CN115282176A - 用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物及其制备方法 - Google Patents
用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供了用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物及其制备方法,所述组合物包括:亚麻籽木酚素、D‑手性肌醇、红参和含锌化合物。本发明通过将亚麻籽木酚素与D‑手性肌醇、红参以及含锌化合物进行复配,克服了亚麻籽木酚素在pH2~pH6的水溶液中不稳定的问题。同时,上述组分之间能够起到协同增效的作用,从而能够显著改善多囊性卵巢综合征和更年期的各种症状,进一步达到延缓卵巢衰老的功效。
Description
技术领域
本发明涉及医药和食品领域,具体涉及用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物及其制备方法。
背景技术
卵巢的主要功能是排卵和分泌女性激素,随着年龄的增长,女性的卵巢功能在45-50岁左右开始衰退,雌激素水平下降,进入围绝经期。但是有些40岁之前的女性因为环境、饮食、不良生活习惯、心理或者病理等因素,发生卵巢早衰的问题。此外长期月经不调,多囊性卵巢综合征导致育龄期妇女出现月经稀发,停经或者荷尔蒙异常,也是加速卵巢衰老的一个重要因素。卵巢衰老会给会引起女性身体和生理上的变化,比如月经改变、骨质疏松、血压升高、皮肤皱纹增多或者出现潮热、情绪稳定易怒等更年期的症状,身体免疫能力下降,继而加速衰老,严重影响女性的生活质量。
目前,尚没有明确有效的治疗卵巢衰老的药物,主要的方法是通过激素替代治疗(HRT)。虽然HRT疗法可以在一定程度上消除更年期综合征,降低骨质疏松的风险,但是激素治疗停药后有复发的现象,且增加了乳腺癌、子宫内膜癌以及引起血栓、卒中的风险,所以HRT疗法并不是一种安全有效的治疗手段,对于围绝经期的女性不是最佳的选择。另外还有中药治疗,服用汤药或者冲服颗粒剂,中药治疗周期较长,对于上班族女性来说,服药不方便且不能按时服药,难以坚持治疗。
目前市售的改善多囊性卵巢综合征或者延缓卵巢衰老的食品或者保健食品种类较少,其中主要成分为大豆异黄酮类,成分简单且治疗效果不理想。
发明内容
有鉴于此,本发明提供了用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物及其制备方法。本发明组合物中各组分间协同增效,可明显改善多囊性卵巢综合征和更年期综合征,达到延缓卵巢衰老的功效,且可长期使用,安全无副作用。
为解决上述技术问题,本发明采用以下技术方案:
第一方面,本发明提供了一种用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物,所述组合物包括:
亚麻籽木酚素、D-手性肌醇、红参和含锌化合物。
进一步地,所述组合物还包括:玫瑰。
进一步地,所述亚麻籽木酚素的来源包括亚麻籽;所述亚麻籽为经过浓缩加工的亚麻籽浓缩粉,所述亚麻籽浓缩粉中亚麻籽木酚素的含量≥5%;和/或
所述D-手性肌醇的来源包括角豆;所述角豆为经过提取的角豆提取物,所述角豆提取物中D-手性肌醇的含量≥80%。
进一步地,所述含锌化合物包括硫酸锌、柠檬酸锌、三水柠檬酸锌、葡萄糖酸锌、氧化锌、乳酸锌、乙酸锌和氯化锌中的至少一种。
进一步地,所述组合物中:亚麻籽木酚素:D-手性肌醇:红参:含锌化合物的质量比为(0.1-15):(0.4-12):(0.7-15):(0.01-0.1);或
亚麻籽浓缩粉:角豆提取物:红参:含锌化合物的质量比为(2-15):(0.5-12):(0.7-15):(0.01-0.1)。
进一步地,所述组合物中:亚麻籽木酚素:D-手性肌醇:红参:玫瑰:含锌化合物的质量比为(0.1-15):(0.4-12):(0.7-15):(2~15):(0.01-0.1)。
进一步地,所述组合物中还包括:维生素;和/或
矿物质;和/或
一种或多种药学上可接受的赋形剂。
第二方面,本发明提供了如上所述组合物的制备方法,所述制备方法为:将所述亚麻籽木酚素、D-手性肌醇、红参和含锌化合物混合后得到所述组合物。
第三方面,本发明提供了如上所述的组合物在制备用于延缓卵巢衰老和改善多囊性卵巢综合征的药物中的用途。
进一步地,所述药物的剂型包括片剂、液体制剂、胶囊剂和散剂。
本发明的上述技术方案的有益效果如下:
本发明提供了一种用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物,所述组合物包括:亚麻籽木酚素、D-手性肌醇、红参和含锌化合物。本发明通过将亚麻籽木酚素与D-手性肌醇、红参以及含锌化合物进行复配,克服了亚麻籽木酚素在pH2~pH6的水溶液中不稳定的问题。同时,上述组分之间能够起到协同增效的作用,从而能够显著改善多囊性卵巢综合征和更年期的各种症状,进一步达到延缓卵巢衰老的功效。
具体实施方式
为了进一步理解本发明,下面结合实施例对本发明优选实施方案进行描述,但是应当理解,这些描述只是为进一步说明本发明的特征和优点,而不是对本发明的限制。
第一方面,本发明提供了一种用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物,所述组合物包括:亚麻籽木酚素、D-手性肌醇、红参和含锌化合物。
针对目前尚没有明确有效的治疗卵巢衰老的药物的问题,本发明中提供了一种用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物,所述组合物中主要包括亚麻籽木酚素、D-手性肌醇、红参和含锌化合物这几种有效成分。
其中,亚麻籽木酚素具有较强的抗氧化和抗癌作用,亚麻籽木酚素还是一种与人体雌激素生理活性十分相似的植物雌激素。亚麻籽木酚素作为植物雌激素,不仅会对内源性激素的新陈代谢起作用,还会影响到细胞的分化和增生等,当年轻或围绝经期女性雌激素缺乏时,木酚素可作用于细胞的雌激素受体,加速细胞的成熟,刺激雌激素的生成,另外还可以加速生成催乳激素,降低绝经妇女血清中低密度脂蛋白的密度,延缓骨质疏松等,可缓解更年期的一系列症状。亚麻籽木酚素在人体内的代谢与荷尔蒙类似,安全性较高。亚麻籽木粉素中最多的成分是开环异落叶松脂酚二葡萄糖苷(SDG),开环异落叶松脂酚(SECO)是SDG的糖苷形式,亚麻籽木酚素多数以二聚体形式存在,也有少数的三聚体和四聚体,具有亲水性,可生物酶或有机酸水解,有研究表明,亚麻籽木酚素中SDG在pH2~pH6的水溶液中不稳定,降解率为13%-43%,而常规饮料pH为3-6,这大大限制了其在口服液中的应用,因此需要提供一种有效的办法克服亚麻籽木酚素在pH2~pH6的水溶液中不稳定的问题。本发明中发现,通过将亚麻籽木酚素与D-手性肌醇、红参以及含锌化合物进行复配,能够有效克服亚麻籽木酚素在pH2~pH6的水溶液中不稳定的问题。
D-手性肌醇(DCI)除了具有肌醇促进肝脏脂代谢功能外,还具有胰岛素增敏作用,其能够降血糖,改善多囊卵巢综合症(PCOS)患者的排卵情况,同时能够调节激素平衡,改善月经失调,以及具有抗氧化、抗衰老、抗炎等特殊的生理功能。
红参是由鲜人参经过浸润、清洗、分选、蒸制、晾晒、烘干炮制而成,后期可根据需求加工成粉末或者浸膏。红参可大补元气,复脉固脱,益气摄血,有研究表明红参中主要的活性成分人参皂甙Rg1,一种被证明的植物雌激素,在人类乳腺癌细胞(MCF-7)上发挥类雌激素活性,而不直接作用与雌激素受体(ERs)。红参可以缓解多囊性卵巢综合征,改善更年期骨质疏松、盗汗、心慌等一系列症状。
锌,一种矿物质,有研究表明,多囊卵巢综合征(PCOS)患者血清中锌水平与PCOS患者各项指标有相关性,PCOS患者血清中锌水平明显降低,且在胰岛素抵抗的PCOS患者中进一步降低;其与BMI、TG、HDL及TG/HDL显著相关,提示锌缺乏可能在PCOS生理病理学方面发挥重要作用。
根据本发明的一些实施例,所述组合物还包括:玫瑰。
玫瑰花粉具有理气和血、舒肝解郁、降脂减肥、润肤养颜等作用。特别对妇女经痛、月经不调有效。玫瑰花中具有番茄红素、Rubixanthin、Rugosin A、β-谷甾醇、豆甾醇、维生素E、去甲氧基茵陈色原酮、β-胡萝卜素和槲皮素等有效化合物,可发挥抗氧化、抗肿瘤、抗炎、抗病毒、免疫调节和保肝等药理作用,同时起到降糖、降脂、抗衰老及改善皮肤等保健功能。
本发明的组合物中包含有效成分亚麻籽木酚素、D-手性肌醇、红参和含锌化合物,优选地还可以包括玫瑰,通过联合使用上述有效成分,发明人发现:上述组分之间能够起到协同增效的作用,从而能够显著改善多囊性卵巢综合征和更年期的各种症状,进一步达到延缓卵巢衰老的功效。
根据本发明的一些实施例,所述亚麻籽木酚素的来源包括亚麻籽;所述亚麻籽为经过浓缩加工的亚麻籽浓缩粉,所述亚麻籽浓缩粉中亚麻籽木酚素的含量≥5%;和/或所述D-手性肌醇的来源包括角豆;所述角豆为经过提取的角豆提取物,所述角豆提取物中D-手性肌醇的含量≥80%。
亚麻籽中含有的亚麻籽木酚素含量较高,将亚麻籽作为亚麻籽木酚素的来源添加到组合物中时,一般需对亚麻籽进行提取浓缩加工,浓缩后的亚麻籽浓缩粉中亚麻籽木酚素含量≥5%,优选地,所述亚麻籽浓缩粉中亚麻籽木酚素含量≥30%。角豆中含有的D-手性肌醇含量较高,将角豆作为D-手性肌醇的来源添加到组合物中时,一般需对角豆进行提取,所述角豆经过热水提取、酶法处理过滤,结晶出来的一种类白色粉末,即为角豆提取物。所述角豆提取物中D-手性肌醇的含量≥80%,优选地,所述角豆提取物中D-手性肌醇的含量≥90%。
根据本发明的一些实施例,所述含锌化合物包括硫酸锌、柠檬酸锌、三水柠檬酸锌、葡萄糖酸锌、氧化锌、乳酸锌、乙酸锌和氯化锌中的至少一种。
根据本发明的一些实施例,所述组合物中:亚麻籽木酚素:D-手性肌醇:红参:含锌化合物的质量比为(0.1-15):(0.5-12):(0.7-15):(0.01-0.1);或亚麻籽浓缩粉:角豆提取物:红参:含锌化合物的质量比为(2-15):(0.5-12):(0.7-15):(0.01-0.1)。
优选地,所述组合物中:亚麻籽木酚素:D-手性肌醇:红参:含锌化合物的质量比为(1.5-10):(1.8-6):(1-10):(0.02-0.06)。同时,亚麻籽浓缩粉:角豆提取物:红参:含锌化合物的质量比为(5-10):(2-6):(1-10):(0.02-0.06)。
根据本发明的一些实施例,所述组合物中:亚麻籽木酚素:D-手性肌醇:红参:玫瑰:含锌化合物的质量比为(0.1-15):(0.5-12):(0.7-15):(2~15):(0.01-0.1)。
优选地,所述组合物中:亚麻籽木酚素:D-手性肌醇:红参:玫瑰:含锌化合物的质量比为(1.5-10):(1.8-6):(1-10):(6~10):(1-10)。
根据本发明的一些实施例,所述组合物中还包括:维生素;和/或矿物质;和/或一种或多种药学上可接受的赋形剂。
可选地,所述维生素包括维生素C、维生素B;所述矿物质包括硒;所述赋形剂包括填充剂、润滑剂等。
第二方面,本发明提供了如上所述组合物的制备方法,所述制备方法为:将所述亚麻籽木酚素、D-手性肌醇、红参和含锌化合物混合后得到所述组合物。
第三方面,本发明提供了如上所述的组合物在制备用于延缓卵巢衰老和改善多囊性卵巢综合征的药物中的用途。
根据本发明的一些实施例,所述药物的剂型包括片剂、液体制剂、胶囊剂和散剂。
本发明中提供了一种延缓卵巢衰老或改善多囊性卵巢综合征的组合物的制备方法,所述制备方法为:按照配方质量份数称取亚麻籽木酚素、D-手性肌醇、红参和含锌化合物等混合后得到所述组合物。
具体地,所述亚麻籽木酚素的存在形式可以为亚麻籽浓缩粉,所述D-手性肌醇的存在形式可以为角豆提取物,所述红参的存在形式可以为红参粉或浸膏,所述锌可包含柠檬酸锌和/或葡萄糖酸锌。
将所述亚麻籽浓缩粉、角豆提取物、红参粉或浸膏、柠檬酸锌和/或葡萄糖酸锌混合均匀,分装即得固态组合物;优选地,可向上述组分中再多加一种有效成分—玫瑰粉并混合均匀。
进一步地,可向上述固态组合物中加入纯化水、果蔬汁或者果粉、调味剂、防腐剂、增稠剂等进行冲调,过滤,分装,灭菌即得液态饮料;
进一步地,可向上述固态组合物中加入果粉、调味剂、增稠剂等进行混合,制粒或不制粒、干燥或不干燥、分装即得固体饮料;
进一步地,可向上述固态组合物中加入赋形剂、润滑剂进行混合,制粒或不制粒、干燥或不干燥、再进行压片或者灌装即得片剂或胶囊剂。
下面通过一些具体实施例对本发明作进一步说明。
以下实施例和对比例中使用的亚麻浓缩粉和角豆提取物为市售产品,其中亚麻浓缩粉中亚麻籽木酚素的含量为40±5%,角豆提取物中D-手性肌醇的含量≥95%。
实施例1
制备方法:
(1)按表1中的用量准备好各组分;
(2)将所有组分加入到纯化水中,搅拌溶解,灌装封口,灭菌,即得所述组合物的液体饮料。
实施例2~7
制备方法同实施例1,具体的配方组成见表1,表1中的数字为各组分的用量份数,所述份数为重量份,“/”表示未添加,“余量”表示其余均为纯化水。
表1实施例1~7的组分表
对比例1~6
制备方法同实施例1,具体的配方组成见表2,表2中的数字为各组分的用量份数,所述份数为重量份,“/”表示未添加,“适量”表示通过调整柠檬酸的用量,使对比例1~6和实施例1~7的pH值保持基本一致。
表2对比例1~6的组分表
测试
1.亚麻籽木酚素稳定性测试
1.1检测方法
测试样品:对比例5-6,实验例1-7;
测试条件:高温(40℃);
取样时间:0天、7天、14天、28天;
检测指标:亚麻籽木酚素含量,测定方法参照企业标准,采用HPLC法进行测试,含量要求90-110%。
1.2实验结果
亚麻籽木酚素含量统计结果见表3。
表3稳定性试验溶液亚麻籽木酚素含量统计结果
表3结果显示,在高温条件下放置28天,本发明对比例5-6样品高温放置7天后,亚麻籽木酚素含量明显降低,7天时含量即降低约35%;放置28天后,本发明实验例1-7中亚麻籽木酚素的含量稍有下降,但均高于90%,可见本发明组合物中亚麻籽木酚素的稳定性明显高于对比例。
2.囊性卵巢综合征模型PCOS动物试验
为了验证本发明中的组合物在改善多囊性卵巢综合征方面的效果,进行如下实验:
2.1分组与模型制备
采用雌性8-10周龄SD大鼠130只,体重250-300g,随机分成正常组10只,PCOS模型组120只。其中,正常组进行常规饲养,PCOS模型组的大鼠于23日龄开始,在颈背部皮下注射DHEA(脱氢表雄酮,美国IL公司)60mg/kg/d,连续20天,所有大鼠均在注药后的第20日(即大鼠42日龄)开始禁食。并在禁食后12h后,于眼眶后静脉取血,分离血清,放免法测血清中T雄激素(T)、卵泡刺激素(FSH)、黄体生成素(LH)、雌二醇(E2)水平。通过阴道涂片观察动情周期变化。阴道涂片失去完整动情周期及血清T升高者,为PCOS模型。
将造模成功地PCOS大鼠随机分为模型空白组、对比例1-4组、实施例1-7组。
2.2给药
对比例1-4组PCOS大鼠分别灌胃给予对比例1-4中的样品2.3g/kg/d,实施例1-7组PCOS大鼠分别灌胃给予实施例1-7样品2.3g/kg/d,连续21天。正常组及模型空白组均给灌胃等体积的0.9%生理盐水,所有动物给予正常饲料喂养。
2.3检测
所有大鼠于灌胃给予生理盐水或对比例或实施例样品后的次日,空腹12小时以上后眼眶取血,分离血清,放免法测血清中T雄激素(T)、卵泡刺激素(FSH)、黄体生成素(LH)水平。所有数据以均数±标准差(x±s)表示,采用SPSS 11.5统计软件进行统计学分析,多组间比较采用单因素方差分析,事后多重比较采用LSD-t检验,以P<0.05具有统计学意义。
结果如表4、5所示。
表4组合物对多囊卵巢综合征的影响
续表4
表5统计分析结果
续表5
注:*P<0.05,**P<0.01,#P>0.05
由以上分析结果可知,对比例和实施例与空白模型组PCOS大鼠比,T、FSH、LH水平均有显著性差异,且实施例明显优于对比例;与正常组大鼠比,对比例和实施例均有显著性差异,实施例明显优于对比例,且实施例2和实施例5中PCOS大鼠LH水平可以恢复至与正常大鼠无明显差异的水平。
3.卵巢早衰模型POF动物实验
为了验证本发明的组合物在延缓卵巢早衰方面的效果,进行如下实验:
3.1分组与建模
大鼠POF模型的建立:
采用雌性8-10周龄SD大鼠50只,体重250-300g,均经阴道脱落细胞涂片筛查性周期正常,随机分成正常组10只,POF模型组40只。正常组给予常规饲养,POF模型组均给予顺铂注射液(诺欣制药,20ml:20mg)1.5mg/kg/d腹腔注射,连续注射7d。注射后,连续5d对雌性SD大鼠进行阴道分泌液采样涂片,观察脱落细胞。观察造模大鼠出现动静周期紊乱,外观毛色发黄、缺少光泽、易脱、易激怒,即造模成功。
将造模成功地POF大鼠随机分为模型空白组、对比例组、实施例组。模型空白组、对比例5、实施例2、实施例5各10只POF大鼠。
3.2给药
实施例2、实施例5和对比例5组的POF大鼠分别灌胃给予对应的实施例或对比例样品2.3g/kg/d,连续21天。正常组及模型空白组均给灌胃等体积的0.9%生理盐水,所有动物给予正常饲料喂养。
3.3检测
所有大鼠与灌胃给予生理盐水或对比例或实施例样品后的次日,空腹12小时以上后眼眶取血,分离血清,放免法测血清中雌二醇(E2)、抗缪勒氏管激素(AMH)水平。所有数据以均数±标准差(x±s)表示,采用SPSS11.5统计软件进行统计学分析,多组间比较采用单因素方差分析,事后多重比较采用LSD-t检验,以P<0.05具有统计学意义。
结果如表6所示。
表6组合物对卵巢早衰大鼠的影响
注:*P<0.05,**P<0.01
由以上分析结果可知,对于POF模型大鼠,空白组与正常组E2和AMH水平有显著差异,对比例5、实施例2和实施例5与空白模型组比均有显著性差异,且实施例大鼠E2和AMH水平明显较对比例5大鼠低,其中以实施例5的结果为最优。
以上测试结果表明,本发明的组合物具有优异的提高亚麻籽木粉素稳定性、延缓卵巢衰老和改善多囊性卵巢征的效果。
以上所述是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明所述原理的前提下,还可以作出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种用于延缓卵巢衰老和改善多囊性卵巢综合征的组合物,其特征在于,所述组合物包括:
亚麻籽木酚素、D-手性肌醇、红参和含锌化合物。
2.根据权利要求1所述的组合物,其特征在于,所述组合物还包括:玫瑰。
3.根据权利要求1所述的组合物,其特征在于,所述亚麻籽木酚素的来源包括亚麻籽;所述亚麻籽为经过浓缩加工的亚麻籽浓缩粉,所述亚麻籽浓缩粉中亚麻籽木酚素的含量≥5%;和/或
所述D-手性肌醇的来源包括角豆;所述角豆为经过提取的角豆提取物,所述角豆提取物中D-手性肌醇的含量≥80%。
4.根据权利要求3所述的组合物,其特征在于,所述含锌化合物包括硫酸锌、柠檬酸锌、三水柠檬酸锌、葡萄糖酸锌、氧化锌、乳酸锌、乙酸锌和氯化锌中的至少一种。
5.根据权利要求4所述的组合物,其特征在于,所述组合物中:
亚麻籽木酚素:D-手性肌醇:红参:含锌化合物的质量比为(0.1-15):(0.4-12):(0.7-15):(0.01-0.1);或
亚麻籽浓缩粉:角豆提取物:红参:含锌化合物的质量比为(2-15):(0.5-12):(0.7-15):(0.01-0.1)。
6.根据权利要求2所述的组合物,其特征在于,所述组合物中:
亚麻籽木酚素:D-手性肌醇:红参:玫瑰:含锌化合物的质量比为(0.1-15):(0.4-12):(0.7-15):(2~15):(0.01-0.1)。
7.根据权利要求1所述的组合物,其特征在于,所述组合物中还包括:维生素;和/或
矿物质;和/或
一种或多种药学上可接受的赋形剂。
8.一种权利要求1所述组合物的制备方法,其特征在于,所述制备方法为:
将所述亚麻籽木酚素、D-手性肌醇、红参和含锌化合物混合后得到所述组合物。
9.权利要求1~7中任一项所述的组合物在制备用于延缓卵巢衰老和改善多囊性卵巢综合征的药物中的用途。
10.根据权利要求9所述的用途,其特征在于,所述药物的剂型包括片剂、液体制剂、胶囊剂和散剂。
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