CN116159102B - 一种治疗餐后不适综合征的中药组合物及其制备方法和用途 - Google Patents
一种治疗餐后不适综合征的中药组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明涉及中药技术领域,具体涉及一种治疗餐后不适综合征的中药组合物及其制备方法和用途。一种中药组合物,包括如下重量份的原料:北柴胡3‑20份,黄芩3‑20份,姜半夏3‑18份,灵芝3‑30份,桂枝3‑30份,生白芍3‑30份,厚朴3‑15份,檀香2‑15份,珍珠粉0.1‑3份,贯叶金丝桃1‑10份,栀子3‑18份和全瓜蒌3‑24份;本发明的上述中药组合物具有舒肝和胃,理气消胀之效,适用于肝胃不和证功能性消化不良餐后不适综合征,尤其是伴有焦虑抑郁等不良情绪的患者。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种治疗餐后不适综合征的中药组合物及其制备方法和用途。
背景技术
功能性消化不良(Functional dyspepsia,FD)是指具有餐后饱胀不适、早饱感、上腹痛、上腹烧灼感中的一项或多项的症状,而不能用器质性、***性或代谢性疾病等来解释产生症状原因的疾病。依据患者的主要症状特征、症状模式以及与症状相关的病理生理学机制将FD分为2个亚型,即上腹痛综合征(Epigastric pain syndrome,EPS)和餐后不适综合征(Postprandial distress syndrome,PDS)。PDS的患病率在FD人群中占比高达60%,因为本病难以彻底根治,容易反复发作,明显影响患者生活质量,因此多数PDS患者伴有焦虑抑郁等不同程度的不良情绪。
目前临床以促胃肠动力、抑酸和抗焦虑药使用为主,此外还有益生菌、消化酶或抗感染药物。胃运动障碍是PDS的重要发病机制,因此促胃动力药作为PDS的一线用药。临床最常使用莫沙必利、伊托必利、多潘立酮等促动力药,但研究表明上述药物在疗效及安全性方面均存在一定的局限性。促动力药物在减少疾病整体症状方面具有良好疗效,但在改善患者生活质量方面疗效较低,此外某些药物还存在致心律失常或锥体外系反应的副作用,使其临床应用有待商榷。综上,餐后不适综合征的发病机制是一个复杂网络,多重因素共同参与可能导致本病的发生。该病目前的化学治疗药物多是针对疾病的单方面发病机理,远期疗效不稳定,因此现有药物容易出现疗效不理想、停药后易复发等情况,且缺少对改善焦虑抑郁等不良情绪的治疗干预。目前市场上针对餐后不适综合征的药物种类有限,中成药的种类更是单一。在疗效方面,除了以提高胃肠动力、促进胃肠蠕动外,很少有可以兼顾到患者情志方面的中成药。
发明内容
因此,本发明要解决的技术问题在于现有的药物疗效不理想、停药后易复发、不良反应较多,难以改善焦虑抑郁等不良情绪等问题,从而提供一种治疗餐后不适综合征的中药组合物及其制备方法和用途,所述中药组合物。
为此,本发明提供了如下的技术方案:
一种中药组合物,包括如下重量份的原料:北柴胡3-20份,黄芩3-20份,姜半夏3-18份,灵芝3-30份,桂枝3-30份,生白芍3-30份,厚朴3-15份,檀香2-15份,珍珠粉0.1-3份,贯叶金丝桃1-10份,栀子3-18份和全瓜蒌3-24份。
可选的,包括如下重量份的原料:
北柴胡3-18份,黄芩3-15份,姜半夏3-15份,灵芝3-20份,桂枝3-20份,生白芍3-20份,厚朴3-12份,檀香2-10份,珍珠粉0.1-1.5份,贯叶金丝桃1-9份,栀子3-15份,和全瓜蒌3-18份。
可选的,包括如下重量份的原料:
北柴胡5-15份,黄芩3-12份,姜半夏3-12份,灵芝3-12份,桂枝3-12份,生白芍3-15份,厚朴3-10份,檀香2-8份,珍珠粉0.1-1份,贯叶金丝桃1-6份,栀子3-12份,和全瓜蒌3-12份。
可选的,包括如下重量份的原料:
北柴胡5-10份,黄芩3-9份,姜半夏3-9份,灵芝3-9份,桂枝3-9份,生白芍9-15份,厚朴6-10份,檀香2-5份,珍珠粉0.3-1份,贯叶金丝桃1-3份,栀子3-9份,和全瓜蒌3-9份。
一种如所述的中药组合物的制备方法,包括:
按照配方称取原料药,然后经过水提制备得到。
可选的,包括如下步骤:
按照配方称取原料药,然后加入原料药重量的1-2倍水,浸泡0.4-0.5小时,随后将药液煮至100℃,再降温至温度60-80℃煎煮0.4-0.5小时,过滤得到第一提取液和药渣;
向所述药渣中加入药渣重量1-2倍水,随后将药液煮至100℃,再降温至60-80℃煎煮0.4-0.5小时,过滤得到第二提取液;
将第一提取液和第二提取液混匀。
一种中药制剂,包括以所述的中药组合物或所述的中药组合物的制备方法制备得到的中药组合物为活性成分。
可选的,还包括药学上可接受的辅料;
可选的,所述中药制剂的形式包括液体制剂或固体制剂;
可选的,所述中药制剂的剂型包括注射剂、片剂、胶囊剂、粉剂、颗粒剂或膏剂。
所述的中药组合物、所述的中药组合物的制备方法制备得到的中药组合物或所述的中药制剂具有如下的用途:
(1)、在制备缓解、辅助治疗或治疗功能性消化不良的药物中的用途;
(2)、在制备缓解、辅助治疗或治疗焦虑抑郁的药物中的用途;
(3)、在制备缓解、辅助治疗或治疗功能性消化不良伴有焦虑抑郁的药物中的用途;
(4)、在制备改善血清中胃肠激素和脑肠肽的蛋白表达水平的药物中的用途;
可选的,所述功能性消化不良为餐后不适综合征。
本发明发明人长期从事中医药治疗功能性胃肠病的临床与基础研究,谨守肝胃不和是PDS之关键病机,结合临床经验创立了针对肝胃不和证PDS的药物组合物。根据初步统计,本发明的药物组合物在PDS门诊患者使用中,除了能有效改善患者餐后不适感及相关症状之外,还能有效减轻患者焦虑抑郁等不良情绪,降低本病的抗焦虑抑郁药物使用率。进一步,本发明还在基础实验中发现:与肝胃不和证PDS大鼠比较,本发明的药物组合物能有效提高模型大鼠的胃排空率和小肠推进率,有效减轻大鼠的焦虑情绪状态,改善血清中MTL、GAS、5-HT、LP等胃肠激素和脑肠肽的蛋白表达水平,其疗效在某些方面优于阳性药莫沙必利。
方中:北柴胡:疏散退热,疏肝解郁,升举阳气。
黄芩:清热燥湿,泻火解毒。
姜半夏:温中化痰,降逆止呕。用于痰饮呕吐,胃脘痞满。
灵芝:补气安神,止咳平喘。用于心神不宁,不思饮食。
桂枝:发汗解肌,温通经脉,助阳化气,平冲降气。用于脘腹冷痛,奔豚。
生白芍:养血调经,敛阴止汗,柔肝止痛,平抑肝阳。
厚朴:燥湿消痰,下气除满。用于湿滞伤中,脘痞吐泻,食积气滞。
檀香:行气温中,开胃止痛。用于寒凝气滞,胸膈不舒。
珍珠粉:安神定惊,明目消翳,解毒生肌,润肤祛斑。用于惊悸失眠。
贯叶金丝桃:疏肝解郁,清热利湿,消肿通乳。用于肝气郁结,情志不畅。
栀子:泻火除烦,清热利湿,凉血解毒。
全瓜蒌:清热涤痰,宽胸散结,润燥滑肠。用于结胸痞满。
本发明技术方案,具有如下优点:
1、一种中药组合物,其特征在于,包括如下重量份的原料:北柴胡3-20份,黄芩3-20份,姜半夏3-18份,灵芝3-30份,桂枝3-30份,生白芍3-30份,厚朴3-15份,檀香2-15份,珍珠粉0.1-3份,贯叶金丝桃1-10份,栀子3-18份和全瓜蒌3-24份;本发明的上述中药组合物具有舒肝和胃,理气消胀之效,适用于肝胃不和证功能性消化不良餐后不适综合征,尤其是伴有焦虑抑郁等不良情绪的患者。其中,北柴胡苦平,入肝胆经,疏泄气机之郁滞,为君药。黄芩苦寒,清泄肝胃邪热,姜半夏辛温,化痰降逆,全瓜蒌甘寒,下气涤秽,消郁开胃,上述药味共用,清热降逆,助胃和降,为臣药。佐以桂枝、生白芍、厚朴、檀香、贯叶金丝桃行气解郁,增强君药疏肝理气作用。栀子苦寒,善解热郁;灵芝养心安神、珍珠粉镇心安神,全方共奏舒肝和胃,理气消胀之功,以治疗肝胃不和证功能性消化不良餐后不适综合征;因此,所述中药组合物功能主治为:舒肝和胃,理气消胀,用于治疗功能性消化不良餐后不适综合征肝胃不和证。证见:胃脘胀满,嗳气倒饱,情绪不畅,胸闷喜太息,心神不宁,睡眠欠佳,大便不畅,小便频,舌脉:舌质淡红,苔薄白,脉弦。
进一步的,本发明初步统计,本发明的中药组合物在PDS门诊患者使用中,除了能有效改善患者餐后不适感,还能有效减轻患者的焦虑抑郁等不良情绪,降低本病的抗焦虑药物使用率。
进一步的,本发明在基础研究中发现,与伴有焦虑抑郁的肝胃不和证PDS大鼠比较,本发明的中药组合物能有效提高模型大鼠的胃排空率和小肠推进率,从而可以有效改善餐后不适综合征,同时提高血清中GAS、5-HT等胃肠激素和脑肠肽的蛋白表达水平,从而有效减轻大鼠的焦虑状态,其疗效在某些方面优于阳性药莫沙必利。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案,下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1是本发明实验例中各组的胃排空率检测结果;纵坐标单位为%;
图2是本发明实验例中各组的小肠推进率检测结果;纵坐标单位为%;
图3是本发明实验例中各组的小肠推进率图;图中A、B、C、D、E、F、G、H、I、J、K依次对应空白组、模型组、实施例1组、实施例2组、实施例3组、实施例4组、实施例5组、实施例6组、实施例7组、实施例8组、阳性药组;
图4是本发明实验例中各组的GAS检测结果;纵坐标单位为pg/ml;
图5是本发明实验例中各组的5-HT检测结果;纵坐标单位为pg/ml。
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。
下述实施例中的原料药均为市售产品。
实施例1
本实施例提供了实施例1-的中药组合物,其配方如下表。
表1、中药组合物配方
实施例1的中药组合物的制备方法如下:
按照配方称取原料药,然后加入原料药重量的1倍水,浸泡0.5小时,随后将药液煮至100℃,再降温至60℃煎煮0.5小时,过滤得到第一提取液和药渣;
向所述药渣中加入药渣重量的1倍水,随后将药液煮至100℃,再于温度60℃煎煮0.5小时,过滤得到第二提取液;
将第一提取液和第二提取液混匀,大约300-400ml,放置在冰箱中冷藏保存。实施例2的中药组合物的制备方法如下:
按照配方称取原料药,然后加入原料药重量的2倍水,浸泡0.4小时,随后将药液煮至100℃,再降温至80℃煎煮0.4小时,过滤得到第一提取液和药渣;
向所述药渣中加入药渣重量的2倍水,随后将药液煮至100℃,再于温度80℃煎煮0.4小时,过滤得到第二提取液;
将第一提取液和第二提取液混匀,大约300-400ml,放置在冰箱中冷藏保存。
实施例3的中药组合物的制备方法如下:
按照配方称取原料药,然后加入原料药重量的2倍水,浸泡0.4小时,随后将药液煮至100℃,再降温至70℃煎煮0.4小时,过滤得到第一提取液和药渣;
向所述药渣中加入药渣重量的1倍水,随后将药液煮至100℃,再于温度70℃煎煮0.4小时,过滤得到第二提取液;
将第一提取液和第二提取液混匀,大约300-400ml,放置在冰箱中冷藏保存。
实施例4-实施例8的中药组合物的制备方法与实施例1的相同。
实验例1
本发明所述中药组合物的PDS模型动物药效观察
1材料与方法
1.1实验动物
SPF级健康雄性Wistar大鼠110只,体质量(200±20)g,北京维持通利华实验动物技术有限公司提供[许可证号:SYXK(京)2021-0011]。大鼠在安静适宜环境下适应性饲养6天,室温(22±2)℃,相对湿度55%~60%。饲养期间充足清洁饮水,自由摄食。
1.2实验药品及剂量
中药:
实施例1-8制备的中药组合物。
阳性药:
枸橼酸莫沙必利片(国药准字H19990317):使用去离子水配置成终浓度为1.8mg/10ml的药液。
1.3主要试剂与仪器
GAS大鼠ELISA检测试剂盒(上海酶联);5-HT大鼠ELISA检测试剂盒(上海酶联);
营养性半固体制备:羧甲基纤维素钠10g、奶粉16g、糖8g、淀粉8g、活性炭2g,加入去离子水搅拌成300ml黑色半固体糊状,4℃冰箱保存备用,提前1h取出备用。
低温离心机、-80℃冰箱、酶标分析仪:Rayto RT-6100。
1.4动物造模、分组与给药
采用EXCEL随机数字将110只大鼠随机分为空白组、模型组、中药组合物实施例1-8组和阳性药对照组,每组10只,适应性饲养7天。除空白组外,其余100只大鼠参考郭氏适度夹尾法制作模型:随机选取造模组大鼠尾巴远端1/3处用长海绵钳(纱布缠裹止血钳制作)夹住,以不破皮为度,每次不停刺激30min,激怒大鼠与其他大鼠厮打,使全笼大鼠恼怒。每天刺激4次(8:00-8:30、11:30-12:00、15:00-15:30、18:30-19:00),至少相隔3h刺激1次,持续刺激7日。若打斗剧烈,大鼠被抓伤,可用碘伏擦拭受伤部位,防止感染。
造模结束后,空白组和模型组按1ml/100g剂量灌胃蒸馏水,其余各组以相应药物1ml/100g剂量灌胃干预。每日灌胃1次,连续7天。
1.5指标检测与方法
灌胃干预结束后,所有大鼠禁食不禁水12h,给予营养性半固体糊2ml/只灌胃,30min后戊巴比妥静脉麻醉,腹主动脉采血,低温离心机4℃离心15分钟(3000转/分),分离出血清,-20℃冰箱保存。之后解剖取完整的胃和小肠,做大鼠胃排空率和小肠推进率的检测,保存数据。
1.5.1一般情况观察
观察并记录造模前后以及治疗期间大鼠的精神状态、自由活动度、毛发情况等一般行为学改变。
1.5.2胃排空测定
灌胃干预结束后,所有大鼠禁食不禁水12h,予营养性半固体糊2ml/只灌胃,30min。之后以戊巴比妥腹腔注射麻醉,腹主动脉取血后结扎大鼠贲门和幽门口,剪取下完整的胃,剔除胃表面粘膜,用滤纸擦净表面粘液、血液,称取重量为全胃重量;沿胃大弯处剪开胃体,以生理盐水冲洗干净胃壁,滤纸擦拭吸干,称取重量为胃的净重。利用公式计算胃排空率。
胃排空率(%)=[1-(全胃重量-胃净重量)/所灌半固体重量]*100%。
1.5.3小肠推进率测定
截取小肠全段(小肠全段为幽门至盲肠上端),测定小肠全长和幽门至碳末上缘距离,利用公式计算小肠推进率。
小肠推进率(%)=碳末推进长度/小肠全长*100%。
1.5.4血清指标测定
腹主动脉真空采血后,室温静置2h,在4℃条件下,以3000r/min离心15min,分离并收集血清。采用ELISA法测定血清中胃泌素(GAS)、5-羟色胺(5-HT)的含量。
2数据统计
采用SPSS22.0软件进行数据分析。正态分布的计量资料采用均数±标准差进行统计描述,以单因素方差分析进行组间均值比较;非正态分布的计量资料及技数资料以中位数(四分位数间距)进行统计描述,。
3结果
与肝胃不和证PDS模型组比较,结果如图1-5所示。从图1中可以看到,相比模型组,实施例1-实施例8组和阳性药组显著提高了胃排空率。从图2和图3中可以看到,相比模型组,实施例1-实施例8组和阳性药组显著提高了小肠推进率。从图4中可以看到,相比模型组,实施例1-实施例8组和阳性药组显著提高了血清中GAS的含量。从图5中可以看到,相比模型组,实施例1-实施例8组和阳性药组显著提高了血清中5-HT含量。
综上,本发明中药组合物能有效提高肝胃不和证PDS大鼠的胃排空率和小肠推进率,显著减轻了餐后不适综合征,同时通过改善血清中GAS、5-HT等胃肠激素和脑肠肽的蛋白表达量,有效减轻模型大鼠的焦虑状态。
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 (11)
1.一种中药组合物,其特征在于,由如下重量份的原料组成:北柴胡3-20份,黄芩3-20份,姜半夏3-18份,灵芝3-30份,桂枝3-30份,生白芍3-30份,厚朴3-15份,檀香2-15份,珍珠粉0.1-3份,贯叶金丝桃1-10份,栀子3-18份和全瓜蒌3-24份。
2.根据权利要求1所述的中药组合物,其特征在于,由如下重量份的原料组成:
北柴胡3-18份,黄芩3-15份,姜半夏3-15份,灵芝3-20份,桂枝3-20份,生白芍3-20份,厚朴3-12份,檀香2-10份,珍珠粉0.1-1.5份,贯叶金丝桃1-9份,栀子3-15份,和全瓜蒌3-18份。
3.根据权利要求1或2所述的中药组合物,其特征在于,由如下重量份的原料组成:
北柴胡5-15份,黄芩3-12份,姜半夏3-12份,灵芝3-12份,桂枝3-12份,生白芍3-15份,厚朴3-10份,檀香2-8份,珍珠粉0.1-1份,贯叶金丝桃1-6份,栀子3-12份,和全瓜蒌3-12份。
4.根据权利要求1或2所述的中药组合物,其特征在于,由如下重量份的原料组成:
北柴胡5-10份,黄芩3-9份,姜半夏3-9份,灵芝3-9份,桂枝3-9份,生白芍9-15份,厚朴6-10份,檀香2-5份,珍珠粉0.3-1份,贯叶金丝桃1-3份,栀子3-9份,和全瓜蒌3-9份。
5.一种如权利要求1-4任一项所述的中药组合物的制备方法,其特征在于,包括如下步骤:
按照配方称取原料药,然后加入原料药重量的1-2倍水,浸泡0.4-0.5小时,随后将药液煮至100℃,再降温至温度60-80℃煎煮0.4-0.5小时,过滤得到第一提取液和药渣;
向所述药渣中加入药渣重量1-2倍水,随后将药液煮至100℃,再降温至60-80℃煎煮0.4-0.5小时,过滤得到第二提取液;
将第一提取液和第二提取液混匀。
6.一种中药制剂,其特征在于,以权利要求1-4任一项所述的中药组合物或权利要求5所述的中药组合物的制备方法制备得到的中药组合物及药学上可接受的辅料制成。
7.根据权利要求6所述的中药制剂,其特征在于,所述中药制剂的形式包括液体制剂或固体制剂。
8.根据权利要求7所述的中药制剂,其特征在于,
所述中药制剂的剂型包括片剂、胶囊剂、粉剂、颗粒剂或膏剂。
9.权利要求1-4任一项所述的中药组合物、权利要求5所述的中药组合物的制备方法制备得到的中药组合物或权利要求6或7或8所述的中药制剂在制备缓解、辅助治疗或治疗功能性消化不良的药物中的用途。
10.根据权利要求9所述的用途,其特征在于,所述用途为在制备缓解、辅助治疗或治疗功能性消化不良伴有焦虑抑郁的药物中的用途。
11.根据权利要求9或10所述的用途,其特征在于,所述功能性消化不良为餐后不适综合征。
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