CN107362292A - 一种具有改善女性生殖泌尿系统炎症的组合物、制备方法及应用 - Google Patents
一种具有改善女性生殖泌尿系统炎症的组合物、制备方法及应用 Download PDFInfo
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Abstract
本发明公开一种用于改善女性生殖泌尿系统炎症的组合物、制备方法及应用,属于药物制剂技术领域。本发明提供的具有用于改善女性生殖泌尿系统炎症的组合物的活性成分由如下原料制成:蔓越莓,蓝莓,覆盆子,淡竹叶,菊花,复合益生菌。本发明提供的具有用于改善女性生殖泌尿系统炎症的组合物充分考虑了机体内的肠道菌群与口服中药的相互作用的机理,并且效果明显。
Description
技术领域
本发明涉及药物制剂技术领域,具体涉及一种中药与益生菌联用组方的功能性食品。
背景技术
女性生殖道感染是妇科常见疾病之一,严重影响着女性的身心健康。有资料显示在一次流行病学调查中发现就诊的5万多例患者中,因感染性疾病而来就诊者就占一半以上。患者就诊时排在前3位的感染性疾病是阴道炎症、宫颈炎和盆腔炎。阴道炎作为女性生殖道感染最常见的疾病,是不同疾病引起的多种阴道黏膜炎性疾病的总称,多由念珠菌、滴虫、细菌等引起,患者常伴有分泌物增多、瘙痒等症状,给患者带来极大的痛苦。
阴道炎在传统中医学中属于带下、阴痒的范畴,多因湿浊蕴结,感染邪毒所致。阴道炎的主要病因是“湿”,有内湿、外湿之分。主要病机可归纳为肝脾肾功能失调,湿邪伤及任带二脉,使任脉失固、带脉失约。治疗上以清热燥湿、杀虫止痒同时兼以补虚,扶助正气的论治原则。因此,植物类药材或食材对于泌尿生殖系统的感染也具有相当的益处。
为此,中国专利文献CN101773581A公开一种治疗女性生殖泌尿系统炎症的药品,该药品的原料包括龙胆草,泽泻,白鲜皮,黄连,苦参,木通,贯众,荆芥,柴胡,车前子,黄柏,僵蚕,穿山甲,丹参,甘草,当归,防风,蛇床子等,该药品对女性生殖泌尿系统炎症具有一定的疗效,但该现有技术药品成分复杂,且并未注意到西方现代医学的研究成果,未考虑机体内的肠道菌群与口服中药的相互作用。而现有技术中并未发现效果明显的采用中药组方与益生菌相互结合的用于改善女性生殖泌尿系统炎症的食品或制剂。
发明内容
因此,本发明要解决的技术问题在于克服现有技术中并未发现效果明显的采用中药组方与益生菌相互结合的用于改善女性生殖泌尿系统炎症的食品或制剂的缺陷,从而提供一种具有改善女性生殖泌尿系统炎症的组合物、制备方法及应用。
为此,本发明提供如下技术方案:
一种具有改善女性生殖泌尿系统炎症的组合物,该组合物的活性成分由如下原料制成:蔓越莓,蓝莓,覆盆子,淡竹叶,菊花,复合益生菌。
所述组合物的活性成分的重量份配比为:蔓越莓300-700份,蓝莓400-1200份,覆盆子60-180份,淡竹叶60-180份,菊花50-150份,复合益生菌桔梗0.5-1.5份。
所述组合物的活性成分的重量份配比为:
蔓越莓500份,蓝莓800份,覆盆子120份,淡竹叶120份,菊花100份,复合益生菌桔梗1份;
或蔓越莓300份,蓝莓600份,覆盆子180份,淡竹叶60份,菊花120份,复合益生菌桔梗0.5份;
或蔓越莓700份,蓝莓1200份,覆盆子130份,淡竹叶60份,菊花150份,复合益生菌桔梗1.2份;
或蔓越莓600份,蓝莓400份,覆盆子60份,淡竹叶180份,菊花80份,复合益生菌桔梗1.5份;
或蔓越莓400份,蓝莓1000份,覆盆子90份,淡竹叶150份,菊花50份,复合益生菌桔梗0.8份。
所述活性成分指蔓越莓鲜果,蓝莓鲜果,覆盆子提取物,淡竹叶提取物,菊花提取物,以及复合益生菌;
所述复合益生菌包括:鼠李糖乳杆菌HN001,嗜酸乳杆菌La-14和嗜酸乳杆菌NCFM;
所述组合物还包括药学上可接受的辅料或辅助性成分。
所述覆盆子提取物为所述覆盆子水的提取物,所述淡竹叶提取物为淡竹叶水的提取物,所述菊花提取物为菊花的水提取物。
所述复合益生菌包括:配比为:1-3:1-3:1-3的鼠李糖乳杆菌HN001,嗜酸乳杆菌La-14和嗜酸乳杆菌NCFM。
所述鼠李糖乳杆菌HN001,所述嗜酸乳杆菌La-14和所述嗜酸乳杆菌NCFM的重量份配比为:1:1:1。
包括所述的组合物的食品,所述食品指固体饮料或压片糖果。
所述的组合物在制备具有改善女性生殖泌尿系统炎症的药物中的应用。
所述的组合物的制备方法,其特征在于,
(1)按比例称取蔓越莓和蓝莓鲜果或浓缩果汁,低温干燥制成水果粉;
(2)按比例称取覆盆子、淡竹叶和菊花药材混合,加8倍量水微沸回流提取1小时,提取液过滤;
(3)重复步骤(2)2-3次,合并滤液,浓缩,干燥,粉碎,得提取物干粉;
(4)将步骤(1)所得的水果粉以及步骤(3)所得的提取物干粉与益生菌粉混合,即得。
益生菌被视为临床研发的最强大的、可用来预防和治疗慢性感染的替代品。鉴于患者的巨大负担以及由尿路感染引起的科学和经济方面的问题,益生菌的调查研究在患者利益和临床研究方面具有潜在的、至关重要的价值。活性微生物试验和临床研究开辟了一个重大的伴有大量的调查和试验的研究领域。几乎没有人了解人与正常菌群之间复杂的相互作用。而从进化的角度来看,活性微生物为人体提供了消化和免疫调节方面的重要功能。事实上人体不必非得开发这类功能,可以利用这些微生物菌体的代谢功能来调制我们自身生理机能。而中药作为中华民族的瑰宝治病已有几千年历史,中药除含有具有直接医疗价值的有效成分外,还含有蛋白质、多糖、微量元素、维生素等多种营养成分,这使得中药具有多种药理作用。并且中药一般以口服的形式进入体内,因而复杂的中药成分必须经过肠道菌的作用才能被吸收,从而在小肠内会与肠道菌群相互作用。而机体内的肠道菌群对口服中药的药理作用的发挥起着重要作用,同时中药有助于维持机体肠道菌群的平衡,因而充分考虑机体内的肠道菌群与口服中药的多种复杂成分相互作用的机理至关重要。
本发明技术方案,具有如下优点:
1.本发明提供的具有改善女性生殖泌尿系统炎症的组合物是基于临床验方基础上,选择既可用于药品又可用于食品的植物性原料名单原料,按照“君、臣、佐、使”的原则辨证配伍,同时配伍独特的益生菌组合,采纳中西方医学之优势,利用现代医学研究成果与传统中医养生理念的结合,相辅相成,达到协同作用的功效,较之单独作用更胜一筹。
2.本发明提供的具有改善女性生殖泌尿系统炎症的组合物不限于产品的形式,各原料组分配比科学合理,各中药材中的植物大分子多糖、蛋白质、氨基酸维生素、以及多种菌类相互缀合形成大分子缀合物,各组成成分之间协同增效,从而使得本发明组合物在改善女性生殖泌尿系统炎症的组合物方面效果明显。
3.本发明提供的具有改善女性生殖泌尿系统炎症的组合物所选药材均是临床有效、安全性较高的药食同源的中药配伍方,联用对泌尿系统感染有明确保护作用的益生菌组合,达到改善泌尿生殖系统感染,无副作用,安全可靠的保健效果,两者协同作用,整体效果远高于纯中药或纯益生菌的配方。
4.本发明提供的具有改善女性生殖泌尿系统炎症的组合物以三种具有抑制泌尿道细菌感染的浆果——蔓越莓、蓝莓和覆盆子,联合起效,共同作用于女性生殖泌尿系统,起到抗炎、镇痛、抑菌作用;同时复配一花(菊花)一叶(淡竹叶),利用其两味药材清热除烦、利尿通淋的药效,并结合复合益生菌的作用于机体的优势,针对女性肝肾失调、湿浊蕴结导致的泌尿生殖系统感染达到极佳的抗炎效果。
中药材保健功能筛选:
蔓越莓:(Vaccinium macrocarpon Ait.)是北美三大水果之一,除具有食品营养功效外,人们发现其相关成分还可抑制细菌生长和细菌黏附侵袭。国外近年文献报道显示:蔓越莓及其制剂具有预防泌尿道感染,降低龋齿、牙周炎发生率等作用。国外研究人员对蔓越莓抑菌作用的做了大量研究。分别用蔓越莓汁、蔓越莓浓缩汁、蔓越莓提取物对包括大肠埃希菌、金黄色葡萄球菌在内的数种革兰阳性菌、革兰阴性菌做了抑菌实验,得到了不同程度的抑菌效果,证实蔓越莓抑菌作用的存在。
蓝莓:药理活性研究表明,蓝莓具有很好的抗炎、镇痛、抗氧化和清除自由基、抑菌等作用。Eliane Torri等研究了蓝莓70%乙醇提取物的抗炎镇痛活性,300mg/kg蓝莓提取物剂量可以有效的抑制角叉菜胶和组胺导致的小鼠足跖肿胀,降低髓过氧化物酶(MPO)活性,减小肉芽肿胀的大小;200mg/kg蓝莓提取物剂量可以有效的抑制乙酸和福尔马林引起的小鼠腹痛,表明蓝莓提取物有很好的抗炎镇痛作用。Deividas Burdulis等研究不同品种来源的蓝莓果实及其果皮的抑菌活性,表明蓝莓果实及果皮提取物对部分革兰氏阴性和阳性菌及酵母菌都具有活性。
覆盆子:是一种蔷薇科悬钩子属的木本植物,是一种水果,果实味道酸甜,植株的枝干上长有倒钩刺。覆盆子中文学名是悬钩子,有很多别名,例如:覆盆、覆盆莓、托盘、饽饽头、公饭、泡儿树梅、树莓、野莓、木莓、乌藨子、小托盘、竻藨子、花蜜托盘、蛇莓、蛇头莓、桑莓、红莓、泡泡。覆盆子的果实是一种聚合果,有红色、金色和黑色,在欧美作为水果,在中国大量分布但却很少人食用,仅在东北地区有少量栽培,市场上比较少见。覆盆子油属于不饱和脂肪酸,可促进前列腺分泌荷尔蒙。归经:肝;肾经;功效分类:收涩药;补肾药;中药化学成分:复盆子含有机酸、糖类及少量维生素C,并没食子酸(ellagic acid),β-谷甾醇(β-sitosterol),复盆子酸(fupenzic acid)。
功效:补肝益肾,固精缩尿,明目;主治;阳痿早泄,遗精滑精,宫冷不孕,带下清稀,尿频遗溺,目昏暗,须发早白。覆盆子含有的生物活性成分丰富多样,经过长时间的研究开发已经证明其在临床上有广泛的药理作用。研究证明,覆盆子提取物可以抑制COX-2能力的表达,其产生的抗炎效果与非甾体类抗炎药不相上下。因此覆盆子可以在一定程度上代替非甾体抗炎药,且更安全有效。基质金属蛋白酶在正常的生理和病理过程中承担重要的角色,它们参与正常皮肤的功能,比如老化、愈合、发育以及皮肤的炎症反应。肿瘤坏死因子(TNF-α)诱导产生金属基质蛋白酶(MMP-1和MMP-9),覆盆子能抑制MMP-1的活性,能显著抑制TNF-α诱导产生的白细胞介素-8(IL-8)的分泌,可用于治疗皮肤细胞的炎症反应。妇炎消糖浆以党参、覆盆子等制成糖浆剂治疗妇科炎症,临床观察18 8例,显效108例,有效75例。
淡竹叶:淡竹叶味甘、淡,性寒;归心、肺、胃、膀胱经;体轻渗泄,具有清热除烦,利尿通淋的功效。临床医生有用淡竹叶进行妇女阴道炎的治疗,服用水煎剂,10天即可痊愈。
菊花:菊花甘、苦,微寒,归肺、肝经。散风清热,平肝明目,清热解毒。菊花抗菌谱广,对金黄色葡萄球菌大肠杆菌、白喉杆菌、伤寒杆菌、、变形杆菌、痢疾杆菌、铜绿抱假单抱菌、福氏志贺菌有较强的抑制作用。
益生菌保健功能筛选:
本发明选择的益生菌部分配方为:鼠李糖乳杆菌HN001,嗜酸乳杆菌La-14和嗜酸乳杆菌NCFM的菌株比例为:1-3:1-3:1-3,混合制成复合益生菌粉。
研究表明:口服摄入嗜酸乳杆菌,鼠李糖乳杆菌及乳铁蛋白混合物,用分子生物学技术可以在阴道检测出益生菌。
本发明组合物成分配比如下表1:
表1本发明组合物成分配比列表
原料 | 重量份 |
蔓越莓 | X1=300-700 |
蓝莓 | X2=400-1200 |
覆盆子 | X3=60-180 |
淡竹叶 | X4=60-180 |
菊花 | X5=50-150 |
复合益生菌 | X6=0.5-1.5 |
根据本发明的实验,本发明组合物中各组分的含量可以取所列数值范围内的任一数值,具体而言,蔓越莓(鲜果)的重量组分可以是300、301、302、303、、、、、、700份,蓝莓(鲜果)的重量组分可以是400、401、402、403、、、、、、1200份,覆盆子的重量组分可以是60、61、62、63、、、、、、180份,淡竹叶的重量组分可以是60、61、62、63、、、、、、180份,菊花的重量组分可以是50、51、52、53、、、、、、150份,复合益生菌的重量组分可以是0.5、0.6、0.7、0.8、、、、、、1.5份。选择这些数值所得组合物都能实现如具体实施例部分几个代表性配方所呈现的组方内原料之间的协调增效的作用。
具体实施方式
提供下述实施例是为了更好地进一步理解本发明,并不局限于所述最佳实施方式,不对本发明的内容和保护范围构成限制,任何人在本发明的启示下或是将本发明与其他现有技术的特征进行组合而得出的任何与本发明相同或相近似的产品,均落在本发明的保护范围之内。
实施例中未注明具体实验步骤或条件者,按照本领域内的文献所描述的常规实验步骤的操作或条件即可进行。所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规试剂产品。
本发明随机挑选了所有请求保护的范围内的若干组合物进行改善女性生殖泌尿系统炎症的临床试验,都表现出良好的改善女性生殖泌尿系统炎症的效果,特别是组合物内原料之间产生了显著的协同增效的作用,即组合物在改善女性生殖泌尿系统炎症的效果显著优于单纯中药组方或单纯复合益生菌组方的效果。
实施例1-2
本实施例提供具有改善女性泌尿生殖系统感染功能的固体饮料,制备方法如下:
按比例将蔓越莓和蓝莓鲜果或浓缩果汁,低温干燥制成水果粉。
覆盆子、淡竹叶和菊花药材混合,加8倍量水微沸回流提取1小时,提取液过滤,以上步骤重复2-3次,合并滤液,减压浓缩(50℃-70℃),喷雾干燥(或微波干燥,粉碎)得提取物干粉。
以上几种原料与益生菌粉混合,制成固体饮料。
实施例3-5
本实施例提供具有改善女性泌尿生殖系统功能的压片糖果,制备方法如下:
按比例蔓越莓和蓝莓鲜果或浓缩果汁,低温干燥制成水果粉。
覆盆子、淡竹叶和菊花饮片混合,加8倍量水微沸回流提取1小时,提取液过滤,以上步骤重复2-3次,合并滤液,减压浓缩(50℃-70℃),喷雾干燥(或微波干燥,粉碎)得提取物干粉。
以上几种原料与益生菌粉混合,压片制成片剂。
实施例1-5组合物配方如表2:(每人每日服用82.05g,可一次或分次服用)
表2实施例1-5组合物配方
实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | |
蔓越莓(鲜果) | 25000g | 300g | 700g | 600g | 400g |
蓝莓(鲜果) | 40000g | 600g | 1200g | 400g | 1000g |
覆盆子 | 6000g | 180g | 130g | 60g | 90g |
淡竹叶 | 6000g | 60g | 600g | 180g | 150g |
菊花 | 5000g | 120g | 150g | 80g | 50g |
复合益生菌粉 | 50g | 0.5g | 1.2g | 1.5g | 0.8g |
实施例1-5的复合益生菌粉的配方如表3:
表3实施例1-5的符合益生菌粉的配方
对比例
中国专利文献CN101773581A的实施例1所公开的治疗女性生殖泌尿系统炎症的药品,记为X1。
本发明实施例1中的中药组方相同的中药配方,记为X2。
本发明实施例1中的复合益生菌组方相同配方的益生菌,记为X3。
实验例
为验证本发明组合物改善女性生殖泌尿系统炎症的效果,本发明做出如下临床试验:
观察对象:选择有急慢性阴道炎、外阴瘙痒、白带增多、异味、宫颈炎、宫颈糜烂、盆腔炎、卵巢囊肿、乳腺增生、子宫下垂、子宫肌瘤、子宫内膜异位、分娩后遗留症状等一项或几项症状的视为患者。
将患者分为8组,每组200人,分别服用本发明实施例1-5的制品,以及对比例X1、X2、X3制品,其中实施例1-5,以及X2、X3制品每天服用82.05g,服用三周,每周为一个疗程,而X1每天3次服用,饭后口服,每次4粒,服用15天*3(3个疗程)。
第一疗程:症状减轻;第二疗程:症状基本消失;第三疗程:症状彻底消失;为有效治愈。但对于子宫肌瘤患者而言,本发明制品能消除并发炎症,活血化瘀,消除胀痛便被视为有效治愈。
治疗效果如表4:
表4本发明实施例以及对比例的预防效果数据
由表4数据可以看出,本发明提供的具有改善女性泌尿生殖系统的效果的制品在改善女性泌尿生殖系统方面的效果明显,并且优于同组方的纯中药组合物X2以及同组方的纯复合益生菌X3。由于子宫肌瘤发病原因主要与激素分泌相关,而本发明制品对于子宫肌瘤患者主要起到消除并发炎症,活血化瘀,消除胀痛的辅助性治疗。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种具有改善女性生殖泌尿系统炎症的组合物,其特征在于,该组合物的活性成分由如下原料制成:蔓越莓,蓝莓,覆盆子,淡竹叶,菊花,复合益生菌。
2.根据权利要求1所述的组合物,其特征在于,所述组合物的活性成分的重量份配比为:蔓越莓300-700份,蓝莓400-1200份,覆盆子60-180份,淡竹叶60-180份,菊花50-150份,复合益生菌桔梗0.5-1.5份。
3.根据权利要求2所述的组合物,其特征在于,所述组合物的活性成分的重量份配比为:
蔓越莓500份,蓝莓800份,覆盆子120份,淡竹叶120份,菊花100份,复合益生菌桔梗1份;
或蔓越莓300份,蓝莓600份,覆盆子180份,淡竹叶60份,菊花120份,复合益生菌桔梗0.5份;
或蔓越莓700份,蓝莓1200份,覆盆子130份,淡竹叶60份,菊花150份,复合益生菌桔梗1.2份;
或蔓越莓600份,蓝莓400份,覆盆子60份,淡竹叶180份,菊花80份,复合益生菌桔梗1.5份;
或蔓越莓400份,蓝莓1000份,覆盆子90份,淡竹叶150份,菊花50份,复合益生菌桔梗0.8份。
4.根据权利要求3所述的组合物,其特征在于,所述活性成分指蔓越莓鲜果,蓝莓鲜果,覆盆子提取物,淡竹叶提取物,菊花提取物,以及复合益生菌;
所述复合益生菌包括:鼠李糖乳杆菌HN001,嗜酸乳杆菌La-14和嗜酸乳杆菌NCFM;
所述组合物还包括药学上可接受的辅料或辅助性成分。
5.根据权利要求4所述的组合物,其特征在于,所述覆盆子提取物为所述覆盆子水的提取物,所述淡竹叶提取物为淡竹叶水的提取物,所述菊花提取物为菊花的水提取物。
6.根据权利要求5所述的组合物,其特征在于,所述复合益生菌包括:配比为:1-3:1-3:1-3的鼠李糖乳杆菌HN001,嗜酸乳杆菌La-14和嗜酸乳杆菌NCFM。
7.根据权利要求6所述的组合物,其特征在于,所述鼠李糖乳杆菌HN001,所述嗜酸乳杆菌La-14和所述嗜酸乳杆菌NCFM的重量份配比为:1:1:1。
8.包括权利要求1-7所述的组合物的食品,所述食品指固体饮料或压片糖果。
9.权利要求1-7所述的组合物在制备具有改善女性生殖泌尿系统炎症的药物中的应用。
10.权利要求1-7所述的组合物的制备方法,其特征在于,
(1)按比例称取蔓越莓和蓝莓鲜果或浓缩果汁,低温干燥制成水果粉;
(2)按比例称取覆盆子、淡竹叶和菊花药材混合,加8倍量水微沸回流提取1小时,提取液过滤;
(3)重复步骤(2)2-3次,合并滤液,浓缩,干燥,粉碎,得提取物干粉;
(4)将步骤(1)所得的水果粉以及步骤(3)所得的提取物干粉与复合益生菌混合,即得。
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CN115137758B (zh) * | 2022-06-08 | 2024-01-19 | 诺佰克(武汉)生物科技有限公司 | 一种有利于女性生殖道健康的益生菌的制备及其应用 |
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