CN106620522A - 一种治疗肝硬化的中西药组合物及其制备方法 - Google Patents
一种治疗肝硬化的中西药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗肝硬化的中西药组合物,所述治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸20‑35份、葡醛内酯35‑45份、地黄提取液4‑8份、三七提取液17‑22份、水蛭提取液R24‑9份、僵蚕提取液1‑4份、郁金提取液1‑4份、卢西定7‑13份、谷维素8‑15份、阿米替林2‑6份。本发明药物根据肝硬化的认识机理对原料成分进行严格挑选,从而达到全面康复的目的,具有起效快、作用稳定、携带服用方便、长期服用无毒副作用的特点。
Description
技术领域
本发明涉及一种医药制备领域,具体是一种治疗肝硬化的中西药组合物。
背景技术
肝硬化是临床常见的慢性进行性肝病,由一种或多种病因长期或反复作用形成的弥漫性肝损害。在我国大多数为肝炎后肝硬化,少部分为酒精性肝硬化和血吸虫性肝硬化。病理组织学上有广泛的肝细胞坏死、残存肝细胞结节性再生、结缔组织增生与纤维隔形成,导致肝小叶结构破坏和假小叶形成,肝脏逐渐变形、变硬而发展为肝硬化。早期由于肝脏代偿功能较强可无明显症状,后期则以肝功能损害和门脉高压为主要表现,并有多系统受累,晚期常出现上消化道出血、肝性脑病、继发感染、脾功能亢进、腹水、癌变等并发症。患有肝硬化后,务必要及早进行治疗,不要让肝硬化的危害继续扩展。如果不及时治疗,肝硬化很有可能转化为肝癌。很多早期肝硬化患者症状轻微,于是忽略肝硬化的严重性,拖延治疗,往往带来预料不到的后果。不但延误病情使病情难以控制,还增加了花费,患者也徒增痛苦。现有治疗肝硬化的方法主要是药物治疗和手术治疗,药物治疗主要是静脉输入高渗葡萄糖液以补充热量,病情较重者可输入白蛋白、新鲜血浆,但这种治疗方法治疗速度较为缓慢,给患者带来了痛苦,而手术治疗风险大,而且需要花费巨额财力,这样就给患者增加了极大的经济压力。因此,我们需要研发一种安全、无副作用的中西药组合物来治疗肝硬化。
发明内容
本发明的目的在于提供一种治疗肝硬化的中西药组合物,以解决上述背景技术中提出的问题。
为实现上述目的,本发明提供如下技术方案:
一种治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸20-35份、葡醛内酯35-45份、地黄提取液4-8份、三七提取液17-22份、水蛭提取液R24-9份、僵蚕提取液1-4份、郁金提取液1-4份、卢西定7-13份、谷维素8-15份、阿米替林2-6份。
作为本发明进一步的方案:所述治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸24-31份、葡醛内酯39-42份、地黄提取液4-8份、三七提取液18-21份、水蛭提取液R24-9份、僵蚕提取液1-4份、郁金提取液1-4份、卢西定9-12份、谷维素8-15份、阿米替林2-6份。
作为本发明进一步的方案:所述治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸28份、葡醛内酯41份、地黄提取液6份、三七提取液20份、水蛭提取液R27份、僵蚕提取液3份、郁金提取液3份、卢西定11份、谷维素12份、阿米替林4份。
一种治疗肝硬化的中西药组合物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取腺苷蛋氨酸、葡醛内酯、地黄提取液、三七提取液、水蛭提取液R2、僵蚕提取液、郁金提取液、卢西定、谷维素、阿米替林,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4-8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4-8℃,包装即得治疗肝硬化的中西药组合物。
作为本发明进一步的方案:具体步骤中混合6min。
作为本发明进一步的方案:具体步骤中温度控制在6℃。
与现有技术相比,本发明的有益效果是:
本发明药物根据肝硬化的认识机理对原料成分进行严格挑选,从而达到全面康复的目的,具有起效快、作用稳定、携带服用方便、长期服用无毒副作用的特点。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸20份、葡醛内酯35份、地黄提取液4份、三七提取液17份、水蛭提取液R24份、僵蚕提取液1份、郁金提取液1份、卢西定7份、谷维素8份、阿米替林2份。
一种治疗肝硬化的中西药组合物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取腺苷蛋氨酸、葡醛内酯、地黄提取液、三七提取液、水蛭提取液R2、僵蚕提取液、郁金提取液、卢西定、谷维素、阿米替林,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4℃,包装即得治疗肝硬化的中西药组合物。
实施例2
一种治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸24份、葡醛内酯39份、地黄提取液4份、三七提取液18份、水蛭提取液R24份、僵蚕提取液1份、郁金提取液1份、卢西定9份、谷维素8份、阿米替林2份。
一种治疗肝硬化的中西药组合物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取腺苷蛋氨酸、葡醛内酯、地黄提取液、三七提取液、水蛭提取液R2、僵蚕提取液、郁金提取液、卢西定、谷维素、阿米替林,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4℃,包装即得治疗肝硬化的中西药组合物。
实施例3
一种治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸28份、葡醛内酯41份、地黄提取液6份、三七提取液20份、水蛭提取液R27份、僵蚕提取液3份、郁金提取液3份、卢西定11份、谷维素12份、阿米替林4份。
一种治疗肝硬化的中西药组合物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取腺苷蛋氨酸、葡醛内酯、地黄提取液、三七提取液、水蛭提取液R2、僵蚕提取液、郁金提取液、卢西定、谷维素、阿米替林,过筛,机械混匀后添加超纯水,放置制药混合机中,混合6min,控制RSD≤5%,混合后压片并低温干燥,温度控制在6℃,包装即得治疗肝硬化的中西药组合物。
实施例4
一种治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸31份、葡醛内酯42份、地黄提取液8份、三七提取液21份、水蛭提取液R29份、僵蚕提取液4份、郁金提取液4份、卢西定12份、谷维素15份、阿米替林6份。
一种治疗肝硬化的中西药组合物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取腺苷蛋氨酸、葡醛内酯、地黄提取液、三七提取液、水蛭提取液R2、僵蚕提取液、郁金提取液、卢西定、谷维素、阿米替林,过筛,机械混匀后添加超纯水,放置制药混合机中,混合8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在8℃,包装即得治疗肝硬化的中西药组合物。
实施例5
一种治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸35份、葡醛内酯45份、地黄提取液8份、三七提取液22份、水蛭提取液R29份、僵蚕提取液4份、郁金提取液4份、卢西定13份、谷维素15份、阿米替林6份。
一种治疗肝硬化的中西药组合物的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取腺苷蛋氨酸、葡醛内酯、地黄提取液、三七提取液、水蛭提取液R2、僵蚕提取液、郁金提取液、卢西定、谷维素、阿米替林,过筛,机械混匀后添加超纯水,放置制药混合机中,混合8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在8℃,包装即得治疗肝硬化的中西药组合物。
药理学试验
1、急性毒性试验
以本发明实施例3制得的中西药组合物为试验,采用灌胃给药方式,在24h内连续给药2次,每次间隔6h,每次给药300mg/kg药量,每天累积药物总量达600mg药物/kg,相当于人临床用量的60倍。给药后7d内,小鼠活动、进食、排泄均正常,生长良好,毛色光亮,其平均体重均随实验时间的延长而增加。第8d处死后解剖每只小鼠,肉眼观察心、肝、脾、肺、肾、脑、胸腺、胃、肠等均未发现颜色及形态异常,未能测出半数致死量(LD50)。结果表明:本发明中西药组合物无急性毒性反应。
2、长期毒性试验
以本发明实施例3制得的中西药组合物为试验,采用灌胃给药方式,将本发明中西药组合物分为低剂量、中剂量、高剂量三组,各组的药物用量分别为100、200、300mg药物/kg/d,相当于临床剂量的10、20、30倍。灌胃给药24周后,本发明药物对动物的一般状况、血液学指标、血液生化指标均无明显的影响,系统解剖、脏器系数及组织病理学检查也未发现异常病理改变。停药2周也未见明显改变。结果表明:本发明中西药组合物在长期毒性试验中,未发现明显毒性反应和延迟毒性反应。可见,本发明中西药组合物无毒性反应,长期用药安全可靠。
3、临床试验
2015年8月至2016年3月收治的肝硬化患者;共300例患者,其中,男性167例,女性133例;两组病例的病程、症状轻重程度基本一致,无显著差异,具有可比性。
给予本发明实施例3制备的中西药组合物,按照10mg/kg/天,10天为一疗程(治疗两个疗程)进行症状随访记录;临床疗效判定标准为,(1)治愈:乏力、消瘦、面色晦暗,尿少、下肢水肿、食欲减退、腹胀、胃肠功能紊乱、腹腔积液、肝掌、贫血等肝硬化症状痊愈;(2)有效:上述症状有所缓解;(3)无效:病症无变化。
治疗结果:300例患者,223例痊愈,52例有效,25例无效,总有效率91.7%。
对于本领域技术人员而言,显然本发明不限于上述示范性实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。因此,无论从哪一点来看,均应将实施例看作是示范性的,而且是非限制性的,本发明的范围由所附权利要求而不是上述说明限定,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (6)
1.一种治疗肝硬化的中西药组合物,其特征在于,按照重量份的主要原料为:腺苷蛋氨酸20-35份、葡醛内酯35-45份、地黄提取液4-8份、三七提取液17-22份、水蛭提取液R24-9份、僵蚕提取液1-4份、郁金提取液1-4份、卢西定7-13份、谷维素8-15份、阿米替林2-6份。
2.根据权利要求1所述的治疗肝硬化的中西药组合物,其特征在于,所述治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸24-31份、葡醛内酯39-42份、地黄提取液4-8份、三七提取液18-21份、水蛭提取液R24-9份、僵蚕提取液1-4份、郁金提取液1-4份、卢西定9-12份、谷维素8-15份、阿米替林2-6份。
3.根据权利要求1或2所述的治疗肝硬化的中西药组合物,其特征在于,所述治疗肝硬化的中西药组合物,按照重量份的主要原料为:腺苷蛋氨酸28份、葡醛内酯41份、地黄提取液6份、三七提取液20份、水蛭提取液R27份、僵蚕提取液3份、郁金提取液3份、卢西定11份、谷维素12份、阿米替林4份。
4.一种如权利要求1-3任一所述的治疗肝硬化的中西药组合物的制备方法,其特征在于,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取腺苷蛋氨酸、葡醛内酯、地黄提取液、三七提取液、水蛭提取液R2、僵蚕提取液、郁金提取液、卢西定、谷维素、阿米替林,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4-8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4-8℃,包装即得治疗肝硬化的中西药组合物。
5.根据权利要求4所述的治疗肝硬化的中西药组合物的制备方法,其特征在于,具体步骤中混合6min。
6.根据权利要求4所述的治疗肝硬化的中西药组合物的制备方法,其特征在于,具体步骤中温度控制在6℃。
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