CN104491802A - 一种中药制剂在制备治疗急慢性胃炎药物中的用途 - Google Patents
一种中药制剂在制备治疗急慢性胃炎药物中的用途 Download PDFInfo
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Abstract
本发明涉及一种中药制剂在制备治疗急慢性胃炎药物中的用途。该中药制剂是由中药材：茯苓、山楂、枸杞子、厚朴、陈皮、砂仁、升麻、五味子、柴胡、干姜、桂枝、小茴香、延胡索、牡蛎、大枣、白芍、淮山药、甘草，经其专用的制备工艺制成方便易用的中药成品制剂，该制剂在治疗急慢性胃炎方面，具有见效快、标本兼治、侧重调理、不易复发、无毒副作用等技术优势，并且其操作工艺简便、药效稳定、易于推广应用。
Description
技术领域
本发明涉及一种中药制剂在制备治疗急慢性胃炎药物中的用途，属于中药领域。
背景技术
急慢性胃炎的主要病因有细菌和毒素的感染，理化因素的刺激，肌体应激反应及全身疾病的影响等。根据病因的不同可以分为急性外周性胃炎和急性内周性胃炎(急性感染性胃炎、急性化脓性胃炎)。临床一般以急慢性单纯性胃炎为多见。家庭生活中一般在暴饮暴食或食用了污染食物、服对胃有刺激的药后数小时至24小时发病。
慢性胃炎是最常见的胃病，属中医学“胃脘痛”、“痞满”、“吞酸”、“嘈杂”、“纳呆”等病范畴。中医认为，慢性胃炎多因长期情志不遂，饮食不节，劳逸失常，导致肝气郁结，脾失健运，胃脘失和，日久中气亏虚，从而引发种种症状。在临床上应根据病人的实际情况给予辨证论治。
食滞伤胃型患者饮食不节致使脾胃受损，食积胃脘，胀满痞痛，恶心呕吐，嗳腐吞酸，大便秘结有腐败异臭，舌质红，苔厚黄腻，脉象弦滑。证属食滞伤胃、腑气不通，宜健脾和中、消食开胃。
脾胃虚寒型患者胃脘坠胀不舒，食欲不振，呕吐酸水，隐隐作痛，遇寒加重，得暖则轻，饿时疼甚，进食稍减，大便稀溏，神疲乏力，舌质淡、胖大、边有齿印，苔薄白，脉象沉细弱或浮大无力。证属中气不足、脾胃虚寒，宜补中益气，健脾温胃。
胃阴亏虚型患者胃脘灼热疼痛，嘈杂不适，虽饥而纳差，口干口渴，大便艰涩，舌质红有裂纹，舌苔光剥或少苔，脉象弦细数。证属肝脾不和、胃阴亏虚，宜疏肝健脾、益阴养胃。
热邪犯胃型患者胃脘灼热疼痛，嘈杂易饥，口苦咽干，泛吐酸苦水，便秘，舌质红苔薄黄，脉象弦细。证属热邪犯胃、中焦郁滞，宜疏利中焦、清热和胃。
肝郁犯胃型患者胃脘痞满隐痛，两胁撑胀疼痛，嗳气频频，时有泛酸，食欲减退，舌质红苔薄白微黄，脉象弦细。证属肝郁气滞、胃失和降，宜疏肝理气、健脾安胃。
瘀滞伤胃型患者胃脘刺痛或锐痛，痛处拒按，时感胃部灼热嘈杂，纳差，舌质暗紫有瘀斑苔薄黄，脉象涩滞。证属气滞血瘀、郁热伤胃。宜活血化瘀、行气理胃。
肝火犯胃型患者因久病脾胃气虚，情志不舒，郁而化火，致使胃脘痞满隐痛，食后疼痛加重，经常烧心泛酸，口苦发黏，便溏，舌质淡红，苔黄腻，脉细数。证属虚实夹杂、肝火犯胃。治宜舒肝理气、清热调胃。
湿困脾胃型患者胃脘痞闷，纳呆，少食即感胀，口淡无味，渴而少饮，肠鸣辘辘，大便稀溏，身重乏力，困倦懒动，舌质淡胖苔白腻，脉象濡细。证属湿阻脾胃，困遏中焦。宜健脾祛湿、理气醒胃。
发明人根据中药配伍理论和中医对急慢性胃炎的辨证分型，合理配伍药材兼顾各个分型，发明了一个对各种分型均有较好效果的中药组方。
发明内容
本发明要解决的技术问题是开发一种中药制剂在制备治疗急慢性胃炎药物中的用途，提供一种对急慢性胃炎有较好治疗效果的中药，并且该中药要能够被制成适合现代临床需求的、方便易用的成品制剂。
发明人的解决方案是结合自身经验和临床实践重新配伍组方，使新发明的中药组方在保证疗效的基础上，可以利用为其开发的现代制剂工艺，制成成品制剂，该新发明包括如下重量份的中药：
茯苓11-25份、山楂9-21份、枸杞子10-22份、厚朴6-18份、陈皮7-21份、砂仁6-16份、升麻5-15份、五味子6-14份、柴胡6-18份、干姜7-19份、桂枝7-17份、小茴香5-13份、延胡索14-26份、牡蛎15-27份、大枣6-18份、白芍9-21份、淮山药6-14份、甘草8-16份。
在实际应用过程中总结出4个效果最优的中药材配比如下（以重量份计）：
配比1：茯苓18份、山楂15份、枸杞子16份、厚朴12份、陈皮14份、砂仁11份、升麻10份、五味子10份、柴胡12份、干姜13份、桂枝12份、小茴香9份、延胡索20份、牡蛎21份、大枣12份、白芍15份、淮山药10份、甘草12份。
配比2：茯苓19份、山楂17份、枸杞子15份、厚朴13份、陈皮12份、砂仁12份、升麻9份、五味子12份、柴胡13份、干姜11份、桂枝10份、小茴香10份、延胡索22份、牡蛎23份、大枣13份、白芍14份、淮山药9份、甘草11份。
配比3：茯苓20份、山楂16份、枸杞子17份、厚朴14份、陈皮15份、砂仁10份、升麻11份、五味子13份、柴胡10份、干姜12份、桂枝10份、小茴香11份、延胡索21份、牡蛎22份、大枣11份、白芍13份、淮山药9份、甘草13份。
配比4：茯苓18份、山楂16份、枸杞子18份、厚朴14份、陈皮12份、砂仁13份、升麻12份、五味子13份、柴胡11份、干姜12份、桂枝10份、小茴香9份、延胡索23份、牡蛎24份、大枣11份、白芍16份、淮山药11份、甘草13份。
将本发明中药组方做成制剂的工艺方法为：
步骤1、按本发明中药组方准确称取：茯苓、山楂、枸杞子、厚朴、陈皮、砂仁、升麻、五味子、柴胡、干姜、桂枝、小茴香、延胡索、牡蛎、大枣、白芍、淮山药、甘草，分别粉碎，混合；
步骤2、加7-11倍重量的纯化水，浸泡6-12小时，回流煎煮2-4小时，过滤得滤液；在滤渣中加入初始药材3-7倍重量的纯化水，回流煎煮1-3小时，过滤得滤液；在滤渣中再加入初始药材3-7倍重量的纯化水，回流煎煮1-2小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
步骤3、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成中药成品制剂，如颗粒剂、口服液、散剂、胶囊剂、片剂、糖浆剂、丸剂等剂型。
本发明所用中药材的性质特点：
茯苓：本品为多孔菌科真菌茯苓的干燥菌核。味甘、淡，性平；归心、脾、肾经；渗湿利水、健脾和胃、宁心安神。
山楂：本品为蔷薇科植物山里红或山楂的干燥成熟果实。味酸、甘、性微温；归脾、胃、肝经；消食健胃，行气散瘀。
枸杞子：本品为茄科植物宁夏枸杞的干燥成熟果实。味甘；性平。归肝经；肾经；肺经。养肝；滋肾；润肺。
厚朴：本品为木兰科植物厚朴或凹叶厚朴的干燥干皮、根皮及枝皮。味苦、辛，性温；归脾、胃、肺、大肠经；燥湿消痰，下气除满。
陈皮：为芸香科植物橘及其栽培变种的成熟果皮。味苦、辛，性温；归肺、脾经；理气健脾，燥湿化痰。
砂仁：本品为姜科植物阳春砂、绿壳砂或海南砂的干燥成熟果实。味辛，性温；归脾、胃、肾经；化湿开胃，温脾止泻，理气安胎。
升麻：本品为毛茛科植物大三叶升麻、兴安升麻或升麻的干燥根茎。味辛、微甘，性微寒；归肺、脾、胃、大肠经；发表透疹，清热解毒，升举阳气。
五味子：本品为木兰科植物五味子或华中五味子的干燥成熟果实。味酸、甘，性温；归肺，心、肾经；收敛固涩，益气生津，补肾宁心。
柴胡：本品为伞形科植物柴胡或狭叶柴胡的干燥根。味苦，性微寒；归肝、胆经；和解表里，疏肝，升阳。
干姜：本品为姜科植物姜的干燥根茎。味辛、性热；归脾、胃、肾、心、肺经；干姜温中散寒，回阳通脉，燥湿消痰。
桂枝：本品为樟科植物肉桂的干燥嫩枝。味辛、甘，性温；归心、肺、膀胱经；发汗解肌，温通经脉，助阳化气，平冲降气。
小茴香：本品为伞形科植物茴香的干燥成熟果实；其根、叶和全草也可药用。味辛，性温；归肝、肾、脾、胃经；散寒止痛，理气和胃。
延胡索：本品为罂粟科植物延胡索的干燥块茎。味辛、苦，性温；归肝、脾经；活血，利气，止痛。
牡蛎：本品为牡蛎科动物长牡蛎、大连湾牡蛎或近江牡蛎的贝壳。味咸，性微寒；归肝、胆、肾经；重镇安神，潜阳补阴，软坚散结。
大枣：本品为鼠李科枣属植物枣的干燥成熟果实。味甘，性温；归脾、胃经；补中益气，养血安神。
白芍：本品为毛茛科植物芍药的干燥根。味苦、酸，性微寒；归肝、脾经；平肝止痛，养血调经，敛阴止汗。
淮山药：本品为单子叶植物薯蓣科薯蓣的根茎。味甘，性平。归脾，肺，肾经。补脾养胃，生津益肺，补肾涩精。
甘草：本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘，性平；归心、肺、脾、胃经；补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。
本发明中药制剂的中药组方分析：
以牡蛎、延胡索、茯苓、枸杞子、山楂为君药，潜阳补阴、活血利气、健脾和胃、消食健胃、祛风散寒；以陈皮、白芍、干姜、大枣为臣药，理气健脾、平肝养血、温中散寒、养血安神；以厚朴、砂仁、升麻、五味子为佐药，下气除满、化湿开胃、升举阳气、益气生津；以柴胡、桂枝、小茴香、淮山药为使药，和解表里、温通经脉、散寒止痛、补脾养胃；以甘草调和诸药性，使诸药性阴阳配合、互为辅助、协同作用，从而形成活血利气、健脾和胃、温中散寒、养血安神、温通经脉等功效，对急慢性胃炎具有十分显著的治疗效果。
与现有技术相比，本发明中药制剂在治疗急慢性胃炎方面，具有见效快、标本兼治、侧重调理、不易复发、无毒副作用等技术优势，并且其可以做成方便易用的成品中药制剂，操作工艺简便、药效稳定、易于推广应用。
具体实施方式
实施例1
按本发明中药组方最大范围量生产：
（1）、按本发明中药组方准确称取：茯苓2500g、山楂2100g、枸杞子2200g、厚朴1800g、陈皮2100g、砂仁1600g、升麻1500g、五味子1400g、柴胡1800g、干姜1900g、桂枝1700g、小茴香1300g、延胡索2600g、牡蛎2700g、大枣1800g、白芍2100g、淮山药1400g、甘草1600g，分别粉碎，混合；
（2）、加10倍重量的纯化水，浸泡8小时，回流煎煮3小时，过滤得滤液；在滤渣中加入初始药材5倍重量的纯化水，回流煎煮2小时，过滤得滤液；在滤渣中再加入初始药材5倍重量的纯化水，回流煎煮1.5小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成胶囊剂，折合生药含量约为0.84g生药/粒胶囊。
实施例2
按本发明中药组方最小范围量生产：
（1）、按本发明中药组方准确称取：茯苓1100g、山楂900g、枸杞子1000g、厚朴600g、陈皮700g、砂仁600g、升麻500g、五味子600g、柴胡600g、干姜700g、桂枝700g、小茴香500g、延胡索1400g、牡蛎1500g、大枣600g、白芍900g、淮山药600g、甘草800g，分别粉碎，混合；
（2）、加10倍重量的纯化水，浸泡8小时，回流煎煮3小时，过滤得滤液；在滤渣中加入初始药材5倍重量的纯化水，回流煎煮2小时，过滤得滤液；在滤渣中再加入初始药材5倍重量的纯化水，回流煎煮1.5小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成胶囊剂，折合生药含量约为0.84g生药/粒胶囊。
实施例3
按本发明中药组方范围内任意量生产：
（1）、按本发明中药组方准确称取：茯苓1200g、山楂2000g、枸杞子1100g、厚朴1700g、陈皮800g、砂仁1500g、升麻600g、五味子1300g、柴胡1700g、干姜800g、桂枝800g、小茴香1200g、延胡索2500g、牡蛎1600g、大枣700g、白芍1000g、淮山药1300g、甘草1500g，分别粉碎，混合在一起；
（2）、加10倍重量的纯化水，浸泡8小时，回流煎煮3小时，过滤得滤液；在滤渣中加入初始药材5倍重量的纯化水，回流煎煮2小时，过滤得滤液；在滤渣中再加入初始药材5倍重量的纯化水，回流煎煮1.5小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成胶囊剂，折合生药含量约为0.84g生药/粒胶囊。
实施例4
按本发明中药组方最优配比1的量生产：
（1）、按本发明中药组方准确称取：茯苓1800g、山楂1500g、枸杞子1600g、厚朴1200g、陈皮1400g、砂仁1100g、升麻1000g、五味子1000g、柴胡1200g、干姜1300g、桂枝1200g、小茴香900g、延胡索2000g、牡蛎2100g、大枣1200g、白芍1500g、淮山药1000g、甘草1200g，分别粉碎，混合；
（2）、加10倍重量的纯化水，浸泡8小时，回流煎煮3小时，过滤得滤液；在滤渣中加入初始药材5倍重量的纯化水，回流煎煮2小时，过滤得滤液；在滤渣中再加入初始药材5倍重量的纯化水，回流煎煮1.5小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成胶囊剂，折合生药含量约为0.84g生药/粒胶囊。
实施例5
按本发明中药组方最优配比2的量生产：
（1）、按本发明中药组方准确称取：茯苓1900g、山楂1700g、枸杞子1500g、厚朴1300g、陈皮1200g、砂仁1200g、升麻900g、五味子1200g、柴胡1300g、干姜1100g、桂枝1000g、小茴香1000g、延胡索2200g、牡蛎2300g、大枣1300g、白芍1400g、淮山药900g、甘草1100g，分别粉碎，混合；
（2）、加10倍重量的纯化水，浸泡8小时，回流煎煮3小时，过滤得滤液；在滤渣中加入初始药材5倍重量的纯化水，回流煎煮2小时，过滤得滤液；在滤渣中再加入初始药材5倍重量的纯化水，回流煎煮1.5小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成胶囊剂，折合生药含量约为0.84g生药/粒胶囊。
实施例6
按本发明中药组方最优配比3的量生产：
（1）、按本发明中药组方准确称取：茯苓2000g、山楂1600g、枸杞子1700g、厚朴1400g、陈皮1500g、砂仁1000g、升麻1100g、五味子1300g、柴胡1000g、干姜1200g、桂枝1000g、小茴香1100g、延胡索2100g、牡蛎2200g、大枣1100g、白芍1300g、淮山药900g、甘草1300g，分别粉碎，混合；
（2）、加10倍重量的纯化水，浸泡8小时，回流煎煮3小时，过滤得滤液；在滤渣中加入初始药材5倍重量的纯化水，回流煎煮2小时，过滤得滤液；在滤渣中再加入初始药材5倍重量的纯化水，回流煎煮1.5小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成胶囊剂，折合生药含量约为0.84g生药/粒胶囊。
实施例7
按本发明中药组方最优配比4的量生产：
（1）、按本发明中药组方准确称取：茯苓1800g、山楂1600g、枸杞子1800g、厚朴1400g、陈皮1200g、砂仁1300g、升麻1200g、五味子1300g、柴胡1100g、干姜1200g、桂枝1000g、小茴香900g、延胡索2300g、牡蛎2400g、大枣1100g、白芍1600g、淮山药1100g、甘草1300g，分别粉碎，混合；
（2）、加10倍重量的纯化水，浸泡8小时，回流煎煮3小时，过滤得滤液；在滤渣中加入初始药材5倍重量的纯化水，回流煎煮2小时，过滤得滤液；在滤渣中再加入初始药材5倍重量的纯化水，回流煎煮1.5小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成胶囊剂，折合生药含量约为0.84g生药/粒胶囊。
实施例8
本发明实施例1-7所制胶囊剂的动物毒性试验：
1、试验药品：本发明实施例1-7所制得中药胶囊剂，破除胶囊壳，加纯化水调制成稀糊。
试验所用动物：普通级NIH小鼠，体重25g±4g，雌雄各半，雌性小鼠均无孕；SD大鼠，初始体重224±8g，雌雄各半，雌性大鼠均无孕。
2、急性毒性试验
应用小鼠进行急性毒性实验表明：小鼠灌胃本发明的中药口服液，在751.9g生药/kg剂量下，给药后小鼠出现轻微活动减少，2小时左右恢复正常，给药后连续观察7天，无一小鼠死亡，且全身状况、饮食、摄水、小便和体重增长均正常。实验结果表明：小鼠灌胃本发明的中药胶囊剂的最大给药量为751.9g生药/kg/d（LD50＞751.9g生药/kg）。本发明的中药制剂每日临床用药总量为0.14g生药/kg/d；按体重计，小鼠灌胃本发明中药制剂的耐受量为临床病人的5370.7倍。提示该药急性毒性极低，临床用药安全。
3、长期毒性试验
选用SD大鼠，给予三种剂量的本发明中药胶囊剂：25.2g生药/kg、8.4g生药/kg、2.8g生药/kg（单位体重给药量按临床用药量的20倍计算，临床用药量依据《中华人民共和国药典》2010 年版一部）。每天灌胃一次，连续90天，末次给药后24小时各组活杀1/2动物（雌雄各半），其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化；给药后90天和停药2周进行血液学（RBC、HB、网织红细胞、PLT、CT、WBC及分类）和血液生化（AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL）、尿液生化、脏器系数、病理组织学等指标检查。
试验结果表明：本发明的中药制剂在高、中、低剂量组动物一般状态良好，外观体征、行为活动、进食量和体重增长均无异常变化；三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围，组间无显著差异；各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍，根据试验结果：本发明中药制剂在高、中、低三个剂量（25.2g生药/kg、8.4g生药/kg、2.8g生药/kg）连续90天给药对大鼠无明显影响，无明确的毒性靶器官和敏感指标，恢复期观察也未见延迟性毒性反应，提示本发明的中药制剂临床应用的剂量安全性很高。
实施例9
本发明实施例4-7所制胶囊剂的临床试验
1、试验基本资料
本次临床试验的受试者由某市第二人民医院提供，该院于2011年6月至2014年1月共收治了392名急慢性胃炎患者，从中挑选出250名适合并且愿意参与临床试验的患者，其中慢性胃炎患者150名，其中男60名，年龄20-65岁，女90名，年龄21-62岁；急性胃炎患者100名，其中男50名，年龄18-55岁，女50名，年龄19-53岁。将所有受试者按急性胃炎和慢性胃炎，分别平均分成5个组，依次编号为：对照组、试验1、试验2、试验3、试验4组。
2、受试药品
对照药：奥美拉唑肠溶片，国药准字H20067717，浙江华立南湖制药有限公司。
试验药：本发明实施例4-7所制造的胶囊剂，折合生药含量为0.84g生药/粒胶囊。
3、试验方法
对照组患者口服奥美拉唑肠溶片，每日2次，每次2片。试验1-4组分别口服实施例4-7所制作的胶囊，每日2次，每次5粒（折合生药量为8.4g生药/天）。1周为一个疗程，连续治疗四个疗程，治愈者可即时中止给药。治疗过程中记录患者体征变化、不良反应等情况，对治愈者在六个月后进行跟踪回访，记录复发病例。
4、评价标准
治愈：胃炎所有症状消失，经胃部CT扫描确认，医生确诊已经完全康复。
有效：胃炎部分症状消失或好转，仍需要继续治疗。
无效：胃炎的症状没有任何改善，甚至更加严重。
复发：治愈后6个月内，重新患上原有疾病。
5、试验结果统计分析
（1）、体征结果对比：对照组共有15名患者（慢性胃炎10例，急性胃炎5例）出现了不同程度的腹泻、头痛、恶心、腹痛、胃肠胀气、便秘等不良反应，试验组无一例不良反应；对照组在治愈后往往食欲不振，虚弱，中气不足，试验组患者在治愈后，食欲良好、面色红润、中气足。
（2）、试验全部结束后，将试验数据统计分析如表1所示。
表1 试验数据统计分析表
6、结论
（1）、从体征结果对比可以看出，本发明中药制剂充分发挥了中药毒副作用小、调治结合的技术优势，与现有技术相比，有显著的技术进步。
（2）、从治疗数据统计分析结果可以看出，对于慢性胃炎试验组的平均治愈率为79.2%，比对照组高35.9个百分点，平均总有效率为97.5%，比对照组高14.2个百分点，而平均复发率为4.1%，仅为对照组的1/19；对于急性胃炎，试验组的平均治愈率为80.0%，比对照组高20个百分点，平均总有效率为98.8%，比对照组高8.8个百分点，并且试验组无复发病例，对照组的复发率为16.7%。
综上，本发明中药制剂相对于现有技术，在治疗急慢性胃炎方面具有十分显著的技术优势，取得了创造性的进步和出人意料的技术效果。
Claims (7)
1.一种中药制剂在制备治疗急慢性胃炎药物中的用途，其特征在于，所述中药制剂包括如下重量份的中药：
茯苓11-25份、山楂9-21份、枸杞子10-22份、厚朴6-18份、陈皮7-21份、砂仁6-16份、升麻5-15份、五味子6-14份、柴胡6-18份、干姜7-19份、桂枝7-17份、小茴香5-13份、延胡索14-26份、牡蛎15-27份、大枣6-18份、白芍9-21份、淮山药6-14份、甘草8-16份。
2.如权利要求1所述的用途，其特征在于，所述中药制剂包括如下重量份的中药：
茯苓18份、山楂15份、枸杞子16份、厚朴12份、陈皮14份、砂仁11份、升麻10份、五味子10份、柴胡12份、干姜13份、桂枝12份、小茴香9份、延胡索20份、牡蛎21份、大枣12份、白芍15份、淮山药10份、甘草12份。
3.如权利要求1所述的用途，其特征在于，所述中药制剂包括如下重量份的中药：
茯苓19份、山楂17份、枸杞子15份、厚朴13份、陈皮12份、砂仁12份、升麻9份、五味子12份、柴胡13份、干姜11份、桂枝10份、小茴香10份、延胡索22份、牡蛎23份、大枣13份、白芍14份、淮山药9份、甘草11份。
4.如权利要求1所述的用途，其特征在于，所述中药制剂包括如下重量份的中药：
茯苓20份、山楂16份、枸杞子17份、厚朴14份、陈皮15份、砂仁10份、升麻11份、五味子13份、柴胡10份、干姜12份、桂枝10份、小茴香11份、延胡索21份、牡蛎22份、大枣11份、白芍13份、淮山药9份、甘草13份。
5.如权利要求1所述的用途，其特征在于，所述中药制剂包括如下重量份的中药：
茯苓18份、山楂16份、枸杞子18份、厚朴14份、陈皮12份、砂仁13份、升麻12份、五味子13份、柴胡11份、干姜12份、桂枝10份、小茴香9份、延胡索23份、牡蛎24份、大枣11份、白芍16份、淮山药11份、甘草13份。
6.如权利要求1-5任一所述的用途，其特征在于，所述中药制剂的制备工艺为以下步骤：
步骤（1）、按本发明中药组方准确称取：茯苓、山楂、枸杞子、厚朴、陈皮、砂仁、升麻、五味子、柴胡、干姜、桂枝、小茴香、延胡索、牡蛎、大枣、白芍、淮山药、甘草，分别粉碎，混合；
步骤（2）、加7-11倍重量的纯化水，浸泡6-12小时，回流煎煮2-4小时，过滤得滤液；在滤渣中加入初始药材3-7倍重量的纯化水，回流煎煮1-3小时，过滤得滤液；在滤渣中再加入初始药材3-7倍重量的纯化水，回流煎煮1-2小时，过滤得滤液；将3次滤液混合，进行减压浓缩，直到混合液的相对密度为1.21-1.28（65-70℃测）时停止浓缩，即为中药浓缩液；
步骤（3）、将中药浓缩液添加辅料，利用现代通用的中药制剂技术制成中药成品制剂。
7.如权利要求1-5任一所述的用途，其特征在于，所述中药制剂可以制成颗粒剂、口服液、散剂、胶囊剂、片剂、糖浆剂和丸剂。
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| CN107715098A (zh) * | 2017-11-23 | 2018-02-23 | 鹿寨县中医医院 | 一种和胃散寒、清泄胆热制剂 |
| CN110339333A (zh) * | 2019-08-21 | 2019-10-18 | 重庆市江北区中医院 | 一种治疗慢性功能性便秘的陈皮柠檬膏及其制备方法 |
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