CN105708849A - 一种治疗急性化脓性胆管炎的药物组合物及其制备方法 - Google Patents
一种治疗急性化脓性胆管炎的药物组合物及其制备方法 Download PDFInfo
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- CN105708849A CN105708849A CN201610049787.XA CN201610049787A CN105708849A CN 105708849 A CN105708849 A CN 105708849A CN 201610049787 A CN201610049787 A CN 201610049787A CN 105708849 A CN105708849 A CN 105708849A
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Abstract
本发明公开了一种治疗急性化脓性胆管炎的物组合物及其制备方法,所述治疗急性化脓性胆管炎的药物组合物是由以下重量份的成分组成:朝蓟素、波棱醛、混合甙、白桦脂酸、生物碱衍生物、山柰酚、佛手柑内酯、氯霉素、木质素、熊果酸、缬氨酸、谷维素、维生素B6;本发明将西药和多种中药有效成分相结合,使其共同发挥抗菌消炎、排脓解毒、解痉镇痛、清热利胆的作用,同时可补充所需营养,提高免疫力,用于急性化脓性胆管炎的非手术治疗,可有效稳定病情,控制感染,疗效显著,可推广于临床应用。
Description
技术领域
本发明涉及胆管炎用药技术领域,具体是涉及一种治疗急性化脓性胆管炎的药物组合物及其制备方法。
背景技术
在食品卫生安全形势越来越严峻的现代社会,各种细菌性感染带来的疾病严重威胁着人民的生活质量和生命安全。急性化脓性胆管炎就是由于胆道感染而引起的疾病,其感染因素也是导致病人死亡的最直接的原因,它是由于胆管阻塞,胆汁淤积,继发大肠杆菌、克雷白杆菌、粪链球菌和某些厌氧菌感染而引起的,多数为胆管结石和胆道蛔虫病的继发感染,此病多发于40-60岁之间,病死率可高达20-23%。此病发病急,多半数非手术治疗的病例中常见突发剑突下或右上腹剧烈疼痛,高热,脉率增快可达120次/分钟以上,伴有恶心呕吐等症,甚至出现情绪失调,意识不清,昏迷及神经系统抑制的表现,病情严重者可出现败血症和感染性休克等。
急性化脓性胆管炎主要是由于胆道梗阻和细菌感染引起的,而胆管结石和胆道寄生虫是引起胆道阻塞的直接原因,胆管结石主要来自于胆囊中的小结石排入胆道,从而导致胆管变窄,造成梗阻,继而引发细菌性感染,但其症状轻重并不是和结石大小成一定比例,更多的是和胆道梗阻程度和细菌的毒性相关。胆道寄生虫常见为胆道蛔虫症,大多由于肠道蛔虫病引起的并发症,在我国农村地区发病几率相当高,这和农村卫生条件得不到有效保障息息相关,由于我国国情的特殊性,农村经济发展缓慢,继而使配套的医疗卫生条件达不到城镇的标准,由于胃肠功能的紊乱和驱虫药的不当使用使得蛔虫进入胆道,造成胆道梗阻和胆汁淤积,从而使细菌大量滋生,继发急性化脓性胆管炎。
急性化脓性胆管炎的治疗分为手术治疗和非手术治疗,非手术治疗一般用在发病早期,病情不是很严重的情况下,从而避免手术的风险和创伤。非手术治疗一般是使用解痉镇痛,利胆药物和抗生素,以缓解胆道压力,改善胆道环境,控制感染,但抗生素给人体带来的副作用也是不可忽视的,故如何有效地治疗该病,并能调节机体机能,使药物副作用降到最低就是我们要研究的。
发明内容
本发明解决的技术问题是,提供一种治疗急性化脓性胆管炎的药物组合物及其制备方法,该治疗急性化脓性胆管炎的药物组合物能够抗菌消炎、排脓解毒、解痉镇痛、清热利胆,同时可以补充所需营养,提高免疫力,用于急性化脓性胆管炎的非手术治疗。
本发明的技术方案是,一种治疗急性化脓性胆管炎的药物组合物,是由以下重量份的成分组成:朝蓟素3.2-6.4份、波棱醛3.0-6.0份、混合甙2.5-5.3份、白桦脂酸2.1-4.9份、生物碱衍生物1.8-4.5份、山柰酚1.4-4.0份、佛手柑内酯1.3-3.6份、氯霉素1.0-2.6份、木质素0.8-2.1份、熊果酸0.7-1.9份、缬氨酸0.05-0.17份、谷维素0.03-0.11份、维生素B60.02-0.08份。
进一步地,一种治疗急性化脓性胆管炎的药物组合物,是由以下重量份的成分组成:朝蓟素4.8份、波棱醛4.5份、混合甙3.9份、白桦脂酸3.5份、生物碱衍生物3.15份、山柰酚2.7份、佛手柑内酯2.45份、氯霉素1.8份、木质素1.45份、熊果1.3份、缬氨酸0.11份、谷维素0.07份、维生素B60.05份。
进一步地,所述混合甙为杧果甙、花锚甙和马栗树皮甙以质量比为1:1:3的比例混合而成,成分界定准确,更好地发挥疏肝利胆,抗菌镇痛的功效。
进一步地,所述生物碱衍生物为白叶藤碱硝基衍生物和白叶藤碱甲氧基衍生物以质量比为2:1的比例混合而成,具有抗菌消炎和抗虫活性的作用。
进一步地,一种治疗急性化脓性胆管炎的药物组合物的制备方法为:将所述重量组份的朝蓟素、波棱醛、混合甙、白桦脂酸、生物碱衍生物、山柰酚、佛手柑内酯、氯霉素、木质素、熊果酸、缬氨酸、谷维素、维生素B6用搅拌机以300-500r/min的转速搅拌10min,再置于均质机里在32-46MPa的压力下均质处理2-3次,即得到所述治疗急性化脓性胆管炎的药物组合物,灭菌后密封储存。
进一步地,向所述的药物组合物中加入填充剂、粘合剂、崩解剂、润滑剂,经过混合、制粒、干燥、整粒、分装等工序制成颗粒剂。
进一步地,所述的填充剂为淀粉、乳糖、糊精、糖粉、硫酸钙、蔗糖、甘露醇、微晶纤维素、葡萄糖中的一种或几种混合而成,填充剂可增加颗粒剂的重量,便于制粒。
进一步地,所述的粘合剂为淀粉浆、预胶化淀粉、糊精、聚维酮、乙基纤维素、羟丙基纤维素、葡萄糖中的一种或几种混合而成,粘合剂可使药物细粉粘合,便于制粒。
进一步地,所述的崩解剂为淀粉、羧甲基淀粉钠、微晶纤维素、交联羧甲基纤维素钠、低取代-羟丙基纤维素、枸橼酸、聚山梨酯80中的一种或几种混合而成,崩解剂可使药物迅速溶解,便于人体吸收。
进一步地,所述的润滑剂为粘液质、聚乙二醇、十二烷基硫酸钠、氢化植物油、氢氧化铝凝胶、氧化镁、石蜡、白油、甘油、甘氨酸中的一种或几种混合而成,润滑剂可改善药物的粉体性质,使制剂在生产过程中顺利进行。
本发明的有益效果是:本发明将西药和多种中药有效成分相结合,具有抗菌消炎、排脓解毒、解痉镇痛、清热利胆的作用,其中,熊果酸、杧果甙、山柰酚、氯霉素、生物碱衍生物具有抗菌,抗炎,清热解毒的作用;朝蓟素、波棱醛、木质素、花锚甙具有平肝利胆、舒筋活络、排除积淤的胆汁,减小胆道压力的功效;佛手柑内酯、马栗树皮甙、白桦脂酸具有消肿镇痛的作用,可有效缓解患者的疼痛症状;缬氨酸、谷维素、维生素B6可以增强人体免疫能力,为机体提供能量,从而降低药物副作用,用于急性化脓性胆管炎的非手术治疗,可有效稳定病情,控制感染,疗效显著。
具体实施方式
实施例1:
一种治疗急性化脓性胆管炎的药物组合物,是由以下重量份的成分组成:朝蓟素3.2份、波棱醛3.0份、混合甙2.5份、白桦脂酸2.1份、生物碱衍生物1.8份、山柰酚1.4份、佛手柑内酯1.3份、氯霉素1.0份、木质素0.8份、熊果酸0.7份、缬氨酸0.05份、谷维素0.03份、维生素B60.02份。
治疗该急性化脓性胆管炎的药物组合物的制备方法为:将所述重量组份的朝蓟素、波棱醛、混合甙、白桦脂酸、生物碱衍生物、山柰酚、佛手柑内酯、氯霉素、木质素、熊果酸、缬氨酸、谷维素、维生素B6用搅拌机以300r/min的转速搅拌10min,再置于均质机里在32MPa的压力下均质处理2次,得到药物组合物,再向所述药物组合物中加入填充剂、粘合剂、崩解剂、润滑剂,经过混合、制粒、干燥、整粒、分装等工序制成颗粒剂。
其中,所述混合甙为杧果甙、花锚甙和马栗树皮甙以质量比为1:1:3的比例混合而成,具有疏肝利胆,抗菌镇痛的功效;所述生物碱衍生物为白叶藤碱硝基衍生物和白叶藤碱甲氧基衍生物以质量比为2:1的比例混合而成,具有抗菌消炎和抗虫活性的作用;所述的填充剂为淀粉、糖粉和糊精以质量比为2:1:1的比例混合而成,填充剂可增加颗粒剂的重量,便于制粒;所述的粘合剂为羟丙基纤维素,粘合剂可使药物细粉粘合,便于制粒;所述的崩解剂为微晶纤维素,崩解剂可使药物迅速溶解,便于人体吸收;所述的润滑剂为粘液质,润滑剂可改善药物的粉体性质,使制剂在生产过程中顺利进行。
实施例2:
一种治疗急性化脓性胆管炎的药物组合物,是由以下重量份的成分组成:朝蓟素4.8份、波棱醛4.5份、混合甙3.9份、白桦脂酸3.5份、生物碱衍生物3.15份、山柰酚2.7份、佛手柑内酯2.45份、氯霉素1.8份、木质素1.45份、熊果1.3份、缬氨酸0.11份、谷维素0.07份、维生素B60.05份。
治疗该急性化脓性胆管炎的药物组合物的制备方法为:将所述重量组份的朝蓟素、波棱醛、混合甙、白桦脂酸、生物碱衍生物、山柰酚、佛手柑内酯、氯霉素、木质素、熊果酸、缬氨酸、谷维素、维生素B6用搅拌机以400r/min的转速搅拌10min,再置于均质机里在39MPa的压力下均质处理2次,得到药物组合物,再向所述药物组合物中加入填充剂、粘合剂、崩解剂、润滑剂,经过混合、制粒、干燥、整粒、分装等工序制成颗粒剂。
其中,所述混合甙为杧果甙、花锚甙和马栗树皮甙以质量比为1:1:3的比例混合而成,具有疏肝利胆,抗菌镇痛的功效;所述生物碱衍生物为白叶藤碱硝基衍生物和白叶藤碱甲氧基衍生物以质量比为2:1的比例混合而成,具有抗菌消炎和抗虫活性的作用;所述的填充剂为淀粉、糖粉和糊精以质量比为2:1:1的比例混合而成,填充剂可增加颗粒剂的重量,便于制粒;所述的粘合剂为羟丙基纤维素,粘合剂可使药物细粉粘合,便于制粒;所述的崩解剂为微晶纤维素,崩解剂可使药物迅速溶解,便于人体吸收;所述的润滑剂为粘液质,润滑剂可改善药物的粉体性质,使制剂在生产过程中顺利进行。
实施例3:
一种治疗急性化脓性胆管炎的药物组合物,是由以下重量份的成分组成:朝蓟素6.4份、波棱醛6.0份、混合甙5.3份、白桦脂酸4.9份、生物碱衍生物4.5份、山柰酚4.0份、佛手柑内酯3.6份、氯霉素2.6份、木质素2.1份、熊果酸1.9份、缬氨酸0.17份、谷维素0.11份、维生素B60.08份。
治疗该急性化脓性胆管炎的药物组合物的制备方法为:将所述重量组份的朝蓟素、波棱醛、混合甙、白桦脂酸、生物碱衍生物、山柰酚、佛手柑内酯、氯霉素、木质素、熊果酸、缬氨酸、谷维素、维生素B6用搅拌机以500r/min的转速搅拌10min,再置于均质机里在46MPa的压力下均质处理3次,得到药物组合物,再向所述药物组合物中加入填充剂、粘合剂、崩解剂、润滑剂,经过混合、制粒、干燥、整粒、分装等工序制成颗粒剂。
其中,所述混合甙为杧果甙、花锚甙和马栗树皮甙以质量比为1:1:3的比例混合而成,具有疏肝利胆,抗菌镇痛的功效;所述生物碱衍生物为白叶藤碱硝基衍生物和白叶藤碱甲氧基衍生物以质量比为2:1的比例混合而成,具有抗菌消炎和抗虫活性的作用;所述的填充剂为淀粉、糖粉和糊精以质量比为2:1:1的比例混合而成,填充剂可增加颗粒剂的重量,便于制粒;所述的粘合剂为羟丙基纤维素,粘合剂可使药物细粉粘合,便于制粒;所述的崩解剂为微晶纤维素,崩解剂可使药物迅速溶解,便于人体吸收;所述的润滑剂为粘液质,润滑剂可改善药物的粉体性质,使制剂在生产过程中顺利进行。
本发明药物组合物在治疗急性化脓性胆管炎中的应用:
一、动物毒性试验:
1、动物模型制备及给药:选取200只兔子,随机分成a组、b组、c组、d组、e组,每组40只,a组为对照组,胆管内注射生理盐水,b组、c组、d组、e组胆管内注射大肠杆菌使兔子诱发急性胆管炎模型,分别给b组、c组、d组兔子服用本发明实施例1到3的药物组合物,给e组兔子服用3倍量的实施例2的药物组合物。
2、试验数据统计及结果:对照组胆管结构正常,未出现任何不适,b组、c组、d组、e组兔子病情得到控制,经检查胆汁淤积排除,胆管内压力降低,也未继发感染,e组兔子也并未出现用药过量的不适之症,解剖后未出现内脏器官的损伤。
二、临床资料:
1、发明人选取160例急性化脓性胆管炎的患者,年龄在40-60岁,症状见右上腹疼痛,发热,恶心呕吐,情绪不稳,意识障碍等。将其随机分成四组,每组40人,其中一组为对照组,服用普通治疗急性化脓性胆管炎的药物,给其余三组患者分别服用本发明实施例1、实施例2和实施例3制备的药物组合物,连服3日,症状消失即可停药。
2、疗效标准:
(1)痊愈:临床症状消失,病情稳定,感染得到控制;
(2)有效:症状好转,身体机能有所改善;
(3)无效:症状无改善,治疗前后无变化。
3、治疗统计结果:
表1—四组疗效比较
组别 | 病例人数 | 痊愈 | 显效 | 无效 | 不良反应 | 总有效率% |
实施例1 | 40 | 27 | 10 | 3 | 0 | 92.5 |
实施例2 | 40 | 30 | 8 | 2 | 0 | 95 |
实施例3 | 40 | 28 | 9 | 3 | 0 | 92.5 |
对照组 | 40 | 16 | 15 | 9 | 2 | 77.5 |
4、结论:由表1可看出,本发明的治疗急性化脓性胆管炎的药物组合物具有很好的临床效果,总有效率达到92.5%以上,具有抗菌消炎、排脓解毒、解痉镇痛、清热利胆的作用,同时可补充所需营养,提高免疫力,用于急性化脓性胆管炎的非手术治疗,可有效稳定病情,控制感染,疗效显著,值得推广。
尽管已参照其具体实施方案描述和阐明了本发明,但本领域技术人员会认识到,可以在不背离本发明的精神和范围的情况下对其作出各种改变、修改和取代。例如,由于被治疗特定病症的人的响应能力的变化,如上阐述的优选剂量以外的有效剂量可能适用。同样地,观察到的药理学响应可能根据和依赖所选特定活性化合物或是否存在药用载体以及制剂类型和所用给药模式而变,根据本发明的目的和实践预想到结果中的这类预期变化或差异。因此,本发明意在仅受下列权利要求的范围限制且这些权利要求应在合理的程度上尽可能广义地解释。
Claims (10)
1.一种治疗急性化脓性胆管炎的药物组合物,其特征在于,是由以下重量份的成分组成:朝蓟素3.2-6.4份、波棱醛3.0-6.0份、混合甙2.5-5.3份、白桦脂酸2.1-4.9份、生物碱衍生物1.8-4.5份、山柰酚1.4-4.0份、佛手柑内酯1.3-3.6份、氯霉素1.0-2.6份、木质素0.8-2.1份、熊果酸0.7-1.9份、缬氨酸0.05-0.17份、谷维素0.03-0.11份、维生素B60.02-0.08份。
2.如权利要求1所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于,是由以下重量份的成分组成:朝蓟素4.8份、波棱醛4.5份、混合甙3.9份、白桦脂酸3.5份、生物碱衍生物3.15份、山柰酚2.7份、佛手柑内酯2.45份、氯霉素1.8份、木质素1.45份、熊果1.3份、缬氨酸0.11份、谷维素0.07份、维生素B60.05份。
3.如权利要求1所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于,所述混合甙为杧果甙、花锚甙和马栗树皮甙。
4.如权利要求1所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于,所述生物碱衍生物为白叶藤碱硝基衍生物和白叶藤碱甲氧基衍生物。
5.如权利要求1至4任意一项所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于所述制备方法为:将所述重量组份的朝蓟素、波棱醛、混合甙、白桦脂酸、生物碱衍生物、山柰酚、佛手柑内酯、氯霉素、木质素、熊果酸、缬氨酸、谷维素、维生素B6用搅拌机搅拌均匀,再置于均质机里均质处理2-3次,即得到所述治疗急性化脓性胆管炎的药物组合物,灭菌后密封储存。
6.如权利要求5所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于向所述的药物组合物中加入填充剂、粘合剂、崩解剂、润滑剂,经过混合、制粒、干燥、整粒、分装等工序制成颗粒剂。
7.如权利要求6所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于,所述的填充剂为淀粉、乳糖、糊精、糖粉、硫酸钙、蔗糖、甘露醇、微晶纤维素、葡萄糖中的一种或几种混合而成。
8.如权利要求6所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于,所述的粘合剂为淀粉浆、预胶化淀粉、糊精、聚维酮、乙基纤维素、羟丙基纤维素、葡萄糖中的一种或几种混合而成。
9.如权利要求6所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于,所述的崩解剂为淀粉、羧甲基淀粉钠、微晶纤维素、交联羧甲基纤维素钠、低取代-羟丙基纤维素、枸橼酸、聚山梨酯80中的一种或几种混合而成。
10.如权利要求6所述的一种治疗急性化脓性胆管炎的药物组合物,其特征在于,所述的润滑剂为粘液质、聚乙二醇、十二烷基硫酸钠、氢化植物油、氢氧化铝凝胶、氧化镁、石蜡、白油、甘油、甘氨酸中的一种或几种混合而成。
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