CN113940960A - 一种防治肝功能损伤的中药组合物 - Google Patents
一种防治肝功能损伤的中药组合物 Download PDFInfo
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Abstract
本发明提供一种防治肝损伤的中药组合物，所述中药组合物由桃仁、茵陈、甜瓜蒂、胡芦巴和桑叶按一定重量配比制备而成。它可以与适宜的药用辅料按照常规的制剂工艺制备成任何一种常用口服制剂的剂型。本发明中药组合物药味简单，药效显著，能有效防治肝损伤。
Description
技术领域
本发明属于中药技术领域，特别是涉及一种防治肝功能损伤的中药组合物，所述中药组合物含有葫芦巴。
技术背景
肝脏是人体最大的解毒防御器官，是合成蛋白的重要场所，随着社会节奏不断加快，近年来病毒性肝炎，肝纤维化，脂肪肝，酒精肝，药物性肝损害及肝硬化，肝癌等肝病发病率逐年上升，是当今社会威胁人类健康的主要疾病之一。据最新统计病毒性肝炎和乙肝病毒携带者在我国人群当中有14％以上人口感染。肝病已经成为人类常见病，多发病，其发病率正在不断上升，严重威胁人类健康。常规的口服药如核苷类药物在治疗肝脏疾病时因不可避免地对肝脏产生二次损伤，且存在副作用大、价格昂贵等问题，故从中药和民族药中找寻并研发一种新型的防治肝功能损伤药物势在必行。
我国治疗包括乙肝和酒精引起的慢性肝炎与肝硬化等肝病时最常用的中药材主要有：桃仁、丹参、当归、地鳖虫及大黄等，这类药材均属于“活血化瘀类”中药。临床研究证实：上述中药材疗效确切，故利用中药治疗肝病应该是一种行之有效的治疗手段。
传统中成药如柴胡舒肝丸、加味逍遥丸、越鞠丸、大黄蛰虫丸等在临床中应用于治疗肝病也是广泛有效的。但上述中成药中味数较多，成分复杂，较易引起不良反应。故为了减轻肝功能负担，本发明人经长期临床摸索，从我国传统的中医理论出发，以“清热解毒，理气消食，升清降浊，温阳利水”为治则，精简方剂味数，以常用的五味中草药研制出一种防治肝功能损伤的中药组合物，该验方本发明组合物药味少，用量不大，副作用小。
发明内容
本发明所解决的技术问题旨在提供一种防治肝功能损伤的中药组合物，并采用以下技术方案来实现：
本发明中药组合物选择将甜瓜蒂、胡芦巴、桃仁、茵陈和桑叶进行组合，其中所选用的桃仁味苦、甘，性平，归心、肝、大肠经，具有活血祛瘀，润肠通便，止咳平喘的功效；茵陈味苦，辛，性微寒，归脾、胃、膀胱经，具备清利湿热、利胆退黄之功效；甜瓜蒂味苦性寒，入脾、胃，兼入肝、胆四经，能涌吐痰食，除湿退黄；用于瘕瘕痞块，肠燥便秘，咳嗽气喘；三者配伍能产生较好的协同作用，共奏活血祛瘀、消肿散结、除湿退黄、止咳平喘的功效，从而有效改善肝脏微循环，防止肝细胞坏死，减少胶原纤维化产生，增强胶原酶活性和防止肝内出现纤维性结节，进而防治肝功能损伤。
为了达到更好的疗效，本发明组合物还在上述原料药中加入胡芦巴和桑叶。胡芦巴味苦、性温，具温阳利水，散寒止痛之功；桑叶味苦、甘，性寒，归肺、肝经，具疏散风热、清肺之功，二者共助上述各药散寒疏风，温阳利水，对肝病的防治具有增强疗效的作用。
防治肝损伤的关键环节为解毒、化痰、活血，故本发明以“清热解毒，理气消食，升清降浊，温阳利水”为治则，选用本具活血化痰之效的桃仁，并将其连皮粉碎进行醇提，走肝经，主破蓄血，逐月水，则有活血行血之功效，能去瘀生新之功，故为君药。茵陈清热解毒，甜瓜蒂乃阳明经除湿热之药，故能升能降，升则吐，诸恶毒在上焦者皆可除；降则泻，凡积聚在下焦者皆能下之，故具升清降浊之效，二者共奏清热解毒、升清降浊之效，合为臣药。胡芦巴则具温阳利水之功，桑叶疏散风热，二者均为佐药，诸药合用，具有改善因肝功能低下表现的肝区不适，腹胀，食欲减退，乏力等症状的功效，且具有恢复肝功能、促进胆红素排泄的作用，故能防治肝损伤。
本发明中药组合物各原料组分的用量也是发明人经过临床治疗摸索总结得出的，各组分用量为在下述重量份范围内对防治肝功能损伤都具有较好的疗效：
甜瓜蒂5～25份、胡芦巴10～40份、桃仁20～40份、茵陈30～60份和桑叶20～40份。
较优选的，本发明中药组合物各原料的重量份为甜瓜蒂10～20份、胡芦巴20～30份、桃仁20～30份、茵陈40～50份和桑叶20～30份。
最佳疗效的，本发明中药组合物各原料的重量份为：甜瓜蒂15份、胡芦巴25份、桃仁25份、茵陈45份和桑叶25份。
本发明口服有效日剂量为20～50g生药材，分3次服用。
本发明中药组合物可以采用中药制剂的常规方法制备成任何常规口服制剂。例如可以将这些原料药研成粉末混合均匀制成散剂冲服；也可以将这些原料一起水煎，然后浓缩水煎液制成；但为了使该药物的各原料更好地发挥药效，优选对原料药中的胡芦巴和桃仁粉碎进行醇提。但是这些均不能用于限制本发明的保护范围。
优选的，本发明所述中药组合物由下述制备方法制备而成：
A、按重量配比称取的甜瓜蒂、胡芦巴、桃仁、茵陈和桑叶；
B、将胡芦巴和桃仁粉碎成粗粉，过筛，加入药材量3～8倍量的50％～80％乙醇回流提取1～3次，每次1～3小时，浓缩，过滤，滤液备用；
C、将甜瓜蒂、茵陈、胡芦巴和桑叶加入5～10倍水煎煮2～3次，滤过，合并滤液，再加入B步所得滤液，滤液混合均匀后浓缩至相对密度为1.25～1.35的浓缩液，干燥得浸膏；
D、将C步所得浸膏加入相应的药物制剂用的辅料，按照常规药物制备方法得到相应的药物制剂。
为了达到更佳的疗效，本发明所述中药组合物由下述制备方法制备而成：
A、按重量配比称取的桃仁、茵陈、甜瓜蒂、胡芦巴和桑叶；
B、将胡芦巴和桃仁粉碎成粗粉，过筛，加入药材量5倍量的70％乙醇回流提取2次，第1次2小时，第2次1小时，浓缩，过滤，滤液备用；
C、将甜瓜蒂、茵陈和桑叶加入8倍水煎煮3次，滤过，合并滤液，再加入B步所得滤液，滤液混合均匀后浓缩至相对密度为1.30的浓缩液，干燥得浸膏；
D、将C步所得浸膏加入相应的药物制剂用的辅料，按照常规药物制备方法得到相应的药物制剂。
本发明药物的活性成分可以加入制备不同剂型时所需的各种常规辅料，如崩解剂、润滑剂、粘合剂等，并以常规的中药制剂方法制备成任何一种常用口服剂型，如丸剂、散剂、片剂、胶囊剂和口服液等。
为了更进一步详细说明本发明的技术内容、所实现目的及效果，以下结合实施方式予以说明，并非因此限制本发明的专利范围，凡是利用本发明说明书内容所作的等同变换，或直接或间接运用在相关的技术领域，均同理包括在本发明的专利保护范围内。
具体实施方式
实验例1 本发明片剂抗实验性肝损伤药效学研究
实验材料：本发明片剂自制，0.45g/片(每片含生药4.35g)，临床用药量25～50g/d(生药)。秋水仙碱片为广东彼迪药业有限公司生产，每片含药0.5mg。
实验方法：SD大鼠，雌雄各半，体重180～220g，分笼饲养，除对照组外喂饲高脂低蛋白饲料，首次皮下注射40％CCl4 5mL/kg，对照组给予等体积橄榄油，以后每3d注射40％CCl4 3mL/kg 1次，持续6周，检测各大鼠肝功能指标的变化以确定肝损伤程度。除对照组外，其余大鼠随机分为5组，即：模型组，秋水仙碱组(0.25rag/kg)，本发明片剂小剂量组、中剂量组和大剂量组，其剂量分别为0.84g、1.68g、3.36g生药/kg。模型组及各给药组每3天注射40％CCl4 3mL/kg 1次，对照组给予等体积橄榄油，持续4周，给药自分组之日开始，按体重灌胃1mL/100g，对照组及模型组给予生理盐水，各给药组给予相应药物，每日1次。给药结束后，大鼠眶后静脉取血，离心取血清，进行肝功能指标(ALT、AST、ALP、TBiLi)检测，结果见表1。另各组均取肝脏同一部位做病理组织学检查。
表1各组大鼠血清肝功能指标的比较
| 组别 | 大鼠数 | ALT | AST | ALP | TBLi |
| 对照组 | 10 | 30.2±6.25 | 153.1±21.3 | 201.3±102.4 | 15.4±2.1 |
| 模型组 | 12 | 131.2±42.7** | 362.5±102.1** | 759.6±196.3** | 20.3±5.0** |
| 秋水仙碱组 | 12 | 49.2±12.4Δ | 189.7±35.8ΔΔ | 514.7±123.6Δ | 17.4±3.9 |
| 小剂量组 | 12 | 95.6±34.2 | 153.9±17.5ΔΔ | 501.8±132.5Δ | 19.2±3.4 |
| 中剂量组 | 12 | 86.4±29.4 | 232.1±14.2Δ | 548.1±134.2 | 18.0±2.5 |
| 大剂量组 | 12 | 75.3±13.1Δ | 143.2±42.1ΔΔ | 425.2±137.4Δ | 17.3±3.1Δ |
(与对照组比较，*P＜0.05，**P＜0.01；与模型组比较ΔP＜0.05，ΔΔP＜0.01)
由上述实验结果表明，模型组大鼠肝功能各项指标(ALT、AST、ALP、TBLi)较对照组明显升高；而给予本发明片剂的3个剂量组肝功能指标均有不同程度的改善，其中对ALT、AST、ALP的抑制作用尤其明显。另其病理组织学检查结果表明本发明3个剂量组可明显减轻肝脏病变程度，上述结果表明本发明中药组合物对CCl4所致的大鼠慢性肝损伤具有一定的肝保护作用。
以下通过实施例来进一步阐述本发明组合物的制备方法。
实施例1、本发明口服液
称取的桃仁40g、茵陈80g、甜瓜蒂25g、胡芦巴40g和桑叶40g；将胡芦巴和桃仁粉碎成粗粉，过120目筛，加入药材量5倍量的70％乙醇回流提取2次，第1次2小时，第2次1小时，浓缩，过滤，滤液备用；另将甜瓜蒂、茵陈和桑叶加入8倍水煎煮3次，滤过，合并滤液，再加入上述胡芦巴和桃仁的醇提滤液，滤液混合均匀后浓缩至相对密度为1.30的浓缩液，干燥得浸膏；加入适量水和适宜的口服液辅料，制备成口服液100瓶，每瓶10ml。
实施例2、本发明胶囊剂
称取的桃仁80g、茵陈150g、甜瓜蒂50g、胡芦巴85g和桑叶80g；将胡芦巴和桃仁粉碎成粗粉，过120目筛，加入药材量5倍量的70％乙醇回流提取2次，第1次2小时，第2次1小时，浓缩，过滤，滤液备用；另将甜瓜蒂、茵陈和桑叶加入8倍水煎煮3次，滤过，合并滤液，再加入上述胡芦巴和桃仁的醇提滤液，滤液混合均匀后浓缩至相对密度为1.30的浓缩液，干燥得浸膏；加入适量适宜的胶囊剂辅料，制备成胶囊剂100粒。
实施例3、本发明片剂
称取的桃仁50g、茵陈270g、甜瓜蒂100g、胡芦巴45g和桑叶90g；将胡芦巴和桃仁粉碎成粗粉，过100目筛，加入药材量3倍量的80％乙醇回流提取3次，每次1小时，浓缩，过滤，滤液备用；另将甜瓜蒂、茵陈和桑叶加入10倍水煎煮2次，滤过，合并滤液，再加入上述胡芦巴和桃仁的醇提滤液，滤液混合均匀后浓缩至相对密度为1.30的浓缩液，干燥得浸膏；加入适量适宜的片剂辅料，制备成片剂100粒。
实施例4、本发明颗粒剂
称取的桃仁180g、茵陈1300g、甜瓜蒂25g、胡芦巴50g和桑叶100g；将胡芦巴和桃仁粉碎成粗粉，过100目筛，加入药材量8倍量的50％乙醇回流提取3小时，浓缩，过滤，滤液备用；另将甜瓜蒂、茵陈和桑叶加入5倍水煎煮3次，滤过，合并滤液，再加入上述胡芦巴和桃仁的醇提滤液，滤液混合均匀后浓缩至相对密度为1.30的浓缩液，干燥得浸膏；加入适量适宜的颗粒剂辅料，制备成颗粒剂100包。
Claims (8)
1.一种防治肝功能损伤的中药组合物，其特征在于由下述重量份的各原料药：桃仁15～40份、茵陈30～60份、甜瓜蒂5～25份、胡芦巴10～40份和桑叶20～40份与药学可接受的辅料组成。
2.根据权利要求1所述的中药组合物，其特征在于所述各原料的重量份为：桃仁20～30份、茵陈40～50份、甜瓜蒂10～20份、胡芦巴20～30份和桑叶20～30份。
3.根据权利要求2所述的中药组合物，其特征在于所述各原料的重量份为：桃仁25份、茵陈45份、甜瓜蒂15份、胡芦巴25份和桑叶25份。
4.根据权利要求1～3任一项所述的中药组合物，其特征在于所述中药组合物是药剂学上允许的任何一种现代制剂。
5.根据权利要求4所述的中药组合物，其特征在于所述中药组合物由下述制备方法制备而成：
A、按重量配比称取的桃仁、茵陈、甜瓜蒂、胡芦巴和桑叶；
B、将胡芦巴和桃仁粉碎成粗粉，过筛，加入药材量3～8倍量的50％～80％乙醇回流提取1～3次，每次1～3小时，浓缩，过滤，滤液备用；
C、将茵陈、甜瓜蒂和桑叶加入5～10倍水煎煮2～3次，滤过，合并滤液，再加入B步所得滤液，滤液混合均匀后浓缩至相对密度为1.25～1.35的浓缩液，干燥得浸膏；
D、将C步所得浸膏加入相应的药物制剂用的辅料，按照常规药物制备方法得到相应的药物制剂。
6.根据权利要求5所述的中药组合物，其特征在于所述中药组合物由下述制备方法制备而成：
A、按重量配比称取的桃仁、茵陈、甜瓜蒂、胡芦巴和桑叶；
B、将胡芦巴和桃仁粉碎成粗粉，过筛，加入药材量5倍量的70％乙醇回流提取2次，第1次2小时，第2次1小时，浓缩，过滤，滤液备用；
C、将甜瓜蒂、茵陈和桑叶加入8倍水煎煮3次，滤过，合并滤液，再加入B步所得滤液，滤液混合均匀后浓缩至相对密度为1.30的浓缩液，干燥得浸膏；
D、将C步所得浸膏加入相应的药物制剂用的辅料，按照常规药物制备方法得到相应的药物制剂。
7.根据权利要求4所述的中药组合物，其特征在于所述中药组合物是胶囊剂。
8.根据权利要求7所述的中药组合物，其特征在于所述胶囊剂由下述方法制备而成：
按重量配比称取的桃仁、茵陈、甜瓜蒂、胡芦巴和桑叶；将胡芦巴和桃仁粉碎成粗粉，过筛，加入药材量5倍量的70％乙醇回流提取2次，第1次2小时，第2次1小时，，浓缩，过滤，所得滤液备用；另将甜瓜蒂、茵陈和桑叶加入8倍水煎煮3次，滤过，合并滤液；再加入上述所得胡芦巴和桃仁提取物滤液，滤液混合均匀后浓缩至相对密度为1.30得到浓缩液，干燥，加入相应的胶囊用的辅料，按照常规药物制备方法本发明胶囊剂。
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Application publication date: 20220118 |