CN112402565A - 一种益气活血、除湿消肿的中药组合物及其制备方法 - Google Patents
一种益气活血、除湿消肿的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域，具体涉及一种益气活血、除湿消肿的中药组合物及其制备方法。中药组合物由以下重量份的原料药组成：三七1‑10份、黄芪1‑10份、防己5‑20份、丹参1‑10份、芍药1‑10份、泽泻1‑10份、薏苡仁5‑20份、茯苓1‑10份、牛膝1‑10份。本发明的中药组合物治疗膝关节滑膜炎，标本兼治，效率高、无明显的毒副反应，处方运用灵活且费用低廉。
Description
技术领域
本发明属于中药领域，具体涉及一种益气活血、除湿消肿的中药组合物及其制备方法。
背景技术
急性膝关节滑膜炎为骨科的常见病，其定义为膝关节滑膜受到急性创伤或慢性劳损等刺激时引起滑膜损伤、破裂等，产生膝关节腔内积血或积液的一种非感染性炎症反应，临床表现以膝关节肿痛、皮温升高、关节活动受限、浮髌试验阳性为主。膝关节滑膜炎主要是因为多类疾病造成的炎症性反应，滑膜组织一般表现包括了水肿、充血、增生等病理性变化，最终造成膝关节部位疼痛、肿胀，关节腔内积液，从而很大程度上的制约膝关节的生理功能。
按照大量的临床研究结果表明，治疗方案有：(1)将膝关节的滑膜切开的切除术的临床疗效较为明显，然而还是具有较多的治疗不足，同时术后并发症发生率往往较高；(2)关节镜下膝关节滑膜清除术；(3)独活除湿汤可祛除风寒湿气；(4)采用改良火针、刺血拔罐术治疗；(5)通络灵酊剂透皮疗法治疗膝关节滑膜炎临床疗效显著，安全便利；(6)采用针灸、理疗结合中药外敷治疗；(7)滑膜炎颗粒联合红外线局部照射；(8)火针结合中药熏蒸治疗。
以上治疗方案均存在治疗有不适感，易发作及止痛效果差的缺点，在此治疗背景下，中药口服剂型对膝关节滑膜炎的疗效更显现出前所未有的新优势。
发明内容
本发明的目的就是针对现有技术存在的缺陷，利用中医药理论，进行辨证配伍组方，提供一种益气活血、除湿消肿的中药组合物及制备方法和用途。
本发明的第一个目的在于提供一种益气活血、除湿消肿的新的中药组合物，该组合物由以下原料药组成：
上述中药组合物由以下重量份的原料药组成：三七1-10份、黄芪1-10份、防己5-20份、丹参1-10份、芍药1-10份、泽泻1-10份、薏苡仁5-20份、茯苓1-10份、牛膝1-10份。
优选地，上述中药组合物由以下重量份的原料药组成：三七3-8份、黄芪6-10份、防己5-12份、丹参3-8份、芍药3-8份、泽泻3-8份、薏苡仁5-15份、茯苓4-8份、牛膝4-10份。
在一个具体的实施方案中，本发明的中药组合物由以下重量份的原料药组成：三七3份、黄芪10份、防己10份、丹参6份、芍药6份、泽泻6份、薏苡仁10份、茯苓6份、牛膝6份。
在一个具体的实施方案中，本发明的中药组合物由以下重量份的原料药组成：三七6份、黄芪8份、防己8份、丹参6份、芍药10份、泽泻8份、薏苡仁10份、茯苓8份、牛膝8份。
在一个具体的实施方案中，本发明的中药组合物由以下重量份的原料药组成：三七6份、黄芪10份、防己10份、丹参6份、芍药8份、泽泻5份、薏苡仁10份、茯苓4份、牛膝4份。
在一个具体的实施方案中，本发明的中药组合物由以下重量份的原料药组成：三七5份、黄芪10份、防己8份、丹参5份、芍药6份、泽泻6份、薏苡仁5份、茯苓4份、牛膝4份。
在一个具体的实施方案中，本发明的中药组合物中所述黄芪为生黄芪或炮制品，如炙黄芪或炒黄芪。
在一个具体的实施方案中，本发明的中药组合物中所述薏苡仁为生薏苡仁或炮制品。
在一个具体的实施方案中，本发明的中药组合物中所述牛膝为川牛膝、怀牛膝或其炮制品。
本发明中三七为君药，归肝、胃经，有散瘀止血，消肿定痛之功效，用于治疗咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹刺痛，跌扑肿痛等症；黄芪益气利水，防己利水消肿止痛，共为臣药；丹参、赤芍佐三七之活血利水，泽泻、薏苡仁、茯苓佐防己渗湿利水，共为佐药；牛膝引药下行，使诸药达于膝，为使药。以上诸药合用，共凑活血利水，消肿止痛之功，治疗膝骨关节炎有效。
黄芪
豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。性甘，微温。归肺、脾经。补气升阳，固表止汗，利水消肿，生津养血，行滞通痹，托毒排脓，敛疮生肌。用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，内热消渴，血虚萎黄，半身不遂，痹痛麻木，痈疽难溃，久溃不敛。
主要化学成分有黄酮类、多糖类、皂苷类、氨基酸类、以及多种微量元素(如Sc，Se，Cr，Mn，Co，C)、甾醇类物质、叶酸、亚麻酸、亚油酸、甜菜碱、胆碱、咖啡酸、香豆素、尼克酸、核黄素、维生素P、淀粉E等
药理作用：黄芪具有促进机体代谢，促进血清和肝脏蛋白质的更新，增强和调节机体免疫，增强心肌收缩功能，具有降血糖、抗肿瘤、抗疲劳、抗菌等作用。
三七
五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根和根茎。性甘、微苦，温。归肝、胃经。散瘀止血，消肿定痛。用于咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹刺痛，跌扑肿痛。
主要活性成分为黄酮类、皂苷、多糖、挥发油、无机离子与无机盐类、氨基酸、黄酮类、三七多糖、生物碱、抗菌蛋白糖类、聚炔醇类、瑙醇、三七素以及三七皂甙类等。最主要的活性成分是三七皂甙类，当前，已经从三七中分离提纯出近30种皂甙类成分，诸如Rb1，Rb2，Rc及F2等
药理作用：三七可用于治疗人体免疫系统、中枢神经系统、生殖与泌尿系统、消化系统以及循环系统等疾病。其药理作用主要包括以下几个方面：清咽润肺、镇痛作用、抗炎作用、保肝利胆功效、抗心律失常、促进造血功效、抗血栓、止血功效等。
丹参
唇形科植物丹参Salvia miltiorrhiza Bge.的干燥根和根茎。苦，微寒。归心、肝经。活血祛瘀，通经止痛，清心除烦，凉血消痈。用于胸痹心痛，脘腹胁痛，癥瘕积聚，热痹疼痛，心烦不眠，月经不调，痛经经闭，疮疡肿痛。
其主要化学成分有丹参酮、丹参酚酸类、挥发油及无机元素等。现代药理研究表明，丹参具有保护血管内皮细胞、抗心律失常、抗动脉粥样硬化、改善微循环等作用。
赤芍
毛茛科植物芍药Paeonia lactiflora PalL或川赤芍Paeonia veitchii Lynch的干燥根。性苦，微寒。归肝经。清热凉血，散瘀止痛。用于热入营血，温毒发斑，吐血衄血，目赤肿痛，肝郁胁痛，经闭痛经，癥瘕腹痛，跌扑损伤，痈肿疮疡。
赤芍含有芍药甙(paeoniflorin)、芍药内酯苷、没食子酸乙酯、熊果苷、芍药醇、氧化芍药苷、苯甲酸芍药苷、儿茶素、氧化芍药甙(oxy-paeoniflorin)、苯甲酰芍药甙(benzoylpaooniflorin)、β-谷甾醇-α-葡萄糖苷、白芍甙(albi-florin)、芍药甙无酮(paeoniflorigenone)、4-乙基-芍药苷、没食子酰芍药苷、没食子酰芍药甙(galloylpaeoniflorin)、芍药吉酮、芍药新苷、β-蒎-10-烯基-β-巢菜甙(z－1s，5R-β-pinen-10-yl-β-vicianoside)、芍药新甙(lacioflorin)、芍药内酯(paeoni-lactone)A、胡萝卜苷、山柰酚等成分。
药理作用：抗凝和抗血栓作用、降血脂和抗动脉硬化作用直接扩张冠脉作用、对烫伤大鼠的细动脉的收缩有明显的对抗作用、抗肿瘤作用等。
防己
防己科植物粉防己Stephania tetrandra S.Moore的干燥根。性苦，寒。归膀胱、肺经。祛风止痛，利水消肿。用于风湿痹痛，水肿脚气，小便不利，湿疹疮毒。
主要化学成分有多种生物碱，其中大部分是双苄基异喹啉类生物碱，包括粉防己碱(tetrandrine)，即汉防己甲素；防己诺林碱(fangchinoline)，即汉防己乙素；汉防己丙素(hanfangchin C)；门尼新碱(menisine)；门尼定(menisidine)和轮环藤酚碱(cyclanolin e)，亦含有小檗胺(berba-mine)、氧化防己碱(oxofangchirine)、防己菲碱(stephanthrine)等。其中，粉防己碱和防己诺林碱是公认的防己主要活性成分，也是药典中规定防己的指标性成分。除生物碱外，防己中还含有黄酮苷、酚类、有机酸、挥发油、糖类等。双苄基异喹啉类生物碱，包括粉防己碱、防己诺林碱等，现代药理学研究发现防己及其主要成分在抗炎、抗病原微生物、抗肿瘤、抗高血压、抗心律失常、抗心肌缺血、抗纤维化、抗矽肺、抑制瘢痕等方面均具有广泛的药理活性，应用前景广阔。
泽泻
为泽泻科植物泽泻Alisma orientale(Sam.)Juzep.的干燥块茎。性甘、淡，寒。归肾、膀胱经。利水渗湿，泄热，化浊降脂。用于小便不利，水肿胀满，泄泻尿少，痰饮眩晕，热淋涩痛，高脂血。主要化学成分为三萜类成分
药理作用：泽泻的药理作用集中在降血脂、降血压、降血糖、利尿、抗草酸钙结石、免疫调节与抗炎、抗氧化保护血管内皮等，近年发现泽泻还具有抗脂肪肝以及抗癌等功效。
薏苡仁
禾本科植物薏苡Coix lacryma-jobi L.var.ma-yuen(Roman.)Stapf的干燥成熟种仁。甘、淡，凉。归脾、胃、肺经。利水渗湿，健脾止泻，除痹，排脓，解毒散结。用于水肿，脚气，小便不利，脾虚泄泻，湿痹拘挛，肺痈，肠痈，赘疣，癌肿。包含多种有效成分薏苡仁油，糖类，矿物元素等。
茯苓
多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核，甘、淡，平。归心、肺、脾、肾经。利水渗湿，健脾，宁心。用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠。
茯苓的化学成分有萜类、多糖类、还有其他多种化合物，如甾醇、脂肪酸、树胶、卵磷脂、蛋白质等
药理作用：三萜类化合物具有抗肿瘤、抗炎、抗惊厥等药理作用，茯苓多糖的抗肿瘤和免疫调节功效一直是研究重点。
川牛膝
为苋科植物川牛膝Cyathula officinalis Kuan的干燥根。性甘、微苦，平。归肝、肾经。逐瘀通经，通利关节，利尿通淋。用于经闭癥瘕，胞衣不下，跌扑损伤，风湿痹痛，足痿筋挛，尿血血淋。
在一个具体的实施方案中，本发明的中药组合物，其中还包含可药用辅料，所述的药用辅料是本领域技术人员公知的。
本发明的中药组合物可以按本领域技术人员公知的技术制成各种常用剂型，比如片剂、颗粒剂、胶囊剂、丸剂、散剂、口服液体制剂，优选颗粒剂。
本发明的另一目的，是制备本发明的中药组合物的方法。
本发明中药组合物所含的有效成分可以这样制备：将上述原料药干燥研成粉末，混匀，得到有效成分。
本发明中药组合物所含的有效成分还可以这样制备：
方法一：将上述原料药水提，得所述中药组合物的有效成分；
方法二：将上述原料药醇提，得所述中药组合物的有效成分；
方法三：将上述原料药水提醇沉，得所述中药组合物的有效成分。
本发明中药组合物所含的有效成分的制备步骤中，
水提条件为：加所述原料药总重量的6-12倍量水提取2-3次，每次1-3小时；
醇提条件为：加所述原料药总重量的4-10倍量40-80％乙醇提取2-3次，每次1-3小时；
水提醇沉条件为：加所述原料药总重量的6-12倍量水提取2-3次，每次1-3小时，滤过，滤液浓缩至60-70℃时相对密度为1.15-1.20的清膏，加乙醇使含醇量达40-70％，静置。
本发明中药组合物所含的有效成分更优选下列步骤制备：
方法一：取所述原料药，混合后加水提取2-3次，每次加水量相当于药材总重量的6-12倍，每次提取时间为1-3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，得有效成分；
方法二：取所述原料药，混合后用40-80％乙醇回流提取2-3次，每次乙醇用量为该两味药材总量的4-10倍，提取时间为1-3小时，合并提取液，回收乙醇并浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，得有效成分；
方法三：取所述原料药，混合后加水提取2-3次，每次加水量相当于药材总重量的6-12倍，每次提取时间为1-3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.15-1.20的清膏，加入乙醇，使乙醇含量为40-70％，静置12-24小时，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，得有效成分。
制得的有效成分可以直接入药服用或可药用辅料按本领域技术人员公知的技术制备成所需制剂。
上述制备方法仅对本发明所提制法进行列举，但不应将此理解为本发明制备方法仅仅限于上述所列举方法。
本发明的第三个目的，是提供上述中药组合物用于制备预防或治疗膝关节炎的药物的应用。
优选地，上述中药组合物用于制备预防或治疗膝关节滑膜炎的药物的应用。
本发明中，如无特别说明，其中：
术语“水提”是指原料药水煮后取汁的过程。
术语“醇提”是指将原料药中有效成分溶解在乙醇溶液中，以提取出有效成分的过程。
术语“水提醇沉”是指原料药经水提后的水提液经过加乙醇达到不同含醇量，某些药物成分在醇中溶解度降低而析出沉淀，固液分离后使水提液得以精制的过程。
术语“有效成分”，是指原料药经提取之后起治疗作用的提取物的干燥粉末。
与现有技术相比，本发明具有以下有益效果：
1、本发明结合现代中药药理研究，以益气活血，除湿消肿为主，采用本发明的中药组合物治疗膝关节滑膜炎，标本兼治，效率高、无明显的毒副反应，处方运用灵活且费用低廉。
2、采用本发明的中药组合物制成口服制剂，疗效显著，且疗程短，使用便利，刺激性小。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述，但本领域技术人员将会理解，下列实施例仅用于说明本发明，而不应视为限定本发明的范围。实施例中未注明具体条件者，按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者，均为可以通过市购获得的常规产品。
实施例1-10本发明中药组合物的制备
实施例1
取三七3g、生黄芪10g、防己10g、丹参6g、赤芍6g、泽泻6g、生薏苡仁10g、茯苓6g、川牛膝6g，加水提取2次，每次加水量相当于九味药材总重量的6倍，每次提取时间为1小时，滤过，60℃浓缩至相对密度为1.20的清膏，干燥，粉碎成细粉，即得有效成分。
实施例2
取三七5g、生黄芪8g、防己10g、丹参6g、赤芍6g、泽泻8g、生薏苡仁5g、茯苓6g、川牛膝6g，加水提取3次，每次加水量相当于九味药材总重量的8倍，每次提取时间为1.5小时，滤过，60℃浓缩至相对密度为1.20的清膏，干燥，粉碎成细粉，即得有效成分。
实施例3
取三七6g、生黄芪10g、防己10g、丹参6g、赤芍8g、泽泻5g、生薏苡仁10g、茯苓4g、川牛膝4g，加水提取3次，每次加水量相当于九味药材总重量的8倍，每次提取时间为1.5小时，滤过，70℃浓缩至相对密度为1.25的清膏，干燥，粉碎成细粉，即得有效成分。
实施例4
取三七6g、生黄芪10g、防己10g、丹参6g、赤芍8g、泽泻5g、生薏苡仁10g、茯苓4g、川牛膝4g，混合后用70％乙醇回流提取2次，每次乙醇用量为药材总量的5倍，提取时间为1小时，合并提取液，过滤，滤液浓缩至70℃时相对密度为1.30的清膏，干燥，粉碎成细粉，即得有效成分。
实施例5
取三七5g、生黄芪6g、防己8g、丹参5g、赤芍6g、泽泻6g、生薏苡仁10g、茯苓4g、川牛膝4g，混合后用80％乙醇回流提取3次，每次乙醇用量为药材总量的8倍，提取时间为1小时，合并提取液，过滤，滤液浓缩至65℃时相对密度为1.25的清膏，干燥，粉碎成细粉，即得有效成分。
实施例6
取三七5g、生黄芪10g、防己8g、丹参5g、赤芍6g、泽泻6g、生薏苡仁5g、茯苓4g、川牛膝4g，混合后用40％乙醇回流提取2次，每次乙醇用量为药材总量的10倍，提取时间为1小时，合并提取液，过滤，滤液浓缩至70℃时相对密度为1.20的清膏，干燥，粉碎成细粉，即得有效成分。
实施例7
取三七8g、生黄芪8g、防己12g、丹参10g、赤芍4g、泽泻4g、生薏苡仁12g、茯苓8g、川牛膝8g，加水提取2次，每次加水量相当于九味药材总重量的12倍，每次提取时间为3小时，滤过，60℃浓缩至相对密度为1.25的清膏，干燥，粉碎成细粉，即得有效成分。
实施例8
取三七10g、生黄芪10g、防己15g、丹参8g、赤芍8g、泽泻8g、生薏苡仁15g、茯苓8g、川牛膝10g，混合后用60％乙醇回流提取3次，每次乙醇用量为药材总量的4倍，提取时间为1小时，合并提取液，过滤，滤液浓缩至70℃时相对密度为1.20的清膏，干燥，粉碎成细粉，即得有效成分。
实施例9
取三七3g、生黄芪8g、防己8g、丹参3g、赤芍3g、泽泻3g、生薏苡仁8g、茯苓6g、川牛膝8g，加水提取3次，每次加水量相当于九味药材总重量的8倍，每次提取时间为3小时，滤过，70℃浓缩至相对密度为1.20的清膏，干燥，粉碎成细粉，即得有效成分。
实施例10
取三七6g、生黄芪8g、防己8g、丹参6g、赤芍10g、泽泻8g、生薏苡仁10g、茯苓8g、川牛膝8g，混合后用70％乙醇回流提取3次，每次乙醇用量为药材总量的8倍，提取时间为1小时，合并提取液，过滤，滤液浓缩至70℃时相对密度为1.30的清膏，干燥，粉碎成细粉，即得有效成分。
试验例：本发明所述组合物对膝关节创伤性滑膜炎的治疗作用
1、实验动物、药物与仪器
1.1实验动物
新西兰大白兔，普通级：体重2.5-2.8kg，雌雄各半，动物年龄3-4月龄，购自北京市昌平西山养殖场；许可证编号：SCXK(京)2014-0004。
动物房：试验期间动物饲养于北京盈科瑞药物安全有效性研究有限公司，实验设施许可证：SYXK(京)2017-0026；设施管理遵循中华人民共和国国家标准GB14925-2001《实验动物环境及设施》。
喂养条件：采用人工光照12小时明暗周期，环境温度维持在20～24℃，湿度在40％～70％，每小时换气15次；动物饲养于不锈钢家兔饲养笼，每笼饲养1只家兔；每天清洁一次动物笼和垫料。
饲料：兔维持饲料，批号：19034221，北京科澳协力饲料有限公司，每天上午进行一次全面的补料，其它时间根据剩料多少而补料。
饮用水：试验动物饮用水，动物可自由摄取，每日更换新的水瓶和新鲜水。
1.2药物
应用本发明实施例的处方进行实验研究。按照实施例1、实施例4的处方和制备方法将原料药得到的有效成分配置成浓缩液。
阳性对照品：塞来昔布胶囊(辉瑞制药有限公司)。
本实验中人类体重按照70kg计算，大白兔体重按照2.5kg计算，按照体表面积则算后各组大鼠给予对应受试物剂量见下表1。
表1：阳性对照品及受试物的等效剂量换算
其中，中剂量临床剂量折算家兔给药剂量换算方式如下：
70kg的人体表面积＝0.1057×702/3＝1.7953m2
2.5kg的家兔的体表面积＝0.1014×2.52/3＝0.0639m2
本药物人的使用剂量为5.67g生药/kg，即药物的使用剂量为221.0773g生药/m，家兔的使用剂量为5.65g生药/kg。
1.3仪器与试剂
仪器：电子天平：YP30002，上海越平仪器仪表有限公司；
分析天平：CPA225D，赛多利斯；
超纯水系统：Milli-Q Reference A+法国Millipore SAS；
病理取材台：OML-QCA湖北欧美莱医疗科技有限公司。
试剂和药品：
3％戊巴比妥钠，生产厂家，北京华业寰宇化工有限公司；
0.9％氯化钠注射液，100ml/瓶，石家庄四药有限公司。
2、实验方法
将新西兰大白兔按数字随机表法分为9组，每组12只。
分为正常对照组、模型对照组、塞来昔布胶囊组、本发明实施例1和4的低剂量组、中剂量组、高剂量组。将其固定后3％戊巴比妥钠按1ml/kg由耳缘静脉推注深度麻醉，将兔侧卧于试验台上，造模肢朝上，褪毛，用针灸针垂直刺入兔后肢股四头肌中点和腓肠肌中点，连接电针仪，通电，频率50hz，强度1.5kPa，使其膝关节不停地被动屈伸，每天2次，共10天。造模24h后各组家兔均采用每日1次、连续2周的灌胃给药。末次给药24h后，家兔戊巴比妥钠过量麻醉，膝关节注射生理盐水1ml，回抽关节液，-80℃低温冷冻保存。打开关节，取出滑膜组织，固定、切片、HE染色观察，镜下观察滑膜组织、膝关节软骨面和细胞结构等病理组织学变化并拍片。
评分标准如下：
0级：滑膜完整，细胞排列整齐，无充血水肿，无炎性细胞浸润；关节软骨完整，无剥离，无坏死；潮线清晰可见。
Ⅰ级：滑膜血管充血水肿，表层细胞增生；骨膜增生，骨质疏松；潮线间断。
Ⅱ级：滑膜细胞显著增生，滑膜内血管增生，肉芽组织形成；关节软骨糜烂；潮线消失。
Ⅲ级：滑膜内肉芽组织纤维化；关节软骨有灶性坏死。
表2本发明对膝关节创伤性滑膜炎的作用病理学评分
“&”与假手术组(G1)比较p＜0.05；“&&”与假手术组(G1)比较p＜0.05
“＊”与模型对照组(G2)比较p＜0.05；“＊＊与模型对照组比较p＜0.01
从上表2可以看出，与正常对照组相比，模型对照组在膝关节创伤性滑膜炎均具有统计学意义的差异。与模型对照组相比，阳性对照组和实施例组均具有治疗膝关节创伤性滑膜炎的作用。
Claims (7)
1.一种益气活血的中药组合物，其特征在于，所述组合物由以下重量份的原料药组成：三七1-10份、黄芪1-10份、防己5-20份、丹参1-10份、芍药1-10份、泽泻1-10份、薏苡仁5-20份、茯苓1-10份、牛膝1-10份。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物由以下重量份的原料药组成：三七3-8份、黄芪6-10份、防己5-12份、丹参3-8份、芍药3-8份、泽泻3-8份、薏苡仁5-15份、茯苓4-8份、牛膝4-10份；
优选地，所述中药组合物由以下重量份的原料药组成：三七3份、黄芪10份、防己10份、丹参6份、芍药6份、泽泻6份、薏苡仁10份、茯苓6份、牛膝6份；
优选地，所述中药组合物由以下重量份的原料药组成：三七6份、黄芪8份、防己8份、丹参6份、芍药10份、泽泻8份、薏苡仁10份、茯苓8份、牛膝8份；
优选地，所述中药组合物由以下重量份的原料药组成：三七6份、黄芪10份、防己10份、丹参6份、芍药8份、泽泻5份、薏苡仁10份、茯苓4份、牛膝4份；
优选地，所述中药组合物由以下重量份的原料药组成：三七5份、黄芪10份、防己8份、丹参5份、芍药6份、泽泻6份、薏苡仁5份、茯苓4份、牛膝4份。
3.根据权利要求1或2所述的中药组合物，其特征在于，所述黄芪为生黄芪或炮制品；所述芍药为赤芍或白芍或其炮制品；所述薏苡仁为生薏苡仁或炮制品；所述牛膝为川牛膝、怀牛膝或其炮制品。
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，所述中药组合物的剂型为片剂、颗粒剂、胶囊剂、丸剂、散剂或口服液体制剂。
5.一种制备权利要求1-4任一项所述中药组合物的方法，其特征在于，将所述原料药干燥研成粉末，混匀，得到有效成分；或将所述原料药水提或醇提或水提醇沉；任选的按技术人员公知的技术制成制剂。
6.根据权利要求5所述的制备方法，其特征在于，其中，
水提条件为：加所述原料药总重量的6-12倍量水提取2-3次，每次1-3小时；
醇提条件为：加所述原料药总重量的4-10倍量40-80％乙醇提取2-3次，每次1-3小时；
水提醇沉条件为：加所述原料药总重量的6-12倍量水提取2-3次，每次1-3小时，滤过，滤液浓缩至60-70℃时相对密度为1.15-1.20的清膏，加乙醇使含醇量达40-70％，静置。
7.根据权利要求5或6所述的制备方法，其特征在于,如下1)至3)中的一项：
1)取所述原料药，混合后加水提取2-3次，每次加水量相当于药材总重量的6-12倍，每次提取时间为1-3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，得有效成分；
2)取所述原料药，混合后用40-80％乙醇回流提取2-3次，每次乙醇用量为该两味药材总量的4-10倍，提取时间为1-3小时，合并提取液，回收乙醇并浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，得有效成分；
3)取所述原料药，混合后加水提取2-3次，每次加水量相当于药材总重量的6-12倍，每次提取时间为1-3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.15-1.20的清膏，加入乙醇，使乙醇含量为40-70％，静置12-24小时，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，得有效成分。
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| CN101732618A (zh) * | 2008-11-11 | 2010-06-16 | 张家口长城药业有限责任公司 | 一种治疗滑膜炎的药物及制备工艺 |
| CN104096130A (zh) * | 2014-07-15 | 2014-10-15 | 上海中医药大学附属岳阳中西医结合医院 | 一种治疗类风湿关节炎的中药组合物 |
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