CN110151898A - 一种改善男性生育力的组合物及其应用 - Google Patents
一种改善男性生育力的组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种改善男性生育力的组合物,包括以下重量份的原料:水解蛋黄粉5‑30份,蛹草5‑30份,富锌富硒大葱微粉10‑100份,维生素C0.01‑20份,维生素E 0.01‑20份,B族维生素0.01‑20份,柠檬酸0.01‑5份,结晶果糖0.01‑8份,乳酸镁1‑5份和葡萄糖酸钙1‑8份,其中,富锌富硒大葱的平均硒含量≥0.018mg/kg,平均锌含量≥290mg/kg。本发明还提供了所述的改善男性生育力的组合物在保健品和/或功能食品中的应用。本发明的改善男性生育力的组合物无毒副作用,高效利用大葱整体营养物质,能够有效作用于男性生殖细胞,有效提高精液量、精子密度和精子活力,对少精症、弱精症、少精弱精症的有效率达到80%以上。
Description
技术领域
本发明涉及药品食品领域,更具体的说是涉及一种改善男性生育力的组合物及其应用。
背景技术
随着环境污染日益加重,工作生活压力不断加大,加之不良的生活习惯,近年来,我国不孕不育症的发病率呈不断上升的趋势,给患者本人和家庭带来了沉重的精神和经济负担,成为影响家庭和睦的重要因素之一。在不孕不育病例中,男性不育约占到30%~40%,其中,60%的患者一般表现为少精弱精、精子活率低下、精子畸形、精子前向运动能力差等精子质量异常症状。可见,解决精子数量、质量和活力的问题是改善男性生育力的关键。
针对此病,中医多认为是肾精不足,治疗方剂偏于温补益肾和滋阴益肾两大类。而葱白由于具有温通壮的作用,常被用于温补益肾的方剂中。并且,进一步的研究证明,大葱中含有的锌、硒元素与生殖系统代谢功能密切相关,对生殖细胞的分裂、繁殖、精子形成过程所需的一系列酶的变化以及精子的活动环境均有重要作用。
因此,开发一种富含锌、硒元素、可以高效利用大葱整体营养物质的、且可以用于改善男性生育力的组合物就成为了本领域技术人员亟需解决的问题。
发明内容
有鉴于此,本发明提供了一种富含锌、硒元素、可以高效利用大葱整体营养物质的、且可以用于改善男性生育力的组合物。
为了实现上述目的,本发明采用如下技术方案:
一种改善男性生育力的组合物,包括以下重量份的原料:水解蛋黄粉5-30份,蛹草5-30份,富锌富硒大葱微粉10-100份,维生素C 0.01-20份,维生素E 0.01-20份,B族维生素0.01-20份,柠檬酸0.01-5份,结晶果糖0.01-8份,乳酸镁1-5份和葡萄糖酸钙1-8份。
其中,所采用的各活性成分的药用性能如下所示:
蛹草:味甘、性平,入肺、肾二经;有益肺肾,补精髓,补血化痰之功;现代医学研究表明,蛹草含丰富的腺苷,可有效增强精子活力,延长其生存时间;
富锌富硒大葱微粉:锌、硒是人体所必需的重要的微量元素,与生殖系统代谢功能密切相关,对生殖细胞的分裂、繁殖、精子形成过程所需的一系列酶的变化以及精子的活动环境均有重要作用;研究认为,微量元素锌和硒对精子质量的影响很大,男性生殖道内锌、硒含量较高时,生精能力也较为活跃,低锌低硒是男性不育的重要原因之一;锌与精子密度、精子活力和精子数量均密切相关,对机体的性发育、性功能、生殖细胞的生成起到重要的作用;人体的睾丸、前列腺、精液当中都含有高浓度的锌,当人体内锌的含量缺乏时,性功能会因此而低下,合成睾丸素酶发生紊乱,男子将会引起阳瘘;锌对激发精子活动,有着特殊的作用,缺锌会造成精子活动力的下降;硒则在精子的生成和维持精子结构的稳定性等方面有很大的作用,硒是精子线粒体外膜蛋白的成分之一,可防治膜上的脂质氧化,从而对胞膜及线粒体有保护作用,如果细胞生物膜受到损伤,就会影响DNA的复制,最终影响精子的生成。
优选的,所述富锌富硒大葱微粉的制备方法为:
I、选拣清洗:筛选无霉变、无虫蛀的富锌富硒大葱整葱,摊放在干燥、通风、清洁的架板上,在20-25℃下进行干燥,所述架板为筛状,层高为10-15cm,并按照现有工艺对富锌富硒大葱进行清洗、精选;
II、灭菌消毒:取步骤I所得到的富锌富硒大葱切成3-5cm的葱段,放入不锈钢料盘中,送入-22~-25℃低温冷冻库中冷冻72~96小时,然后取出,在20~25℃条件下解冻48~96小时,循环进行冷冻-解冻步骤2~4次,再送入-25℃冷冻0.5小时,得到未解冻的富锌富硒大葱;
III、干制:将步骤II所得到的未解冻的富锌富硒大葱送至真空干燥仓内进行脱水干燥,真空度控制在55Pa,将干燥仓内加热板温度在0.5-2小时内升至30-50℃,保持2-3小时,再将温度在1-2小时内升至60℃,保持5小时,再将温度在2小时内降至30-50℃,保持1小时,再将温度在1小时内降至20-25℃,干燥至富锌富硒大葱的含水量在4%以下;
IV、超微粉碎:将干制的富锌富硒大葱送至超微粉碎机中,超微粉碎至4000-8000目的细度,得到富锌富硒大葱微粉。
为了提高富锌富硒大葱的适口性和有效成分的吸收利用率,本发明采用超微粉碎工艺,制备得到了4000-8000目的富锌富硒大葱微粉。
而考虑到新鲜大葱的含水量较大,不利于超微粉碎加工,本发明采用20-25℃摊放干燥与真空脱水干燥相结合的方法,在保证富锌富硒大葱的营养成分不流失的前提下,干燥至富锌富硒大葱的含水量在4%以下,便于超微粉碎的加工。
同时,为了保证富锌富硒大葱微粉的食品安全,本发明采用冻融处理的方法杀灭富锌富硒大葱原料中潜在的虫卵和幼虫,以达到纯物理方法防虫保鲜的目的,避免了使用化学保鲜剂和药剂熏蒸杀虫可能带来的安全风险。
并且,为了方便超微粉碎的彻底,本发明将冻融细胞破壁技术与冻融灭杀虫卵、真空脱水干燥相结合,一方面使细胞膜的疏水键结构破裂,从而增加细胞的亲水性能,另一方面使细胞内水结晶,形成冰晶粒,引起细胞膨胀而使细胞膜破裂,再缓慢融化至冰晶消失,反复多次,至细胞壁完全破裂,达到破壁处理的目的,使活性成分更丰富,更易被人体吸收。
更为优选的,所述步骤I中筛选的富锌富硒大葱的平均硒含量≥0.018mg/kg,平均锌含量≥290mg/kg。
值得说明的是,所述改善男性生育力的组合物可以制备为粉剂、片剂、丸剂,也可以作为底方添加在其他组合物中。
本发明还提供了所述的改善男性生育力的组合物在保健品和/或功能食品中的应用。
优选的,所述保健品和/或功能食品的剂型为片剂、冲剂或胶囊剂。
经由上述的技术方案可知,与现有技术相比,本发明提供了一种改善男性生育力的组合物,具有以下有益效果:
1、本发明提供的改善男性生育力的组合物,无毒副作用,配方中的原料相互作用,组方科学合理,发挥整体调节的优势,具有促进精子生成,提高精子成活率,改善男性生育能力的作用;
2、采用整葱作为富锌富硒大葱微粉的原料,除传统中医药所采用的葱白的温通壮阳的功效外,还利用了葱叶中的锌、硒元素含量高于葱白的特性,高效利用大葱整体营养物质;
3、采用结合型锌、硒元素,与传统的补锌补硒产品相比,避免了游离锌元素对肠胃的刺激作用,克服了游离锌、硒元素的补充吸收率低、副作用大的缺陷,能快速有效的被人体吸收利用,维护了前列腺及生殖系统的生理功能;
4、通过20-25℃干燥与真空脱水干燥相结合的干燥方法使富锌富硒大葱的含水量低于4%,便于后续的超微粉碎处理;
5、利用冻融处理法达到纯物理防虫保鲜的目的,避免了使用化学保鲜剂和药剂熏蒸杀虫可能带来的安全风险;
6、采用冻融细胞破壁技术,使富锌富硒大葱的细胞壁完全破裂,增加了富锌富硒大葱所含活性成分的释放,提高了有效成分的溶出速度和溶出率,有利于营养成分的保留和利用;
7、采用超微粉碎工艺,制备得到4000-8000目的粒径的富锌富硒大葱微粉,提高了组合物适口性的同时,提高了富锌富硒大葱的资源利用率,还有利于人体对营养物质的吸收,该组合物具有很好的应用潜力。
具体实施方式
下面将对本发明实施例中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。
当实施例给出数值范围时,应理解,除非本发明另有说明,每个数值范围的两个端点及两个端点之间任何一个数值均可选用。除非另外定义,本文中使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同意义。
如无特殊说明,本发明所采用的原料均为普通市售产品。
实施例1:
一种改善男性生育力的组合物,包括以下重量份的原料:水解蛋黄粉20份,蛹草20份,富锌富硒大葱微粉80份,维生素C 3份,维生素E 3份,B族维生素3份,柠檬酸2份,结晶果糖5份,乳酸镁1份和葡萄糖酸钙1份。将上述原料按常规方法混合,得到组合物。
所述富锌富硒大葱微粉的制备方法为:
I、选拣清洗:筛选无霉变、无虫蛀的富锌富硒大葱整葱,摊放在干燥、通风、清洁的架板上,在20-25℃下进行干燥,所述架板为筛状,层高为15cm,并按照现有工艺对富锌富硒大葱进行清洗、精选;
II、灭菌消毒:取步骤I所得到的富锌富硒大葱切成4cm的葱段,放入不锈钢料盘中,送入-25℃低温冷冻库中冷冻72小时,然后取出,在20℃条件下解冻48小时,循环进行冷冻-解冻步骤4次,再送入-25℃冷冻0.5小时,得到未解冻的富锌富硒大葱;
III、干制:将步骤II所得到的未解冻的富锌富硒大葱送至真空干燥仓内进行脱水干燥,真空度控制在55Pa,将干燥仓内加热板温度在1.5小时内升至40℃,保持2小时,再将温度在1小时内升至60℃,保持5小时,再将温度在2小时内降至40℃,保持1小时,再将温度在1小时内降至20-25℃,干燥至富锌富硒大葱的含水量在4%以下;
IV、超微粉碎:将干制的富锌富硒大葱送至超微粉碎机中,超微粉碎至8000目的细度,得到富锌富硒大葱微粉。
所述步骤I中筛选的富锌富硒大葱的平均硒含量为0.027mg/kg,平均锌含量为292mg/kg。
实施例2~10:
一种改善男性生育力的组合物,包括如表1所示重量份的原料,将上述原料按常规方法混合,得到组合物。
表1
所述富锌富硒大葱微粉的制备方法同实施例1。
所述步骤I中筛选的富锌富硒大葱的平均硒含量为0.018mg/kg,平均锌含量为292mg/kg。
实施例11:
一种改善男性生育力的组合物,包括如实施例3的重量份的原料,将上述原料按常规方法混合,得到组合物。
所述富锌富硒大葱微粉的制备方法为:
I、选拣清洗:筛选无霉变、无虫蛀的富锌富硒大葱整葱,摊放在干燥、通风、清洁的架板上,在20-25℃下进行干燥,所述架板为筛状,层高为10cm,并按照现有工艺对富锌富硒大葱进行清洗、精选;
II、灭菌消毒:取步骤I所得到的富锌富硒大葱切成3cm的葱段,放入不锈钢料盘中,送入-23℃低温冷冻库中冷冻84小时,然后取出,在25℃条件下解冻84小时,循环进行冷冻-解冻步骤2次,再送入-25℃冷冻0.5小时,得到未解冻的富锌富硒大葱;
III、干制:将步骤II所得到的未解冻的富锌富硒大葱送至真空干燥仓内进行脱水干燥,真空度控制在55Pa,将干燥仓内加热板温度在0.5小时内升至30℃,保持2小时,再将温度在1小时内升至60℃,保持5小时,再将温度在2小时内降至30℃,保持1小时,再将温度在1小时内降至20-25℃,干燥至富锌富硒大葱的含水量在4%以下;
IV、超微粉碎:将干制的富锌富硒大葱送至超微粉碎机中,超微粉碎至6000目的细度,得到富锌富硒大葱微粉。
所述步骤I中筛选的富锌富硒大葱的平均硒含量为0.018mg/kg,平均锌含量为290mg/kg。
实施例12:
一种改善男性生育力的组合物,包括如实施例8的重量份的原料,将上述原料按常规方法混合,得到组合物。
所述富锌富硒大葱微粉的制备方法为:
I、选拣清洗:筛选无霉变、无虫蛀的富锌富硒大葱整葱,摊放在干燥、通风、清洁的架板上,在20-25℃下进行干燥,所述架板为筛状,层高为15cm,并按照现有工艺对富锌富硒大葱进行清洗、精选;
II、灭菌消毒:取步骤I所得到的富锌富硒大葱切成5cm的葱段,放入不锈钢料盘中,送入-22℃低温冷冻库中冷冻96小时,然后取出,在23℃条件下解冻72小时,循环进行冷冻-解冻步骤3次,再送入-25℃冷冻0.5小时,得到未解冻的富锌富硒大葱;
III、干制:将步骤II所得到的未解冻的富锌富硒大葱送至真空干燥仓内进行脱水干燥,真空度控制在55Pa,将干燥仓内加热板温度在2小时内升至50℃,保持3小时,再将温度在2小时内升至60℃,保持5小时,再将温度在2小时内降至40℃,保持1小时,再将温度在1小时内降至20-25℃,干燥至富锌富硒大葱的含水量在4%以下;
IV、超微粉碎:将干制的富锌富硒大葱送至超微粉碎机中,超微粉碎至4000目的细度,得到富锌富硒大葱微粉。
所述步骤I中筛选的富锌富硒大葱的平均硒含量为0.032mg/kg,平均锌含量为300mg/kg。
实施例13:
一种改善男性生育力的组合物,包括如实施例5的重量份的原料,将上述原料按常规方法混合,得到组合物。
所述富锌富硒大葱微粉的制备方法为:
I、选拣清洗:筛选无霉变、无虫蛀的富锌富硒大葱整葱,摊放在干燥、通风、清洁的架板上,在20-25℃下进行干燥,所述架板为筛状,层高为15cm,并按照现有工艺对富锌富硒大葱进行清洗、精选;
II、灭菌消毒:取步骤I所得到的富锌富硒大葱切成4cm的葱段,放入不锈钢料盘中,送入-22℃低温冷冻库中冷冻96小时,然后取出,在25℃条件下解冻96小时,循环进行冷冻-解冻步骤4次,再送入-25℃冷冻0.5小时,得到未解冻的富锌富硒大葱;
III、干制:将步骤II所得到的未解冻的富锌富硒大葱送至真空干燥仓内进行脱水干燥,真空度控制在55Pa,将干燥仓内加热板温度在2小时内升至32℃,保持2.5小时,再将温度在2小时内升至60℃,保持5小时,再将温度在2小时内降至35℃,保持1小时,再将温度在1小时内降至20-25℃,干燥至富锌富硒大葱的含水量在4%以下;
IV、超微粉碎:将干制的富锌富硒大葱送至超微粉碎机中,超微粉碎至6000目的细度,得到富锌富硒大葱微粉。
所述步骤I中筛选的富锌富硒大葱的平均硒含量为0.021mg/kg,平均锌含量为342.7mg/kg。
实施例14:
一种改善男性生育力的保健品,其包含实施例1所示的组合物,所述保健品的剂型为片剂。
实施例15:
一种改善男性生育力的功能食品,其包含实施例9所示的组合物,所述功能食品的剂型为冲剂。
实施例16:
一种改善男性生育力的保健品和功能食品,其包含实施例12所示的组合物,所述保健品和功能食品的剂型为胶囊剂。
试验例:
(1)诊断标准
肾阳虚诊断标准:参照《中医病症诊断疗效标准》和《中医诊断学》拟定:畏寒肢冷、腰膝酸软、小便清长、舌质淡、舌苔薄白、脉沉细。
疾病诊断标准:夫妻同居一年以上,性生活正常,未采取任何避孕措施而不孕,经检查排除女方因素者。参照WHO《人类精液及精子-宫颈粘液相互作用实验室检验手册》制定,少精症:精子密度<20×109/L,余均正常;弱精症:精子中前向运动的精子(a级+b级)<50%或a级<25%,未见其他明显原因所致。
纳入标准:复合肾阳虚型少、弱精症诊断标准,同意接受本治疗,并可以追踪观察的患者纳入观察对象;有生殖系统炎症、睾丸病变者均不列为观察对象。
(2)临床资料:
对符合诊断标准的100例患者按症状分为3组,年龄22-40岁,平均年龄30±1岁,病程1-10年,平均5±2.5年,其中少精症25例,弱精症40例,少精弱精症35例。
(3)治疗方法:
服用本发明实施例9中的组合物,2周随访1次,连续服用3个月为1疗程,治疗期间患者停止服用其他药物,禁烟酒、勿劳累、忌高温作业及热水泡浴,避免工业污染,放射线及电磁波,穿棉质宽松衣裤,注意营养平衡,并嘱患者配偶倍加关心、鼓励,以减轻患者压力、增强信心。随访患者妻子受孕情况。
(4)疗效判定标准:
疗效标准根据世界卫生组织(WHO)《不育夫妇标准检查与诊断手册》,并参照《中药新药临床研究指导原则》中有关疗效标准进行评定。
临床治愈:少精症治疗后精子密度≥20×109/L,弱精症精子活动力a级≥25%或a+b级≥50%,或治疗后女方怀孕。
显效:少精症治疗后精子密度提升≥50%,弱精症精子活动力a+b级提升≥25%或a级提升≥12.5%,但未达到正常指标。
有效:少精症治疗后精子密度提升≥15%,弱精症治疗后精子活力a+b级或a级提升≥5%;
无效:治疗后精子密度提升<15%及精子活力提升<5%或无变化。
(5)治疗效果
治疗前后各组疗效见表2,治疗前后各组的精液参数比较见表3。
表2
组别 | 总数 | 治愈 | 显效 | 有效 | 无效 | 总有效率(%) |
少精症组 | 25 | 3 | 7 | 10 | 5 | 80 |
弱精症组 | 40 | 6 | 15 | 16 | 3 | 92.5 |
少精弱精症组 | 35 | 4 | 10 | 19 | 2 | 94.3 |
合计 | 100 | 13 | 32 | 45 | 10 | 90 |
表3
由表2和表3可知,本发明的组合物能够有效作用于男性生殖细胞,有效提高精液量、精子密度和精子活力,对少精症、弱精症、少精弱精症的有效率达到80%以上。
总之,以上所述仅为本发明的最佳实施例,对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (5)
1.一种改善男性生育力的组合物,其特征在于,包括以下重量份的原料:水解蛋黄粉5-30份,蛹草5-30份,富锌富硒大葱微粉10-100份,维生素C 0.01-20份,维生素E 0.01-20份,B族维生素0.01-20份,柠檬酸0.01-5份,结晶果糖0.01-8份,乳酸镁1-5份和葡萄糖酸钙1-8份。
2.根据权利要求1所述的一种改善男性生育力的组合物,其特征在于,所述富锌富硒大葱微粉的制备方法为:
I、选拣清洗:筛选无霉变、无虫蛀的富锌富硒大葱整葱,摊放在干燥、通风、清洁的架板上,在20-25℃下进行干燥,所述架板为筛状,层高为10-15cm,并按照现有工艺对富锌富硒大葱进行清洗、精选;
II、灭菌消毒:取步骤I所得到的富锌富硒大葱切成3-5cm的葱段,放入不锈钢料盘中,送入-22~-25℃低温冷冻库中冷冻72~96小时,然后取出,在20~25℃条件下解冻48~96小时,循环进行冷冻-解冻步骤2~4次,再送入-25℃冷冻0.5小时,得到未解冻的富锌富硒大葱;
III、干制:将步骤II所得到的未解冻的富锌富硒大葱送至真空干燥仓内进行脱水干燥,真空度控制在55Pa,将干燥仓内加热板温度在0.5-2小时内升至30-50℃,保持2-3小时,再将温度在1-2小时内升至60℃,保持5小时,再将温度在2小时内降至30-50℃,保持1小时,再将温度在1小时内降至20-25℃,干燥至富锌富硒大葱的含水量在4%以下;
IV、超微粉碎:将干制的富锌富硒大葱送至超微粉碎机中,超微粉碎至4000-8000目的细度,得到富锌富硒大葱微粉。
3.根据权利要求2所述的一种改善男性生育力的组合物,其特征在于,所述步骤I中筛选的富锌富硒大葱的平均硒含量≥0.018mg/kg,平均锌含量≥290mg/kg。
4.权利要求1~3任一项所述的组合物在保健品和/或功能食品中的应用。
5.根据权利要求4所述的在保健品和/或功能食品中的应用,其特征在于,所述保健品和/或功能食品的剂型为片剂、冲剂或胶囊剂。
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