CN107050192A - 一种保护视力的组合物及其制备方法 - Google Patents
一种保护视力的组合物及其制备方法 Download PDFInfo
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- CN107050192A CN107050192A CN201610964273.7A CN201610964273A CN107050192A CN 107050192 A CN107050192 A CN 107050192A CN 201610964273 A CN201610964273 A CN 201610964273A CN 107050192 A CN107050192 A CN 107050192A
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Abstract
本发明公开了一种保护视力的组合物,该组合物包括以下重量份的组分:维生素C钠30‑100份、维生素A 0.1-1份、叶黄素1-10份、牛磺酸10‑20份、花茶果提取物10‑30份。本发明针对现有含维生素C含片溶解后酸性大、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,含片易吸湿受潮等问题,提供一种具有提高免疫力,清热、明目、美白养颜等功效,能明显改善视力模糊、眼干涩、眼胀、眼痛、畏光等症状的组合物。
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,特别是涉及一种保护视力的组合物及其制备方法。
背景技术
随着现代科技的日新月异以及互联网的普及,电脑的使用越来越普遍,我国网民规模达7.1亿,互联网普及率达到51.7%,随着移动通讯网络环境的不断改善以及智能手机的进一步普及,移动互联网应用向网民生活渗透,手机上网使用率也日益增长,目前我国手机网民规模达6.56亿人。电脑、手机辐射对眼睛的伤害越来越大,造成眼疾的患者越来越多,我国近视人数高达4.5亿,青少年近视患病率已高居世界首位,随着年龄的增长,中老年白内障、青光眼等各类眼疾的患病率也逐年递增。为了改善人们日常生活中由于电脑、手机的使用引起的视力模糊、眼干涩、眼胀、眼痛、畏光等症状,从而减少眼疾病的发生,市场上出现了大量保护视力产品,其功效成份主要以牛磺酸、叶黄素、维生素等化学成份为主,作用比较单一。
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。由于维生素C水溶液PH值接近2左右,酸性较大,口服使用对口腔、咽喉食道以及胃粘膜刺激较大,不宜长期服用,也不适合与酸性药物同时服用,在使用上受到一定限制。而维生素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。
发明内容
本发明针对现有保护视力产品作用比较单一以及含维生素C含片溶解后酸性大、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、含片易吸湿受潮等问题,提供一种保护视力同时具有提高免疫力、清热、明目、美白养颜等功效的组合物及其制备方法,解决了市面上类似产品作用比较单一,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。本发明保护视力的组合物,安全、无毒副作用,可长期用于改善视力模糊、眼干涩、眼胀、眼痛、畏光等症状;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:
一种保护视力的组合物,包括以下重量份的组分:维生素C钠30-100份、维生素A0.1-1份、叶黄素1-10份、牛磺酸10-20份、花茶果提取物10-30份。
以上所述花茶果提取物由以下重量份的原料制成:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份。
以上所述花茶果提取物的制备方法为:
S1:按以下重量份称取原料:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份;
S2:取称量好的密蒙花、金花茶,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花茶提取液;
S3:取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;
S4:将花茶提取液于柠檬果汁混合,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℃,得花茶果提取物。
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。
以上所述的保护视力的组合物,优选还包括以下重量份的组分:淀粉100-300份、蔗糖200-500份、甘露醇5-20份、微晶纤维素10-50份、羧甲基淀粉钠20-100份、聚维酮K-305-20份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、薄荷香精0.1-0.5份。
以上所述的保护视力的组合物,最佳优选包括以下重量份的组分:维生素C钠70份、维生素A 0.5份、叶黄素5份、牛磺酸15份、花茶果提取物20份、淀粉200份、蔗糖400份、甘露醇10份、微晶纤维素30份、羧甲基淀粉钠60份、聚维酮K-30 15份、十二烷基硫酸钠10份、硬脂酸镁3份、薄荷香精0.3份。
以上所述花茶果提取物最佳优选由以下重量份的原料制成:密蒙花50份、金花茶30份、鲜柠檬8份。
以上所述保护视力的组合物的制备方法,包括如下步骤:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份;取称量好的密蒙花、金花茶,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液与柠檬果汁混合,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℃,得花茶果提取物;
T2:分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠,粉碎,过100目筛,备用;
T3:分别按配方量称取T2项下各原辅料,以等量递增法混合均匀,得混合粉;
T4:取T3项下的混合粉,一边搅拌一边加30-50%蔗糖溶液制软材、过筛制粒,干燥4小时,控制水分为2-4%,过筛整粒,得颗粒;
T5:按配方量称取硬脂酸镁、薄荷香精,与T4项下颗粒混合均匀,压片,即得。
所述步骤T4项下干燥的温度优选为60-65℃,这样得到的颗粒硬度适中,更有利于压片;所述步骤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含片溶解后酸性大、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、含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.本发明方中花茶果提取物的各原料均为“药食同源”品种,其中密蒙花具祛风,凉血,润肝,明目之功效,用于治疗目赤肿痛,多泪羞明,青盲翳障,风弦烂眼,为眼科专用药;金花茶是一种药用价值、保健价值极高的植物,为广西特有,属无毒级,含有400多种营养物质,经研究表明金花茶对于调节人体血脂、血糖、胆固醇,增强机体免疫力有明显的效果,在民间一直被用于提神醒脑、清肝火、解热毒、养元气;鲜柠檬具有美白护肤、清热化痰、抗菌消炎、预防心血管疾病等功效;三药相伍具有提高免疫力、降血糖、血压、血脂,清热、明目、美白养颜等功效,进一步加强其改善视力模糊、眼干涩、眼胀、眼痛、畏光等症状的作用,克服了市面上保护视力产品的成份、作用单一的问题。
3.本发明保护视力的组合物,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,口感香甜,质量稳定,利于携带,食用方便,尤其适用于儿童、老年人,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.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、60%乙醇做粘合剂,结果见表1。
表1 润湿剂考察结果表
从表1中的试验结果可知:本发明使用40%蔗糖制粒情况效果最好,故本发明粘合剂选择蔗糖溶液。为进一步优化蔗糖溶液浓度,本发明继续优化蔗糖溶液浓度,试验结果见表2。
表2 蔗糖溶液浓度考察结果表
序号 | 湿润剂 | 制粒情况 | 颗粒外观 |
1 | 20%蔗糖溶液 | 不成团,制粒困难 | 颗粒松 |
2 | 30%蔗糖溶液 | 成团,制粒不结块 | 颗粒松紧合适 |
3 | 40%蔗糖溶液 | 成团,制粒不结块 | 颗粒松紧合适 |
4 | 50%蔗糖溶液 | 成团,制粒不结块 | 颗粒松紧合适 |
5 | 60%蔗糖溶液 | 成团,制粒结块 | 颗粒紧 |
从表2中的试验结果可知:本发明使用30%-50%蔗糖溶液制粒情况效果较好,浓度低太松,浓度高太紧,均影响制粒,故本发明粘合剂选择30%-50%蔗糖溶液。
2.润滑剂的选择
压片时为增加颗粒的流动性,使填充良好、片剂密度分布均匀,需加入一定的润滑剂,以解决压片时出现颗粒流动性差、易粘冲等现象。本发明试验中对比了硬脂酸镁、微粉硅胶、滑石粉、十二烷基硫酸钠、甘露醇做润滑剂时的压片情况,结果见表3。
表3 润滑剂试用结果表
从表3中的试验结果可知:加入硬脂酸镁、十二烷基硫酸钠、甘露醇,流动性均较好,且压片不粘冲,压出来的片硬度合适,片面光滑美观,加入微粉硅胶、滑石粉,流动性均不好,压片时粘冲,压出来的片硬度大,崩解时限不符合规定。故本发明选用硬脂酸镁、十二烷基硫酸钠、甘露醇作为润滑剂。为了调节咀嚼片的口感以及基于对生产成本的考虑,本发明试验中还对比了硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例,结果表明:硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例为3:3:1或者4:4:1其口感达到最佳。
二、保护视力的组合物的制备方法
实施例1
保护视力的组合物的制备方法,包括如下步骤:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花40kg、金花茶20kg、鲜柠檬5kg;取称量好的密蒙花、金花茶,加6倍量水,浸泡30分钟,超声提取3次,每次30分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液于柠檬果汁混合,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℃,得花茶果提取物;
T2:分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠,粉碎,过100目筛,备用;
T3:分别按以下重量份称取T2项下各原辅料:维生素C钠30kg、维生素A 0.1kg、叶黄酸1kg、牛磺酸10kg、花茶果提取物10kg、淀粉100kg、蔗糖200kg、甘露醇5kg、微晶纤维素10kg、羧甲基淀粉钠20kg、聚维酮K-30 5kg、十二烷基硫酸钠5kg,以等量递增法混合均匀,得混合粉;
T4:取T3项下的混合粉,一边搅拌一边加30%蔗糖溶液制软材、过20目筛制粒,62℃干燥4小时,控制水分为2-4%,过20目筛整粒,得颗粒;
T5:按以下重量份称取以下组分:取硬脂酸镁1kg、薄荷香精0.1kg,与T4项下颗粒混合均匀,压片,即得。
实施例2
保护视力的组合物的制备方法,包括如下步骤:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花50kg、金花茶30kg、鲜柠檬8kg份;取称量好的密蒙花、金花茶,加8倍量水,浸泡30分钟,加热回流提取2次,每次40分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液于柠檬果汁混合,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℃,得花茶果提取物;
T2:分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠,粉碎,过100目筛,备用;
T3:分别按以下重量份称取T2项下各原辅料:维生素C钠70kg、维生素A 0.5kg、叶黄酸5kg、牛磺酸15kg、花茶果提取物20kg、淀粉200kg、蔗糖350kg、甘露醇10kg、微晶纤维素30kg、羧甲基淀粉钠60kg、聚维酮K-30 15kg、十二烷基硫酸钠10kg,以等量递增法混合均匀,得混合粉;
T4:取T3项下的混合粉,一边搅拌一边加40%蔗糖溶液制软材、过30目筛制粒,60℃干燥4小时,控制水分为2-4%,过30目筛整粒,得颗粒;
T5:按以下重量份称取以下组分:取硬脂酸镁3kg、薄荷香精0.3kg,与T4项下颗粒混合均匀,压片,即得。
实施例3
保护视力的组合物的制备方法,包括如下步骤:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花60kg、金花茶40kg、鲜柠檬10kg;取称量好的密蒙花、金花茶,加10倍量水,浸泡30分钟,超声提取3次,每次40分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液于柠檬果汁混合,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干燥,控制干燥温度为65℃,得花茶果提取物;
T2:分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠,粉碎,过100目筛,备用;
T3:分别按以下重量份称取T2项下各原辅料:维生素C钠100kg、维生素A 1kg、叶黄素10kg、牛磺酸20kg、花茶果提取物30kg、淀粉300kg、蔗糖500kg、甘露醇20kg、微晶纤维素50kg、羧甲基淀粉钠100kg、聚维酮K-30 20kg、十二烷基硫酸钠20kg,以等量递增法混合均匀,得混合粉;
T4:取T3项下的混合粉,一边搅拌一边加70%蔗糖溶液制软材、过14目筛制粒,65℃干燥4小时,控制水分为2-4%,过14目筛整粒,得颗粒;
T5:按以下重量份称取以下组分:取硬脂酸镁5kg、薄荷香精0.5kg,与T4项下颗粒混合均匀,压片,即得。
三、稳定性试验
将上述实施例1-3样品分别用双层铝塑复合膜包装好,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、崩解时限、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4。
表4 保护视力的含片稳定性试验结果表
Claims (11)
1.一种保护视力的组合物,其特征在于,包括以下重量份的组分:维生素C钠30-100份、维生素A 0.1-1份、叶黄素1-10份、牛磺酸10-20份、花茶果提取物10-30份;
所述花茶果提取物由以下重量份的原料制成:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份。
2.如权利要求1所述的保护视力的组合物,其特征在于,所述花茶果提取物的制备方法为:
S1:按以下重量份称取原料:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份;
S2:取称量好的密蒙花、金花茶,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花茶提取液;
S3:取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;
S4:将花茶提取液与柠檬果汁混合,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℃,得花茶果提取物。
3.如权利要求2所述的保护视力的组合物,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所述的保护视力的组合物,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.如权利要求2-4中任一所述的保护视力的组合物,其特征在于,加辅料制成保健食品、食品上允许的制剂。
6.如权利要求5所述的保护视力的组合物,其特征在于,所述制剂为颗粒剂、丸剂、片剂、胶囊、口服液、糖浆剂、饮料或茶饮。
7.如权利要求6所述的保护视力的组合物,其特征在于,所述片剂为含片。
8.一种如权利要求7所述的保护视力的组合物制成含片,其特征在于,还包括以下重量份的组分:淀粉100-300份、蔗糖200-500份、甘露醇5-20份、微晶纤维素10-50份、羧甲基淀粉钠20-100份、聚维酮K-30 5-20份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、薄荷香精0.1-0.5份。
9.一种如权利要求7所述的保护视力的组合物制成含片的方法,其特征在于,包括以下步骤:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份;取称量好的密蒙花、金花茶,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液与柠檬果汁混合,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℃,得花茶果提取物;
T2:分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠,粉碎,过100目筛,备用;
T3:分别按配方量称取T2项下各原辅料,以等量递增法混合均匀,得混合粉;
T4:取T3项下的混合粉,一边搅拌一边加30-50%蔗糖溶液制软材、过筛制粒,干燥4小时,控制水分为2-4%,过筛整粒,得颗粒;
T5:按配方量称取硬脂酸镁、薄荷香精,与T4项下颗粒混合均匀,压片,即得。
10.如权利要求9所述的保护视力的组合物制成含片的方法,其特征在于,步骤T4项下干燥的温度为60-65℃。
11.如权利要求9所述的保护视力的组合物制成含片的方法,其特征在于,步骤T4项下所述的过筛步骤所用的筛网为14-30目。
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