CN109200265A - 一种治疗肝硬化腹水的中药组合物及其散剂的制备方法 - Google Patents

一种治疗肝硬化腹水的中药组合物及其散剂的制备方法 Download PDF

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CN109200265A
CN109200265A CN201811312442.4A CN201811312442A CN109200265A CN 109200265 A CN109200265 A CN 109200265A CN 201811312442 A CN201811312442 A CN 201811312442A CN 109200265 A CN109200265 A CN 109200265A
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王世豪
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Abstract

本发明公开了一种治疗肝硬化腹水的中药组合物,按重量百分比由以下组分组成:鳖甲1‑7%,桃仁1‑7%,丹皮1‑7%,赤芍1‑7%,白芍1‑7%,三棱1‑7%,莪术1‑7%,柴胡1‑7%,厚朴1‑7%,党参3‑9%,车前子1‑7%,泽泻3‑9%,生姜皮3‑9%,鸡内金1‑7%,山楂3‑9%,神曲3‑9%,大腹皮1‑7%,白花蛇草10‑16%,龟板9‑15%,冬虫夏草1‑7%,上述各组分的重量百分比之和为100%。其制备方法是将各组分分别粉碎后充分混合即成。本发明一种治疗肝硬化腹水的中药组合物具益气健脾,活血通络,行气利尿,能提高机体免疫功能,促进蛋白合成,显著减轻患者痛苦。

Description

一种治疗肝硬化腹水的中药组合物及其散剂的制备方法
技术领域
本发明属于医药技术领域,涉及一种治疗肝硬化腹水的中药组合物,本发明还涉及该治疗肝硬化腹水的中药组合物的散剂的制备方法。
背景技术
肝硬化腹水是指由于肝脏疾病导致肝脏反复炎症,纤维化及肝硬化形成后由于多种病理因素,如门脉高压、低蛋白血症、水钠潴留等引起腹腔内积液的临床症状。目前,临床上对肝硬化腹水主要通过服用利尿剂、穿刺放腹水、超滤浓缩腹水回输系统应用等方法治疗,治疗难度大,副作用大,病情易反复,患者往往十分痛苦。
发明内容
本发明的目的是提供一种治疗肝硬化腹水的中药组合物,解决现有的肝硬化腹水治疗过程中对病情疗效小,副作用大的问题。
本发明的另一个目的是提供上述一种治疗肝硬化腹水的中药组合物散剂的制备方法。
本发明所采用的技术方案是,一种治疗肝硬化腹水的中药组合物,按重量百分比由以下组分组成:鳖甲1-7%,桃仁1-7%,丹皮1-7%,赤芍1-7%,白芍1-7%,三棱1-7%,莪术1-7%,柴胡1-7%,厚朴1-7%,党参3-9%,车前子1-7%,泽泻3-9%,生姜皮3-9%,鸡内金1-7%,山楂3-9%,神曲3-9%,大腹皮1-7%,白花蛇草10-16%,龟板9-15%,冬虫夏草1-7%,上述各组分的重量百分比之和为100%;
本发明所采取的另一个技术方案是,一种治疗肝硬化腹水的中药组合物的散剂的制备方法,具体按照以下步骤实施:
步骤1,按照重量百分比分别称取鳖甲1-7%,桃仁1-7%,丹皮1-7%,赤芍1-7%,白芍1-7%,三棱1-7%,莪术1-7%,柴胡1-7%,厚朴1-7%,党参3-9%,车前子1-7%,泽泻3-9%,生姜皮3-9%,鸡内金1-7%,山楂3-9%,神曲3-9%,大腹皮1-7%,白花蛇草10-16%,龟板9-15%,冬虫夏草1-7%,上述各组分的重量百分比之和为100%;
步骤2,将步骤1称取的各组分分别粉碎;
步骤3,将步骤2获得的粉末充分混合,得到治疗溃疡的中药组合物散剂。
本发明的特点还包括,
将步骤1称取的各组分分别粉碎为粒径小于60μm的粉末。
本发明的有益效果是,本发明一种治疗肝硬化腹水的中药组合物具有以下优点:益气健脾,活血通络,行气利尿,兼以清热利湿,能提高机体免疫功能,促进蛋白合成,显著减轻患者痛苦,明显缩短病程。
经累计300例病人的临床应用,疗效极佳,对因湿热疫毒久侵、肝气郁结,气滞血瘀,脉络壅塞,血瘀水停,同时肝气犯脾、脾虚运化失职,水湿泛滥,隧道不通,水液停留,便成鼓胀多种原因导致的肝硬化腹水能够减轻患者痛苦,无毒,对皮肤无过敏,无刺激及原料易于获得的优点,且其散剂的制备方法简单,容易实施。
具体实施方式
下面结合具体实施方式对本发明进行详细说明。
本发明一种治疗肝硬化腹水的中药组合物,按重量百分比由以下组分组成:按照重量百分比分别称取白花蛇草10-16%,龟板9-15%,党参3-9%,山楂3-9%,神曲3-9%,泽泻3-9%,生姜皮3-9%,鳖甲1-7%,桃仁1-7%,丹皮1-7%,赤芍1-7%,白芍1-7%,三棱1-7%,莪术1-7%,柴胡1-7%,厚朴1-7%,车前子1-7%,鸡内金1-7%,大腹皮1-7%,冬虫夏草1-7%,上述各组分的重量百分比之和为100%。
各组分在本发明中药组合物中的功能:
以白花蛇草为君,清热解毒,利湿,主肺热喘咳,咽喉肿痛,肠痈,疖肿疮疡,毒蛇咬伤,热淋涩痛,水肿,痢疾,肠炎,湿热黄疸,癌肿。
以龟板为臣,滋肾潜阳,益肾健骨,养血补心,主治阴虚阳亢,阴虚内热,虚风内动,肾虚骨痿,囟门不合,阴血亏虚,惊悸,失眠,健忘。
党参,具有补中益气,健脾益肺之功效,党参有增强免疫力、扩张血管、降压、改善微循环、增强造血功能等作用。山楂,消食积,散瘀血,驱绦虫,治肉积,症瘕,痰饮,痞满,吞酸,泻痢,肠风,腰痛,疝气产后儿枕痛,恶露不尽,小儿乳食停滞。消食健胃,行气散瘀。用于肉食积滞、胃烷胀满、泻痢腹痛、瘀血经闭、产后瘀阻、心腹刺痛、疝气疼痛、高血脂症。神曲:健脾和胃,消食化积,用于饮食停滞,消化不良,脘腹胀满,食欲不振,呕吐泻痢。泽泻:利水,渗湿,泄热。治小便不利,水肿胀满,呕吐,泻痢,痰饮,脚气,淋病,尿血。生姜皮,行水消肿。用于水肿初起,小便不利。以上诸药为使。
鳖甲,滋阴潜阳,退热除蒸,软坚散结,用于阴虚发热,骨蒸劳热,阴虚阳亢,头晕目眩,虚风内动,经闭,癥瘕,久疟,疟母。桃仁,活血祛瘀,润肠通便,止咳平喘,用于经闭痛经,瘕瘕痞块,肺痈肠痈,跌扑损伤,肠燥便秘,咳嗽气喘。丹皮,有镇静、降温、解热、镇痛、解痉等中枢抑制作用及抗动脉粥样硬化、利尿、抗溃疡等作用。赤芍,清热凉血,散瘀止痛。用于热人营血,温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,瘾瘕腹痛,跌扑损伤,痈肿疮疡。白芍,平肝止痛,养血调经,敛阴止汗,用于头痛眩晕,胁痛,腹痛,四肢挛痛,血虚萎黄,月经不调,自汗,盗汗。三棱,具有破血行气,消积止痛的功效,用于症瘕痞块,痛经,瘀血经闭,胸痹心痛,食积胀痛。莪术,气血凝滞,心腹胀痛,症瘕,积聚,宿食不消,妇女血瘀经闭,跌打损伤作痛。柴胡,和解表里,疏肝解郁,升阳举陷,退热截疟。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛。厚朴,行气消积,燥湿除满,降逆平喘,主治食积气滞;腹胀便秘,湿阻中焦,脘痞吐泻,痰壅气逆,胸满喘咳。车前子:利水,清热,明目,祛痰,治小便不通,淋浊,带下,尿血,暑湿泻痢,咳嗽多痰,湿痹,目赤障翳。鸡内金,健胃消食,涩精止遗,通淋化石,用于食积不消,呕吐泻痢,小儿疳积,遗尿,遗精,石淋涩痛,胆胀胁痛。大腹皮:行气宽中,行水消肿。用于湿阻气滞,脘腹胀闷,大便不爽,水肿胀满,脚气浮肿,小便不利。冬虫夏草:调节免疫系统功能、抗肿瘤、抗疲劳、补肺益肾,止血化痰,秘精益气、美白祛黑等多种功效。以上诸药为佐。
功能主治:对因湿热疫毒久侵、肝气郁结,气滞血瘀,脉络壅塞,血瘀水停,同时肝气犯脾、脾虚运化失职,水湿泛滥,隧道不通,水液停留,便成鼓胀多种原因导致的肝硬化腹水。
用法用量:分别称取鳖甲10g,桃仁10g,丹皮10g,赤芍10g,白芍10g,三棱10g,莪术10g,柴胡10g,厚朴10g,党参15g,车前子10g,泽泻15g,生姜皮15g,鸡内金10g,山楂15g,神曲15g,大腹皮10g,白花蛇草35g,龟板30g,冬虫夏草10g,粉碎之后混合均匀,制成散剂。一日一剂,水煎服,十剂一个疗程。先将药用水浸泡30分钟,大火煎开,然后小火煎20分钟即可,每剂煎两次,早晚各一服。
上述一种治疗肝硬化腹水的中药组合物的散剂的制备方法,具体按照以下步骤实施:
步骤1,按照重量百分比分别称取鳖甲1-7%,桃仁1-7%,丹皮1-7%,赤芍1-7%,白芍1-7%,三棱1-7%,莪术1-7%,柴胡1-7%,厚朴1-7%,党参3-9%,车前子1-7%,泽泻3-9%,生姜皮3-9%,鸡内金1-7%,山楂3-9%,神曲3-9%,大腹皮1-7%,白花蛇草10-16%,龟板9-15%,冬虫夏草1-7%,上述各组分的重量百分比之和为100%;
步骤2,将步骤1称取的各组分分别粉碎为粒径小于60μm的粉末;
步骤3,将步骤2获得的粉末充分混合,得到治疗溃疡的中药组合物散剂。
实施例1
步骤1,按照重量分别称取鳖甲10g,桃仁10g,丹皮10g,赤芍10g,白芍10g,三棱10g,莪术10g,柴胡10g,厚朴10g,党参15g,车前子10g,泽泻15g,生姜皮15g,鸡内金10g,山楂15g,神曲15g,大腹皮10g,白花蛇草35g,龟板30g,冬虫夏草10g;
步骤2,将步骤1称取的各组分分别粉碎60μm的粉末;
步骤3,将步骤2获得的粉末充分混合,得到治疗溃一种治疗肝硬化腹水的中药组合物散剂。
实施例2
步骤1,按照重量百分比分别称取鳖甲6g,桃仁6g,丹皮6g,赤芍6g,白芍6g,三棱6g,莪术6g,柴胡6g,厚朴6g,党参11g,车前子6g,泽泻11g,生姜皮11g,鸡内金6g,山楂11g,神曲11g,大腹皮6g,白花蛇草31g,龟板26g,冬虫夏草6g;
步骤2,将步骤1称取的各组分分别粉碎为粒径50μm的粉末;
步骤3,将步骤2获得的粉末充分混合,得到一种治疗肝硬化腹水的中药组合物散剂。
实施例3
步骤1,按照重量百分比分别称取鳖甲8g,桃仁8g,丹皮8g,赤芍8g,白芍8g,三棱8g,莪术8g,柴胡8g,厚朴8g,党参13g,车前子8g,泽泻13g,生姜皮13g,鸡内金8g,山楂13g,神曲13g,大腹皮8g,白花蛇草33g,龟板28g,冬虫夏草8g;
步骤2,将步骤1称取的各组分粉碎为粒径55μm的粉末;
步骤3,将步骤2获得的粉末充分混合,得到一种治疗肝硬化腹水的中药组合物散剂。
实施例4
步骤1,按照重量百分比分别称取鳖甲12g,桃仁12g,丹皮12g,赤芍12g,白芍12g,三棱12g,莪术12g,柴胡12g,厚朴12g,党参17g,车前子12g,泽泻17g,生姜皮17g,鸡内金12g,山楂17g,神曲17g,大腹皮12g,白花蛇草37g,龟板32g,冬虫夏草12g;
步骤2,将步骤1称取的各组分粉碎为粒径60μm的粉末;
步骤3,将步骤2获得的粉末充分混合,得到一种治疗肝硬化腹水的中药组合物散剂。
实施例5
步骤1,按照重量百分比分别称取鳖甲15g,桃仁15g,丹皮15g,赤芍15g,白芍15g,三棱15g,莪术15g,柴胡15g,厚朴15g,党参20g,车前子15g,泽泻20g,生姜皮20g,鸡内金15g,山楂20g,神曲20g,大腹皮15g,白花蛇草40g,龟板35g,冬虫夏草15g;
步骤2,将步骤1称取的各组分粉碎为粒径55μm的粉末;
步骤3,将步骤2获得的粉末充分混合,得到一种治疗肝硬化腹水的中药组合物。
经动物药效学试验表明:本发明一种治疗肝硬化腹水的中药组合物具镇痛作用、抗炎作用、抑菌作用、止血作用。实验具体过程如下:
选体重150-200g的Wistar大鼠,将D-氨基半乳糖配制成10%的生理盐水溶液,用1N的NaOH将pH调节至7.0,以250mg的剂量行腹内注射,每天一次,每周6天,约半年左右即可形成肝硬化。在采用上述剂量D-氨基半乳糖长期多次注入大鼠腹腔时,动物耐受性较好。逐渐出现进食活动减少,有时解稀糖大便,腹部较为膨隆,肝硬化腹水动物模型建立。大鼠分为生理盐水组、实验组及对照组。基质组使用生理盐水,实验组给予本发明中药组合物,对照组给予螺内酯和呋塞米,半年内与对照组相比,分析结果:
自股动脉取血作肝功能试验,包括血清蛋白测定、浊度试验、转氨酶、乳酸脱氢酶(LDH)、单胺氧化酶(MAO)、5'-核苷酸酶(5'-NA)、γ-谷氨酰转肽酶(γ-GT)及胆碱酯酶。分批处死动物进行尸解,观察腹水,心、肝、脾、肺肾等器官形态,用4%甲醛溶液固定,石蜡包埋,切片厚5微米,进行HE、网状纤维(Gordon与Sweet法)、胶原纤维(Van Gieson法)及弹力纤维(Weiger法)染色。
尸检时可见腹腔内有腹水,0-20ml不等,生理盐水组与对照组相比,心、脾、肺、肾、无明显差异,早期肝明显增大、重量增加,色泽较灰黄,以后体积逐渐缩小,质地变硬,边缘较钝,肝表面可见弥漫性分布的细颗粒状结节,结节大小不一,直径约为0.5-1.5mm,结节间可见弥漫分布的纤维间隔,间隔一般较细小,其凹凸程度随病变而加深。
切片HE染色、光镜下检查,在注射氨基半乳糖5个月后,肝小叶结构开始紊乱,形成大小不等的肝细胞团,有的仍见好的中央静脉,但其周围门脉区胆管上皮高度增生,其间夹有残留的个别肝细胞及少量单核多核白细胞及褐色素沉着。随着病程的延长,增生的胆管及纤维母细胞向四周呈星芒状伸展,有的与中央静脉相连。
一般肝细胞变性坏死少见,大多呈增生表现。Gordon与Sweet法染色显示肝细胞团中网状纤维少见而周围组织中存在着大量疏松的网状纤维。胶原纤维及弹性纤维均未见增多。除肝外,其余实质器官切片无异常发现。实验组动物在出现肝硬化后,及时给予本发明一种治疗肝硬化腹水的中药组合物血清白蛋白含量增加,浊度试验降低,血清GPT、LDH、MAO、5'-NA、γ-GT与胆碱脂酶均有明显改变。
经毒理学试验表明:本发明中药组合物单次、连续用药刺激性试验结果显示无刺激作用。具体实验过程如下:
实验过程:取清洁级白化豚鼠10只,雌雄各半,持续用药24h,用药完毕后的1h、24h、48h、72h观察皮肤的红斑和水肿等反应,根据《中药新药研究指南》中的评分标准及刺激强度评价标准进行评价。连续用药实验操作及评价方式同与上述单次用药实验相同,连续用药7d,每天持续6h,于末次给药后1h、24h、48h、72h观察皮肤的红斑和水肿等反应。
实验结果:在单次用药及连续用药实验中,在完整皮肤组和破损皮肤组豚鼠均没有出现红斑和水肿,各个时间段红斑和水肿评分均为0,且豚鼠的一般状况良好,未有皮肤产生干硬、粗糙等异常反应出现,说明单次及连续用药中,本发明中药组合物对豚鼠没有刺激性。
临床应用:
1.李某,女,47岁,以被踢伤右上腹出现腹胀为主诉,当地诊为“上消化道出血”,住院查出肝硬化。因劳累加重,此后病情反复发作。半年前诸症加重伴腹部膨隆、尿少、双下肢水肿,当地治疗效果欠佳,遂来我院。入院时精神差、形体消瘦,腹高度膨隆,脐部突出如拳头大小,质硬,腹水征阳性,下肢水肿。B超:肝硬化、门脉高压、脾大、大量腹水。予院内制剂肝复康,消臌软坚丸、治腹水汤药等,配合西药、腹水回输等,半月后腹水消退,下肢无水肿。本发明一种治疗肝硬化腹水的中药组合物服用后,多次回访,病情稳定无反复,收效明显,肝功能改善迅速、水肿消退满意,但出院后仍需要长服缓图以巩固疗效并防止复发。
2.陈某,男,53岁,以肝硬化腹水使腹部饱满及移动性浊音为主诉,诊断为典型的肝硬化腹水,多出现蛙腹状,且腹软,多无压痛,移动性浊音两侧对称,本发明一种治疗肝硬化腹水的中药组合物服用后,病情稳定无反复,水肿消退明显。
3.赵某,男,60岁,以为主肝硬化腹水为主诉,当地医院治疗半年,病情无明显好转,前来就医。此例确诊病例,结核性腹膜炎腹型可呈尖球状,腹壁较为紧张,触诊时腹壁有柔韧感,急性腹膜炎时则腹肌紧张,有压痛、反跳痛,且腹式呼吸减弱或消失,当炎性腹水腹内有黏连时,虽有大量腹水,腹部膨隆,但可无明显移动性浊音或两侧移动性浊音不相对称,本发明一种治疗肝硬化腹水的中药组合物服用后,病情稳定无反复,水肿消退明显。

Claims (3)

1.一种治疗肝硬化腹水的中药组合物,其特征在于,按重量百分比由以下组分组成:鳖甲1-7%,桃仁1-7%,丹皮1-7%,赤芍1-7%,白芍1-7%,三棱1-7%,莪术1-7%,柴胡1-7%,厚朴1-7%,党参3-9%,车前子1-7%,泽泻3-9%,生姜皮3-9%,鸡内金1-7%,山楂3-9%,神曲3-9%,大腹皮1-7%,白花蛇草10-16%,龟板9-15%,冬虫夏草1-7%,上述各组分的重量百分比之和为100%。
2.根据权利要求1所述的一种治疗肝硬化腹水的中药组合物的散剂的制备方法,其特征在于,具体按照以下步骤实施:
步骤1,按照重量百分比分别称取鳖甲1-7%,桃仁1-7%,丹皮1-7%,赤芍1-7%,白芍1-7%,三棱1-7%,莪术1-7%,柴胡1-7%,厚朴1-7%,党参3-9%,车前子1-7%,泽泻3-9%,生姜皮3-9%,鸡内金1-7%,山楂3-9%,神曲3-9%,大腹皮1-7%,白花蛇草10-16%,龟板9-15%,冬虫夏草1-7%,上述各组分的重量百分比之和为100%;
步骤2,将步骤1称取的各组分分别粉碎;
步骤3,将步骤2获得的粉末充分混合,得到治疗一种治疗肝硬化腹水的中药组合物散剂。
3.根据权利要求2所述的一种治疗肝硬化腹水的中药组合物的散剂的制备方法,其特征在于,将步骤1称取的各组分分别粉碎为粒径小于60μm的粉末。
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