CN106938041A - 一种治疗胃溃疡的中药制剂及其制备方法和其药物用途 - Google Patents
一种治疗胃溃疡的中药制剂及其制备方法和其药物用途 Download PDFInfo
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Abstract
本发明涉及一种治疗胃溃疡的中药制剂及其制备方法和其药物用途，属于医药技术领域。黄芩20‑30份、白芍20‑30份、地榆20‑30份、甘草20‑30份、生姜4‑6份、柴胡20‑30份、延胡索20‑30份、防己1‑2份，红参1‑2份。优点是原料药协同作用起到具有起效快、疗效确切、安全性高和用药简单的作用，制备工艺简单、对环境友好,可以有效缓解胃溃疡引起的腹部疼痛、反酸、烧心、上腹饱胀、恶心、呕吐、食欲减退等症状,没有毒副作用,为临床缓解胃溃疡引起的各种症状提供了一个新选择。
Description
技术领域
本发明涉及医药应用技术领域,具体是一种治疗胃溃疡的中药制剂及其制备方法和用途。
背景技术
溃疡病或消化性溃疡是一种常见的消化道疾病，可发生于食管、胃或十二指肠，也可发生于胃-空肠吻合口附近或含有胃黏膜的Meckel憩室内，因为胃溃疡和十二指肠溃疡最常见，故一般所谓的消化性溃疡是指胃溃疡和十二指肠溃疡。
之所以称之为消化性溃疡，是因为既往认为胃溃疡和十二指肠溃疡是由于胃酸和胃蛋白酶对黏膜自身消化所形成的，事实上胃酸和胃蛋白酶只是溃疡形成的主要原因之一，还有其他原因可以形成消化性溃疡。由于胃溃疡和十二指肠溃疡的病因和临床症状有许多相似之处，有时难以区分是胃溃疡还是十二指肠溃疡，因此往往诊断为消化性溃疡，或胃、十二指肠溃疡。如果能明确溃疡在胃或十二指肠，那就可直接诊断为胃溃疡或十二指肠溃疡。
临床表现：上腹部疼痛是本病的主要症状。多位于上腹部，也可出现在左上腹部或胸骨、剑突后。常呈隐痛、钝痛、胀痛、烧灼样痛。胃溃疡的疼痛多在餐后1小时内出现，经1～2小时后逐渐缓解，直至下餐进食后再复现上述节律。部分患者可无症状，或以出血、穿孔等并发症作为首发症状。
胃溃疡的诊断主要依靠典型的周期性上腹疼痛和X线钡餐检查、内镜检查。
胃溃疡与十二指肠溃疡鉴别：消化性溃疡中十二指肠溃疡多见；胃溃疡疼痛多在饭后疼，十二指肠溃疡多在饭前疼痛且夜间疼痛也较多见。
病因包括：
1.幽门螺杆菌感染：Marshall和Warren因1983年成功培养出幽门螺杆菌，并提出其感染在消化性溃疡发病中起作用而获得2005年度诺贝尔医学奖。大量研究充分证明，幽门螺杆菌感染是消化性溃疡的主要原因。
2.药物及饮食因素：长期服用阿司匹林、皮质类固醇等药物易致此病发生，此外长期吸烟，长期饮酒和饮用浓茶、咖啡似亦有一定关系。
易致胃溃疡的药品:(1)各种阿司匹林制剂长期或大剂量服用可引起胃痛及不适，严重者可有呕血、黑便等，胃镜检查可发现胃黏膜炎症、糜烂及溃疡形成。(2)激素替代药消炎痛和保泰松这类药物属激素替代药，对胃黏膜有直接的损害作用，可导致急性胃溃疡。(3)解热镇痛药如A.P.C，扑热息痛，去痛片以及感冒通等感冒药。(4)治疗冠心病的药物如藻酸双酯钠(P.S.S)、潘生丁、利血平，也可导致胃溃疡，甚至胃出血。(5)消炎药红霉素、乙酰螺旋霉素等大环内酯类抗生素，容易造成胃的不适。(6)抗癌药及其他各类化疗药物往往造成胃肠刺激。
3.胃酸和胃蛋白酶：消化性溃疡的最终形成是由于胃酸/胃蛋白酶自身消化所致，胃酸是溃疡发生的决定性因素。
4.应激精神因素：急性应激可引起应激性溃疡。长期精神紧张、焦虑或情绪波动的人易患消化性溃疡。
5.遗传因素：在一些罕见的遗传综合征中，如多发性内分泌腺腺瘤I型、系统性肥大细胞增多症等，消化性溃疡为其临床表现一部分。
6.胃运动异常：部分胃溃疡患者存在胃运动障碍，如胃排空延缓所致胃酸分泌增加和十二指肠-胃反流所致胆汁、胰液和溶血卵磷脂对胃黏膜的损伤。
7.其他因素：I型单纯疱疹病毒局部感染可能有关。肾移植或免疫缺陷的患者中，巨细胞病毒感染亦可能参与。
一般按消化性溃疡的治疗原则用药：首先应用减少损害因素的药物：如制酸剂、抗胆碱能药物、H2受体拮抗药、丙谷胺、前列腺素E2的合成剂及奥美拉唑等，同时给予胃黏膜保护的药物：如硫糖铝、铋剂、甘珀酸(生胃酮)等以及抗生素的应用。彻底根除幽门螺杆菌(Hp)，因为目前认为Hp感染与本病有一定关系，所以要积极治疗。
因消化性溃疡是一种长期性和反复性很强的疾病，临床上随着三联疗法治疗Hp感染的推广，Hp耐药性越来越严重，目前根除Hp治疗方案耐药率高，且因药物本身不良反应重，影响了患者的依从性。为了避免出现治疗周期长、病情反复的情况，2012年我国专家共识推荐中药用于根除治疗。中药起效虽然没有西药快，但中药副作用小，对身体有保健作用，如改善粘膜血流，促进粘膜愈合，增加黏膜屏障，提高患者免疫功能，抑制Hp的繁殖等，正好弥补了西药的不足。
发明内容
本发明提供一种治疗胃溃疡的中药制剂及其制备方法和其药物用途。
本发明采取的技术方案是，由以下重量份的原料制成的：
黄芩20-30份、白芍20-30份、地榆20-30份、甘草20-30份、生姜4-6份、柴胡20-30份、延胡索20-30份、防己1-2份，红参1-2份。
进一步的，本发明由以下重量份的原药材制成：黄芩25-28份、白芍23-27份、地榆22-26份、甘草21-26份、生姜5-6份、柴胡28-30份、延胡索22-27份、防己1份，红参1份。
进一步的，本发明由以下重量份的原药材制成：黄芩21-22份、白芍26-28份、地榆20-21份、甘草26-29份、生姜6份、柴胡22-26份、延胡索21-23份、防己1.5份，红参1.5份。
本发明治疗胃溃疡的中药制剂的制备方法，包括下列步骤：
(1)按照重量份称取各原药材；
(2)将红参和防己分别粉碎成极细粉；
(3)将其余黄芩等七味药材，洗净,放入容器内,加3倍量水煎煮2次，每次2小时，煎液滤过，滤液合并，浓缩成相对密度为1.05-1.10(60℃)；
(4)加入5倍量75％乙醇充分搅拌，静置，滤过，滤液回收乙醇，浓缩至适量，得稠膏；
(5)稠膏与上述粉末和适量的糊精混匀，干燥，粉碎，制成胶囊。
本发明辅料包括润滑剂、崩解剂和润湿剂。
所述润滑剂、崩解剂和润湿剂的比例为1:6:1。
润滑剂为硬脂酸镁、单硬脂酸甘油醋、硬脂酸或滑石粉。
崩解剂为交联纤维素、玉米淀粉、交联聚维酮、预胶化淀粉、淀粉钠或海藻酸。
润湿剂为聚山梨醋或十二烷基硫酸钠。
本发明所述的中药制剂是在制备治疗胃溃疡药物中的应用。
本发明优点是原料药协同作用起到具有起效快、疗效确切、安全性高和用药简单的作用，制备工艺简单、对环境友好,可以有效缓解胃溃疡引起的腹部疼痛、反酸、烧心、上腹饱胀、恶心、呕吐、食欲减退等症状,没有毒副作用,为临床缓解胃溃疡引起的各种症状提供了一个新选择。
具体实施方式
实施例1
由以下重量份的原料组成：黄芩20份、白芍20份、地榆20份、甘草20份、生姜4份、柴胡20份、延胡索20份、防己1份，红参1份；
所述治疗胃溃疡的中药制剂的制备方法,具体步骤如下：按照重量份称取各原药材；将红参和防己分别粉碎成极细粉；将其余黄芩等七味药材，洗净,放入容器内,加3倍量水煎煮2次，每次2小时，煎液滤过，滤液合并，浓缩成相对密度为1.05-1.10(60℃)；加入5倍量75％乙醇充分搅拌，静置，滤过，滤液回收乙醇，浓缩至适量，得稠膏。稠膏与上述粉末和适量的糊精混匀，干燥，粉碎，制成胶囊。
用法用量：口服。一次2-4g,一日3次。
实施例2
由以下重量份的原料组成：黄芩25份、白芍25份、地榆25份、甘草5份、生姜5份、柴胡25份、延胡索25份、防己1.5份，红参1.5份；
所述治疗胃溃疡的中药制剂的制备方法,具体步骤如下：按照重量份称取各原药材；将红参和防己分别粉碎成极细粉；将其余黄芩等七味药材，洗净,放入容器内,加3倍量水煎煮2次，每次2小时，煎液滤过，滤液合并，浓缩成相对密度为1.05-1.10(60℃)；加入5倍量75％乙醇充分搅拌，静置，滤过，滤液回收乙醇，浓缩至适量，得稠膏。稠膏与上述粉末和适量的糊精混匀，干燥，粉碎，制成胶囊。
用法用量：口服。一次2-4g,一日3次。
实施例3
由以下重量份的原料组成：黄芩30份、白芍30份、地榆30份、甘草30份、生姜6份、柴胡30份、延胡索30份、防己2份，红参2份；
所述治疗胃溃疡的中药制剂的制备方法,具体步骤如下：按照重量份称取各原药材；将红参和防己分别粉碎成极细粉；将其余黄芩等七味药材，洗净,放入容器内,加3倍量水煎煮2次，每次2小时，煎液滤过，滤液合并，浓缩成相对密度为1.05-1.10(60℃)；加入5倍量75％乙醇充分搅拌，静置，滤过，滤液回收乙醇，浓缩至适量，得稠膏。稠膏与上述粉末和适量的糊精混匀，干燥，粉碎，制成胶囊，即得本发明所述的治疗胃溃疡的中药制剂。
用法用量：口服。一次2-4g,一日3次。
下边通过实验例进一步说明本发明的效果。
实验例1：临床试验：
试验对象采用本发明共治疗例患者，其中男20例，女25例。年龄最大者60岁,年龄最小者18岁；
诊断标准：参照《中药新药临床研究指导原则试行》中药新药临床研究指导原则试行制定。西医诊断标准：①具有下列症状的一种或多种慢性、节律性、周期性的上腹部疼痛暖气、泛酸、呕恶等胃部不适有呕血、黑便等出血表现。②经胃镜和钡餐等相关辅助检查确诊并排除类似疾病。中医辨证标准：①气滞证多与情志有关的胃院胀痛,舌苔白腻,脉弦细。②疲血证固定不移的胃院部针刺样疼痛,多伴有呕血、黑便,舌有癖点、苔薄黄,脉细涩。③郁热证急骤的胃院部灼热痛,伴有搜赤黄,大便干结,舌红、苔黄,脉弦数。④虚寒证胃痛缠绵日久,按之则舒,伴有纳呆便塘,舌淡、苔白,脉沉细。⑤阴虚证胃院隐痛,舌红、少苔,脉细数。
治疗方法：将例病人平均分为五组,每组男4例,女5例,一组、二组和三组均为治疗组,一组、二组和三组分别服用实施例1——实施例3制备得到的本发明的治疗胃溃疡的中药制剂,四组和五组分别为阳性药对照组和不使用药物组。方法是口服。一次2-4g,一日3次,一个月为一疗程。
治疗标准:治愈:临床症状消失,辅助检查示溃疡消失或形成瘫痕组织；有效:临床症状减轻或部分消失,辅助检查示溃疡明显缩小；无效:临床症状无好转或较前加重,辅助检查示溃疡无明显改变。
治疗结果:患者27例病例中服药后多在三周后见效,1-2个疗程治愈其中治愈8例,有效14例,无效5例,总有效率达81.4％.
实验例2收体外幽门螺杆菌抑菌试验：
1、制备含药琼脂平板：将受试物按倍比稀释配制不同药物浓度的培养基,加热,调至各自所需pH值,10磅30min灭菌,冷至45℃。倾注成无菌平板(平皿d＝65mm、10ml/平皿),最终使培养基中含受试物原液(0.38g/ml)的稀释倍数分别为1∶2,1∶4,……1∶1024。同时做空白对照培养基。
2、接种取传至第3代的幼龄菌,别用生理盐水按标准比浊管校正浓度为108cfu/ml的待检菌液,分别接种于不同倍比稀释的各自含药琼脂表面,同时接种平行点3点,使每点含2μl菌液,每一接种点的液滴直径为5～8mm。待接种点干燥后,翻转平板于36℃恒温培养箱培养72h观察结果。同时做空白对照,判定标准:以不出现菌落的琼脂平板上的最低稀释受试物浓度为其最低抑菌浓度MIC。结果如表1：
表1体外幽门螺杆菌抑菌试验结果
实验例3动物模型试验：
1、模型制备：大鼠70只,随机抽取其中10只作为正常对照组(不感染,不治疗),其余动物进行造模:在禁食12h后,先给动物灌胃5％NaHCO3溶液2ml/只。15min后灌胃幽门螺杆菌菌液1.5ml/只。30min后给食。每周感染1次,共5次。于末次感染后1周,取尾血进行血清学检查,查抗幽门螺杆菌相关成分抗体,抗体阳性者视为造模成功。
2、分组与实验方法:选择抗体阳性的动物共40只进入治疗实验,将造模动物随机分为4组,即模型对照组(10只)、实施例1制备制剂组(10只)、实施例2制备制剂组(10只)、实施例3制备制剂组(10只)。治疗组给药量分别为0.3g/kg、0.3g/kg、0.3g/kg,配成相应浓度,均按1.0ml/100g灌胃给药,模型对照组以等体积蒸馏水灌胃,每日1次,共10d。
3、动物的处理:实验期间,各组动物常规饲养,定期观察动物一般情况,包括动物的精神状态、活动情况、毛发光泽度及食欲。每周测1次体重。给药结束1个月后进行有关指标检测。禁食24h后,采取脱颈椎的方法处死动物,无菌操作取出鼠胃,沿胃大弯剪开胃腔,用生理盐水冲洗胃，取完整的胃组织；一半用10％的甲醛液固定，进行HE染色和改良Giemsa染色，另一半行快速尿素酶试验和Hp细菌培养。并进行病理组织学检查。
4、实验结果
4.1各组动物一般情况:正常对照组大鼠活动灵敏,被毛光泽,食量较大,体重增长较快；模型对照组大鼠一般情况较差,活动迟缓,毛色无光泽,食量小,体重增长缓慢,形体较小。各治疗组较模型对照组的情况有明显改善,食量较前增加,体重渐回升,实施例1、2、3制备制剂组的情况改善均较明显。
4.2组织学的观察结果
肉眼观察:正常对照组大鼠胃黏膜呈粉红色,表面平整光滑,胃壁肌张力较强。模型对照组动物胃黏膜颜色较浅或暗红色,表面缺少光泽,胃壁肌张力较差。各治疗组胃黏膜呈淡红色或暗红色,胃壁肌张力较模型组有不同程度的改善。
光镜观察胃黏膜炎症变化:正常对照组大鼠胃黏膜上皮完整,固有层内有密集排列的腺体,部分大鼠胃窦部的黏膜底部可见极少量散在的淋巴细胞。模型对照组大鼠胃窦部的炎症程度较重,固有层内可见较多的淋巴细胞、嗜酸性粒细胞及中性粒细胞浸润,但未见黏膜的糜烂、出血和溃疡等改变。各治疗组动物的胃窦部炎症均较模型对照组有所减轻,其中实施例1、2、3制备制剂组的动物炎症几乎全部消失。
4.3快速尿素酶试验、Gimsa染色及胃黏膜组织细菌培养的结果，见表2。以3项检查均阴性作为幽门螺杆菌根除标准。正常组动物未查见幽门螺杆菌感染，模型组全部感染(0/10)，实施例1、2、3制备制剂组幽门螺杆菌感染阳性动物数较模型组不同程度减少。
表2各组胃黏膜幽门螺杆菌检测结果比较
表3各组幽门螺杆菌根除率比较
| 组别 | HP阳性数 | HP阴性数 | HP根治率/％ |
| 正常组 | 0 | 10 | |
| 模型组 | 10 | 0 | 0 |
| 实施例1制备制剂 | 7 | 3 | 70 |
| 实施例2制备制剂 | 4 | 6 | 68 |
| 实施例3制备制剂 | 2 | 8 | 72 |
由表3可知，模型组动物无根除，本中药制剂3组Hp根除率分别为70％，68％，72％，说明该中药制剂对Hp具有一定根除作用。
Claims (5)
1.一种治疗胃溃疡的中药制剂，其特征在于，由以下重量份的原料制成的：
黄芩20-30份、白芍20-30份、地榆20-30份、甘草20-30份、生姜4-6份、柴胡20-30份、延胡索20-30份、防己1-2份，红参1-2份。
2.根据权利要求1所述的一种治疗胃溃疡的中药制剂，其特征在于，由以下重量份的原药材制成：黄芩25-28份、白芍23-27份、地榆22-26份、甘草21-26份、生姜5-6份、柴胡28-30份、延胡索22-27份、防己1份，红参1份。
3.根据权利要求1所述的一种治疗胃溃疡的中药制剂，其特征在于，由以下重量份的原药材制成：黄芩21-22份、白芍26-28份、地榆20-21份、甘草26-29份、生姜6份、柴胡22-26份、延胡索21-23份、防己1.5份，红参1.5份。
4.如权利要求1所述的一种治疗胃溃疡的中药制剂的制备方法，其特征在于，包括下列步骤：
(1)按照重量份称取各原药材；
(2)将红参和防己分别粉碎成极细粉；
(3)将其余黄芩等七味药材，洗净,放入容器内,加3倍量水煎煮2次，每次2小时，煎液滤过，滤液合并，浓缩成相对密度为1.05-1.10(60℃)；
(4)加入5倍量75％乙醇充分搅拌，静置，滤过，滤液回收乙醇，浓缩至适量，得稠膏；
(5)稠膏与上述粉末和适量的糊精混匀，干燥，粉碎，制成胶囊。
5.如权利要求1～3所述的一种治疗胃溃疡的中药制剂在制备治疗胃溃疡药物中的应用。
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