CN104491782A - 用于幼儿腹泻的药物 - Google Patents
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Abstract
本发明涉及一种用于幼儿腹泻的药物,其由下述原料制备而得:丁香、肉桂、山药、小檗、茯苓、蒲公英、草果、大腹皮、山楂、乌梅、黄芪、薏苡仁、木瓜、麦芽、牡丹皮、薄荷、甘草、玳瑁、桃仁、枸杞子、铁苋菜、栀子花、杏仁、干姜、乳香、没药。诸药合用,相得益彰,对幼儿腹泻起效快,安全、效果好。
Description
技术领域
本发明属于中药药物技术领域,具体的,涉及一种以中草药为原料治疗幼儿腹泻的药物。
背景技术
幼儿腹泻,又名幼儿消化不良,是幼儿期的一种急性胃肠道功能紊乱,以腹泻、呕吐为主的综合征,以夏秋季节发病率最高。本病致病因素分为三方面:体质、感染及消化功能紊乱。临床主要表现为大便次数增多、排稀便和水电解质紊乱。本病治疗得当,效果良好,但不及时治疗以至发生严重的水电解质紊乱时可危及幼儿生命。目前临床上西医治疗以抗病毒药物为主,其治疗措施主要有:(1)补充锌、铁、维生素PP、A、C、B1、B12和叶酸等微量元素与维生素;(2)蒙脱石粉等肠黏膜保护药;(3)双歧杆菌、嗜酸乳杆菌和粪链球菌等微生态调节制剂或菌群调节剂。治疗药物主要有五维葡钙、思密达、金双歧或妈咪爱。上述疗效常不理想,且存在滥用抗生素,滥用静脉补液等问题。幼儿患病后病情危重,静脉给药有一定困难,口服给药患儿常不合作,而且疗效欠佳。给治疗上带来很多困难,使病情迁延,同时也给家长及患儿在精神上,经济上都带来了沉重的负担。
中医称腹泻病为“泄泻”,是以大便次数增多,粪质稀薄或如水样为其主证。乃幼儿最常见的疾病之一,年龄愈小,发病率愈高。本病虽四时均可发生,但以夏秋季节较多,冬季亦可发生,且往往引起流行。幼儿脾胃薄弱,无论感受外邪,内伤乳食或脾肾虚寒,均可导致脾胃运化功能失调而发生泄泻。发病之后,易耗伤气液,如治疗失当,可转成慢性,出现伤阴、伤阳或阴阳两伤等危重变证,甚至气脱液竭而死亡。迁延不愈者,可引起营养不良,影响生长发育,成为疳证。故幼儿泄泻在临床上较成人为多见,其症状的表现亦较成人为复杂,预后亦比成人为严重。
引起幼儿泄泻的原因,以感受外邪,内伤乳食和脾胃虚弱等为多见。其主要的病变在于脾胃,因胃主腐熟水谷,脾主运化精微,如脾胃受病,则饮食入胃,水谷不化,精微不布,合污而下,致成泄泻。故《景岳全书·泄泻》说:“泄泻之本,无不由于脾胃,盖胃为水谷之海,而脾主运化,脾健胃和,则水谷腐熟,而化气化血,以行营卫,若饮食失节,起居不时,以致脾胃受伤,则水反为湿,谷反为滞,精华之气,不能输化,乃致会污下降,而泻利作矣”。其常见的病因有四方面:
1感受外邪:幼儿脏腑脆嫩,卫外不固,易为外邪所侵。且因脾胃薄弱,不耐受邪,若脾受邪侵,运化失职,升降失调,水谷不分,合污而下,则为泄泻。故幼儿泄泻与时令气候的变化,有着密切的关系。外感风、寒、暑、湿均可致病。盖脾喜燥而恶湿,湿易伤脾,所以有“湿多成五泄”之说。故泄泻虽有多种不同因素,但未有不原于湿者。夏秋季节,暑气当令,气候炎热,雨水较多,湿热交蒸,幼儿更易感触而发病。暑热之邪伤人最速,易耗津气,故每致热迫大肠、骤成暴泻;湿胜则儒泻,故夏秋季节之泄泻,多见者为湿热泻。
2内伤饮食:由于调护失宜,乳哺不当,饮食失节或过食生冷瓜果,或不消化食物,皆能损伤脾胃,脾伤则运化功能失职,胃伤则不能消磨水谷,宿食内停,清浊不分,并走大肠,因成泄泻。故《素问·痹论》中说:“饮食自信,肠胃乃伤”。
3脾胃虚弱:先天禀赋不足,后天调护失宜,或久病迁延不愈,皆可导致脾胃虚弱。脾虚则健运失司,胃弱则不能熟腐水谷,因而水反为湿,谷反为滞,清阳不升,乃致合污而下,成为脾虚泄泻。
4脾肾阳虚:脾以阳为运,肾寄命门真火。若因幼儿禀赋不足,或久病、久泻均可损伤脾肾之阳。命门火衰,火不暖土,阴寒内盛,水谷不化,并走大肠,致泻便为澄、澈、清、冷,洞泄不禁。盖肾为胃关,开窍于二阴,职司二便,如肾中阳气不足,则阴寒独盛,故令洞泄不止。
由于幼儿具有“稚阴、稚阳”的生理特点和“易虚易实,易寒易热”的病理特点,且幼儿泄泻又易于损伤气液,故如病情较重,常可发生“伤阴”、“伤阳”的变证。其中暴泻者常伤阴,久泻者常伤阳,病情严重者亦可同时阴阳两伤。
现有技术中药处方缺乏辩证,配方陈旧,从天然药物中寻找有效、安全的药物,已经成为临床幼儿腹泻重要方向。
发明内容
本发明参考祖国医学对幼儿腹泻发病机理的认识以及治疗的宝贵经验,参阅已有合理组方,辨证论治,按照中国药典及药理配伍,推陈致新有所增益,辨证论治一直是中医药治疗疾病的核心理论,如何针对主要病机用药同时兼顾次要病机,兼顾共性与个性的治疗,从而最大程度体现中医治疗疾病的内涵与外延,是中成药配伍的一个现实难题。发明者针对幼儿腹泻的主要病机特点,结合大量秘方根据多年的医行实践,通过对传统中药的研究,并结合辩证论证,多方收集众家之长,寻求最佳治疗方案,从祖国医学宝库中,筛选出补脾温肾,调中止泻、清热散邪、和胃止呕、的天然中药,按中医理论组方,提取精华,结合传统中医技术精心配制成本发明的用于幼儿腹泻的药物,相对于西药,本发明的中药起效快、作用强、疗程短、安全性高、无明显毒副作用。
为实现本发明目的,本发明采用的技术方案如下:
用于幼儿腹泻的药物,其由下述重量份的原料制备而得:
丁香25份、肉桂25份、山药25份、小檗22份、茯苓22份、
蒲公英20份、草果20份、大腹皮20份、山楂20份、乌梅18份、
黄芪18份、薏苡仁15份、木瓜15份、麦芽15份、牡丹皮15份、
薄荷15份、甘草12份、玳瑁12份、桃仁12份、枸杞子10份、
铁苋菜10份、栀子花10份、杏仁5份、干姜5份、乳香5份、没药5份。
本发明的药物的制备方法为:取上述重量份数的原料药制备颗粒,具体操作为:
1)称取各原料药,备用;
2)取丁香、肉桂、山药、乌梅、麦芽、牡丹皮、薄荷、甘草、玳瑁、乳香、没药混合均匀,加8倍重量的水武火煮沸,然后文火煎煮1小时,过滤收集滤液和滤渣;往滤渣中添加水,以没过滤渣为准,武火煮沸,然后文火煎煮1小时,过滤收集滤液;合并上述两次滤液,冷却后,浓缩成密度为1.2g/ml的浸膏;80℃烘干后,粉碎成粉末,即为复合物A;
3)取剩余成分加入相对于混合物5倍重量75%的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.2g/ml的清膏,80℃烘干,粉碎制备复合物B;
4)将复合物A和复合物B混合搅拌均匀,灭菌消毒制得胶囊剂产品,口服<1岁每次0.2g,1-2岁每次0.3g,2-3岁每次0.5g,均一日三次。
本发明药物的组分均采用天然的中药原料,其配制简便,药源广泛,成本低廉,诸药合用,相得益彰。通过实验研究发现,本方能令滞留于肠中的水湿邪毒改道从小便而去,同时又可以促进肠道吸收及运转功能的恢复,有利于肠腔对水、电解质的吸收,降低肠腔渗透压,减少肠液的分泌,加强补液疗法对失水、失电解质、酸碱失衡的纠正作用。同时有促进消化液分泌,增进饮食、镇吐作用,因此治疗幼儿腹泻疗效显著。
具体实施方式
实施例1
用于幼儿腹泻的药物,其由下述重量份的原料制备而得:
丁香25份、肉桂25份、山药25份、小檗22份、茯苓22份、
蒲公英20份、草果20份、大腹皮20份、山楂20份、乌梅18份、
黄芪18份、薏苡仁15份、木瓜15份、麦芽15份、牡丹皮15份、
薄荷15份、甘草12份、玳瑁12份、桃仁12份、枸杞子10份、
铁苋菜10份、栀子花10份、杏仁5份、干姜5份、乳香5份、没药5份。
本发明的药物的制备方法为:取上述重量份数的原料药制备颗粒,具体操作为:
1)称取各原料药,备用;
2)取丁香、肉桂、山药、乌梅、麦芽、牡丹皮、薄荷、甘草、玳瑁、乳香、没药混合均匀,加8倍重量的水武火煮沸,然后文火煎煮1小时,过滤收集滤液和滤渣;往滤渣中添加水,以没过滤渣为准,武火煮沸,然后文火煎煮1小时,过滤收集滤液;合并上述两次滤液,冷却后,浓缩成密度为1.2g/ml的浸膏;80℃烘干后,粉碎成粉末,即为复合物A;
3)取剩余成分加入相对于混合物5倍重量75%的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.2g/ml的清膏,80℃烘干,粉碎制备复合物B;
4)将复合物A和复合物B混合搅拌均匀,灭菌消毒制得胶囊剂产品,口服<1岁每次0.2g,1-2岁每次0.3g,2-3岁每次0.5g,均一日三次。
实施例2
一、毒性实验
本实验采用健康SD大鼠,口服给药实施例1制备的药物连续给药30天,经观察大鼠给药期间及停药后1周之内动物生长状态、活动饮食、血液学、血液生化学、脏器组织结构以及尿常规等均无明显影响,表明临床用药安全可靠。
二、对蓖麻油所致小鼠泄泻模型的影响
取ICR小鼠60只,随机分成对照组、思密达组、实验(实施例1药物)组,对照组给予等体积生理盐水,每日一次,连续三天。末次给药40分钟后,每只动物灌胃给予0.2ml蓖麻油。然后将小鼠放入正下方放有滤纸的单元隔离笼内,每格一只。观察指标:湿粪计数;每单元格正下方铺10cm×10cm面积的滤纸作湿粪计数。以湿粪粒数反应泄泻程度,前1~6小时每小时更换滤纸一次,7~24小时换纸一次,记录24小时内各只动物的累积湿粪总数,结果如下:
表1对蓖麻油所致泄泻影响
组别 | 例数 | 24h稀便次数 |
对照组 | 20 | 7.37±1.06 |
思密达组 | 20 | 2.89±1.21 |
实验组 | 20 | 1.38±1.15 |
由上表可见,本发明对蓖麻油所致小鼠腹泻有显著作用。
实施例3
共试验幼儿急、慢性腹泻患者93例,其中女47例,男46例,年龄介于半岁-3岁之间。
将上述患者随机分为两组:治疗组46例,对照组47例;
诊断标准
按照《实用儿科诊疗规范》幼儿腹泻诊断标准,以舌质淡舌苔白作为脾虚型分型的主要依据,全部患者均诊断为幼儿腹泻患者。
治疗方法
治疗组口服实施例1制备药物,<1岁每次0.2g,1-2岁每次0.3g,2-3岁每次0.5g,一日三次。
对照组口服口服思密达,<1岁每次1g,1-2岁每次2g,2-3岁每次3g,均一日三次。
轮状病毒性肠炎3天一个疗程,大肠杆菌肠炎、非感染性腹泻6天为一个疗程。一个疗程完成者,即可列为统计病例。 观察过程中,禁止使用抗生素及其他止泻的中西药物,保证单独服用观察药物。
疗效评价标准
根据1998年北京全国腹泻病防治学术研讨会组织委员会修订的《腹泻病疗效判断标准的补充建议》,制定如下疗效评价标准:
治愈:治疗2天内,腹泻次数减少到3次以内,腹泻总量<150ml;3天内粪便形状及次数恢复正常,全身症状消失。
有效:用药2天内,腹泻次数减少到5次以内,腹泻总量<250ml;3天内粪便形状及次数明显好转,全身症状明显改善。
无效:用药后2天内,腹泻次数仍在5次以上,腹泻总量>300ml,3天内粪便形状、次数及全身症状均无明显好转甚至恶化。
疗效结果见下表:
组别 | 例数 | 治愈 | 有效 | 无效 | 总有效率 |
治疗组 | 46 | 35 | 9 | 2 | 95.6% |
对照组 | 47 | 23 | 17 | 7 | 85.1% |
实验组较对照组差异显著。
以上列举的仅是本发明的最佳具体实施例。显然,本发明不限于以上实施例,还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形,均应认为是本发明的保护范围。
Claims (3)
1. 用于幼儿腹泻的药物,其特征在于,所述药物由下述重量份的原料制备而得:
丁香25份、肉桂25份、山药25份、小檗22份、茯苓22份、
蒲公英20份、草果20份、大腹皮20份、山楂20份、乌梅18份、
黄芪18份、薏苡仁15份、木瓜15份、麦芽15份、牡丹皮15份、
薄荷15份、甘草12份、玳瑁12份、桃仁12份、枸杞子10份、
铁苋菜10份、栀子花10份、杏仁5份、干姜5份、乳香5份、没药5份。
2.权利要求1所述的药物,其特征在于,所述药物的制备方法包括如下步骤:
1)按照重量份称取各原料,备用;
2)取丁香、肉桂、山药、乌梅、麦芽、牡丹皮、薄荷、甘草、玳瑁、乳香以及没药,混合均匀,加8倍重量的水武火煮沸,然后文火煎煮1小时,过滤收集滤液和滤渣;往滤渣中添加水,以没过滤渣为准,武火煮沸,然后文火煎煮1小时,过滤收集滤液;合并上述两次滤液,冷却后,浓缩成密度为1.2g/ml的浸膏;80℃烘干后,粉碎成粉末,即为复合物A;
3)取剩余成分加入相对于混合物5倍重量的75%的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.2g/ml的清膏,80℃烘干,粉碎制备复合物B;
4)将复合物A和复合物B混合搅拌均匀,灭菌消毒即得。
3.权利要求1-2所述药物用于幼儿腹泻。
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