CN104491606B - 一种中药组合物和制剂及其用途 - Google Patents
一种中药组合物和制剂及其用途 Download PDFInfo
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Abstract
本发明属于中药或食品技术领域，本发明公开了一种中药组合物和制剂及其用途，该中药组合物包括：陈皮、乌梅、茯苓、麦芽；申请人经过多年的试验，在临床试验和动物试验的基础上，经过系统性、创造性的试验，获得一个药味少、活性高的中药组合物，该中药组合物以陈皮、乌梅、茯苓、麦芽为组方，以期达到健脾消食，开胃生津，促进消化等功效。
Description
技术领域
本发明属于中药技术或食品技术领域，具体涉及一种含有陈皮、乌梅等药味的中药组合物。
背景技术
消化不良(dyspepsia)是指一组表现为上腹部疼痛或烧灼感、餐后上腹饱胀和早饱的症状群，可伴食欲不振、嗳气、恶心或呕吐等症状。消化不良症状的产生与胃肠疾病有关，也可由胰、胆、肝脏疾病等引起。消化不良从病因上可分为器质性消化不良(organicdyspepsia，OD)和功能性消化不良(functional dyspepsia，FD)，其中器质性消化不良以消化性溃疡和胃食管反流病(GERD)最为多见，功能性消化不良患者的症状源于上腹部，血生化和内镜等检查无异常发现，其临床表现难以用器质性疾病解释，属中医“痞满”、“胃脘痛”、“积滞”范畴。
目前对于消化不良的发病原因和发病机制尚不完全清楚，中医认为消化不良的病位在胃，主要涉及肝、脾二脏，情志不畅和饮食积滞存在于消化不良发病的整个过程，脾虚气滞是消化不良的中心病理环节。针对该病症，适宜辨证施治，可通过健脾和胃，疏肝理气，消食导滞等法进行治疗。
发明内容
本发明目的是提供一种具有促进消化功能的中药组合物。
本发明的另外一个目的是提供了该中药组合物的制备方法。
本发明通过以下技术方案实现：
一种中药组合物，该中药组合物包括：陈皮、乌梅、茯苓、麦芽。
优选的中药组合物：其中陈皮1～10重量份，乌梅1～25重量份，茯苓1～10重量份，麦芽1～10重量份。
进一步优选的中药组合物：其中陈皮1重量份，乌梅6重量份，茯苓2重量份，麦芽4重量份。
上述所述的中药组合物在制备健脾消食、开胃生津或促进消化食品中的应用。
上述所述的中药组合物在制备健脾消食、开胃生津或促进消化药物中的应用。
上述所述的中药组合物制备成口服制剂。
上述所述中药组合物的制备方法如下：
将陈皮、乌梅、茯苓、麦芽采用超微粉碎、挥发油提取、水提、水提醇沉等工艺中的任意1～4种工艺进行组合提取，提取液浓缩成一定相对密度的稠膏或提取液浓缩、干燥后加入制备不同剂型时所需的各种常规辅料，如稀释剂、崩解剂、赋形剂、粘合剂、润滑剂、表面活性剂、填充剂、防腐剂、稳定剂、矫味剂、增稠剂、助流剂等，以常规的中药制剂方法制备成任何一种常用口服剂型，如片剂、咀嚼片、含片、泡腾片、口腔崩解片、分散片、胶囊剂、微囊剂、丸剂、散剂、滴丸剂、颗粒剂、口服液、缓释制剂、控释制剂等。
本发明中药组合物的优选制备方法如下：
取陈皮，先粉碎成粗粉，再进行超微粉碎成超微粉；另取乌梅、茯苓、麦芽等三味，加水提取两次，提取液滤过，滤液合并，浓缩至相对密度1.20～1.30(60℃)，减压干燥，制得干浸膏，粉碎成细粉；将上述超微粉及干浸膏细粉，加入制备不同剂型时所需的各种常规辅料，如稀释剂、崩解剂、赋形剂、粘合剂、润滑剂、表面活性剂、填充剂、防腐剂、稳定剂、矫味剂、增稠剂、助流剂等，以常规的中药制剂方法制备成任何一种常用口服剂型，如片剂、分散片、泡腾片、口腔崩解片、含片、咀嚼片、胶囊剂、微囊剂、丸剂、散剂、滴丸剂、颗粒剂、缓释制剂、控释制剂等。
本发明的作用机理如下：
申请人经过多年的试验，在我国中医中药思想的指导下，利用中药材提取有效成分制成的中药制剂素有作用效果明显并且安全、毒副作用低的特点。在临床试验和动物试验的基础上，经过系统性、创造性的试验，获得一个药味少、活性高的中药组合物及制备方法，该中药组合物以陈皮为君药，乌梅为臣药，辅以茯苓、麦芽为佐使药，以期达到健脾消食，开胃生津，促进消化等功效。
陈皮味苦、辛，性温，归肺、脾经，具有理气健脾、燥湿化痰之功效。脾胃主运化水湿，由于陈皮温能养脾，辛能醒脾，苦能健脾，使脾胃气行通畅，通过祛湿、健脾发挥消食的功效。
乌梅酸甘化阴，能滋养脾胃气阴，促进食欲，且能疏肝气，舒肝体，充盈胃津，旺盛脾气，舒畅肝脾，促进脾胃纳化正常。
茯苓既能健脾，又能渗湿，对于脾虚运化失常有标本兼顾的功效。
麦芽归脾经，是大麦的萌芽，具生发之性，不仅能顺肝木将军之气，也可顺脾气主升发之性，促使脾胃运化功能正常，促进食物消化吸收。
以上四味中药配伍所成的中药组合物具有健脾消食，开胃生津，促进消化的功效，可用于脾虚夹积和脾胃阴虚两型所致的消化不良、厌食、挑食等症状。
本发明所述中药组合物通过以下实验来进一步阐述健脾消食、开胃生津或促进消化的优良效果。
一、本发明中药组合物具有促进大鼠胃排空的作用。
(1)试验材料：
试验药物：本发明实例1及实例2的中药组合物0.80g/片，给药前碾碎至粉末状并用蒸馏水配绕为一定浓度的溶液，灌胃给药。
试验动物：健康SPF级Wistar大鼠70只，雌雄各半，体重180～220g。
(2)实验方法及结果：
采用SPF级Wistar大鼠进行试验，大鼠每组10只，雌雄各半，随机分成7组：本发明实例1、2组0.324g药粉/kg、0.648g药粉/kg、1.296g药粉/kg，空白对照组给予等容积生理盐水灌胃，大鼠的灌胃为0.2ml/100g。各组连续灌胃30天，末次给药时，将本发明中药组合物各剂量组水溶液及生理盐水加入20粒琥珀色树脂小球(直径约0.5mm)，用胃饲器灌入胃，2小时后迅速处死大鼠，检出胃和小肠中琥珀色树脂小球数，定量反映本发明中药组合物对胃排空的影响。结果见表1。
表1对大鼠胃排空的影响
注：与生理盐水组比较*P＜0.05
本实验结果表明，本发明组合物实例1及实例2低、中、高各剂量组与空白对照组比较，具有显著性差异。根据以上实验结果，可判断本发明中药组合物具有促进胃排空的作用。
二、本发明中药组合物能增加大鼠体重、提高大鼠摄食量和食物利用率。
(1)试验材料：
试验药物：本发明实例1及实例3的中药组合物0.80g/片，给药前碾碎至粉末状并用蒸馏水配置为一定浓度的溶液，灌胃给药。
试验动物：健康SD大鼠70只，雌雄各半，体重180～220g。
(2)实验方法及结果：采用健康SD大鼠进行试验，大鼠每组10只，雌雄各半，随机分成7组：本发明实例1、3组0.324g药粉/kg、0.648g药粉/kg、1.296g药粉/kg，空白对照组给予等容积生理盐水灌胃，大鼠的灌胃为0.2ml/100g。各组连续灌胃30天，每周称2次体重和食物摄入量，试验结束时计算大鼠体重、体重增重、摄食量和食物利用率，见表2。
表2对大鼠体重、摄食量和食物利用率的影响
注：与空白对照组比较*P＜0.05
本实验结果表明，本发明组合物实例1及实例3低、中、高各剂量组与空白对照组比较，具有显著差异。根据以上实验结果，可判断本发明中药组合物具有增加大鼠体重、提高大鼠摄食量和食物利用率的作用。
三、本发明中药组合物有增强小鼠小肠蠕动的作用。
(1)试验材料：
试验药物：本发明实例1的中药组合物0.80g/片，实例4的中药组合物8g/袋，给药前碾碎至粉末状并用蒸馏水配置为一定浓度的溶液，灌胃给药。
试验动物：健康KM小鼠70只，雌雄各半，体重18～22g。
(2)实验方法及结果：
采用KM小鼠进行试验，每组10只，雌雄各半，随机分成7组：本发明实例1、4组0.468g药粉/kg、0.936g药粉/kg、1.872g药粉/kg，空白对照组给予等容积生理盐水灌胃，小鼠的灌胃为0.02ml/10g，各组连续灌胃30天。实验当天以本发明中药组合物各剂量组水溶液及生理盐水(各药液均含10％碳末)灌胃0.5小时后，脱颈椎处死小鼠，立即剖腹取出胃肠，不加牵引平铺于光滑平板上，测量炭末头端在肠管内的移动距离(推进距离)和小肠全长(自幽门至回盲部)，计算炭末推进百分率(％)：炭末推进百分率(％)＝推进距离/小肠全长×100％。结果见表3。
表3对小鼠小肠蠕动的影响
注：与空白对照组比较*P＜0.05
本实验结果表明，本发明组合物实例1及实例4低、中、高各剂量组与空白对照组比较，具有显著差异。根据以上实验结果，可判断本发明中药组合物具有促进小鼠小肠蠕动的作用。
药理试验结论：本发明中药组合物在各给药剂量下，具有明显的促进大鼠胃中小球向肠道排出、增强小鼠小肠中碳未向下移动，显示本发明中药组合物显有明显的促进胃排空作用和增强小肠蠕动作用；另外，本发明中药组合物还具有增加大鼠体重、提高大鼠摄食量和食物利用率的作用。提示本发明中药组合物具有开发成健脾消食、开胃生津、促进消化功能的保健食品、药品的潜力。
具体实施方式
为了帮助本领域的技术人员更全面地理解本发明，详细叙述本发明的具体实施方式。但所列举的具体实施例不以任何方式限制本发明的权利。
实施例1：本发明中药组合物的咀嚼片剂的制备
原料：陈皮31.25g，乌梅187.50g，茯苓62.50g，麦芽125.00g
制备工艺：取陈皮，先粉碎成粗粉，再进行超微粉碎成超微粉；另取乌梅、茯苓、麦芽，加水煎煮两次，提取液滤过，合并滤液，真空浓缩至相对密度1.20～1.30(60℃)的稠膏，减压干燥，制得干浸膏，粉碎成细粉；取上述陈皮超微粉及干浸膏细粉，加入适量甘露醇、乳糖、食盐、阿斯巴甜、麦芽糊精混合均匀，制粒，干燥，整粒，加入硬脂酸镁，混匀，压片，即得。
实施例2：本发明中药组合物的咀嚼片剂的制备
原料：陈皮126.95g，乌梅12.70g，茯苓12.70g，麦芽253.90g
制备工艺：取陈皮，先粉碎成粗粉，再进行超微粉碎成超微粉；另取乌梅、茯苓、麦芽，加水煎煮两次，提取液滤过，合并滤液，真空浓缩至每克相当于2g生药材的稠膏；取上述陈皮超微粉，加入适量的甘露醇、乳糖、食盐、阿斯巴甜、麦芽糊精混合均匀，加入提取所得稠膏，制粒，干燥，整粒，加入硬脂酸镁，混匀，压片，即得。
实施例3：本发明中药组合物的含片剂的制备
原料：陈皮106.91g，乌梅267.27g，茯苓10.69g，麦芽21.38g
制备工艺：取陈皮，先粉碎成粗粉，再进行超微粉碎成超微粉；另取乌梅、茯苓、麦芽，加水煎煮两次，提取液滤过，合并滤液，真空浓缩至相对密度1.20～1.30(60℃)的稠膏，减压干燥，制得干浸膏，粉碎成细粉；取上述陈皮超微粉及干浸膏细粉，加入适量的异麦芽酮糖醇、乳糖、蔗糖、食盐、阿斯巴甜混合均匀，制粒，干燥，整粒，加入硬脂酸镁，混匀，压片，即得。
实施例4：本发明中药组合物的颗粒剂的制备
原料组成：陈皮1269.53g，乌梅126.95g，茯苓126.95g，麦芽2539.06g
制备工艺：取陈皮，先粉碎成粗粉，再进行超微粉碎成超微粉；另取乌梅、茯苓、麦芽，加水煎煮两次，提取液滤过，合并滤液，真空浓缩至相对密度1.14～1.16(60℃)的清膏，加乙醇使含醇量达60％，搅拌均匀，冷藏12小时，滤过，滤液回收乙醇并浓缩至相对密度为1.25～1.30(60℃)的稠膏；取上述陈皮超微粉，加入适量蔗糖、糊精、食盐、阿斯巴甜混合均匀，加入上述稠膏，制粒，干燥，整粒，分装，即得。
实施例5：本发明中药组合物的口服液制剂的制备
原料：陈皮165.00g，乌梅750.00g，茯苓250.00g，麦芽500.00g
制备工艺：各味药材净选，除杂质。陈皮水蒸气蒸馏提取挥发油，蒸馏后的芳香水溶液另器收集；药渣与乌梅、茯苓、麦芽，加水煎煮两次，提取液滤过，合并滤液，真空浓缩至相对密度为1.14～1.16(60℃)的清膏，加乙醇使含醇量达60％，搅拌均匀，冷藏12小时，滤过，滤液回收乙醇并浓缩至相对密度为1.14～1.16(60℃)的清膏，加入适量聚山梨酯-80、陈皮蒸馏挥发油及其芳香水溶液，混匀，再加水至4000ml，混匀，冷藏24小时，滤过，滤液加入适量山梨酸，加水至5000ml，搅匀，灌装，灭菌，即得。
Claims (4)
1.一种健脾消食、开胃生津或促进消化的中药组合物，其特征在于中药组合物组成为：陈皮1～10重量份，乌梅1～25重量份，茯苓1～10重量份，麦芽1～10重量份。
2.根据权利要求1所述的一种健脾消食、开胃生津或促进消化的中药组合物，其中陈皮1重量份，乌梅6重量份，茯苓2重量份，麦芽4重量份。
3.根据权利要求1-2任一项所述的一种健脾消食、开胃生津或促进消化的中药组合物，其特征在于该中药组合物制备成口服制剂。
4.根据权利要求3所述的一种健脾消食、开胃生津或促进消化的中药组合物，其中口服制剂为片剂、胶囊剂、颗粒剂、口服液、微囊剂或滴丸剂。
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