CN117442681A - 一种预防或治疗便秘的中药组合物及其制备方法和应用 - Google Patents
一种预防或治疗便秘的中药组合物及其制备方法和应用 Download PDFInfo
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- CN117442681A CN117442681A CN202311693735.2A CN202311693735A CN117442681A CN 117442681 A CN117442681 A CN 117442681A CN 202311693735 A CN202311693735 A CN 202311693735A CN 117442681 A CN117442681 A CN 117442681A
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Abstract
本发明提供一种预防或治疗便秘的中药组合物及其制备方法和应用,包括以下重量份原料:党参25‑45份、白术12‑25份、茯苓18‑22份、炒地榆10‑18份、沉香5‑12份、乌药8‑15份、玄参5‑10份、麦冬3‑8份、生地黄2‑6份、神曲2‑8份、大黄3‑9份、枳实1‑5份、厚朴2‑7份、芒硝1‑5份、木香2‑8份、炙甘草2‑7份、柴胡2‑6份,按照君药、臣药和佐使药的配伍,分步制备提取药物中的活性成分,使药效发挥更充分,有效改善肠道内部微生态环境,防止便秘的发生,给药后秘症状得到明显改善,排便次数增加,大便形状正常,排便费力程度减轻,有效预防或治疗实秘型便秘症状。
Description
技术领域
本发明涉及中药技术领域,特别涉及一种预防或治疗便秘的中药组合物及其制备方法和应用。
背景技术
中医将便秘分为实秘和虚秘两种类型:实秘类型包括肠胃积热、气机阻滞和阴寒积滞。其中,肠胃积热的症状为口渴多饮,大便秘结;气机阻滞的症状为胸胁胀满、大便干结;阴寒积滞的症状为四肢不温、大便干结等;虚秘类型包括气虚便秘、血虚便秘和阳虚便秘,包括大便干结或不干结,虽有便意但排便乏力,且汗出气短、神疲乏力、肢倦懒言等。
便秘是一种常见的消化系统疾病,表现为排便次数减少、排便费力、粪质较硬或呈球状、排便不尽感等症状。实秘型便秘是其中一种类型,主要是由于肠道蠕动减缓、粪便在肠道内停留时间过长、水分被过度吸收所致。治疗实秘型便秘的方法包括药物治疗和非药物治疗,其中药物治疗主要采用中药或西药。西医治疗便秘的药物较多,起效时间相对较快,能够迅速缓解便秘症状,西药治疗便秘的副作用相对较大,如可能导致药物依赖、肠道菌群失调等,而且西药治疗便秘的疗效可能不稳定,容易受到饮食、生活习惯等因素的影响。
中药治疗便秘具有独特的优势,主要是由于中药具有整体调节作用,能够针对病因进行治疗,同时具有副作用较小的优点。在中药组合物方面,已有许多方剂被用于治疗便秘,以增强肠道蠕动、软化粪便、缓解便秘症状。尽管已有一些中药组合物被用于治疗便秘,但仍存在一些问题,不同患者的病情和体质存在差异,实型虚型便秘形式不同,需对不同类型的便秘进行辨证施治,且中药的成分相对复杂,不同药物之间可能存在相互作用,搭配不当会导致疗效不稳定等。
发明内容
鉴于此,本发明提出一种预防或治疗便秘的中药组合物及其制备方法和应用,解决上述问题。
本发明的技术方案是这样实现的:一种预防或治疗便秘的中药组合物:包括以下重量份原料:党参25-45份、白术12-25份、茯苓18-22份、炒地榆10-18份、沉香5-12份、乌药8-15份、玄参5-10份、麦冬3-8份、生地黄2-6份、神曲2-8份、大黄3-9份、枳实1-5份、厚朴2-7份、芒硝1-5份、木香2-8份、炙甘草2-7份、柴胡2-6份。
进一步的,一种预防或治疗便秘的中药组合物:包括以下重量份原料:党参30-40份、白术15-20份、茯苓19-21份、炒地榆15-17份、沉香7-10份、乌药10-13份、玄参6-8份、麦冬4-6份、生地黄3-5份、神曲4-6份、大黄4-8份、枳实3-5份、厚朴3-5份、芒硝2-4份、木香4-6份、炙甘草3-5份、柴胡3-5份。
进一步的,包括以下重量份原料:党参35份、白术18份、茯苓20份、炒地榆16份、沉香8份、乌药12份、玄参7份、麦冬5份、生地黄4份、神曲5份、大黄6份、枳实4份、厚朴4份、芒硝3份、木香5份、炙甘草4份、柴胡4份。
进一步的,以所述原料加入药学上可接受的辅料制备成任意剂型。
进一步的,一种预防或治疗便秘的中药组合物的制备方法,包括以下步骤:
S1、按照配方分别称取原料党参、白术、茯苓、炒地榆、沉香、乌药经干燥、粉碎过筛得到粗粉I,备用;取玄参、麦冬、生地黄、神曲经干燥、粉碎过筛得到粗粉II;
S2、将上述粗粉I和粗粉II混合,加入纯化水,超声浸提2-4次,每次40-60min,过滤,合并得到滤液I;
S3、取大黄、枳实、厚朴、芒硝、木香、炙甘草、柴胡放入-20℃以下冷冻干燥后粉碎,放入提取罐内,再使用无水乙醇进行提取,提取时间3-5h,提取后过滤,得到滤液II;
S4、将上述滤液I和滤液II混合,调整pH为5-7,浓缩至相对密度为1.10-1.2,制得流浸膏。
进一步的,所述S1中粗粉I和粗粉II的粉碎粒径为850±70μm。
进一步的,所述S2中粗粉I和粗粉II的混合料和纯化水的质量体积g/mL为4-8:20。
进一步的,所述S2中超声浸提的功率为300-400W,超声频率为20-100KHz。
进一步的,一种预防或治疗便秘的中药组合物在制备预防或治疗便秘的药物中的应用。
与现有技术相比,本发明的有益效果是:
本发明中药组合物为临床经验方,方中党参、白术、茯苓、炒地榆、沉香、乌药为君药,具有补中益气、健脾益肺、收敛止血等作用,玄参、麦冬、生地黄、神曲为臣药,可以增强君药的作用,具有养阴生津、润燥通便、消食和中等作用。可以协助君药治疗脾胃虚弱、肺气不足等病症,并可以缓解因疾病引起的便秘、食欲不振等症状;大黄、枳实、厚朴、芒硝、木香互为佐药,具有清热泻火、行气通便、消食化积等作用,可以辅助君药和臣药治疗热性病症,炙甘草具有调和诸药的作用,可以增强药效,使得方剂整体更加平和,减少不良反应的发生。柴胡具有疏肝解郁的作用,可以增强君药和臣药的疗效,可以增强沉香、乌药的行气作用,缓解因便秘引起的腹胀、腹痛等症状。本发明方剂可用于治疗肠胃积热、气机阻滞、肺气不足等病症,并可以缓解因疾病引起的便秘、食欲不振等症状。
按照君药、臣药和佐使药的配伍,分步制备提取药物中的活性成分,并进行混合复配,动物实验证实本发明中药组合物具有增加肠胃蠕动、润肠通便的功能,能明显改善肠胃积热、气机阻滞和阴寒积滞动物模型的便秘症状;临床实验证实本发明中药组合物可明显减少肠胃积热、气机阻滞和阴寒积滞带来的便秘症状,缓解胃肠道不适。
具体实施方式
为了更好理解本发明技术内容,下面提供具体实施例,对本发明做进一步的说明。
本发明实施例所用的实验方法如无特殊说明,均为常规方法。
本发明实施例所用的材料、试剂等,如无特殊说明,均可从商业途径得到。
以下依据《中国药典》、《中药大辞典》以及《中华草本》等介绍主要原料药的基本情况。
党参:性味归经:甘,平。归脾、肺经。功能主治:补中益气,健脾益肺。用于脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴。
白术:性味归经:苦、甘,温。归脾、胃经。功能主治:健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。
茯苓:性味归经:甘、淡,平。归心、肺、脾、肾经。功能主治:利水渗湿,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。
炒地榆:性味归经:苦、酸、涩,微寒。归肝、大肠经。功能主治:凉血止血,解毒敛疮。用于便血,痔血,血痢,崩漏,水火烫伤,痈肿疮毒。
沉香:性味归经:辛、苦,微温。归脾、胃、肾经。功能主治:行气止痛,温中止呕,纳气平喘。用于胸腹胀闷疼痛,胃寒呕吐呃逆,肾虚气逆喘急。
乌药:性味归经:辛,温。归肺、脾、肾、膀胱经。功能主治:行气止痛,温肾散寒。用于胸腹胀痛,寒疝腹痛,尿频遗尿。
玄参:性味归经:甘、苦、咸,寒。归肺、胃、肾经。功能主治:清热凉血,滋阴解毒。用于热入营血,温毒发斑,热病伤阴,舌绛烦渴,津伤便秘,骨蒸劳嗽,目赤咽痛,瘰疬痰核,痈疽疮毒。
麦冬:性味归经:甘、微苦,微寒。归心、肺、胃经。功能主治:养阴生津,润肺止咳。用于肺胃阴虚之津少口渴、干咳咯血;心阴不足之心悸易惊及热病后期热伤津液等证。
生地黄:性味归经:甘、苦,寒。归心、肝、肾经。功能主治:清热生津,凉血止血。用于热风伤阴口渴舌绛,阴虚内热消渴多饮。
神曲:性味归经:甘、辛,温。归脾、胃经。功能主治:消食和胃。用于饮食积滞证。
大黄:性味归经:苦,寒。归脾、胃、大肠、肝、心包经。功能主治:泻热通肠,凉血逐瘀通经。用于实热便秘,积滞腹痛,泻痢不爽,湿热黄疸等症。
枳实:性味归经:苦、辛、酸,温。归脾、胃经。功能主治:破气消积,化痰除痞。用于积滞内停、痞满胀痛、泻痢后重、大便不通、痰滞气阻胸痹等证。
厚朴:性味归经:苦、辛,温。归脾、胃经和大肠经功能主治:行气燥湿,消积平喘用于湿阻中焦证和胃肠积滞症及咳喘痰多等症。
芒硝:性味归经:咸、苦,寒.归胃,大肠经.功能主治:泻热通便,润燥软坚,清火消肿.用于实热便秘,大便燥结,腹满胀痛;外治乳痈,痔疮肿痛,红眼肿痛未溃.
木香:性味归经:辛;苦;温功能主治:行气止痛;调中宣滞.主胞胁胀满足;脘腹胀痛;嗳吐泄泻;痢疾后重.用于胸脘胀痛,泻痢后重,食积不消,不思饮食.
炙甘草:性味归经:甘;平.归心;肺;脾;胃经功能主治:补脾和胃;益气复脉.主脾胃虚弱;倦怠乏力;心动悸;脉结代.用于脾胃虚弱,倦乏力,心动悸,脉结代.
柴胡:性味归经:苦、辛,微寒。归肝、胆、肺经。功能主治:疏散退热,舒肝,升阳,生津止渴。用于感冒发热,寒热往来,
实施例1
一种预防或治疗便秘的中药组合物,包括以下重量原料:党参25克、白术12克、茯苓18克、炒地榆10克、沉香5克、乌药8克、玄参5克、麦冬3克、生地黄2克、神曲2克、大黄3克、枳实1克、厚朴2克、芒硝1克、木香2克、炙甘草2克、柴胡2克。
实施例2
一种预防或治疗便秘的中药组合物,包括以下重量原料:党参45克、白术25克、茯苓22克、炒地榆18克、沉香12克、乌药15克、玄参10克、麦冬8克、生地黄6克、神曲8克、大黄9克、枳实5克、厚朴7克、芒硝5克、木香8克、炙甘草7克、柴胡6克。
上述实施例1-2采用以下制备方法:
S1、按照配方分别称取原料党参、白术、茯苓、炒地榆、沉香、乌药经干燥、粉碎过筛得到粗粉I,备用;取玄参、麦冬、生地黄、神曲经干燥、粉碎过筛得到粗粉II;所述粗粉I和粗粉II的粉碎粒径为780μm;
S2、将上述粗粉I和粗粉II混合,加入纯化水,粗粉I和粗粉II的混合料和纯化水的质量体积g/mL为4:20,超声浸提2次,超声浸提的功率为300W,超声频率为20KHz,每次40min,过滤,合并得到滤液I;
S3、取大黄、枳实、厚朴、芒硝、木香、炙甘草、柴胡放入-20℃以下冷冻干燥后粉碎,放入提取罐内,再使用无水乙醇进行提取,提取温度为80℃,提取压力为20KG/cm2,提取时间3h,提取后过滤,得到滤液II;
S4、将上述滤液I和滤液II混合,调整pH为5,浓缩至相对密度为1.10,制得流浸膏,加入药学上可接受的载体,制成颗粒剂。
实施例3
一种预防或治疗便秘的中药组合物,包括以下重量原料:党参40克、白术20克、茯苓21克、炒地榆17克、沉香10克、乌药13克、玄参8克、麦冬6克、生地黄5克、神曲6克、大黄8克、枳实5克、厚朴5克、芒硝4克、木香6克、炙甘草5克、柴胡5克。
实施例4
一种预防或治疗便秘的中药组合物,包括以下重量原料:党参30克、白术15克、茯苓19克、炒地榆15克、沉香7克、乌药10克、玄参6克、麦冬4克、生地黄3克、神曲4克、大黄4克、枳实3克、厚朴3克、芒硝2克、木香4克、炙甘草3克、柴胡3克。
上述实施例3-4采用以下制备方法:
S1、按照配方分别称取原料党参、白术、茯苓、炒地榆、沉香、乌药经干燥、粉碎过筛得到粗粉I,备用;取玄参、麦冬、生地黄、神曲经干燥、粉碎过筛得到粗粉II;所述粗粉I和粗粉II的粉碎粒径为920μm;
S2、将上述粗粉I和粗粉II混合,加入纯化水,粗粉I和粗粉II的混合料和纯化水的质量体积g/mL为8:20,超声浸提4次,超声浸提的功率为400W,超声频率为100KHz,每次60min,过滤,合并得到滤液I;
S3、取大黄、枳实、厚朴、芒硝、木香、炙甘草、柴胡放入-20℃以下冷冻干燥后粉碎,放入提取罐内,再使用无水乙醇进行提取,提取温度为90℃,提取压力为50KG/cm2,提取时间5h,提取后过滤,得到滤液II;
S4、将上述滤液I和滤液II混合,调整pH为7,浓缩至相对密度为1.2,制得流浸膏,加入药学上可接受的载体,制成丸剂。
实施例5
一种预防或治疗便秘的中药组合物,包括以下重量原料:党参35克、白术18克、茯苓20克、炒地榆16克、沉香8克、乌药12克、玄参7克、麦冬5克、生地黄4克、神曲5克、大黄6克、枳实4克、厚朴4克、芒硝3克、木香5克、炙甘草4克、柴胡4克。
上述实施例5采用以下制备方法:
S1、按照配方分别称取原料党参、白术、茯苓、炒地榆、沉香、乌药经干燥、粉碎过筛得到粗粉I,备用;取玄参、麦冬、生地黄、神曲经干燥、粉碎过筛得到粗粉II;所述粗粉I和粗粉II的粉碎粒径为850μm;
S2、将上述粗粉I和粗粉II混合,加入纯化水,粗粉I和粗粉II的混合料和纯化水的质量体积g/mL为6:20,超声浸提3次,超声浸提的功率为350W,超声频率为70KHz,每次50min,过滤,合并得到滤液I;
S3、取大黄、枳实、厚朴、芒硝、木香、炙甘草、柴胡放入-20℃以下冷冻干燥后粉碎,放入提取罐内,再使用无水乙醇进行提取,提取温度为85℃,提取压力为30KG/cm2,提取时间4h,提取后过滤,得到滤液II;
S4、将上述滤液I和滤液II混合,调整pH为6,浓缩至相对密度为1.11,制得流浸膏,加入药学上可接受的载体,制成胶囊剂。
试验实施例5中药组合物在制备预防或治疗便秘的药物中的应用
1、动物实验:
1.1、实验动物:SPF小鼠,体质量为30±5g,雄雌各半,实验前动物适应性喂养1周。各实验相关操作均符合《实验动物管理和使用指南》的要求。
1.2、受试药物:采用本发明的实施例5的中药组合物。
1.3、造模、给药:将小鼠分为3组,包括正常对照组、模型对照组、实施例5中药治疗组,每组10只,除正常对照组外,其余各组分别进行肠胃积热模型小鼠造模,将小鼠放置在特制的笼子中,限制其活动,并提供高脂、高蛋白、低纤维的饲料;将中药组合物用生理盐水配制成2g/100ml的溶液,然后给小鼠灌胃,每100g体重分别灌1ml药物溶液。
1.4、观察指标:在给药前和给药后不同时间点,观察小鼠的排便情况。包括排便次数、大便形状指标。
1.5、实验结果:
从上述结果可知,本发明的中药组合物具有增加肠胃蠕动、润肠通便的功能,有效改善小鼠肠道内部微生态环境,防止便秘的发生,给药后有效改善小鼠的排便次数,大便形状呈长条形或椭圆形,颜色为深褐色或黑色,质地软硬适中,小鼠的大便重量平均2.6g与进食量和饮水量相适应,保持一定的平衡。
2、临床试验:
2.1试验对象:共招募了100名符合条件的便秘患者,年龄在18-65岁之间,均存在肠胃积热、气机阻滞和阴寒积滞不同程度的便秘症状,如排便次数减少、大便干燥、排便费力等。
2.2试验方法:采用随机对照试验的方法,将患者分为实验组和对照组,每组各50人。实验组患者接受中药组合物治疗,对照组患者接受安慰剂治疗。
2.3给药方式:实验组患者口服中药组合物,每次3粒,每天3次,连续服用2周。对照组患者口服安慰剂,每次3粒,每天3次,连续服用2周。
2.4观察指标:记录患者治疗前后的便秘症状变化,包括排便次数、大便形状、排便费力程度等。同时观察患者的不良反应情况。
2.5疗效标准:
显效:排便次数增加,大便形状正常,排便畅通,大便松软,排便费力程度减轻,症状消失;
有效:排便次数每日一次或隔日一次,大便形状正常,排便畅通,大便松软,排便费力,症状消失或有所缓解;
无效:排便次数同治疗前,症状未能缓解。
2.5数据分析:对观察到的指标进行统计和分析,比较实验组和对照组患者的便秘症状改善情况和不良反应发生情况。
2.6试验结果:
例数 | 显效 | 有效 | 无效 | 总有效率% | |
实验组 | 50 | 48 | 2 | 0 | 100 |
对照组 | 50 | 12 | 2 | 36 | 28.0 |
实验组患者在治疗后,便秘症状得到明显改善,排便次数增加,大便形状正常,排便费力程度减轻。对照组患者在治疗后,便秘症状无明显改善,根据实验结果,本发明的中药组合物治疗便秘的疗效优于安慰剂治疗,且不良反应发生率较低。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种预防或治疗便秘的中药组合物,其特征在于:包括以下重量份原料:党参25-45份、白术12-25份、茯苓18-22份、炒地榆10-18份、沉香5-12份、乌药8-15份、玄参5-10份、麦冬3-8份、生地黄2-6份、神曲2-8份、大黄3-9份、枳实1-5份、厚朴2-7份、芒硝1-5份、木香2-8份、炙甘草2-7份、柴胡2-6份。
2.如权利要求1所述的一种预防或治疗便秘的中药组合物,其特征在于:包括以下重量份原料:党参30-40份、白术15-20份、茯苓19-21份、炒地榆15-17份、沉香7-10份、乌药10-13份、玄参6-8份、麦冬4-6份、生地黄3-5份、神曲4-6份、大黄4-8份、枳实3-5份、厚朴3-5份、芒硝2-4份、木香4-6份、炙甘草3-5份、柴胡3-5份。
3.如权利要求1所述的一种预防或治疗便秘的中药组合物,其特征在于:包括以下重量份原料:党参35份、白术18份、茯苓20份、炒地榆16份、沉香8份、乌药12份、玄参7份、麦冬5份、生地黄4份、神曲5份、大黄6份、枳实4份、厚朴4份、芒硝3份、木香5份、炙甘草4份、柴胡4份。
4.如权利要求1-3任一项所述的一种预防或治疗便秘的中药组合物,其特征在于:以所述原料加入药学上可接受的辅料制备成任意剂型。
5.如权利要求1所述的一种预防或治疗便秘的中药组合物的制备方法,其特征在于:包括以下步骤:
S1、按照配方分别称取原料党参、白术、茯苓、炒地榆、沉香、乌药经干燥、粉碎过筛得到粗粉I,备用;取玄参、麦冬、生地黄、神曲经干燥、粉碎过筛得到粗粉II;
S2、将上述粗粉I和粗粉II混合,加入纯化水,超声浸提2-4次,每次40-60min,过滤,合并得到滤液I;
S3、取大黄、枳实、厚朴、芒硝、木香、炙甘草、柴胡放入-20℃以下冷冻干燥后粉碎,放入提取罐内,再使用无水乙醇进行提取,提取时间3-5h,提取后过滤,得到滤液II;
S4、将上述滤液I和滤液II混合,调整pH为5-7,浓缩至相对密度为1.10-1.2,制得流浸膏。
6.如权利要求5所述的一种预防或治疗便秘的中药组合物的制备方法,其特征在于:所述S1中粗粉I和粗粉II的粉碎粒径为850±70μm。
7.如权利要求1所述的一种预防或治疗便秘的中药组合物的制备方法,其特征在于:所述S2中粗粉I和粗粉II的混合料和纯化水的质量体积g/mL为4-8:20。
8.如权利要求1所述的一种预防或治疗便秘的中药组合物的制备方法,其特征在于:所述S2中超声浸提的功率为300-400W,超声频率为20-100KHz。
9.如权利要求1所述的一种预防或治疗便秘的中药组合物的制备方法,其特征在于:所述S3中提取温度为80-90℃,提取压力为20-50KG/cm2。
10.如权利要求1-7任一项所述的一种预防或治疗便秘的中药组合物在制备预防或治疗便秘的药物中的应用。
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