CN109106882A - 一种治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物、制剂及其制备方法 - Google Patents
一种治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物、制剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物、制剂及其制备方法,属于中药领域。本发明的中药组合物的制备原料包含以下重量份的组分:柴胡10~30份、黄连8~15份、菊花8~19份、桂花5~15份、蝉蜕6~13份、大枣10~30份、山楂5~15份、黑豆皮8~17份、熟三七9~16份、薏苡仁5~14份、薄荷7~15份、昙花5~15份、胖大海6~19份。本发明的中药组合物使用纯中药原材料,君臣佐使,配药齐全,切中病例,有效的治疗慢性胃炎,无毒副作用,疗程短,效果好,尤其是针对幽门螺旋杆菌引起的慢性胃炎,经过临床试验发现,本发明的药物治疗的有效率为99%以上。
Description
技术领域
本发明涉及一种治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物、制剂及其制备方法,属于中药领域。
背景技术
胃炎(gastritis)是各种原因引起的胃黏膜炎症,为最常见的消化系统疾病之一。按临床发病的缓急,一般可分为急性和慢性胃炎两大类型;按病因不同可分为幽门螺杆菌相关性胃炎、应激性胃炎、自身免疫性胃炎等。不同病因引起的胃炎其病理改变亦不同,通常包括三个过程即上皮损伤、黏膜炎症反应和上皮再生。急性胃炎根据其病理改变又可分为单纯性、糜烂出血性、腐蚀性、化脓性胃炎等,慢性胃炎根据其病理改变可分为非萎缩性、萎缩性和特殊类型胃炎三大类。各型胃炎的诊断和鉴别诊断主要依据胃镜检查。
目前治疗胃炎的药品有很多,在西药领域,比如保护胃黏膜药常用的药物有胶体次枸橼酸铋(CBS)、硫糖铝、麦滋林-S、氢氧化铝凝胶、胃膜素等;调整胃肠运动功能药物上腹饱胀用多潘立酮等;打嗝、腹胀或有反流现象为主者,可用胃动力药;抗生素如果胃镜检查发现幽门螺杆菌阳性,应服用抗生素,克拉霉素、羟氨苄阿莫西林等,都有清除Hp(幽门螺杆菌)的作用,一般可选用两种,常与胃黏膜保护剂和抑酸剂联合应用;制酸剂常用的药物有碳酸氢钠、氢氧化镁、氢氧化铝凝胶等;止痛药上腹疼痛较重者可口服阿托品、普鲁本辛、颠茄片,以减少胃酸分泌和缓解腹痛症状;其他对症治疗药可用助消化药,如胰酶、酵母片、乳酶生、二甲硅油片等;如有反酸现象也可用抑酸药如西咪替丁、雷尼替丁、法莫替丁等;防止胆汁反流可服铝碳酸镁、消胆胺以吸附胆汁;有呕血便血者,甲氰米胍口服。
慢性胃炎最为常见,其中又以幽门螺杆菌导致的慢性胃炎最为常见,西药治疗对胃肠的刺激难以估计,且具有一定的依赖性。临床常规治疗胃炎的西药疗程较长,见效快速,但是药物副作用大,对胃部有一定的损伤,有的患者需要服用胶体果胶铋等药物来保护胃粘膜,服用多余的药物容易引起药物副反应,同时加重了用药患者的经济负担,而且病症经常反复发作,严重影响了人们的生活健康。服用期间根据个人的体质不同反应情况也不一样,关于治疗此类疾病的中药,国内也有报道。
申请号为CN201010506194.4的专利申请公开了一种胃炎胶囊,由黄连、吴萸、三七、黄芪、苍术、沉香、红花、元胡索、柴胡组成,具有软坚散结、活血化瘀、清热滋阴等功能,清热燥湿,泻火解毒,散寒止痛,健脾养胃等功能。该申请未提及对幽门螺杆菌的抑杀作用,也未以药效学实验为依据。
申请号为CN201711302715.2的专利申请公开了一种胃炎、肠炎胶囊及其制备方法,胃炎、肠炎胶囊包括厚朴、陈皮、蝉蜕、茯苓、草豆蔻仁、木香、桂花。本发明的胃炎、肠炎胶囊。该申请未提及对幽门螺杆菌的抑杀作用,也未以药效学实验为依据。
目前,中药在治疗消化性溃疡方面尚未有重大突破,传统的中成药对功能性溃疡疗效尚好,对器质性疾病溃疡的疗效则不尽如人愿。近年来开发的一些中成药多为治疗肝淤气滞、寒凝症及中西药合壁制酸止痛剂,治虚寒证兼治淤血证功能者所见不多,既符合中医传统理论又能抑杀幽门螺杆菌的中成药尚未见到。虽然有些上市的品种克服了化学药品起效快但毒副作用大易反弹的不足,但当前面市的中成药,能有效抑杀幽门螺杆菌的很少,实际上没有药效学实验为依据。
发明内容
本发明的目的在于克服上述现有技术的不足之处而提供一种治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物、制剂及其制备方法,该组合物使用纯中药原材料,君臣佐使,配药齐全,切中病例,有效的治疗慢性胃炎,无毒副作用,疗程短,效果好,尤其是针对幽门螺旋杆菌引起的慢性胃炎,经过临床试验发现,本发明的药物治疗的有效率为99%以上。
为实现上述目的,本发明采取的技术方案为:一种治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物,所述中药组合物的制备原料包含以下重量份的组分:柴胡10~30份、黄连8~15份、菊花8~19份、桂花5~15份、蝉蜕6~13份、大枣10~30份、山楂5~15份、黑豆皮8~17份、熟三七9~16份、薏苡仁5~14份、薄荷7~15份、昙花5~15份、胖大海6~19份。
本发明的治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物中所使用的各味中药材的功用如下:
柴胡,味苦、微寒;归肝、胆经;功能主治:和解表里,疏肝,升阳,用于感冒发热,寒热往来,胸胁胀痛,月经不调,子官脱垂,脱肛。
菊花,味甘、微寒;归肺、肝经;功能主治:散风清热,平肝明目,用于风热感冒,头痛眩晕,目赤肿痛,眼目昏花。
熟三七,味甘、性温;归肝、胃经;功能主治:散瘀止血,消肿定痛,用于咯血吐血,衄血便血,崩漏,外伤出血,胸腹剌痛,跌扑肿痛。
薄荷,味辛、性凉;归肺、肝经;功能主治:宣散风热。清头目,透疹,用于风热感冒,风温初起,头痛,目赤,喉痹,口疮,风疹麻疹,胸胁胀闷。
黄连,味苦、性寒;归心、脾、胃、肝、胆、大肠经;功能主治:清热燥湿,泻火解毒,用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓,酒黄连善清上焦火热,用于目赤,口疮,姜黄连清胃和胃止呕,用于寒热互结,湿热中阻,痞满呕吐,萸黄连舒肝和胃止呕。用于肝胃不和,呕吐吞酸。
昙花,性微寒味甘淡;主要成份:花含胶质,醣类。
胖大海,味甘、性寒;归肺、大肠经;功能主治:清热润肺,利咽解毒,润肠通便,用于肺热声哑,干咳无痰,咽喉干痛,热结便闭,头痛目赤。
桂花,性温、味辛;入肺经、大肠经(脏腑归属:归肺经、大肠经中药);功效:化痰,散阏,温中散寒,暖胃止痛;主治:痰饮喘咳,肠风血痢,牙痛,口臭。
薏苡仁,性味甘、淡、凉;归脾、胃、肺经;功能主治:健脾渗湿,除痹止泻,清热排浓,用于水肿,脚气,小便不利,湿痹拘挛,脾虚泄泻,肺痈,肠痈,扁平疣。
蝉蜕,性味甘、寒;归肺、肝经;功能主治:散风除热,利咽,透疹,退翳,解痉,用于风热感冒,咽痛,音哑,麻疹不透,风疹瘙痒,目赤翳障,惊风抽搐,破伤风。
大枣,味甘、性温;归脾、胃经;功能主治:补中益气,养血安神,用于脾虚食少,乏力便溏,妇人脏躁,行气,月经不调,红崩,白带。
山楂,味甘、性温;归脾、胃经;功能主治:补中益气,养血安神,缓和药性,用于脾虚少便溏,倦怠乏力,血虚萎黄及妇女脏腑,神志不安,保护正气。
黑豆皮,味甘、性凉;归脾、肺、肾经;功能主治:养血平肝、祛风解毒,主治头痛,阴虚烦热,盗汗,风痹,湿毒,痈疮,眩晕等。
根据中医理论,胃炎分为慢性胃炎和急性胃炎,慢性胃炎应以调理为主。上述诸药中,本发明组合物中以黄连、薏苡仁为君药,其苦寒之性,能清胃火,其性又甘,又可滋养胃阴,尤其是对性胃炎起到主要治疗作用;柴胡、黑豆皮、桂花、菊花、蝉蜕为臣药,发挥疏肝理气,养血平肝,行气解郁,和血止痛的功效;以大枣、山楂、熟三七、昙花、胖大海为佐药,补脾益气,清热解毒,缓和药性,消除积食,和中清胃,进一步滋养胃;薄荷为使药,在于调和诸药药效,矫正方剂滋味,配伍科学,成分简单,取材方便,成本低,临床对慢性胃炎具有显著地疗效。
作为本发明所述治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物的优选实施方式,所述中药组合物的制备原料包含以下重量份的组分:柴胡10~20份、黄连8~10份、菊花15~19份、桂花9~13份、蝉蜕8~10份、大枣15~25份、山楂8~12份、黑豆皮10~13份、熟三七11~14份、薏苡仁8~12份、薄荷10~12份、昙花10~15份、胖大海6~12份。
作为本发明所述治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物的优选实施方式,所述中药组合物的制备原料包含以下重量份的组分:柴胡15份、黄连9份、菊花17份、桂花11份、蝉蜕9份、大枣20份、山楂10份、黑豆皮11份、熟三七12份、薏苡仁10份、薄荷11份、昙花13份、胖大海6份。
第二方面,本发明提供了上述的中药组合物的制备方法,包括以下步骤:
(1)按配比称取薏苡仁、昙花、胖大海、菊花、柴胡、大枣、桂花、黑豆皮、薄荷,加水浸泡、煮沸、过滤,浓缩得浓缩液;
(2)按配比称取黄连、山楂、熟三七、蝉蜕,去杂质、洗净、烘干,研磨后过筛,得细粉;
(3)将上述步骤(1)所得的浓缩液和步骤(2)所得的细粉合并,混合均匀,浓缩成稠膏,调节pH值至5.5~6.5,减压干燥,粉碎后过筛,得中药组合物。
作为本发明所述中药组合物的制备方法的优选实施方式,如下(a)~(c)中的至少一项:
(a)所述步骤(1)的具体步骤为:按配比称取薏苡仁、昙花、胖大海、菊花、柴胡、大枣、桂花、黑豆皮,去除杂质,加入10~13倍量水浸泡0.5~2.5小时,武火煎煮沸腾15分钟,再加入薄荷,再用文火煎煮1.5~5.0小时,然后过滤,滤渣加入5~8倍量水,武火煎煮沸腾之后文火煎煮1.0~2.5小时,过滤,合并两次滤液,滤液浓缩至70℃下相对密度为1.05~1.20,调节pH值至3.5~5.5,得浓缩液;
(b)所述步骤(2)中,过筛目数为60~80目;
(c)所述步骤(3)中,稠膏的相对密度为1.25~1.35,过筛目数为60~80目。
第三方面,本发明提供了含有该药物组合物的药物制剂,所述药物制剂由上述中药组合物与药学上可接受的辅料制成。
作为本发明所述药物制剂的优选实施方式,所述药物制剂的剂型为片剂、颗粒剂、胶囊剂、合剂、丸剂、滴丸、固体分散剂或微囊。
第四方面,本发明提供了一种胶囊剂,所述胶囊剂由上述中药组合物与药学上可接受的辅料按重量份比1:1~10制成。
作为本发明所述胶囊剂的优选实施方式,如下(a)~(b)中的至少一项:
(a)所述胶囊剂由上述中药组合物与药学上可接受的辅料按重量份比1:1.5~5.5制成;
(b)所述药学上可接受的辅料包括填充剂和粘合剂,所述填充剂为甘露醇、乳糖、蔗糖、环糊精中的至少一种,优选乳糖,所述粘合剂为3%PVP的75%乙醇溶液、3%羟丙甲纤维素的50%乙醇溶液、10%聚维酮K30的水溶液、30%淀粉浆中的至少一种,优选3%羟丙甲纤维素的50%乙醇溶液。
第五方面,本发明提供了上述胶囊剂的制备方法,包括如下步骤:将中药组合物与填充剂混合均匀,再与粘合剂混合制粒,干燥后装入胶囊,即得胶囊剂。
与现有技术相比,本发明的有益效果为:
(1)本发明使用的纯中药原材料,君臣佐使,配药齐全,切中病例,有效的治疗慢性胃炎,无毒副作用,疗程短,效果好,尤其是针对幽门螺旋杆菌引起的慢性胃炎,经过临床试验发现,本发明的药物治疗的有效率为99%以上。
(2)本发明配伍科学,成分简单,取材方便,成本低,通过动物生理学试验对小鼠PGE2、EGF的含量测定发现,本发明的中药组合物对慢性胃炎,尤其是幽门螺杆菌引起的胃炎具有显著地疗效。
(3)本发明的胶囊剂掩盖不良口感,制备过程简单,优选了制备方法,适合工艺化大生产。
具体实施方式
为更好地说明本发明的目的、技术方案和优点,下面将结合具体实施例对本发明作进一步说明。
实施例1
本发明胶囊剂的一种实施例,本实施例所述胶囊剂中中药组合物的原料成分如表1所示。
本实施例所述的胶囊剂的制备方法为:
(1)按配比称取薏苡仁、昙花、胖大海、菊花、柴胡、大枣、桂花、黑豆皮,去除杂质,加入12倍量水浸泡1.5小时,武火煎煮沸腾15分钟,再加入薄荷,再用文火煎煮3小时,然后过滤,滤渣加入6倍量水,武火煎煮沸腾之后文火煎煮1.5小时,过滤,合并两次滤液,滤液浓缩至70℃下相对密度为1.20,调节pH值至4.5,得浓缩液;
(2)将黄连、山楂、熟三七、蝉蜕,去杂质、洗净、烘干,研磨成60~80目细粉;
(3)将上述步骤(1)所得的浓缩液和步骤(2)所得的细粉合并,浓缩至相对密度为1.25的稠膏,调节pH值至5.5减压干燥,粉碎后过70目筛,得中药组合物;
(4)将步骤(3)所得的中药组合物与乳糖混合均匀,再与适量的pH值为6.0的3%羟丙甲纤维素的50%乙醇溶液混合制粒,干燥后装入胶囊,即得胶囊剂。
实施例2~5
实施例2~5所述的胶囊剂中中药组合物的原料成分如表1所示,实施例2~5所述的胶囊剂的制备方法同实施例1。
对比例1~2
对比例1~2所述的胶囊剂中中药组合物的原料成分如表1所示,对比例1所述的胶囊剂的制备方法同实施例1。
对比例2所述的胶囊剂的制备方法为:
(1)按配比称取薏苡仁、昙花、胖大海、菊花、柴胡、大枣、桂花、黑豆皮,去除杂质,加入12倍量水浸泡1.5小时,武火煎煮沸腾15分钟,再加入薄荷,再用文火煎煮3小时,然后过滤,滤渣加入6倍量水,武火煎煮沸腾之后文火煎煮1.5小时,过滤,合并两次滤液,滤液浓缩至70℃下相对密度为1.20,调节pH值至6.0,得浓缩液;
(2)将黄连、山楂、熟三七、蝉蜕,去杂质、洗净、烘干,研磨成60~80目细粉;
(3)将上述步骤(1)所得的浓缩液和步骤(2)所得的细粉合并,浓缩至相对密度为1.25的稠膏,调节pH值至3.5减压干燥,粉碎后过70目筛,得中药组合物;
(4)将步骤(3)所得的中药组合物与乳糖混合均匀,再与适量的pH值为7.0的3%羟丙甲纤维素的50%乙醇溶液混合制粒,干燥后装入胶囊,即得胶囊剂。
表1
实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 对比例1 | 对比例2 | |
柴胡 | 10 | 30 | 10 | 20 | 15 | 35 | 35 |
黄连 | 8 | 15 | 8 | 10 | 9 | 5 | 9 |
菊花 | 8 | 19 | 15 | 19 | 17 | 19 | 20 |
桂花 | 5 | 15 | 9 | 13 | 11 | 15 | 11 |
蝉蜕 | 6 | 13 | 8 | 10 | 9 | 13 | 9 |
大枣 | 10 | 30 | 15 | 25 | 20 | 30 | 8 |
山楂 | 5 | 15 | 8 | 12 | 10 | 15 | 10 |
黑豆皮 | 8 | 17 | 10 | 13 | 11 | 17 | 11 |
熟三七 | 9 | 16 | 11 | 14 | 12 | 6 | 12 |
薏苡仁 | 5 | 14 | 8 | 12 | 10 | 14 | 10 |
薄荷 | 7 | 15 | 10 | 12 | 11 | 15 | 5 |
昙花 | 5 | 15 | 10 | 15 | 13 | 15 | 17 |
胖大海 | 6 | 19 | 6 | 12 | 6 | 5 | 6 |
效果例1
本发明实施例1~5和对比例1~2的治疗效果试验
(1)临床资料
本发明人于2013年5月至2018年5月,通过筛选对1200例幽门螺杆菌导致的胃炎患者进行临床观察治疗,年龄在28~58岁。其中男性600例,女性600例,随机将患者服用本发明实施例1~5、对比例1~2的胶囊剂和观察组的香砂养胃丸,两组患者的一般资料差异无显著性(P>0.05)。
香砂养胃丸的主要成分为:木香、砂仁、白术、陈皮、茯苓、半夏(制)、香附(醋制)、枳实(炒)、豆蔻(去壳)、厚朴(姜制)、广藿香、甘草。本品具有调整消化液分泌功能;对胃肠道平滑肌具有良好的双向调节作用;对胃溃疡的形成有明显的抑制作用,可降低溃疡发病率;有较强的抑菌作用;有利胆作用,可增加胆汁的分泌,松弛奥狄氏括约肌,并降低胆囊的压力。
(2)疗效判定标准
治愈:临床症状体征消失,恢复正常;
显效:临床症状体征基本或大部分消失;
有效:临床症状明显好转;
反弹:1个月电话随访又复发;
反弹率:(1个月电话随访又复发)/(治愈)
无效:临床症状体征无改善。
(3)诊断标准
中医诊断标准:(1989年11月中国中西医结合学会消化系统疾病专业委员会制定的诊断试行标准)
肝胃不和型:主要要证候:①胃脘胀痛或痛串两胁,②嗳气频繁,③嘈杂泛酸。次要证候:①胃粘膜急性活动性炎症,②胆汁返流。舌象脉象:舌质淡红,苔薄白或白厚;脉弦。证型确定:①具备主症两项,舌脉象基本符合,②具备主症1项和次症1项,舌脉象基本符合。具备任何1条者即可确定。
脾胃虚弱(包括虚寒)型:主要证候:①胃脘隐痛,②胃痛喜按喜暖,③食后胀闷痞满,④纳呆少食,⑤便溏腹泻,⑥乏力四肢酸软。次要证候:①胃粘膜红白相间以白为主,②粘液稀薄而多,③胃酸偏低。舌象脉象:①舌质淡红,苔薄白或白,有齿痕,②脉沉细。证型确定:①具备主证3项,舌脉基本符合,②具备主症两项和次症1项,舌脉基本符合。具备任何1条即可确定。
脾胃湿热型:主要证候:①胃脘灼热胀痛,②口苦口臭,③尿黄,④脘腹痞闷,渴不欲饮。次要证候:胃粘膜急性、活动性炎症、充血糜烂明显。舌象脉象:舌质红,边尖深红,苔黄厚或腻。脉滑,脉紧。证型确定:①具备主症两项,舌脉基本符合,②具备主症1项及次症,舌脉基本符合。具备任何1条即可确定。
胃阴不足型:主要证候:①胃脘灼热疼痛,②口干舌燥,③大便干燥。次要证候:①胃粘膜片状红白相间,粘膜变薄,②胃粘膜干燥,粘液少,③胃酸偏低。舌象脉象:①舌红少津或有裂纹,②脉细或弦细。证型确定:①具备主症两项及舌脉符合,②具备主症1项及次症两项,舌脉基本符合。具备以上任何1条即可确定。
胃络瘀血型:主要症候:①胃脘痛有定处,不喜按,②胃疼日久不愈,③大使潜血阳性或黑血便。次要症候:胃粘膜充血肿胀,伴瘀斑或出血点。舌象脉象:①舌质暗红,或紫暗,或有瘀斑,②脉弦涩。证型确定:①具备主症两项,舌脉基本符合,②具备主症1项加次症;舌脉基本符合。具备以上任何1条即可确定。
(4)治疗方法
每组共150人,男75人,女75人;服用本发明实施例1~5和对比例1~2制备的胶囊剂,每次2粒,每日3次,饭后服用7天一疗程;
观察组:男75人,女75人,服用香砂养胃丸,服次口8丸,一日3次,饭后服用7天一疗程。
(5)治疗效果
对于1200例患者在治疗过程中进行跟踪观察,未发现明显的不良反应。治疗结果如表2所示。本发明配制简单,吸收效果好,疗效显著,无副作用,安全性高,有利于患者及时减轻病状。
表2
从表2可以看出,经过3个疗程的治疗后,服用本发明实施例1~5的胶囊剂,治愈率高达90%以上;对比例1的中药组合物的重量份不全在本发明范围内,其治愈率不如本发明,对比例2的中药组合物的重量份不全在本发明范围内,制备方法不同于本发明,其治愈率不如本发明;观察组治愈率为50%以下。本发明实施例1~5、对比例1~2、观察组的总有效率分别为100%、80%和90%,本发明的反弹率在5%以下,而对比例1~2的反弹率接近50%,观察组的反弹率超过30%。可见,本发明实施例1~5的治愈率和总有效率明显优于对比例1~2和观察组。经统计学处理,两组患者临床疗效间差异有统计学意义(P<0.05)。并且,当柴胡为10~20重量份,黄连为8~10重量份,菊花为15~19重量份,桂花为9~13重量份,蝉蜕为8~10重量份,大枣为15~25重量份,山楂为8~12重量份,黑豆皮为10~13重量份,熟三七为11~14重量份,薏苡仁为8~12重量份,薄荷为10~12重量份,昙花为10~15重量份,胖大海为6~12重量份时,胶囊剂的治愈率和总有效率更高、反弹率更低。当柴胡为15重量份,黄连为9重量份,菊花为17重量份,桂花为11重量份,蝉蜕为9重量份,大枣为20重量份,山楂为10重量份,黑豆皮为11重量份,熟三七为12重量份,薏苡仁为10重量份,薄荷为11重量份,昙花为13重量份、,胖大海为6重量份时,胶囊剂的治愈率和总有效率最高、反弹率最低。
效果例2
本发明实施例1~5和对比例1~2的生化性指标测定
对本发明实施例1~5和对比例1~2制备的胶囊剂进行分散均匀性、崩解时限、含水量及长期性检测的试验,检测结果如表3所示。
含水量的测定方法:采用烘干法计算胶囊的含水量。
分散均匀性的检测方法:将实施例1~5和对比例1~2制备的胶囊剂各取2粒,将内部胶囊置于20℃±1℃的100mL水中,振摇3min,过2号药筛。
崩解时限检测方法:将实施例1~5和对比例1~2制备的胶囊剂各取6粒,在温度为37℃±1℃的水中,利用升降式片剂崩解仪进行检测。
长期性检测:在温度25℃±2℃、相对湿度60%±10%的条件下放置36个月,然后进行卫生学性能检测。
表3
由表3可看出,本发明实施例1~5的胶囊剂,崩解效果较好,能在规定的时间的内崩解完成(药典规定30分钟崩解完全),尤其是实施例5的各项指标优于其他实施例;对比例1的中药组合物的重量份不全在本发明范围内,长期稳定试验中,崩解时限明显延长,含水量明显增加,不符合中国药典关于胶囊剂崩解时限的要求,含水量也接近临界值;对比例2的中药组合物的重量份不全在本发明范围内,制备方法不同于本发明,技术效果不如本发明。
可见,中药组合物的成分按本发明所述重量份组合在一起,具有良好的崩解效果,符合中国药典关于胶囊剂崩解时限的要求。并且,当柴胡为15重量份,黄连为9重量份,菊花为17重量份,桂花为11重量份,蝉蜕为9重量份,大枣为20重量份,山楂为10重量份,黑豆皮为11重量份,熟三七为12重量份,薏苡仁为10重量份,薄荷为11重量份,昙花为13重量份,胖大海为6重量份时,胶囊剂的崩解效果最佳。
效果例3
本发明实施例5的幽门螺杆菌药理试验
(1)试验方法
本发明实施例选择中药和西药进行对比试验。其中:
香砂养胃丸主要治疗胃中胃于不用阳温和足、湿阻气滞所致的胃痛、痞满,症见胃痛隐隐、脘闷不舒、呕吐酸水、嘈杂不适、不思饮食、四肢倦怠,是一种治疗胃溃疡具有显著疗效的药物,本发明用来做中药阳性对照试验组(D组)。
奥美拉唑肠溶片+阿莫西林,适应症慢性胃炎、胃溃疡等疾病,尤其是针对幽门螺杆菌引起的胃炎、胃溃疡治疗效果较好,本发明选择其作为西药阳性对照组(E组)。
昆明小鼠,70只雄性,灌胃幽门螺旋杆菌(H.pylori SS1)菌株建立在体感染,感染后第2周后采用快速尿素酶法和PCR法检测感染成功率;确认感染成功,建立H.pylori相关慢性胃炎动物模型。随机分为正常组10只及感染组60只。感染组经口服H.pylori确认感染成功后,再随机分为模型组、A组、B组、C组、D组、E组,每组10只。正常组小鼠灌胃同剂量的生理盐水。
(2)给药方式以及操作
造模后以及对照组小鼠禁食12h,自由饮用口服补液盐。12h后正常进食水,饮用水为纯水,每日投放的鼠粮要定量管理。D组的香砂养胃丸按人剂量的9.01倍计算小鼠有效剂量,灌胃,每日一次;E组的奥美拉唑(阿斯利康)+阿莫西林(山东鲁抗)按人剂量的9.01倍计算小鼠有效剂量,每日一次;本发明实施例5的胶囊剂低剂量、中剂量、高剂量组分别给药量为2g/kg、4g/kg、8g/kg,分别为A、B、C组,每日一次。给药时间均为9:00,连续饲养7天后,脱椎处死,开腹,腹主动脉采血,不抗凝,低温静置2h后3000r/min离心10min,收集血清备用ELISA法检测。
(3)胃组织匀浆PGE2含量检测
小鼠胃组织称重后剪碎,按10mL/g加生理盐水匀浆,得到胃组织匀浆液。加样品稀释液作为空白对照,将标准品各50μL依次加入孔中,其余各孔加样品50μL。样品孔中加入10μL生物素标记液,在标准品孔和样品孔中加入100μL的酶标记液,36℃温育反应60min。洗液清洗5次后每孔加入底物A、B液各50μL,36℃避光温育反应15min。每孔加入50μL终止液,终止反应。测定450nm OD值。根据标准曲线回归方程计算样品的浓度。
(4)胃组织匀浆EGF含量检测
小鼠胃组织称重后剪碎,按10mL/g加生理盐水匀浆,得到胃组织匀浆液。加样品稀释液作为空白对照,将标准品各50μL依次加入孔中,其余各孔加样品50μL。实验过程同PGE2含量检测。
(5)统计学方法
采用SPSS 13.0软件,组间比较用单因素方差分析,结果均以表示,以P<0.05为差异有统计学意义,结果如表4所示。
表4
注:与正常对照组比较,##P<0.01;与模型对照组比较,@P<0.05,@@P<0.01;与香砂养胃丸组相比,%P<0.05,%%P<0.01;与奥美拉唑组+阿莫西林组比较,¥P<0.05,¥¥P<0.01。
从表4可以看出,通过PGE2、EGF含量,模型组明显低于正常对照组(P<0.01),表明造模成功。通过比较PGE2、EGF含量,奥美拉唑+阿莫西林组(E组)、香砂养胃丸组(D组)及本发明的胶囊剂(A、B、C组)与模型对照组具有统计学差异,适合进一步推广应用。
效果例4
本发明实施例1~5的毒性试验
(1)急性毒性试验
受试中药制剂:本发明实施例1~5所得的胶囊剂,按1:2加纯化水,制成溶液,备用。
试验动物:普通级昆明小鼠,体重20g±5g,雌雄各半,雌性小鼠均无孕。
小鼠灌胃本发明中药药物制剂配制的溶液,当灌胃剂量达到735.5g生药/kg剂量时,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常。
试验结果表明:小鼠灌胃实施例1~5所得的胶囊剂的最大给药量为735.5g生药/kg/d(LD50>735.5g生药/kg)。本发明的中药粉每日临床用药总量最大为0.15g生药/kg/d;按体重计,小鼠灌胃水煎剂的耐受量为临床病人的4903.3倍。提示该药急性毒性极低,临床用药安全。
(2)动物长期毒性试验
受试中药制剂:本发明实施例1~5所得的胶囊剂,按1:2加纯化水,制成溶液,备用。
试验动物:普通级SD大鼠,体重210g±14g,雌雄各半,雌性大鼠均无孕。
方法与结果:实施例1~5的胶囊剂分别分为高、中、低三个剂量组,单位体重给药量分别为患者服用量的180、60、20倍;将实验鼠随机分成16组,其中15组分别灌胃3种三个剂量的胶囊剂溶液,剩余1组灌胃生理盐水(患者服用量的40倍);所有16组均连续灌胃180天,观察动物全身毒性反应及严重程度,处死后按操作规程检查各部位,并进行血液学,ALT、BUN及心、肝、脾、肺、肾、胃等主要脏器的病理学检查;经过长期喂食,16组小鼠均未出现毒性反应。发育良好。肉眼外观及主要脏器未见异常。外周血象及血清ALT、BUN与对照组比较无病理性改变。病理报告心、肝、脾、肺、肾、胃等均未有意义的改变,因此,认为经病理证实,3种中药水煎剂对动物无慢性毒性表现。
通过急性毒性试验和动物长期毒性试验,说明本发明实施例1~5所得的胶囊剂是安全的,无毒副作用,可以被患者服用。
最后所应当说明的是,以上实施例仅用以说明本发明的技术方案而非对本发明保护范围的限制,尽管参照较佳实施例对本发明作了详细说明,本领域的普通技术人员应当理解,可以对本发明的技术方案进行修改或者等同替换,而不脱离本发明技术方案的实质和范围。
Claims (10)
1.一种治疗幽门螺旋杆菌引起的慢性胃炎的中药组合物,其特征在于,所述中药组合物的制备原料包含以下重量份的组分:柴胡10~30份、黄连8~15份、菊花8~19份、桂花5~15份、蝉蜕6~13份、大枣10~30份、山楂5~15份、黑豆皮8~17份、熟三七9~16份、薏苡仁5~14份、薄荷7~15份、昙花5~15份、胖大海6~19份。
2.如权利要求1所述的中药组合物,其特征在于,所述中药组合物的制备原料包含以下重量份的组分:柴胡10~20份、黄连8~10份、菊花15~19份、桂花9~13份、蝉蜕8~10份、大枣15~25份、山楂8~12份、黑豆皮10~13份、熟三七11~14份、薏苡仁8~12份、薄荷10~12份、昙花10~15份、胖大海6~12份。
3.如权利要求2所述的中药组合物,其特征在于,所述中药组合物的制备原料包含以下重量份的组分:柴胡15份、黄连9份、菊花17份、桂花11份、蝉蜕9份、大枣20份、山楂10份、黑豆皮11份、熟三七12份、薏苡仁10份、薄荷11份、昙花13份、胖大海6份。
4.如权利要求1~3任一项所述的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)按配比称取薏苡仁、昙花、胖大海、菊花、柴胡、大枣、桂花、黑豆皮、薄荷,加水浸泡、煮沸、过滤,浓缩得浓缩液;
(2)按配比称取黄连、山楂、熟三七、蝉蜕,去杂质、洗净、烘干,研磨后过筛,得细粉;
(3)将上述步骤(1)所得的浓缩液和步骤(2)所得的细粉合并,混合均匀,浓缩成稠膏,调节pH值至5.5~6.5,减压干燥,粉碎后过筛,得中药组合物。
5.如权利要求4所述的中药组合物的制备方法,其特征在于,如下(a)~(c)中的至少一项:
(a)所述步骤(1)的具体步骤为:按配比称取薏苡仁、昙花、胖大海、菊花、柴胡、大枣、桂花、黑豆皮,去除杂质,加入10~13倍量水浸泡0.5~2.5小时,武火煎煮沸腾15分钟,再加入薄荷,再用文火煎煮1.5~5.0小时,然后过滤,滤渣加入5~8倍量水,武火煎煮沸腾之后文火煎煮1.0~2.5小时,过滤,合并两次滤液,滤液浓缩至70℃下相对密度为1.05~1.20,调节pH值至3.5~5.5,得浓缩液;
(b)所述步骤(2)中,过筛目数为60~80目;
(c)所述步骤(3)中,稠膏的相对密度为1.25~1.35,过筛目数为60~80目。
6.一种药物制剂,其特征在于,所述药物制剂由权利要求1~3任一项所述的中药组合物与药学上可接受的辅料制成。
7.如权利要求6所述的药物制剂,其特征在于,所述药物制剂的剂型为片剂、颗粒剂、胶囊剂、合剂、丸剂、滴丸、固体分散剂或微囊。
8.一种胶囊剂,其特征在于,所述胶囊剂由权利要求1~3任一项所述的中药组合物与药学上可接受的辅料按重量份比1:1~10制成。
9.如权利要求8所述的胶囊剂,其特征在于,如下(a)~(b)中的至少一项:
(a)所述胶囊剂由权利要求1~3任一项所述的中药组合物与药学上可接受的辅料按重量份比1:1.5~5.5制成;
(b)所述药学上可接受的辅料包括填充剂和粘合剂,所述填充剂为甘露醇、乳糖、蔗糖、环糊精中的至少一种,所述粘合剂为3%PVP的75%乙醇溶液、3%羟丙甲纤维素的50%乙醇溶液、10%聚维酮K30的水溶液、30%淀粉浆中的至少一种。
10.如权利要求8~9任一项所述的胶囊剂的制备方法,其特征在于,包括如下步骤:将中药组合物与填充剂混合均匀,再与粘合剂混合制粒,干燥后装入胶囊,即得胶囊剂。
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