CN108498562B - 具有抗疲劳抗肿瘤增强免疫的油脂乳状液及其应用 - Google Patents
具有抗疲劳抗肿瘤增强免疫的油脂乳状液及其应用 Download PDFInfo
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Abstract
本发明涉及一种具有抗疲劳、促使身体机能快速恢复，具有抗肿瘤、提高癌症患者术后免疫功能的油脂乳状液及其应用，属于药物领域。所述油脂乳状液，其按重量份比计包括15～20份的MCT、1～7份的大豆油和2～7份的鱼油。本发明油脂乳状液各油脂组分之间产生了明显的协同作用，可以抵抗疲劳，加快机体恢复，抗肿瘤发展及明显改善癌症术后患者的免疫功能。
Description
技术领域
本发明涉及一种抗疲劳、促使身体机能快速恢复，具有抗肿瘤、提高癌症患者术后免疫功能的油脂乳状液及其应用，属于药物领域。
背景技术
饮食与肿瘤的发生、发展和预后均有重要的关系，通过合理的饮食调整可以增强机体的抵抗力，改善肿瘤患者的生活质量和延长生命时间，但肿瘤患者在能量和三大基础供能物质(蛋白质、脂肪、碳水化合物)方面均发生代谢改变。文献查阅，肿瘤患者在脂肪代谢方面的异常主要表现为脂肪动员(包括脂肪降解和脂肪酸氧化)增加，具体为：1.脂肪组织分解动员增强，内源性脂肪分解加速，体内游离脂肪酸与甘油的转化和氧化加速，进一步加快了内源性脂肪消耗，但是由于缺乏脂肪代谢的关键酶对外源性脂肪摄入利用差；2.另一方面脂蛋白酯酶(LPL)的活性下降导致循环中甘油三酯水解减少，引起血脂升高，同时血浆脂蛋白也升高；3.免疫功能低下。
临床和实验研究，不合理脂肪酸配比的脂肪乳在供能的同时有损机体的免疫功能，并增加感染发生的概率。脂肪酸主要以两种方式影响宿主，一是通过改变细胞膜磷脂的脂肪酸成分，从而影响膜的流动性和水；二是可影响白介素、肿瘤坏死因子等的合成、释放或结合，它们是重要的免疫调节因子，对B细胞、T细胞和非特异性的免疫T细胞产生信号而维持细胞免疫功能。
多项研究表明中链脂肪甘油三酯(MCT)、大豆油、鱼油等具有多种功效：MCT能量密度较低，且对胆盐和胰酶的依赖性较小，在肠道中容易水解，氧化迅速完全，可被充分吸收供能，不易在脂肪组织和肝组织中蓄积，是一种新型的能量来源，且对免疫系统副作用小；大豆油含有机体生命活动不可缺少的必须脂肪酸α-亚麻酸和亚油酸，且两者均对肿瘤细胞的生长具有明显抑制作用；橄榄油含有较高比例的单不饱和脂肪酸油酸，近年来对其研究发现具有调节血脂、降血糖和降胆固醇的作用，同时可具有与DHA、EPA协同增效作用，提升白细胞营养状况，提高免疫力；亚麻籽油富含α-亚麻酸(含量可达60％)、木酚素和可溶性膳食纤维等多种抗肿瘤活性成分，对肿瘤患者具有预防和治疗作用，同时研究证明α-亚麻酸在人体内通过去饱和酶和碳链延长酶的催化作用，合成EPA和DHA；沙棘籽油含有丰富的不饱和脂肪酸、生育酚、β－类胡萝卜素和甾醇类物质，除了具有对心脑血管和胃肠道的保护等多种丰富的药理作用外，还具有一定的保护化学性肝损伤、抗炎、抗氧化、增强免疫力的功能，支持肿瘤患者术后免疫力提高；月见草油中含有亚油酸、油酸、多种脂肪酸和维生素等，其中亚油酸含量为73.5％～81.9％，具有抗氧化、抗炎、抗血栓、降糖减脂的作用，γ-亚麻酸含量为6.9％～12.6％，具有抗癌等多种生物学功效；鱼油主要生理活性成分是ω-3多不饱和脂肪酸，其中主要为DHA和EPA，研究表明鱼油脂肪乳可提高恶性肿瘤患者术后重症病人的免疫功能，降低术后感染并发症的发生率。
中国专利CN 1965806公开了一种含大豆油、中链甘油三酯、橄榄油和鱼油的脂肪乳注射液及其生产方法。这种脂肪乳剂的成分为大豆油48-72克/升，中链甘油三酯48-72克/升，橄榄油40-60克/升，鱼油24-36克/升，dl-α-生育酚108-162毫克/升，蛋黄卵磷脂9.6-14.4克/升，无水甘油22.5-27.5克/升，油酸钠240-360毫克/升，氢氧化钠18-22毫克/升，其余为注射用水至总体积1升。脂肪乳中ω-6与ω-3脂肪酸比例为3.0～2.2∶1。该产品是一种综合了四种类型甘油三酯(油)有效作用的全新概念的脂肪乳剂，其中的脂肪酸模式是优化和平衡的，之前已问世的任何类型的脂肪乳均没有这种良好的脂肪酸模式。这种优化模式使其可以成为临床患者、尤其是重症患者的最佳选择。
中国专利CN102348469A公开了一种乳状液，该乳状液包括：油成分和水成分。该油成分包括：占油成分的重量的约60％至约90％的鱼油甘油三酯，其中鱼油甘油三酯包括表现为甘油三酯形式的ω-3脂肪酸，其含量占鱼油甘油三酯中脂肪酸的总重量的至少60％，其中鱼油甘油三酯包括表现为甘油三酯形式的EPA和DHA，其总含量占鱼油甘油三酯中脂肪酸的总重量的至少45％；和至少一种中链甘油三酯，其中该至少一种中链甘油三酯的总量占油成分的重量的约10％至约40％。
中国专利CN 101124928公开了一种含ω-3多不饱和脂肪酸的营养均衡调和油，该调和油是由花生油、葵花籽油等植物油脂为原料油，海狗油、海藻油、鱼油或多烯鱼油为掺和油，茶多酚、维生素E为抗氧剂组成。根据不同人群的生理和营养需要及各油脂的脂肪酸含量计算添加量，每100g调和油含SFA 12～18g，MUFA 39～46g，ω-6PUFA 31～38g，ω-3PUFA 5～9g，其中ω-3LCPUFA 0.1～5.0g，DHA∶(DPA+EPA)为0.25～10∶1，DHA∶EPA为4∶1～60∶1，或DHA∶DPA为2∶1～10∶1，不含EPA，或为DHA，不含DPA、EPA。该调和油具有促进大脑发育、预防近视和心脑血管疾病等作用。
发明内容
一种具有提高癌症患者术后免疫功能的油脂乳状液，其按重量份比计包括15～20份的MCT、1～7份的大豆油和2～7份的鱼油。
在一个实施方案中，所述油脂乳状液还包括橄榄油、亚麻籽油、沙棘籽油、月见草油、卵磷脂中的一种或几种。
在进一步地实施方案中，所述油脂乳状液还按重量份比计包括0.8～2.0份的橄榄油、1～12份的亚麻籽油、1～7份的沙棘籽油、1-5份的月见草油、0.3～1.2份的卵磷脂中的一种或几种。
在优选地实施方案中，所述油脂乳状液其按重量份比计包括15～20份的MCT、1～4份的大豆油、2～5份的鱼油、0.8～2.0份的橄榄油、5～10份的亚麻籽油、1～4份的沙棘籽油、1-4份的月见草油和0.6～1.0份的卵磷脂。
在优选地实施方案中，所述油脂乳状液中所含脂肪酸需满足以下条件：
①长链脂肪酸中的S:M:P比例为1:(1.5-2):(3.5-5.0)；
②ω-6/ω-3的比例为(1～1.5):1；
③LA亚油酸/ALA亚麻酸的比例为1-3:1；
④MCT/LCT比例为(0.6～1):1。
一种制备上述油脂乳状液的方法，其包括：
1)按重量份比将上述所有组分与纯化水按照1:5～8份搅拌混合；
2)混合后进行剪切乳化，然后巴氏消毒；
3)消毒后均质2～3次，再终端灭菌即得到所述乳状液。
在一个实施方案中，步骤2中所述剪切乳化的条件为3000-4000rpm剪切30-40min；所述巴氏消毒的条件为80-95℃消毒30-60s,终端灭菌条件为121℃，时间10～12min。
在另一个实施方案中，所述均质的条件为300-600bar，次数为2-3，时间为30-60min。
本发明采用多种植物油进行调和后得到最佳的脂肪酸配比，加入乳化剂，作为提供脂肪和碳水化合物来源的粉末油脂的前期乳状液，本发明提供的油种可配比成最优化比例的混合功能油脂供肿瘤患者术后食用，本发明油脂乳状液可以明显改善癌症术后患者的免疫功能，并且油脂组分之间产生了明显的协同作用。
具体实施方式
还可进一步通过实施例来理解本发明，其中所述实施例说明了一些制备或使用方法。然而，要理解的是，这些实施例不限制本发明。现在已知的或进一步开发的本发明的变化被认为落入本文中描述的和以下要求保护的本发明范围之内。
实施例1油脂乳状液的制备
取17.0份MCT、3.0份大豆油、1.4份橄榄油、7.0份亚麻籽油、3.0份沙棘籽油、4.0份鱼油、3.0份月见草油和0.8份卵磷脂，加入油罐中，在氮气保护下搅拌混合；再将200份纯化水和油罐的油相混合，通过管线式剪切机乳化后(3000rpm，35min)，进入巴氏灭菌热交换器中进行巴氏灭菌。设定巴氏灭菌温度为80～95℃，时间为30～60秒；然后进入均质机均质，均质压力为600Bar，均质两次，每次均质时间为40min；均质后，冷却，进入周转罐；根据pH值测定结果，调节pH值至中性(7.0～7.5)。
实施例2油脂乳状液的制备
取20份MCT、2份大豆油、1.4份橄榄油、5份鱼油、8份亚麻籽油、3份沙棘籽油、3份月见草油和0.6份卵磷脂，加入油罐中，在氮气保护下搅拌混合；再将220份纯化水和油罐的油相混合，通过管线式剪切机乳化后(3000rpm，35min)，进入巴氏灭菌热交换器中进行巴氏灭菌。设定巴氏灭菌温度为80～95℃，时间为30～60秒；然后进入均质机均质，均质压力为600Bar，均质两次，每次均质时间为30min；均质后，冷却，进入周转罐；根据pH值测定结果，调节pH值至中性(7.0～7.5)。
取实施例1和实施例2制备的油脂乳状液样品，采用氢氧化钾和甲醇进行甲酯衍生化，上气相色谱检测，具体的条件：毛细管柱100m×0.25mm×0.2μm，进样器温度270℃，检测器FID温度280℃，初始温度：100℃，程序升温至230℃，柱中载气流速1.0ml/min，分流比100:1，进样量1.0μL。结果表明，实施例1和2制备的油脂乳状液符合以下条件：
①长链脂肪酸中的S:M:P比例为1:(1.5-2):(3.5-5.0)；
②ω-6/ω-3的比例为(1～1.5):1；
③LA亚油酸/ALA亚麻酸的比例为1-3:1；
④MCT/LCT比例为(0.6～1):1。
效果例1抗疲劳试验
昆明种小鼠，雄性，体重20.0g±1.0g，来源于军事医学科学院动物繁育中心。每个试验小鼠均随机分成6组，每组10只。对照组采用食用大豆油，试验组为本发明组合物实施例1和实施例2，剂量相当于人体推荐剂量的10倍，灌胃体积为0.1mL/10g·bw。
抗疲劳试验结果
①游泳耐力试验：连续灌胃30d，末次给样30min后，在小鼠尾部负重5％的铅皮，将小鼠放入水深为30cm，水温为25℃±1℃的游泳箱内，每次游泳放入5只小鼠，记录小鼠负重游泳从开始至死亡的时间。②血清尿素氮测定：连续灌胃30d，末次给样30min后，将小鼠放入水深为30cm，水温为30℃的游泳箱内(每次5只)不负重游泳90min后取出，再休息60min，将眼睛处理干净整洁后眼球取血，检测血清中尿素氮的含量。③血乳酸测定：连续灌胃30d，末次给样30min后从内眦静脉采血，然后将小鼠放入水深为30cm，水温为30℃的游泳箱内(为了方便采血，每隔1min放入1只)，负重4％体重游泳10min后取出小鼠立即采血，然后再休息20min后采血，测定游泳前、游泳后休息20min的血内血乳酸含量，试验结果如下。
与灌胃食用大豆油组(对照组)比较，*P＜0.05，**P＜0.01
对比例1的油脂组成为17.0份MCT、3.0份大豆油、4.0份鱼油和0.8份卵磷脂，制备方法同实施例1.
对比例2的油脂组成为17.0份MCT、3.0份大豆油、7.0份亚麻籽油、4.0份鱼油和0.8份卵磷脂，制备方法同实施例1.
对比例3的油脂组成为17.0份MCT、3.0份大豆油、7.0份亚麻籽油、3.0份月见草油、4.0份鱼油和0.8份卵磷脂，制备方法同实施例1.
效果例2油脂乳状液的临床效果
从医院收集癌症术后患者100例，根据随机表随机选取入选的病人序号并分组。各组患者于术后开始接受肠外营养支持，脂肪供能为每日总热量的35％，蛋白质和碳水化合物的热量给予为65％，自行研发供所有受试者使用；其中给药组肠外给予不同配比的等剂量乳剂(10mg/kg)，对照组给予等剂量生理盐水，试验时间为10天。观察肠外给予不同配比的乳剂后对其免疫功能的作用。
测定指标：体液与细胞免疫指标，术后第10d静脉取血，用贝克曼分析仪测定IgG、IgA、IgM，用免疫荧光法测定CD3、CD4、CD8。
试验过程，各原料按照下述添加份数后制成的乳剂总体积一致，均在无菌营养实验室配制。试验结果如下：
术后注射结果与术前比较，#P＜0.05，##P＜0.01；与未注射功能油脂乳剂(对照组)比较，*P＜0.05，**P＜0.01
对比例1的油脂组成为17.0份MCT、3.0份大豆油、4.0份鱼油和0.8份卵磷脂，制备方法同实施例1.
对比例2的油脂组成为17.0份MCT、3.0份大豆油、7.0份亚麻籽油、4.0份鱼油和0.8份卵磷脂，制备方法同实施例1.
对比例3的油脂组成为17.0份MCT、3.0份大豆油、7.0份亚麻籽油、3.0份月见草油、4.0份鱼油和0.8份卵磷脂，制备方法同实施例1.
本发明内容仅仅举例说明了要求保护的一些具体实施方案，其中一个或更多个技术方案中所记载的技术特征可以与任意的一个或多个技术方案相组合，这些经组合而得到的技术方案也在本申请保护范围内，就像这些经组合而得到的技术方案已经在本发明公开内容中具体记载一样。
Claims (7)
1.一种抗疲劳、促使身体机能快速恢复，具有抗肿瘤、提高癌症患者术后免疫功能的油脂乳状液，其按重量份比计，由如下组分组成：15～20份的MCT、1～7份的大豆油、2～7份的鱼油、0.8～2.0份的橄榄油、1～12份的亚麻籽油、1～7份的沙棘籽油、1-5份的月见草油和0.3～1.2份的卵磷脂。
2.根据权利要求1所述的油脂乳状液，其特征在于，所述油脂乳状液，其按重量份比计，由如下组分组成：15～20份的MCT、1～4份的大豆油、2～5份的鱼油、0.8～2.0份的橄榄油、5～10份的亚麻籽油、1～4份的沙棘籽油、1-4份的月见草油和0.6～1.0份的卵磷脂。
3.根据权利要求2所述的油脂乳状液，其特征在于，所述油脂乳状液中所含脂肪酸需满足以下条件：
①长链脂肪酸中的S:M:P比例为1:(1.5-2):(3.5-5.0)；
②ω-6/ω-3的比例为(1～1.5):1；
③LA亚油酸/ALA亚麻酸的比例为1-3:1；
④MCT/LCT比例为(0.6～1):1。
4.一种制备权利要求1-3任一项所述油脂乳状液的方法，其包括：
1)按重量份比将上述组分与纯化水按照1:5～8份搅拌混合；
2)混合后进行剪切乳化，然后巴氏消毒；
3)消毒后均质2～3次即得到所述乳状液。
5.根据权利要求4所述的制备方法，其特征在于，步骤2中所述剪切乳化的条件为3000-4000rpm剪切30-40min；所述巴氏消毒的条件为80-95℃消毒30-60s，终端灭菌条件为121℃，时间为10～12min。
6.根据权利要求4所述的制备方法，其特征在于，步骤3中所述均质的条件为300-600bar，次数为2-3，时间为30-60min。
7.权利要求1-3任一项所述油脂乳状液在制备改善癌症患者术后免疫功能药物中的应用。
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