CN1248697C - 一种治疗慢性肠炎的药物组合物及其制备方法 - Google Patents
一种治疗慢性肠炎的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种以传统中草药和西药原料制成的治疗慢性肠炎的药物组合物及其制备方法,所述药物组合物包括乳香4-8、没药4-8、利福平1-5、吡哌酸4-8、甲硝唑7-11,可将上述药物,粉碎,混合,过筛,再按常规制剂法制成各种制剂,尤其为胶囊剂。本发明临床对慢性肠炎治疗观察总有效率97.6%,且与对照组相比疗效显著,未见毒副作用。
Description
技术领域
本发明涉及一种治疗慢性肠炎的药物组合物及其制备方法,尤其涉及一种以传统中草药和西药原料制成的治疗慢性肠炎的药物组合物。
背景技术
慢性肠炎属中医“泄泻”、“利疾”、“肠风”范畴,属于现代医学的慢性胃肠炎、慢性结肠炎、过敏性结肠炎,属肠功能紊乱等原因造成的,本病谈起来容易,治起来非常棘手。慢性肠炎是老、中、青、少常见病,多发病。常见的有复方苯乙哌啶片、肠炎灵等,药物治疗,疗效慢,效果差,且容易复发,或存在毒副作用,
发明内容
本发明的目的是提供一种治疗慢性肠炎的药物组合物及其制备方法,尤其提供一种以中草药和西药原料制成的治疗慢性肠炎的药物组合物,克服了上述药物的缺点。
本发明的目的是通过以下技术方案来实现的:
一种治疗慢性肠炎的药物组合物,是由包括以下组分制成的药剂:乳香、没药、利福平、吡哌酸、甲硝唑;
没药,为没药树的干燥胶树脂,味苦,性平。入心、肝经。能活血取瘀、消痈止痛。
乳香,为乳香树的干燥胶树脂,味苦,辛,性温。入心、肝经。能活血化瘀、消痈止痛。
利福平为力复霉素(链丝菌产生的抗生素),力复霉素在硫酸中,经维生素C还原,并与1-甲基-4-氨基哌嗪缩合而得。
吡哌酸为喹诺酮类抗菌药物,对杀灭或抑制微生物具有较强的作用。
甲硝唑,又名硝羟乙唑,为抗原虫药。
本发明原料均可购于市场。
所述组分可为以下重量份组分:乳香4-8、没药4-8、利福平1-5、吡哌酸4-8、甲硝唑7-11;
所述组分优选为以下重量份组分:乳香5-7、没药5-7、利福平2-4、吡哌酸5-7、甲硝唑8-10;
所述组分最好为以下重量份组分:乳香6、没药6、利福平3、吡哌酸6、甲硝唑9。
所述药剂可为任何一种药学上所说的剂型,尤其为胶囊剂、丸剂、片剂、颗粒剂。
本发明还提供了所述治疗慢性肠炎的药物组合物的制备方法,包括以下步骤:按上述比例称取乳香、没药、利福平、吡哌酸、甲硝唑,粉碎,混合,过筛,再按常规制剂法制成各种制剂。
本发明药物是基于以下机理制备而成的:本发明药物是在传统中医理论的基础上结合现代医学制成的复方制剂。它的机理在于:
本药的主要成份是乳香、没药,《本草拾遗》有“止大肠泄澼”的作用,中药学论述有活血、止疼、生肌的功能,能使皮肤溃疡收口,临床观察对胃肠道溃疡炎症同样有效,现代医学研究认为乳香、没药对胃肠粘膜有极强的覆盖能力,能成为粘膜的屏障,并能固定肠道病毒,细菌及其毒素,促使粘膜病变修复。
本药中利福平、甲硝唑、吡哌酸能较强地抑制杀灭利疾杆菌、霍乱菌、沙门菌、非霍乱弧菌、弯曲菌及肠杆菌,协助乳香、没药杀灭清除粘膜细菌、毒素,促使肌体康复。
本药为中西药合用,协同作用于胃肠腺壁细胞,抑制了胃肠分泌,增强了止血、止痛、抗菌的功能;刺激了胃肠真皮细胞,上皮细胞组织的增生、***,加速了溃疡面的愈合。本药中西药合用后,协同调节肌体免疫,抑制了炎症和免疫反应,缓解了毒性症状,改善了肠道内环境,促进了炎症的吸收,特别是合用后抗菌力倍增,免疫力增强,取得了较好的疗效。
通过临床观察试用:本药高效、安全,不成瘾,愈后不易复发,适合门诊治疗,值得临床推广。药理作用表明,本药物对利疾杆菌和其它肠道致病菌均有良好的抗菌效能,主要适用于治疗急慢性肠炎、菌痢、结肠炎、过敏性肠炎、冰箱性肠炎等。
为证明本发明的治疗效果,进行了如下临床试验:选用本发明实施例1药物(慢肠康)治疗慢性肠炎210例,临床观察,收效满意。
1、临床资料:210患者均为1999年1月至2003年7月间的门诊患者,符合1986年全国慢性腹泻学术讨论会病例选择标准。其中,治疗组:男120例,女90例,年龄9-75岁,病程最短2个月,最长30年;对照组:男80例,女30例,年龄12-67岁,病程最短1个月,最长20年;两组具有可比性。
2、治疗方法
治疗组:给实施例1胶囊剂(慢肠康),主要成份乳香、没药、利夫平、吡哌酸、甲硝唑,每粒0.5g,每次6粒,每日三次,饭后服用,本药物对喹诺酮药物过敏者禁用,婴幼儿禁用;肝肾功能不全者、高血压、糖尿病、胃及十二指肠溃肠及心力衰竭慎用;服药后,小便发红是药物正常反应。对照组:复方苯乙哌啶片2片,每日三次;肠炎灵4粒,每日1次。两组均以10日为一疗程,连服2个疗程,评价治疗效果。治疗期间每日观察大便次数、性状。
3、治疗效果
3.1疗效评定标准,参见《常见病例的诊断与疗效判定标准》(第1版,吴少贞等,北京,中国中医药出版社,1999,305-306)
治愈:症状消失,排便正常,1月以上无复发;显效:症状消失,受凉再次复发;有效:服药排便正常,不服药排便异常;无效:服药后症状均无改善。
3.2治疗效果(见表1)
表1 本发明药物治疗慢性肠炎效果
组别 | 例数 | 治愈 | 显效 | 有效 | 无效 | 有效率% |
治疗组 | 210 | 145 | 35 | 25 | 5 | 97.6% |
对照组 | 110 | 27 | 23 | 20 | 40 | 36.36 |
4、典型病例
李某,男,47岁,1999年3月12日以慢性肠炎初诊,自诉腹痛、腹泻发作20多年,有时在情绪波动、进食、油腻时,大便稀溏,便中有粘液,轻则每日2-3次,重则每日6-7次,有时黎明前脐下作痛,肠鸣即泄,吃些西药、中成药,时轻时重,缠绵难愈。查体面白肢冷,神疲体倦,纳呆,腹部隐作痛,诊其脉沉细,舌皮淡,白腻,治以:内服本发明上述慢肠康,服药10天,症状明显好转,又服药10天,诸症消失,痊愈,随访至今,未再复发。
具体实施方式
实施例1
胶囊剂
称取以下药物原料(Kg):乳香6、没药6、利福平3、吡哌酸6、甲硝唑9。
制备方法:按上述比例称取乳香、没药、利福平、吡哌酸、甲硝唑,粉碎,混合,过筛100目,装胶囊,紫外灭菌即得。
规格:0.5g×100粒。用法与用量:口服;每日三次,每次6粒,饭后服用,或遵医嘱。
实施例2
胶囊剂
称取以下药物原料(Kg):乳香5、没药5、利福平2、吡哌酸5、甲硝唑8。
制备方法:同实施例1。
实施例3
片剂
称取以下药物原料(Kg):乳香7、没药7、利福平4、吡哌酸7、甲硝唑10。
制备方法:按上述比例称取乳香、没药、利福平、吡哌酸、甲硝唑,粉碎,混合,60%乙醇整粒,过14目筛,加入硬脂酸镁200g,充分混合均匀后压成片即得。
实施例4
丸剂
称取以下药物原料(Kg):乳香4、没药4、利福平1、吡哌酸4、甲硝唑7。
制备方法:按上述比例称取乳香、没药、利福平、吡哌酸、甲硝唑,粉碎,混合,以60%乙醇整粒,过200目筛,压成片,包糖衣,灭菌,即得。
实施例5
颗粒剂
称取以下药物原料(Kg):乳香8、没药8、利福平5、吡哌酸8、甲硝唑11。
制备方法:按上述比例称取乳香、没药、利福平、吡哌酸、甲硝唑,粉碎,混合,以55%乙醇制成颗粒,过10目筛,包装,灭菌,即得。
Claims (5)
1、一种治疗慢性肠炎的药物组合物,由以下重量份的原料药制成:乳香4-8、没药4-8、利福平1-5、吡哌酸4-8、甲硝唑7-11。
2、根据权利要求1所述的治疗慢性肠炎的药物组合物,其特征在于各原料药的重量份是:乳香5-7、没药5-7、利福平2-4、吡哌酸5-7、甲硝唑8-10。
3、根据权利要求2所述的治疗慢性肠炎的药物组合物,其特征在于各原料药的重量份是:乳香6、没药6、利福平3、吡哌酸6、甲硝唑9。
4、根据权利要求1或2所述的治疗慢性肠炎的药物组合物,其特征在于所述药物组合物的制剂为胶囊剂、丸剂、片剂或颗粒剂。
5、一种制备权利要求1-4所述的任一一项药物组合物的方法,包括以下步骤:按权利要求1-3所述的任一比例称取乳香、没药、利福平、吡哌酸、甲硝唑,粉碎,混合,过筛,再按常规制剂法制成各种制剂。
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