CN114468291A - 一种改善女性不孕的肌醇组合物及其制备方法 - Google Patents
一种改善女性不孕的肌醇组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种改善女性不孕的肌醇组合物,其包含如下组分:角豆提取物、亚麻籽浓缩粉、左旋肉碱、肌醇、白燕窝、速溶绿茶粉、药食同源植物组合物、蓝莓浓缩汁、蔓越莓浓缩汁、赤藓糖醇、乳酸钙、葡萄糖酸亚铁、葡萄糖酸锌、叶酸、维生素B6、维生素B12、余量水。其中,药食同源植物组合物包括等质量份的中药粉:白芷粉、桃仁粉、茯苓粉、马齿苋粉。本发明提供的一种改善女性不孕的肌醇组合物能够促进女性排卵,改善女性不孕症状,且酸甜适口,安全健康,能够满足消费者的营养和口感需求。同时本发明提供的一种改善女性不孕的肌醇组合物的制备方法设备简单,易于操作,成本低,生产周期短,生产效率高,适合大规模生产。
Description
技术领域
本发明涉及功能性食品技术领域,具体的说涉及一种改善女性不孕的肌醇组合物及其制备方法。
背景技术
现代夫妻不孕不育的程度大幅上升,其中,女方因素约为60%左右。不孕症是影响男女双方身心健康的世界性问题,由于它不是一个独立的疾病,而是许多疾病所共有一个症状或者所致的一种后遗症或结果,病因复杂,发病率高,研究涉及面广,所以又是世界性共同关注的常见疑难病症。
女性不孕症是指无避孕措施正常性生活两年以上,男性生殖功能正常,女性未受孕;或曾孕育未避孕而又两年以上未再受孕。造成女性不孕的原因主要有以下几种:(1)妇科炎症,如阴道炎、宫颈炎、子宫内膜炎等;(2)妇科内分泌异常;(3)创伤,如刮宫过重损伤子宫内膜基底层,可能导致宫腔粘连,引起精子通过障碍及受精卵着床障碍;(4)子宫内膜异位;(5)输卵管异常,如输卵管形态异常、输卵管痉挛、输卵管结核、输卵管积液等;(6)性疾、糖尿病等疾病因素,个人心理因素、环境和工业毒物的增加,也可以影响男女双方的生殖系统;(7)长期处于高强度辐射下。
随着生活和工作压力的增加以及污染、婚育年龄的推迟等综合影响,女性不孕症发生率呈现明显上升趋势,依照不同统计计算方式,该病在我国发病率已经达到10-20%,成为阻碍家庭正常生活乃至计生政策的重大问题。世界卫生组织的调查证实,不孕不育症已经成为目前世界上继肿瘤和心脑血管病后的第三大疾病。
目前,西医对于不孕症的治疗主要有药物治疗和手术治疗,但是西药副作用大,且手术治疗风险大,成本高,患者痛苦大,目前最常用的是“试管婴儿技术”,成功率仅达到35-45%,花费高且副作用多;在中医方面一般认为女性不孕症产生的原因为本虚肾虚,标实湿热癖阻,可以以清热祛湿,扶正活血化瘀的治法治疗,但疗效欠佳,疗程较长,患者长期承受较大的心理压力,即使长期使用药物调理,怀孕的几率仍然很低。因此,研究出一种配方合理,疗效显著,疗程短,成本低的一种改善女性不孕的组合物具有重要意义。
发明内容
为了实现上述目的,本发明采用的技术方案如下:
本发明的第一方面提供了一种改善女性不孕的肌醇组合物,该功能食品由以下重量份的各组分组成:
角豆提取物100-200份、亚麻籽浓缩粉10-30份、左旋肉碱75-100份、肌醇2.5-5份、白燕窝8-12份、速溶绿茶粉15-40份、药食同源植物组合物120-200份、蓝莓浓缩汁3000-6000份、蔓越莓浓缩汁1500-3000份、赤藓糖醇1500-4000份、乳酸钙10-15份、葡萄糖酸亚铁0.1-0.3份、葡萄糖酸锌0.05-0.2份、叶酸0.001-0.0035份、维生素B60.008-0.02份、维生素B120.0001-0.0003份、余量水。
进一步地,药食同源植物组合物包括等质量份的中药粉:
白芷粉30-50份、桃仁粉30-50份、茯苓粉30-50份、马齿苋粉30-50份。
具体地,所述改善女性不孕的肌醇组合物由以下重量份的各组分组成:
角豆提取物150份、亚麻籽浓缩粉20份、左旋肉碱90份、肌醇3.5份、白燕窝10份、速溶绿茶粉30份、药食同源植物组合物160份、蓝莓浓缩汁4000份、蔓越莓浓缩汁2000份、赤藓糖醇3000份、乳酸钙13.5份、葡萄糖酸亚铁0.15份、葡萄糖酸锌0.1份、叶酸0.0027份、维生素B60.014份、维生素B120.0002份、余量水。
进一步地,药食同源植物组合物包括等质量份的中药粉:
白芷粉40份、桃仁粉40份、茯苓粉40份、马齿苋粉40份。
优选地,所述角豆提取物从天然角豆中提取,含有手性肌醇。
优选地,所述角豆提取物中的手性肌醇与所述肌醇的比例为1:3.6。
优选地,所述亚麻籽浓缩粉含有亚麻木粉素,含量占0.9%~1.5%。
优选地,所述白燕窝含有燕窝肽,含量占8%以上;所述的白燕窝用传统的常规方法进行干燥、净化加工后,将燕窝剪成或切成长宽各3 cm左右的小块,然后放入普通粉碎机,粉碎成细粉,得200目的燕窝粉体,将上述燕窝粉体多维摆动式球磨机中,对燕窝粉体进行研磨,球磨机连续运转3-4小时,即得纳米燕窝微粒。
优选地,所述蓝莓浓缩汁与所述蔓越莓浓缩汁的质量比为2:1,两者可溶性固形物含量均为60~70 Brix。
优选地,所述角豆提取物、所述亚麻籽浓缩粉、所述速溶绿茶粉、所述药食同源植物组合物的粉末大小为60-100目。
优选地,所述赤藓糖醇既可以作为甜味剂,也可以作为填充剂、赋形剂,其纯度为大于97%,目数在40目以上。
本发明第二方面提供了一种改善女性不孕的肌醇组合物的制备方法,其特征在于所述制备方法包括如下步骤:
(1)称取配方量的角豆提取物、亚麻籽浓缩粉、速溶绿茶粉、药食同源植物组合物溶解于20倍质量的水中,置于加热锅中,80-90℃煎煮0.5-1.5 h,完全溶解后冷却静置到10-20℃后过滤,得到浓缩液A;
(2)将配方量的蓝莓浓缩汁、蔓越莓浓缩汁混合,加入抗氧化剂,在100-200 r/min的转速下搅拌5-10 min,得混合汁液B;
(3)称取配方量的左旋肉碱、肌醇、白燕窝、赤藓糖醇、乳酸钙、葡萄糖酸亚铁、葡萄糖酸锌、叶酸、维生素B6、维生素B12加入到20倍体积的水中充分搅拌溶解得到溶液C,搅拌时间为20 min,转速为55 r/min;
(4)将混合汁液A、浓缩液B和溶液C充分搅拌浓缩得到预混液,对得到的预混液进行灌装,在115-121℃温度条件下,灭菌15-20 min,冷却,即得成品。
本发明配方可以按照本领域的常规制剂技术,制备成常用的食用剂型,例如,粉剂、液体、膏剂等。
本发明配方优选制备成液体。
本发明的一种改善女性不孕的肌醇组合物中各活性成分的功效如下:
角豆提取物(含手性肌醇)是一种来源于角豆的天然降糖成分,取自地中海沿岸吱声的豆类植物,实验证明它可以提高女性排卵、调节月经不匀、提高胰岛素作用,还具有降血脂、抗炎、抗氧化作用。
亚麻籽浓缩粉含有对人体健康有重要保健作用的木酚素,因其在化学结构上与人体雌激素十分相似,故又称为植物雌激素。亚麻木酚素具有双向调节作用:(1)类雌激素作用:因其在化学结构上与人体雌激素十分相似,当体内雌激素水平较低时,摄入后,转化为肠内脂(Enterodiol,END)和肠二醇(Enterolactone,ENL)。END和ENL在结构上类似于雌激素,具有抗氧化活性和弱雌激素作用。可以通过与其受体连接来平衡体内雌激素的作用,可以一定程度地可缓解更年期症状。(2)阻碍雌激素作用:当体内雌激素水平骗高的时候,END和ENL也可以作为抗雌激素分子,因为结构非常类似于雌激素的主要形式,但是又不具备完全相同的雌激素的作用,当与一些有增殖活跃的乳腺细胞受体结合后,相当于一种占位而不起作用,阻碍了雌激素的作用,从而抑制这种细胞的生长。
左旋肉碱作为脂肪代谢过程中一种必需的辅酶,能促进脂肪酸进入线粒体进行氧化分解,即促进脂肪转化成能量。左旋肉碱是细胞膜功能、神经传递、必需脂肪酸代谢、能量代谢和防氧化保护所需要的物质。
肌醇也被称为维生素B8,是一种类似维生素的化学物质,其作用可以促进细胞新陈代谢,助长发育,促进食欲。研究发现,对于患有多囊卵巢综合征和其他相关疾病的女性,肌醇可能有助于促进排卵,降低高血压、高胆固醇、高甘油三酯和高血清睾酮水平,还可能有助于促进生育能力和提高胚胎质量。
白燕窝含有大量的蛋白质、碳水化合物、钙离子、铁离子等微量元素,以及人体必需的氨基酸,能够补血活血,调节内分泌;性质温平,可以调理虚劳,改善女性月经不调的问题;护卵巢,有效的帮助女性调节内分泌失调。
速溶绿茶粉具有良好的抗氧化和镇静作用,可减轻疲劳。
药食同源植物组合物中的白芷粉味辛、略甘,可以入胃经和大肠经以及肺经,主要用于散风除温、止痛消肿和排脓;桃仁粉活血祛瘀,润肠通便,止咳平喘,用于经闭,痛经,癓瘕痞块,肠燥便秘,肺痈、肠痈,咳嗽气喘,常用于淤血阻滞诸证;茯苓粉健脾,宁心,用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠;马齿苋粉清热解毒,利水去湿,散血消肿,除尘杀菌,消炎止痛,止血凉血。
蓝莓浓缩汁含有多种丰富的氨基酸、微量元素、花青素和花色苷以及儿茶酸等多酚类物质,具有清除氧自由基、保护视力、延缓脑神经衰老、提高记忆力的作用。
蔓越莓浓缩汁保留了蔓越莓原有的香气和滋味,含有纤维素、果胶、钾、维生素C、叶酸、肌醇、生物类黄酮、柠檬烯等多种营养成分,具有保健美容、抗氧化、降血脂血压、改善肠道功能、增强免疫力等有益功效。
赤藓糖醇是一种天然、零热量、可替代蔗糖的填充型甜味剂,有着同蔗糖相似的清澈甜味,不参与糖代谢和血糖变化,有清凉感,能够掩盖高倍甜味剂的不良口感,有助于配方产品整体口感改善。
乳酸钙的溶解性好,可用作食品添加剂;也可用于防冶钙缺乏症及妊娠和哺乳期妇女的钙盐补充、慢性肾衰竭患者的低钙血症、过敏性疾病及结核病的辅助治疗。
葡萄糖酸亚铁风味平和无涩味,在乳饮料中强化较多,但容易引起食品色泽和风味变化;作为铁源,经十二指肠吸收,作用温和,吸收较好铁利用率高,起效快,对胃肠道刺激小。
葡萄糖酸锌为补锌药,主要用于婴儿及老年,妊娠妇女因缺锌引起的生长发育迟缓,营养不良,厌食症,复发性口腔溃疡,皮肤痤疮等症。
叶酸是一种B族维生素,是人体细胞生长和分裂所必需的物质之一,主要是参与核酸合成和促进氨基酸合成蛋白质,还参与血红蛋白以及肾上腺素、胆碱、肌酸等重要化合物合成。叶酸可以预防孕妇贫血,同时可以降低婴儿出生缺陷风险。
维生素B6又称吡哆素,是某些氨基酸,如谷氨酸、色氨酸、蛋氨酸,在体内代谢转化的辅酶,在中枢神经系统、血液以及皮肤的代谢中具有重要作用。
维生素B12又叫钴胺素,是唯一含金属元素的维生素。维生素b12的作用及功能主要有促进红细胞的发育和成熟、预防恶性贫血、增加叶酸的利用率、促进碳水化合物、脂肪和蛋白质的代谢等。
与现有技术相比,本发明可以获得包括以下技术效果:
(1)本发明提供的一种改善女性不孕的肌醇组合物能够促进女性排卵,改善女性不孕症状,且酸甜适口,安全健康,能够满足消费者的营养和口感需求。
(2)本发明提供的一种改善女性不孕的肌醇组合物中添加角豆提取物,其含有的手性肌醇对经量过少、停经、青春痘、荷尔蒙紊乱排卵功能、内分泌综合征等均具有很好的改善作用。
(3)本发明提供的一种改善女性不孕的肌醇组合物中添加的角豆提取物(含手性肌醇)与肌醇的具有最优比,研究表明肌醇与D-手性肌醇在3.6:1效果最佳。
(4)本发明提供的一种改善女性不孕的肌醇组合物中亚麻籽浓缩粉中含有亚麻木粉素,对雌激素依赖性疾病乳腺癌、前列腺癌、经期综合征、骨质疏松有预防作用。
(5)本发明提供的一种改善女性不孕的肌醇组合物中添加药食同源的药材,既能够充分发挥中药材的作用,又不会对人体造成二次伤害。
(6)本发明提供的一种改善女性不孕的肌醇组合物经发明人大量的实验和研究,配方优良、产品稳定,原料之间各种功效相辅相成,得到显著改善女性不孕食品的最佳组分和最佳配比。
(7)本发明提供的一种改善女性不孕的肌醇组合物的制备方法设备简单,易于操作,成本低,生产周期短,生产效率高,适合大规模生产。
具体实施方式
下面将结合本发明的实施例,对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种改善女性不孕的肌醇组合物,该功能食品由以下重量份的各组分组成:
角豆提取物100份、亚麻籽浓缩粉10份、左旋肉碱75份、肌醇2.5份、白燕窝8份、速溶绿茶粉15份、药食同源植物组合物120份、蓝莓浓缩汁3000份、蔓越莓浓缩汁1500份、赤藓糖醇3000份、乳酸钙13.5份、葡萄糖酸亚铁0.15份、葡萄糖酸锌0.1份、叶酸0.0027份、维生素B6 0.014份、维生素B12 0.0002份、余量水。其中,药食同源植物组合物包括等质量份的中药粉:白芷粉30份、桃仁粉30份、茯苓粉30份、马齿苋粉30份。
制备方法为:
(1)称取配方量的角豆提取物、亚麻籽浓缩粉、速溶绿茶粉、药食同源植物组合物溶解于20倍质量的水中,置于加热锅中,80-90℃煎煮0.5-1.5 h,完全溶解后冷却静置到10-20℃后过滤,得到浓缩液A;
(2)将配方量的蓝莓浓缩汁、蔓越莓浓缩汁混合,加入抗氧化剂,在100-200 r/min的转速下搅拌5-10 min,得混合汁液B;
(3)称取配方量的左旋肉碱、肌醇、白燕窝、赤藓糖醇、乳酸钙、葡萄糖酸亚铁、葡萄糖酸锌、叶酸、维生素B6、维生素B12加入到20倍体积的水中充分搅拌溶解得到溶液C,搅拌时间为20 min,转速为55 r/min;
(4)将混合汁液A、浓缩液B和溶液C充分搅拌浓缩得到预混液,对得到的预混液进行灌装,在115-121℃温度条件下,灭菌15-20 min,冷却,即得成品。
实施例2
一种改善女性不孕的肌醇组合物,该功能食品由以下重量份的各组分组成:
角豆提取物150份、亚麻籽浓缩粉20份、左旋肉碱90份、肌醇3.5份、白燕窝10份、速溶绿茶粉30份、药食同源植物组合物160份、蓝莓浓缩汁4000份、蔓越莓浓缩汁2000份、赤藓糖醇3000份、乳酸钙13.5份、葡萄糖酸亚铁0.15份、葡萄糖酸锌0.1份、叶酸0.0027份、维生素B6 0.014份、维生素B12 0.0002份、余量水。其中,药食同源植物组合物包括等质量份的中药粉:白芷粉40份、桃仁粉40份、茯苓粉40份、马齿苋粉40份。
制备方法同实施例1。
实施例3
一种改善女性不孕的肌醇组合物,该功能食品由以下重量份的各组分组成:
角豆提取物200份、亚麻籽浓缩粉30份、左旋肉碱100份、肌醇5份、白燕窝12份、速溶绿茶粉40份、药食同源植物组合物200份、蓝莓浓缩汁6000份、蔓越莓浓缩汁3000份、赤藓糖醇3000份、乳酸钙13.5份、葡萄糖酸亚铁0.15份、葡萄糖酸锌0.1份、叶酸0.0027份、维生素B6 0.014份、维生素B12 0.0002份、余量水。其中,药食同源植物组合物包括等质量份的中药粉:白芷粉50份、桃仁粉50份、茯苓粉50份、马齿苋粉50份。
制备方法同实施例1。
实施例4
各实施例的微生物检测。
根据根据2015版《中国药典》微生物通则进行颗粒微生物学检验。情况对比见表1。
表1 微生物检测结果
从表1可以看出,各实施例的微生物检测均合格。
实施例5
本发明的一种改善女性不孕的肌醇组合物对不孕大鼠排卵的影响实验
1 材料与方法
1.1 实验动物及造模
SD大鼠50只(购于斯贝福(北京)生物技术有限公司)。参照李晓丽等(2016)实验方法,制作无排卵大鼠模型(ASR模型),并进行后续的实验。取50只第9日龄雌性SD大鼠于颈背部皮下注射丙酸睾丸酮注射液2.25 mg/只(0.05 ml/只),第22日龄断奶,利用自然光照,室温维持在20℃左右,同样条件饲养。第70日龄大鼠体质量约150 g左右阴道开口,连续阴道涂片10天,阴道上皮无性周期变化、呈持续性角化,提示无排卵大鼠模型制作成功。
1.2 分组
随机将造模成功的50只大鼠分为模型组10只,实施例1组10只,实施例2组10只,实施例3组10只,同时设健康80日龄SD大鼠10只为正常组。
1.3 给药方法
从第80天开始分别按临床用药以60 kg的人为标准,按照体表面积剂量换算法计算大鼠给药剂量,每日给予1 mL/kg灌胃。每天灌胃1次,均连续灌胃28天。正常组每日给予蒸馏水灌胃;模型组每日给予蒸馏水灌胃;实施例1组每日给实施例1的组合物灌胃;实施例2组每日给实施例2的组合物灌胃;实施例3组每日给实施例3的组合物灌胃。
1. 4 检测指标
1.4.1 显微镜下卵巢的观察
采血后处死大鼠,取出卵巢组织,左侧卵巢放于4%多聚甲醛固定,经梯度乙醇脱水,透明、浸蜡、包埋,石蜡切片,裱于载玻片上,于400倍光镜下观察,在3个视野下,统计各级卵泡和病理性囊性卵泡的个数,求平均值。
1.4.2 卵巢组织中FSHR、LHR含量检测
采用Westenblot法检测卵巢组织中FSHR(卵泡刺激素受体)、LHR(黄体生成素受体)的含量:取各组小鼠4只,将右侧卵巢组织,液氮研磨成粉末,称重,粉末放入2.5 mL离心管中,加40 ul裂解混合液(RIPA:PMSF=100:1),冰浴30 min;离心15 min(1100 rpm,4℃);吸取上清液,-80℃保存备用。BCA法测定蛋白质浓度,通过计算,取各组等量蛋白质用于SDS-PAGE电泳,用10%-12%的梯度预制胶分离蛋白质,将凝胶上蛋白质经电转移到PVDF膜上,经过封闭、漂洗、一抗孵育、漂洗、二抗孵育和漂洗后加入新配制的ECL显色液显影、曝光。用凝胶成像系统分析软件定量蛋白质,所有数据均用内参Actin进行标准化处理。
1.5 统计方法
采用SPSS17.0软件,实验数据用(x̅±s)表示,采用t检验,P<0.05差异有统计学意义。
2 结果
2.1 显微镜下卵巢的观察结果
模型组卵巢苍白,表面见卵泡,但卵泡多呈囊性扩张,大量闭锁卵泡和原始卵泡存在,无成熟卵泡,卵泡较小,无黄体,卵泡内含大量浆液性物质,卵泡壁颗粒细胞稀疏,层次明显减少。正常组、实施例1组、实施例2组和实施例3组大鼠卵巢色泽鲜红,卵泡各级数目明显多于模型组,卵泡明显增大,表面见较多黄体。卵巢HE染色后,在400倍光镜下观察,在3个视野下,统计各级卵泡和病理性囊性卵泡个数,求平均值,结果模型组卵泡数目明显少于正常组、实施例1组、实施例2组和实施例3组,有显著差异(P<0.05);模型组病理性囊性卵泡明显多于实施例1组、实施例2组和实施例3组,有显著性差异(P<0.05)。见表2。
表2 各组大鼠各级卵泡和病理性囊性卵泡个数比较
注:*与模型组比较P<0.05
2.2 各组大鼠卵巢FSHR、LHR蛋白水平表达
大鼠卵巢FSHR蛋白水平的比较,正常组、实施例1组、实施例2组和实施例3组均高于模型组(P<0.05)。大鼠卵巢LHR蛋白水平的比较,正常组、实施例1组、实施例2组和实施例3组均高于模型组(P<0.05)。
表3 各组大鼠卵巢FSHR、LHR蛋白水平的比较
注:*与模型组比较P<0.05
3 结论
从上述实验可以看出,实施例1组、实施例2组和实施例3组均能在一定程度上显著增加大鼠各级卵泡总数、减少病理性卵泡个数,重建性周期变化,并且通过增强卵巢FSHR、LHR的表达,促进卵泡的发育、成熟,有利于优势卵泡的形成,从而达到排卵的目的,从而可以增加大鼠受孕的几率。
实施例2与实施例3相比于实施例1具有更好的促进排卵的效果;实施例3比实施例2具有更高的重量份,但促进排卵的效果没有明显差异,所以实施例2为本发明的一种改善女性不孕的肌醇组合物的最佳组分和最佳配比。
实施例6
本发明的一种改善女性不孕的肌醇组合物用于治疗女性不孕患者的临床观察
1 诊断标准
婚后夫妻性生活正常,超过2年未受孕者;婚后曾受孕而行人流,但以后未避孕,又超过2年未受孕者;曾生育一胎,欲生二胎,夫妻有正常的性生活,未避孕,超过2年不孕者。同时行子宫输卵管造影证实输卵管不通畅阻塞或积水等,或者在腹腔镜检查下做输卵管通液,证实输卵管不通畅或不通。
2 临床资料
2018年1月至2019年8月,符合上述标准的中和堂门诊收治的女性不孕的病患80人,随机分为2组,分为两组,对照组为40例,实施例组为40例。两组病例经统计学分析差异无统计学意义(P>0.05),具有可比性。
3 治疗方法
对照组正常饮食,在医生指导下服用促排卵药物枸橼酸氯米芬;实施例组在正常饮食的基础上,饮用本发明的实施例2的肌醇组合物。
本发明的一种改善女性不孕的肌醇组合物的用法与用量:每次1袋,每袋30mL,早晚饭后半小时温服1袋,30天一疗程,月经期间停止服用。
4 疗效判定标准
治疗结束后,随访1年判断疗效。
痊愈:经治疗后成功妊娠,并且已经生育。
显效:经治疗后输卵管已通畅,促排卵己成功,或免疫性因素己转阴,具备了受孕条件,但尚未妊娠;或己妊娠,因各种原因致自然流产、人工流产及引产者;曾怀孕发生流产者再次妊娠,在随访期内尚未生育者。
有效:经治疗后输卵管已基本通畅,彩超监测偶有成熟卵泡,内分泌失调症状有所好转,妇科炎症有所减轻。
无效:经治疗输卵管未能疏通,或疏通后又发生堵塞,内分泌失调未得到纠正,促排卵产生耐药者。
5 统计学方法
对实验数据利用SPSS17.0软件进行处理和分析,计量资料以(x̅±s)表示,采用t检验,计数资料采用x2检验,P<0.05表示差异具有统计学意义。
6 结果
经过治疗发现:在对照组中,痊愈23例,显效1例,有效7例,无效9例,总有效率为77.5%;在实施例组中,痊愈25例,显效3例,有效2例,无效10例,总有效率为75%。
实验结果表明:本发明的一种改善女性不孕的肌醇组合物能够起到改善女性不孕的效果,治疗效果与服用促排卵药物的效果相当。
表4 治疗效果比较 [n(%)]
7 不良反应和毒副作用监管
通过检测治疗过程中患者的血压、脉搏、是否出现恶心、呕吐、眩晕的临床症状来判断不良反应。发现患者的血压和脉搏全部都在正常范围内,并且没有出现恶心、呕吐、眩晕的临床症状。这说明本发明的一种改善女性不孕的肌醇组合物没有明显的不良反应,对于人体没有明显的毒副作用。
Claims (10)
1.一种改善女性不孕的肌醇组合物,其特征在于包含如下重量份的组份:
角豆提取物100-200份、亚麻籽浓缩粉10-30份、左旋肉碱75-100份、肌醇2.5-5份、白燕窝8-12份、速溶绿茶粉15-40份、药食同源植物组合物120-200份、蓝莓浓缩汁3000-6000份、蔓越莓浓缩汁1500-3000份、赤藓糖醇1500-4000份、乳酸钙10-15份、葡萄糖酸亚铁0.1-0.3份、葡萄糖酸锌0.05-0.2份、叶酸0.001-0.0035份、维生素B6 0.008-0.02份、维生素B120.0001-0.0003份、余量水;其中,药食同源植物组合物包括等质量份的中药粉:白芷粉30-50份、桃仁粉30-50份、茯苓粉30-50份、马齿苋粉30-50份。
2.根据权利要求1所述的一种改善女性不孕的肌醇组合物,其特征在于包含如下重量份的组份:
角豆提取物150份、亚麻籽浓缩粉20份、左旋肉碱90份、肌醇3.5份、白燕窝10份、速溶绿茶粉30份、药食同源植物组合物160份、蓝莓浓缩汁4000份、蔓越莓浓缩汁2000份、赤藓糖醇3000份、乳酸钙13.5份、葡萄糖酸亚铁0.15份、葡萄糖酸锌0.1份、叶酸0.0027份、维生素B60.014份、维生素B12 0.0002份、余量水;其中,药食同源植物组合物包括等质量份的中药粉:白芷粉40份、桃仁粉40份、茯苓粉40份、马齿苋粉40份。
3.根据权利要求1或2所述的一种改善女性不孕的肌醇组合物,所述角豆提取物从天然角豆中提取,含有手性肌醇。
4.根据权利要求1或2所述的一种改善女性不孕的肌醇组合物,所述角豆提取物中的手性肌醇与所述肌醇的比例为1:3.6。
5.根据权利要求1或2所述的一种改善女性不孕的肌醇组合物,所述亚麻籽浓缩粉含有亚麻木粉素,含量占0.9%~1.5%。
6.根据权利要求1或2所述的一种改善女性不孕的肌醇组合物,所述白燕窝含有燕窝肽,含量占8%以上;所述的白燕窝用传统的常规方法进行干燥、净化加工后,将燕窝剪成或切成长宽各3 cm左右的小块,然后放入普通粉碎机,粉碎成细粉,得200目的燕窝粉体,将上述燕窝粉体多维摆动式球磨机中,对燕窝粉体进行研磨,球磨机连续运转3-4小时,即得纳米燕窝微粒。
7.根据权利要求1或2所述的一种改善女性不孕的肌醇组合物,所述蓝莓浓缩汁与所述蔓越莓浓缩汁的质量比为2:1,两者可溶性固形物含量均为60~70 Brix。
8.根据权利要求1或2所述的一种改善女性不孕的肌醇组合物,所述角豆提取物、所述亚麻籽浓缩粉、所述速溶绿茶粉、所述药食同源植物组合物的粉末大小为60-100目。
9.根据权利要求1或2所述的一种改善女性不孕的肌醇组合物,所述赤藓糖醇既可以作为甜味剂,也可以作为填充剂、赋形剂,其纯度为大于97%,目数在40目以上。
10.一种权利要求1或者2所述的叶黄素酯组合物的制备方法,其特征在于包含如下步骤:
(1)称取配方量的角豆提取物、亚麻籽浓缩粉、速溶绿茶粉、药食同源植物组合物溶解于20倍质量的水中,置于加热锅中,80-90℃煎煮0.5-1.5 h,完全溶解后冷却静置到10-20℃后过滤,得到浓缩液A;
(2)将配方量的蓝莓浓缩汁、蔓越莓浓缩汁混合,加入抗氧化剂,在100-200 r/min的转速下搅拌5-10 min,得混合汁液B;
(3)称取配方量的左旋肉碱、肌醇、白燕窝、赤藓糖醇、乳酸钙、葡萄糖酸亚铁、葡萄糖酸锌、叶酸、维生素B6、维生素B12加入到20倍体积的水中充分搅拌溶解得到溶液C,搅拌时间为20 min,转速为55 r/min;
(4)将混合汁液A、浓缩液B和溶液C充分搅拌浓缩得到预混液,对得到的预混液进行灌装,在115-121℃温度条件下,灭菌15-20 min,冷却,即得成品。
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