CN107485699A - 香诃止泻组合物 - Google Patents
香诃止泻组合物 Download PDFInfo
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- CN107485699A CN107485699A CN201710739261.9A CN201710739261A CN107485699A CN 107485699 A CN107485699 A CN 107485699A CN 201710739261 A CN201710739261 A CN 201710739261A CN 107485699 A CN107485699 A CN 107485699A
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Abstract
本发明涉及一种香诃止泻组合物及其制备方法,其原料包括如下重量百分比的组分:广藿香5‑30g,炒车前子5‑30g,诃子5‑30g,茯苓5‑30g,石榴皮5‑30g,炒白术5‑30g,葛根5‑30g,焦山楂5‑30g,仙鹤草5‑30g,木香5‑30g,白芍5‑30g,炒扁豆5‑30g,炒薏苡仁5‑30g,乌梅5‑30g,防风5‑30g,泽泻5‑30g。本方配伍严谨,利湿止泻不忘健运脾胃,攻补兼施,共奏止泻补虚之效。
Description
技术领域
本发明涉及中药领域,具体涉及一种治疗小儿腹泻的香诃止泻组合物及其制备方法。
背景技术
小儿腹泻或称腹泻病(Diarrhea Diseases)是一组多病原多因素引起的消化道疾病。在我国小儿中属第二位常见多发病(仅次于呼吸道感染),按病因分为感染性和非感染性两种。感染性腹泻多因细菌、病毒、真菌、寄生虫等引起,非感染性腹泻通常包括症状性腹泻、过敏性腹泻、非特异性溃疡性结肠炎、糖原性腹泻等,多由气候变化、腹部受凉、饮食不当、食物过敏、消化道酶的缺乏、胃肠功能紊乱等所致。由于小儿一次腹泻后其身高体重发育要落后6个月,严重危害生长发育,因此腹泻病被列为我国儿科重点防治和研究的“四病”之一。且近年来因抗菌药物的滥用,增加了小儿肠道菌群失调失调的发病率,腹泻反复发作或久治不愈更屡见不鲜。
泄泻多因感受外邪、内伤饮食、脾胃虚弱等引起。中医素有“无湿不成泄”之说(《医宗必读》)。小儿脏腑娇弱,气血未充,脾常不足,小儿脾胃功能较常人更为薄弱,无论感受外邪或内伤饮食,都易影响脾胃的运化,导致湿邪为患。脾为太阴湿土之脏,喜燥恶湿,湿邪最易困脾。脾为湿困,致运化失职,水谷不化,则湿邪停聚成患,加之肠道未能分清泌浊,则水湿积滞下趋大肠而为泄泻。
西医多用抗菌素、抗病毒药、蒙脱石散、微生态制剂等治疗、强调补液的重要性,疗效不稳定,尤其是迁延性腹泻疗效并不显著。小儿腹泻宁、小儿止泻灵胶囊、丁桂儿脐贴等,虽然能缓解腹泻,但是对于腹泻后的脾胃功能的恢复疗效不显著。
目前本发明已发表的相关文章/学位论文以及研究的基础如下:
[1]王霖,熊磊.二陈汤运用刍议[J].云南中医学院学报,2004,01:23-24.
[2]聂坚,解宇环,陈柏君,熊磊.芳香类中药在儿科临床运用及展望[J].云南中医学院学报,2015,02:87-89+100.
发明内容
发明人熊磊教授认为泻由脾湿,湿由脾虚,所谓“脾不伤不泻”、“无湿不成泻”。昆明饮食多辛辣鲜咸,过食易损伤脾胃,导致湿邪停而为患,而小儿“脾尤不足”,加之“肝常有余”,土虚木乘,脾土更虚,运化失职,则泄泻易迁延不愈,故脾虚泻在慢性泄泻中最为常见。
本发明的治疗小儿腹泻的香诃止泻组合物系熊磊教授用于治疗小儿泄泻的经验方,包括以下原料药:广藿香5-30g,炒车前子5-30g,诃子5-30g,茯苓5-30g,石榴皮5-30g,炒白术5-30g,葛根5-30g,焦山楂5-30g,仙鹤草5-30g,木香5-30g,白芍5-30g,炒扁豆5-30g,炒薏苡仁5-30g,乌梅5-30g,防风5-30g,泽泻5-30g。
组合物主治健脾化湿,涩肠止泻。主治小儿泄泻,大便清稀,量多次频,食欲不振,口渴思饮,舌红少苔,脉滑。香诃止泻颗粒尊《景岳全书·泄泻》谓:“泄泻之病,多见小水不利,水谷分则泻自止”之旨,以健脾利湿为大法,平陈汤为基础方化裁而来。方由藿香、诃子、车前子、茯苓等组成,方中藿香芳香而辛温,清分微温,善理中州湿浊痰涎,为醒脾快胃,振动消阳妙品。芳香而不嫌其猛烈,温煦而不偏于燥热,能祛除阴霾湿邪,而助脾胃正气。为湿困脾阳,怠倦无力,饮食不甘,舌苔浊垢者最捷之药(《本草正义》)。藿香可化湿醒脾助运,促脾之升清降浊,湿邪为患乃泄泻之主因,故选用藿香为主治泄泻之要药;藿香又为治脾胃吐逆最要之药(《本草图经》)。脾之运化功能受阻,升降失司,清浊不分;而脾亦与胃相表里,脾之功能不利可影响胃之升降,胃气上逆,发为呕吐,故藿香之芳香止呕之功在此方亦可发挥作用。诃子苦酸涩而平,其气温而无毒。苦所以泄,涩所以收,温所以通,惟敛故能主冷气,心腹胀满;惟温故下食。甄权用以止水道,萧炳用以止肠僻久泄(《本草经疏》),本方取其收敛固涩、专攻久泻久痢之功,为本方之要药。两药共为君药,奏化湿运脾止泻之功。炒车前子气薄滑利,甘寒润下,能清能降,善走气分,炒用可增收敛之功。可利尿通淋,利小便以实大便,促水谷之分清;又可泄膀肤、渗湿热、降火邪、调气机、消奎滞,故为治泻之要药。茯苓益气健脾,利水渗湿;共为臣药。本方配伍严谨,利湿止泻不忘健运脾胃,攻补兼施,共奏止泻补虚之效。
更具体而言,藿香辛温,归脾、胃、肺经,芳香化湿,驱暑止呕;炒车前子甘、微寒,归肝、肾、肺、小肠经,分清別浊,渗湿止泻,利小便以实大便;诃子苦、酸、涩、平,归肺、大肠经,既可收又可降,善涩肠止泻,专治久泻久痢,为主治脾肾虚泄之要药;以上为君药,芳香化浊,收敛止泻。茯苓甘、淡、平,归心、脾、肾经,利水渗湿、健脾;石榴皮酸、涩、温,归肺、大肠经涩肠止泻,为治疗久泻久痢之要药;炒白术甘、苦、温,归脾、胃经,益气健脾、燥湿利水;葛根甘、辛、凉,归脾、胃经,生津止渴,升阳止泻;共为臣药,渗湿健脾,生津止渴。焦山楂酸、甘、微温,归脾、胃、肝经,消食化积、行气散淤、止泻;仙鹤草苦、涩、平,归心、肝经,补虚止泻,以上共为佐药;木香,辛、苦,温,使药,归脾、胃、大厂、三焦、胆经。行气止痛,健脾消食。乌梅,味酸、涩,性平。敛肺,涩肠,生津,安蛔;泽泻,甘、淡,寒。归肾、膀胱经。利水渗湿,泄热。炒扁豆,归脾、胃经,健脾化湿。炒薏苡仁,甘,淡,健脾利湿。白芍,味苦、酸,性微寒,养血调经,敛阴止汗。以上共为使药。诸药合用,共奏化湿健脾,涩肠止泻之功效。
本发明的目的即是提供一种效果显著的,治疗小儿腹泻的香诃止泻组合物,其原料包括如下重量的组分:广藿香5-30g,炒车前子5-30g,诃子5-30g,茯苓5-30g,石榴皮5-30g,炒白术5-30g,葛根5-30g,焦山楂5-30g,仙鹤草5-30g。
优选的,各组分的重量为:广藿香15-25g,炒车前子15-25g,诃子15-25g,茯苓5-15g,石榴皮5-15g,炒白术5-15g,葛根5-15g,焦山楂5-10g,仙鹤草5-10g。
进一步优选的,各组分的重量为:广藿香20g,炒车前子20g,诃子20g,茯苓15g,石榴皮15g,炒白术15g,葛根15g,焦山楂10g,仙鹤草10g。
藿香:为唇形科植物广藿香或藿香的全草。快气,和中,辟秽,祛湿。治感冒暑湿,寒热,头痛,胸脘痞闷,呕吐泄泻,疟疾,痢疾,口臭。
诃子:使君子科植物诃子Terminalia chebula Retz.或绒毛诃子Terminaliachebula Retz.var.tomentella Kurt.的干燥成熟果实。秋、冬二季果实成熟时采收,除去杂质,晒干。涩肠敛肺,降火利咽。用于久泻久痢,便血脱肛,肺虚喘咳,久嗽不止,咽痛音哑。
车前子:车前科植物车前Plantago asiatica L.或平车前Plantago depressaWilld.的干燥成熟种子。夏、秋二季种子成熟时采收果穗,晒干,搓出种子,除去杂质。清热利尿,渗湿通淋,明目,祛痰。用于水肿胀满,热淋涩痛,暑湿泄泻,目赤肿痛,痰热咳嗽。
茯苓:多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。多于7~9月采挖,挖出后除去泥沙,堆置“发汗”后,摊开晾至表面干燥,再“发汗”,反复数次至现皱纹、内部水分大部散失后,阴干,称为“茯苓个”;或将鲜茯苓按不同部位切制,阴干,分别称为“茯苓皮”及“茯苓块”。利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
石榴皮:石榴科植物石榴Punica granatum L.的干燥果皮。秋季果实成熟后收集果皮,晒干。涩肠,止血,驱虫。治久泻,久痢,便血,脱肛,滑精,崩漏,带下,虫积腹痛,疥癣。
白术:菊科植物白术的根茎。霜降至立冬采挖,除去茎叶和泥土,烘干或晒干,再除去须根即可。烘干者称"烘术";晒干者称"生晒术",亦称"冬术"。补脾,益胃,燥湿,和中,安胎。治脾胃气弱,不思饮食,倦怠少气,虚胀,泄泻,痰饮,水肿,黄疸,湿痹,小便不利,头晕,自汗,胎气不安。
葛根:豆科植物野葛Pueraria lobata(Willd.)Ohwi或甘葛藤Puerariathomsonii Benth.的干燥根。秋、冬二季采挖,野葛多趁鲜切成厚片或小块;干燥;甘葛藤习称“粉葛”,多除去外皮,用硫黄熏后,稍干,截段或再纵切两半,干燥。解肌退热,生津,透疹,升阳止泻。用于外感发热头痛、项背强痛,口渴,消渴,麻疹不透,热痢,泄泻;高血压颈项强痛。
山楂: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。秋季果实成熟时采收,切片,干燥。消食健胃,行气散瘀。用于肉食积滞,胃脘胀满,泻痢腹痛,瘀血经闭,产后瘀阻,心腹刺痛,疝气疼痛;高脂血症。焦山楂消食导滞作用增强。用于肉食积滞,泻痢不爽。
仙鹤草:蔷薇科植物龙牙草Agrimonia pilosa Ledeb.的干燥地上部分。夏、秋二季茎叶茂盛时采割,除去杂质,干燥。收敛止血,截疟,止痢,解毒。用于咳血,吐血,崩漏下血,疟疾,血痢,脱力劳伤,痈肿疮毒,阴痒带下。
本发明香诃止泻的组合物的制备方法包括以下步骤:
(1)粉碎各药物,过40目筛,取广藿香,加6-10倍量的水蒸馏,提取挥发油;以获得挥发油6-10倍的β-CD 50℃包合2-5小时,自然冷却后置冰箱中冷藏12-36小时,抽滤并置干燥器中干燥24-72小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加4-8倍量水,煎煮1-3小时;第二次加3-6倍量水,煎煮0.5-1.5小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达50-90%,搅拌后静置12-36小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,制备得到所需制剂。
优选的,本发明香诃止泻的组合物的制备方法包括以下步骤:
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,制备得到所需制剂。
所述的香诃止泻的组合物,还可以根据实际需要制备为口服液、丸、散、滴丸、胶囊等剂型。
一种香诃止泻颗粒,其制备方法为:
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,加糊精和蔗糖适量制成颗粒。
一种香诃止泻片剂,其制备方法为:
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,混合均匀后加入适量淀粉制粒、干燥,混匀,压制成片,包衣。
一种香诃止泻胶囊,其制备方法为:
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,混合均匀后加入适量微粉硅胶和糊精,用95%乙醇制软材,过筛制粒,干燥,整粒,加入步骤(1)获得的包合物,混匀,装胶囊。
具体实施方式
实施例1香诃止泻颗粒的制备实施例
取广藿香20g,炒车前子20g,诃子20g,茯苓15g,石榴皮15g,炒白术15g,葛根15g,焦山楂10g,仙鹤草10g,木香5g,白芍5g,炒扁豆5g,炒薏苡仁5g,乌梅5g,防风5g,泽泻5g。
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,加糊精和蔗糖适量制成颗粒。
实施例2香诃止泻颗粒的制备实施例
取广藿香25g,炒车前子20g,诃子15g,茯苓12g,石榴皮12g,炒白术18g,葛根8g,焦山楂15g,仙鹤草10g,木香5g,白芍5g,炒扁豆5g,炒薏苡仁5g,乌梅5g,防风5g,泽泻5g。
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,加糊精和蔗糖适量制成颗粒。
实施例3香诃止泻颗粒的制备实施例
取广藿香12g,炒车前子10g,诃子5g,茯苓5g,石榴皮10g,炒白术5g,葛根5g,焦山楂10g,仙鹤草5g,木香5g,白芍5g,炒扁豆5g,炒薏苡仁5g,乌梅5g,防风5g,泽泻5g。
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,加糊精和蔗糖适量制成颗粒。
实施例4治疗小儿泄泻效果试验
将150例符合纳入标准的脾虚湿困型小儿腹泻患儿随机分为治疗组、对照1组和对照2组各50例。
治疗组口服香诃止泻颗粒,组方制备方法按照实施例1制备。
对照1组口服洛哌丁胺。
对照2组同样用口服对照颗粒,组方制备方法为:太子参25g、白术25g、法半夏20g、陈皮20g、茯苓15g、葛根20g、木香10g、薏苡仁15g、扁豆15g、生甘草5g;取上述药材加水煎煮两次,第一次加4-10倍量水,第二次加水4-10倍量,每次煎煮1-4小时,过滤,收集滤液,浓缩,干燥,加糊精和蔗糖适量制成颗粒。
三组均连续治疗5天。治疗组和对照组患儿在年龄、性别、病程等方面比较差异无统计学意义(P>0.05),具有可比性。治疗组总有效率96%,对照1组总有效率80%,对照2组总有效率82%,治疗组总疗效优于对照组,差异有统计学意义(P<0.05)。
实施例5止泻作用的动物模型试验
将昆明小鼠随机分为3组,每组10只。
治疗组采用实施例1制备的香诃止泻颗粒灌胃给药,2.5mL/100g,连续给药7d;
阳性对照组采用洛哌丁胺,灌胃给药,剂量:10mg/100g,连续给药7d;
阴性对照组均采用生理盐水灌胃给药,2.5mL/100g,连续给药7d。
实验前24h禁食,不禁水。于末次给药后1h灌胃番泻叶和炭末混悬液0.5mL。给药后30min脱颈椎处死,打开腹腔分离肠系膜,剪取上至幽门,下至回盲部的肠管,置于托盘上,轻轻将小肠拉成直线,测量肠管长度作为“小肠全长”,从幽门至炭末前沿的距离作为“炭末推进距离”,计算炭末推进百分率。(炭末推进百分率=炭末推进距离/小肠全长*100%),结果见下表所示。
各组小鼠炭末推进百分率(g)
组别 | 动物数 | 炭末推进百分率(%) |
治疗组 | 10 | 60.15±8.14** |
阳性对照组 | 10 | 50.61±5.78** |
阴性对照组 | 10 | 84.61±12.97 |
**P<0.01
结果证实,本发明的香诃止泻颗粒能明显延缓番泻叶所致的小鼠小肠推进运动亢进,炭末推进率较空白组明显减小。
实施例6典型病例举隅
病案一:
杨某,男,1岁3月,2016年7月5日
反复腹泻1周余,水样便量大,未见不消化物,3次/日,无便时哭闹,矢气不甚,大便气臭不甚,小便少,纳少,眠差,舌质红苔黄腻。
查:心肺(-),腹软,咽红(+)
拟方:香诃止泻颗粒。
叁剂而愈。
病案二:
王某,男,11岁,2015年4月20日
腹泻2余天,大便日行2次,呈水样便,无粘液,纳差,眠可,出汗甚,舌质红苔腻。
查:心肺(-),腹软,咽(-)
拟方:香诃止泻颗粒
叁剂而愈。
病案三:
唐某,女,5岁,2014年9月17日
腹泻3天,无明显诱因出现腹泻,口服思密达,症状有所好转,现腹泻水样便伴腹痛,色黄,3-4次/日,眠可,无呕吐,无发热,纳差,小便少。
查:心肺(-),腹软,咽(-)
拟方:香诃止泻颗粒。
叁剂而愈。
病案四:
简某,男,3岁。2013年6月10日
腹泻3天,5-6次/日,便如蛋花汤样便,体倦,眠纳可,小便可,舌质红少津,苔白腻。
查:心肺(-),腹软,咽(-)
拟方:香诃止泻颗粒。
叁剂而愈。
病案五:
张某,男,5岁。2012年10月17日
腹泻4天,2-3次/日,大便溏,无呕吐,无腹痛、咳嗽,晨起稍流涕,纳眠少,小便调。
查:心肺(-),腹软,咽(-)
拟方:香诃止泻颗粒。
叁剂而愈。
Claims (10)
1.一种香诃止泻组合物,其原料药包括如下重量的组分:广藿香5-30g,炒车前子5-30g,诃子5-30g,茯苓5-30g,石榴皮5-30g,炒白术5-30g,葛根5-30g,焦山楂5-30g,仙鹤草5-30g,木香5-30g,白芍5-30g,炒扁豆5-30g,炒薏苡仁5-30g,乌梅5-30g,防风5-30g,泽泻5-30g。
2.如权利要求1所述的香诃止泻组合物,各组分的重量为:广藿香15-25g,炒车前子15-25g,诃子15-25g,茯苓5-15g,石榴皮5-15g,炒白术5-15g,葛根5-15g,焦山楂5-10g,仙鹤草5-10g,木香5-10g,白芍5-10g,炒扁豆5-10g,炒薏苡仁5-10g,乌梅5-10g,防风5-10g,泽泻5-10g。
3.如权利要求2所述的香诃止泻组合物,各组分的重量为:广藿香20g,炒车前子20g,诃子20g,茯苓15g,石榴皮15g,炒白术15g,葛根15g,焦山楂10g,仙鹤草10g,木香5g,白芍5g,炒扁豆5g,炒薏苡仁5g,乌梅5g,防风5g,泽泻5g。
4.权利要求1-3任一项所述的香诃止泻组合物的制备方法,包括以下步骤:
(1)粉碎各药物,过40目筛,取广藿香,加6-10倍量的水蒸馏,提取挥发油;以获得挥发油6-10倍的β-CD 50℃包合2-5小时,自然冷却后置冰箱中冷藏12-36小时,抽滤并置干燥器中干燥24-72小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加4-8倍量水,煎煮1-3小时;第二次加3-6倍量水,煎煮0.5-1.5小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达50-90%,搅拌后静置12-36小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,制备得到所需制剂。
5.如权利要求4所述的制备方法,包括以下步骤:
(1)粉碎各药物,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,制备得到所需制剂。
6.一种香诃止泻颗粒,其制备方法为:
(1)粉碎权利要求1的各原料药,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,加糊精和蔗糖适量制成颗粒。
7.一种香诃止泻片剂,其制备方法为:
(1)粉碎权利要求1的各原料药,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,加入步骤(1)获得的包合物,混合均匀后加入适量淀粉制粒、干燥,混匀,压制成片,包衣。
8.一种香诃止泻胶囊,其制备方法为:
(1)粉碎权利要求1的各原料药,过40目筛,取广藿香,加8倍量的水蒸馏,提取挥发油;以获得挥发油8倍的β-CD 50℃包合5小时,自然冷却后置冰箱中冷藏24小时,抽滤并置干燥器中干燥48小时,得包合物,备用;
(2)取广藿香药渣与其余药材采用加水煎煮两次,第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1小时,合并煎液,滤过,减压浓缩至膏状,加乙醇至药液含醇量达80%,搅拌后静置24小时,取上清液滤过,滤液回收乙醇至无醇味,真空干燥,得干浸膏,粉碎成细粉,混合均匀后加入适量微粉硅胶和糊精,用95%乙醇制软材,过筛制粒,干燥,整粒,加入步骤(1)获得的包合物,混匀,装胶囊。
9.权利要求1-3任一项所述的香诃止泻组合物,根据实际需要制备为颗粒、膏、丹、口服液、散、滴丸、丸、胶囊剂型。
10.权利要求1-3任一项所述的香诃止泻组合物在制备治疗小儿腹泻药物中的用途。
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