0.5%的乳糖。
以上所述的增强免疫力的泡腾片,最佳优选包括以下重量份的组分:维生素C钠120份、牛磺酸20份、葡萄糖酸锌20份、花果提取物15份、酒石酸80份、碳酸氢钠90份、阿斯巴甜20份,还包括占以上所述组分总重量0.8%的海藻糖及占以上所述组分总重量0.4%的乳糖。
以上所述花果提取物由以下重量份的原料制成:密蒙花40份、鲜桑葚50份、鲜葡萄8份。
以上所述增强免疫力的泡腾片的制备方法,包括如下步骤:
T1:花果提取物的制备:按重量份称取以下原料:密蒙花30-50份、鲜桑葚30-60份、鲜葡萄5-10份;取称量好的密蒙花,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花提取液;取称量好的鲜桑葚、鲜葡萄,洗净,榨取原汁,滤过,得果汁;将花茶提取液与果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18-1.22的流浸膏,将流浸膏进行干燥,控制干燥温度为65-80℃,得花果提取物;
T2:按重量份称取以下组分:维生素C钠50-200份、牛磺酸10-30份、葡萄糖酸锌10-30份、花果提取物10-20份、酒石酸50-120份、碳酸氢钠50-130份、阿斯巴甜10-30份;再称取占所述组分总重量0.5-1.0%的海藻糖及占所述组分总重量0.3-0.5%的乳糖;
T3:取酒石酸、花果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入50-60%乙醇溶液,混匀,制粒,过筛,干燥,整粒,得酸剂;
T4:取碳酸氢钠、花果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入50-60%乙醇溶液,混匀,制粒,过筛,干燥,整粒,得碱剂;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。
所述步骤T3、T4项下干燥的温度优选为80℃以下,这样得到的颗粒硬度适中,更有利于压片,同时利用崩解;所述步骤T3、T4项下所述的过筛步骤所用的筛网优选为14-30目。
本发明的有益效果是:
1.本发明克服现有含维生素C泡腾片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用,及存储过程中维生素C容易氧化失效、泡腾片易吸湿受潮等问题,使产品稳定性更好,疗效更确切,适用于消费者或患者长期服用,无副作用。
2.本发明方中花果提取物的各原料均为“药食同源”品种和日常食用水果,安全无毒副作用。其中密蒙花,味甘,性微寒,归肝经,含多种氨基酸、维生素、微量元素、黄酮及其苷类、三萜皂苷、黄色素等成分,能清肝火,养肝润燥,而明目退翳;桑葚,味甘,性寒,含有丰富的活性蛋白、维生素、氨基酸、胡萝卜素、矿物质、黄酮等多种活性成分,具有增强人体免疫力、营养肌肤、延缓衰老、生津止渴、促进消化、补肝益肾、滋阴补血等功效,被称为“民间圣果”;葡萄,含有多种矿物质、维生素以及人体所需的氨基酸,具有抗衰老、缓解疲劳、健脾胃、预防血栓、缓解低血糖等作用,由于其营养价值高,葡萄汁被科学家誉为“植物奶”;以上三种原料,通过合理配制,气味芳香、口感好,具有增强免疫力、清热解毒、补肾健脾、美容养颜等功效,还可以补充人体所需的营养、缓解疲劳、延缓衰老,特别针对中老年人的健体美颜、抗衰老以及免疫力低下的癌症患者的康复。
3.本发明增强免疫力的泡腾片,制剂简便,颗粒流动性好,压片不粘冲,所制得的片剂表面光滑,不易吸湿,泡腾产气均匀,崩解时间短,崩解后溶液透明澄清,口感香甜,质量稳定,携带方便,兼具了固体制剂和液体制剂的特点,尤其适用于儿童、老年人和不能吞咽固体制剂的患者,生物利用度高,使用更安全有效,可作为营养补充液长期服用。
具体实施方式
虽然本说明书通过特别指出并清楚要求保护本发明的权利要求书作出结论,但应该相信下列说明将更好地理解本发明。
如本文所用,单词“优选”及变体是指在特定环境下能够提供特定有益效果的本发明的实施方案。然而,其它的实施方案在相同或其它的环境下也可以是优选的。此外,一个或多个优选实施方案的详述并不表示其它实施方案是无用的,并且不旨在从本发明的范畴排除其它的实施方案。
一、制剂条件筛选
1.酸源和碱源的选择
泡腾片中常用的酸源有酒石酸、柠檬酸、富马酸、己二酸、苹果酸等;碱源有碳酸氢钠、碳酸钾、碳酸氢钾、碳酸钙等。用碳酸氢钠作为碱源制成的泡腾片在水中能迅速崩解,且泡腾溶液的pH值适宜维生素C钠的稳定,故本发明碱源选择碳酸氢钠。在固定碱源为碳酸氢钠的基础上,按下表1中的配方对酒石酸、柠檬酸、富马酸、苹果酸、己二酸进行选择试验,以确定泡腾片中最佳的酸源种类。
表1酸源和碱源优选试验
从表1中的试验结果可知:本发明使用酒石酸与维生素C钠、碳酸氢钠、阿斯巴甜混和,好制粒,腾崩解时间短,溶液澄清,口感好,只是压片时有粘冲现象,相比其他酸源最好,故本发明酸源选择酒石酸,碱源选择碳酸氢钠。
2.粘合剂选择
本发明对比了干法压片、湿法制粒再压片,干法压片采用普通压片机效果不好,对设备要求高,故本发明采用湿法制粒再压片。试验中对比了30%淀粉浆、40%蔗糖糖浆、5%羟丙甲纤维素水溶液、55%乙醇做粘合剂,结果见表2。
表2粘合剂考察结果表
从表2中的试验结果可知:本发明使用55%乙醇制粒情况及泡腾效果最好,故本发明粘合剂选择55%乙醇。为进一步优化乙醇浓度,本发明继续优化乙醇浓度,试验结果见表3。
表3乙醇浓度考察结果表
序号 | 粘合剂 | 制粒情况 | 颗粒外观 | 泡腾效果 |
1 | 20%乙醇 | 不成团,制粒困难 | 颗粒松 | 泡腾崩解时间3分钟,溶液澄清 |
2 | 30%乙醇 | 不成团,制粒困难 | 颗粒松紧合适 | 泡腾崩解时间3分钟,溶液澄清 |
3 | 50%乙醇 | 成团,制粒不结块 | 颗粒松紧合适 | 泡腾崩解时间3.5分钟,溶液澄清 |
4 | 60%乙醇 | 成团,制粒不结块 | 颗粒松紧合适 | 泡腾崩解时间4分钟,溶液澄清 |
5 | 70%乙醇 | 成团,制粒结块 | 颗粒紧 | 泡腾崩解时间6.5分钟,溶液澄清 |
从表3中的试验结果可知:本发明使用50%-60%乙醇制粒情况及泡腾效果较好,浓度低太松,浓度太高影响泡腾时间,故本发明粘合剂选择50%-60%乙醇。
3.稳定剂的选择
维生素C钠是维生素C的钠盐,性能较维生素C更稳定,但制备成泡腾片剂,在酸剂、碱剂、其他辅料及空气中水分及氧化等的影响,要在保质期内保证产品的质量稳定,还是需要加入稳定剂。试验中对比了0.02%EDTA二钠、1%海藻糖、0.2%亚硫酸钠,将分别用上述稳定剂制成的样品,分别用铝塑复合膜包装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,试验结果见表4。
表4稳定剂试验结果表
从表4中的试验结果可知:采用EDTA二钠及亚硫酸钠作为稳定剂,含水量变化较大,容易造成酸剂碱剂内部反应,溶液pH降低及加速氧化,导致维生素C钠含量降低。以1%海藻糖为稳定剂,加速试验后,水分变化不大,外观、泡腾反应时间、溶液pH及维生素C钠含量变化小,故本发明使用1%海藻糖作为稳定剂,为此,进一步考察海藻糖的加入量并将所得样品进行加速试验,试验方法同表4,结果详见表5。
表5海藻糖的加入量试验结果表
从表5中的试验结果可知:加入0.2-0.4%海藻糖后泡腾片的水分、外观、泡腾反应时间、溶液pH及维生素C钠含量变化均较大;而含0.5-1.0%海藻糖的泡腾片各项理化指标在3个月的加速时间内变化小,质量稳定;含1.2-1.5%海藻糖的泡腾片在3个月的加速时间内外观、pH值、含量指标变化不大,3个月加速时间内质量仍稳定,但水分、泡腾反应时间变化超出质量标准规定。故本发明控制海藻糖的加入量为0.5-1.0%。
4.润滑剂的选择
本发明在压片前的物料有酸剂、维生素C钠、甜味剂、碱剂,物料颗粒大小、质地不均,压片时出现颗粒流动性差、压片时易粘冲等现象。本发明试验中除润滑剂外其余配方相同,经初步试验确定可用比例后,具体对比了不同加入量的十二烷基硫酸镁、乳糖、甘露醇,并将分别用上述润滑剂制成的样品,分别用铝塑复合膜包装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,结果见表6。
表6润滑剂试用结果表
从表6中的试验结果可知:加入0.3-0.5%乳糖的流动性好,且压片不粘冲,片面光滑美观,但加速试验发现,加入乳糖量增加,含水量增加,泡腾反应时间也增加很多,不符合泡腾剂崩解时间要求,故本发明选用0.3-0.5%的乳糖作为润滑剂。
二、缓解视疲劳的组合物的制备方法
实施例1
增强免疫力的泡腾片的制备方法,包括如下步骤:
T1:花果提取物的制备:按重量份称取以下原料:密蒙花40份、鲜桑葚50份、鲜葡萄8份;取称量好的密蒙花,加8倍量水,浸泡30分钟,加热回流提取3次,每次30分钟,滤过,得花提取液;取称量好的鲜桑葚、鲜葡萄,洗净,榨取原汁,滤过,得果汁;将花提取液与果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.20的流浸膏,将流浸膏进行喷雾干燥,控制干燥温度为70℃,得花果提取物;
T2:按重量份称取以下组分:维生素C钠120份、牛磺酸20份、葡萄糖酸锌20份、花果提取物15份、酒石酸80份、碳酸氢钠90份、阿斯巴甜20份;再称取占所述组分总重量0.5%的海藻糖及占所述组分总重量0.3%的乳糖;
T3:取酒石酸、花果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入55%乙醇溶液,混匀,制粒,过20目筛,80℃下干燥,整粒,得酸剂;
T4:取碳酸氢钠、花果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入55%乙醇溶液,混匀,制粒,过20目筛,80℃下干燥,整粒,得碱剂;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。
实施例2
增强免疫力的泡腾片的制备方法,包括如下步骤:
T1:花果提取物的制备:按重量份称取以下原料:密蒙花30份、鲜桑葚30份、鲜葡萄5份;取称量好的密蒙花,加6倍量水,浸泡30分钟,超声提取3次,每次30分钟,滤过,得花提取液;取称量好的鲜桑葚、鲜葡萄,洗净,榨取原汁,滤过,得果汁;将花提取液与果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18的流浸膏,将流浸膏进行喷雾干燥,控制干燥温度为80℃,得花果提取物;
T2:按重量份称取以下组分:维生素C钠50份、牛磺酸10份、葡萄糖酸锌10份、花果提取物10份、酒石酸50份、碳酸氢钠50份、阿斯巴甜10份;再称取占所述组分总重量0.5%的海藻糖及占所述组分总重量0.3%的乳糖;
T3:取酒石酸、花果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入50%乙醇溶液,混匀,制粒,过30目筛,80℃下干燥,整粒,得酸剂;
T4:取碳酸氢钠、花果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入50%乙醇溶液,混匀,制粒,过30目筛,80℃下干燥,整粒,得碱剂;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。
实施例3
增强免疫力的泡腾片的制备方法,包括如下步骤:
T1:花果提取物的制备:按重量份称取以下原料:密蒙花50份、鲜桑葚60份、鲜葡萄10份;取称量好的密蒙花,加10倍量水,浸泡30分钟,加热回流提取2次,每次40分钟,滤过,得花提取液;取称量好的鲜桑葚、鲜葡萄,洗净,榨取原汁,滤过,得果汁;将花提取液与果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.22的流浸膏,将流浸膏放时烘箱进行加热干燥,控制干燥温度为65℃,得花果提取物;
T2:按重量份称取以下组分:维生素C钠200份、牛磺酸30份、葡萄糖酸锌30份、花果提取物20份、酒石酸120份、碳酸氢钠130份、阿斯巴甜30份;再称取占所述组分总重量0.5%的海藻糖及占所述组分总重量0.3%的乳糖;
T3:取酒石酸、花果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入60%乙醇溶液,混匀,制粒,过14目筛,80℃下干燥,整粒,得酸剂;
T4:取碳酸氢钠、花果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入60%乙醇溶液,混匀,制粒,过14目筛,80℃下干燥,整粒,得碱剂;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。
三、稳定性试验
将上述实施例1-3样品分别用铝塑复合膜包装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,结果实施例1-3样品的外观性状、水分、泡腾反应时间、溶液pH值、主要成分含量等稳定性重点考察指标与0时样品测定结果比较,均无明显变化,说明本发明实施例1-3样品质量较为稳定,可满足贮存、运输、使用的稳定性要求。试验结果见表7。
表7缓解视疲劳的泡腾片稳定性试验结果表
Claims (9)
1.一种增强免疫力的泡腾片,其特征在于,包括以下重量份的组分:维生素C钠50-200份、牛磺酸10-30份、葡萄糖酸锌10-30份、花果提取物10-20份;
所述花果提取物由以下重量份的原料制成:密蒙花30-50份、鲜桑葚30-60份、鲜葡萄5-10份。
2.如权利要求1所述的增强免疫力的泡腾片,其特征在于,所述花果提取物的制备方法为:
S1:按以下重量份称取原料:密蒙花30-50份、鲜桑葚30-60份、鲜葡萄5-10份;
S2:取称量好的密蒙花,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花提取液;
S3:取称量好的鲜桑葚、鲜葡萄,洗净,榨取原汁,滤过,得果汁;
S4:将花提取液与果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18-1.22的流浸膏,将流浸膏进行干燥,控制干燥温度为65-80℃,得花果提取物。
3.如权利要求2所述的缓解视疲劳的组合物,其特征在于,步骤S2项下提取方法为加热回流提取、超声提取。
4.如权利要求2所述的缓解视疲劳的组合物,其特征在于,步骤S4项下干燥方法为烘箱加热干燥、喷雾干燥。
5.一种如权利要求1所述的增强免疫力的泡腾片,其特征在于,还包括以下重量份的组分:酒石酸50-120份、碳酸氢钠50-130份、阿斯巴甜10-30份。
6.如权利要求5所述的增强免疫力的泡腾片,其特征在于,还包括占以上所述组分总重量0.5-1.0%的海藻糖及占以上所述组分总重量0.3-0.5%的乳糖。
7.一种如权利要求6所述的增强免疫力的泡腾片的制备方法,其特征在于,包括以下步骤:
T1:花果提取物的制备:按重量份称取以下原料:密蒙花30-50份、鲜桑葚30-60份、鲜葡萄5-10份;取称量好的密蒙花,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花提取液;取称量好的鲜桑葚、鲜葡萄,洗净,榨取原汁,滤过,得果汁;将花提取液与果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18-1.22的流浸膏,将流浸膏进行干燥,控制干燥温度为65-80℃,得花果提取物;
T2:按重量份称取以下组分:维生素C钠50-200份、牛磺酸10-30份、葡萄糖酸锌10-30份、花果提取物10-20份、酒石酸50-120份、碳酸氢钠50-130份、阿斯巴甜10-30份;再称取占所述组分总重量0.5-1.0%的海藻糖及占所述组分总重量0.3-0.5%的乳糖;
T3:取酒石酸、花果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入50-60%乙醇溶液,混匀,制粒,过筛,干燥,整粒,得酸剂;
T4:取碳酸氢钠、花果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入50-60%乙醇溶液,混匀,制粒,过筛,干燥,整粒,得碱剂;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。
8.如权利要求5所述的增强免疫力的泡腾片的制备方法,其特征在于,步骤T3、T4项下干燥的温度为80℃以下。
9.如权利要求5所述的增强免疫力的泡腾片的制备方法,其特征在于,步骤T3、T4项下所述的过筛步骤所用的筛网为14-30目。
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