CN106606708A - 一种促消化组合物及其制备方法 - Google Patents
一种促消化组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种促消化组合物,包括下列重量份的原料:山楂20~40份,鸡内金5~20份,炒麦芽10~30份,葛根10~35份,山药10~40份,陈皮10~40份,枳实10~40份。所述的促消化组合物的制备方法,包括以下步骤:(1)称取,净选,混合均匀;(2)提取;(3)过滤;(4)浓缩成稠膏,稠膏与挥发油再与赋形剂制成各种剂型;(5)灭菌;(6)包装。本发明所提供的组合物以健胃消食的山楂果,行气开胃的麦芽,为主药;辅以鸡内金促进胃液分泌,葛根开发脾胃清阳之气,山药强化脾胃消化吸收;佐以陈皮枳理气调中,消积导滞。诸药合用,取其精华,共具益气、健脾、养胃、消食、导滞之功。疗效确切,几乎无副反应。
Description
技术领域
本发明涉及一种中药组合物及其制备工艺,具体是一种促消化组合物及其制备方法。
背景技术
消化不良系指上腹不适症状反复发作,排除器质性消化不良的一组症侯群,亦称功能性消化不良。是一种常见、多发病。
功能性消化不良是一种由于胃动力发生障碍所引起的疾病,常见的症状为上腹部不适或疼痛、胃胀、烧心、嗳气等。患者常因胸闷、胃饱、腹胀等不适而不愿进食。西医治疗功能性消化不良主要是以一些促胃肠动力、抑制胃酸分泌药物为主。如吗叮啉、西沙必利、莫沙必利等,但这些药物长期使用后会产生一定的副作用,不少患者在应用西沙必利后出现Q-T间期延长及心律失常,特别是尖端扭转型室速等严重不良反应,甚至导致死亡。有关专家认为:治疗功能性消化不良最好能选用相对安全的中成药。
目前市场上反应效果的中成药有:
保和丸:该药由山楂(焦)、六神曲、半夏、茯苓、陈皮、连翘、莱菔子、炒麦芽八味中药组成,具有和胃、消食导滞的功效,可治疗因饮食不节所导致的胃脘胀满、食欲不振、嗳腐吞酸等症。
山楂丸:该药由山楂、六神曲、炒麦芽三味中药组成,具有消积化食的功效,主要用于治疗食用肉食过多引起的脘腹胀闷等症,尤其适用于小儿食积症。
复方鸡内金片:该药由鸡内金和六神曲组成,具有健脾开胃、消积化食的功效,可治疗因脾胃不和引起的食积腹胀、饮食停滞、呕吐泄泻等症。
沉香化滞丸:该药由沉香、牵牛子、枳实、五灵脂、山楂、枳壳、陈皮、香附、厚朴、莪术、砂仁、三棱、木香、青皮、大黄十五味中药组成,具有理气化滞的功效,可治疗饮食停滞、腹中胀痛、吞酸等症。
六味安消胶囊:该药由土木香、大黄、山奈、寒水石、诃子、碱花六味中药组成,具有和胃健脾、导滞消积、行血止痛的功效。该药因含有少量的大黄,因此特别适合胃脘胀痛、大便秘结、食积化热者服用。
祖方选录:
治一切食积:山楂200克白术200克神曲100克.上为末蒸饼丸梧子大服七十丸白汤下(《丹溪心法》)
治食肉不消:山楂肉200克水煮食之并饮其汁.(《简便单方》)
治食积腹满:鸡内金研末,乳服。(《本草求原》)
治脾胃湿寒,饮食减少,长作泄泻,完谷不化:白术200克,干姜100克,鸡内金100克,熟枣肉250克。上药四味,白术、鸡内金各自轧细焙熟;再将干姜轧细,共和枣肉,同捣如泥,作小饼,木炭火上炙干。空心时,当点心,细嚼咽之。(《医学衷中参西录》益脾饼)
消食滞,化痞积:山楂(炒)麦芽(炒)神曲(炒)槟榔(炒)鸡内金(炒)二丑(炒)各500克,共为细末。(《北京市中药成方选集》化积散)
发明内容
本发明的目的是根据消化不良病人的病理、临床表现及促消化药物的药理和作用机制,结合“药食同源”的产品的“四气五性”,借鉴祖方和已经上市的中成药和保健品,研制出一种既能达到促消化效果,又能改善脾胃功能,提高消化能力和免疫力,并且安全、方便、无副作用的促消化组合物及其制备方法。
为实现上述目的,本发明提供如下技术方案:
一种促消化组合物,包括下列重量份的原料:山楂20~40份,鸡内金5~20份,炒麦芽10~30份,葛根10~35份,山药10~40份,陈皮10~40份,枳实10~40份。
作为本发明进一步的方案:包括下列重量份的原料:山楂15~35份,鸡内金7~15份,炒麦芽10~25份,葛根10~20份,山药10~20份,陈皮10~30份,枳实10~25份。
作为本发明再进一步的方案:包括下列重量份的原料:山楂30份,鸡内金10份,炒麦芽15份,葛根10份,山药15份,陈皮10份,枳实10份。
作为本发明再进一步的方案:所述的促消化组合物的制备方法,包括以下步骤:
(1)将山楂、鸡内金、麦芽、葛根、山药、陈皮和枳实按重量份称取,经净选,混合均匀;
(2)加8~10倍量水浸泡0.5~2h后煎煮提取2~3小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮2~3小时;
(3)两次煎煮提取液分别以160~180目筛过滤;
(4)过滤后的滤液经减压浓缩至相对密度1.30~1.35、60℃的稠膏,稠膏与挥发油再与赋形剂制成各种剂型;
(5)灭菌;
(6)包装。
作为本发明再进一步的方案:步骤(4)中所述的各种剂型包括胶囊、片剂、颗粒、丸剂、滴丸、糖浆剂和泡腾片。
山楂:性微温,味酸甘,入脾、胃、肝经,有消食健胃、活血化淤、收敛止痢之功能。山楂中脂肪酶可促进脂肪分解;山楂酸等可提高蛋白分解酶的活性,有帮助消化的作用.山楂的主要成分是黄酮类物质,对心血管***有明显的药理作用。目前,从山楂中分离的黄酮成分有30余种,主要有含碳键的黄酮苷类、黄酮醇及其苷类、双氧黄酮苷类、聚合黄酮类。另一类较为重要的成分是三萜类物质,有强心、增加冠脉血流、改善血流循环等重要作用。此外,山楂中含有机酸如氯原酸、咖啡酸及鞣质、鞣酐、表儿茶酚、胆碱、乙酰胆碱、β谷甾醇、胡萝卜素及大量Vit C等。《本经》云:味酸,气冷,然观其能消食积,行瘀血,则气非冷矣。有积滞则成下痢,产后恶露不尽,蓄于太***分则为儿枕痛。山楂能入脾胃消积滞,散宿血,故治水痢及产妇腹中块痛也。大抵其功长于化饮食,健脾胃,行结气,消瘀血,故小儿产妇宜多食之。
鸡内金:味甘,性寒。归脾、胃、小肠、膀胱经。健胃消食,涩精止遗,通淋化石。消食健胃助消化,涩精止遗。可以促进胃液分泌,提高胃酸度及消化力,使胃运动功能明显增强,胃排空加快。用于食积不消,呕吐泻痢,小儿疳积,遗尿,遗精,石淋涩痛,胆胀胁痛。《医学衷中参西录》:鸡内金,鸡之脾胃也。中有瓷石、铜、铁皆能消化,其善化瘀积可知。(脾胃)居中焦以升降气化,若有瘀积,气化不能升降,是以易致胀满,用鸡内金为脏器疗法。若再与白术等分并用,为消化瘀积之要药,更为健补脾胃之妙品,脾胃健壮,益能运化药力以消积也。不但能消脾胃之积,无论脏腑何处有积,鸡内金皆能消之,是以男子痃癖,女子症瘕,久久服之,皆能治愈。又凡虚劳之证,其经络多瘀滞,加鸡内金于滋补药中,以化其经络之瘀滞,而病始可愈。至以治室女月信一次未见者,尤为要药。盖以能助当归、白芍以通经,又能助健补脾胃之药,多进饮食以生血也。
麦芽:味甘,性平。归脾、胃经、肝经。行气消食,健脾开胃,回乳消胀。用于食积不消,脘腹胀痛,脾虚食少,乳汁郁积,***胀痛,妇女断乳,肝郁胁痛,肝胃气痛。麦芽含消化酶及维生素B,有助消化作用。其所含淀粉酶不耐高温,将麦芽炒黄、炒焦或制成煎剂,其效力均明显降低,因此麦芽宜生用或微炒冲服。人体实验表明:麦芽煎剂有轻度促进胃酸(总酸与游离酸)和胃蛋白酶的分泌。
葛根:味甘、辛,性凉。入脾、胃经。葛根内含12%的黄酮类化合物,如葛根素、大豆黄酮苷、花生素等营养成分,还有蛋白质、氨基酸、糖、和人体必需的铁、钙、铜、硒等矿物质,是老少皆宜的名贵滋补品,有“千年人参”之美誉。早在汉代张仲景的《伤寒论》中就有“葛根汤”这一著名方剂,至今仍是重要的解表方。《本草正义》谓葛根“最能开发脾胃清阳之气”。明朝著名的医学家李时珍对葛根进行了***的研究,认为葛根的茎、叶、花、果、根均可入药。他在《本草纲目》中这样记载:“葛,性甘、辛、平、无毒,主治:消渴、身大热、呕吐、诸弊,起阴气,解诸毒”。
山药:味甘,性平。归脾、肺、肾经。补脾养胃,生津益肺,补肾涩精。山药含有淀粉酶、多酚氧化酶等物质,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。
陈皮:性温,味辛、味苦。入脾经、胃经、肺经。理气健脾,调中,燥湿,化痰。主治脾胃气滞之脘腹胀满或疼痛、消化不良。湿浊阻中之胸闷腹胀、纳呆便溏。痰湿壅肺之咳嗽气喘。用于胸脘胀满,食少吐泻,咳嗽痰多。
陈皮又称橘皮,《纲目》:“橘皮,苦能泻能燥,辛能散,温能和。其治百病,总是取其理气燥湿之功,同补药则补,同泻药则泻,同升药则升,同降药则降。脾乃元气知母,肺乃摄气之要,故橘皮为二经气分之要,但随所配而补泻升降也。”《日用本草》:″橘皮,能散能泻,能温能补,能消膈气,化痰涎,和脾止嗽,通五淋。中酒呕吐恶心,煎饮之效。″
陈皮有三大类作用,一是导胸中寒邪,二破滞气,三益脾胃。这三大作用中,主要作用是行脾胃之气。脾胃主运化水湿,故脾胃之气行则能去湿、健脾、化痰,故又可以说,陈皮温能养脾,辛能醒脾,苦能健脾。
枳实:苦;辛;寒。归脾;胃;肝;心经。苦泄力大,行气力强,故为破气之药,性沉降而下行,功能理气除痞,以除胸腹痞满,兼能化痰以开痹,消积以导滞,实乃破气结之峻剂,治痞满、导积滞之要药。又具升高血压之能,治阴挺脱肛之用。枳实理气行气作用较强,故一般认为本品有破气作用,功用行气滞、除胀满,用于胸腹胀满,常与木香、橘皮等同用。此外,对食积不化、脘腹胀满者,可配山渣、神曲等同用。
与现有技术相比,本发明的有益效果是:本发明所提供的组合物以健胃消食的山楂果,行气开胃的麦芽,为主药;辅以鸡内金促进胃液分泌,葛根开发脾胃清阳之气,山药强化脾胃消化吸收;佐以陈皮枳理气调中,消积导滞。诸药合用,取其精华,共具益气、健脾、养胃、消食、导滞之功。疗效确切,几乎无副反应。
附图说明
图1为促消化组合物的制备方法的流程图。
具体实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
取山楂600克,鸡内金200克,麦芽(炒)200克,葛根200克,山药300克,陈皮200克,枳实300克,经净选,混合均匀,加10倍量水浸泡1h后煎煮提取2小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮3小时,两次煎煮提取液分别以160~180目筛过滤,滤液经减压浓缩至相对密度1.30~1.35(60℃)的稠膏,稠膏与辅料适量,制成片剂,制备流程如图1所示。
实施例2
取山楂600克,鸡内金250克,麦芽(炒)200克,葛根200克,山药300克,陈皮200克,枳实250克,经净选,混合均匀,加10倍量水浸泡1h后煎煮提取2小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮3小时,两次煎煮提取液分别以160~180目筛过滤,滤液经减压浓缩至相对密度1.30~1.35(60℃)的稠膏,稠膏与辅料适量,制成颗粒剂,制备流程如图1所示。
实施例3
取山楂600克,鸡内金200克,麦芽(炒)300克,葛根200克,山药300克,陈皮200克,枳实200克,经净选,混合均匀,加10倍量水浸泡1h后煎煮提取2小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮3小时,两次煎煮提取液分别以160~180目筛过滤,滤液经减压浓缩至相对密度1.30~1.35(60℃)的稠膏,稠膏与辅料适量,制成软胶襄剂,制备流程如图1所示。
实施例4
取山楂600克,鸡内金200克,麦芽(炒)200克,葛根200克,山药300克,陈皮250克,枳实250克,经净选,混合均匀,加10倍量水浸泡1h后煎煮提取2小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮3小时,两次煎煮提取液分别以160~180目筛过滤,滤液经减压浓缩至相对密度1.30~1.35(60℃)的稠膏,稠膏与辅料适量,制成滴丸剂,制备流程如图1所示。
实施例5
取山楂600克,鸡内金200克,麦芽(炒)250克,葛根200克,山药250克,陈皮250克,枳实250克,经净选,混合均匀,加10倍量水浸泡1h后煎煮提取2小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮3小时,两次煎煮提取液分别以160~180目筛过滤,滤液经减压浓缩至相对密度1.30~1.35(60℃)的稠膏,稠膏与辅料适量,制成糖浆剂,制备流程如图1所示。
实施例6
取山楂600克,鸡内金200克,麦芽(炒)250克,葛根200克,山药250克,陈皮300克,枳实200克,经净选,混合均匀,加10倍量水浸泡1h后煎煮提取2小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮3小时,两次煎煮提取液分别以160~180目筛过滤,滤液经减压浓缩至相对密度1.30~1.35(60℃)的稠膏,稠膏与辅料适量,制成丸剂,制备流程如图1所示。
实施例7
取山楂600克,鸡内金300克,麦芽(炒)250克,葛根200克,山药250克,陈皮200克,枳实200克,经净选,混合均匀,加10倍量水浸泡1h后煎煮提取2小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮3小时,两次煎煮提取液分别以160~180目筛过滤,滤液经减压浓缩至相对密度1.30~1.35(60℃)的稠膏,稠膏与辅料适量,制成泡腾片,制备流程如图1所示。
以下实验以实施例1制备方法所获得的样品-促消化组合物。其他实施例所获得的实验数据基本接近,不再赘述。
促消化组合物药效学试验数据
根据实验项目可选用单一性别成年小鼠或大鼠。小鼠18g~22g,每组10只~15只,大鼠120g~150g,每组8只~12只。
实验设三个剂量组和一个阴性对照组,以人体推荐量的10倍(小鼠)或5倍(大鼠)为其中的一个剂量组,另设二个剂量组,必要时设阳性对照组和模型对照组。受试样品给予时间30d(小肠运动实验受试样品给予时间7d~15d),必要时可延长至45d。
促消化组合物对复方地芬诺酯致肠功能低下小鼠的影响
选用同一性别的小鼠,分不同剂量实验组、空白对照组和模型对照组,模型对照组用复方地芬诺酯。可用墨汁或炭末加***树胶作为指示剂。经口给予受试样品。实验结束前禁食不禁水20h,于测定当天各实验组和空白及模型对照组再给予一次受试样品或蒸馏水,30min后各实验组和模型对照组给予复方地芬诺酯5mg/kgbw~6mg/kgbw(依据复方地芬诺酯的实用剂量取用,用研钵研碎呈粉末后按实验所需浓度配制,注意要待溶质完全溶解、充分摇匀后使用。),空白对照组给予蒸馏水,30min后各组再给予指示剂(精确称取***树胶100g,加水800ml,煮沸至溶液透明,称取活性碳粉100g加至上述溶液中煮沸三次,待溶液凉后定容到1000ml,于冰箱中4℃保存,用前摇匀),25min后断颈处死动物,计算墨汁推进率。结果见表一:
表一:促消化组合物对复方地芬诺酯致肠功能低下小鼠的肠推进影响
“*”表示给药组与对照组比较,P<0.05,“**”P<0.01,下同;促消化组合物对复方地芬诺酯致肠功能低下小鼠有肠推进作用,与空白对照组比较,促消化组合物组的高剂量组4.0g(生药)/kg、中剂量组2.0g(生药)/kg、低剂量组1.0g(生药)/kg小肠碳末推进均有作用,三个剂量组对复方地芬诺酯致致肠功能低下小鼠有肠推进作用有一定量效关系。高剂量组作用极为显著(P<0.01)。说明促消化组合物具有促进复方地芬诺酯致小鼠肠功能低下的肠推进功能。
促消化组合物对大鼠胃蛋白酶活性和胃蛋白酶排出量的影响
选用同一性别的大鼠。分不同剂量实验组和阴性对照组,实验开始时动物体重的差异应不超过平均体重的10%。经口给予受试样品。实验结束前各组动物禁食不禁水24h,采用***麻醉大鼠幽门结扎法收集一定时间内排出的胃液,测定单位时间内胃液量。取胃液1mL放入50mL的三角烧瓶中,加入0.05mol/L盐酸溶液15mL摇匀,放入新鲜制作的蛋白管两根。塞好瓶口,在37℃恒温箱中孵育24h,取出蛋白管,用尺测量蛋白管两端透明部分的长度(mm),以四端之值求其平均值。计算胃蛋白酶活性和胃蛋白酶排出量。结果见表二:
表二:促消化组合物对胃蛋白酶活性和胃蛋白酶排出量的影响
结果显示:促消化组合物高剂量组4.0g(生药)/kg、中剂量组2.0g(生药)/kg及保和丸对胃液和胃蛋白酶排出量有明显的促进作用,胃液中胃蛋白活力也明显高于对照组(P<0.05)。
本发明所述的具有的既能达到促消化效果,又能改善脾胃功能,提高消化能力和免疫力的组合物的原料来源于“药食同源”,比传统的含有中药成分的保健食品更安全。比如CN201210102605所述的组合物含有中药成分白术。并且本发明所述的组合物不仅具有促消化功能,还有改善脾胃,提高免疫力功能,适合长期服用。
对于本领域技术人员而言,显然本发明不限于上述示范性实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。因此,无论从哪一点来看,均应将实施例看作是示范性的,而且是非限制性的,本发明的范围由所附权利要求而不是上述说明限定,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。不应将权利要求中的任何附图标记视为限制所涉及的权利要求。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (5)
1.一种促消化组合物,其特征在于,包括下列重量份的原料:山楂20~40份,鸡内金5~20份,炒麦芽10~30份,葛根10~35份,山药10~40份,陈皮10~40份,枳实10~40份。
2.根据权利要求1所述的促消化组合物,其特征在于,包括下列重量份的原料:山楂15~35份,鸡内金7~15份,炒麦芽10~25份,葛根10~20份,山药10~20份,陈皮10~30份,枳实10~25份。
3.根据权利要求1所述的促消化组合物,其特征在于,包括下列重量份的原料:山楂30份,鸡内金10份,炒麦芽15份,葛根10份,山药15份,陈皮10份,枳实10份。
4.一种如权利要求1-3任一所述的促消化组合物的制备方法,其特征在于,包括以下步骤:
(1)将山楂、鸡内金、麦芽、葛根、山药、陈皮和枳实按重量份称取,经净选,混合均匀;
(2)加8~10倍量水浸泡0.5~2h后煎煮提取2~3小时,提取液滤过,滤液备用,药渣再加8倍重量的水,煎煮2~3小时;
(3)两次煎煮提取液分别以160~180目筛过滤;
(4)过滤后的滤液经减压浓缩至相对密度1.30~1.35、60℃的稠膏,稠膏与挥发油再与赋形剂制成各种剂型;
(5)灭菌;
(6)包装。
5.根据权利要求4所述的促消化组合物的制备方法,其特征在于,步骤(4)中所述的各种剂型包括胶囊、片剂、颗粒、丸剂、滴丸、糖浆剂和泡腾片。
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