CN107259566B - 一种稳定高效护眼、提高视力的组合物及制备方法和应用 - Google Patents
一种稳定高效护眼、提高视力的组合物及制备方法和应用 Download PDFInfo
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Abstract
本发明提供一种稳定高效组合物及其制备方法和应用。所述组合物由重量份数200~400份的雨生红球藻、7~12份的叶黄素酯、480~600份的蓝莓果粉、548~648份的花生四烯酸油脂、500~556份的DHA藻油组成。雨生红球藻经CO2超临界抽提,抽提物与DHA藻油、花生四烯酸油脂混合制备包合微囊粉,再与叶黄素酯、蓝莓果粉混合制得组合物。其中,雨生红球藻虾青素含量为2%~3%;DHA藻油中DHA含量为36%~40%,花生四烯酸油脂中花生四烯酸含量为38%~45%,叶黄素酯中叶黄素二棕榈酸酯的含量为56%~62%,蓝莓果粉系人工种植采收蓝莓经脱水粉碎制得。实验表明:本发明所述组合物能显著提高各组成物质功能成分稳定性及生物利用度,具有稳定高效护眼和提高视力的保健功能。
Description
技术领域
本发明涉及一种高稳定性高生物利用度用于护眼、提高视力的组合物及其制备方法和应用。
技术背景
如今,电脑和手机已经成为人们工作生活不可或缺的工具,用手机阅读小说,每天盯着电脑屏幕时间过长,致使眼睛出现诸多不适,如眼胀、眼痛、畏光、视物模糊、眼干涩等症状,严重者甚至出现头痛、恶心、呕吐等全身症状。
雨生红球藻为国家卫计委(原***)批准的新资源食品(公告号:2010年第17号),富含类胡萝卜素、蛋白质、不溶性膳食纤维、维生素B2、维生素B12、烟酸、钙、镁、锌等营养成分,是维生素B1、维生素B6的来源。另外,在生长过程中,受极端环境影响(如氨缺乏、强光照、温度剧烈变化等不适宜条件),藻体会由运动的营养细胞转变为厚壁的静孢子,同时大量积累红色虾青素,被誉为天然虾青素的“来源”、“浓缩品”。虾青素有保护眼睛、增强免疫功能、缓解运动疲劳、抑制肿瘤发生、预防心血管疾病、防止皮肤衰老及中枢神经***等多种生理功能。
花生四烯酸油脂为国家卫计委(原***)批准的新资源食品(公告号:2010年第3号),其主要成分为花生四烯酸(Arachidonic acid,AA或ARA)是ω-6系列的一种人体重要的多不饱和脂肪酸,在维持机体细胞的结构与功能方面具有重要作用。AA在视网膜中的含量很高,可以形成视网膜感光体,并且与视网膜光感受器的发育快慢有密切关系,可以促进神经元树状突大量增加和延长以及髓鞘的形成,能提高视敏度。
叶黄素酯为国家卫计委(原***)批准的新资源食品(公告号:2008年第12号),食用后在体内转化为叶黄素被人体吸收利用。叶黄素是一种类胡萝卜素,能够预防眼睛光损伤,防止因叶黄素缺失而引起的视力退化和失明证,防止眼睛的生理结构和功能变异,是眼睛视网膜和黄斑不能缺失的重要组成物质。
DHA藻油为国家卫计委(原***)批准的新资源食品(公告号:2010年第3号)。DHA是大脑神经视觉细胞中重要的脂肪酸成分,是构成视网膜的基本原料,为维持视紫红质的正常功能所必须,对促进视网膜组织的发育,促进视功能的发展,改善视敏锐性等有重要作用。
蓝莓中含有花青素是一种天然的抗氧化剂。有观点认为花青素是迄今发现的最有效的天然水溶性自由基清除剂,与其他抗氧化剂不同的是它能通过血脑屏障,直接保护大脑神经***。同时蓝莓中还含有维生素A,维生素A可以促进眼内感光色素的生成,防止夜盲症和视力减退。
本发明旨在采用国家批准的新资源食品为原料,通过本发明特定比例、特定工艺及质量控制技术方案,制备各组成物质功能成分高稳定性、高生物利用度用于护眼和提高视力的组合物。
发明内容
本发明的第一目的在于提供一种高稳定性、高生物利用度用于护眼和提高视力的组合物及其制备方法,第二目的在于提供该组合物的应用。
本发明的第一目的是采用以下技术方案来实现的。
首先,所述组合物由重量份数200~400份的雨生红球藻、重量份数7~12份的叶黄素酯、重量份数480~600份的蓝莓果粉、重量份数548~648份的花生四烯酸油脂、重量份数500~556份的DHA藻油组成。
优选地,所述组合物由重量份数235~330份的雨生红球藻、重量份数9~12份的叶黄素酯、重量份数510~570份的蓝莓果粉、重量份数582~632份的花生四烯酸油脂、重量份数520~548份的DHA藻油组成。
进一步优选,所述组合物由重量份数265~268份的雨生红球藻、重量份数11~12份的叶黄素酯、重量份数535~545份的蓝莓果粉、重量份数614~617份的花生四烯酸油脂、重量份数539~541份的DHA藻油组成。
其次,雨生红球藻、花生四烯酸油脂、DHA藻油、叶黄素酯、蓝莓果粉系采用国家批准的新资源食品或食品。其中,雨生红球藻虾青素质量百分含量为2.0%~4.0%,优先为2.5%~3.5%,进一步优选为2.8%~3.2%;DHA藻油中DHA的质量百分含量为36%~40%,优选为36%~39%,进一步优选为37%~38%;花生四烯酸油脂中花生四烯酸的质量百分含量为38%~45%,优选为39%~43%,进一步优选为40%~41%;叶黄素酯中叶黄素二棕榈酸酯的质量百分含量为56%~62%,优选为57%~60%,进一步优选为58%~59%;蓝莓果粉系指采用人工种植采收的新鲜蓝莓,经脱水干燥、粉碎过60~80目筛制成。
再其次,所述组合物包含雨生红球藻CO2超临界抽提,抽提物与DHA藻油、花生四烯酸油脂混合制备油相,油相添加药学可接受的辅料制备包合微囊粉两个工艺步骤。具体为:
步骤1:称取雨生红球藻,移置至CO2超临界萃取设备(HA121-50-02型萃取装置,江苏华安科研仪器有限公司)中,于萃取温度65~75℃、萃取压力40~50MPa、CO2流速25L/h下连续抽提4h,收集抽提物至洁净混合容器中,添加本发明重量份数及优选重量份数的DHA藻油、花生四烯酸油脂,充分搅拌使混合均匀,得油相。
步骤2:按油相:药学可接受辅料质量比(m/m)为=25:12~25,优选为25:15~22,进一步优选为25:17~20称取β-环糊精、明胶、聚维酮K30、改性淀粉、维生素E、维生素C、迷迭香提取物、L-乳酸钙中的一种或几种,置乳化锅中加60℃水或50%乙醇制备成饱和溶液。开机并在60℃保温条件下缓慢加入油相,边加边充分搅拌、研磨至油相添加结束,继续搅拌研磨30分钟,冷却至室温得糊状物,挤压过20目筛,40℃~60℃干燥,粉碎过60~80目筛即得包合微囊粉。
最后,将包合微囊粉移至洁净混合容器,按本发明重量份数及优选重量份数称取叶黄素酯、蓝莓果粉添加至混合容器,经充分搅拌使混合均匀,过80目筛,即得本发明组合物。
本发明的第二目的是采用下述技术方案实现的:
首先,本发明所述组合物,具有护眼、提高视力功能/功效,可应作为药品、保健食品、功能性普通食品、特殊医学食品、特殊膳食食品原料应用于所述产品开发。
其次,本发明所述组合物,根据需要可添加或不添加药品、保健食品、功能性普通食品、特殊医学食品、特殊膳食食品可接受的辅料,进一步制成粉剂、颗粒剂、片剂、硬胶囊剂等固体口服制剂。
具体实施方式
下面结合实施例对本发明做进一步说明,但不以任何方式对本发明加以限制,基于本发明教导所作出的任何变换或替换,均属于本发明的保护范围。
实施例1:原料准备
雨生红球藻:购置新资源食品原料。经检测:虾青素含量为3.0%;
叶黄素酯:购置新资源食品原料。经检测:叶黄素二棕榈酸酯含量为58%;
花生四烯酸油脂:购置新资源食品原料。经检测:花生四烯酸含量为40%;
DHA藻油:购置新资源食品原料。经检测:DHA含量为37%;
蓝莓果粉:采用人工种植、采收的新鲜蓝莓,脱水干燥、粉碎过80目筛,即得。
实施例2:组合物制备1
步骤1:称取雨生红球藻358g,置CO2超临界萃取设备中,于萃取温度65~75℃、萃取压力40~50MPa、CO2流速25L/h下连续抽提4h,得抽提物100g(得率为28%)。将收集的抽提物移至洁净混合容器中,添加实施例1准备的DHA藻油278g、花生四烯酸油脂274g,充分搅拌使混合均匀,得油相。
步骤2:按油相:药学可接受辅料质量比(m/m)为=25:14,称取迷迭香提取物、聚维酮(PVP)、β-环糊精、L-乳酸钙共365g,置乳化锅中加60℃水,于60℃下制备成饱和溶液。开机并在60℃保温条件下缓慢加入油相,边加边充分搅拌、研磨至油相添加结束,继续搅拌研磨30分钟,冷却至室温得糊状物,挤压过20目筛,40℃~60℃干燥,粉碎过80目筛即得包合微囊粉1016g。
步骤3:将步骤2制备的包合微囊粉移至洁净混合容器,称取实施例1制备的蓝莓果粉300g、实施例1准备的叶黄素酯6g加入混合容器,充分搅拌使混合均匀,过80目筛,得组合物1310g。经检测,虾青素含量为0.227%。
实施例3:组合物制备2
步骤1:称取雨生红球藻140g,按实施例2步骤1的方法制备抽提物,得抽提物39g。将其移至洁净混合容器中,添加实施例1准备的DHA藻油91g、花生四烯酸油脂97g,充分搅拌使混合均匀,得油相。
步骤2:按油相:药学可接受辅料质量比(m/m)为=25:20,称取迷迭香提取物、聚维酮(PVP)、β-环糊精、改性淀粉共182g,置乳化锅中加60℃水,于60℃下制备成饱和溶液。开机并在60℃保温条件下缓慢加入油相,边加边充分搅拌、研磨至油相添加结束,继续搅拌研磨30分钟,冷却至室温得糊状物,挤压过20目筛,40℃~60℃干燥,粉碎过80目筛即得包合微囊粉405g。
步骤3:将步骤2制备的包合微囊粉,实施例1制备的蓝莓果粉95g、实施例1准备的叶黄素酯2g移至干燥洁净的混合容器中,充分搅拌使混合均匀,过80目筛,得组合物500g。经检测,虾青素含量为0.23%。
实施例4:组合物制备3
步骤1:称取雨生红球藻383g,按实施例2步骤1制备抽提物107g。收集抽提物移至洁净混合容器中,添加实施例1准备的DHA藻油216g、花生四烯酸油脂246g,充分搅拌使混合均匀,得油相。
步骤2:按油相:药学可接受辅料质量比(m/m)为=25:18,称取迷迭香提取物、聚维酮(PVP)、β-环糊精、维生素E、L-乳酸钙共410g,置乳化锅中加50%乙醇,于60℃下制备饱和溶液。开机并在60℃保温条件下缓慢加入油相,边加边充分搅拌、研磨至油相添加结束,继续搅拌研磨30分钟,冷却至室温得糊状物,挤压过20目筛,40℃~60℃干燥,粉碎过80目筛即得包合微囊粉970g。
步骤3:将步骤2制备的包合微囊粉,实施例1制备的蓝莓果粉216g、实施例1准备的叶黄素酯5g移至干燥洁净的混合容器中,充分搅拌使混合均匀,过80目筛,得组合物1180g。经检测,虾青素含量为0.267%。
实施例5:粉剂的制备
称取实施例2制备的组合物500g置干压机内,调节适合的滚筒压力干压、过筛、包装成8克/袋,即得具有高稳定性高生物利用度用于护眼、提高视力的粉剂。
实施例6:颗粒剂的制备
称取实施例4制备的组合物450g,添加糊精、乳糖、羟丙基淀粉等辅料适量,经制粒、干燥、包装,即得具有高稳定性高生物利用度用于护眼、提高视力的颗粒剂。
实施例7:片剂的制备
称取实施例4制备的组合物600g,添加预胶化淀粉、微晶纤维素、硬脂酸镁少许,经湿法制粒、干燥、压片、包装,即得具有高稳定性高生物利用度用于护眼、提高视力的片剂。
实施例8:硬胶囊剂的制备
称取实施例3制备的组合物350g,添加处方量0.5%的硬脂酸镁,经混合、制粒、充填、包装,即得具有高稳定性高生物利用度用于护眼、提高视力的硬胶囊。
实施例9:丸剂的制备
称取实施例2制备的组合物400g,添加维生素E、甘油少许,经制丸、烘干,得高稳定性高生物利用度用于护眼、提高视力的丸剂。
为了对本发明作进一步的说明,本发明选取实施例1准备的雨生红球藻、实施例4步骤2制备的包合微囊粉和实施例1准备的花生四烯酸油脂、DHA藻油作为对照样品,依次编号为①、②、③、④,选取实施例4所制备的组合物作为试验样品,编号为⑤,开展加速稳定性试验、生物利用度试验。另外,选举实施例1准备的叶黄素酯、和购置的叶黄素单体,分别编号为⑥、⑦进行生物利用度实验并对结果进行比较,具体如下:
1.加速稳定性试验
考察指标确定:一方面,本发明组合物组成物质明确了功能成分并限定其含量;另一方面,国家及行业标准对食用油脂质量及其稳定性有明确规定。为充分验证本发明组合物质量稳定性情况,我们选取虾青素、花生四烯酸、DHA、叶黄素二棕榈酸酯、食用油脂过氧化值作为稳定性考察指标,开展组合物各组成物质、包合微囊粉与本发明组合物6个月加速稳定性对比考察。因叶黄素酯稳定,不易氧化衰竭,故本发明不对其进行稳定性考察。
试验方案设计:按原料药物与制剂稳定性试验指导原则(《中国药典》2015版四部9001),分别取编号为①、②、③、④、⑤的试验样品各100g,置于洁净透明玻璃瓶中,置温度为40℃士2℃、相对湿度75%士5%的条件下放置6个月,分别于0个月、1个月、2个月、3个月、6个月取样,进行组合物及其各组成物质所对应的功能成分检测,同时开展组合物与组成物质花生四烯酸油脂过氧化值考察,结果见表1、表2。
表1:功能成分含量稳定性考察结果
表2:过氧化值稳定性考察结果
由表1、表2看出:经6个月加速试验后,样品①功能成分虾青素衰竭率为100%;样品②功能成分虾青素衰竭率为10%、花生四烯酸衰竭率为13%、DHA衰竭率为42%;样品③功能成分花生四烯酸衰竭率为61%,样品④功能成分DHA衰竭率为60%,样品⑤功能成分虾青素衰竭率为4.8%、花生四烯酸衰竭率为4.8%、DHA衰竭率为36%。样品②过氧化值增大约8.27倍,样品③过氧化值增大约38.78倍,样品⑤过氧化值增大约6.41倍。
试验结论:经6个月加速稳定性考察,样品①、③、④功能成分出现明显衰竭;样品②虽然衰竭减缓,但6个月衰竭率也在10%以上;样品⑤(本发明所述组合物)6个月加速试验功能成分衰竭不明显、过氧化值增高相较于②、③存在数量级差别。表明本发明所述组合物取得了显著提高稳定性技术效果。
2.吸收利用率试验
⑴.虾青素生物利用度测定
监测指标确定:以①、②、⑤为测试样品,以功能成分虾青素为监测指标,考察灌胃和静注给予各样品后被吸收进入血液的虾青素浓度,从而计算生物利用度。
试验方案设计:试验动物采用体重约3kg的健康家兔(由四川大学实验动物中心提供),动物随机分为三组,每组6只。试验前预先禁食12h后,分别灌胃给予上述样品,剂量按虾青素折算为0.6mg/kg(相当于60kg成人日服用虾青素12mg),给予样品后密集测定血浆中虾青素含量,至达峰时间后半小时,检测血药峰浓度(Cmax)。试验样品灌胃结束后,停药一周,至动物体内样品完全代谢,然后静脉注射给予等剂量虾青素标准品溶液,并测定血浆中虾青素含量(μg/mL),以此作为参比数据计算虾青素生物利用度,结果见表3。
表3:各样品中虾青素生物利用度检测结果
由表3看出:样品①中的虾青素生物利用度低于30%;样品②、⑤中虾青素生物利用度均提升至90%以上。样品⑤(即本发明所述组合物)相较于样品①,其生物利用度提高了4.2倍;相较于②,其生物利用度同样更具优势。
⑵.叶黄素酯生物利用度测定
监测指标确定:选取⑤、⑥、作为测试样品,⑦作为参比样品,以叶黄素单体作为监测指标(叶黄素酯体内经水解成叶黄素方可被吸收进入血液循环)。考察灌胃给予各样品后被吸收进入血液的叶黄素单体浓度,从而计算生物利用度。
试验方案设计:实验动物选用雄性SD大鼠30只,实测体重为350±2.5g,随机分为3组(每组10只),每只灌胃1mL灌胃液。试验前预先禁食12h后,分别灌胃给予上述样品,本发明所述组合物(试验样品⑤)60kg成年人给样剂量确定为2g/天,据此折算每天大鼠给样剂量为300mg/kg BW。依据等剂量给样可比原则确定对照样品⑥、⑦每天给样剂量均为1.26mg/kg BW。给予样品后密集测定血浆中叶黄素含量,至达峰时间后半小时,检测血药峰浓度(Cmax)。以此作为参比数据计算叶黄素生物利用度,结果见表4。
表4:各样品中叶黄素单体生物利用度检测结果
由表4看出:样品⑥中的叶黄素生物利用度仅为20%左右,而样品⑤中叶黄素生物利用度提高至70%以上,生物利用度显著提高。
试验结论:样品⑤中叶黄素的生物利用度是样品⑥的4倍,取得了实质性技术效果。
Claims (6)
1.一种高稳定性高生物利用度用于护眼、提高视力的组合物,其特征在于:所述组合物以重量份为200~400份的雨生红球藻经CO2超临界抽提,抽提物添加重量份为548~648份花生四烯酸油脂、重量份为500~556份DHA藻油混合得油相,添加油相与药学可接受辅料质量比为25:12~25的药学可接受辅料制得包合微囊粉,与重量份为7~12份叶黄素酯、重量份为480~600份蓝莓果粉混合制得组合物;所述雨生红球藻中虾青素质量百分含量为2.0%~4.0%、花生四烯酸油脂中花生四烯酸质量百分含量为38%~45%、DHA藻油中DHA质量百分含量为36%~40%、叶黄素酯中叶黄素二棕榈酸酯质量百分含量为56%~62%;所述雨生红球藻CO2超临界抽提物系将雨生红球藻于萃取温度65~75℃、萃取压力40~50MPa、CO2流速25L/h、连续抽提4h制得;所述蓝莓果粉系采用人工种植采收的新鲜蓝莓、经脱水干燥、粉碎过60~80目筛制得。
2.如权利要求1所述组合物,其特征在于:所述组合物以重量份为235~330份的雨生红球藻经CO2超临界抽提,抽提物添加重量份为582~632份花生四烯酸油脂、重量份为520~548份DHA藻油混合得油相,添加油相与药学可接受辅料质量比为25:15~22的药学可接受辅料制得包合微囊粉,与重量份为9~12份叶黄素酯、重量份为510~570份蓝莓果粉混合制得组合物;所述雨生红球藻中虾青素质量百分含量为2.5%~3.5%、花生四烯酸油脂中花生四烯酸质量百分含量为39%~43%、DHA藻油中DHA质量百分含量为36%~39%、叶黄素酯中叶黄素二棕榈酸酯质量百分含量为57%~60%。
3.如权利要求1所述组合物,其特征在于:所述组合物以重量份为265~268份的雨生红球藻经CO2超临界抽提,抽提物添加重量份为614~617份花生四烯酸油脂、重量份为539~541份DHA藻油混合得油相,添加油相与药学可接受辅料质量比为25:17~20的药学可接受辅料制得包合微囊粉,与重量份为11~12份叶黄素酯、重量份为535~545份蓝莓果粉混合制得组合物;所述雨生红球藻中虾青素质量百分含量为2.8%~3.2%、花生四烯酸油脂中花生四烯酸质量百分含量为40%~41%、DHA藻油中DHA质量百分含量为37%~38%、叶黄素酯中叶黄素二棕榈酸酯质量百分含量为58%~59%。
4.如权利要求1~3任意一项所述组合物,其特征在于:所述包合微囊粉制备系将药学可接受辅料置乳化锅中加60℃水或50%乙醇制备饱和溶液,保温、搅拌、研磨条件下缓慢添加油相至添加结束,继续搅拌研磨30分钟,冷却至室温得糊状物,挤压过20目筛,40℃~60℃干燥,粉碎过80目筛制得。
5.如权利要求4所述包合微囊粉,其特征在于:药学可接受的辅料为β-环糊精、明胶、聚维酮K30、改性淀粉、维生素E、维生素C、迷迭香提取物、L-乳酸钙中的一种或几种。
6.如权利要求1~3任意一项所述组合物,其特征在于:所述组合物用于制备护眼、提高视力的药品、保健食品、功能性普通食品、特殊医学食品;添加或不添加药品、保健食品、功能性普通食品、特殊医学配方食品可接受辅料,进一步制成粉剂、片剂、胶囊剂、颗粒剂或丸剂。
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