CN110236198A - 富含Omega-3不饱和脂肪酸的口服乳剂及其制备方法 - Google Patents
富含Omega-3不饱和脂肪酸的口服乳剂及其制备方法 Download PDFInfo
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- CN110236198A CN110236198A CN201910529080.2A CN201910529080A CN110236198A CN 110236198 A CN110236198 A CN 110236198A CN 201910529080 A CN201910529080 A CN 201910529080A CN 110236198 A CN110236198 A CN 110236198A
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Abstract
本申请涉及一种富含Omega‑3不饱和脂肪酸的口服乳剂及其制备方法。所述口服乳剂包含:相对于所述口服乳剂的总质量,1%‑50%的富含Omega‑3不饱和脂肪酸的油脂,0.2%‑10%的乳化剂,0.01%‑0.8%乳化膜稳定剂,0.01%‑0.6%吸收促进剂,0.01%‑0.6%抗氧化剂,0‑40%的其他药品或食品中可接受的原辅料和1%‑90%的去离子水。所述口服乳及可以有效提高富含Omega‑3不饱和脂肪酸的油脂的生物利用度,促进小肠上皮细胞的吸收,同时掩盖油脂的不良气味。
Description
技术领域
本申请涉及食品、保健食品和特殊医学食品领域和药品领域,主要涉及一种富含Omega-3不饱和脂肪酸的口服乳以及其制备方法。本申请所述的口服乳剂可以提高Omega-3不饱和脂肪酸的生物利用度,并掩盖油脂类物质的腥味。
背景技术
随着社会经济的发展,人们的生活水平得到了很大的提升,生活方式也发生了巨大的变化。由于吸烟、不合理膳食、超重、运动缺乏等因素使得我国心脑血管病危险趋势明显,心脑血管病的患病率处于持续上升状态。药物治疗是心脑血管最常见的治疗方式,同时在日常生活中调节饮食结构,增加促心脑血管物质的摄入,对心脑血管的治疗有更好的促进作用。食品类的物质更易被人们所接受,服用、携带便捷,没有药物较强的不良反应,可以长时间服用,同时还可以起到辅助调节心脑血管的作用。
Omega-3不饱和脂肪酸是一组多元不饱和脂肪酸,主要来源于海洋生物或深海鱼类,对人体健康尤其是心脑血管方面十分有益。Omega-3不饱和脂肪酸有助于健脑益智,保持血管畅通,预防血栓或血脂等心脑血管等疾病的发生。Omega-3不饱和脂肪酸中的二十二碳六烯酸(DHA)经口服吸收后,迅速进入细胞膜,成为膜磷脂的基本成分,膜磷脂中花生四烯酸(AA)含量减少,因而对血小板聚集有强烈作用的TXA2的生成也减少,对预防血栓的生成有很大的促进作用。Omega-3不饱和脂肪酸中的二十碳五烯酸(EPA)和DHA参与前列腺素合成代谢,对血小板有强抑制作用的前列环素I3(PGI3)的产生增加,达到预防血栓形成、抗心律失常和抗血小板聚集等作用。
由于Omega-3在体内不能自我合成,所以Omega-3不饱和脂肪酸只能从食物中摄取,而日常食品中所含少量的Omega-3不饱和脂肪酸不能满足人体的需要,故通过服用深海鱼油等以补充这类必需的不饱和脂肪酸,改善人体的健康状况。
常见的富含Omega-3不饱和脂肪酸的油类包括海藻油、鱼油、磷虾油、海豹油和亚麻油等。Omega-3系多不饱和脂肪酸(Omega-3PUFA),主要包括二十碳五烯酸(EPA)、二十二碳六烯酸(DHA),二十二碳五烯酸(DPA)、α-亚麻酸(ALA)等。鱼油和海藻油中的EPA和DHA主要以脂肪酸乙酯或甘油三酯的形式存在,而磷虾油中的EPA和DHA主要以磷脂和甘油三酯的形式存在。
海藻油是海藻中全部油类物质的总称,常温下多为略带腥味的淡黄色液体。研究表明海藻油具有降血脂,降血压,降胆固醇,改善血栓,预防心血管疾病的作用,给高血脂的人每天食用1.5gDHA,2-15周之后,甘三酯含量降低了14%-26%,高密度脂蛋白含量有明显的上升趋势;鱼油是从鱼类中提取的油脂,与其他动物油脂以饱和脂肪酸为主不同,鱼油中的多不饱和脂肪酸(PUFA)含量丰富,主要成分有EPA和DHA,以及人体必需脂肪酸如花生四烯酸、亚麻酸和亚油酸等。鱼油具有多种营养和保健功能,可以显著降低血脂胆固醇,降低冠心病等心血管疾病发病率,对于预防心血管疾病具有重要作用;磷虾油是由南极海域野生的磷虾提取所得,磷虾油富含EPA、DHA、磷脂、维生素A、维生素E、虾青素等多种营养成分,其不饱和脂肪酸含量占脂肪酸总量的46.35%,其中EPA、DHA含量高达15.86%,安全且无毒副作用。研究表明,磷虾油能显著降低高脂血症大鼠的血清胆固醇、甘油三酯和低密度脂蛋白,具有明显的降血脂作用;海豹油来源深海哺乳动物海豹,其EPA、DHA、DPA的含量高达25%,具有调节血脂,降低胆固醇,抑制血小板凝集,预防血栓和心脑血管疾病等功能。
目前,市售的富含Omega-3不饱和脂肪酸成分如二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)的保健品,主要以胶囊的形式出现,如DHA藻油软胶囊、鱼油软胶囊、磷虾油胶囊等,而胶囊中的油包载量并不多,富含Omega-3不饱和脂肪酸的油溶解性较差,不利于人体吸收,其生物利用度并不高,影响产品发挥辅助调节心脑血管的作用,同时海藻油、鱼油、磷虾油胶囊服用后会出现腥味回味、嗳气等现象,严重影响使用者的服用体验。也有关于鱼油、海藻油等乳剂或液体饮料的相关报导,但其主要研究成分、比例,对其机制、生物利用度方面涉及并不多;掩味方面也往往只采用单一的方式。
因此,开发一种富含Omega-3不饱和脂肪酸的口服乳剂,提高生物利用度并掩盖油类物质气味具有重要意义。
发明内容
本申请的目的在于提供一种富含Omega-3不饱和脂肪酸的口服乳剂,其可以有效提高富含Omega-3不饱和脂肪酸的油脂的生物利用度,促进小肠上皮细胞的吸收,同时掩盖油脂的不良气味。
乳剂可以通过将油脂包裹在较小的乳滴中,减少油脂与味蕾的接触。然而口腔中含有大量的消化酶,会使乳滴迅速破坏而无法实现良好的掩味效果。本申请制备的纳米口服乳剂将油脂包裹在乳滴中,通过加入乳化膜稳定剂,可有效避免口腔中消化酶对乳滴的破坏作用,最大程度地减少油脂与味蕾的接触,实现采用物理屏障的方法来达到掩盖不良气味的目的。同时,本申请还加入调味剂,如食用香精、果糖等,这些都对油脂的腥味有缓解作用,可以使油脂的腥味掩盖有更好的效果。此外,Omega-3不饱和脂肪酸含有不饱和键,放置过程中容易被氧化,其氧化后不仅减弱疗效,而且油酯不良气味更加明显。本申请制备的口服乳一方面通过稳定的乳化膜包裹油脂,减少油脂和空气中的氧气接触;另一方面通过添加少量的抗氧化剂,进一步降低不饱和脂肪酸的氧化作用,避免长期放置过程中的口味变化,改善使用者的服用体验。
本申请采用磷脂等乳化剂,使油滴的粒径减小达到纳米尺度,不仅可以使难溶的油类物质的溶解度显著增加,促进其在体内的吸收,还可使油脂的表面积显著增大,这样与小肠接触的面积大大增加,使其更容易通过小肠粘膜到达微绒毛上,在该部位的脂肪酸、甘油酯等物质通过脂质膜进入小肠上皮细胞,并与细胞中的载脂蛋白、磷脂形成乳糜微粒,其形成的乳糜微粒较小,故能更好地提高油类物质在体内的吸收。
本申请的乳剂因独特的处方和制备工艺使粒径达到纳米尺度,同时本申请还加入一些口服吸收促进剂,使吸收进一步得到了提高,其生物利用也相应地得到提高。促吸收剂通过降低油脂在小肠中的粘稠度,增加油脂在胃肠道的扩散速度,增加肠粘膜的流动性,改变细胞间紧密连接,调节P糖蛋白外排作用抑制顶端极化外排系统,增加不饱和脂肪酸在肠道的渗透率等作用,增加Omega-3不饱和脂肪酸的吸收,进一步提高生物利用度。
本申请提供了一种富含Omega-3不饱和脂肪酸的口服乳剂,其包含:相对于所述口服乳剂的总质量,1%-50%的富含Omega-3不饱和脂肪酸的油脂,0.2%-10%的乳化剂,0.01%-0.8%乳化膜稳定剂,0.01%-0.6%吸收促进剂,0.01%-0.6%抗氧化剂,0-40%的其他药品或食品中可接受的原辅料和1%-90%的去离子水。更优选地,所述口服乳剂包含:相对于所述口服乳剂的总质量,1%-40%的富含Omega-3不饱和脂肪酸的油脂,0.3%-6.6%的乳化剂,0.1%-0.6%乳化膜稳定剂,0.1%-0.5%吸收促进剂,0.1%-0.5%抗氧化剂,0-30%的其他药品或食品中可接受的原辅料和25%-90%的去离子水。本申请的口服乳剂中的乳滴的粒径为小于500nm。
其中,所述富含Omega-3不饱和脂肪酸的油脂选自海藻油、鱼油、磷虾油中的一种。海藻油主要来源于海洋生物(如海藻),鱼油主要来源于深海鱼类(如三文鱼、金枪鱼、鳟鱼等),磷虾油来源于南极磷虾油,是由南极海域野生的磷虾提取或人工半合成所得。基于所述富含Omega-3不饱和脂肪酸的油脂的总重量,Omega-3不饱和脂肪酸的含量为1%-40%。
所述Omega-3不饱和脂肪酸的主要成分是二十碳五烯酸(EPA)、二十二碳六烯酸(DHA),其中,基于所述Omega-3不饱和脂肪酸的总重量,EPA占10%-80%,DHA占10%-80%,其他成分占5%-20%。
所述乳化剂可选自大豆磷脂、蔗糖酯、柠檬酸脂肪酸甘油酯类、脂肪酸甘油脂类、聚山梨酯类、脂肪酸山梨坦类、环糊精、聚氧乙烯脂肪酸酯类、聚氧乙烯聚氧丙烯共聚物类、聚氧乙烯脂肪醇醚类、聚乙二醇、泊洛沙姆、甲壳质、甲壳胺、胆酸及其盐类等的一种或多种。
所述乳化膜稳定剂可选自卡拉胶、羧甲基纤维素钠CMC-Na、黄原胶、微晶纤维素MCC、海藻酸钠、明胶、琼脂中的一种或多种。
所述吸收促进剂可选自卡波姆、壳聚糖、泊洛沙姆、聚乙二醇400(PEG400)、聚氧乙烯蓖麻油中的一种或多种。
所述抗氧化剂可选自亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、维生素C及其酯类和生育酚及其酯类中的一种或多种。
所述口服乳剂可选择性加入其他药品或食品中可接受的原辅料,其可选自油脂、调味剂、界面膜稳定剂、pH调节剂中的一种或多种。
其中,所述油脂可选自下述中的一种或多种:大豆油、核桃油、沙棘油、橄榄油、薏米油、葡萄籽油、生姜油、椰子油、山茶油、玫瑰油、薄荷油、柠檬油、链长在C8-C10之间的脂肪酸甘油酯(包括例如中链三酸甘油酯)等。
所述调味剂可选自水果口味香精、天然植物香料、果糖、甜味剂等中的一种或多种。
界面膜稳定剂可选自丙三醇、丙二醇、甘露醇、油酸、油酸钠和胆固醇中的一种或多种。
pH调节剂可选自于各类缓冲盐体系如柠檬酸-柠檬酸钠、醋酸-醋酸钠、磷酸盐剂等,以及NaOH溶液,HCl等碱和酸中的一种或多种。
根据本发明的另一方面,提供了一种制备所述富含Omega-3不饱和脂肪酸的口服乳剂的方法,包括如下步骤:
a)在惰性气体保护下,将配方中的油相成分配制成油相,搅拌混合,直至形成均一的油溶液;优选地,所述惰性气体为氮气;
b)在去离子水中,将配方中的水相成分配制成水相,搅拌溶解直至形成均一的水溶液;
c)将步骤a)所得的油溶液和步骤b)所得的水溶液混合,通过剪切搅拌或高压均质形成水包油的乳剂。
优选地,本发明的制备所述富含Omega-3不饱和脂肪酸的口服乳剂的方法进一步包括:
d)将步骤c)所得的口服乳剂进行过滤、灭菌和包装。
根据本申请所述方法制备口服乳剂,在特定的处方配比下通过剪切搅拌或高压均质,使其乳滴的粒径具有纳米级尺寸,例如其粒径小于500nm。
根据本申请的又一方面,提供了所述口服乳剂在制备食品、保健品或药物中的用途。本申请的口服乳剂用于改善血栓、血脂、血压等,达到辅助调节心脑血管的目的,此外,本申请的口服乳剂在提高生物利用度的同时采用掩味技术,提高了服用者的使用体验,使得服用者更易接受,对保证心脑血管的疗效起到一定的促进作用。
本申请发明人经过研究发现,根据本申请所述方法制备的富含Omega-3不饱和脂肪酸的口服乳剂,不仅可以掩盖油脂的不良气味,还可以促进有效成分的口服吸收,提高其生物利用度,增强辅助调节心脑血管的作用。本申请所述富含Omega-3不饱和脂肪酸的口服乳剂可显著提高活性成分的口服生物利用度,EPA和DHA的生物利用度可提高2-3倍;相比已授权专利的纳乳DHA饮料(浙江九旭药业有限公司,CN104719913A),本申请的DHA生物利用度提高1-2倍。
另外,本申请发明人经过研究发现,制备的富含Omega-3不饱和脂肪酸的口服乳剂的粒径小于500nm,可以增加油类溶解度,增强油类在胃肠道黏膜渗透性,极大地增加肠细胞的吸收作用,故可提高对心脑血管辅助调节作用,促进机体恢复正常的生理状态,同时本申请采用的掩味技术也提高了服用者的顺应性,使富含Omega-3不饱和脂肪酸的油脂更有效可行地被人体吸收。
附图说明
图1为实施例4中制备的富含Omega-3不饱和脂肪酸的口服乳剂中海藻油(鱼油/磷虾油)DHA小肠促吸收效果图。
图2为实施例5中制备的富含Omega-3不饱和脂肪酸的口服乳剂中海藻油(制剂15)EPA的体内促吸收效果线形图。
图3为实施例5中制备的富含Omega-3不饱和脂肪酸口服的乳剂中鱼油(制剂15)EPA的体内促吸收效果线形图。
图4为实施例5中制备的富含Omega-3不饱和脂肪酸的口服乳剂中磷虾油(制剂15)EPA的体内促吸收效果线形图。
图5为实施例5中制备的富含Omega-3不饱和脂肪酸的口服乳剂中海藻油(制剂15)DHA的体内促吸收效果线形图。
图6为实施例5中制备的富含Omega-3不饱和脂肪酸的口服乳剂中鱼油(制剂15)DHA的体内促吸收效果线形图。
图7为实施例5中制备的富含Omega-3不饱和脂肪酸的口服乳剂中磷虾油(制剂15)DHA的体内促吸收效果线形图。
具体实施方式
下面结合具体的实施例,并参照数据进一步详述本申请。这些实施例只是为了举例说明本申请,旨在说明本申请的具体配方组成、制备方法及其功能和效果,而非以任何方式限制本申请的范围。在以下实施例中,未详细描述的各种过程和方法是本领域中公知的常规方法。
制剂实施例
主要原料来源:海藻油、鱼油、磷虾油;大豆卵磷脂、蔗糖酯、聚山梨酯、脂肪酸山梨坦类、环糊精、聚氧乙烯脂肪酸酯类、聚氧乙烯聚氧丙烯共聚物类;卡波姆、壳聚糖、泊洛沙姆、聚氧乙烯蓖麻油、PEG400;海藻酸钠、微晶纤维素MCC、卡拉胶、羧甲基纤维素钠CMC-Na、黄原胶;生育酚、亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠;大豆油、核桃油、沙棘油、橄榄油、薏米油、葡萄籽油、生姜油、椰子油;水果口味香精、天然植物香料、果糖、甜味剂;丙三醇、丙二醇、甘露醇;柠檬酸-柠檬酸钠、醋酸-醋酸钠等。
实施例1:制备富含Omega-3不饱和脂肪酸的口服乳剂
如下表1所示,制备富含Omega-3不饱和脂肪酸的口服乳剂的制备方法如下:
1、制备油相:将海藻油或鱼油或磷虾油,大豆磷脂,生育酚油相成分,在氮气保护下混合均匀,备用;
2、制备水相:将蔗糖酯和水溶性原辅料成分溶于1000mL去离子水中,形成均一的水溶液,备用;
3、制备乳剂:在氮气保护下,将水相通过搅拌涡旋加入油相,通过剪切搅拌或高压均质形成水包油的乳剂,制得粒径小于500nm的口服乳剂;
4、过滤封装:将纳米乳经过0.5μm的滤膜过滤后,灌装,充氮,密封;
5、高压灭菌:将灌装纳米乳在高压灭菌器中灭菌,115℃,30min后即得富含Omega-3不饱和脂肪酸口服乳剂。
表1富含Omega-3不饱和脂肪酸的口服乳剂的不同处方
按照表1中的粒径大小可知,在固定量的海藻油或鱼油或磷虾油中,加入0.3%-6.6%的乳化剂,0.1%-0.6%乳化膜稳定剂,0.1%-0.5%吸收促进剂,0.1%-0.5%抗氧化剂,0-30%的其他药品或食品中可接受的原辅料,25%-90%去离子水,制备口服乳的液滴粒径小于500nm。
实施例2:富含Omega-3不饱和脂肪酸的口服乳剂抗氧化实验
1、实验试剂
海藻油口服乳组:采用实施例1中制剂15的处方(海藻油)制备口服乳剂,体积10mL;鱼油口服乳组:采用实施例1中制剂15的处方(鱼油)制备口服乳剂,体积10mL;磷虾油口服乳组:采用实施例1中制剂15的处方(磷虾油)制备口服乳剂,体积10mL;市售组:已授权专利的纳乳DHA饮料(浙江九旭药业有限公司,CN104719913A)
饱和碘化钾溶液:称取14gHI,加水10ml溶解;三氯甲烷-冰醋酸混合液:量取40ml三氯甲烷,加冰醋酸60ml,混匀;0.002mol/l硫代硫酸钠标准溶液;10g/l淀粉指示剂。
乙醇-乙醚混合溶液:无水乙醚与95%乙醚1:1(V)混合,每100ml溶剂加入0.3ml酚酞指示剂,0.1M KOH标准溶液,1%酚酞指示剂(1g酚酞溶于100ml95%乙醇中)。
2、过氧化值的测定:准确称取2-3g混匀的样品,必要时过滤,置于250ml碘量瓶中,加入30ml三氯甲烷-冰醋酸混合液,使样品完全溶解。加入1.00ml饱和碘化钾溶液,轻轻振摇30s,然后在暗处放置3min。取出加100ml水,摇匀,立即用硫代硫酸钠标准溶液滴定至淡黄色为止,再加1ml淀粉指示剂,继续滴定至蓝色消失为止。
3、游离脂肪酸的测定:精密称取样品5.0g至锥形瓶中,加入中和的乙醚-乙醇混合液50ml,使其溶解,加入1%酚酞5滴,用氢氧化钾标准溶液滴至粉红色,10s内不褪色,记录消耗氢氧化钾标准溶液的体积。
4、因本申请所述的乳剂中含有不饱和脂肪酸,有酸败的风险,故采用过氧化值和游离脂肪酸来评价其抗氧化性,衡量本申请中油脂的稳定程度。样品过氧化值的计算公式是w=(v2-v1)c×0.1296/m×100%,其中w-(过氧化物)样品的过氧化值,v2-样品消耗硫代硫酸钠标准溶液的体积(ml),v1-试剂空白消耗硫代硫酸钠标准溶液的体积(ml),c-硫代硫酸钠标准溶液的浓度(mol/l),m-样品的质量(g)。游离脂肪酸其中V-消耗氢氧化钾标准溶液的体积(ml),C-氢氧化钾标准溶液浓度(mol/l),M-样品质量(g)。
表2富含Omega-3不饱和脂肪酸口服乳剂抗氧化实验结果
体内实施例
实施例3:掩味技术实验
1、实验对象:6名志愿者
2、本实施例分为八个组,途径具体如下所示:
(1)纯牛奶组:纯牛奶(蒙牛乳业(集团)股份有限公司)
(2)海藻油胶囊组:剪开海藻油胶囊(威海紫光生物技术开发有限公司),取胶囊中液体10mL。
(3)鱼油胶囊组:鱼油胶囊(汤臣倍健股份有限公司),取胶囊中液体10mL。
(4)磷虾油胶囊组:磷虾油胶囊(曲阜圣康莱健康产业有限公司),取胶囊中液体10mL。
(5)纳乳组:已授权专利的纳乳DHA饮料(浙江九旭药业有限公司,CN104719913A),取纳乳10mL。
(6)海藻油口服乳组:采用实施例1中制剂15的处方(海藻油),在氮气保护下混合均匀,加入1000mL空白水相进行乳化,通过高压均质机反复均质乳化,制得粒径小于500nm的口服乳剂,从其中取10mL液体。
(7)鱼油口服乳组:采用实施例1中制剂15的处方(鱼油),在氮气保护下混合均匀,加入1000mL空白水相进行乳化,通过高压均质机反复均质乳化,制得粒径小于500nm的口服乳剂,从其中取10mL液体。
(8)磷虾油口服乳组:采用实施例1中制剂15的处方(磷虾油),在氮气保护下混合均匀,加入1000mL空白水相进行乳化,通过高压均质机反复均质乳化,制得粒径小于500nm的口服乳剂,从其中取10mL液体。
3、掩味效果评估方法
对于样品的口感评价结果,采用“稀释倍数评分法”的评价方法。采用单盲试验方法,将胶囊组和口服乳组中的液体用纯牛奶稀释,搅拌均匀,使八组液体外观一致,请6名志愿者对其进行评价,直至八组液体口味一致为止,并记下各组的稀释倍数,稀释倍数越高说明腥味越重。分别统计八组的稀释倍数,并进行比较。
4、实验结果
口服乳组的稀释倍数明显比胶囊组和纳乳组要低,说明海藻油口服乳组比海藻油胶囊组味道明显要好,鱼油口服乳组比鱼油胶囊组味道明显要好,磷虾油口服乳组比磷虾油胶囊组味道明显要好;说明海藻油口服乳组比纳乳组味道明显要好,这表明本申请制备的口服乳比已授权专利的纳乳组的掩味效果更好。该实验结果说明了将海藻油、鱼油和磷虾油做成口服乳剂型可以达到掩味的效果。
表3胶囊组与口服乳组稀释倍数的比较
实施例4:促进小肠吸收实验
1、实验条件
实验动物:雄性Wistar大鼠(上海实验动物研究中心),体重260-280g。
2、本实施例分为7个实验组,具体实验步骤如下。
(1)对照组1:海藻油2mL。
(2)对照组2:鱼油2mL。
(3)对照组3:磷虾油2mL。
(4)阳性对照组4:已授权专利的纳乳DHA饮料(浙江九旭药业有限公司,CN104719913A),取纳乳2mL。
(5)海藻油口服乳组:按实施例1中制剂15的处方(海藻油)制备海藻油乳剂。
(6)鱼油口服乳组:按实施例1中制剂15的处方(鱼油)制备鱼油乳剂。
(7)磷虾油口服乳组:按实施例1中制剂15的处方(磷虾油)制备磷虾油乳剂。
3、将Wistar大鼠随机分成七组,每组3只。实验前将大鼠禁食过夜,不禁水,用乌拉坦腹腔注射麻醉。沿腹中线打开腹腔,剪下小肠,去除肠系膜,一端用细线扎紧,将肠管翻转使黏膜面朝外,浆膜侧向内,结扎小肠近胃端扎紧固定于取样口(细玻璃管)一端。用注射器从取样口处向肠内注满空白K-R(Krebs-Ringer’s)营养液,作为受药体系。然后将其分别垂直放入含有海藻油(鱼油/磷虾油)、海藻油(鱼油/磷虾油)口服乳的三颈烧瓶中,受药体系液面高于供药体系液面,在烧瓶中通入气体(95%O2及5%CO2),整个装置在37℃恒温水浴中进行实验。分别在15、30、45、60、75和90min从肠囊内取出受药体系溶液,同时补充同体积的37℃空白K-R营养液,取出肠内液用0.45μm的微孔滤膜过滤,续滤液用HPLC法进行测定。
4、海藻油、鱼油和磷虾油中富含Omega-3不饱和脂肪酸,而Omega-3不饱和脂肪酸的主要成分是二十碳五烯酸(EPA)、二十二碳六烯酸(DHA),本研究中以二十二碳六烯酸(DHA)作为Omega-3不饱和脂肪酸的指标成分,采用HPLC检测滤液中DHA的含量。
5、实验结果
海藻油口服乳在小肠中的吸收比海藻油好,鱼油口服乳在小肠中的吸收比鱼油好,磷虾油口服乳在小肠中的吸收比磷虾油好,同时,海藻油口服乳在小肠中的吸收比已授权专利的纳乳DHA饮料好,该实验结果说明了本申请所述的口服乳剂可以进一步促进小肠吸收。
实验结果参见图1。
实施例5:提高生物利用度的功能实验
1、实验动物
实验动物:雄性Wistar大鼠(上海实验动物研究中心),体重260-280g。
2、本实施例分为10个实验组:各组给药剂量,浓度以及给药途径具体如下所示:
(A1)对照组1:市售海藻油胶囊(威海紫光科技园有限公司),给药剂量为300mg/kg。
(A2)对照组2:市售鱼油胶囊(汤臣倍健股份有限公司),给药剂量为300mg/kg。
(A3)对照组3:市售磷虾油胶囊(曲阜圣康莱健康产业有限公司),给药剂量为300mg/kg。
(A4)对照组4:市售已授权专利的纳乳DHA饮料(浙江九旭药业有限公司),给药剂量为300mg/kg。
(B1)海藻油液体组:采用实施例1中制剂15的处方(海藻油),在氮气保护下混合均匀,加入1000mL空白水相进行乳化,不通过高压均质机均质乳化,制得粒径大于500nm的口服乳剂,给药剂量300mg/kg。
(B2)鱼油液体组:采用实施例1中制剂15的处方(鱼油),在氮气保护下混合均匀,加入1000mL空白水相进行乳化,不通过高压均质机均质乳化,制得粒径大于500nm的口服乳剂,给药剂量为300mg/kg。
(B3)磷虾油液体组:采用实施例1中制剂15的处方(磷虾油),在氮气保护下混合均匀,加入1000mL空白水相进行乳化,不通过高压均质机均质乳化,制得粒径大于500nm的口服乳剂,给药剂量为300mg/kg。
(C1)海藻油口服乳剂组(制剂1):采用实施例1中制剂15的处方(海藻油)制备得到的海藻油口服乳,海藻油给药剂量300mg/kg。
(C2)鱼油口服乳剂组(制剂2):采用实施例1中制剂15的处方(鱼油)制备得到的鱼油口服乳,鱼油给药剂量为300mg/kg。
(C3)磷虾油口服乳剂组(制剂3):采用实施例1中制剂15的处方(磷虾油)制备得到的磷虾油口服乳,磷虾油给药剂量为300mg/kg。
3、将Wistar大鼠随机分为10组,每组6只,实验前禁食12h,不禁水。给大鼠分别灌胃,在给药0.25h,0.5h,1h,2h,4h,6h,8h,12h和24h后,眼眶静脉丛采血0.5mL,收集于肝素化试管中,37℃水浴保温30min后,低温离心10min(5000r/min),分离血浆取上清液,于-20℃保存待测定其药物浓度。
4、Omega-3不饱和脂肪酸的主要成分是二十碳五烯酸(EPA)、二十二碳六烯酸(DHA),故本研究中以EPA和DHA为Omega-3不饱和脂肪酸的指标成分,采用HPLC检测血浆中两种成分的含量;本申请采用相对生物利用度F(如AUC鱼油口服乳/AUC鱼油胶囊)来进行评价。
5、实验结果
Wistar大鼠灌胃不同制剂,其血药浓度-时间曲线测定数据经“DAS”药动学计算(表4至表6——二十碳五烯酸(EPA);表7至表9——二十二碳六烯酸(DHA)),结果表明,制剂组的AUC值均高于对照组,EPA的生物利用度可提高2.05倍,DHA的生物利用度可提高2.06倍,海藻油口服乳组的DHA生物利用度相比纳乳组提高1.50倍,故本申请制备的口服乳可促进海藻油、鱼油和磷虾油在人体的吸收,对心脑血管疾病的治疗有很大的促进作用。本申请中制备得到的口服乳剂粒径在500nm以下,可以更进一步地增加肠细胞的吸收并且提高生物利用度。
对照组中海藻油或鱼油或磷虾油胶囊的生物利用度明显低于相同剂量的口服乳剂型,同时纳乳的生物利用度也低于相应的海藻油口服乳组,表明海藻油或鱼油或磷虾油采用口服乳剂型可以提高生物利用度。
表4海藻油口服乳(制剂15)中的EPA生物利用度结果
表5鱼油口服乳(制剂15)中的EPA生物利用度结果
表6磷虾油口服乳(制剂15)中的EPA生物利用度结果
表7海藻油口服乳(制剂15)中的DHA生物利用度结果
表8鱼油口服乳(制剂15)中的DHA生物利用度结果
表9磷虾油口服乳(制剂15)中的DHA生物利用度结果
Claims (10)
1.一种富含Omega-3不饱和脂肪酸的口服乳剂,其包含:相对于所述口服乳剂的总质量,1%-50%的富含Omega-3不饱和脂肪酸的油脂,0.2%-10%的乳化剂,0.01%-0.8%乳化膜稳定剂,0.01%-0.6%吸收促进剂,0.01%-0.6%抗氧化剂,0-40%的其他药品或食品中可接受的原辅料和1%-90%的去离子水。
2.根据权利要求1所述的口服乳剂,其包含:相对于所述口服乳剂的总质量,1%-40%的富含Omega-3不饱和脂肪酸的油脂,0.3%-6.6%的乳化剂,0.1%-0.6%乳化膜稳定剂,0.1%-0.5%吸收促进剂,0.1%-0.5%抗氧化剂,0-30%的其他药品或食品中可接受的原辅料和25%-90%的去离子水。
3.根据权利要求1或2所述的口服乳剂,其中,所述富含Omega-3不饱和脂肪酸的油脂选自海藻油、鱼油、磷虾油中的一种。
4.根据权利要求1至3中任一项所述的口服乳剂,其中,所述Omega-3不饱和脂肪酸的主要成分是二十碳五烯酸(EPA)、二十二碳六烯酸(DHA),其中,基于所述Omega-3不饱和脂肪酸的总重量,EPA占10%-80%,DHA占10%-80%,其他成分占5%-20%。
5.根据权利要求1至4中任一项所述的口服乳剂,其中,所述口服乳剂的粒径小于500nm。
6.根据权利要求1至5中任一项所述的口服乳剂,其中,所述乳化剂选自大豆磷脂、蔗糖酯、柠檬酸脂肪酸甘油酯类、脂肪酸甘油脂类、聚山梨酯类、脂肪酸山梨坦类、环糊精、聚氧乙烯脂肪酸酯类、聚氧乙烯聚氧丙烯共聚物类、聚氧乙烯脂肪醇醚类、聚乙二醇、泊洛沙姆、甲壳质、甲壳胺、胆酸及其盐类的一种或多种;所述乳化膜稳定剂选自卡拉胶、羧甲基纤维素钠CMC-Na、黄原胶、微晶纤维素MCC、海藻酸钠、明胶、琼脂中的一种或多种;所述吸收促进剂选自卡波姆、壳聚糖、泊洛沙姆、聚乙二醇400(PEG400)、聚氧乙烯蓖麻油中的一种或多种;所述抗氧化剂选自亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、维生素C及其酯类和生育酚及其酯类中的一种或多种。
7.根据权利要求1至6中任一项所述的口服乳剂,其中,所述口服乳剂可选择性加入其他药品或食品中可接受的原辅料,其选自油脂、调味剂、界面膜稳定剂、pH调节剂中的一种或多种;
其中,所述油脂选自下述中的一种或多种:大豆油、核桃油、沙棘油、橄榄油、薏米油、葡萄籽油、生姜油、椰子油、山茶油、玫瑰油、薄荷油、柠檬油、链长在C8-C10之间的脂肪酸甘油酯(包括例如中链三酸甘油酯);所述调味剂选自水果口味香精、天然植物香料、果糖、甜味剂中的一种或多种;所述界面膜稳定剂选自丙三醇、丙二醇、甘露醇、油酸、油酸钠和胆固醇中的一种或多种;所述pH调节剂选自于各类缓冲盐体系如柠檬酸-柠檬酸钠、醋酸-醋酸钠、磷酸盐剂,以及如NaOH溶液、HCl的碱和酸中的一种或多种。
8.一种制备权利要求1至7中任一项所述富含Omega-3不饱和脂肪酸的口服乳剂的方法,包括如下步骤:
a)在惰性气体保护下,将配方中的油相成分配制成油相,搅拌混合,直至形成均一的油溶液;优选地,所述惰性气体为氮气;
b)在去离子水中,加入配方中的水相成分配制成水相,搅拌溶解直至形成均一的水溶液;
c)将步骤a)所得的油溶液和步骤b)所得的水溶液混合,通过剪切搅拌或高压均质形成水包油的乳剂。
9.根据权利要求8所述的方法,进一步包括:
d)将步骤c)所得的口服乳剂进行过滤、灭菌和包装。
10.根据权利要求1至7中任一项所述的口服乳剂在制备食品、保健品或药物中的用途。
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