CN116350739B - 一种治疗细菌性阴道炎的中药组合物及其制备方法 - Google Patents
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Abstract
本发明涉及中药组合物技术领域,尤其涉及一种治疗细菌性阴道炎的中药组合物及其制备方法。本发明提供的治疗细菌性阴道炎的中药组合物,由包含如下重量份的组分制备得到:生姜40~50份,五味子35~45份,肉桂30~40份,艾叶30~40份,党参25~35份,复合中药发酵液25~35份,白头翁20~30份,金银花20~25份,蒲公英15~20份,木通15~20份,虎杖10~15份,白术5~10份,所述复合中药发酵液由嗜酸性乳酸杆菌发酵苦参、青蒿、杜仲和黄连得到。本发明中药组合物外用对皮肤温和无刺激,对于治疗细菌性阴道炎具有显著的积极作用,应用前景十分广阔。
Description
技术领域
本发明涉及中药组合物技术领域,尤其涉及一种治疗细菌性阴道炎的中药组合物及其制备方法。
背景技术
在正常情况下,阴道本身有一种自净作用,这源于阴道内大量的乳酸杆菌,它不仅可以维持阴道内正常的pH,也能防止外来微生物的入侵,但当人体的这种酸碱平衡一被打破的时候,乳酸杆菌就会变少,其他的细菌例如动弯杆菌、加德纳菌、动弯杆菌、类杆菌、消化链球菌、紫丹胞菌等厌氧菌就会繁殖,导致细菌性阴道炎(BV)。细菌性阴道炎是一种由阴道加特纳菌和一些厌氧菌的混合感染,导致阴道内微生态平衡失调,引起的阴道分泌物增多,白带有鱼腥臭味及外阴瘙痒灼热的综合征。细菌性阴道炎可分为嗜血杆菌性阴道炎、棒状杆菌阴道炎、厌氧菌性阴道病炎、加特纳菌性阴道炎等。细菌性阴道炎可造成不孕、影响胎儿发育、诱发其他(生殖器感染、盆腔炎、肾周炎、性交痛等)疾病等不良影响,还会影响夫妻生活质量。在阴道炎临床治疗上,药物治疗一般有口服西药、洗液、传统中药汤剂。但由于新的病原微生物以及耐药性的出现,阴道炎的复发率变高,患者的依从性差,西药治疗显效虽快但容易产生耐药性,可能复发。而传统的中药汤剂味苦且用量较大,汤剂久置后易发霉变质,不方便携带,患者的依从性差。中药妇科洗剂是一般具有较强的消炎、杀虫的作用,能有效治疗女性生殖道感染疾病,具备较广阔的应用价值和市场前景。但目前还缺乏一种治疗效果较好的治疗细菌性阴道炎的中药配方。
发明内容
为克服现有技术中存在的上述缺陷,本发明提供了一种治疗细菌性阴道炎的中药组合物及其制备方法。
为了实现上述发明目的,本发明提供以下技术方案:
本发明提供了一种治疗细菌性阴道炎的中药组合物,由包含如下重量份的组分制备得到:生姜40~50份,五味子35~45份,肉桂30~40份,艾叶30~40份,党参25~35份,复合中药发酵液25~35份,白头翁20~30份,金银花20~25份,蒲公英15~20份,木通15~20份,虎杖10~15份,白术5~10份,所述复合中药发酵液由嗜酸性乳酸杆菌发酵苦参、青蒿、杜仲和黄连得到。
优选的,所述复合中药发酵液的具体制备步骤包括:
1)将苦参、青蒿、杜仲和黄连混合,粉碎过筛,收集筛下组分;
2)将所述筛下组分与水混合,进行第一煎煮,得药液a和药渣a;
3)将药渣a与水混合,进行第二煎煮,得药液b和药渣b;
4)将药渣b与水混合,进行第三煎煮,得药液c和药渣c;
5)将药液a,药液b和药液c混合,减压浓缩至原体积的1/6~1/4,得复合中药水提液;
6)将嗜酸性乳酸杆菌接种于所述复合中药水提液中进行发酵,得复合中药发酵液。
优选的,步骤1)中所述苦参、青蒿、杜仲和黄连的混合质量比为2~4:1~3:1~3:1~2,所述粉碎过筛的目数为150~250目。
优选的,步骤2)中所述筛下组分与水的混合比例为1g:7~9mL,所述第一煎煮的温度为90~100℃,所述第一煎煮的时间为45~55min;
步骤3)中所述药渣a与水的混合比例为1g:4~6mL,所述第二煎煮的温度为80~90℃,所述第二煎煮的时间为40~50min;
步骤4)中所述药渣b与水的混合比例为1g:2~4mL,所述第三煎煮的温度为70~80℃,所述第三煎煮的时间为30~40min。
优选的,步骤5)中所述减压浓缩的温度为35~45℃。
优选的,步骤6)中所述嗜酸性乳酸杆菌的接种量为占复合中药水提液体积的4~6%,所述发酵的温度为35~40℃,所述发酵的时间为25~45h。
本发明还提供了上述治疗细菌性阴道炎的中药组合物的制备方法,包括如下步骤:
(1)将生姜与五味子、肉桂、艾叶、党参、白头翁、金银花、蒲公英、木通、虎杖、白术混合,粉碎过筛,收集筛下组分;
(2)将所述筛下组分与水混合进行煎煮,得混合液;
(3)将所述混合液减压浓缩至原体积的1/6~1/4后,与复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物。
优选的,步骤(1)中所述粉碎过筛的目数为150~250目。
优选的,步骤(2)中所述筛下组分与水的混合比例为1g:4~6mL,所述煎煮的温度为80~90℃,所述煎煮的时间为40~50min。
优选的,步骤(3)中所述减压浓缩的温度为35~45℃。
生姜:性温,味辛。归肺、脾、胃经。具有止吐,止痰,止咳,减轻鱼蟹毒的作用。有挥发油、姜辣素、二苯基庚烷等活性成分。挥发油:主要成分是单萜类化合物,例如α-蒎烯,β-吡喃,α-谷氨酰胺等,且倍半萜烯占50%至60%,氧化倍半萜烯占17%,其余主要是单萜烯和氧化单萜烯。姜辣素:分为姜酚,姜烯酚,姜油酮,姜油酮和姜二醇,它们都含有3-甲氧基-4-羟基苯官能团,其中6-姜辣素含量超过30%,具有抗氧化、抗菌、抗炎、降低胆固醇、抗动脉粥样硬化、增强免疫力、防辐射、保肝和抗过敏等药理作用。研究表明,生姜含有生姜精油0.15~0.17%,多糖5.97%,烯烃61.41%,黄酮类2.63%等多种活性物质,具有开胃健脾,促进食欲,抗氧化,抗肿瘤,降温和防暑,杀菌和解毒等多种药理作用。
五味子:味酸、甘,性温。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗盗汗,津伤口渴,内热消渴,心悸失眠。五味子还具有很好的抑菌性能,可抑制常见的金色葡萄球菌、肺炎杆菌、肠道沙门氏菌、绿脓杆菌等的生长与繁殖。
肉桂:味辛、甘,性大热。用于阳痿宫冷,腰膝冷痛,肾虚作喘,虚阳上浮,眩晕目赤,心腹冷痛,虚寒吐泻,寒疝腹痛,痛经经闭。肉桂不仅抗真菌,而且抗细菌。对大肠杆菌、沙门氏菌、假单胞菌以及多药耐药细菌具有抑制作用。
艾叶:性温、味苦。归肝、脾、肾经。外用具有祛湿止痒功效。用于呕吐血液,子宫出血,月经过多,胎儿漏血,腹部冷痛,月经不调,子宫寒冷,皮肤瘙痒。研究表明,艾叶具有抗病毒,抗菌,抗哮喘,祛痰和镇咳,镇静,利胆,止血,兴奋子宫等药理作用;艾叶挥发油,艾叶水浸剂,艾叶醇提取物,艾叶熏蒸等可抑制或杀灭各种细菌和真菌,病毒,支原体。
党参:党参味甘,性平。有补中益气、止渴、健脾益肺,养血生津。用于脾肺气虚,食少倦怠,咳嗽虚喘,气血不足,面色萎黄,心悸气短,津伤口渴,内热消渴。懒言短气、四肢无力、食欲不佳、气虚、气津两虚、气血双亏以及血虚萎黄等症。
白头翁:性苦,寒。具有清热解毒,凉血止痢之功效,常用于热毒血痢,阴痒带下。
金银花:性甘、寒。清热解毒,消炎退肿。主治外感风热或温病发热,中暑,热毒血痢,痈肿疔疮,喉痹等多种感染性疾病。
蒲公英:味苦、甘,寒。主要用于疔疮肿毒,乳痈,瘰疬,目赤,咽痛,肺痈,肠痈,湿热黄疸,热淋涩痛等。
木通:味苦,性寒。有利尿通淋,清心除烦,通经下乳的功效。用于淋证,水肿,心烦尿赤,口舌生疮,经闭乳少,湿热痹痛。
虎杖:味微苦,性微寒。具有利湿退黄,清热解毒,散瘀止痛,止咳化痰的功效。用于湿热黄疸,淋浊,带下,风湿痹痛,痈肿疮毒,水火烫伤,经闭,症瘕,趺打损伤,肺热咳嗽。
白术:苦、甘,温。具有补气健脾,燥湿利水,止汗,安胎等功效。主治脾气虚弱,神疲乏力,食少腹胀,大便溏薄,水饮内停,小便不利,水肿,痰饮眩晕,湿痹酸痛,气虚自汗,胎动不安。
与现有技术相比,本发明的有益效果如下:
1、本发明提供的复合中药发酵液由嗜酸性乳酸杆菌发酵苦参、青蒿、杜仲和黄连得到。嗜酸性乳酸杆菌属于乳酸菌家族中的一类重要成员,该菌株对女性非常重要,因为它的生物产品之一是乳酸,有助于维持阴道健康。苦参具有清热燥湿,杀虫,利尿之功。用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癣麻风,外治滴虫性阴道炎;青蒿具有清虚热,除骨蒸,解暑热,截疟,退黄之功效。常用于温邪伤阴,夜热早凉,阴虚发热,骨蒸劳热,暑邪发热,疟疾寒热,湿热黄疸等病症的治疗;杜仲自身所含的黄酮类、绿原酸等活性物质具有强化免疫细胞分化提高免疫细胞活性和应答,激活免疫系统并且增强免疫器官发育的作用,绿原酸还可抑制有害菌的繁殖,改善菌群微环境;黄连具有清热燥湿,泻火解毒的功效。经本发明研究意外发现,将苦参、青蒿、杜仲和黄连联用,可具有显著抑制阴道加德纳氏菌(GV)、消化链球菌和普通拟杆菌的功效。本发明利用发酵的手段将嗜酸性乳酸杆菌与上述四味中药的功能进行结合,发现二者可起到双向增效的作用。一方面,嗜酸性乳酸杆菌可增加苦参、青蒿、杜仲和黄连中黄酮类、萜类、氨基酸等有效成分的含量,促进无活性物质转化为抑菌活性物质,协助苦参、青蒿、杜仲和黄连抑菌功能的发挥,提高四味中药的生物利用度,大大增强其抑菌功能。另一方面,苦参、青蒿、杜仲和黄连联用,也可协同调节发酵菌种的活性,为嗜酸性乳酸杆菌提供营养成分,显著促进嗜酸性乳酸杆菌的增殖,将嗜酸性乳酸杆菌定植到阴道中,进而起到平衡阴道菌群环境的作用,从根本上解决细菌性阴道炎的困扰。
2、本发明将生姜与五味子、肉桂、艾叶等组分按照合理的比例复配制备水煎液,符合中药配伍原则。再与复合中药发酵液混合,不仅加强了对阴道有害菌的抑制作用,使抑菌性能稳定持久,还能同时补充阴道有益菌数量,改善阴道菌群环境,而且由于各组分均为天然植物药物,安全可靠,温寒相抵,外用对皮肤温和无刺激,对于治疗细菌性阴道炎具有显著的积极作用,应用前景十分广阔。
具体实施方式
本发明提供了一种治疗细菌性阴道炎的中药组合物,由包含如下重量份的组分制备得到:生姜40~50份,五味子35~45份,肉桂30~40份,艾叶30~40份,党参25~35份,复合中药发酵液25~35份,白头翁20~30份,金银花20~25份,蒲公英15~20份,木通15~20份,虎杖10~15份,白术5~10份,所述复合中药发酵液由嗜酸性乳酸杆菌发酵苦参、青蒿、杜仲和黄连得到。
在本发明中,所述治疗细菌性阴道炎的中药组合物,优选由包含如下重量份的组分制备得到:生姜42~48份,五味子38~42份,肉桂32~38份,艾叶32~38份,党参28~32份,复合中药发酵液28~32份,白头翁22~28份,金银花22~24份,蒲公英17~19份,木通17~19份,虎杖12~14份,白术7~9份。
在本发明中,所述治疗细菌性阴道炎的中药组合物,进一步优选由包含如下重量份的组分制备得到:生姜45份,五味子40份,肉桂35份,艾叶35份,党参30份,复合中药发酵液30份,白头翁25份,金银花23份,蒲公英18份,木通18份,虎杖13份,白术8份。
在本发明中,所述复合中药发酵液的具体制备步骤包括:
1)将苦参、青蒿、杜仲和黄连混合,粉碎过筛,收集筛下组分;
2)将所述筛下组分与水混合,进行第一煎煮,得药液a和药渣a;
3)将药渣a与水混合,进行第二煎煮,得药液b和药渣b;
4)将药渣b与水混合,进行第三煎煮,得药液c和药渣c;
5)将药液a,药液b和药液c混合,减压浓缩至原体积的1/6~1/4,得复合中药水提液;
6)将嗜酸性乳酸杆菌接种于所述复合中药水提液中进行发酵,得复合中药发酵液。
在本发明所述复合中药发酵液的具体制备步骤中,步骤1)中所述苦参、青蒿、杜仲和黄连的混合质量比优选为2~4:1~3:1~3:1~2,进一步优选为3:2:2:1;所述粉碎过筛的目数优选为150~250目,进一步优选为180~220目,更进一步优选为200目。
在本发明所述复合中药发酵液的具体制备步骤中,步骤2)中所述筛下组分与水的混合比例优选为1g:7~9mL,进一步优选为1g:8mL;所述第一煎煮的温度优选为90~100℃,进一步优选为92~98℃,更进一步优选为95℃;所述第一煎煮的时间优选为45~55min,进一步优选为48~52min,更进一步优选为50min。
在本发明所述复合中药发酵液的具体制备步骤中,步骤3)中所述药渣a与水的混合比例优选为1g:4~6mL,进一步优选为1g:5mL;所述第二煎煮的温度优选为80~90℃,进一步优选为82~88℃,更进一步优选为85℃;所述第二煎煮的时间优选为40~50min,进一步优选为42~48min,更进一步优选为45min。
在本发明所述复合中药发酵液的具体制备步骤中,步骤4)中所述药渣b与水的混合比例优选为1g:2~4mL,进一步优选为1g:3mL;所述第三煎煮的温度优选为70~80℃,进一步优选为72~78℃,更进一步优选为75℃;所述第三煎煮的时间优选为30~40min,进一步优选为32~38min,更进一步优选为35min。
在本发明所述复合中药发酵液的具体制备步骤中,步骤5)中所述将药液a,药液b和药液c混合,减压浓缩至原体积的1/6~1/4,得复合中药水提液,进一步优选为将药液a,药液b和药液c混合,减压浓缩至原体积的1/5,得复合中药水提液。
在本发明所述复合中药发酵液的具体制备步骤中,步骤5)中所述减压浓缩的温度优选为35~45℃,进一步优选为38~42℃,更进一步优选为40℃。
在本发明所述复合中药发酵液的具体制备步骤中,步骤6)中所述嗜酸性乳酸杆菌的接种量优选为占复合中药水提液体积的4~6%,进一步优选为占复合中药水提液体积的5%;所述发酵的温度优选为35~40℃,进一步优选为36~38℃,更进一步优选为37℃;所述发酵的时间优选为25~45h,进一步优选为30~40h,更进一步优选为35h。
本发明还提供了上述治疗细菌性阴道炎的中药组合物的制备方法,包括如下步骤:
(1)将生姜与五味子、肉桂、艾叶、党参、白头翁、金银花、蒲公英、木通、虎杖、白术混合,粉碎过筛,收集筛下组分;
(2)将所述筛下组分与水混合进行煎煮,得混合液;
(3)将所述混合液减压浓缩至原体积的1/6~1/4后,与复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物。
在本发明中,步骤(1)中所述粉碎过筛的目数优选为150~250目,进一步优选为180~220目,更进一步优选为200目。
在本发明中,步骤(2)中所述筛下组分与水的混合比例优选为1g:4~6mL,进一步优选为1g:5mL;所述煎煮的温度优选为80~90℃,进一步优选为82~88℃,更进一步优选为85℃;所述煎煮的时间优选为40~50min,进一步优选为42~48min,更进一步优选为45min。
在本发明中,步骤(3)中所述减压浓缩的温度优选为35~45℃,进一步优选为38~42℃,更进一步优选为40℃。
在本发明中,步骤(3)中所述将所述混合液减压浓缩至原体积的1/6~1/4后,与复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物,进一步优选为将所述混合液减压浓缩至原体积的1/5后,与复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物。
下面结合实施例对本发明提供的技术方案进行详细的说明,但是不能把它们理解为对本发明保护范围的限定。
以下实施例中的嗜酸性乳酸杆菌购买自北纳生物-河南省工业微生物菌种工程技术研究中心,菌种编号为BNCC336636;对比例中的保加利亚乳杆菌购买自北纳生物-河南省工业微生物菌种工程技术研究中心,菌种编号为BNCC189751;其余原料均为普通市售可得。
实施例1
一、复合中药发酵液的制备:
1)将苦参、青蒿、杜仲和黄连按照2:1:1:1的质量比混合,粉碎过150目筛,收集筛下组分;
2)将所述筛下组分与水按照1g:7mL的比例混合,于90℃下进行第一煎煮45min,得药液a和药渣a;
3)将药渣a与水按照1g:4mL的比例混合,于80℃下进行第二煎煮40min,得药液b和药渣b;
4)将药渣b与水按照1g:2mL的比例混合,于70℃下进行第三煎煮30min,得药液c和药渣c;
5)将药液a,药液b和药液c混合,于35℃下减压浓缩至原体积的1/4,得复合中药水提液;
6)将嗜酸性乳酸杆菌按照占复合中药水提液体积的4%的接种量接种于所述复合中药水提液中于35℃下进行发酵25h,得复合中药发酵液。
二、一种治疗细菌性阴道炎的中药组合物的制备:
(1)按照重量份数,准备25份上述复合中药发酵液,40份生姜,35份五味子,30份肉桂,30份艾叶,25份党参,20份白头翁,20份金银花,15份蒲公英,15份木通,10份虎杖,5份白术;
(2)将40份生姜与35份五味子、30份肉桂、30份艾叶、25份党参、20份白头翁、20份金银花、15份蒲公英、15份木通、10份虎杖、5份白术混合,粉碎过150目筛,收集筛下组分;
(3)将所述筛下组分与水按照1g:4mL的比例混合于80℃下进行煎煮40min,得混合液;
(4)将所述混合液于35℃下减压浓缩至原体积的1/4后,与25份复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物。
实施例2
一、复合中药发酵液的制备:
1)将苦参、青蒿、杜仲和黄连按照3:2:2:1的质量比混合,粉碎过200目筛,收集筛下组分;
2)将所述筛下组分与水按照1g:8mL的比例混合,于95℃下进行第一煎煮50min,得药液a和药渣a;
3)将药渣a与水按照1g:5mL的比例混合,于85℃下进行第二煎煮45min,得药液b和药渣b;
4)将药渣b与水按照1g:3mL的比例混合,于75℃下进行第三煎煮35min,得药液c和药渣c;
5)将药液a,药液b和药液c混合,于40℃下减压浓缩至原体积的1/5,得复合中药水提液;
6)将嗜酸性乳酸杆菌按照占复合中药水提液体积的5%的接种量接种于所述复合中药水提液中于37℃下进行发酵35h,得复合中药发酵液。
二、一种治疗细菌性阴道炎的中药组合物的制备:
(1)按照重量份数,准备30份上述复合中药发酵液,45份生姜,40份五味子,35份肉桂,35份艾叶,30份党参,25份白头翁,23份金银花,18份蒲公英,18份木通,13份虎杖,8份白术;
(2)将45份生姜与40份五味子、35份肉桂、35份艾叶、30份党参、25份白头翁、23份金银花、18份蒲公英、18份木通、13份虎杖、8份白术混合,粉碎过200目筛,收集筛下组分;
(3)将所述筛下组分与水按照1g:5mL的比例混合于85℃下进行煎煮45min,得混合液;
(4)将所述混合液于40℃下减压浓缩至原体积的1/5后,与30份复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物。
实施例3
一、复合中药发酵液的制备:
1)将苦参、青蒿、杜仲和黄连按照4:3:3:2的质量比混合,粉碎过250目筛,收集筛下组分;
2)将所述筛下组分与水按照1g:9mL的比例混合,于100℃下进行第一煎煮55min,得药液a和药渣a;
3)将药渣a与水按照1g:6mL的比例混合,于90℃下进行第二煎煮50min,得药液b和药渣b;
4)将药渣b与水按照1g:4mL的比例混合,于80℃下进行第三煎煮40min,得药液c和药渣c;
5)将药液a,药液b和药液c混合,于45℃下减压浓缩至原体积的1/6,得复合中药水提液;
6)将嗜酸性乳酸杆菌按照占复合中药水提液体积的6%的接种量接种于所述复合中药水提液中于40℃下进行发酵45h,得复合中药发酵液。
二、一种治疗细菌性阴道炎的中药组合物的制备:
(1)按照重量份数,准备35份上述复合中药发酵液,50份生姜,45份五味子,40份肉桂,40份艾叶,35份党参,30份白头翁,25份金银花,20份蒲公英,20份木通,15份虎杖,10份白术;
(2)将50份生姜与45份五味子、40份肉桂、40份艾叶、35份党参、30份白头翁、25份金银花、20份蒲公英、20份木通、15份虎杖、10份白术混合,粉碎过250目筛,收集筛下组分;
(3)将所述筛下组分与水按照1g:6mL的比例混合于90℃下进行煎煮50min,得混合液;
(4)将所述混合液于45℃下减压浓缩至原体积的1/6后,与35份复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物。
对比例1
除省去步骤6)嗜酸性乳酸杆菌对复合中药水提液进行发酵的步骤之外,其余步骤及步骤参数均与实施例2保持一致。
对比例2
除将步骤6)改为“将保加利亚乳杆菌按照占复合中药水提液体积的5%的接种量接种于所述复合中药水提液中于42℃下进行发酵35h,得复合中药发酵液”之外,其余步骤及步骤参数均与实施例2保持一致。
对比例3
除将步骤1)中的“苦参、青蒿、杜仲和黄连”改为“黄芩、藿香、百部和黄柏”之外,其余步骤及步骤参数均与实施例2保持一致。
对比例4
除省去生姜这一组分外,其余步骤及步骤参数均与实施例2保持一致。
对比例5
除省去复合中药发酵液的制备及添加之外,其余步骤及步骤参数均与实施例2保持一致。
实验例1
以实施例2和对比例1~5为例,将不同中药组合物分别用15倍体积的水稀释,检测不同中药组合物稀释液对阴道加德纳氏菌(GV)(购买自宁波泰斯拓生物技术有限责任公司,编号为TS275631)、消化链球菌(购买自宁波泰斯拓生物技术有限责任公司,编号为TS321157)、普通拟杆菌(购买自宁波泰斯拓生物技术有限责任公司,编号为TS307466)的抑制作用,结果如表1所示。
表1不同中药组合物稀释液的抑菌率(%)
由表1可知,与对比例1~5相比,本发明实施例2的中药组合物对阴道加德纳氏菌(GV)、消化链球菌和普通拟杆菌的抑制效果更佳,对各致病菌的抑制率均高达98%以上。与对比例1不采用嗜酸性乳酸杆菌进行发酵相比,本发明实施例2采用了嗜酸性乳酸杆菌进行发酵的方式更有利于对阴道致病菌的抑制作用。这表明,采用嗜酸性乳酸杆菌发酵苦参、青蒿、杜仲和黄连,可大大增强其抑菌功能。
实验例2
以实施例2和对比例2~3为例,以MRS培养基(蛋白胨10.0g,牛肉膏10.0g,酵母粉4.0g,葡萄糖20.0g,硫酸镁0.2g,乙酸钠5.0g,柠檬酸三铵2.0g,磷酸氢二钾2.0g,硫酸锰0.04g,吐温80 1.0g,蒸馏水1.0L。pH 5.7。121℃,15min灭菌)和MRS培养基(蛋白胨10.0g,牛肉浸粉8.0g,酵母粉4.0g,葡萄糖20.0g,硫酸镁0.2g,乙酸钠5.0g,柠檬酸二铵2.0g,磷酸氢二钾2.0g,硫酸锰0.04g,吐温80 1.0g,蒸馏水1.0L。pH 5.7。118℃,15min灭菌)分别为空白对照1和空白对照2。其中,空白对照1的培养菌及其接种量与实施例2、对比例3保持一致,空白对照1的培养条件为37℃,35h,厌氧;空白对照2的培养菌及其接种量与对比例2保持一致,空白对照2的培养条件为42℃,35h,厌氧。检测实施例2和对比例2~3的复合中药发酵液中的乳酸菌活菌数以及空白对照1、空白对照2培养后的乳酸菌活菌数,结果如表2所示。
表2不同处理的乳酸菌活菌数
分组 | 活菌数(CFU/mL) |
实施例2 | 4.43×1010 |
对比例2 | 3.51×108 |
对比例3 | 3.26×107 |
空白对照1 | 2.28×108 |
空白对照2 | 3.25×108 |
由表2可知,与空白对照1相比,本发明实施例2可明显提高嗜酸性乳酸杆菌的活菌数,而对比例3却显著降低了嗜酸性乳酸杆菌的活菌数。这表明,并非对任意中药发酵均可提高乳酸菌的活菌数,只有发酵本发明的中药才能促进嗜酸性乳酸杆菌的增殖。与空白对照2相比,对比例2可提高保加利亚乳杆菌的活菌数,但增幅及最终的活菌数均远远小于本发明实施例2。这表明,发酵菌种也会影响最终的发酵效果,只有采用嗜酸性乳酸杆菌发酵本发明的中药才能大大提高乳酸菌的活菌数。
实验例3
以实施例2和对比例1~5中的中药组合物为例,以普通市售的洁尔阴和妇炎洁为对照组,研究不同产品对细菌性阴道炎患者的治疗效果:2022年6月,将80名确诊细菌性阴道炎患者(年龄35~45周岁)随机分成8组,每组10人,分别使用本发明实施例2、对比例1~5中的中药组合物以及洁尔阴和妇炎洁。使用方法为:将实施例2和对比例1~5制备的中药组合物分别与60℃的温开水按照1:15的体积比混合,冲洗阴道,每天一次。洁尔阴和妇炎洁按照说明书使用。7天为一个疗程,2个疗程以后,复查阴道分泌物。若患者治疗期间慢慢好转,2个疗程后复查阴道分泌物正常,没有阴道炎表现,且随访3个月,未复发,则表明患者被治愈。随访结束后统计结果如表3所示。
表3不同产品对细菌性阴道炎患者的治疗效果
分组 | 治愈人数 |
实施例2 | 10 |
对比例1 | 4 |
对比例2 | 6 |
对比例3 | 4 |
对比例4 | 3 |
对比例5 | 2 |
洁尔阴 | 4 |
妇炎洁 | 5 |
由表3可知,与对比例1~5和洁尔阴组、妇炎洁组相比,使用本发明实施例2的中药组合物,治愈率可高达100%。说明本发明的中药组合物对于治疗细菌性阴道炎有明显有益效果,可大大提高患者生活质量。
以上所述仅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,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (9)
1.一种治疗细菌性阴道炎的中药组合物,其特征在于,由如下重量份的组分制备得到:生姜40~50份,五味子35~45份,肉桂30~40份,艾叶30~40份,党参25~35份,复合中药发酵液25~35份,白头翁20~30份,金银花20~25份,蒲公英15~20份,木通15~20份,虎杖10~15份,白术5~10份,所述复合中药发酵液由嗜酸性乳酸杆菌发酵苦参、青蒿、杜仲和黄连得到;
所述复合中药发酵液的具体制备步骤包括:
1)将苦参、青蒿、杜仲和黄连混合,粉碎过筛,收集筛下组分;
2)将所述筛下组分与水混合,进行第一煎煮,得药液a和药渣a;
3)将药渣a与水混合,进行第二煎煮,得药液b和药渣b;
4)将药渣b与水混合,进行第三煎煮,得药液c和药渣c;
5)将药液a,药液b和药液c混合,减压浓缩至原体积的1/6~1/4,得复合中药水提液;
6)将嗜酸性乳酸杆菌接种于所述复合中药水提液中进行发酵,得复合中药发酵液;
步骤(1)中所述苦参、青蒿、杜仲和黄连的混合质量比为2~4:1~3:1~3:1~2;
步骤6)中所述嗜酸性乳酸杆菌的接种量为占复合中药水提液体积的4~6%。
2.根据权利要求1所述的一种治疗细菌性阴道炎的中药组合物,其特征在于,步骤1)中所述粉碎过筛的目数为150~250目。
3.根据权利要求1所述的一种治疗细菌性阴道炎的中药组合物,其特征在于,步骤2)中所述筛下组分与水的混合比例为1g:7~9mL,所述第一煎煮的温度为90~100℃,所述第一煎煮的时间为45~55min;
步骤3)中所述药渣a与水的混合比例为1g:4~6mL,所述第二煎煮的温度为80~90℃,所述第二煎煮的时间为40~50min;
步骤4)中所述药渣b与水的混合比例为1g:2~4mL,所述第三煎煮的温度为70~80℃,所述第三煎煮的时间为30~40min。
4.根据权利要求1所述的一种治疗细菌性阴道炎的中药组合物,其特征在于,步骤5)中所述减压浓缩的温度为35~45℃。
5.根据权利要求1所述的一种治疗细菌性阴道炎的中药组合物,其特征在于,步骤6)中所述发酵的温度为35~40℃,所述发酵的时间为25~45h。
6.权利要求1~5任意一项所述的治疗细菌性阴道炎的中药组合物的制备方法,其特征在于,包括如下步骤:
(1)将生姜与五味子、肉桂、艾叶、党参、白头翁、金银花、蒲公英、木通、虎杖、白术混合,粉碎过筛,收集筛下组分;
(2)将所述筛下组分与水混合进行煎煮,得混合液;
(3)将所述混合液减压浓缩至原体积的1/6~1/4后,与复合中药发酵液混合,得治疗细菌性阴道炎的中药组合物。
7.根据权利要求6所述的治疗细菌性阴道炎的中药组合物的制备方法,其特征在于,步骤(1)中所述粉碎过筛的目数为150~250目。
8.根据权利要求6所述的治疗细菌性阴道炎的中药组合物的制备方法,其特征在于,步骤(2)中所述筛下组分与水的混合比例为1g:4~6mL,所述煎煮的温度为80~90℃,所述煎煮的时间为40~50min。
9.根据权利要求6所述的治疗细菌性阴道炎的中药组合物的制备方法,其特征在于,步骤(3)中所述减压浓缩的温度为35~45℃。
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