CN102552828A - 一种护肝药物及其制备方法 - Google Patents
一种护肝药物及其制备方法 Download PDFInfo
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Abstract
本发明公开一种护肝药物，其包括以下重量份数的中药原料组分制成的：葛根1-20g、姜黄1-15g、厚朴1-15g、山楂1-20g、丹参1-20g、黄芪1-30g、酸枣仁1-10g、陈皮1-15g、茯苓1-15g、麦芽1-10g。本发明还提供所述药物的制备方法。本发明具有以下优点：药物能保护受损肝脏，改善肝脏功能，降低转氨酶，对多种因素引起的肝损伤有良好的预防和治疗作用。并对各种肝病引起的肝区胀痛、烦躁易怒、黄疸，口干口苦，小便赤黄，腹胀纳呆、嗳气吞酸、大便溏泄等症状有很好的改善作用。
Description
技术领域
本发明涉及一种护肝药物及其制备方法，属于中药技术领域。
背景技术
肝病是临床常见的危害人类健康的疾病，肝病时肝功能有不同程度的损害，肝脏解毒、排泄功能及贮备和再生能力降低，肝血流量减少，各种进入肝脏的药物使代谢负荷加重，从而发生内环境紊乱，进而造成肝损伤。
引起肝损伤病理因素众多，如病毒、生物、药物、酒精等，都可以导致肝损伤。据统计，目前临床应用的500-1000余种中西药物，均可引起不同程度的肝病。据报道，有20％的暴发性肝衰竭由药物引起。病毒性肝炎、肝硬化等肝病会使肝细胞通过旁分泌和自分泌的形式产生各种化学介质，从而导致免疫性肝损伤；不合理的用药会导致肝细胞中毒性损伤，近年来，药物性肝损伤呈上升趋势，其中以抗痨药物最常见，如利福平和异烟肼联用时肝损伤的发生率为82％。抗菌药物则引起的急性肝损伤，激素类药物及其代谢产物也能引起肝损伤。
目前肝损伤多以预防为主，当出现肝损伤临床表现时，肝脏受损程度多已较重。对于急性药物性肝损伤现代医学没有特效的治疗方法，多以提供休息饮食条件，促进肝细胞再生。中医药在肝损伤的治疗方面主要为对证治疗，根据不同证选用不同的治疗药物。现代研究发现很多中药能通过抑制MDA，减少TNF-α、NF-kB、IL-1等因子，调节免疫，提高抗氧化能力，而起到保肝护肝作用。
发明内容
本发明目的就是解决上述问题，按照中医药理论科学组方，采用现代提取、制剂工艺研制出一种具有改善肝功能、降低转氨酶的药物。中医认为肝为刚脏，喜条达，主藏血和疏泄。本发明结合肝的生理特性，以行气止痛、活血化瘀、健胃消食为主要功效用于治疗多种原因所致肝脏功能失调而出现的气滞血瘀、胸胁刺痛、食少纳呆等症状。现代药理研究证明处方中所选药物多具有改善肝功能的作用。这为利用该药物治疗肝损伤提供了现实基础。
本发明的目的还在于提供所述药物的制备方法。
本发明的护肝药物的重量份数组成如下：葛根1-20g、姜黄1-15g、厚朴1-15g、山楂1-20g、丹参1-20g、黄芪1-30g、酸枣仁1-10g、陈皮1-15g、茯苓1-15g、麦芽1-10g。
本发明植物饮料的主要成份包括：
葛根：异黄酮类、葛根苷类、三萜皂苷、生物碱等。
姜黄：倍半萜类、姜黄素类、多糖类。
厚朴：木脂素类、生物碱类、挥发油类等。
山楂：黄酮类、三萜类、甾体类、有机酸类等。
丹参：二萜醌类、酚酸类、黄酮类、甾醇类等。
黄芪：皂苷类、黄酮类、多糖类等。
酸枣仁：皂苷类、黄酮类、生物碱类、脂肪酸类等。
陈皮：黄酮类、挥发油类等。
茯苓：三萜类、多糖类等。
麦芽：淀粉酶、转化糖酶、酯酶、蛋白分解酶、蛋白质、维生素、大麦芽碱等。
本发明所述药物采用部分醇提部分水提，提取液浓缩后混匀。
本发明所述药物的具体制备方法是：葛根、姜黄、厚朴、山楂、丹参等5味药材加5-12倍量乙醇溶液提取1-3次，滤过，滤液回收乙醇并溶缩至规定相对密度；黄芪、酸枣仁、陈皮、茯苓、麦芽等5味药材加4-12倍量水煎煮1-3次，滤过，滤液浓缩至规定相对密度；将醇提浓缩液与水提溶缩混合均匀备用；取混合液按下列方法制成相应的固体和液体制剂。(1)固体制剂：取混合液继续溶缩成相对密度为1.25-1.35(60℃)的稠膏，将稠膏置≤75℃中干燥，干膏粉碎过100目筛，取干膏粉加入相应的稀释剂、黏合剂、助流剂、矫味剂等混合均匀，经制粒，灌装或压片制得。(2)液体制剂：取混合液加入适量水、矫味剂、防腐剂等经调配、过滤、灭菌、灌装制得。
本发明与现有技术相比，具有如下优点：
1、本发明所述药物组方紧密结合肝脏的中医学生理特性，同时参考所选药味的现代药理研究成果，采用现代提取、制剂技术加工而成，对多种因素引起的肝损伤具有显著的预防和治疗作用。
2、本发明所述药物以药食同源或可用于保健食品的中药为原料，制剂过程中所用辅料均可用于食品且用法用量符合国家有关规定，因而该药物具有明显的安全优势，可供具有肝损伤的隐患和存在肝损伤的人群长期使用。
3、本法明所述药物以中医药理论为指导，针对肝脏的生理特性组方，对由于肝藏血、疏泄功能失司所致的胸胁刺痛、烦躁易怒、舌质绛紫等症状有很好的治疗作用，同时又考虑到肝的功能失调多累及脾胃，故配以健脾消食药物以治疗腹胀纳呆、嗳气吞酸、大便溏泄等症状。
具体实施方式
实例1护肝颗粒
葛根12kg、姜黄9kg、厚朴6kg、山楂12kg、丹参10kg、黄芪9kg、酸枣仁6kg、陈皮9kg、茯苓6kg、麦芽9kg。
取葛根、姜黄、厚朴、山楂、丹参等5味药加10倍量70％乙醇回流提取2次，每次2小时，滤过，滤液合并回收乙醇并浓缩至相对密度为1.06-1.08(60℃)；取黄芪、酸枣仁、陈皮、茯苓、麦芽等5味药材加8倍量水煎煮2次，第一次2小时，第二次1小时，滤过，合并滤液并浓缩至相对密度为1.06-1.08(60℃)。将醇提浓缩液加入到水提液浓缩液中，混匀，继续浓缩成相对密度为1.30-1.35(60℃)的稠膏；取稠膏置75℃的烘箱中干燥至含水量在6％以下，并粉碎过100目筛得干膏粉；取干膏粉加入乳糖、麦芽糊精、甜菊糖苷、柠檬酸，混合均匀，加入80％乙醇制软材，于20目筛中制粒，干燥，整粒，灌装，即得。
实例2护肝口服液
葛根12kg、姜黄9kg、厚朴6kg、山楂12kg、丹参10kg、黄芪kg、酸枣仁6kg、陈皮9kg、茯苓6kg、麦芽9kg。
取葛根、姜黄、厚朴、山楂、丹参等5味药加10倍量70％乙醇回流提取2次，每次2小时，滤过，滤液合并回收乙醇并浓缩至相对密度为1.06-1.08(60℃)；取黄芪、酸枣仁、陈皮、茯苓、麦芽等5味药材加8倍量水煎煮2次，第一次2小时，第二次1小时，滤过，合并滤液并浓缩至相对密度为1.06-1.08(60℃)。将醇提浓缩液加入到水提浓缩液中，混合均匀，加入适量水、甜菊糖苷、柠檬酸、苯甲酸钠溶解后，静置12小时，滤过，滤液灌装，灭菌，即得。
实验研究
1、材料
1.1试验动物昆明种小鼠，体重20-25g，由广东省实验动物中心提供。
1.2药物及试剂：D-半乳糖胺盐酸盐(上海沪峰生化试剂有限公司)，受试药物：按实例1所述方法提取并浓缩至以生药量计2g/mL(高剂量)、1g/mL(中剂量)、0.5g/mL(低剂量)的药液；门冬氨酸氨基转移酶试剂盒(AsT)，丙氨酸氨基转移酶试剂盒(ALT)、微量丙二醛(MDA)测定试剂盒、还原型谷胱甘肽(GSH)测定试剂盒。
2、实验方法
2.1分组、给药与造模将试验动物随机分成空白对照组、模型组、高剂量组、低剂量组；空白组与模型组每天灌胃给予0.3mL/20g蒸馏水，给药组分别给以相应药物(0.3mL/20g)，持续14天；给药第13天，模型组和各给药组分别腹腔注射D-半乳糖胺盐酸盐(16mg/20g)造模，空白对照组腹腔注射生理盐水。
2.2方法给药14天后，动物开始禁食，12小时后实验动物称定体重，并眼眶取血，血样离心分离血清，按照试剂盒规定的方法测定ALT与AST含量；取血完成后处死动物，迅速摘取肝脏，用生理盐水洗涤血液，并用滤纸吸干，称定肝脏重量，计算肝脏系数；肝脏称重后迅速取肝右叶的一小块肝组织，加4℃生理盐水制成10％的肝匀浆。2000r/min离心10分钟，分取上清液，按试剂盒规定的方法测定丙二醛(MDA)和谷胱甘肽过氧化物酶(GSH-Px)的含量。
2.3数据处理统计学处理数据用均数±标准差表示，计量资料用t检验，用SPSS统计软件分析。
3、结果
3.1护肝药物的保肝作用实验结果显示，造模后模型组MDA、ALT、AST含量显著增加，而GSH-Px含量显著下降，与空白对照比较具有显著性差异(P＜0.01)，肝脏系数略有增加，但无显著性差异，表明造模成功；各给药治疗组对实验小鼠肝脏均有保护作用，其中以高剂量组最为明显，其MDA、GSH-Px、ALT、AST值与空白对照组一致均显著优于模型组(P＜0.01)；中剂量组的MDA、GSH-Px、ALT、AST含量介于模型组与空白对照组之间；低剂量组仅对ALT含量有显著改善作用(P＜0.05)。结果见表1、2。
表1 护肝药物对实验小鼠肝脏系数、MDA和GSH含量的影响。(n＝10)
与空白对照组比较，aP＜0.05，bP＜0.01；与模型组比较，cP＜0.05，dP＜0.01
表2 护肝药物对实验小鼠ALT、AST及肝脏系数的影响(n＝10)
与空白对照组比较，aP＜0.05，bP＜0.01；与模型组比较，cP＜0.05，dP＜0.01
3.2通过研究发现造模药物能破坏实验小鼠肝脏，但提前给药治疗后再给予造模药物则能减轻造模药物对实验小鼠肝脏的损伤，且呈现量效关系，当给药量达到高剂量(0.6g/20g)时则能拮抗造模药物对实验小鼠肝脏的损害作用。因而认为该护肝药物能保护肝脏，对肝损伤具有预防与治疗作用。
Claims (10)
1.一种护肝药物，其特征在于，包括以下重量份数的中药原料组成的：葛根1-20、姜黄1-15、厚朴1-15、山楂1-20、丹参1-20、黄芪1-30、酸枣仁1-10、陈皮1-15、茯苓1-15、麦芽1-10。
2.根据权利要求1所述的一种护肝药物，其特征在于，包括以下重量份数组分制成：葛根5-15、姜黄5-10、厚朴5-10、山楂5-15、丹参5-15、黄芪5-25、酸枣仁3-7、陈皮5-10、茯苓5-10、麦芽3-7。
3.根据权利要求1或2所述的一种护肝药物的制备方法，其特征在于，其包括的步骤如下：
(1)提取：按以上重量份数比例取葛根、姜黄、厚朴、山楂、丹参等5味药材并加入上述五种成分总重量5-12倍量的体积浓度为30-80％的乙醇溶液提取1-3次，滤液回收乙醇至无醇味并浓缩制得醇提清膏；
(2)其它组份的提取：按以上重量份数取黄芪、酸枣仁、陈皮、茯苓、麦芽等5味药材并加入上述五种成分总重量4-12倍量的水提取1-3次，滤过，合并滤液，滤液浓缩制得清膏；
(3)成品制备：将(2)步骤所得的醇提清膏与(3)步骤所得的清膏混合均匀；取混合液按下列方法制成相应的固体和液体制剂。1)固体制剂：取混合清膏继续浓缩至在60℃下规定相对密度为1.25-1.35的稠膏，将稠膏置≤75℃中干燥，干膏粉碎过100目筛，取干膏粉加入相应的稀释剂、黏合剂、助流剂、矫味剂等混合均匀，经制粒，灌装或压片制得。2)液体制剂：取混合液加入适量水、矫味剂、防腐剂等经调配、过滤、灭菌、灌装制得。
4.权利要求2所述稀释剂包括：糖粉、糊精、淀粉、乳糖、甘露醇、山梨醇、木糖醇等。
5.权利要求3所述黏合剂包括：海藻酸钠、羧甲基纤维素钠、交联聚维酮、淀粉浆、糖浆等。
6.权利要求3所述矫味剂包括：白砂糖、甜菊糖苷、三氯蔗糖、阿斯巴甜、甜蜜素、木糖醇等。
7.权利要求3所述助流剂包括：微粉硅胶、滑石粉、硬脂酸镁等。
8.权利要求3所述防腐剂包括：苯甲酸钠、山梨酸钾等。
9.权利要求3所述的固体制剂包括：胶囊剂、颗粒剂、片剂等。
10.权利要求3所述的液体制剂包括：口服液、糖浆剂等。
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| 郭海涛,王冠民，等: "郭书升治疗肝病用药经验", 《天津中医药》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106266811A (zh) * | 2016-10-27 | 2017-01-04 | 吉林省盛世华鑫生物科技有限公司 | 一种用于改善化学系肝损伤的中药组合物及其制备方法和应用 |
| CN106266811B (zh) * | 2016-10-27 | 2019-03-05 | 吉林省盛世华鑫生物科技有限公司 | 一种用于改善化学性肝损伤的中药组合物及其制备方法和应用 |
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|---|---|
| CN102552828B (zh) | 2014-02-26 |
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