CN104958646A - 一种润肠通便的中药制剂及其制备方法 - Google Patents
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Abstract
本发明属于中药技术领域,涉及一种润肠通便的中药制剂及其制备方法。该中药制剂包括以下原料:胖大海、山楂、番泻叶、决明子、罗汉果、陈皮、肉苁蓉、火麻仁、土茯苓、沙参、山药和甘草。该中药制剂具有清热解毒、润肠通便、滋补肾肝的功效,专门用于泻热导滞、清洁肠道,对热结便秘、内热肠燥等症状具有显著的疗效,还具有制备工艺简单、疗效好、副作用低、服用方便等优点。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种润肠通便的中药制剂及其制备方法。
背景技术
便秘是临床常见的复杂症状,主要是指排便次数减少、粪便量减少、粪便干结、排便费力等。便秘的原因是大肠功能传导失常,胃肠积热,津液耗伤,大肠干结,导致大便不通畅,在肠道内滞留时间长而秘结,年老体弱或长期卧床患者为多发群体,便秘对人体的危害较大,便秘时,排便困难、粪便干燥,肛门处静脉受压迫容易形成痔疮,而且排便困难,选择努便的话,容易造成肛裂,还可引发直肠炎等。同时便秘患者屏气使劲排便容易造成的心、脑血管疾病发作。有的患者为了解决排便困难,服用泻药或采用中药灌肠,但都不能解决根本问题。
由于便秘是一种较为普遍的症状,症状轻重不一,大部分人常常不去特殊理会,认为便秘不是病,不用治疗,但实际上便秘的危害很大。便秘在有些疾病如结肠癌、肝性脑病、乳腺疾病的发生中起重要作用。因此,早期预防和合理治疗便秘将会大大减轻便秘带来的严重后果,改善生活质量,减轻社会和家庭负担。
中国专利201310226440.4公开了一种润肠通便的中药组合物,所述中药组合物主要由以下重量组分的原料药或其有效成分的提取物制成:白术260-400份,枳壳260-400份,木瓜260-400份,当归260-400份,该中药组合物具有健脾行气、补血润肠通便之功效,但是该中药组合物所需的原料较多,不利于生产。
发明内容
本发明要解决的技术问题是提供一种润肠通便的中药制剂及其制备方法,该中药制剂具有清热解毒、润肠通便、滋补肾肝的功效,专门用于泻热导滞、清洁肠道,对热结便秘、内热肠燥等症状,具有显著的疗效,还具有制备工艺简单、疗效好、副作用低、服用方便等优点,此外,本发明还提供相应的制造工艺将该药物组合物在保证疗效的前提下制成方便易用的制剂。
本发明中药制剂由以下重量份的原料制备而成:胖大海3-10份、山楂3-12份、番泻叶2-6份、决明子9-15份、罗汉果9-15份、陈皮3-10份、肉苁蓉3-9份、火麻仁9-15份、土茯苓5-20份、沙参3-15份、山药10-30份和甘草1-10份。
进一步地,所述中药制剂由以下重量份的原料制备而成:胖大海3份、山楂3份、番泻叶2份、决明子9份、罗汉果9份、陈皮3份、肉苁蓉3份、火麻仁9份、土茯苓5份、沙参3份、山药10份和甘草1份。
进一步地,所述中药制剂由以下重量份的原料制备而成:胖大海10份、山楂12份、番泻叶6份、决明子15份、罗汉果15份、陈皮10份、肉苁蓉9份、火麻仁15份、土茯苓20份、沙参15份、山药30份和甘草10份。
进一步地,所述中药制剂由以下重量份的原料制备而成:胖大海6份、山楂8份、番泻叶4份、决明子12份、罗汉果12份、陈皮6份、肉苁蓉6份、火麻仁12份、土茯苓12份、沙参10份、山药20份和甘草5份。
进一步地,所述中药制剂为口服制剂。
再进一步地,所述的口服制剂为片剂、胶囊剂、颗粒剂、散剂或口服液。
相应的,所述中药制剂的制备方法包含下述步骤:
称取胖大海、山楂、番泻叶、决明子、罗汉果、陈皮、肉苁蓉、火麻仁、土茯苓、沙参、山药和甘草,加药材总重量的5-10倍的水,浸泡30-60分钟,煎煮1-3次,每次1-3小时,过滤,合并滤液,滤液在60-80℃下减压浓缩至相对密度1.25-1.35的浸膏,加入乙醇至含醇量为70-90%(v/v),静置24小时,取上清液,减压蒸馏回收乙醇,干燥,粉碎成粉末,再加入辅料,按照传统工艺制备成临床需要的中药制剂。
胖大海为梧桐科植物胖大海的干燥成熟种子,又名莫大、澎大海、安南子、大海子、大洞果、胡大海、胡大发。胖大海的功效与作用如下,胖大海主治清热润肺,利咽解毒,润肠通便。胖大海用于肺热声哑,干咳无痰,咽喉干痛,热结便闭,头痛目赤。胖大海味甘、性凉,入肺、大肠经,具有清肺热、利咽喉、解毒、润肠通便之功效。用于肺热声哑、咽喉疼痛、热结便秘以及用嗓过度等引发的声音嘶哑等症。
山楂以果实作药用,有消食健胃、活血化淤、收敛止痢之功能。对肉积痰饮、痞满吞酸、泻痢肠风、腰痛疝气、产后儿枕痛、恶露不尽、小儿乳食停滞等,均有疗效。胃酸过多、消化性溃疡和龋齿者、消化不良者、心血管疾病患者、癌症患者、肠炎患者及服用滋补药品期间忌服用。脾胃虚弱者慎服。山楂含有多种维生素及有机酸,可帮助补充细胞内液,从而有生津止渴的效果,山楂中维生素、有机酸,能帮助胃肠对食物进行消化,山楂中蕴含有大量人体必需的营养物质,如糖类、多种维生素、有机酸等,供给人体养分,提高机体免疫力。
番泻叶别名又叫旃那叶、泻叶、泡竹叶,番泻叶为豆科植物狭叶番泻或尖叶番泻的小叶,番泻叶为刺激性泻药,具有泻热导滞的功效,番泻叶常被用作治疗腹部胀满与热结便秘,还常作为检查前或手术前后的清洁肠道之用。由于番泻叶泻下作用广泛而强烈,用于治疗便秘时,番泻叶宜小量用于急性便秘,不适宜慢性便秘。对久病本虚,年老体弱者宜慎用,对过敏者以及痔疮、月经期和孕妇及完全肠梗阻等患者均应禁止使用。
决明子为豆科植物决明和小决明的成熟种子。有清肝益肾,明目,利水通便的功效。主治目赤肿痛,羞明泪多、青盲、雀目、头痛头晕、视物昏暗、肝硬化腹水、小便不利、习惯性便秘。外治肿毒、癣疾。对风热赤眼、高血压、肝炎、肝硬腹水习惯性便秘等有疗效。决明子性味甘咸寒,兼入大肠经而能清热润肠通便,用于内热肠燥,大便秘结,可与火麻仁、瓜蒌仁等同用。
罗汉果是药食两用名贵中药材,别名:拉汗果、假苦瓜、光果木鳖、金不换、罗汉表、裸龟巴。其所含罗汉果甜甙比蔗糖甜300倍,不产生热量,是饮料、糖果行业的名贵原料,是蔗糖的最佳替代品。常饮罗汉果茶,可防多种疾病,现代医学证明,罗汉果对支气管炎、高血压等疾病有显著疗效,还是起到防治冠心病、血管硬化、肥胖症的作用。
陈皮具有理气和中,燥湿化痰,利水通便的功效。主治脾胃不和,脘腹胀痛,不思饮食,呕吐哕逆,痰湿阻肺,咳嗽痰多,胸膈满闷,头目眩晕,水肿,小便不利,大便秘结,乳痈疥癣,中鱼蟹毒、酒毒。陈皮为芸香科植物橘及其栽培变种的干燥成熟果皮。,别名:橘皮、贵老、红皮、黄橘皮、广橘皮、新会皮、柑皮、广陈皮。
肉苁蓉别名:肉松蓉、黑司令、纵蓉、地精、马足、马芝、大芸、寸芸。肉苁蓉为列当科植物肉苁蓉或苁蓉、迷肉苁蓉等的肉质茎。有补肾,益精,润燥,滑肠功效,主治男子阳痿,女子不孕,带下,血崩,腰膝冷痛,血枯便秘。素有“沙漠人参”的美誉,是我国所发现的60多种补益中药中品位最高的药物,含有大量氨基酸、胱氨酸、维生素和矿物质珍稀营养滋补成份。
火麻仁为桑科植物大麻的种仁,火麻仁的功效:润燥滑肠、利水通淋、活血,火麻仁的作用:治肠燥便秘、月经不调、丹毒,火麻仁别名麻子、麻于仁、麻仁、大麻子、大麻仁、冬麻子、火麻子、线麻子、黄麻仁,火麻仁用药禁忌:脾胃虚弱之便溏者,孕妇以及肾虚阳痿、遗精都不太适合饮用火麻仁。火麻仁可将体内多余的脂肪、胆固醇等有害物质排出体外,既能排毒减肥,又可养阴滋补肾肝。
土茯苓具有除湿,解毒,通利关节的作用。用于湿热淋浊,带下,痈肿,瘰疬,疥癣,梅毒及汞中毒所致的肢体拘挛,筋骨疼痛。凡治梅毒,可单用该品大剂量煎汤频服,或与生苡仁、金银花、防风、木通等配伍。凡湿热淋浊,小便赤涩者,可与木通、蒲公英、扁蓄等配伍,以利尿解毒泄浊。
沙参清热养阴,润肺止咳。主治气管炎,百日咳,肺热咳嗽,咯痰黄稠。沙参别名南沙参、泡参、泡沙参,具有养阴清肺,益胃生津,补气,化痰的功效。适用于脾肺气虚,倦怠乏力,食少,自汗,舌淡,脉弱者。
薯蓣,通称山药。多年生草本植物,茎蔓生,常带紫色,块根圆柱形,叶子对生,卵形或椭圆形,花乳白色,雌雄异株。山药除含蛋白质、碳水化合物、钙、磷、铁、胡萝卜素及维生素等多种营养成分外,尚含淀粉酶、胆碱、粘液汁酶及薯蓣皂苷等。其中的淀粉酶又叫消化素,能分解淀粉等物质,若与碱性物质相混合,则淀粉酶作用消失。补而不腻,香而不燥。历代医家盛赞山药为“理虚之要药”。 山药还有利于脾胃消化吸收功能,是一味平补脾胃的药食两用之品。不论脾阳亏或胃阴虚,皆可食用。临床上常与胃肠饮同用治脾胃虚弱,食少体倦,泄泻等病症。
甘草为豆科植物甘草、胀果甘草或光果甘草的干燥根,甘草含有多种化学成分,主要成分有甘草酸、甘草甙等,在中医学术里,经常用甘草来调和诸药,甘草具有清热解毒、补脾益气、祛痰止咳等功效。
与现有技术相比,本发明中药制剂具有如下技术优势:
1、本发明中药制剂具有清热解毒、润肠通便、滋补肾肝的功效,专门用于泻热导滞、清洁肠道,对热结便秘、内热肠燥等症状具有显著的疗效。
2、本发明中药制剂为天然纯中药制剂,不良反应和副作用显著降低,且本发明中药制剂从根源上解决患者的问题,药物治疗效果更佳。
3、本发明中药制剂还具有配伍科学、制备工艺简单、疗效好、副作用低、服用方便和易于推广应用等优点。
具体实施方式
本领域技术人员应理解,以下实施例中所公开的技术代表本发明人发现的在本发明的实践中发挥良好作用的技术。然而,在所公开的具体实施方案中可以做出许多改变,并仍然获得相同或相似的结果,而不脱离本发明的精神和范围。
实施例1:
本发明实施例1中药制剂包括以下重量份数的制备原料:胖大海3份、山楂3份、番泻叶2份、决明子9份、罗汉果9份、陈皮3份、肉苁蓉3份、火麻仁9份、土茯苓5份、沙参3份、山药10份和甘草1份。
制备方法如下:
称取胖大海、山楂、番泻叶、决明子、罗汉果、陈皮、肉苁蓉、火麻仁、土茯苓、沙参、山药和甘草,加药材总重量的5倍的水,浸泡30分钟,煎煮1次,每次1小时,过滤,合并滤液,滤液在60℃下减压浓缩至相对密度1.25的浸膏,加入乙醇至含醇量为70%(v/v),静置24小时,取上清液,减压蒸馏回收乙醇,干燥,粉碎成粉末,即得本发明实施例1中药制剂。将细粉过80目筛,除去粗大的细粉,加入10%的淀粉浆,制备得到软材,过14目尼龙筛制粒,于70℃下干燥至水分3%以下,装入3号软胶囊壳中,即得本发明实施例1中药制剂的胶囊剂。
实施例2:
本发明实施例2中药制剂包括以下重量份数的制备原料:胖大海10份、山楂12份、番泻叶6份、决明子15份、罗汉果15份、陈皮10份、肉苁蓉9份、火麻仁15份、土茯苓20份、沙参15份、山药30份和甘草10份。
制备方法如下:
称取胖大海、山楂、番泻叶、决明子、罗汉果、陈皮、肉苁蓉、火麻仁、土茯苓、沙参、山药和甘草,加药材总重量的8倍的水,浸泡40分钟,煎煮2次,每次2小时,过滤,合并滤液,滤液在70℃下减压浓缩至相对密度1.30的浸膏,加入乙醇至含醇量为80%(v/v),静置24小时,取上清液,减压蒸馏回收乙醇,干燥,粉碎成粉末,即得本发明中药制剂。将细粉过80目筛,除去粗大的细粉,加入10%的淀粉浆,制备得到软材,过14目尼龙筛制粒,于70℃下干燥至水分3%以下,装入3号软胶囊壳中,即得本发明实施例2中药制剂的胶囊剂。
实施例3:
本发明实施例3中药制剂包括以下重量份数的制备原料:胖大海6份、山楂8份、番泻叶4份、决明子12份、罗汉果12份、陈皮6份、肉苁蓉6份、火麻仁12份、土茯苓12份、沙参10份、山药20份和甘草5份。
制备方法如下:
称取胖大海、山楂、番泻叶、决明子、罗汉果、陈皮、肉苁蓉、火麻仁、土茯苓、沙参、山药和甘草,加药材总重量的10倍的水,浸泡60分钟,煎煮3次,每次3小时,过滤,合并滤液,滤液在80℃下减压浓缩至相对密度1.35的浸膏,加入乙醇至含醇量为90%(v/v),静置24小时,取上清液,减压蒸馏回收乙醇,干燥,粉碎成粉末,即得本发明中药制剂。将细粉过80目筛,除去粗大的细粉,加入10%的淀粉浆,制备得到软材,过14目尼龙筛制粒,于70℃下干燥至水分3%以下,装入3号软胶囊壳中,即得本发明实施例3中药制剂的胶囊剂。
临床疗效观察
1、病例选择:在300例患便秘临床志愿者患者中,男性患者180例,女性患者120例,年龄段为18-60岁,平均年龄为39岁,所有患者在性别、年龄、病程上无统计学差异。
2、疗效评定标准:
治愈:2天以内排便1次,便质转润,解时通畅,短期无复发;
显效:3天以内排便,便质转润,排便欠畅;
有效:3至4天以内排便;
无效:症状无改善;
总有效率=(治愈+显效+有效)/总例数×100%。
3、服用方法:将300名患者随机分为4组,每组75人,分别为治疗A组、治疗B组、治疗C组和对照组,治疗A组、治疗B组、治疗C组分别服用本发明实施例1、2、3制备得到的胶囊剂(0.3g*60粒/瓶),每日2次,每次4粒,口服一周,一周为一个疗程;对照组服用复方芦荟胶囊(河北万邦复临药业有限公司,国药准字Z13020306),口服,一次1-2粒,一日1-2次,服用一周。
4、治疗结果:如表1所示。
表1 治疗结果
本试验采用复方芦荟胶囊作为对照组,复方芦荟胶囊具有清肝泻热,润肠通便,宁心安神的作用,用于心肝火盛,大便秘结,腹胀腹痛,烦躁失眠。令发明人意想不到的是,本发明中药制剂的治愈率达到80.0%以上,总有效率达到90.0%以上,高于对照组的治愈率和总有效率,其中以治疗C组的治疗效果最好,可见,本发明中药制剂的疗效好,痊愈率高,可作为润肠通便的药物使用。
典型病例
病例1:胡某某,女,23岁,腹胀,常便秘,一般大便6-8 天一次,乏力,常感头昏,胃口差,舌淡苔少,脉细软,服用本发明中药后第2天通畅排便,后继续服用1 周,并结合适量运动,多吃蔬菜水果,以后大便一直很正常,痊愈。
病例2:张某某,男,36 岁,公司职员,因长期久坐,缺乏运动,加上饮食偏爱辛辣荤腥,导致便秘多年。2014年3月开始服用本发明的润肠通便的中药,次日排出大量宿便,一个星期后,排出的大便软硬适中,一个月后,形成了每日定时排便的习惯。
病例3:李某某,女,45岁,大便干结难下5年,4-6日一行,服用开塞露通便,兼症:乏力,口干,面色萎黄无华,两颊黑斑,畏寒,不思饮食,口干喜冷饮,症状秋冬季节加重,舌质暗淡、舌苔白,脉弦细。诊断为阴阳气血都虚的虚秘,治则滋阴润燥,益气养血。服用本发明中药,服用2天后,大便顺畅,2日一行,口干好转,继续服用一个月后,诸症消失,大便正常,一日一行,面色红润,痊愈。
由于已经通过以上较佳实施例描述了本发明,在本发明的精神和/或范围内,任何针对本发明的替换/或组合来实施本发明,对于本领域的技术人员来说都是显而易见的,且包含在本发明之中。
Claims (7)
1.一种润肠通便的中药制剂,其特征在于由以下重量份的原料制备而成:胖大海3-10份、山楂3-12份、番泻叶2-6份、决明子9-15份、罗汉果9-15份、陈皮3-10份、肉苁蓉3-9份、火麻仁9-15份、土茯苓5-20份、沙参3-15份、山药10-30份和甘草1-10份。
2.如权利要求1所述的润肠通便的中药制剂,其特征在于由以下重量份的原料制备而成:胖大海3份、山楂3份、番泻叶2份、决明子9份、罗汉果9份、陈皮3份、肉苁蓉3份、火麻仁9份、土茯苓5份、沙参3份、山药10份和甘草1份。
3.如权利要求1所述的润肠通便的中药制剂,其特征在于由以下重量份的原料制备而成:胖大海10份、山楂12份、番泻叶6份、决明子15份、罗汉果15份、陈皮10份、肉苁蓉9份、火麻仁15份、土茯苓20份、沙参15份、山药30份和甘草10份。
4.如权利要求1所述的润肠通便的中药制剂,其特征在于由以下重量份的原料制备而成:胖大海6份、山楂8份、番泻叶4份、决明子12份、罗汉果12份、陈皮6份、肉苁蓉6份、火麻仁12份、土茯苓12份、沙参10份、山药20份和甘草5份。
5.如权利要求1-4任一所述的润肠通便的中药制剂,其特征在于:所述中药制剂为口服制剂。
6.如权利要求5所述的润肠通便的中药制剂,其特征在于:所述的口服制剂为片剂、胶囊剂、颗粒剂、散剂或口服液。
7.一种制备如权利要求1-4任一所述的润肠通便的中药制剂的方法,其特征在于包括下述工艺步骤:称取胖大海、山楂、番泻叶、决明子、罗汉果、陈皮、肉苁蓉、火麻仁、土茯苓、沙参、山药和甘草,加药材总重量的5-10倍的水,浸泡30-60分钟,煎煮1-3次,每次1-3小时,过滤,合并滤液,滤液在60-80℃下减压浓缩至相对密度1.25-1.35的浸膏,加入乙醇至含醇量为70-90%v/v,静置24小时,取上清液,减压蒸馏回收乙醇,干燥,粉碎成粉末,再加入辅料,按照传统工艺制备成临床需要的中药制剂。
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