CN103550740B - 一种治疗黄疸型肝炎的中药组合物及其应用 - Google Patents
一种治疗黄疸型肝炎的中药组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种治疗黄疸型肝炎的中药组合物，涉及中药技术领域。其由如下重量份的中药材制备而成：茯苓25-35份、附子25-35份、丹参16-22份、川芎16-22份、黄芪16-22份、干姜10-16份、白茅根18-26份、大青叶18-26份、板蓝根18-26份、紫花地丁20-25份、甘草8-14份。本发明的中药组合物清热解毒，活血化瘀，健脾益气养阴，利胆退黄，兼顾全身，提高机体免疫力，配合西药治疗黄疸型肝炎的疗效显著。
Description
技术领域
本发明涉及一种治疗黄疸型肝炎的中药组合物，属于中药技术领域。
背景技术
黄疸型肝炎患者肝细胞损伤，肝内循环障碍，血液黏稠度高，血管紧张素Ⅱ增加，肝脏亚微结构改变，使毛细胆管内胆汁流动不畅，胆汁瘀积。TBil超过171 μmol/L，黄疸深，持续时间长，不易消退，常规护肝、利胆退黄，只是治标不治本，效果不满意。
发明内容
本发明根据传统中医理论，经过对药物组分的大量筛选、重组、尝试、又通过大量动物实验研究作出的。因此，本发明的目的在于提供了一种更加安全可靠的治疗黄疸型肝炎的中药组合物及其应用。
本发明的目的是这样实现的：
本发明一种治疗黄疸型肝炎的中药组合物，由如下重量份的中药材原料制备而成：茯苓25-35份、附子25-35份、丹参16-22份、川芎16-22份、黄芪16-22份、干姜10-16份、白茅根18-26份、大青叶18-26份、板蓝根18-26份、紫花地丁20-25份、甘草8-14份。
优选地，如上所述的治疗黄疸型肝炎的中药组合物，由如下重量份的中药材原料制备而成：茯苓28-32份、附子28-32份、丹参18-20份、川芎18-20份、黄芪18-20份、干姜12-14份、白茅根20-23份、大青叶20-23份、板蓝根20-23份、紫花地丁22-24份、甘草10-12份。
在本发明一个最优选的实施例中，其由如下重量份的中药材原料制备而成：茯苓30份、附子30份、丹参20份、川芎20份、黄芪20份、干姜12份、白茅根22份、大青叶22份、板蓝根22份、紫花地丁24份、甘草10份。
进一步优选地，所述的治疗黄疸型肝炎的中药组合物是口服制剂。
再进一步优选地，所述的治疗黄疸型肝炎的中药组合物是口服液、颗粒剂、片剂或胶囊剂。
通过大量临床试验研究发现，由上述中药材原料制备而成的药物组合物在治疗黄疸型肝炎方面具有显著的疗效，尤其特别适合重度黄疸型肝炎。因此，本发明的第二个目的在于提供一种医药新用途，即上述的中药组合物在制备治疗黄疸型肝炎的药物中的应用。
根据中医药史料记载，上述中药材原料具有如下药理活性和功能主治：
茯苓：具有渗湿利水，健脾和胃，宁心安神的功效。可治小便不利，水肿胀满，痰饮咳逆，呕逆，恶阻，泄泻，遗精，淋浊，惊悸，健忘等症。选用多孔菌科真菌茯苓Poria cocos （Schw.）Wolf 的干燥菌核。
附子：回阳救逆，补火助阳，散寒止痛。主治：用于阴盛格阳，大汗亡阳，吐泻厥逆，肢冷脉微，心腹冷痛，冷痢，脚气水肿，风寒湿痹，阳痿，宫冷，虚寒吐泻，阴寒水肿，阳虚外感，阴疽疮疡以及一切沉寒痼冷之疾。选自毛茛科植物乌头Aconitum carmichaelii Debx.的子根的加工品。
丹参：活血调经，祛瘀止痛，凉血消痈，清心除烦，养血安神。主治月经不调，经闭痛经， 症瘕积聚，胸腹刺痛，热痹疼痛，疮疡肿痛，心烦不眠；肝脾肿大，心绞痛。选自双子叶植物唇形科 Labiatae鼠尾草属植物丹参 Salvia miltiorrhiza Bge. 的干燥根及根茎。
川芎：活血行气，祛风止痛。用于安抚神经，正头风头痛，症瘕腹痛，胸胁刺痛，跌扑肿痛，头痛，风湿痹痛。选用伞形科植物川芎的根茎。
黄芪：有益气固表、敛汗固脱、托疮生肌、利水消肿之功效。用于治疗气虚乏力，中气下陷，久泻脱肛，便血崩漏，表虚自汗，痈疽难溃，久溃不敛，血虚萎黄，内热消渴，慢性肾炎，蛋白尿，糖尿病等。炙黄芪益气补中，生用固表托疮。
干姜：温中散寒，回阳通脉，燥湿消痰，温肺化饮。主治脘腹冷痛；呕吐；泄泻，亡阳厥逆；寒饮喘咳；寒湿痹痛。选用姜科植物姜Zingiber officinale Rosc.的干燥根茎。
白茅根：凉血，止血，清热，利尿。治热病烦渴，吐血，衄血，肺热喘急，胃热哕逆，淋病，小便不利，水肿，黄疸。选用禾本科植物白茅 Imperata cylindrical (L.) Beauv. var. major (Nees) C. E. Hubb. 的干燥根茎。
大青叶：清热，解毒，凉血，止血。治温病热盛烦渴，流行性感冒，急性传染性肝炎，菌痢，急性胃肠炎，急性肺炎，丹毒，吐血，衄血，黄疸，痢疾，喉痹，口疮，痈疽肿毒。选用十字花科植物菘蓝 Isatis indigotica Fort. 的干燥叶。
板蓝根：清热，解毒，凉血，利咽。主治：温毒发斑；高热头痛；大头瘟疫；舌绛紫暗，烂喉丹痧；丹毒；痄腮；喉痹；疮肿、痈肿；水痘；麻疹；肝炎；流行性感冒，流脑，乙脑，肺炎，神昏吐衄，咽肿，火眼，疮疹；可防治流行性乙型脑炎、急慢性肝炎、流行性腮腺炎、骨髓炎。选用十字花科植物菘篮和草大青的根。
紫花地丁：清热解毒，凉血消肿。主治黄疸、痢疾、乳腺炎、目赤肿痛、咽炎；外敷治跌打损伤、痈肿、毒蛇咬伤等。选用紫花地丁的干燥全草。
甘草：补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。选用为双子叶植物豆科 Leguminosae甘草 Glycyrrhiza uralensis Fisch. ，胀果甘草 G. inflata Bat.， 或光果甘草 G. glabra L. 的根及根茎。
将上述各中药材制备成本发明的复方口服液的制备方法，包括如下步骤：称取清洗干净且干燥的药材合并，加水煎煮两次，合并煎液，减压浓缩至70℃时相对密度为1.15-1.20，加乙醇使含醇量的体积百分比达75-85%，搅拌，静置，过滤，滤液减压浓缩至70℃时相对密度为1.25-1.30并回收乙醇得浓缩液，将浓缩液加水及辅料配制成口服液。
与现有技术相比，本发明的中药组合物清热解毒，活血化瘀，健脾益气养阴，利胆退黄，兼顾全身，提高机体免疫力，配合西药治疗黄疸型肝炎的疗效显著，达到了西药治标中药治本的目的，效果满意。
具体实施方式
下面通过实施例进一步说明本发明。本发明的实施例仅仅是用于说明本发明，而不是对本发明的限制，在本发明的构思前提下对本发明制备方法的简单改进都属于本发明要求保护的范围。
实施例1
生药处方：茯苓30份、附子30份、丹参20份、川芎20份、黄芪20份、干姜12份、白茅根22份、大青叶22份、板蓝根22份、紫花地丁24份、甘草10份。
制备方法：称取上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达75%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，加水及蔗糖配制成口服液。
实施例2
生药处方：茯苓25份、附子33份、丹参22份、川芎16份、黄芪22份、干姜16份、白茅根18份、大青叶25份、板蓝根20份、紫花地丁22份、甘草14份。
制备方法：称取上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，加水及蔗糖配制成口服液。
实施例3
生药处方：茯苓32份、附子26份、丹参16份、川芎20份、黄芪16份、干姜12份、白茅根26份、大青叶18份、板蓝根26份、紫花地丁25份、甘草10份。
制备方法：称取上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.20，加95%(v/v)乙醇使含醇量达80%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，加水及蔗糖配制成口服液。
实施例4 本发明中药组合物对重度黄疸型肝炎患者的影响
中药样品制备：称取茯苓30份、附子30份、丹参20份、川芎20份、黄芪20份、干姜12份、白茅根22份、大青叶22份、板蓝根22份、紫花地丁24份和甘草10份，将上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达75%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，即可。
52例患者，男34例，女18例，年龄最小17岁，最大60岁，病程最短2d，最长16d。所有患者诊断均符合2000年西安会议修订的病毒性肝炎防治诊断标准，并伴有谷丙转氨酶(ALT)升高，血清总胆红素(TBil)超过171μmol/L。所有患者随机分为对照组(26例)和中药组(26例)，两组在性别、年龄、病程等方面没有显著性差异。
对照组单纯西药治疗，即甘利欣200mg/d，门冬氨酸鸟氨酸2.5g/d对症护肝，15d为1个疗程，连续用药2个疗程。根据肝功能情况及时调整用药剂量。中药组在对照组基础上加上述中药治疗，患者每日早晚口服20mL，连续服用一个月。治疗结束后，按如下疗效评定标准统计治疗结果：
显效：主要症状消失，肝功能正常，TBil恢复到17.1μmol/L以下；
有效：主要症状明显好转，TBil降至治疗前的1/3～1/2，ALT、r-GT明显降低；
无效：症状体征无改善，肝功能无变化，甚至病情加重。
表1 两组患者总体疗效比较
通过本实验可以看出，本发明中西药结合治疗重度黄疸型肝炎，标本兼治，总有效率达到88.5％，效果满意，值得临床上推广。
Claims (4)
1.一种治疗黄疸型肝炎的中药组合物，其特征在于：所述的中药组合物由如下重量份的中药材原料制备而成：茯苓30份、附子30份、丹参20份、川芎20份、黄芪20份、干姜12份、白茅根22份、大青叶22份、板蓝根22份、紫花地丁24份、甘草10份。
2.根据权利要求1所述的治疗黄疸型肝炎的中药组合物，其特征在于：所述中药组合物为口服制剂。
3.根据权利要求2所述的治疗黄疸型肝炎的中药组合物，其特征在于：所述中药组合物为口服液、颗粒剂、片剂或胶囊剂。
4.权利要求1所述的治疗黄疸型肝炎的中药组合物在制备治疗黄疸型肝炎的药物中的应用。
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