CN110123753B - 一种口服微乳及其制备方法和应用 - Google Patents
一种口服微乳及其制备方法和应用 Download PDFInfo
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- CN110123753B CN110123753B CN201910527293.1A CN201910527293A CN110123753B CN 110123753 B CN110123753 B CN 110123753B CN 201910527293 A CN201910527293 A CN 201910527293A CN 110123753 B CN110123753 B CN 110123753B
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Abstract
本发明提供了一种口服微乳及其制备方法和应用。本发明的口服微乳包含:基于所述口服微乳的总重量,5‑40重量%的藻油DHA,2‑20重量%的磷脂酰丝氨酸,1‑10重量%的γ‑氨基丁酸,0.1‑10重量%的脂溶性乳化剂,0.1‑5重量%的水溶性乳化剂,0‑40重量%的其他药品和/或食品中可接受的原辅料,1‑90重量%的去离子水。本发明的口服微乳能够提高藻油DHA的体内吸收和生物利用度,以发挥增强记忆力的功效。
Description
技术领域
本发明涉及功能饮料技术、食品加工领域,更具体涉及一种口服微乳及其制备方法和应用。
背景技术
记忆力减退会造成做事丢三落四,学生上学或成人上班过程中会注意力分散,不能集中,无法专心听课或上班,影响正常的工作和学习,这不得不引起我们的重视。临床上通常采用食物和药物的方法来增强记忆力。临床医生一般推荐食物疗法,如维生素、蛋白质、矿物质、乙酰胆碱和卵磷脂等;药物治疗有归脾丸、脑力宝丸、健脑丸、参乌健脑胶囊、复方活脑舒胶囊以及神经节苷脂和神经细胞肾生长因子等药物。食物疗法通过食物中摄取相关物质来提高记忆力,食物种类繁多,所含增强记忆力的有效成份并不高,不同食物之间所含的营养成分及含量也会有差异,这就使得从食物中摄取营养非常有限,达不到理想的效果。然而药物治疗会对人的身体造成一定的伤害,引起肠胃不适如恶心呕吐,长期使用会对肝肾功能造成损伤,并且有些药物增强记忆力的疗效并不理想。目前针对记忆力减退的治疗方法有很多,且均有一定的疗效,但也存在着明显的不足。因此急需研发一种具有改善记忆力功效的功能性食品。
藻油来源于海洋微藻,富含人体所必需的多不饱和脂肪酸(PUFA)家族中n-3系列的二十二碳六烯酸(DHA),俗称脑黄金,是一种对人体非常重要的多不饱和脂肪酸。DHA是人体脑细胞脂质膜中含量最多的n-3系多不饱和脂肪酸,是大脑和视网膜的重要构成脂肪酸,在人体大脑皮层中含量高达20%,在眼睛视网膜中所占比例最大,约占50%,参与了大脑的发育和功能形成,可以通过抑制乙型淀粉蛋白斑块合成酶的活性,预防大脑退化,对大脑发育、心脑血管疾病的预防及视力发展具有非常重要的影响。
磷脂酰丝氨酸(PS)又称复合神经酸,由三部分组成:亲水性的甘油骨架为头部,丝氨酸以及2个较长氢链的亲油基团组成的尾部,PS是细胞膜中的活性物质,它广泛存在于所有动物、高等植物以及微生物的膜中,是细胞膜重要的组分之一。磷脂酰丝氨酸是一种重要的神经成分,主要功能是改善神经细胞功能,调节神经脉冲的传导,也能调节大脑中的胆固醇与磷脂的比例,恢复脑细胞膜的正常流动性和化学组成,活化脑细胞,增进大脑记忆功能。另外,研究表明,磷脂酰丝氨酸能显著降低从事紧张工作的人们体内过多的应激激素的水平,可以促进注意力集中和提高记忆力,缓解不良情绪。磷脂酰丝氨酸能营养和活化脑中各种酶的活性、减缓神经递质的减少、通过翻转到细胞外侧修复大脑损伤、清除有害物质,提高注意力、集中精力、改善过动状态,进而减缓由于脑神经递质数量不足而产生多动症的现象的发生。磷脂酰丝氨酸具有很强的亲脂性,吸收后能够迅速通过血脑屏障进入大脑,起到舒缓血管平滑肌细胞,增加脑部供血的作用。同时磷脂作为一种生物活性物质,有着独特的理化性质和营养价值。
γ-氨基丁酸别名4-氨基丁酸(简称GABA),是一个四碳非蛋白质氨基酸,γ-氨基丁酸(GABA)首先在马铃薯的块茎中发现,后在动植物以及微生物中有较多的发现。GABA是中枢神经系统中最重要的抑制性神经递质,其神经元约占人体神经元总量的25%~30%,且在调控兴奋电位传导中具有重要的作用,主要存在于大脑皮层、海马、纹状体等区域,海马中约10%的海马神经元为抑制性的,其中大多数为GABA能神经元。GABA可抑制皮层及海马等脑区中兴奋性神经元的活性,进而维持正常的神经网络活动水平。GABA作为一种重要的抑制性神经递质,在谷氨酸脱羧酶(GAD)的作用下由谷氨酸脱羧生成,与突触后膜的GABA受体结合而发挥作用。当GABA系统发生异常时,会引起严重的精神类疾病。正常情况下,脑内GABA与谷氨酸等兴奋性神经递质维持平衡状态,在人类中枢神经系统中发挥着重要作用。GABA主要具有抗焦虑、抗抑郁和舒缓心情、增加睡眠时间的功效。人口服GABA后入睡时间缩短,实验表明服用GABA后延长了慢波睡眠II期和快动眼睡眠期。此外,现有的一些促眠药物正是通过增加GABA受体的亲合力发挥功效。多项动物和人群实验指出GABA能够增强记忆力,目前认为GABA对人记忆力潜在的增强效果是长期累积的作用。
一些研究者通过体外培养发现单纯DHA的增加对神经2A细胞不能起到保护作用,而当DHA与磷脂酰丝氨酸结合后才能对2A细胞发挥保护功能。藻油DHA与磷脂酰丝氨酸组合使用,DHA可以促进磷脂酰丝氨酸在体内的积累,在考虑到两种营养成分本身的保健作用的同时,又发挥了两者在吸收上的相互促进作用。也有研究发现磷脂酰丝氨酸和γ-氨基丁酸协同使用具有促进大脑活动,增强记忆力的作用,既可以提高生物利用度,又可确保营养成分的充分吸收。
发明内容
本发明的一个目的是提供一种含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳。本发明的口服微乳能够提高藻油DHA的体内吸收和生物利用度,以发挥增强记忆力的功效。
本发明的另一个目的是提供上述含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的制备方法。
本发明的再一个目的是提供上述含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的用途。
根据一个方面,本发明提供了一种口服微乳,其包含(优选由以下组成):基于所述口服微乳的总重量,5-40重量%的藻油DHA,2-20重量%的磷脂酰丝氨酸,1-10重量%的γ-氨基丁酸,0.1-10重量%的脂溶性乳化剂,0.1-5重量%的水溶性乳化剂,0-40重量%的其他药品和/或食品中可接受的原辅料,1-90重量%的去离子水。
进一步优选地,本发明提供了一种口服微乳,其包含(优选由以下组成):基于所述口服微乳的总重量,6-35重量%的藻油DHA、2-10重量%的磷脂酰丝氨酸,1-5重量%的γ-氨基丁酸,1-8重量%的脂溶性乳化剂,1-2重量%的水溶性乳化剂,0-30重量%的其他药品和/或食品中可接受的原辅料,15-80重量%的去离子水。
本发明的口服微乳中,优选地,所述脂溶性乳化剂可为选自大豆卵磷脂、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、甲壳质等中的一种或多种。
本发明的口服微乳中,优选地,所述水溶性乳化剂可为选自蔗糖酯、泊洛沙姆、阿拉伯胶、果胶、明胶、皂苷、胆酸及其盐类等中的一种或多种。
本发明的口服微乳中,优选地,根据需要,所述口服微乳可选择性加入其他药品和/或食品中可接受的原辅料,其可为选自油脂、抗氧化剂、调味剂和防腐剂中的一种或多种。
其中,优选地,所述油脂可为选自下述中的一种或多种:核桃油、沙棘油、生姜油、薄荷油和链长在C8-C10之间的脂肪酸甘油酯(包括中链三酸甘油酯)等中的一种或多种。
其中,优选地,所述抗氧化剂可为选自生育酚、亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、维生素C及其酯类中的一种或多种。
其中,优选地,所述调味剂可为选自水果口味香精、天然植物香料、甜味剂等中的一种或多种。例如,所述调味剂可为果糖。
其中,优选地,所述防腐剂可为选自苯甲酸、苯甲酸钠、山梨酸、山梨酸钾、丙酸钙等中的一种或多种。
根据另一个方面,本发明提供了一种制备上述口服微乳的方法,包括:
(1)将藻油DHA、磷脂酰丝氨酸、脂溶性乳化剂(优选地,大豆卵磷脂)和任选的其他药品和/或食品中可接受的脂溶性原辅料(优选地,抗氧化剂(例如,生育酚))按照配方称重后,搅拌混匀,水浴加热至50-70℃,制备成油相;
(2)将γ-氨基丁酸、水溶性乳化剂(优选地,蔗糖酯)、任选的其他药品和/或食品中可接受的水溶性原辅料(优选地,调味剂(例如,果糖))和去离子水按照配方称重后,混匀,水浴加热至50-70℃,制备成水相;
(3)在定制转子式剪切机作用下,将油相与水相混合均匀,形成组分均一的粗乳;以及
(4)混合后的粗乳进一步在300-400bar均质压力下形成均一的乳状液体。
本发明的制备方法中,优选地,所述方法进一步包括:
(5)将(4)中制备的乳状液体灌装至20ml的口服液瓶中,115℃条件下高压灭菌30分钟。
本申请的发明人经过研究发现,通过优化配比制备的本发明的含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸口服微乳粒径小于500nm,可以极大地增加肠细胞的吸收作用,促进其健脑作用。
根据再一个方面,本发明提供了上述口服微乳在制备用于健脑和/或提高记忆力的药物中的用途。
根据又一个方面,本发明提供了上述口服微乳在制备保健品或功能性食品中的用途。
本发明人经试验验证发现,主要由藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸制成的口服微乳具有显著的改善记忆力的功效,坚持食用对记忆力的提高有良好的治疗效果。因此,开发一种含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳,以提高生物利用度,增强记忆力。
藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸并不是随意组合就可以达到增强记忆力的效果,这两种或三种物质需要通过一定的配比才能制成具有增强记忆力功效的口服乳。本发明的口服微乳中,藻油DHA的含量在5-40重量%范围内,磷脂酰丝氨酸的含量在2-20重量%范围内,γ-氨基丁酸的含量在1-10重量%范围内,具有较好地协同增强记忆力的功效。
本发明制作的口服微乳是通过将油脂包裹在较小的乳滴中,减少油脂与味蕾的接触,采用物理屏障的方法来达到掩盖不良气味的目的,改善了使用者的服用体验;同时本发明还加入调味剂,如水果口味的香精、甜味剂等来掩盖藻油DHA的腥味,两种方法协同作用,使其能更好地掩盖不良气味。
本发明例如采用大豆卵磷脂和蔗糖酯等分别作为脂溶性乳化剂和水溶性乳化剂,其中大豆卵磷脂是细胞膜的组成部分,它能增强人体细胞传递信息的能力,同时还能提高大脑的活力,对记忆力的增长有促进作用。本发明采用的大豆卵磷脂不仅具有乳化功能,还可以促进记忆力的增长,达到一物多用的效果。本发明制成的口服微乳可以使油滴的粒径减小达到纳米尺度,不仅可以使藻油DHA的溶解度显著增加,促进其在体内的吸收,还可使其表面积显著增大,这样与小肠接触的面积就大大增加,体内吸收也显著增加,相应的生物利用度也得到了提高。
附图说明
图1为显示实施例3中制备的含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳提高生物利用度的效果图。
图2为实施例5中增强记忆力中的学习成绩柱状图。
图3为实施例5中增强记忆力中的记忆成绩柱状图。
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发明。这些实施例只是为了举例说明本发明,旨在说明本发明的具体配方组成、制备方法及其功能和效果,而非以任何方式限制本发明的范围。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。
实施例1:考察含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的处方量
含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的具体制备方法如下:
(1)将藻油、磷脂酰丝氨酸、大豆卵磷脂和生育酚按照配方称重后,搅拌混匀,水浴加热至50-70℃,制备成油相。将γ-氨基丁酸、蔗糖酯、果糖和去离子水按照配方称重后,混匀,水浴加热至50-70℃,制备成水相。
(2)在定制转子式剪切机作用下,将油相与水相混合均匀,形成组分均一的粗乳。
(3)混合后的粗乳进一步在300-400bar均质压力下形成均一的乳状液体。
(4)将乳状液体灌装至20ml的口服液瓶中。
(5)115℃条件下高压灭菌30分钟。
表1:含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的处方
按照表1中的粒径结果可看出,本发明的口服微乳中,固定量的藻油、磷脂酰丝氨酸和γ-氨基丁酸,加入0.1-10重量%的脂溶性乳化剂,0.1-5重量%的水溶性乳化剂,0-40重量%的其他原辅料(抗氧化剂等),可形成稳定性良好、且粒径在500nm以下的亚微米乳剂。
因此,本发明的口服微乳中,脂溶性乳化剂用量应为0.1-10重量%,优选为1-8重量%,水溶性乳化剂用量应为0.1-5重量%,优选为1-2重量%。
实施例2:含有不同比例的藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的制备
采用实施例1的制备方法,根据以下表2中各成分的量制备含有不同比例的藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳。
表2:含有不同比例的藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的处方
按照上表2中处方组分制备的口服微乳稳定性良好,乳品的液滴大小均值小于0.5μm,该比例下的配方可以使藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸更好地相互促进,协同发挥增强记忆力的效果。
实施例3: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5个实验组:各组给药剂量,浓度以及给药途径具体如下所示:
(1)对照组1:市售的藻油DHA与磷脂酰丝氨酸组合产品(荣格科技集团),给药剂量为300mg/kg。
(2)对照组2:市售的磷脂酰丝氨酸和γ-氨基丁酸组合产品(钟祥亿源生物科技有限公司),给药剂量为300mg/kg。
(3)对照组3:藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸联合给药组,使用市售的藻油DHA胶囊,将磷脂酰丝氨酸溶在大豆磷脂中,将γ-氨基丁酸溶在去离子水中,分别制成液体溶液;藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的给药剂量分别为300mg/kg、75mg/kg和37.5mg/kg。
(4)对照组4:藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳,使用实施例2中4号制剂的处方不进行均质处理制备得到的口服微乳,制得粒径大于500nm的口服微乳;藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的给药剂量分别为300mg/kg、75mg/kg和37.5mg/kg。
(5)制剂组:藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳,使用实施例2中4号制剂的处方制备得到的口服微乳,通过高压均质机反复均质乳化,制得粒径小于500nm的口服微乳;藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的给药剂量分别为300mg/kg、75mg/kg和37.5mg/kg
3、将Wistar大鼠随机分为5组,每组6只,实验前禁食12h,不禁水。给大鼠分别灌胃5组制剂,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。
藻油中的DHA是其健脑益智、增强记忆力的主要成分,也很具有代表性,故本研究以DHA为含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的指标性成分。
4、实验结果
Wistar大鼠灌胃不同制剂的口服微乳,其血药浓度-时间曲线测定数据经“DAS”药动学计算(下表3-DHA),结果表明,制剂组的生物利用度均高于对照组,且提高到2.54倍。
其中,对照组中藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸联合给药,其生物利用度明显低于相同剂量的制剂组的含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳,表明仅仅同时服用藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸,其生物利用度仍较低。同时,本发明人发现,口服乳粒径小于500nm,利于口服吸收,其生物利用度得到进一步提高。
表3:藻油中DHA的生物利用度结果
实施例4:掩味技术实验
1、实验对象:6名志愿者
2、本实施例分为三个组,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)海藻油口服微乳组:采用实施例2中制剂4的处方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,将海藻油胶囊组和海藻油口服微乳组中的液体用纯牛奶稀释,搅拌均匀,使三组液体外观一致,请6名志愿者对其进行评价,直至三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。分别统计三组的稀释倍数,并进行比较。
4、实验结果
海藻油口服微乳组比海藻油胶囊组的稀释倍数明显要小,味道要好。该实验结果说明了本发明的含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳剂型可以达到掩味的效果。
表4:海藻油胶囊组和海藻油口服微乳组稀释倍数比较
实施例5:含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳的增强记忆力能力实验
(1)一般资料
模型对照组(对照组1)
阳性对照组(对照组2):维生素EC颗粒(华润双鹤药业股份有限公司);
藻油DHA组(对照组3):采用实施例2中4号制剂处方,但不加磷脂酰丝氨酸和γ-氨基丁酸制备藻油DHA口服微乳;
磷脂酰丝氨酸组(对照组4):采用实施例2中4号制剂处方,但不加藻油DHA和γ-氨基丁酸制备磷脂酰丝氨酸口服微乳;
γ-氨基丁酸组(对照组5):采用实施例2中4号制剂处方,但不加藻油DHA和磷脂酰丝氨酸制备γ-氨基丁酸口服微乳;
制剂组:采用实施例2中4号制剂处方制备含有藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸的口服微乳;
剂量:0.10g/kg体重;
动物:ICR小鼠,18-22g,由上海实验动物研究中心提供。
(2)试验方法
取120只小鼠按体重随机分为6组,分别为模型对照组、阳性对照组、藻油DHA组、磷脂酰丝氨酸组、γ-氨基丁酸组和制剂组6组,每组20只,雌雄各半。各组皮下注射5%D-半乳糖溶液,0.5ml/只,每日一次,连续6周,制作出记忆力减弱的小鼠模型。
模型对照组不给药;阳性对照组给予维生素EC颗粒;其他对照组给予相应的口服微乳;制剂组给予藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸按一定配比组合的口服微乳。
造模和给药结束时,将小鼠置于跳台仪中适应环境3min,然后底部铜栅通以36V交流电,记录动物受到电击后跳上跳台的反应时间(潜伏期)和5min内受电击的次数(错误次数),作为学习成绩。24h后将小鼠直接放于跳台上记录其第1次跳下平台的潜伏期和3min内受电击的次数(错误次数),作为记忆成绩。
(3)试验结果
由表5可得,相比较模型对照组,其他对照组和制剂组均能缩短学习反应时间,减少错误次数,对记忆成绩测试,可延长跳台潜伏期,并减少错误次数。制剂组中三者配合组合的口服乳比单独配伍的口服微乳和阳性对照组增强记忆力的效果明显要好,说明藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸经过合理配比后,三者协同作用可以促进记忆力的增长。综上,表明本发明的藻油DHA、磷脂酰丝氨酸和γ-氨基丁酸口服微乳能够明显改善记忆功能。
Claims (17)
1.一种口服微乳,其组成为:基于所述口服微乳的总重量,5-40重量%的藻油DHA,2-6重量%的磷脂酰丝氨酸,1-3重量%的γ-氨基丁酸,1-8重量%的脂溶性乳化剂,0.1-5重量%的水溶性乳化剂,0-40重量%的其他药品和/或食品中可接受的原辅料,1-90重量%的去离子水,其中,所述口服微乳粒径小于500nm,
其中,所述脂溶性乳化剂为选自大豆卵磷脂、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、甲壳质中的一种或多种,
其中,所述水溶性乳化剂为选自蔗糖酯、泊洛沙姆、阿拉伯胶、果胶、明胶、皂苷、胆酸及其盐类中的一种或多种,
其中,所述其他药品和/或食品中可接受的原辅料为选自油脂、抗氧化剂、调味剂和防腐剂中的一种或多种,其中,所述油脂为选自下述中的一种或多种:核桃油、沙棘油、生姜油、薄荷油和链长在C8-C10之间的脂肪酸甘油酯中的一种或多种,所述抗氧化剂为选自生育酚、亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、维生素C及其酯类中的一种或多种,所述调味剂为选自水果口味香精、天然植物香料、甜味剂中的一种或多种,所述防腐剂为选自苯甲酸、苯甲酸钠、山梨酸、山梨酸钾、丙酸钙中的一种或多种。
2.根据权利要求1所述的口服微乳,
其中,所述脂溶性乳化剂为大豆卵磷脂,
所述水溶性乳化剂为蔗糖酯。
3.根据权利要求1所述的口服微乳,其中,所述口服微乳通过包括以下步骤的方法制备:
(1)将藻油DHA、磷脂酰丝氨酸、脂溶性乳化剂和任选的其他药品和/或食品中可接受的原辅料按照配方称重后,搅拌混匀,水浴加热至50-70℃,制备成油相;
(2)将γ-氨基丁酸、水溶性乳化剂、任选的其他药品和/或食品中可接受的原辅料和去离子水按照配方称重后,混匀,水浴加热至50-70℃,制备成水相;
(3)在定制转子式剪切机作用下,将油相与水相混合均匀,形成组分均一的粗乳;以及
(4)混合后的粗乳进一步在300-400bar均质压力下形成均一的乳状液体;
其中,步骤(1)中所述任选的其他药品和/或食品中可接受的原辅料为抗氧化剂。
4.根据权利要求3所述的口服微乳,其中,步骤(2)中所述任选的其他药品和/或食品中可接受的原辅料为调味剂。
5.根据权利要求3所述的口服微乳,其中,所述抗氧化剂为生育酚;
所述口服微乳的组成为:200g的藻油DHA、50g的磷脂酰丝氨酸、25g的γ-氨基丁酸、15g的大豆卵磷脂、7g的蔗糖酯、10g的生育酚、100g的果糖和加至1L的去离子水。
6.根据权利要求4所述的口服微乳,其中,所述调味剂为果糖。
7.根据权利要求1所述的口服微乳,其中,所述脂溶性乳化剂为选自大豆卵磷脂、柠檬酸脂肪酸甘油酯类、聚氧乙烯聚氧丙烯共聚物类和脂肪酸山梨坦类中的一种或多种。
8.一种制备权利要求1所述的口服微乳的方法,包括:
(1)将藻油DHA、磷脂酰丝氨酸、脂溶性乳化剂和任选的其他药品和/或食品中可接受的原辅料按照配方称重后,搅拌混匀,水浴加热至50-70℃,制备成油相;
(2)将γ-氨基丁酸、水溶性乳化剂、任选的其他药品和/或食品中可接受的原辅料和去离子水按照配方称重后,混匀,水浴加热至50-70℃,制备成水相;
(3)在定制转子式剪切机作用下,将油相与水相混合均匀,形成组分均一的粗乳;以及
(4)混合后的粗乳进一步在300-400bar均质压力下形成均一的乳状液体。
9.根据权利要求8所述的方法,其中,所述脂溶性乳化剂为大豆卵磷脂。
10.根据权利要求8所述的方法,其中,步骤(1)中所述任选的其他药品和/或食品中可接受的原辅料为抗氧化剂。
11.根据权利要求10所述的方法,其中,所述抗氧化剂为生育酚。
12.根据权利要求8所述的方法,其中,所述水溶性乳化剂为蔗糖酯。
13.根据权利要求8所述的方法,其中,步骤(2)中所述任选的其他药品和/或食品中可接受的原辅料为调味剂。
14.根据权利要求13所述的方法,其中,所述调味剂为果糖。
15.根据权利要求8所述的方法,进一步包括:
(5)将(4)中制备的乳状液体灌装至20ml的口服液瓶中,115℃条件下高压灭菌30分钟。
16.权利要求1至7中任一项所述的口服微乳在制备用于健脑和/或提高记忆力的药物中的用途。
17.权利要求1至7中任一项所述的口服微乳在制备保健品或功能性食品中的用途。
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