CN104491816A - 一种中药组合物在制备治疗慢性肠胃炎药物中的用途 - Google Patents
一种中药组合物在制备治疗慢性肠胃炎药物中的用途 Download PDFInfo
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Abstract
本发明公开一种中药组合物在制备治疗慢性肠胃炎药物中的用途,属于中药领域。该中药的原料有乌梅、川楝子、鹤虱、槟榔、枳壳、黄柏、苍术、白术、木香、榧子仁、干姜、川椒、桂枝、山楂、皂角刺、甘草等16味药材,利用本发明开发的制备工艺可以将该中药组合物制成方便易用的中药制剂。经药理实验和临床实验证实本发明中药组合物具有显著的治疗慢性肠胃炎的效果,因而具有广阔的医学推广价值。
Description
技术领域
本发明公开一种中药组合物在制备治疗慢性肠胃炎药物中的用途,属于中药领域。
背景技术
慢性肠胃炎是指由不同病因所致的胃粘膜慢性炎症。慢性胃炎的临床表现主要为食欲减退、上腹部不适或隐痛、嗳气、反酸、恶心、呕吐等,并呈持续或反复发作。发病诱因常见的有长期、大量地饮酒和吸烟,饮食无规律、饮食物过冷或过热、过粗糙坚硬,浓茶、咖啡和辛辣刺激性食物等都易诱发或加重病情。饮食不卫生所导致的胃粘膜受到幽门螺杆菌的感染所致的慢性胃炎不易痊愈。慢性肠胃炎一般分为两个类型:炎症病变比较表浅,局限在胃粘膜表面一层(不超过三分之一)者,称作慢性浅表性胃炎;而炎症病变波及胃粘膜的全层,并伴有胃腺体萎缩者,则为慢性萎缩性胃炎。慢性肠胃炎是常见病和多发病。胃镜普查证实,我国人群中慢性胃炎的发病率高达60%以上,萎缩性胃炎约占其中的 20%。
中医治疗慢性胃炎有很好的疗效。慢性胃炎在中医多属于胃脘痛、胃痞证。常见7个类型:
a.脾胃虚弱型:素体脾虚,或饮食不节、饥饱失常,使脾胃受伤而虚弱,表现为胃脘痞满胀痛、食欲不振、食后腹胀、倦怠乏力。
b.脾胃虚寒型:脾虚较重,脾阳不足,或贪食生冷,损伤脾阳,致阴寒内盛,表现为胃脘隐痛、喜得温按、饭后痛减、空腹痛重、四肢清冷。
c.肝气犯胃型:情志不畅,郁怒伤肝,肝气犯胃,气机阻滞,升降失常,表现为胃胁胀痛、嗳气频繁、嗳气或排气后减轻,或伴有心烦易怒、胸闷善太息、颈部憋闷、咽部有异物感等症状。
d.肝火犯胃型:肝气郁滞,日久化火,肝火犯胃,致胃中灼痛、口苦、心烦、大便干燥。
e.胃阴亏虚型,肝火灼伤胃阴或嗜食辛辣,耗伤胃津,引起胃脘隐痛、知饥不食、口燥咽干、大便干结。
f.血瘀胃络型:肝郁气滞或脾气虚,日久使血行不畅,瘀停于胃,产生胃脘刺痛或割痛、痛有定处、痛处拒按,舌质暗或有瘀暗斑点。
g.寒热错杂型:既有口苦、口干、口臭、胃中灼热、想饮食冷物、大便干燥等胃热症状,又有胃部怕冷、进食冷饮食或胃部受寒后引起胃部不适、胃痛、胃胀等脾寒的症状。
现有技术中化学药物治标不治本,且容易损伤胃肠道粘膜,药物毒副作用大,而中药则存在疗效不确定,缺少相应药物制剂。中医中药治疗是临床常用的方法,其效果也较好,秉承中医脾胃同治,其胃乃安的理论,可达治愈的目的。中医药源远流长,其在治疗慢性肠胃炎证以方面积累了丰富的临床实践和中医理论,如以中医理论为指导,则有补肾壮阳,益气健脾、活血调肝等方法。
发明内容
本发明要解决的技术问题是提供一种中药组合物在制备治疗慢性肠胃炎药物中的用途,开发一种治疗慢性肠胃炎的中药组合物,该中药组合物见效快、疗程短、治愈率高的中药。
为了解决上述技术问题,发明人的技术方案为:依据中医对慢性肠胃炎的辨证认知,结合自身临床行医经验和现代慢性肠胃炎的特点,重新配伍药材,经过临床实践的反复调整和验证,最终获得一个对慢性肠胃炎有显著疗效的中药组合物,并通过一系列的科研攻关将该组合物在保证药效的情况下制成成品制剂。技术方案中的中药组合物包括如下重量份的原料:
乌梅10-26份、川楝子10-24份、鹤虱6-17份、槟榔5-20份、枳壳11-19份、黄柏12-25份、苍术13-26份、白术6-18份、木香12-24份、榧子仁6-18份、干姜10-17份、川椒5-13份、桂枝12-26份、山楂15-30份、皂角刺7-18份、甘草20-30份。
实践中优选出来的疗效显著的配比为(以重量份计):
乌梅25份、川楝子15份、鹤虱12份、槟榔18份、枳壳15份、黄柏20份、苍术24份、白术16份、木香22份、榧子仁16份、干姜15份、川椒9份、桂枝24份、山楂28份、皂角刺10份、甘草30份。
将该中药组合物制成成品制剂的工艺步骤为:
步骤1、按组方比例准确称取各味原料药材,分别粉碎,备用;
步骤2、将各味药材混合,加入10倍的纯化水,浸泡20小时,回流煎煮4小时,过滤,再加6倍重量的纯化水,回流煎煮3小时,过滤(保留滤渣),将两次滤液混合,蒸馏浓缩至相对密度1.10(65℃测),即为水提浓缩液,备用;
步骤3、将步骤(2)的滤渣加入8倍重量的60%的食用乙醇溶液,回流煎煮4小时,过滤,重复操作一次,将两次滤液混合,减压蒸馏出去乙醇,即为醇提浓缩液,备用;
步骤4、将水提浓缩液与醇提浓缩液混合,减压蒸馏,浓缩至相对密度为1.35(65℃测),即为中药浸膏;
步骤5、利用现代通用的中药制剂技术将中药浸膏制成临床需要的成品制剂,例如:胶囊剂、片剂、丸剂、颗粒剂、散剂、糖浆剂等剂型。
本发明所用的中药原料药材的性质及来源:
乌梅:本品为蔷薇科植物梅的干燥近成熟果实。味酸、涩,性平;归肝、脾、肺、大肠经;敛肺,涩肠,生津,安蛔。
川楝子:本品为楝科植物川楝的干燥成熟果实。味苦,性寒;归肝、小肠、膀胱经;舒肝行气止痛,除湿热,清肝火,止痛。
鹤虱:为菊科植物天名精的果实。味苦;辛;性平;归脾;胃;大肠经;清热解毒,健脾和胃。
槟榔:本品为棕榈科植物槟榔的干燥成熟种子。味苦、辛,性温;归胃、大肠经;辛散苦泄,行胃肠之气,消积导滞,缓泻通便。
枳壳:本品为芸香科植物酸橙及其栽培变种的干燥未成熟果实。味苦、辛、酸,性温;归脾、胃经。疏肝和胃;理气止痛;消积化滞。
黄柏:本品为芸香科植物黄皮树或黄檗的干燥树皮。味苦,性寒;归肾、膀胱经;清热燥湿,泻火除蒸,解毒疗疮。
苍术:本品为菊科植物茅苍术或北苍术的干燥根茎。味辛、苦,性温;归脾、胃、肝经;燥湿健脾,祛风散寒,明目。
白术:本品为菊科植物白术的干燥根茎。味苦、甘,性温;归脾、胃经;健脾益气,燥湿利水,止汗,安胎。
木香:本品为菊科植物木香的干燥根。味辛、苦,性温;归脾、胃、大肠、三焦、胆经;行气止痛,健脾消食。
榧子仁:本品为红豆杉科植物榧的干燥成熟种子。味甘,性平;归肺、胃、大肠经;杀虫消积,润燥通便。
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。
川椒:本品为芸香科植物青椒(香椒、青花椒、山椒、狗椒)或花椒(蜀椒、川椒、红椒、红花椒、大红袍)的干燥成熟果皮(花椒)及种子(椒目)入药。味辛,性温;归脾、胃、肾经;温中止痛,杀虫止痒。
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。
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。
皂角刺:本品为豆科植物皂荚的干燥棘刺。味辛,性温;归肝、胃经;消肿托毒,排脓,杀虫。
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。
本发明中药组合物在治疗慢性肠胃炎方面,与现有技术相比具有如下优势:
1)与当前治疗的化学治疗药物相比,本发明中药组合物为天然纯中药制剂,不良反应和副作用显著降低,且本发明中药组合物作用全面,药物治疗效果更佳,显著提高了慢性肠胃炎患者的用药依从性,并提高了患者的生活质量。
2)本发明中药组合物中含有多种药物组分,作用靶点众多,药理实验显示其具有显著的活血化瘀、抗炎等活性,有效地解决了慢性肠胃炎的发病根源,其对慢性肠胃炎的治疗效果起到了标本兼治的效果。
3)本发明是发明人在祖传秘方的基础上,结合多年临床经验的总结,经过反复实验而得,因此该药物对各种原因引起的慢性肠胃炎有独特的疗效,该药配伍科学,疗效迅速,见效快、疗程短、治愈率高、费用小的优点。
药理学资料:本发明中药组合物对慢性肠胃炎的治疗作用
(一)本发明中药组合物对二甲苯所致小鼠炎症模型的抗炎作用
氢化可的松具有较强的抗炎活性,是人工合成也是天然存在的糖皮质激素,氢化可的松进入细胞后,激活胞浆受体,变构后进入细胞核,与DNA反应元件结合,引起基因转录的抑制或诱导,使炎症相关蛋白的表达发生变化。
实验方法:
40只KM小鼠,雌雄各半,体重24-28克,按体重随机分成四组,即模型对照组、组合组高剂量组、组合物中剂量组,组合物低剂量组、阳性对照组,每组10只,各给药组小鼠分别给予下述治疗药物:
模型对照组:灌胃给予同体积的生理盐水;
阳性对照组:灌胃给予5mg/kg的氢化可的松药物溶液;
中药高剂量组:灌胃给予50mg/kg实施例3中药组合物片剂,中药组合物按生药量计;
中药中剂量组:灌胃给予20mg/kg实施例3中药组合物片剂,中药组合物按生药量计;
中药低剂量组:灌胃给予5mg/kg实施例3中药组合物片剂,中药组合物按生药量计;
各给药组每天给药一次,连续给药7d。末次给药后取二甲苯20μl,涂于各小鼠右耳。30分钟后取各受试药0.03 ml分别均匀涂于小鼠右耳,右耳给二甲苯3.5小时后处死,测定各组小鼠左右耳重差。耳重差测定方法:沿耳廓基线处剪下两耳,用8mm打孔器在左右耳同一部位打下耳片,称重,耳重差=右耳片重-左耳片重。耳重差可作为评价抗炎指标。
实验结果:
测定各实验组小鼠耳重差评价各用药组药物的抗炎效果。测定结果见表1。
与模型对照组比较, * P<0.05;与模型对照组比较, ** P<0.01;
与阳性对照组比较,# P<0.05;与阳性对照组比较,## P<0.01。
结果显示给予阳性药物和本发明中药组合物均能取得显著的抗炎效果,其中与模型组比较,本发明中药组合物高剂量组、中剂量组和阳性对照组的抗炎效果具有极显著差异,中药组合物高剂量组与阳性对照组比较具有显著性差异,这表明本发明中药组合物的高剂量组抗炎效果显著优于阳性对照组。
(二)本发明中药组合物的临床治疗效果
为表明本发明的中药对慢性肠胃炎的治疗效果,本发明人对80例病例临床观察,其中男39例,女41例,年龄20-70岁。病程最短者3个月,最长者达2年,平均0.5年。
二、诊断标准:
(一) 浅表性胃炎
1、无症状或有上腹痛、饱胀、嗳气、食减等,偶有上消化道出血;
2、X 线钡餐检查缺乏阳性征象;
3、胃液分析:胃酸正常或稍高;
4. 内镜检查见粘膜红白相间(红相为主),水肿,有粘稠粘液附着,可有糜烂与出血;粘膜活检为浅层炎性细胞浸润,腺体正常;
(二) 萎缩性胃炎分型标准如下:
1、胃体胃炎(A型):病变在胃体部, 弥漫性;胃酸缺如或明显减低;血清胃泌素升高;壁细胞抗体(PCA) 等多数阳性;IFA 可阳性,可合并恶性贫血;
2、胃窦胃炎(B型):病变主要在胃窦,可累及体部,灶性;胃酸正常或略低;血清胃泌素正常;BCA,PCA 可能阳性,可癌变(<4%)。镜检:可确诊,病变可局限于胃体部或胃窦部,亦可弥散;粘膜呈灰白或红白相间(白相为主),皱襞变细,粘膜变薄,粘膜下血管透见;有时腺窝增生,局部粘膜变厚呈颗粒状改变(过形成)。粘膜活检见全层炎细胞浸润,腺体大部消失或完全消失(胃萎缩),代以肠腺化生或幽门腺化生,严重者有不典型增生。
三、用法用量:临床应用时,组合物中的组分、用量根据患者的体重、年龄及症状酌情增减。实验组使用实施例3 所得中药片剂,一日两次,每次20mg/kg,于每日早晚饭后半小时服用。对照组服用肠胃舒胶囊。两组均以30天为1个疗程,3个疗程后评定疗效。服药期间忌食生冷、辛辣之物。
四、疗效标准:
(1) 治愈:临床主要症状及体征消失,慢性炎症好转达轻度;
(2) 显效:临床主要症状消失,次要症状基本消失,慢性炎症好转;
(3) 有效:主要症状明显减轻,炎症有所减轻;
(4) 无效;主要症状无变化,也未恶化。
五、治疗效果:
服用本发明药物后,29人治愈,治愈率达72.5%,9人有效,总有效率达95.0%。对照组治愈27例,有效7例,治愈率为67.5%,总有效率为85.0%。表明本发明中药组合物在治疗慢性肠胃炎时,具有显著的治疗效果。
具体实施方式
以下通过具体实施例进一步描述本发明,但本领域技术人员应该知晓,所述实施例并不以任何方式限制本发明。
实施例1
组方:乌梅10kg、川楝子10kg、鹤虱6kg、槟榔5kg、枳壳11kg、黄柏12kg、苍术13kg、白术6kg、木香12kg、榧子仁6kg、干姜10kg、川椒5kg、桂枝12kg、山楂15kg、皂角刺7kg、甘草20kg。
制备方法:
步骤1、按组方比例准确称取各味原料药材,分别粉碎,备用;
步骤2、将各味药材混合,加入10倍的纯化水,浸泡20小时,回流煎煮4小时,过滤,再加6倍重量的纯化水,回流煎煮3小时,过滤(保留滤渣),将两次滤液混合,蒸馏浓缩至相对密度1.10(65℃测),即为水提浓缩液,备用;
步骤3、将步骤(2)的滤渣加入8倍重量的60%的食用乙醇溶液,回流煎煮4小时,过滤,重复操作一次,将两次滤液混合,减压蒸馏出去乙醇,即为醇提浓缩液,备用;
步骤4、将水提浓缩液与醇提浓缩液混合,减压蒸馏,浓缩至相对密度为1.35(65℃测),即为中药浸膏;
步骤5、利用现代通用的中药制剂技术将中药浸膏制成胶囊剂。
实施例2
组方:乌梅26kg、川楝子24kg、鹤虱17kg、槟榔20kg、枳壳19kg、黄柏25kg、苍术26kg、白术18kg、木香24kg、榧子仁18kg、干姜17kg、川椒13kg、桂枝26kg、山楂30kg、皂角刺18kg、甘草30kg。
制备方法:
步骤1、按组方比例准确称取各味原料药材,分别粉碎,备用;
步骤2、将各味药材混合,加入10倍的纯化水,浸泡20小时,回流煎煮4小时,过滤,再加6倍重量的纯化水,回流煎煮3小时,过滤(保留滤渣),将两次滤液混合,蒸馏浓缩至相对密度1.10(65℃测),即为水提浓缩液,备用;
步骤3、将步骤(2)的滤渣加入8倍重量的60%的食用乙醇溶液,回流煎煮4小时,过滤,重复操作一次,将两次滤液混合,减压蒸馏出去乙醇,即为醇提浓缩液,备用;
步骤4、将水提浓缩液与醇提浓缩液混合,减压蒸馏,浓缩至相对密度为1.35(65℃测),即为中药浸膏;
步骤5、利用现代通用的中药制剂技术将中药浸膏制成丸剂。
实施例3
组方:乌梅25kg、川楝子15kg、鹤虱12kg、槟榔18kg、枳壳15kg、黄柏20kg、苍术24kg、白术16kg、木香22kg、榧子仁16kg、干姜15kg、川椒9kg、桂枝24kg、山楂28kg、皂角刺10kg、甘草30kg。
制备方法:
步骤1、按组方比例准确称取各味原料药材,分别粉碎,备用;
步骤2、将各味药材混合,加入10倍的纯化水,浸泡20小时,回流煎煮4小时,过滤,再加6倍重量的纯化水,回流煎煮3小时,过滤(保留滤渣),将两次滤液混合,蒸馏浓缩至相对密度1.10(65℃测),即为水提浓缩液,备用;
步骤3、将步骤(2)的滤渣加入8倍重量的60%的食用乙醇溶液,回流煎煮4小时,过滤,重复操作一次,将两次滤液混合,减压蒸馏出去乙醇,即为醇提浓缩液,备用;
步骤4、将水提浓缩液与醇提浓缩液混合,减压蒸馏,浓缩至相对密度为1.35(65℃测),即为中药浸膏;
步骤5、利用现代通用的中药制剂技术将中药浸膏制成片剂。
Claims (4)
1.一种中药组合物在制备治疗慢性肠胃炎药物中的用途,其特征在于,所述中药组合物由如下重量份的原料制成的:
乌梅10-26份、川楝子10-24份、鹤虱6-17份、槟榔5-20份、枳壳11-19份、黄柏12-25份、苍术13-26份、白术6-18份、木香12-24份、榧子仁6-18份、干姜10-17份、川椒5-13份、桂枝12-26份、山楂15-30份、皂角刺7-18份、甘草20-30份。
2.根据权利要求1所述的用途,其特征在于,所述中药组合物由如下重量份的原料制成的:
乌梅25份、川楝子15份、鹤虱12份、槟榔18份、枳壳15份、黄柏20份、苍术24份、白术16份、木香22份、榧子仁16份、干姜15份、川椒9份、桂枝24份、山楂28份、皂角刺10份、甘草30份。
3.根据权利要求1-2任一所述的用途,其特征在于,所述中药组合物的制备工艺为以下步骤:
步骤1、按组方比例准确称取各味原料药材,分别粉碎,备用;
步骤2、将各味药材混合,加入10倍的纯化水,浸泡20小时,回流煎煮4小时,过滤,再加6倍重量的纯化水,回流煎煮3小时,过滤(保留滤渣),将两次滤液混合,蒸馏浓缩至相对密度1.10(65℃测),即为水提浓缩液,备用;
步骤3、将步骤(2)的滤渣加入8倍重量的60%的食用乙醇溶液,回流煎煮4小时,过滤,重复操作一次,将两次滤液混合,减压蒸馏出去乙醇,即为醇提浓缩液,备用;
步骤4、将水提浓缩液与醇提浓缩液混合,减压蒸馏,浓缩至相对密度为1.35(65℃测),即为中药浸膏;
步骤5、利用现代通用的中药制剂技术将中药浸膏制成临床需要的成品制剂。
4.根据权利要求1-2任一所述的用途,其特征在于,所述中药组合物制成胶囊剂、片剂、丸剂、颗粒剂、散剂或糖浆剂。
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