CN113425817B - 一种健脾和胃、消食化积的中药组合物及其制法与应用 - Google Patents
一种健脾和胃、消食化积的中药组合物及其制法与应用 Download PDFInfo
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Abstract
本发明提供了一种健脾和胃、消食化积的中药组合物及其制法与应用。该中药组合物由以下组分的原料制备而成:焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮。本发明基于对草本植物的认识,参考现代药理研究,创新地将焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮组合,得到可以实现健脾和胃、消食化积功效的组合物,从根本上治疗脾虚食滞引发的小儿厌食、大便稀溏、消瘦体弱。
Description
技术领域
本发明涉及中药技术领域,尤其涉及一种健脾和胃、消食化积的中药组合物及其制法与应用。
背景技术
“小儿厌食症”,通常是指长期的食欲减退或消失、以食量减少为主要症状,是一种慢性消化功能紊乱综合征,是儿科常见病、多发病,1~6岁小儿多见,且有逐年上升趋势。严重者可导致营养不良、贫血、佝偻病及免疫力低下,出现反复呼吸道感染,对儿童生长发育、营养状态和智力发展也有不同程度的影响。目前中医界将小儿厌食症分为脾失健运、脾胃气虚、脾胃阴虚三种证型。
专利CN10224282A公开了一种治疗小儿厌食症的药物组合物,原料含有下列重量份的药物:鸡内金8~23份、山药10~30份、太子参15~45份、白术10~30份、白扁豆8~23份、薏苡仁10~30份、山楂8~23份、神曲8~23份、麦芽8~23份、陈皮5~15份。其方中以鸡内金和山药为君药,白术、太子参、白扁豆、薏苡仁为臣药,助君药健脾益胃之功,山楂、麦芽、神曲三者为消食导滞、健运脾胃的良药,三药为佐药,陈皮为使药。可见,CN10224282A公开的药物组合物以补气、健脾为主,适用于小儿厌食症属脾胃气虚证型。
发明内容
本发明的第一目的在于提供了具有健脾和胃、消食化积功效的中药组合物,该组合物由如下组分的原料制备而成:
焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮。
本发明基于对草本植物的认识,参考现代药理研究,创新地将焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮组合,得到以健脾和胃、消食化积为主功效的中药组合物,从根本上治疗脾虚食滞引发的小儿厌食、大便稀溏、消瘦体弱,适用于小儿厌食证属脾失健运证型。
其中,焦山楂、炒神曲、焦麦芽、鸡内金消食化滞共为君药,山药、薏苡仁健脾渗湿止泻而为臣,党参益气健脾以补脾虚,白扁豆渗湿健脾以止泄泻,二者共同为佐,陈皮理脾气燥脾湿而为使。诸药合用,使脾气健运,食积得化,诸证自消,共成消补兼施,健脾和胃,消食化积之剂。
为了提高治疗效果,该中药组合物,由以下质量份的原料制得:焦山楂5~11份、炒神曲2~8份、焦麦芽5~11份、鸡内金2~8份、山药5~11份、薏苡仁4~10份、党参2~8份、白扁豆4~10份和陈皮2~8份。
在一个优选地实施方式中,该中药组合物,由以下质量份的原料制得:焦山楂6~10份、炒神曲3~7份、焦麦芽6~10份、鸡内金3~7份、山药6~10份、薏苡仁5~9份、党参3~7份、白扁豆5~9份和陈皮3~7份。
在一个更优选地实施方式中,该中药组合物,由以下质量份的原料制得:焦山楂7~9份、炒神曲4~6份、焦麦芽7~9份、鸡内金4~6份、山药7~9份、薏苡仁6~8份、党参4~6份、白扁豆6~8份和陈皮4~6份。
本发明的第二目的在于提供上述中药组合物的制备方法,包括以下步骤:
将焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮进行水提,得到水提液;
将水提液浓缩,获得具有健脾和胃、消食化积功效的中药组合物。
在一些优选实施方案中,所述水提具体为:将焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮混合后,加入相当于原料8~12倍重量的水煎煮提取2次,每次1~2小时,过滤得滤液,将两次水提的滤液合并,得到水提液。
在一些优选实施方案中,所述水提液浓缩至相对密度为1.05~1.10(60℃)。
对于上述制备方法制得的中药组合物,通常将其制成颗粒剂,加入生药材处方重量5%-10%的辅料,混匀,喷雾干燥,再加入生药材处方重量5%-10%的辅料,混匀,制粒,干燥,即得。每次服12g,一日3次。特定情况下也可以采用较高或较低剂量,每个患者的适用剂量由医生根据给药模式,患者的年龄、体重和反应来最终决定。
本发明的第三目的在于提供上述中药组合物在制备具有健脾和胃、消食化积功效的药物中的应用。
本发明的第四目的在于提供一种治疗脾虚食滞引起的小儿厌食症的药物,包括上述中药组合物和药学上可接受的辅料。
其中,药物的剂型为片剂、丸剂、口服溶液剂、胶囊剂、糖浆剂、滴丸剂或颗粒剂。
本发明基于中医理论和现代药理的研究成果,焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮组合,得到可以实现健脾和胃和消食化积的组合物,从根本上治疗脾虚食滞引发的小儿厌食、大便稀溏、消瘦体弱。
本发明中,如无特别说明:
焦山楂,为蔷薇科植物山里红Crataegus pinnatifida Bge.var.major N·E·Br.或山楂Crataegus pinnatifida Bge.的干燥成熟果实的炮制加工品。
炒神曲,为鲜辣蓼、青蒿、鲜苍耳、赤小豆等中药加入面粉混合后经发酵而成的曲剂的炮制加工品。
焦麦芽,为禾本科植物大麦Hordeum vulgare L.的成熟果实经发芽干燥的炮制加工品。
鸡内金,为雉科动物家鸡Callus gallus domesticus Brisson的干燥沙囊内壁。
山药,为薯蓣科植物薯蓣Dioscotea opposita Thunb.的干燥根茎。
薏苡仁,为禾本科植物薏苡Coix lacryma-jobi L.var.ma-yuen(Roman.)Stapf的的干燥成熟种仁。
党参,为桔梗科植物党参Codonopsis pilosula(Franch.)Nannf.、素花党参Codonopsis pilosula Nannf.var.modesta(Nannf.)L.T.Shen或川党参Codonopsistangshen Oliv·的干燥根。
白扁豆,为豆科植物扁豆Dolichos lablab L.的干燥成熟种子。
陈皮,为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟果皮。
具体实施方式
下面结合实施例,对本发明的具体实施方式作进一步详细描述。以下实施例用于说明本发明,但不用来限制本发明的范围。若未特别指明,实施例中所用技术手段为本领域技术人员所熟知的常规手段,所用原料均为市售商品。
实施例1
本实施例提供了一种具有健脾和胃、消食化积功效的中药组合物,其由如下原料制备得到:焦山楂8份、炒神曲4.8份、焦麦芽8份、鸡内金4.8份、山药8份、薏苡仁6.4份、党参4.8份、白扁豆6.4份和陈皮4.8份。
制备方法:以上9味原料,加水煎煮二次,每次加10倍量水,煎煮1小时,滤过,合并煎液,滤液浓缩至相对密度1.05(60℃),加入药材原料重量5%糊精,混匀,喷雾干燥,再加入药材原料重量10%糊精,混匀,制粒,即得。
实施例2
本实施例提供了一种具有健脾和胃、消食化积功效的中药组合物,其由如下原料制备得到:焦山楂5份、炒神曲8份、焦麦芽5份、鸡内金8份、山药5份、薏苡仁10份、党参2份、白扁豆10份和陈皮2份。
制备方法同实施例1。
实施例3
本实施例提供了一种具有健脾和胃、消食化积功效的中药组合物,其由如下原料制备得到:焦山楂11份、炒神曲2份、焦麦芽11份、鸡内金2份、山药11份、薏苡仁4份、党参8份、白扁豆4份和陈皮8份。
制备方法同实施例1。
实施例4
本实施例提供了一种具有健脾和胃、消食化积功效的中药组合物,其由如下原料制备得到:焦山楂6份、炒神曲7份、焦麦芽6份、鸡内金7份、山药6份、薏苡仁9份、党参3份、白扁豆9份和陈皮3份。
制备方法同实施例1。
对比例1
对比例1提供了一种中药组合物,按照专利CN101224282A中实施例1的原料配比制备得到:鸡内金15份、山药20份、太子参30份、白术20份、白扁豆15份、薏苡仁20份、山楂15份、神曲15份、麦芽15份、陈皮10份。
制备方法同本发明实施例1。
对比例2
对比例2为市场上具有健脾和胃、消食化积功能的中成药儿脾醒颗粒,其处方为:山楂320g、麦芽320g、鸡内金240g、山药240g、薏苡仁160g、白扁豆240g、陈皮96g、茯苓96g、蔗糖930g。
对比例3
对比例3提供了一种中药组合物,其由如下原料制备得到:焦山楂12份、炒神曲1份、焦麦芽9份、鸡内金3份、山药3份、薏苡仁9.5份、党参1.5份、白扁豆3.5份和陈皮3份。
制备方法同实施例1。
对比例4
对比例4提供了一种中药组合物,其由如下原料制备得到:焦山楂3份、炒神曲3份、焦麦芽9份、鸡内金5.5份、山药9份、薏苡仁3份、党参5份、白扁豆3份和陈皮3份。
制备方法同实施例1。
动物试验
1.实施例和对比例的中药组合物对脾虚食积模型小鼠肠推进的影响
昆明种小鼠,雄性,体质量18~22g。动物购回后,自由饮食饮水,适应性喂养3d,按其体质量随机分为10组,每组10只,分别为空白对照组、脾虚食积模型组、实施例1-4组、对比例1-4组。空白对照组正常饲养,蒸馏水灌胃0.2mL/10g(体重),其余各组小鼠每天喂以自制的高蛋白、高热量饲料(该饲料由鱼松、豆粉、面粉、牛奶粉按1∶2∶1∶1的比例配成,搅拌匀后,加水做成饼干,用电热恒温鼓风干燥箱烘干即得),同时灌胃50%牛乳,0.2mL/10g(体重),自由摄食和饮水,连续7d,造成脾虚食积模型小鼠。
得到脾虚食积模型小鼠后第2日开始灌胃给药,实施例和对比例组分别灌胃给予4g/kg(体重)的中药组合物,灌胃体积为0.2mL/10g(体重),脾虚食积模型组及空白对照组给予等体积的蒸馏水,每天一次,共7d,末次给药前18h各组小鼠禁食不禁水。末次给药或灌以蒸馏水1h后,各组小鼠灌胃给予新鲜配制的5%炭末混悬液0.2mL/10g。10min后,迅速取出小肠,轻轻剥离肠系膜后铺平,测量小肠全长与炭末混悬液从幽门括约肌推至小肠末端的距离。计算墨汁推进率。
墨汁推进率(%)=墨汁在小肠内推进距离(cm)/小肠总长度(cm)×100%。
组别 | 动物数/只 | 剂量/(g/kg) | 墨汁推进率/% |
空白对照组 | 10 | —— | 55.53±6.61 |
模型组 | 10 | —— | 22.18±4.64<sup>*</sup> |
实施例1 | 10 | 4 | 51.02±3.46<sup>△</sup> |
实施例2 | 10 | 4 | 49.46±2.93<sup>△</sup> |
实施例3 | 10 | 4 | 48.93±4.18<sup>△</sup> |
实施例4 | 10 | 4 | 50.89±5.01<sup>△</sup> |
对比例1 | 10 | 4 | 27.89±2.56 |
对比例2 | 10 | 4 | 28.51±3.11 |
对比例3 | 10 | 4 | 25.92±4.36 |
对比例4 | 10 | 4 | 27.43±2.77 |
注:*与正常对照组比较,P<0.05;△与模型组比较,P<0.05
研究结果可见,实施例组可加快胃肠的蠕动速度提高墨汁在小肠中的推进率,效果优于对比例组。
2.实施例和对比例的中药组合物对脾虚食积模型小鼠胃排空的影响
动物分组及给药情况同上。实施例和对比例组分别灌胃给予4g/kg(体重)的中药组合物,灌胃体积为0.2mL/10g(体重),脾虚食积模型组及空白对照组给予等体积的蒸馏水,每天一次,共7d,末次给药前18h各组小鼠禁食不禁水。末次给药或灌以蒸馏水1h后,灌胃给予各组小鼠0.1%甲基橙溶液0.2mL,20min后脱颈椎处死小鼠,剖腹摘取胃,以蒸馏水将胃内容物充分洗于小烧杯中,倒入离心管后,以3000r/min离心5min,取上清液,加入蒸馏水至10mL,用UV-3100紫外可见分光光度计于420nm波长比色,测定吸光度,作为胃中甲基橙的光密度。另取0.1%甲基橙0.2mL,加入蒸馏水至10mL,摇匀后测定吸光度,作为基数甲基橙吸光度。甲基橙在胃内的残留率=胃中甲基橙的吸光度/基数甲基橙的吸光度×100%
组别 | 动物数/只 | 剂量/(g/kg) | 甲基橙残留率(%) |
空白对照组 | 10 | —— | 45.27±5.41 |
模型组 | 10 | —— | 74.92±4.98<sup>*</sup> |
实施例1 | 10 | 4 | 55.71±3.37<sup>△</sup> |
实施例2 | 10 | 4 | 58.19±2.97<sup>△</sup> |
实施例3 | 10 | 4 | 57.95±4.36<sup>△</sup> |
实施例4 | 10 | 4 | 56.64±3.74△ |
对比例1 | 10 | 4 | 68.63±4.18 |
对比例2 | 10 | 4 | 67.46±4.32 |
对比例3 | 10 | 4 | 69.35±3.78 |
对比例4 | 10 | 4 | 68.51±3.23 |
注:*与正常对照组比较,P<0.05;△与模型组比较,P<0.05
研究结果可见,实施例组可加快胃肠的蠕动速度,提高胃排空速度降低甲基橙的残留率,效果优于对比例组。
临床实验
1 实验方法
1.1 实验对象
100例门诊患者,均符合小儿厌食症的诊断标准。经知情同意后,随机分为治疗组和对照组各50例。对照组中男27例,女23例,年龄6月-5岁,病程2~12个月。治疗组中男28例,女22例,年龄6月-5岁,病程2~12个月。两组患者的性别、年龄、病程经统计学分析,差异均无统计学意义(P>0.05)。
本次纳入研究的对照组50例患儿口服健胃消食片(江中药业股份有限公司,批准文号:Z20013220),每次口服2片,3次/d。一个疗程为期2周,共2个疗程。治疗组50例患儿给予实施例1,12g/次,3次/d,年龄<2岁患儿用量减半。一个疗程为期2周,共2个疗程。治疗结束后对两组临床治疗效果进行对比评价。
1.2诊断标准
西医符合《诸福棠实用儿科学》中所提出的厌食症诊断标准,即食欲减弱,较患病前食量减少30%~50%,病程≥2个月;体质量减轻或不增,存在喂养不当、饮食习惯不良史。
中医符合《中医病证诊断疗效标准》中所提出的厌食症辨证分型标准,即食欲减弱,抵触进食,面色蜡黄,身形消瘦,体质量降低,排便不规律,脉沉细弱,舌苔白腻。
1.3疗效判定标准
根据《中医病证诊断疗效标准》,将临床疗效分为:
显效:治疗后,患儿临床症状消退,食量、食欲相较于原有水平改善75%,且临床证候积分降低70%及以上。
有效:治疗后,患儿临床症状有所缓解,食量、食欲相较于原有水平改善50%,且临床证候积分降低30%~70%。
无效:治疗后,患儿临床症状未变化,食量、食欲未改善且临床证候积分减低<30%。
总体疗效=(总例数-无效例数)/总例×100%
1.4统计学方法
资料用SPSS21.0软件处理,计数资料用卡方检验;计量资料用t检验。最后以P<0.05表示差异统计学意义。
2治疗结果
表3为两组疗效比较,治疗组总有效率为96%,对照组总有效率为84%。两组疗效比较有显著性差异(P<0.05),表明治疗组疗效优于对照组。
表3临床疗效比较
组别 | n | 显效 | 有效 | 无效 | 总有效率% |
治疗组 | 50 | 27 | 21 | 2 | 96* |
对照组 | 50 | 22 | 20 | 8 | 84 |
注:两组疗效比较,*P<0.05。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对其作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (8)
1.一种健脾和胃、消食化积的中药组合物,其特征在于,由以下质量份的原料制得:焦山楂7~9份、炒神曲4~6份、焦麦芽7~9份、鸡内金4~6份、山药7~9份、薏苡仁6~8份、党参4~6份、白扁豆6~8份和陈皮4~6份。
2.根据权利要求1所述的中药组合物,其特征在于,由以下质量份的原料制得:焦山楂8份、炒神曲4.8份、焦麦芽8份、鸡内金4.8份、山药8份、薏苡仁6.4份、党参4.8份、白扁豆6.4份和陈皮4.8份。
3.根据权利要求1或2所述中药组合物的制备方法,其特征在于,包括以下步骤:
将焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮进行水提,得到水提液;
将水提液浓缩,获得具有健脾和胃、消食化积功效的中药组合物。
4.根据权利要求3所述的制备方法,其特征在于,所述水提具体为:将焦山楂、炒神曲、焦麦芽、鸡内金、山药、薏苡仁、党参、白扁豆和陈皮混合后,加入相当于原料8~12倍重量的水煎煮提取2次,每次1~2小时,过滤得滤液,将两次水提的滤液合并,得到水提液。
5.根据权利要求3或4所述的制备方法,其特征在于,所述水提液浓缩至60℃相对密度为1.05~1.10。
6.权利要求1或2所述的中药组合物在制备具有健脾和胃、消食化积功效的药物中的应用。
7.一种治疗脾虚食滞引起的小儿厌食症的药物,其特征在于,包括如权利要求1或2所述的中药组合物和药学上可接受的辅料。
8.根据权利要求7所述的药物,其特征在于,其剂型为片剂、丸剂、口服溶液剂、胶囊剂、滴丸剂或颗粒剂。
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