CN110064041A - 用于消化不良的药物组合提取物及制备方法和用途 - Google Patents
用于消化不良的药物组合提取物及制备方法和用途 Download PDFInfo
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- CN110064041A CN110064041A CN201910411718.2A CN201910411718A CN110064041A CN 110064041 A CN110064041 A CN 110064041A CN 201910411718 A CN201910411718 A CN 201910411718A CN 110064041 A CN110064041 A CN 110064041A
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Abstract
本发明属于中药制剂加工领域,涉及保健品生产领域。本发明一种用于消化不良的药物组合提取物以及制备方法,其特征是由重量份的药物原料制成:生姜8‑15,苦瓜6‑10,陈皮8‑12,蜂蜜1‑3,环糊精3‑9,具体制备方法:首先将新鲜生姜和新鲜苦瓜分别处理干净,打磨成浆与陈皮粉混合后,加入重量为1:8、70%的酒精,浸泡15日后,过滤,回收酒精得浓缩液;滤渣再分别加8倍和5倍的水,煎煮提取2次,经浓缩至提取液重量在1/5时,与前述浓缩液合并,继续浓缩成稠膏,将稠膏与蜂蜜混合,研磨0.5h后,再加入环糊精继续研磨2.5h,然后经干燥、碾碎,过筛,即得。本发明产品作为制备保健品或酒品的用途。
Description
技术领域
本发明属于中药制剂加工领域,具体涉及一种用于消化不良的药物组合提取物,还涉及该药物组合提取物的制备方法和用途。
背景技术
消化不良是人们生活中的常见症状,虽然对健康危害不大,但由于经常产生消化不良,且影响人们的正常饮食,继而影响人体的正常消化机能,导致胃肠机能紊乱,胃动力减弱,因而引起便秘,继而导致口苦、口臭等不良症状,给人们的正常生活带来烦恼。
对于治疗人们消化不良的药品虽然有很多,但大都有它们的局限性,如因蛋白质类造成的消化不良,大都使用胃蛋白酶或加上淀粉酶、多酶片、及乳酶片等给予治疗。因脂肪类食物造成消化不良,大多使用胰酶类助消化药,有时配以酵母片同时服用。有些中药制剂如苦味健胃剂复方龙胆酊,陈皮酊等因其所含的成分的单一性和使用范围的局限性,其临床效果也不显著。另外尚有健胃散、健胃消食片等中成药制剂产品,但因其作用的专属性且作为药品是由医疗机构和药店专营的,给人们的用药不能根据自己的需要而自行选择。利用药食两用且具有良好的助消化功能的药材,组成具有保健性能的产品定会为众多因消化不良而产生的不适提供使用的方便性。
利用生姜、苦瓜、陈皮、蜂蜜中药组合具有清热解毒、暖胃润肠、润脾健胃,通便排毒等功效,能够促进肠胃消化功能,减少便秘的发生,从根本上解决便秘和口臭症状。
生姜为姜科植物姜的新鲜根茎。《药性论》曰:“主痰水气满,下气;生与干并治嗽,疗时疾,止呕逆不下食。”陈皮为芸香科植物橘及其栽培变种的干燥成熟果皮。《神农本草经》曰:“主胸中瘕热,逆气,利水谷,久服去臭,下气。”《名医别录》曰:“下气,止呕咳。”“主脾不能消谷,气冲胸中,吐逆霍乱,止泄。”《本草纲目》曰:“疗呕哕反胃嘈杂,时吐清水,痰痞咳疾,大便闭寒,妇人乳痛。”苦瓜为葫芦科苦瓜属植物苦瓜的果实。《浙江药用植物志》:“主治消化不良。”蜂蜜为蜂蜜科昆虫中华蜂或意大利蜂所酿的蜜。《本草蒙筌》记载:“润燥。蜜寻通大便久闭,蜜浆解虚热骤生。”《医学入门·本草》曰:“润肺燥,(治)消渴、便难及肛门肿塞。”就生姜、苦瓜、陈皮和蜂蜜诸药材组合制备成具有保健功能的提取物和应用,经检索,尚未有相关报道和有关专利申请。
发明内容
本发明的目的在于提供一种用于消化不良的药物组合提取物及制备方法。
本发明的目的还在于提供该药物组合提取物在制备保健品中的用途。
本发明一种用于消化不良的药物组合提取物,其特征,它是由以下重量份的药物原料制成:生姜8-15,苦瓜6-10,陈皮8-12,蜂蜜1-3,环糊精3-9。
制备本发明药物组合提取物优选的是由重量(份)的药物原料制成,
生姜10-13,苦瓜6-8,陈皮8-10,蜂蜜1.5-2.5,环糊精4.5-7.5。
本发明药物组合提取物的最佳优选是由重量(份)的药物原料制成,
生姜11.5,苦瓜7,陈皮9,蜂蜜2,环糊精6。
本发明上述所述的生姜为新鲜生姜。所述的苦瓜为新鲜采摘的成熟苦瓜。
本发明上述所述的环糊精(CYD),可以是β-环糊精,也可以是2,6-二甲基-β-环糊精(DM-β--CYD)、羟乙基-β-环糊精(HE-β-CYD)、羟丙基-β-环糊精(HP-β-CYD)和磺丁基醚-β-环糊精(SBE-β-CYD)中的任意一种。
CYD安全无毒,根据世界卫生组织对食品添加剂的有关规定(FAQ营养学会议NO46WHO/FOOD ADD/70.36),酶化学特征的淀粉无需再做毒性研究;许多试验研究也证明β-CYD具在很高的安全,急性毒性试验显示小鼠口服其LD50>300 mg/kg,急性毒性和慢性毒性试验,致畸致癌、致突变试验等证明了本品使用安全无毒。美国、日本的药典己将B-CYD收载为口服辅料:HP-B-CYD(羟丙基-B-环糊精)已被美国药典和Wade A编著的《Handboofk ofPharrnaceutical Excipients》收载为注射用辅料(赵洁如等主编,现代中药制剂新技术,江苏科学技术出版社,2007年2月第1版,151页)。
根据本发明所述的一种用于消化不良的药物组合提取物的制备方法,其特征在于,工艺步骤如下:(1)将中药原料中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,滤干水分,称取洗净后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净后的新鲜苦瓜,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入药材重量份1:8比例浓度为70%v/v的酒精,充分搅拌均匀后,置于2-4℃环境下浸泡15日,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加水煮沸提取2次,其煮提方法是第一次加药材重量份8倍的水煮沸提取2小时,第二次加药材重量份5倍的水煮沸提取1小时,合并两次煮提液,弃去滤渣,将煮提液过150目筛,浓缩,在浓缩液浓缩至原煮提液重量的1/5时,与步骤(4)回收酒精后的浓缩液合并,继续浓缩成稠膏;(6)将配方量的蜂蜜与步骤(5)的得稠膏混合,置于球磨机内进行研磨0.5小时后,再加入配方量的环糊精,继续充分研磨2.5小时,研磨结束后,取出物料,经干燥至含水量<6%(重量),取出冷却后,经碾碎,过80目筛,即得。
本发明中所述的酒精,在没有做出特定说明时,均为食用级酒精。
本发明中所述的水,在没有特定说明时,均为纯净水。
本发明上述所述的干燥,为采用真空干燥,其真空干燥的条件为温度50℃、真空度为0.2kPa。
本发明所述的用于消化不良的药物组合提取物按常规工艺作为制成片剂、胶囊剂、颗粒剂、丸剂、口服液或酒品作为制备保健品的用途。
生姜,为姜科植物姜Zingiber officinale Rosc.的新鲜根茎。性味辛,微温。归肺、脾、胃经。具有解表散寒,温中止呕,化痰止咳功能。
效用分析:生姜辛散温通,入脾胃经能温中散寒,对寒犯中焦或脾胃虚寒之胃脘冷痛、食少、呕吐者,可收祛寒开胃、止痛止呕之效。生姜辛散温通,入胃经能温胃散寒,和中降逆,其止呕功良,素有“呕家圣药”之称,随证配伍可治疗胃塞呕吐、胃热呕吐、痰饮呕吐等多种呕吐。生姜汁配白蜜:生姜汁辛散,化痰散结止呕;白蜜滋润,养阴润燥通便。二者配伍,辛开与润降并用,相辅相成,并奏辛润开结通降之功,常用治噎膈见有胸脘痞塞、呕吐痰涎、大便干结者(国家药典委员会编《中华人民共和国药典》·临床用药须知·中药饮片卷,2015年版,85P)。
苦瓜,具南京中医药大学编著《中药大辞典》介绍,为葫芦科苦瓜属植物苦瓜Fructus Momordica charantia的果实。一般在9-10月采收果实,切片晒干或鲜用。性味苦,寒。归心、脾、肺经,具有祛暑涤热,明目,解毒功能。主治暑热烦渴,消渴,赤眼疼痛,痢疾,疮痈肿毒等。《浙江药用植物志》:“主治消化不良”。
陈皮,具(国家药典委员会编《中华人民共和国药典》·临床用药须知·中药饮片卷,2015年版)介绍,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。性味苦、辛,温。归肺、脾经。具有理气健脾,燥湿化痰。用于脘腹胀满,食少吐泻,咳嗽痰多。效用分析:陈皮辛散苦降性温,芳香醒脾,长于理气健脾,调中快膈,隆逆止呕,适用于脾胃气滞所致之脘腹胀痛、恶心呕吐、泄泻等。《神农本草经》曰:“主胸中瘕热,逆气,利水谷,久服去臭,下气。”
蜂蜜,为蜜蜂科昆虫中华蜜蜂Apis cerana Fabricius或意大利蜂Apis melliferaLinnaeus所酿的蜜。性味甘,平。归肺、脾、大肠经。具补中,润燥,止痛,解毒;用于脘腹虚痛,肺爆干咳,肠燥便秘。效用分析:蜂蜜甘平,入脾经,既能补中益气,又能缓急止痛,可用治脾胃虚弱,脘腹作痛。蜂蜜味甘,质润滑利,入大肠经,润肠通便,适用于体虚津枯,肠燥便秘(国家药典委员会编《中华人民共和国药典》·临床用药须知·中药饮片卷,2015年版,1124页)。另具《本草蒙签》介绍:蜂蜜“润燥。蜜导通大便久闭,蜜浆解虚热骤生。”《医学入门·本草》曰:“润肺燥,(治)消渴、便难及肛门肿塞。
本发明用于消化不良的药物组合具有祛寒,开胃,止痛止呕之效,脘腹涨满,食少,脾胃气滞所致,脘腹胀痛,消化不良,肠燥便秘等功效。利用本发明上述药物组合制备成提取物,不仅可以作为消化不良调理的保健食品内服,还可以根据需要配制成不同的口服剂型,以便于吞服。可以将中药组合提取物与药学或食品上可以接受的辅料混合配制成颗粒剂,片剂,胶囊,丸剂,口服液,酒制品等;其中片剂优选泡腾片、咀嚼片、口含片,因泡腾片、咀嚼片、口含片与普通片剂相比有以下几点明显优势:(1)服用方便,可嚼服、含服,可化水,由于配制这些片剂都要加入一定量的糖粉作为赋形剂,因而口感好,人们乐意服用,泡腾片加水自溶后犹如一杯饮料,使人们乐于饮用;(2)吸收快,生物利用度高;(3)便于携带,方便运输;(4)易于量化,用量相应准确;其中胶囊剂可制备成软胶囊剂和硬胶囊剂,其中丸剂可制备成水泛丸、滴丸、微丸和蜜丸;其中所述的酒品,由于酒可促进所含中药成分吸收,有同与药学上酊剂,为了方便饮酒的人们利用饮酒达到保健作用,同时,也为有对不同饮酒需求的考虑,可选用现有的白酒、葡萄酒、黄酒和啤酒,经勾兑、陈化公知方法制备成白酒、葡萄酒、黄酒和啤酒制品,以供不同需求的人们选用。
具体实施方式
通过以下实施例是对本发明作进一步的说明,但对本发明的范围不构成任何限制。
实施例1
药物组合提取物的制备
(1)将中药材中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,沥干水分,称取15公斤洗净沥干后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净沥干水分后的新鲜苦瓜10公斤,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮12公斤粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入含量浓度为70%v/v的食用酒精296公斤,充分搅拌均匀后,置于2-4℃环境下浸泡15天,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加296公斤纯净水煮沸提取2小时,滤取煎煮液,药渣再加纯净水185公斤,煮沸提取1小时后,滤取煎煮液,弃去滤渣,将两次煎煮液合并,用150目筛网过滤,将滤液浓缩至96.2公斤时,与步骤(4)所得浓缩液合并,继续浓缩使成稠膏;(6)称取蜂蜜3公斤与步骤(5)所得稠膏混合,置于球磨机内进行研磨0.5小时后,再加入9kgβ-环糊精并入球磨机内继续充分研磨2.5小时,研磨结束后,取出物料,置于真空干燥机内,在温度为50℃、真空度为0.2kPa条件下干燥至含水量在5.8%,取出冷却至室温,碾碎,过80目筛,即得。
所述的药物组合提取物按常规工艺制成片剂、胶囊剂、颗粒剂、丸剂或口服液作为制备保健品的用途。
所述的药物组合提取物与现有的白酒、葡萄酒、黄酒或啤酒经勾兑、陈化作为制备酒品的用途。
实施例2
药物组合提取物的制备
(1)将中药材中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,沥干水分,称取8公斤洗净沥干后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净沥干水分后的新鲜苦瓜6公斤,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮8公斤粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入含量浓度为70%v/v的食用酒精176公斤,充分搅拌均匀后,置于2-4℃环境下浸泡15天,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加176公斤纯净水煮沸提取2小时,滤取煎煮液,药渣再加纯净水110公斤,煮沸提取1小时后,滤取煎煮液,弃去滤渣,将两次煎煮液合并,用150目筛网过滤,将滤液浓缩至57.2公斤时,与步骤(4)所得浓缩液合并,继续浓缩使成稠膏;(6)称取蜂蜜1公斤与步骤(5)所得稠膏混合,置于球磨机内进行研磨0.5小时后,再加入3kg2,6-二甲基-β-环糊精并入球磨机内继续充分研磨2.5小时,研磨结束后,取出物料,置于真空干燥机内,在温度为50℃、真空度为0.2kPa条件下干燥至含水量为5.6%,取出冷却至室温,碾碎,过80目筛,即得。
所述的药物组合提取物按常规工艺制成片剂、胶囊剂、颗粒剂、丸剂或口服液作为制备保健品的用途。
所述的药物组合提取物与现有的白酒、葡萄酒、黄酒或啤酒经勾兑、陈化作为制备酒品的用途。
实施例3
药物组合提取物的制备
(1)将中药材中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,沥干水分,称取11.5公斤洗净沥干后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净沥干水分后的新鲜苦瓜7公斤,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮9公斤粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入含量浓度为70%v/v的食用酒精220公斤,充分搅拌均匀后,置于2-4℃环境下浸泡15天,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加220公斤纯净水煮沸提取2小时,滤取煎煮液,药渣再加纯净水137.5公斤,煮沸提取1小时后,滤取煎煮液,弃去滤渣,将两次煎煮液合并,用150目筛网过滤,将滤液浓缩至71.5公斤时,与步骤(4)所得浓缩液合并,继续浓缩使成稠膏;(6)称取蜂蜜2公斤与步骤(5)所得稠膏混合,置于球磨机内进行研磨0.5小时后,再加6kg的磺丁基醚-β-环糊精并入球磨机内继续充分研磨2.5小时,研磨结束后,取出物料,置于真空干燥机内,在温度为50℃、真空度为0.2kPa条件下干燥至含水量为5.5%,取出冷却至室温,碾碎,过80目筛,即得。
所述的药物组合提取物按常规工艺制成片剂、胶囊剂、颗粒剂、丸剂或口服液作为制备保健品的用途。
所述的药物组合提取物与现有的白酒、葡萄酒、黄酒或啤酒经勾兑、陈化作为制备酒品的用途。
实施例4
药物组合提取物的制备
(1)将中药材中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,沥干水分,称取10公斤洗净沥干后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净沥干水分后的新鲜苦瓜6公斤,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮8公斤粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入含量浓度为70%v/v的食用酒精192公斤,充分搅拌均匀后,置于2-4℃环境下浸泡15天,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加192公斤纯净水煮沸提取2小时,滤取煎煮液,药渣再加纯净水120公斤,煮沸提取1小时后,滤取煎煮液,弃去滤渣,将两次煎煮液合并,用150目筛网过滤,将滤液浓缩至62.4公斤时,与步骤(4)所得浓缩液合并,继续浓缩使成稠膏;(6)称取蜂蜜1.5公斤与步骤(5)所得稠膏混合,置于球磨机内进行研磨0.5小时后,再加羟丙基-β-环糊精4.5kg并入球磨机内继续充分研磨2.5小时,研磨结束后,取出物料,置于真空干燥机内,在温度为50℃、真空度为0.2kPa条件下干燥至含水量在5.7%,取出冷却至室温,碾碎,过80目筛,即得。
所述的药物组合提取物按常规工艺制成片剂、胶囊剂、颗粒剂、丸剂或口服液作为制备保健品的用途。
所述的药物组合提取物与现有的白酒、葡萄酒、黄酒或啤酒经勾兑、陈化作为制备酒品的用途。
实施例5
药物组合提取物的制备
(1)将中药材中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,沥干水分,称取13公斤洗净沥干后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净沥干水分后的新鲜苦瓜8公斤,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮10公斤粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入含量浓度为70%v/v的食用酒精248公斤,充分搅拌均匀后,置于2-4℃环境下浸泡15天,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加248公斤纯净水煮沸提取2小时,滤取煎煮液,药渣再加纯净水155公斤,煮沸提取1小时后,滤取煎煮液,弃去滤渣,将两次煎煮液合并,用150目筛网过滤,将滤液浓缩至80.6公斤时,与步骤(4)所得浓缩液合并,继续浓缩使成稠膏;(6)称取蜂蜜2.5公斤与与步骤(5)所得稠膏混合,置于球磨机内进行研磨0.5小时后,再加羟乙基-β-环糊精7.5kg,并入球磨机内继续充分研磨2.5小时,研磨结束后,取出物料,置于真空干燥机内,在温度为50℃、真空度为0.2kPa条件下干燥至含水量在5.5%,取出冷却至室温,碾碎,过80目筛,即得。
所述的药物组合提取物按常规工艺制成片剂、胶囊剂、颗粒剂、丸剂或口服液作为制备保健品的用途。
所述的药物组合提取物与现有的白酒、葡萄酒、黄酒或啤酒经勾兑、陈化作为制备酒品的用途。
实施例6
药物组合提取物的制备
(1)将中药材中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,沥干水分,称取11公斤洗净沥干后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净沥干水分后的新鲜苦瓜7公斤,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮9公斤粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入含量浓度为70%v/v的食用酒精216公斤,充分搅拌均匀后,置于2-4℃环境下浸泡15天,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加216公斤纯净水煮沸提取2小时,滤取煎煮液,药渣再加纯净水135公斤,煮沸提取1小时后,滤取煎煮液,弃去滤渣,将两次煎煮液合并,用150目筛网过滤,将滤液浓缩至70.2公斤时,与步骤(4)所得浓缩液合并,继续浓缩使成稠膏;(6)称取蜂蜜1.8公斤与5.4公斤β-环糊精混合,置于球磨机内进行研磨0.5小时后,再加5.4kg的羟丙基-β-环糊精并入球磨机内继续充分研磨2.5小时,研磨结束后,取出物料,置于真空干燥机内,在温度为50℃、真空度为0.2kPa条件下干燥至含水量在5.5%,取出冷却至室温,碾碎,过80目筛,即得。
所述的药物组合提取物按常规工艺制成片剂、胶囊剂、颗粒剂、丸剂或口服液作为制备保健品的用途。
所述的药物组合提取物与现有的白酒、葡萄酒、黄酒或啤酒经勾兑、陈化作为制备酒品的用途。
实施例7
可按常规方式生产含有下列组份的片剂:
组份:
称取实施例1药物组合提取物 150g
硬脂酸镁 20g
淀粉 330g
按常规方法制成片剂1000片,每片重量为0.5g。
实施例8
可按常规方式生产含有下列组份的泡腾片:
组份:
称取实施例3药物组合提取物 250g
枸橼酸 600g
碳酸氢钠 1100g
糊精 1200g
将药物组合提取物和其他辅助材料分别过100尼龙目筛,然后以等量递加的方法混合后再过100尼龙筛,并充分混匀,以重量5%-10%聚维酮乙醇溶液(内加适量药剂允许的用量范围的聚山梨酯80)制软材,以20目尼龙筛制粒,40℃烘干,整粒,加入适量聚乙二醇6000作润滑剂,压片,制得2000粒泡腾片,每粒重量为1.575g。
实施例9
可按常规方式生产含有下列组分的胶囊剂:
组分:
称取实施例2所得药物组合提取物 100g
羧甲基纤维素钠 100g
淀粉 100g
将羧甲基纤维素钠和淀粉混合,经120℃干燥处理后,与药物组合提取物混合均匀,过100目筛三次,使之充分均匀后,分别装入胶囊中,制得1000粒胶囊,每粒胶囊含量为0.3g。
实施例10
可按常规方式生产含有下列组分的口服液:
组分:
称取实施例5所得药物组合提取物 100g
单糖浆 50g
柠檬酸 10g
纯净水 加至1000g
取药物组合提取物、柠檬酸、单糖浆分别依次加入适量的纯净水中使溶,然后再加纯净水至1000g,经过滤,分装于容量为10g小瓶中,经封口,采用100℃流通蒸汽灭菌30分钟,制成规格为药物组合提取物为1.0g/10g的口服液。
实施例11
可按常规方式生产含有下列组份的酒:
组份:
称取实施例5药物组合提取物 100g
柠檬酸 10g
28度白酒 加至1000g
取药物组合提取物和柠檬酸分别依次加入适量的28度白酒中使溶,然后加入余量的白酒,搅拌均匀,置于室温暗处,静置1周后,经过滤,分装,密封即得。
实施例12
可按常规方式生产含有下列组分的酒:
组分:
称取实施例4所得药物组合提取物 200g
50度白酒 4800g
称取药物组合提取物加入50度白酒中,充分搅拌,然后放置室温处,密闭陈化15天后,过滤,分装,即得。
实施例13
可按常规方式生产含有下列组份的酒:
组份:
称取实施例6药物组合提取物 50g
葡萄酒 加至1000g
取药物组合提取物加入适量葡萄酒中使溶,然后加入余量的葡萄酒,搅拌均匀,置于3-5℃环境下,静置72小时,过滤,装瓶,封口即得。
本发明产品对病例试验结果:选择消化不良并伴有大便秘结的病例60例,其中男性病例45例,女性病例15例。年龄为25-60岁。
将病例分为服用实施例7片剂组10人,每人日服3次,每次两片;服用实施例8泡腾片剂组20人,每日早晚服2次,每次泡饮2片;服用实施例10口服液组15人,每日早晚服2次,每次10毫升;服用实施例12白酒组10人,每人每日午饭和晚饭前各服1次,每次20毫升;服用实施例13葡萄酒组5人,每人每日午饭和晚饭前各服1次,每次30毫升。
用药结果:服用片剂组10人,其中6人服药三天后,消化不良症状消失,4人服药5天后消化不良症状消失,10人中,5天后便秘症状均得到改善和消失;泡腾片组20人,其中16人服用药5天消化不良症状痊愈,便秘症状消失,4例用药7天消化不良症状痊愈,便秘症状消失;口服液组10人中,均在用药5天后消化不良症状痊愈,便秘症状消失;白酒组10人,均在用药7天消化不良症状消失,便秘症状改善;葡萄酒组5人中,其中4人服用产品5天后,消化不良症状得到改善,便秘症状得到改善,其中1人,用药5天其症状无明显改善。
Claims (10)
1.一种用于消化不良的药物组合提取物,其特征在于,它是由以下重量份的药物原料制成:生姜8-15,苦瓜6-10,陈皮8-12,蜂蜜1-3,环糊精3-9。
2.一种用于消化不良的药物组合提取物,其特征在于,它是由以下重量份的药物原料制成:生姜10-13,苦瓜6-8,陈皮8-10,蜂蜜1.5-2.5,环糊精4.5-7.5。
3.一种用于消化不良的药物组合提取物,其特征在于,它是由以下重量份的药物原料制成:生姜11.5,苦瓜7,陈皮9,蜂蜜2,环糊精6。
4.根据权利要求1-3所述用于消化不良的药物组合提取物,其特征在于,所述的环糊精为β-环糊精(β-CYD)、2,6-二甲基-β-环糊精(DM-β--CYD)、羟乙基-β-环糊精(HE-β-CYD)、羟丙基-β-环糊精(HP-β-CYD)和磺丁基醚-β-环糊精(SBE-β-CYD)中的任意一种。
5.根据权利要求1-3所述一种用于消化不良的药物组合提取物的制备方法,其特征在于,工艺步骤如下:(1)将中药原料中的新鲜生姜拣去杂质,刮去外皮,用清洁水洗涤干净后,再用纯净水冲洗三次,滤干水分,称取洗净后的新鲜生姜,置于果蔬打浆机内打磨成浆备用;(2)将采摘的新鲜苦瓜,切去瓜蒂,纵刀刨开瓜体,清除瓜瓤和籽,用纯净水漂洗干净,捞出,沥干水分,称取洗净后的新鲜苦瓜,置于果蔬打浆机内打磨成浆备用;(3)称取净药材陈皮粉碎成120目粉备用;(4)将步骤(1)和(2)所得生姜浆和苦瓜浆与步骤(3)所得陈皮粉混合,加入药材重量份1:8比例浓度为70%v/v的酒精,充分搅拌均匀后,置于2-4℃环境下浸泡15日,滤取酒精浸泡液,回收酒精得浓缩液备用;(5)将步骤(4)过滤后的滤渣,加水煮沸提取2次,其煮提方法是第一次加药材重量份8倍的水煮沸提取2小时,第二次加药材重量份5倍的水煮沸提取1小时,合并两次煮提液,弃去滤渣,将煮提液过150目筛,浓缩,在浓缩液浓缩至原煮提液重量的1/5时,与步骤(4)回收酒精后的浓缩液合并,继续浓缩成稠膏;(6)将配方量的蜂蜜与步骤(5)的得稠膏混合,置于球磨机内进行研磨0.5小时后,再加入配方量的环糊精,继续充分研磨2.5小时,研磨结束后,取出物料,经干燥至含水量<6%(重量),取出冷却后,经碾碎,过80目筛,即得。
6.根据权利要求5所述的方法,其特征在于,所述的酒精为食用级酒精;所述的水为纯净水。
7.根据权利要求5所述的方法,其特征在于,所述的干燥为真空干燥,其真空干燥的条件为温度50℃、真空度0.2kPa。
8.根据权利要求1-3所述一种用于消化不良的药物组合提取物的用途,其特征在于,作为制成片剂、胶囊剂、颗粒剂、丸剂、口服液或酒品的用途。
9.根据权利要求8所述的用途,其特征在于,所述的片剂为泡腾片、咀嚼片和口含片;所述的胶囊剂为软胶囊和硬胶囊;所述的丸剂为水泛丸、滴丸、微丸和蜜丸。
10.根据权利要求8所述的用途,其特征在于,所述的酒为白酒、葡萄酒、黄酒和啤酒。
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CN1083316A (zh) * | 1993-04-29 | 1994-03-09 | 黄立平 | 蜂蜜茶及其制作方法 |
CN101238840A (zh) * | 2008-02-15 | 2008-08-13 | 黄立平 | 蜂蜜茶膏及其制作 |
CN104258354A (zh) * | 2014-10-15 | 2015-01-07 | 陈隆 | 一种开脾健胃的颗粒冲剂及其制备方法 |
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CN1083316A (zh) * | 1993-04-29 | 1994-03-09 | 黄立平 | 蜂蜜茶及其制作方法 |
CN101238840A (zh) * | 2008-02-15 | 2008-08-13 | 黄立平 | 蜂蜜茶膏及其制作 |
CN104258354A (zh) * | 2014-10-15 | 2015-01-07 | 陈隆 | 一种开脾健胃的颗粒冲剂及其制备方法 |
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