CN106860687A - 一种治疗酒精中毒及护肝的药物组合物 - Google Patents
一种治疗酒精中毒及护肝的药物组合物 Download PDFInfo
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Abstract
本发明公开了一种治疗酒精中毒及护肝的药物组合物,其特征在于该药物组合物主要成分重量份数计为:维生素B1 0.5-1.5份、维生素B2 0.1-1份、烟酰胺份2-4份、右旋泛酸钙0.1-0.5份、维生素B6 0.1-0.5份、裸花紫珠份95-100份。该药物组合物为口服制剂,制备工艺简单,携带方便,采用中西药结合的方式旨在通过保护肝脏,促进肝细胞活性酶的活性,调节肝脏代谢平衡以促进酒精的代谢,达到解酒的效果。
Description
技术领域
本发明属于医药制剂领域,具体涉及一张治疗酒精中毒及护肝的药物组合物。
背景技术
喝酒对身体尤其是肝脏有非常大的伤害,由于酒精主要在肝脏中代谢,饮酒过量会导致肝脏损伤,同时造成头痛,恶心呕吐等一系列的不适反应。
裸花紫珠分散片为一种治疗炎症的中药制剂,复合维生素B片为一种治疗维生素B族缺乏症及维生素B族补充剂。过量酒精造成肝细胞损伤,诱发肝脏轻微
炎症,裸花紫珠分散片能修复肝细胞损伤,调节肝脏代谢平衡,已有动物试验研究表明裸花紫珠能能显著降低血清中ALT、AST的含量(肝损伤的指标物质),降低酒精急性中毒的小鼠的死亡率,缩短酒精引起的睡眠时间;同时维生素B族是肝细胞代谢酶所不可或缺的化合物,能促进肝细胞代谢,加快酒精等有害物质的转化。
目前,市场上并没有一种专门针对酒精中毒的特效药品,且多为中药或西药单独使用护肝或者保护胃肠粘膜制剂,效果往往不佳。本发明通过中药和西药结合的方式,在对肝脏代谢平衡进行调节,从根本上缓解酒精中毒所致的肝脏损伤,同时补充肝脏代谢所需物质,增强肝细胞的活性,加快酒精的代谢,从而达到治疗酒精中毒保护肝脏的作用。
发明内容
本发明旨在提供一种中西药结合的治疗酒精中毒及护肝的药物组合物。
为实现上述发明目的,本发明一种治疗酒精中毒及护肝的药物组合物,具体方案为:
本发明所述一种治疗酒精中毒及护肝的药物组合物,其特征在于该药物组合物包括维生素B1、维生素B2
、烟酰胺、 右旋泛酸钙、维生素B6、裸花紫珠和药用辅料。所述药用辅料为酒石酸、加微晶纤维素、羧甲淀粉钠、交联聚乙烯吡咯烷酮、阿司帕坦,乙醇,硬脂酸镁中的一种或多种。该药物组合物主要成分重量份数计为:维生素B1 0.5-1.5份、维生素B2 0.1-1份、烟酰胺份2-4份、右旋泛酸钙0.1-0.5份、维生素B6
0.1-0.5份、裸花紫珠份24-100份。
进一步地,该药物组合物主要成分重量份数计为:维生素B1 1份、维生素B2 0.5份、烟酰胺份2.5份、右旋泛酸钙0.2份、维生素B6 0.1份、裸花紫珠份96份。
本发明所述一种治疗酒精中毒及护肝的药物组合物,其特征在于该药物组合物为口服制剂。
本发明所述一种治疗酒精中毒及护肝的药物组合物,该制剂的制备方法为:
1)称取处方量裸花紫珠,第一次加10倍量水浸泡0.5小时,煎煮2小时,第二次加8倍量水煎煮1小时,滤过,合并滤液,滤液浓缩至相对密度为1.20(80℃)的清膏,干燥成干膏粉;
2)按处方先称取维生素B2、淀粉搅匀,过80目筛一次,另取处方量烟酰胺、维生素B1、裸花紫珠干膏粉、羧甲淀粉钠、微晶纤维素、交联聚乙烯吡咯烷酮,阿司帕坦搅匀,过60目筛、80目筛各一次,混匀;
3)将右旋泛酸钙、维生素B6溶于2000ml的蒸馏水与60%的乙醇混合后,加入混合机搅拌5分钟,另将含有酒石酸的60%的乙醇加入步骤2)混合料中搅拌均匀,制成适宜的软材;
4)用16目尼龙筛制湿粒,于60—65℃温度干燥;干粒水分控制在2.0%以下;
5)干粒加入硬脂酸镁混匀,用14目尼龙筛整粒、混匀,压片或填充胶囊,即得。
本发明有益效果:
本发明通过中药和西药结合的方式,通过裸花紫珠中药成分对肝脏代谢平衡的调节,从根本上缓解酒精中毒所致的肝脏损伤,同时通过维生素B1、维生素B2 、烟酰胺、 右旋泛酸钙、维生素B6西药成分直接补充肝脏代谢所需物质,增强肝细胞的活性,加快酒精的代谢,从而达到治疗酒精中毒和保护肝脏的作用。配方合理,制备工艺简单,适合规模化生产,极具市场前景。
具体实施方式
下面实施例只为进一步说明本发明,不以任何形式限制本发明范围。
实施例
处方:维生素B1 3g、维生素B2 1.5g、烟酰胺10g、 右旋泛酸钙1g、维生素B60.2g,裸花紫珠干膏粉400g,酒石酸0.03g、微晶纤维素120g、羧甲淀粉钠60g、交联聚乙烯吡咯烷酮110g、阿司帕坦5g,60%乙醇12g,硬脂酸镁 0.64g。
制备工艺:
1)裸花紫珠干膏粉制备过程:称取裸花紫珠1000g,第一次加10倍量水浸泡0.5小时,煎煮2小时,第二次加8倍量水煎煮1小时,滤过,合并滤液,滤液浓缩至相对密度为1.20(80℃)的清膏,干燥成干膏粉,备用。
2)按处方先称取维生素B2、淀粉搅匀,过80目筛一次,另取处方量烟酰胺、维生素B1、裸花紫珠干膏粉、羧甲淀粉钠、微晶纤维素、交联聚乙烯吡咯烷酮,阿司帕坦搅匀,过60目筛、80目筛各一次,二者再混匀,备用。
3)混合料置于混合机中,干混5分钟。将右旋泛酸钙维生素B6溶于2000ml的蒸馏水与60%的乙醇4kg混合后,加入混合机搅拌5分钟,另将含有酒石酸15g的60%的乙醇2kg加入混合料中搅拌均匀,制成适宜的软材。
4)用16目尼龙筛制湿粒,于60—65℃温度干燥。干粒水分控制在2.0%以下。
5)干粒加入硬脂酸镁混匀,用14目尼龙筛整粒、混匀,压片或填充胶囊,即得本发明制剂。
为观察本药物组合对失眠的疗效和不良反应,本发明对60例患者进行了疗效观察,如下:
对象:选择正常人60例,采用随机数字表法随机分为治疗组和对照组1、2。治疗组20例,男l8例,女2例,年龄32—55岁;对照组1患者20例,男15例,女5例,年龄35—55岁;对照组2患者20例,男13例,女7例,年龄35—55岁。
治疗方法:治疗组给予本发明复合维生素B裸花紫珠组合物3片/次。对照组1给予市售复合维生素B片3片/次。对照组2给予市售裸花紫珠分散片5片/次,三组分别饮酒至酒精血药浓度达到100mg/100ml,达到急性酒精中毒(即醉酒)状态,产生嗜睡等一系列醉酒症状。
疗效判定标准:按照《中药新药I临床研究指导原则》 。治愈:临床症状消失或基本消失。显效:临床症状明显改善。有效:临床症状均有好转。无效:临床症状无明显改善,甚至加重。
两组12小时内疗效对比:
Claims (6)
1.一种治疗酒精中毒及护肝的药物组合物,其特征在于该药物组合物包括维生素B1、维生素B2 、烟酰胺、 右旋泛酸钙、维生素B6、裸花紫珠和药用辅料。
2.根据权利要求1所述一种治疗酒精中毒及护肝的药物组合物,其特征在于该药物组合物主要成分重量份数计为:维生素B1 0.5-1.5份、维生素B2 0.1-1份、烟酰胺份2-4份、右旋泛酸钙0.1-0.5份、维生素B6 0.1-0.5份、裸花紫珠份24-100份。
3.根据权利要求1所述一种治疗酒精中毒及护肝的药物组合物,其特征在于该药物组合物主要成分重量份数计为:维生素B1 1份、维生素B2 0.5份、烟酰胺份2.5份、右旋泛酸钙0.2份、维生素B6 0.1份、裸花紫珠份96份。
4.根据权利要求1所述一种治疗酒精中毒及护肝的药物组合物,其特征在于所述药用辅料为酒石酸、加微晶纤维素、羧甲淀粉钠、交联聚乙烯吡咯烷酮、阿司帕坦,乙醇,硬脂酸镁中的一种或多种。
5.根据权利要求1-4所述一种治疗酒精中毒及护肝的药物组合物,其特征在于该药物组合物为口服制剂。
6.根据权利要求5所述口服制剂,其特征在于该制剂的制备方法为:
1)称取处方量裸花紫珠,第一次加10倍量水浸泡0.5小时,煎煮2小时,第二次加8倍量水煎煮1小时,滤过,合并滤液,滤液浓缩至相对密度为1.20(80℃)的清膏,干燥成干膏粉;
2)按处方先称取维生素B2、淀粉搅匀,过80目筛一次,另取处方量烟酰胺、维生素B1、裸花紫珠干膏粉、羧甲淀粉钠、微晶纤维素、交联聚乙烯吡咯烷酮,阿司帕坦搅匀,过60目筛、80目筛各一次,混匀;
3)将右旋泛酸钙、维生素B6溶于2000ml的蒸馏水与60%的乙醇混合后,加入混合机搅拌5分钟,另将含有酒石酸的60%的乙醇加入步骤2)混合料中搅拌均匀,制成适宜的软材;
4)用16目尼龙筛制湿粒,于60—65℃温度干燥;干粒水分控制在2.0%以下;
5)干粒加入硬脂酸镁混匀,用14目尼龙筛整粒、混匀,压片或填充胶囊,即得。
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