CN117427140A - 一种治疗类风湿关节炎疼痛的中药组合物及其应用 - Google Patents
一种治疗类风湿关节炎疼痛的中药组合物及其应用 Download PDFInfo
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Abstract
本发明属于中药领域,具体涉及一种治疗类风湿关节炎疼痛的中药组合物及其应用,所述中药组合物包括以下重量份的原料药:桂枝10‑25份,白芍10‑25份,甘草5‑25份,生姜10‑30份,大枣15‑30份,人参10‑30份,当归10‑30份,巴戟天10‑30份,麦冬10‑30份。临床观察结果表明,本发明的中药组合物能显著降低类风湿关节炎患者的疼痛VAS评分、SJC28、DAS28‑CRP总分。由此表明,本发明的中药组合物能有效改善类风湿关节炎患者的疼痛程度、缓解关节重症和关节活动度。
Description
技术领域
本发明属于中药领域,具体涉及一种治疗类风湿关节炎的中药组合物及其应用。
背景技术
类风湿关节炎(Rheumatoid Arthritis,RA)是一种慢性、系统性的自身免疫性疾病,主要表现为关节炎症、疼痛、肿胀和功能障碍。这种疾病不仅影响患者的身体健康,还对其心理和社会生活造成严重影响。类风湿关节炎对社会的影响是多方面的,除了疼痛会导致患者的劳动能力下降,甚至丧失劳动能力之外,由于疾病的慢性和进行性,患者往往需要长期治疗和休养,不能正常工作,这给社会和家庭带来了经济负担。此外,由于疼痛和关节功能障碍,患者可能无法参与正常的社交活动,导致社交隔离和心理健康问题。类风湿关节炎疼痛不仅对患者个人造成了身体和心理上的痛苦,也对社会产生了经济、劳动力和精神等方面的负面影响。因此,加强对类风湿关节炎的研究和治疗,有助于提高患者的生活质量,减轻社会的负担。
目前,药物治疗是类风湿关节炎核心的治疗措施,使用非甾体抗炎药控制疼痛减轻炎症,糖皮质激素也可以用于控制炎症反应,抗风湿药物、小分子靶向药改善病情并延缓关节破坏的进展,但服药过程中出现的不良反应一直是该类治疗方案所面对的难点,如胃肠道不适、免疫系统抑制等。中医注重整体,综合调理,治病求本,在治疗类风湿关节炎疼痛上有一定的优势。类风湿关节炎在中医中属于“痹证”范畴,主要由于风、寒、湿、热、痰、瘀等邪气滞留关节,导致经络痹阻、气血运行不畅。类风湿关节炎的中医病机主要分为虚证和实证,早期以实证为主,晚期则虚证或虚实并见。类风湿关节炎心肾两虚、气血失和证型的病人常常出现怕风怕冷、手脚凉、精神疲倦、入睡困难、易醒醒后难入睡等不适,目前对于该类证型的类风湿关节炎患者尚缺乏有效的中药治疗。
发明内容
本发明的第一个目的,在于提供一种治疗类风湿关节炎疼痛的中药组合物;本发明的第二个目的,在于提供该中药组合物的制备方法;第三个目的,在于提供该中药组合物的应用。
根据本发明的第一个方面,提供了一种治疗类风湿关节炎疼痛的中药组合物,包括以下重量份的原料药:桂枝10-25份,白芍10-25份,甘草5-25份,生姜10-30份,大枣15-30份,人参10-30份,当归10-30份,巴戟天10-30份,麦冬10-30份。
本发明根据《内经》人体营卫理论,气血理论理论与五脏相互资生关系,结合近年来类风湿关节炎的研究成果,认为类风湿关节炎的核心病机在于风寒湿等外邪侵袭,导致经络痹阻、营卫气血失和,心肾两虚,治疗的关键是通过温阳散寒、调和营卫、调畅气血、交通心肾,从而改善人体类风湿关节疼痛。
本方以足少阴经药巴戟天和手少阴经药人参为君药。巴戟天甘温,补其火而又不烁其水,水火并补,从釜底鼓动元阳,温助阳气以驱散寒邪。人参味甘、微苦,性微温,入手少阴经,补五脏,大补元气,益气养血。巴戟天、人参分别入心肾,一上一下,一南一北,交通心肾。臣以白芍、桂枝辅助君药,桂枝温通经脉,白芍养血柔肝,两药合用,起到调和营卫,配合巴戟天起到温阳散寒之功效;同时臣以麦冬、当归,麦冬养阴生津,当归补血活血,配合人参,调畅周身气血循环,佐以生姜、甘草、大枣枢转中焦气机,使得升降协调,四维轮转才能和缓有序,并能充养津液、行脾胃之津液而和营卫也。君、臣、佐、使各司其职,以守中为本,调节阴阳、气血、寒热、虚实的偏颇状态。全方具有温阳散寒、调和营卫、调畅气血、交通心肾的功效。
本方的原料来源如下:
桂枝:樟科植物肉桂Cinnamomum cassia Presl的干燥嫩枝。归心、肺、膀胱经。辛、甘,温。
白芍:毛茛科植物芍药Paeonia lactiflora Pall.的干燥根。归肝、脾经。苦、酸,微寒。
甘草:豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhizainflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根。归心、肺、脾、胃经。甘,平。炙甘草为甘草的炮制加工品,炮制方法可以为:取净甘草片,加入炼熟的蜂蜜与少许开水,拌匀后稍闷,炒至黄色至深黄色,不粘手时取出,晾凉。
生姜:姜科植物姜Zingiber officinale Rosc.的新鲜根茎。归肺、脾、胃经。辛,微温。
大枣:鼠李科枣属植物枣Ziziphus jujuba Mill.var.inermis(Bunge)Rehd.的干燥成熟果实。归脾、胃经。甘,温。
人参:五加科植物人参Panax ginseng C.A.Mey.的干燥根,栽培者为“园参”,园参经晒干或烘干,称“生晒参”。归脾、肺、心经。甘、微苦,平。
当归:伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根。归肝、心、脾经。甘、辛,温。
巴戟天:茜草科植物巴戟天Morinda officinalis How的干燥根。归肾、肝经。甘,辛,微温。
麦冬:百合科植物麦冬(沿阶草)Ophiopogon japonicus(Thunb.)Ker-Gawl.的干燥块根。归心、肺、胃经。甘,微苦,微寒。
在一些实施方式中,以包括以下重量份的原料药:桂枝15份,白芍15份,甘草12份,生姜18份,大枣18份,人参10份,当归15份,巴戟天15份,麦冬10份。
在一些实施方式中,人参为生晒参,甘草为炙甘草。生晒参药性比较平和,且三萜皂苷的含量远高于新鲜人参。炙甘草味道偏甜,性偏温,健脾益气、温中补虚作用更强。
在一些实施方式中,还包括医学上可接受的辅料。具体地,所用辅料为本领域常用的载体或赋形剂,包括但不限于淀粉、乳糖、葡萄糖、羧甲基纤维素钠、乙基纤维素、甲基纤维素、麦芽、明胶、多元醇(如丙二醇、甘油、甘露糖醇)、压片剂等,以帮助提高药物的稳定性或提高活性,或在口服情况下产生可接受的口感或气味。
在一些实施方式中,所述中药组合物的剂型为汤剂、片剂、胶囊剂、颗粒剂、口服液或滴丸剂。由此,以方便临床给药。
根据本发明的第二个方面,提供了上述所述的治疗类风湿关节炎疼痛的中药组合物的制备方法,所述中药组合物为颗粒剂,其制备方法包括以下步骤:
将各原料药按配比混合后进行水提,将水提取物浓缩、干燥、过筛混匀后制成颗粒即得。
在一些实施方式中,所述过筛的筛网为80目,所述颗粒为12-40目。
在一些实施方式中,其制备方法包括以下步骤:将各原料药按配比混合,加8-10倍重量份的水,水提两次,合并水提液,浓缩至1.08-1.10克药/mL,干燥、过80目筛后混匀,干法制粒制成12-40目颗粒。
当中药组合物为汤剂时,其制备方法包括以下步骤:
将各原料药按配比混合,加8-10倍重量份的水煎煮30-40分钟,滤出药汁即得。
当中药组合物为片剂、胶囊剂、口服液或滴丸剂时,其制备方法包括以下步骤:
将各原料药按配比混合,加8-10倍重量份的水,水提两次,合并水提液,浓缩至1.08-1.10克药/mL,添加辅料,按照本领域的常规方法制成相应剂型,即得。
根据本发明的第三个方面,提供了上述所述的治疗类风湿关节炎疼痛的中药组合物在制备治疗类风湿关节炎疼痛的药物中的应用。
在一些实施方式中,所述类风湿关节炎是中医辨证为心肾两虚、气血失和的病机。本发明所称的心肾两虚、气血失和的类风湿关节炎疼痛指符合1987年美国风湿病学会(ACR)修订的类风湿关节炎分类标准,同时具有怕冷或怕风、白天精神疲乏、心悸或头晕、下眼睑淡白或夹边红、月经量少、手凉等症状。
当治疗类风湿关节炎疼痛的中药组合物为汤剂时,给予患者每日一剂,分2次口服,每次约200mL。一剂药量是指将所述治疗类风湿关节炎疼痛的中药组合物的各原料药按一次的用量(如:桂枝15克,白芍15克,甘草12克,生姜18克,大枣18克,人参10克,当归15克,巴戟天15克,麦冬10克)加水煎煮后得到的滤液量。制得中药汤剂后,可以根据实际需要对中药汤剂进行浓缩得到中药口服液。
当治疗类风湿关节炎疼痛的中药组合物为片剂、胶囊剂、颗粒剂或滴丸剂时,比如生产1000克颗粒剂,可以采用桂枝15克,白芍15克,甘草12克,生姜18克,大枣18克,人参10克,当归15克,巴戟天15克,麦冬10克,其余为辅料,给药量换算为饮片剂量给予冲服。
本发明的有益效果包括:
(1)本发明的中药组合物用于临床已有十余年,经临床观察结果表明,本发明的中药组合物能有效降低类风湿关节炎疼痛患者的疼痛VAS评分、SJC28、DAS28-CRP总分。由此表明,本发明的中药组合物能够缓解类风湿关节炎疼痛。
(2)本发明的中药组合物具有温阳散寒、调和营卫、调畅气血、交通心肾的功效,主治中医辨证为心肾两虚、气血失和的类风湿关节炎。
附图说明
图1是本发明真实世界研究中治疗前后疼痛VAS评分比较结果。
图2是本发明真实世界研究中治疗前后DAS28-CRP总分比较结果。
图3是本发明真实世界研究中治疗前后SJC28比较结果。
具体实施方式
下面结合具体实施例对本发明作进一步详细的说明。如无特别说明,本发明所用原料及试剂均为市场购买得到。
实施例1
本实施例的治疗类风湿关节炎疼痛的中药组合物,剂型为中药颗粒剂,由以下原料药制备得到:桂枝15g,白芍15g,炙甘草12g,生姜18g,大枣18g,生晒参10g,当归15g,巴戟天15g,麦冬10g。
其制备方法为:
(1)提取:将各原料药按配比混合,加10倍重量水,加热至沸(100℃),保持微沸1.5小时,抽滤(200目滤网);将抽滤后的药材加8重量倍水,加热至沸(100℃),保持微沸0.5小时,抽滤(200目滤网);合并滤液;
(2)浓缩:滤液减压浓缩为1.08-1.10克药/mL的清膏;
(3)干燥:将清膏喷雾干燥,得到粉体;
(4)过筛混匀:将粉体过80目筛,过筛后所得干膏粉混合30分钟至均匀;
(5)制粒:采用干法制粒制成12-40目颗粒,即得。
为了验证本发明的中药组合物对类风湿关节炎疼痛的治疗效果,以本发明的中药组合物开展了临床观察研究,研究过程及结果如下:
1、纳入标准:(1)研究对象应符合以下诊断标准:西医RA诊断标准:符合2010年ACR/EULAR的RA分类诊断标准,且按DAS28-CRP评分疾病处于中低疾病活动度的患者(DAS28-CRP≤5.1);(2)年龄在18~70岁,性别不限;(3)由受试者或其家属(监护人)签署的同意参加本试验的书面知情同意书;
2、排除标准:(1)患有急性或慢性感染性疾病,包括乙型肝炎或丙型肝炎感染;既往具有癌症病史;活动性、潜伏性或治疗不当的结核分枝杆菌感染的证据;(2)合并严重的心血管、脑、肺、肝、肾、造血疾病的患者;(3)孕妇、哺乳期妇女或者有已知精神障碍的患者;(4)血红蛋白水平的不到90g/L,白细胞计数小于3.0×109每升,或血小板计数低于100×109每升的患者;(5)肾小球滤过率低于40ml/min的患者;(6)天冬氨酸氨基转移酶或丙氨酸氨基转移酶水平高于正常范围上限1.5倍;(7)长期使用非甾体抗炎药导致的活动性胃十二指肠溃疡或胃炎患者;(8)对试验药物过敏的患者;(9)筛查4周内参与其他临床试验的患者。
3、一般资料:研究对象为2023.4.1-2023.11.22广州市某医院门诊收集的符合纳入标准且不符合排除标准的10例类风湿关节炎患者。
4、治疗方法:所有患者均使用本发明实施例1制得的中药颗粒剂进行治疗,服法:每日2次,每次2小袋,加适量温水冲服。疗程:12周。
5、观察指标:在治疗前后,采用疼痛VAS评分、DAS28-CRP、关节肿胀数对所有患者进行测试。
6、试验结果:10例患者中共有6例患者已完成1个月的药物干预,治疗前后疼痛VAS评分、DAS28-CRP及SJC28变化。
治疗前后疼痛VAS评分、DAS28-CRP、SJC28结果分别如图1、图2、图3所示。对比表1和图1、图2、图3可以看出,与治疗前相比,大部分受试者的疼痛程度(疼痛VAS100mm)、肿胀关节数(SJC28)、疾病活动度(DAS28-CRP)均较前下降,表明治疗对于缓解RA的病情、减轻疼痛和关节肿胀有一定的效果。由此表明,本发明的中药组合物能够有效治疗类风湿关节炎,缓解类风湿关节炎疼痛和关节肿胀程度。
最后所应当说明的是,以上实施例仅用以说明本发明的技术方案而非对本发明保护范围的限制,尽管参照较佳实施例对本发明作了详细说明,本领域的普通技术人员应当理解,可以对本发明的技术方案进行修改或者等同替换,而不脱离本发明技术方案的实质和范围。
Claims (10)
1.一种治疗类风湿关节炎疼痛的中药组合物,其特征在于,包括以下重量份的原料药:桂枝10-25份,白芍10-25份,甘草5-25份,生姜10-30份,大枣15-30份,人参10-30份,当归10-30份,巴戟天10-30份,麦冬10-30份。
2.根据权利要求1所述的治疗类风湿关节炎疼痛的中药组合物,其特征在于,包括以下重量份的原料药:桂枝15份,白芍15份,甘草12份,生姜18份,大枣18份,人参10份,当归15份,巴戟天15份,麦冬10份。
3.根据权利要求1或2所述的治疗类风湿关节炎疼痛的中药组合物,其特征在于,所述人参为生晒参,所述甘草为炙甘草。
4.根据权利要求1或2所述的治疗类风湿关节炎疼痛的中药组合物,其特征在于,还包括医学上可接受的辅料。
5.根据权利要求1或2所述的治疗类风湿关节炎疼痛的中药组合物,其特征在于,所述中药组合物的剂型为汤剂、片剂、胶囊剂、颗粒剂、口服液或滴丸剂。
6.一种如权利要求5所述的治疗类风湿关节炎疼痛的中药组合物的制备方法,其特征在于,所述中药组合物为颗粒剂,其制备方法包括以下步骤:
将各原料药按配比混合后进行水提,将水提取物浓缩、干燥、过筛混匀后制成颗粒即得。
7.根据权利要求6所述的制备方法,其特征在于,所述过筛的筛网为80目,所述颗粒为12-40目。
8.根据权利要求6所述的制备方法,其特征在于,其制备方法包括以下步骤:将各原料药按配比混合,加8-10倍重量份的水,水提两次,合并水提液,浓缩至1.08-1.10克药/mL,干燥、过80目筛后混匀,干法制粒制成12-40目颗粒。
9.权利要求1-5任一项所述的治疗类风湿关节炎疼痛的中药组合物在制备治疗类风湿关节炎疼痛的药物中的应用。
10.根据权利要求9所述的应用,其特征在于,所述类风湿关节炎是中医辨证为心肾两虚、气血失和的病机。
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