CN108159351A - 用于治疗肝硬化腹水的中药组合物及其制备方法 - Google Patents
用于治疗肝硬化腹水的中药组合物及其制备方法 Download PDFInfo
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- CN108159351A CN108159351A CN201810102310.2A CN201810102310A CN108159351A CN 108159351 A CN108159351 A CN 108159351A CN 201810102310 A CN201810102310 A CN 201810102310A CN 108159351 A CN108159351 A CN 108159351A
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Abstract
本发明涉及一种用于治疗肝硬化腹水的中药组合物及其制备方法。中药组合物的原料包括:失笑散、川朴、大腹皮、黄芪、寸冬、白芍、车前子、地胆草、制军、香附根、瓜子金、毛冬青、黑丑、石龙子、三棱、广木香、杏仁、半边莲、丹参、三七、莪术、泽兰、鸡血藤、瞿麦和白术。制备方法:将各原料组分洗净后粉碎,用水提取,过滤并收集滤液;之后浓缩,得到中药组合物。本发明提供的中药组合物具有优异的疏肝理气、活血化瘀、滋肾柔肝等功效,其能够有效治疗肝硬化,尤其是对于早中期肝硬化及肝损伤患者有很好的治疗作用,且安全无毒副作用;此外,本发明提供的中药组合物使用方便,成本较低,具有很好的商业前景。
Description
技术领域
本发明涉及中草药技术领域,具体涉及一种用于治疗肝硬化腹水的中药组合物及其制备方法。
背景技术
肝硬化作为一种临床常见的慢性进行性肝病,是由一种或多种病因长期或反复作用形成的弥漫性肝损害。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。引起肝硬化的病因很多,其中主要是病毒性肝炎所致,如乙肝、丙肝等。同时还有酒精肝、脂肪肝、胆汁淤积、药物、营养等方面的因素长期损害所致。
目前治疗肝硬化的中药多数起辅助作用,一般是用于缓解或者治疗肝硬化的一个小的方面;如:以清热解毒、活血化痰之方药抑制病毒复制;以益气养血、清热利湿解毒之方药调整免疫功能,清除病毒;以祛痰散结、活血化瘀之方药治疗巨脾;以活血化瘀、舒肝通络,祛痰散结之方药软肝缩脾,降低门脉高压,阻断和逆转肝纤维化、肝硬化等。但市面上存在的该类药物疗效较差且成本高昂,从而不能有效治愈该类疾病,减少患者痛楚。基于此,亟需一种新型的、疗效显著且成本较低的能够治疗肝硬化的药物。
基于此,研究一种新型的、安全无毒副作用且可以有效、安全的治疗或缓解肝硬化的药物具有非常重要的意义。
发明内容
针对现有技术中的缺陷,本发明旨在提供一种用于治疗肝硬化腹水的中药组合物及其制备方法。本发明提供的中药组合物具有优异的疏肝理气、活血化瘀、滋肾柔肝等功效,其能够有效治疗肝硬化,尤其是对于早中期肝硬化及肝损伤患者有很好的治疗作用,且安全无毒副作用;此外,本发明提供的中药组合物使用方便,成本较低,具有很好的商业前景。
为此,本发明提供如下技术方案:
第一方面,本发明提供一种用于治疗肝硬化腹水的中药组合物,原料组分按重量份计,失笑散10~20重量份、川朴5~10重量份、大腹皮5~10重量份、黄芪10~20重量份、寸冬10~20重量份、白芍10~15重量份、车前子5~10重量份、地胆草10~20重量份、制军5~10重量份、瓜子金30~40重量份、毛冬青30~60重量份、黑丑5~10重量份、石龙子30~60重量份、三棱10~20重量份、广木香15~20重量份、杏仁10~20重量份、三七10~20重量份、莪术5~10重量份、泽兰10~20重量份、鸡血藤10~20重量份、瞿麦10~20重量份和白术10~15重量份。
优选地,原料组分还包括:香附根10~20重量份、半边莲10~15重量份和丹参10~30重量份。
优选地,该中药组合物由下述原料组分制成:失笑散20重量份、川朴5重量份、大腹皮10重量份、黄芪10重量份、寸冬20重量份、白芍10重量份、车前子10重量份、地胆草10重量份、制军10重量份、香附根10重量份、瓜子金40重量份、毛冬青30重量份、黑丑10重量份、石龙子30重量份、三棱20重量份、广木香15重量份、杏仁20重量份、半边莲10重量份、丹参30重量份、三七10重量份、莪术10重量份、泽兰10重量份、鸡血藤20重量份、瞿麦10重量份和白术15重量份。
优选地,该中药组合物由下述原料组分制成:失笑散13重量份、川朴9重量份、大腹皮9重量份、黄芪16重量份、寸冬15重量份、白芍12重量份、车前子8重量份、地胆草10重量份、制军10重量份、香附根13重量份、瓜子金36重量份、毛冬青50重量份、黑丑8重量份、石龙子50重量份、三棱15重量份、广木香17重量份、杏仁15重量份、半边莲13重量份、丹参20重量份、三七15重量份、莪术8重量份、泽兰16重量份、鸡血藤16重量份、瞿麦13重量份和白术11重量份。
第二方面,本发明提供一种中药组合物的制备方法,包括以下步骤:按照配比称取各原料组分,将其洗净后粉碎,之后用水进行提取,过滤,收集滤液;将滤液浓缩成70℃时相对密度为1.05~1.20的浸膏,得到中药组合物。
优选地,提取为回流提取,且回流提取的温度为70℃~75℃,提取次数为2~3次,每次提取的时间为80min~150min。
优选地,将各原料组分粉碎至30~100目,且回流提取时,加入的水量为原料组分总质量的5~15倍。
需要说明的是,上述方法制备的中药组合物可根据需要进一步制备成药学上可接受的剂型。此外,以上述中药组合物为活性成分制成的药物也属于本发明的保护范围。通过将上述中药组合物,直接制备或者加入药学上可接受的辅料后制备,可制成任何药学上可接受的剂型。以外用制剂为例包括:溶液剂、贴剂、酒剂、酊剂、凝胶剂、搽剂、气雾剂、喷雾剂、软膏剂、栓剂和涂膜剂。上述各种剂型的药物均可以按照药学领域的常规方法制备。在临床应用中,本发明提供的中药组合物的用量一般为每次3g,每天两次。
第三方面,本发明提供的中药组合物在制备治疗肝硬化腹水药物或药物添加剂中的应用。
本发明的上述技术方案相比现有技术具有以下优点:
(1)申请人经过大量研究发现:本发明提供的中药组合物具有优异的疏肝理气、活血化瘀、滋肾柔肝等功效,其能够有效治疗肝硬化,尤其是对于早中期肝硬化及肝损伤患者有很好的治疗作用,且安全无毒副作用;此外,本发明提供的中药组合物使用方便,成本较低,具有很好的商业前景。
(2)采用本发明提供的制备方法,能够在最大限度的保留各原料药活性成分的同时,可以把各原料药材中的有效成分充分释放出来,从而使最终制备得到的中药组合物不仅具有很好的药效,且易于吸收,进而快速达到改善肝硬化腹水的目的。
本发明的附加方面和优点将在下面的描述中部分给出,部分将从下面的描述中变得明显,或通过本发明的实践了解到。
具体实施方式
下面将对本发明技术方案的实施例进行详细的描述。以下实施例仅用于更加清楚的说明本发明的技术方案,因此只作为实例,而不能以此来限制本发明的保护范围。
下述实施例中的实验方法,如无特殊说明,均为常规方法。
下述实施例中所用的试验材料,如无特殊说明,均为自常规试剂商店购买得到的。
以下实施例中的定量试验,均设置三次重复实验,数据为三次重复实验的平均值或平均值±标准差。
下述实施例中所用的失笑散、川朴、大腹皮、黄芪、寸冬、白芍、车前子、地胆草、制军、香附根、瓜子金、毛冬青、黑丑、石龙子、三棱、广木香、杏仁、半边莲、丹参、三七、莪术、泽兰、鸡血藤、瞿麦和白术均符合中国药典(2016年版)一部正文各药材项下的有关规定。投料前,通过鉴定,各味药材实物与名称相符,质量符合标准。
本发明提供一种用于治疗肝硬化腹水的中药组合物,其特征在于,原料组分按重量份计,包括:失笑散10~20重量份、川朴5~10重量份、大腹皮5~10重量份、黄芪10~20重量份、寸冬10~20重量份、白芍10~15重量份、车前子5~10重量份、地胆草10~20重量份、制军5~10重量份、瓜子金30~40重量份、毛冬青30~60重量份、黑丑5~10重量份、石龙子30~60重量份、三棱10~20重量份、广木香15~20重量份、杏仁10~20重量份、三七10~20重量份、莪术5~10重量份、泽兰10~20重量份、鸡血藤10~20重量份、瞿麦10~20重量份、白术10~15重量份、香附根10~20重量份、半边莲10~15重量份和丹参10~30重量份。
另外,针对本发明的中药组合物,本发明专门设计了制备方法,包括以下步骤:
按照配比称取各原料组分,将其洗净后粉碎至30~100目,之后用水进行提取,过滤,收集滤液;将滤液浓缩成70℃时相对密度为1.05~1.20的浸膏,得到中药组合物。其中,提取为回流提取,且回流提取的温度为70℃~75℃,提取次数为2~3次,每次提取的时间为80min~150min,且加入的水量为原料组分总质量的5~15倍。
下面结合具体实施方式进行说明:
实施例一
本实施例提供一种用于治疗肝硬化腹水的中药组合物,由下述原料组分制备而成:失笑散20重量份、川朴5重量份、大腹皮10重量份、黄芪10重量份、寸冬20重量份、白芍10重量份、车前子10重量份、地胆草10重量份、制军10重量份、瓜子金40重量份、毛冬青30重量份、黑丑10重量份、石龙子30重量份、三棱20重量份、广木香15重量份、杏仁20重量份、三七10重量份、莪术10重量份、泽兰10重量份、鸡血藤20重量份、瞿麦10重量份和白术15重量份。
按上述原料组分,采用本发明的制备方法,制备中药组合物:
按照配比称取各原料组分,将其洗净后粉碎至100目,之后用水进行提取,过滤,收集滤液;将滤液浓缩成70℃时相对密度为1.05的浸膏,得到中药组合物。其中,提取为回流提取,且回流提取的温度为75℃,提取次数为2次,每次提取的时间为150min,且加入的水量为原料组分总质量的5倍。
实施例二
本实施例提供一种用于治疗肝硬化腹水的中药组合物,由下述原料组分制备而成:失笑散13重量份、川朴9重量份、大腹皮9重量份、黄芪16重量份、寸冬15重量份、白芍12重量份、车前子8重量份、地胆草10重量份、制军10重量份、瓜子金36重量份、毛冬青50重量份、黑丑8重量份、石龙子50重量份、三棱15重量份、广木香17重量份、杏仁15重量份、三七15重量份、莪术8重量份、泽兰16重量份、鸡血藤16重量份、瞿麦13重量份和白术11重量份。
按上述原料组分,采用本发明的制备方法,制备中药组合物:
按照配比称取各原料组分,将其洗净后粉碎至30目,之后用水进行提取,过滤,收集滤液;将滤液浓缩成70℃时相对密度为1.20的浸膏,得到中药组合物。其中,提取为回流提取,且回流提取的温度为70℃,提取次数为3次,每次提取的时间为80min,且加入的水量为原料组分总质量的15倍。
实施例三
本实施例提供一种用于治疗肝硬化腹水的中药组合物,由下述原料组分制备而成:失笑散20重量份、川朴5重量份、大腹皮10重量份、黄芪10重量份、寸冬20重量份、白芍10重量份、车前子10重量份、地胆草10重量份、制军10重量份、香附根10重量份、瓜子金40重量份、毛冬青30重量份、黑丑10重量份、石龙子30重量份、三棱20重量份、广木香15重量份、杏仁20重量份、半边莲10重量份、丹参30重量份、三七10重量份、莪术10重量份、泽兰10重量份、鸡血藤20重量份、瞿麦10重量份和白术15重量份。
按上述原料组分,采用本发明的制备方法,制备中药组合物:
按照配比称取各原料组分,将其洗净后粉碎至100目,之后用水进行提取,过滤,收集滤液;将滤液浓缩成70℃时相对密度为1.05的浸膏,得到中药组合物。其中,提取为回流提取,且回流提取的温度为75℃,提取次数为2次,每次提取的时间为150min,且加入的水量为原料组分总质量的5倍。
实施例四
本实施例提供一种用于治疗肝硬化腹水的中药组合物,由下述原料组分制备而成:失笑散13重量份、川朴9重量份、大腹皮9重量份、黄芪16重量份、寸冬15重量份、白芍12重量份、车前子8重量份、地胆草10重量份、制军10重量份、香附根13重量份、瓜子金36重量份、毛冬青50重量份、黑丑8重量份、石龙子50重量份、三棱15重量份、广木香17重量份、杏仁15重量份、半边莲13重量份、丹参20重量份、三七15重量份、莪术8重量份、泽兰16重量份、鸡血藤16重量份、瞿麦13重量份和白术11重量份。
按上述原料组分,采用本发明的制备方法,制备中药组合物:
按照配比称取各原料组分,将其洗净后粉碎至30目,之后用水进行提取,过滤,收集滤液;将滤液浓缩成70℃时相对密度为1.20的浸膏,得到中药组合物。其中,提取为回流提取,且回流提取的温度为70℃,提取次数为3次,每次提取的时间为80min,且加入的水量为原料组分总质量的15倍。
另外,为了更好的评价各实施例的功效,进行以下实验:
一、毒性试验
选体重为18~22g的小白鼠80只(雌雄各40只),均分为4组,分别服用本发明实施例一至实施例四得到的中药组合物。具体地,取本发明的中药组合物5g,加去离子水制成浓缩液10mL,每只小白鼠给予浓缩液1.2mL灌胃,每日两次;观察30天,小白鼠均健康生存,无任何毒副作用;解剖观察血象、肝功能、各脏器组织状态,与正常小白鼠比较无差异。实验证明,本发明提供的中药组合物无毒。
二、临床试验
征集年龄25~70岁的肝硬化志愿者100名(男女比例为1:1),将各患者均分为:4组,每组25人,将第一组至第四组分别试用实施例一至实施例四中的中药组合物,每次3g,每日两次,10天为一疗程。两个疗程后统计各患者的具体情况,具体如表1所示。
疗效判断为:
显效:疗程结束后,症状、体征消失或基本消失;有腹水者腹水消失;肝功能恢复正常;门静脉宽度较治疗前减少0.3~0.5cm,脾脏厚度回缩超过0.5cm。有效:疗程结束后,症状、体征分级减少1级以上,但未消失;有腹水者腹水减轻50%以上而未完全消失;肝功能指标下降幅度在50%以上而未完全正常;门静脉宽度较治疗前减少0.1~0.2cm,脾脏厚度回缩0.3~0.5cm。无效:未达上述标准或加重者。其中,总有效率=显效率+有效率。
表1各实施例患者肝硬化症状临床效果统计表
案例数/名 | 显效/名 | 有效/名 | 无效/名 | 总有效率/% | |
实施例一 | 25 | 18 | 7 | 0 | 100 |
实施例二 | 25 | 16 | 9 | 0 | 100 |
实施例三 | 25 | 23 | 2 | 0 | 100 |
实施例四 | 25 | 22 | 3 | 0 | 100 |
当然,除了实施例一至实施例四列举的情况,其他原料组分的种类和重量百分比、制备过程中的条件和参数等也是可以的。
本发明提供的中药组合物具有优异的疏肝理气、活血化瘀、滋肾柔肝等功效,其能够有效治疗肝硬化,尤其是对于早中期肝硬化及肝损伤患者有很好的治疗作用,且安全无毒副作用;此外,本发明提供的中药组合物使用方便,成本较低,具有很好的商业前景。
在本说明书的描述中,需要理解的是,参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。此外,在不相互矛盾的情况下,本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例的特征进行结合和组合。
尽管上面已经示出和描述了本发明的实施例,可以理解的是,上述实施例是示例性的,不能理解为对本发明的限制,本领域的普通技术人员在本发明的范围内可以对上述实施例进行变化、修改、替换和变型。
Claims (8)
1.一种用于治疗肝硬化腹水的中药组合物,其特征在于,原料组分按重量份计,包括:
失笑散10~20重量份、川朴5~10重量份、大腹皮5~10重量份、黄芪10~20重量份、寸冬10~20重量份、白芍10~15重量份、车前子5~10重量份、地胆草10~20重量份、制军5~10重量份、瓜子金30~40重量份、毛冬青30~60重量份、黑丑5~10重量份、石龙子30~60重量份、三棱10~20重量份、广木香15~20重量份、杏仁10~20重量份、三七10~20重量份、莪术5~10重量份、泽兰10~20重量份、鸡血藤10~20重量份、瞿麦10~20重量份和白术10~15重量份。
2.根据权利要求1所述的用于治疗肝硬化腹水的中药组合物,其特征在于:
原料组分还包括:香附根10~20重量份、半边莲10~15重量份和丹参10~30重量份。
3.根据权利要求2所述的用于治疗肝硬化腹水的中药组合物,其特征在于,由下述原料组分制成:
失笑散20重量份、川朴5重量份、大腹皮10重量份、黄芪10重量份、寸冬20重量份、白芍10重量份、车前子10重量份、地胆草10重量份、制军10重量份、香附根10重量份、瓜子金40重量份、毛冬青30重量份、黑丑10重量份、石龙子30重量份、三棱20重量份、广木香15重量份、杏仁20重量份、半边莲10重量份、丹参30重量份、三七10重量份、莪术10重量份、泽兰10重量份、鸡血藤20重量份、瞿麦10重量份和白术15重量份。
4.根据权利要求2所述的用于治疗肝硬化腹水的中药组合物,其特征在于,由下述原料组分制成:
失笑散13重量份、川朴9重量份、大腹皮9重量份、黄芪16重量份、寸冬15重量份、白芍12重量份、车前子8重量份、地胆草10重量份、制军10重量份、香附根13重量份、瓜子金36重量份、毛冬青50重量份、黑丑8重量份、石龙子50重量份、三棱15重量份、广木香17重量份、杏仁15重量份、半边莲13重量份、丹参20重量份、三七15重量份、莪术8重量份、泽兰16重量份、鸡血藤16重量份、瞿麦13重量份和白术11重量份。
5.权利要求1~4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:
按照配比称取各原料组分,将其洗净后粉碎,之后用水进行提取,过滤,收集滤液;将所述滤液浓缩成70℃时相对密度为1.05~1.20的浸膏,得到所述中药组合物。
6.权利要求5所述的中药组合物的制备方法,其特征在于:
所述提取为回流提取,且所述回流提取的温度为70℃~75℃,提取次数为2~3次,每次提取的时间为80min~150min。
7.权利要求6所述的中药组合物的制备方法,其特征在于:
将各原料组分粉碎至30~100目,且所述回流提取时,加入的水量为所述原料组分总质量的5~15倍。
8.权利要求1~4任一项所述的中药组合物在制备治疗肝硬化腹水药物和/或药物添加剂中的应用。
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