CN106942748A - 一种女性不孕专用型临床营养配方及其制备方法 - Google Patents
一种女性不孕专用型临床营养配方及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种女性不孕专用型临床营养配方，包括蛋白质和氨基酸、脂肪、碳水化合物、膳食纤维、常量元素、微量元素、维生素、膳食精华、药食同源成分、天然植物化合物以及新资源食品；其中膳食精华包括黑豆粉；药食同源成分选自薄荷、茯苓、甘草、黄精、菊花、蒲公英、山药、大枣、鱼腥草、桔梗、金银花、葛根中的至少一种；其制备方法为：各组分均预先制备成粉末，然后制成相应的剂型；其中药食同源成分进行水提浓缩、喷雾干燥制成粉末，维生素和脂肪通过微胶囊化处理制成粉末。与现有技术相比，本发明所述的营养配方能够为女性不孕患者提供全面的营养支持，以改善营养不良状态，同时添加补肾、健脾、疏肝的药食同源成分，促进不孕者尽快怀孕。
Description
技术领域
本发明涉及肠内营养制剂领域，具体涉及一种女性不孕专用型临床营养配方及其制备方法。
背景技术
女性不孕是指男女双方若并无不愿生育的愿望，同居一年以上，有正常性生活且均未采取避孕措施仍未受孕的情况。女性不孕的病因可以归结为3个方面：生物学因素、环境因素、社会因素。不同的病因，治疗方法有差异，目前，针对女性不孕的治疗，主要有西医和中医两种途径。
西医学认为女性不孕症的发生主要与排卵障碍、输卵管因素、外阴与阴道因素、宫颈与子宫因素等有关，治疗方法有服用具有促排卵的西药、手术疏通输卵管阻塞或手术输卵管扩张、使用免疫抑制剂等。传统中医认为，脏腑、经络等功能失调都可导致不孕，在脏腑中以肾、脾、肝三脏关系最为密切。由于肾藏精，主生殖，故不孕之病因以肾虚为根本；脾为后天之本，精血生化之源，脾虚则生化无源而致不孕；女子以肝为先天之本，肝藏血，又主调节和疏泄功能，肝的功能异常亦可导致不孕。因此，针对女性不孕的治疗，中医采取补肾、健脾、疏肝相结合的方法。
随着分子生物学、生理学、临床医学的发展，现代营养支持开始发挥“药理营养学”的作用。针对能引起女性不孕的诸如月经不规律、生活饮食习惯不良等问题，现代营养重视具有改善、调理这些机能营养素的应用。通过合适的途径提供适当的营养物质，纠正患者的异常病理、生理改变，维持机体细胞和组织、器官的正常结构和功能，改善身体素质，提高治疗效果。
目前，针对女性不孕治疗，包括西医的药物和手术疗法，以及中医对脏腑的调理疗法，但它们都缺乏对人体整体营养的供给，不能满足机体对各种营养素的需求。为此，研制既能提供病人所需的各种营养素，又能提高治疗效果的产品，具有重要价值和广阔的市场。
发明内容
本发明的目的在于克服现有技术中的缺陷，提供一种女性不孕专用型临床营养配方及其制备方法，本发明制备的女性不孕专用型临床营养配方为女性不孕患者提供全面的营养支持，其含有女性不孕患者所需的适宜能量和各种关键营养素，提供了完全的必需微量营养成分，以改善潜在和已发生的营养不良状态，同时添加补肾、健脾、疏肝的药食同源成分，以改善女性不孕者的身体状态，促进不孕者尽快怀孕。
为实现上述目的，本发明采用如下技术方案：
一方面，本发明提供一种女性不孕专用型临床营养配方，包括如下组分：蛋白质和氨基酸、脂肪、碳水化合物、膳食纤维、常量元素、微量元素、维生素、膳食精华、药食同源成分、天然植物化合物以及新资源食品；其中，所述膳食精华包括黑豆粉；其中，所述药食同源成分选自薄荷、茯苓、甘草、黄精、菊花、蒲公英、山药、大枣、鱼腥草、桔梗、金银花、葛根中的至少一种。
为了进一步优化上述技术方案，本发明所采取的技术措施还包括：
优选地，所述女性不孕专用型临床营养配方，还包括食品增稠剂和食品添加剂，所述食品增稠剂为瓜尔胶、黄原胶、槐豆胶、魔芋胶、果胶、卡拉胶、琼脂、明胶、阿拉伯胶中的至少一种，所述食品添加剂为阿斯巴甜、食用香精香料、红糖中的至少一种。
优选地，所述维生素包括维生素B12和叶酸，其重量份数分别为维生素B120.000003～0.000006份和叶酸0.0003～0.0006份。
优选地，所述蛋白质和氨基酸所提供的优质蛋白质占总蛋白质达到70％以上。
优选地，所述脂肪中n-6脂肪酸：n-3脂肪酸＝3～4:1。
优选地，所述药食同源成分为薄荷、甘草、黄精、桔梗、葛根、蒲公英、金银花、鱼腥草。
优选地，所述组分的重量份数为：蛋白质和氨基酸20～40份、脂肪10～20份、碳水化合物20～40份、膳食纤维2～8份、常量元素0.6～1.2份、微量元素0.01-0.06份、维生素0.05～0.25份、膳食精华0.05～0.2份、药食同源成分0.1～6 份、天然植物化合物0.1-1份以及新资源食品0.01-0.1份。
优选地，所述药食同源成分中各组分的重量份数如下：薄荷0-1份、甘草0-1份、黄精0-1份、桔梗0-1份、葛根0-1份、蒲公英0-1份、金银花0-1份、鱼腥草0-1份。
优选地，所述蛋白质选自乳清蛋白粉、大豆分离蛋白、全脂奶粉、全蛋粉、乳铁蛋白、牛初乳粉、氨基酸、蛋白肽中的至少一种；其中，所述氨基酸选自L-赖氨酸-L-谷氨酸、L-谷氨酸、L-精氨酸、L-色氨酸、L-谷氨酰胺、牛磺酸、L-缬氨酸、L-异亮氨酸、L-亮氨酸中的至少一种；所述蛋白肽选自大豆低聚肽、小麦蛋白肽、蚕蛹蛋白肽、海洋鱼低聚肽粉、可乐肽、氨基肽、卵白蛋白肽中的至少一种。
优选地，所述脂肪包括饱和脂肪酸、多不饱和脂肪酸、单不饱和脂肪酸、OPO结构脂、DHA、EPA、ARA、磷脂中的至少一种，更具体地说所述脂肪包括红花籽油、核桃油、花生油、大豆油、阿甘油、橄榄油、茶油、美藤果油、椰子油、紫苏油、深海鱼油、可可油、棕榈油、牛油、奶油、猪油、中链甘油三酯、卵磷脂、单双甘油脂肪酸酯。
优选地，所述碳水化合物包括果糖、冰糖、乳糖、麦芽糊精、木薯淀粉、抗性淀粉中的至少两种。
优选地，所述膳食纤维包含菊粉、魔芋粉、低聚半乳糖、低聚果糖、低聚异麦芽糖、大豆多糖、环糊精、抗性糊精、大豆纤维中的至少一种。
优选地，所述常量元素选自柠檬酸钙、L-乳酸钙、磷酸氢钙、葡萄糖酸钾、柠檬酸钠和葡萄糖酸镁中的至少一种。
优选地，所述微量元素选自葡萄糖酸亚铁、碘化钾、葡萄糖酸锌、亚硒酸钠、葡萄糖酸铜、硫酸铬、葡萄糖酸锰和钼酸钠中的至少一种。
优选地，所述脂溶性维生素选自维生素A、β-胡萝卜素、维生素D3、维生素E、维生素K1中的至少一种。
优选地，所述水溶性维生素选自维生素B1、维生素B2、维生素B6、维生素B12、维生素C、泛酸、叶酸、烟酸、胆碱、肌醇、生物素中的至少一种。
优选地，所述膳食精华选自谷类、豆类、薯类、蔬菜类、菌藻类、坚果种子类、鱼虾类、禽畜肉类、水果类中的至少一种；其中所述谷类主要由大米粉、小米粉、黑米粉、薏米粉、玉米粉、小麦胚芽粉、燕麦粉、荞麦粉中的一种或至少两种组成，所述豆类主要由豌豆粉、绿豆粉、黑豆粉、红豆粉、大豆粉中的一种或至少两种组成，所述薯类主要由淮山粉组成，所述蔬菜粉主要由胡萝卜粉、白萝卜粉、南瓜粉、菠菜粉、番茄粉、西兰花粉、苦瓜粉、黄瓜粉中的一种或几种组成，所述菌藻类主要由香菇粉和银耳粉中的一种或几种，所述坚果种子类主要是莲子粉，所述鱼虾类主要是由三文鱼粉和鳕鱼粉中的一种或几种组成，所述禽畜肉类主要是由鸡肉粉、牛肉粉中的一种或几种组成，所述水果类主要由红枣粉、桂圆粉、苹果粉、樱桃粉、柑橘粉、雪梨粉中的一种或几种组成；所述膳食精华优选黑豆粉。
优选地，所述天然植物化合物选自左旋肉碱、氨基葡萄糖、低聚果糖、叶黄素、植物甾醇、番茄红素、白藜芦醇、大蒜素中的至少一种；所述天然植物化合物优选为左旋肉碱。
优选地，所述新资源食品选自初乳碱性蛋白、γ-氨基丁酸、壳寡糖、杜仲雄花、蚌肉多糖、竹叶黄酮、酪蛋白磷酸肽、燕麦β-葡聚糖、酵母β-葡聚糖、辣木叶、低聚木糖中的至少一种；所述新资源食品优选为燕麦β-葡聚糖。
另一方面，本发明涉及一种上述女性不孕专用型临床营养配方的制备方法，包括如下步骤：
步骤一、将预定重量份数的蛋白质和氨基酸、脂肪、碳水化合物、膳食纤维、常量元素、微量元素、维生素、药食同源成分、天然植物化合物以及新资源食品分别制备成粒径为150～250μm的粉末；
步骤二、将所述步骤一制备的粉末依次倒入锥形混合机中混合均匀；
步骤三、采用所述步骤一混合均匀的粉末制备成营养粉、营养乳剂、胶囊剂、片剂、丸剂或口服液中的至少一种；
其中，所述药食同源成分的原料进行粉碎、水提浓缩，并将浓缩液进行喷雾干燥制成药食同源成分粉末；
其中，所述维生素和脂肪分别通过微胶囊化处理制备成维生素粉末和脂肪粉末。
优选地，所述药食同源成分粉末的制备过程如下：采用粉碎机对预定重量份数的原料进行粉碎，将粉碎的原料置于容器中，加入重量为原料重量的3～8倍的水，进行浸泡3～4小时，然后对浸泡液进行煎煮30～60min，过滤去除原料，留取煎煮液，对煎煮液进行喷雾干燥、筛分制备药食同源成分粉末。
优选地，所述维生素的微胶囊化处理的具体步骤如下：1)将脂溶性维生素作为芯材，选用羧甲基纤维素钠、明胶、卡拉胶、黄原胶、阿拉伯胶、麦芽糊精、脂蛋白、玉米糖浆、大豆分离蛋白、全脂乳粉、膳食纤维、菊粉、乳清蛋白粉、低聚异麦芽糖、大豆纤维、乳糖、冰糖粉、乳化剂、稳定剂中的一种或多种作为壁材，高压均质乳化，喷雾瞬时干燥，筛分制备脂溶性维生素粉末；2)将水溶性维生素作为芯材，选用羧甲基纤维素钠、明胶、卡拉胶、黄原胶、阿拉伯胶、麦芽糊精、脂蛋白、玉米糖浆、大豆分离蛋白、全脂乳粉、膳食纤维、菊粉、乳清蛋白粉、低聚异麦芽糖、大豆纤维、乳糖、冰糖粉、乳化剂、稳定剂中的一种或多种作为壁材，混合均匀，喷雾瞬时干燥，筛分制备水溶性维生素粉末。
优选地，所述脂肪的微囊包埋技术的具体实施步骤如下：将脂肪、乳化剂、壁材与水混合溶解制备乳化液；将上述乳化液搅拌混合后，进行乳化均质处理，然后进行喷雾干燥，筛分制备粉末油脂，粉末油脂与传统油脂比较，其分散性、水溶性、乳化性、抗氧化性都有很大提高；其中，所述乳化剂选自甘油脂肪酸酯(甘油酯)、丙二醇脂肪酸酯(丙二醇酯)、山梨聚糖脂肪酸酯(山梨聚糖酸)、蔗糖脂肪酸酯(蔗糖酯)、卵磷脂中的一种或多种；所述壁材选自羧甲基纤维素钠、明胶、卡拉胶、黄原胶、阿拉伯胶、麦芽糊精、脂蛋白、玉米糖浆、大豆分离蛋白、全脂乳粉、膳食纤维、菊粉、乳清蛋白粉、低聚异麦芽糖、大豆纤维、乳糖、冰糖粉、乳化剂、稳定剂中的一种或多种。
本发明采用具有补肾、健脾、疏肝作用的药食同源成分，其为薄荷、甘草、黄精、桔梗、葛根、蒲公英、金银花、鱼腥草。
薄荷中的有效成分薄荷油及其主要成分薄荷醇对在离体状态下的家兔、豚鼠回肠活动的张力、强度、强度-张力差有明显的抑制作用，且能对抗组胺、乙酰胆碱、氯化钡等引起的肠管活动亢进；薄荷中的有效成分薄荷油、薄荷醇可抑制核盘菌、匍茎根霉菌、毛霉菌等真菌的生长和繁殖；薄荷油对单纯疱疹病毒的两种亚型(HSV21和HSV22)均显示较强的抑制作用；同时薄荷油有明显的利胆作用，并能轻度增加胆汁中胆汁酸的排出量；且薄荷油对角叉菜胶致大鼠足肿胀有一定的抑制作用，具有消炎镇痛的功效。
甘草可降低肠管紧张度，减少收缩幅度，其所含的异甘草素对卡巴胆碱、氯化钾、氯化钡诱导的小鼠空肠收缩有强的解痉作用，甘草解痉的作用机制可能是异甘草素能非竞争性地抑制乙酰胆碱引起的收缩，同时异甘草素是一种醛糖还原酶抑制剂，通过抑制环氧合酶、脂氧合酶、过氧化物酶的活性来抗血小板凝集，起到抗炎作用；其所含的甘草总皂苷具有直接抗炎作用，其抗炎作用与减少巨噬细胞炎症介质生成与释放、抑制花生四烯酸代谢途径PGE2合成的关键酶密切相关；其所含的甘草甜素能提高小鼠热板实验中小鼠的痛阈值，减少醋酸扭体实验中小鼠扭体次数，对二甲苯致小鼠耳廓肿胀均有明显的抑制作用。
黄精的有效成分黄精多糖黄精多糖不但能增强小鼠体液免疫功能，还可增强小鼠细胞免疫的功能；黄精多糖直接作用于红细胞，增强红细胞膜C3b受体活性，使红细胞免疫黏附功能增强，并且在一定浓度范围内存在量效关系。
桔梗多糖可诱导巨噬细胞RAW264，激活MAPKs信号通路、激活刺激蛋白(stimulatoryprotein 1，Sp1)的DNA结合能力；桔梗多糖对环磷酰胺诱导的免疫抑制小鼠也具有免疫增强作用，能明显增加小鼠的胸腺指数和脾脏指数，剂量依赖性地提高血清中IL-2和TNF-α的含量。
葛根素和葛根总异黄酮具有雌激素受体部分激动剂的特性对雌激素低下动物显示弱雌激素活性在与雌二醇合用时河部分抑制雌二醇的促子宫生长作用。
蒲公英对丘脑下部、脑垂体为中心的性激素的激活作用，蒲公英有使脑垂体分泌的卵泡刺激素(FSH)、黄体生成激素(HL)上升倾向，使泌乳素(PRL)下降，且可使雌二醇(E)、孕激素(P)有上升倾向；蒲公英有促进排卵作用，下丘脑LH-RH增加，脑垂体LH-RH增加，其作用部位为下丘脑-脑垂体系，进一步使神经传导递质、去甲肾上腺素(NE)、多巴胺(DA)、血清素(SR)增加。
金银花对多种致病菌如金黄色葡萄球菌、溶血性链球菌、肺炎球菌、脑膜炎双球菌、绿脓杆菌等有抑菌和杀菌作用，对流感病毒、孤儿病毒、疱疹病毒、钩端螺旋体均有抑制作用；金银花具有清热解毒、疏散风热的作用，可治疗暑热症、泻痢、流感、疮疖肿毒、急慢性扁桃体炎、牙周炎等病。
鱼腥草能增强白细胞的吞噬功能；鱼腥草素能提高血清白细胞介素的水平，鱼腥草可以显著提高外周血T淋巴细胞的比例，促进IgM的生成，这表明鱼腥草能增强机体非特异性和特异性免疫能力。
本发明还添加维生素B12和叶酸，若育龄期女性叶酸、维生素B12水平低于正常时，或检测水平在正常参考范围内但检测值较低时，不孕症发生率会有所增加。
与现有技术相比，本发明具有以下的优异效果：
(1)本发明将现代营养学研究成果与传统中医理论相结合，通过各种组分的有机组合，将各种功能进行融合，并通过有效成分之间的协同作用，增强作用效果。按本发明配方制作的食品不仅可以补充女性不孕患者所需营养，还能利用中草药成分促进机体状况改善。
(2)本发明配方食品采用药食同源成分，其具有提高免疫力、调理脾胃等功效；采用氨基酸易于吸收，可提高机体免疫力，具有补肾、健脾、疏肝作用；采用膳食精华黑豆粉，具有解表清热、养血平肝、补肾壮阴的作用；添加维生素B12和叶酸以降低不孕症发生率；在上述组分和蛋白质、脂肪等的协同作用下，能有效改善女性不孕患者的营养摄入不足及缺铁性女性不孕症状，积极进行女性不孕症状的治疗，以早日康复。
(3)本发明采用微囊包埋技术制备维生素，将维生素被包埋于壁材中，可防止维生素遭受常量元素、微量元素的破坏，延长维生素的保存时间；本发明采用微囊包埋技术制备油脂粉末，使得油脂粉末具有较好的流动性，易于与其他粉状组分混合均匀；且采用微囊包埋技术后，油脂被包埋于壁材中，从而避免了与空气的接触以增强抗氧化性，从而可发挥保健型油脂的最大功效。
(4)本发明所述的女性不孕专用型临床营养配方的原料在制备过程中均预先制备成150～250μm的粉末，这使得在制备成品时，各营养组分能够混合均匀，保证单位体积中的各营养组分的含量相同，同时在制备液体类制剂时，各营养组分能充分分散并完全溶解至溶剂中，防止液体中出现固体沉淀，有效保证了成品产品的功效。
具体实施方式
本发明提供一种针对女性不孕专用型临床营养配方专用型临床营养配方，包括如下重量份数的组分：蛋白质和氨基酸20～40份、脂肪10～20份、碳水化合物20～40份、膳食纤维2～8份、常量元素0.6～1.2份、微量元素0.01-0.06份、维生素0.05～0.25份、膳食精华0.05～0.2份、药食同源成分0.1～6份、天然植物化合物0.1-1份以及新资源食品0.01-0.1份；其中，所述蛋白质和氨基酸所提供的优质蛋白质占总蛋白质达到70％以上；所述脂肪中n-6脂肪酸：n-3脂肪酸＝3～4:1。
下面结合实施例，对本发明的具体实施方式作进一步描述。以下实施例仅用于更加清楚地说明本发明的技术方案，而不能以此来限制本发明的保护范围。
实施例1
本发明所述的女性不孕专用型临床营养配方包括乳清蛋白粉10.33g、大豆分离蛋白5g、全脂奶粉12g、全蛋粉0.33g、牛初乳0.17g、牛磺酸0.12g、海洋鱼低聚肽粉0.1g；橄榄油2.77g、大豆油4.48g、椰子油2.77g、紫苏油0.64g、中链甘油三酯0.21g；麦芽糊精29.77g、冰糖4.87g、乳糖0.67g；膳食纤维中水溶性膳食纤维4.83g、不溶性膳食纤维1.16g，所述膳食纤维为抗性糊精、大豆纤维、低聚异麦芽糖、菊粉、低聚半乳糖；常量元素中钙0.4g、磷0.23g、钾0.08g、钠0.14g、镁0.15g；微量元素中铁0.011g、碘0.00014g、锌0.007g；脂溶性维生素中维生素A 0.0006g、β-胡萝卜素0.000057g、维生素D3 0.000001g、维生素E 0.009g；水溶性维生素中维生素B1 0.001g、维生素B2 0.001g、维生素B6 0.001g、维生素B120.000003g、维生素C 0.117g、泛酸0.003g、叶酸0.0003g、烟酸0.0161g；黑豆粉0.1g；药食同源成分中薄荷0.1g、甘草0.1g、黄精0.1g、桔梗0.1g、葛根0.1g、蒲公英0.1g、金银花0.1g、鱼腥草0.1g；天然植物化合物中左旋肉碱0.667g；新资源食品中燕麦β-葡聚糖0.07g。
实施例2
本发明所述的女性不孕专用型临床营养配方包括乳清蛋白粉10.33g、大豆分离蛋白5g、全脂奶粉12g、全蛋粉0.33g、牛初乳0.17g、牛磺酸0.12g、海洋鱼低聚肽粉0.1g；橄榄油2.77g、大豆油4.48g、椰子油2.77g、紫苏油0.64g、中链甘油三酯0.21g；麦芽糊精29.77g、冰糖4.87g、乳糖0.67g；膳食纤维中水溶性膳食纤维4.83g、不溶性膳食纤维1.16g，所述膳食纤维为抗性糊精、大豆纤维、低聚异麦芽糖、菊粉、低聚半乳糖；常量元素中钙0.4g、磷0.23g、钾0.08g、钠0.14g、镁0.15g；微量元素中铁0.011g、碘0.00014g、锌0.007g；脂溶性维生素中维生素A 0.0006g、β-胡萝卜素0.000057g、维生素D3 0.000001g、维生素E 0.009g；水溶性维生素中维生素B1 0.001g、维生素B2 0.001g、维生素B6 0.001g、维生素B120.000005g、维生素C 0.117g、泛酸0.003g、叶酸0.0005g、烟酸0.0161g；黑豆粉0.17g；药食同源成分中薄荷0.17g、甘草0.17g、黄精0.17g、桔梗0.17g、葛根0.17g、蒲公英0.17g、金银花0.17g、鱼腥草0.17g；天然植物化合物中左旋肉碱0.667g；新资源食品中燕麦β-葡聚糖0.07g。
实施例3
本发明所述的女性不孕专用型临床营养配方包括乳清蛋白粉10.33g、大豆分离蛋白5g、全脂奶粉12g、全蛋粉0.33g、牛初乳0.17g、牛磺酸0.12g、海洋鱼低聚肽粉0.1g；橄榄油2.77g、大豆油4.48g、椰子油2.77g、紫苏油0.64g、中链甘油三酯0.21g；麦芽糊精29.77g、冰糖4.87g、乳糖0.67g；膳食纤维中水溶性膳食纤维4.83g、不溶性膳食纤维1.16g，所述膳食纤维为抗性糊精、大豆纤维、低聚异麦芽糖、菊粉、低聚半乳糖；常量元素中钙0.4g、磷0.23g、钾0.08g、钠0.14g、镁0.15g；微量元素中铁0.011g、碘0.00014g、锌0.007g；脂溶性维生素中维生素A 0.0006g、β-胡萝卜素0.000057g、维生素D3 0.000001g、维生素E 0.009g；水溶性维生素中维生素B1 0.001g、维生素B2 0.001g、维生素B6 0.001g、维生素B120.000006g、维生素C 0.117g、泛酸0.003g、叶酸0.0006g、烟酸0.0161g；黑豆粉0.1g；药食同源成分中薄荷0.17g、甘草0.17g、黄精0.17g、桔梗0.17g、葛根0.1g、蒲公英0.17g、金银花0.17g、鱼腥草0.17g；天然植物化合物中左旋肉碱0.667g；新资源食品中燕麦β-葡聚糖0.07g。
实施例4
本发明所述的女性不孕专用型临床营养配方包括乳清蛋白粉10.33g、大豆分离蛋白5g、全脂奶粉12g、全蛋粉0.33g、牛初乳0.17g、牛磺酸0.12g、海洋鱼低聚肽粉0.1g；橄榄油2.77g、大豆油4.48g、椰子油2.77g、紫苏油0.64g、中链甘油三酯0.21g；麦芽糊精29.77g、冰糖4.87g、乳糖0.67g；膳食纤维中水溶性膳食纤维4.83g、不溶性膳食纤维1.16g，所述膳食纤维为抗性糊精、大豆纤维、低聚异麦芽糖、菊粉、低聚半乳糖；常量元素中钙0.4g、磷0.23g、钾0.08g、钠0.14g、镁0.15g；微量元素中铁0.011g、碘0.00014g、锌0.007g；脂溶性维生素中维生素A 0.0006g、β-胡萝卜素0.000057g、维生素D3 0.000001g、维生素E 0.009g；水溶性维生素中维生素B1 0.001g、维生素B2 0.001g、维生素B6 0.001g、维生素B120.000002g、维生素C 0.117g、泛酸0.003g、叶酸0.000165g、烟酸0.0161g；黑豆粉0.17g；药食同源成分中薄荷0.1g、甘草0.1g、黄精0.1g、桔梗0.1g、葛根0.1g、蒲公英0.1g、金银花0.1g、鱼腥草0.1g；天然植物化合物中左旋肉碱0.667g；新资源食品中燕麦β-葡聚糖0.07g。
实施例5
含有实施例1-实施例4的女性不孕专用型临床营养配方的制备方法如下：
1)制备粉末油脂(粉末脂肪)：
a)制备壁材水溶液：取麦芽糊精8克、大豆分离蛋白4克、全脂乳粉11克、膳食纤维2克(抗性糊精)、菊粉0.5克、乳清蛋白粉5克、低聚异麦芽糖0.5克、大豆纤维1克、阿拉伯胶0.2克、乳糖0.5克、冰糖粉2克、水50毫升搅拌均匀(有条件边加热边搅拌至60℃，保持30分钟后冷却至室温)。
b)将单甘酯取0.1克(总固形物浓度为0.2％)均匀溶于10.2毫升油脂中(橄榄油2.6毫升、大豆油4.2毫升、椰子油2.6毫升、紫苏油0.6毫升、中链甘油三酯0.2毫升)。
c)将吐温80取0.1克(总固形物浓度为0.2％)均匀溶于壁材水溶液中。
d)将添加过乳化剂单甘酯的混合植物油脂与添加过乳化剂吐温80的壁材水溶液充分混合。
e)添加稳定剂琼脂取0.1克(总固形物浓度为0.2％)进混合溶液后，用水定容至200毫升(总固形物浓度为25％)，20000r/min下高速分散2分钟。
f)均质压力为25MPa，均质3次(每次5分钟)，制得均质乳状液。
g)将制得的乳状液进行喷雾干燥，进风温度为195℃，出风温度为80℃。收集粉末油脂(粉末脂肪)。
2)制备药食同源成分粉末：采用粉碎机对预定重量份数的原料进行粉碎，将粉碎的原料置于容器中，加入重量为原料重量的3～8倍的水，进行浸泡3～4小时，然后对浸泡液进行煎煮30～60min，过滤去除原料，留取煎煮液，对煎煮液进行浓缩、喷雾干燥，以60～80目筛分制备药食同源成分粉末；
3)制备维生素粉末：将预定重量份数的脂溶性维生素作为芯材，选用卡拉胶、阿拉伯胶作为壁材，在高压下进行2次乳化均质处理，乳化均质时间为10～15min，然后进行喷雾瞬时干燥，以60～80目筛分制备脂溶性维生素粉末；将预定重量份数的水溶性维生素作为芯材，选用麦芽糊精、脂蛋白作为壁材，混合均匀，喷雾瞬时干燥，以60～80目筛分制备水溶性维生素粉末；
4)将预定重量的蛋白质和氨基酸、碳水化合物、膳食纤维、常量元素、微量元素、膳食精华、天然植物化合物以及新资源食品分别制备成粒径为150～250μm的粉末；
5)将步骤1)～步骤4)所制得的粉末依次加入锥形混合机或其他形式的混合机混合均匀制得配方混合物，经过杀菌处理后，备用；
6)根据常规技术手段将步骤5)中的配方混合物制备成营养粉、营养乳剂、胶囊剂、片剂、丸剂或口服液中的至少一种。
在步骤6)中，可选择性地增加适量的食品增稠剂和食品添加剂。所述食品增稠剂为瓜尔胶、黄原胶、槐豆胶、魔芋胶、果胶、卡拉胶、琼脂、明胶、阿拉伯胶中的至少一种，所述食品添加剂为阿斯巴甜、食用香精香料、红糖中的至少一种；更优选卡拉胶、阿拉伯胶、瓜尔胶、阿斯巴甜、食用香精香料。
上述操作步骤均需在惰性气体的保护下进行，比如氮气、氩气、氦气等，以防止产生粉末爆炸的危险。
实施例6-小鼠不孕实验
本实施例为本发明提供的专用型临床营养配方对雌性小鼠不孕的影响。
取本发明实施例1～4制备的营养粉进行试验，同时设对比例1、对比例2，对比例1采用实施例2的营养配方中删除维生素B12和叶酸制备的营养粉，对比例2采用实施例2的营养配方中删除药食同源成分制备的营养粉，空白对照组喂饲正常饲料。
取Balb/C雌性小鼠96只，实验动物随机分成正常对照组、模型组、给药组1、给药组2、给药组3、给药组4、给药组5、给药组6共8组，给药组1、2、3、4分别胃饲实施例1、2、3、4的营养配方，给药组5、6分别胃饲对比例1、对比例2；造模后一周开始服用配方，至15天各取10只检测ZP3mRNA。
1)标本采集及处理
卵巢组织的取材：造模第7天每组小鼠10只脱颈椎处死，打开腹腔，取出卵巢组织，用含青、链霉素的Hank′s液漂洗3次，剪碎(1～2mm3)，加入0.25％胰酶，消化30min后，1500r/min离心10min，弃上清，加3ml Hank′s冲洗，1500 r/min离心10min，用含5μg/ml LPS的DMEM培养液将卵巢细胞数调整至5×106个/ml，加入24孔培养板内，每孔1ml，于37℃、5％CO2培养箱培养4h。
卵巢细胞总RNA的提取：收集卵巢细胞，离心，弃上清，置于冰盒上，加Trizol 1ml，振荡30s，室温静置5min，加氯仿0.2ml，振荡30s，室温静置2min，4℃、12000r/min离心15min，取上清移至1.5ml离心管中，加500μl异丙醇，室温静置10min，4℃、12000r/min离心10min，弃上清，加75％冷乙醇1ml洗涤，振荡20s，4℃、12 000r/min离心5min，弃上清，真空干燥，加20μl无RNA酶水,-20℃冻存待检。
RT-PCR：PCR薄壁管中依次加入5μlReaction Buffer、0.15μl dNTP、ZP3及上下游引物各0.5μl、2μl SO4、0.5μlAMV、0.5μlTf/DNA polymerase、6μl样本，无RNA酶水补足体积至25μl。按下列程序扩增：94℃0.5min；56℃1min，72℃1.5min，30个循环；72℃10min，4℃备用。取10μl PCR产物，加2μl溴酚蓝上样缓冲液。80V恒电压,1.0％琼脂糖凝胶电泳2h，溴化乙锭浸泡染色15min，在紫外灯下显色并用Acdsee510中文版凝胶成像分析系统拍照，测定其相对吸光度,计算各引物与β-actin的比值(A)作为半定量指标。
其检测结果如下表所示。
表1女性不孕专用型营养配方对免疫性不孕症相关基因ZP3mRNA的影响(x±s)
注：与模型组比较，*P＜0.05
由上表可知，给药的几组实施例组免疫性不孕症鼠卵巢细胞的ZP3mRNA表达较模型组明显减弱，与模型组比较，差异有统计学意义(P<0.05)。对比例1、2组免疫性不孕症鼠卵巢细胞的ZP3mRNA表达较模型组无明显变化。说明女性不孕专用型临床营养配方可下调免疫性不孕症小鼠卵巢细胞ZP3mRNA的水平，抑制免疫性不孕症小鼠卵巢细胞表达ZP3。
以上对本发明的具体实施例进行了详细描述，但其只作为范例，本发明并不限制于以上描述的具体实施例。对于本领域技术人员而言，任何对该实用进行的等同修改和替代也都在本发明的范畴之中。因此，在不脱离本发明的精神和范围下所作的均等变换和修改，都应涵盖在本发明的范围内。
Claims (9)
1.一种女性不孕专用型临床营养配方，其特征在于，包括如下组分：蛋白质和氨基酸、脂肪、碳水化合物、膳食纤维、常量元素、微量元素、维生素、膳食精华、药食同源成分、天然植物化合物以及新资源食品；
其中，所述膳食精华包括黑豆粉；
其中，所述药食同源成分选自薄荷、茯苓、甘草、黄精、菊花、蒲公英、山药、大枣、鱼腥草、桔梗、金银花、葛根中的至少一种。
2.根据权利要求1所述的一种女性不孕专用型临床营养配方，其特征在于，还包括食品增稠剂和食品添加剂，所述食品增稠剂为瓜尔胶、黄原胶、槐豆胶、魔芋胶、果胶、卡拉胶、琼脂、明胶、阿拉伯胶中的至少一种，所述食品添加剂为阿斯巴甜、食用香精香料、红糖中的至少一种。
3.根据权利要求1所述的一种女性不孕专用型临床营养配方，其特征在于，所述维生素包括维生素B12和叶酸。
4.根据权利要求1所述的一种女性不孕专用型临床营养配方，其特征在于，所述蛋白质和氨基酸所提供的优质蛋白质占总蛋白质达到70％以上。
5.根据权利要求1所述的一种女性不孕专用型临床营养配方，其特征在于，所述脂肪中n-6脂肪酸：n-3脂肪酸＝3～4:1。
6.根据权利要求1所述的一种女性不孕专用型临床营养配方，其特征在于，所述药食同源成分为薄荷、甘草、黄精、桔梗、葛根、蒲公英、金银花、鱼腥草。
7.根据权利要求1所述的一种女性不孕专用型临床营养配方，其特征在于，所述组分的重量份数为：蛋白质和氨基酸20～40份、脂肪10～20份、碳水化合物20～40份、膳食纤维2～8份、常量元素0.6～1.2份、微量元素0.01-0.06份、维生素0.05～0.25份、膳食精华0.05～0.2份、药食同源成分0.1～6份、天然植物化合物0.1-1份以及新资源食品0.01-0.1份。
8.根据权利要求7所述的一种女性不孕专用型临床营养配方，其特征在于，所述药食同源成分中各组分的重量份数如下：薄荷0-1份、甘草0-1份、黄精0-1份、桔梗0-1份、葛根0-1份、蒲公英0-1份、金银花0-1份、鱼腥草0-1份。
9.一种如权利要求1～8中任一项所述的女性不孕专用型临床营养配方的制备方法，其特征在于，包括如下步骤：
步骤一、将预定重量份数的蛋白质、脂肪、碳水化合物、膳食纤维、常量元素、微量元素、维生素、药食同源成分、天然植物化合物以及新资源食品分别制备成粒径为150～250μm的粉末；
步骤二、将所述步骤一制备的粉末依次倒入锥形混合机中混合均匀；
步骤三、采用所述步骤二中混合均匀的粉末制备成营养粉、营养乳剂、胶囊剂、片剂、丸剂或口服液中的至少一种；
其中，所述药食同源成分的原料进行粉碎、水提浓缩，并将浓缩液进行喷雾干燥制成药食同源成分粉末；
其中，所述维生素和脂肪分别通过微胶囊化处理制备成维生素粉末和脂肪粉末。
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