CN108159317A - 一种可有效治疗痛风的胶囊剂药物及其制备方法 - Google Patents
一种可有效治疗痛风的胶囊剂药物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药制剂领域,目的是根据中医治疗痛风的认识机理而提供一种可有效治疗痛风的胶囊剂药物,所述药物的各个组分及其质量份比如下:制川乌15~45g、薏苡仁100~350g、木防己50~120g、蚕砂100~160g、滑石100~260g、黄柏80~160g、苍术30~100g、桑枝100~160g、独活30~120g、海风藤60~150g、五加皮50~100g、牛膝50~160g、赤芍60~150g、防风30~120g、秦艽30~120g、大黄30~150g、乳香30~70g、甘草30~150g;本发明提供的药物是一个很好的中药组方。
Description
技术领域
本发明属于中药制剂领域,具体涉及一种可有效治疗痛风的胶囊剂药物,特别是供痛风患者使用的胶囊剂药物及其制备方法的领域。
背景技术
医者认为:痛风是由单钠尿酸盐(MSU)沉积所致的晶体相关性关节病,与嘌呤代谢紊乱和(或)尿酸排泄减少所致的高尿酸血症直接相关,特指急性特征性关节炎和慢性痛风石疾病,主要包括急性发作性关节炎、痛风石形成、痛风石性慢性关节炎、尿酸盐肾病和尿酸性尿路结石,重者可出现关节残疾和肾功能不全。痛风常伴腹型肥胖、高脂血症、高血压、2型糖尿病及其其心血管病等表现。
临床表现:
痛风多见于中年男性,女性仅占5%,主要是绝经后女性,痛风发生有年轻化趋势。痛风的自然病程可分为四期,即无症状高尿酸血症期、急性期、间歇期、慢性期[3]。临床表现如下:
1.急性痛风性关节炎
多数患者发作前无明显征兆,或仅有疲乏、全身不适和关节刺痛等。典型发作常于深夜因关节痛而惊醒,疼痛进行性加剧,在12小时左右达高峰,呈撕裂样、刀割样或咬噬样,难以忍受。受累关节及其其周围组织红、肿、热、痛和功能受限。多于数天或2周内自行缓解。首次发作多侵犯单关节,部分以上发生在第一跖趾关节,在以后的病程中,部分患者累及其其该部位。其次为足背、足跟、踝、膝、腕和肘等关节,肩、髋、脊柱和颞颌等关节少受累,可同时累及其其多个关节,表现为多关节炎。部分患者可有发热、寒战、头痛、心悸和恶心等全身症状,可伴白细胞计数升高、红细胞沉降率增快和C反应蛋白增高等。
2.间歇发作期
痛风发作持续数天至数周后可自行缓解,一般无明显后遗症状,或遗留局部皮肤色素沉着、脱屑及其其刺痒等,以后进入无症状的间歇期,历时数月、数年或十余年后复发,多数患者1年内复发,越发越频,受累关节越来越多,症状持续时间越来越长。受累关节一般从下肢向上肢、从远端小关节向大关节发展,出现指、腕和肘等关节受累,少数患者可影响到肩、髋、骶髂、胸锁或脊柱关节,也可累及其其关节周围滑囊、肌腱和腱鞘等部位,症状趋于不典型。少数患者无间歇期,初次发病后呈慢性关节炎表现。
3.慢性痛风石病变期
皮下痛风石和慢性痛风石性关节炎是长期显著的高尿酸血症,大量单钠尿酸盐晶体沉积于皮下、关节滑膜、软骨、骨质及其其关节周围软组织的结果。皮下痛风石发生的典型部位是耳郭,也常见于反复发作的关节周围及其其鹰嘴、跟腱和髌骨滑囊等部位。外观为皮下隆起的大小不一的黄白色赘生物,皮肤表面菲薄,破溃后排出白色粉状或糊状物,经久不愈。皮下痛风石常与慢性痛风石性关节炎并存。关节内大量沉积的痛风石可造成关节骨质破坏、关节周围组织纤维化和继发退行性改变等。临床表现为持续关节肿痛、压痛、畸形及其其功能障碍。慢性期症状相对缓和,但也可有急性发作。
4.肾脏病变
(1)慢性尿酸盐肾病尿酸盐晶体沉积于肾间质,导致慢性肾小管一间质性肾炎。临床表现为尿浓缩功能下降,出现夜尿增多、低比重尿、小分子蛋白尿、白细胞尿、轻度血尿及其其管型尿等。晚期可致肾小球滤过功能下降,出现肾功能不全。
(2)尿酸性尿路结石尿中尿酸浓度增高呈过饱和状态,在泌尿系统沉积并形成结石。在痛风患者中的发生率在20%以上,且可能出现于痛风关节炎发生之前。结石较小者呈砂砾状随尿排出,可无症状;较大者可阻塞尿路,引起肾绞痛、血尿、排尿困难、泌尿系感染、肾盂扩张和积水等。
(3)急性尿酸性肾病血及其其尿中尿酸水平急骤升高,大量尿酸结晶沉积于肾小管、集合管等处,造成急性尿路梗阻。临床表现为少尿、无尿,急性肾功能衰竭;尿中可见大量尿酸晶体。多由恶性肿瘤及其其放化疗(即肿瘤溶解综合征)等继发原因引起。
那么,就如何找到一种可有效治疗痛风的中药组合物,是本领域技术人员亟待要解决的问题。
发明内容
随着我国中医中药学的不断发展,在治疗痛风上,人们逐渐意识到了中医治疗痛风的优点,且在治疗过程中疗效好、见效快、毒副作用小等优势,针对现有西医治疗痛风的现状,本发明的目的是在于提供一种可有效治疗痛风的胶囊剂药物,以解决痛风患者早日恢复健康的问题。该药物是以常见的中药为原料,通过选择合理的药物及质量份比,可有效治疗上述痛风。
为达到上述发明的目的,本发明所采用的技术方案为:提供一种可有效治疗痛风的胶囊剂药物及其制备方法,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌15~45g、薏苡仁100~350g、木防己50~120g、蚕砂100~160g、滑石100~260g、黄柏80~160g、苍术30~100g、桑枝100~160g、独活30~120g、海风藤60~150g、五加皮50~100g、牛膝50~160g、赤芍60~150g、防风30~120g、秦艽30~120g、大黄30~150g、乳香30~70g、甘草30~150g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
一种可有效治疗痛风的胶囊剂药物及其制备方法,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌18~40g、薏苡仁115~320g、木防己56~105g、蚕砂115~140g、滑石115~230g、黄柏90~140g、苍术36~90g、桑枝115~140g、独活36~105g、海风藤70~130g、五加皮56~90g、牛膝56~140g、赤芍70~130g、防风36~105g、秦艽36~105g、大黄36~130g、乳香36~60g、甘草36~130g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
一种可有效治疗痛风的胶囊剂药物及其制备方法,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌35g、薏苡仁280g、木防己95g、蚕砂120g、滑石200g、黄柏120g、苍术80g、桑枝120g、独活95g、海风藤118g、五加皮80g、牛膝120g、赤芍118g、防风95g、秦艽95g、大黄118g、乳香52g、甘草118g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
一种可有效治疗痛风的胶囊剂药物及其制备方法,其特征在于,所述方法包括如下步骤制备而成:
A、将上述原料中药拣去杂质和粉尘后,按照质量份比共粉碎成(30~50目)颗粒状包煎;
B、①将包好的原料中药放入冷开水中浸泡45min,然后再将浸泡好的药物放入砂锅内,加入原料中药重量7~9倍的冷开水进行第一次武火煎煮,待煎煮到18min时,转文火熬制120min,滤取药液;②药渣中再次加入原料中药重量6~8 倍的冷开水进行第二次武火煎煮,待煎煮到15min时,转文火熬制110min,滤取药液;③将二次药液混合浓缩成相对密度为1.08 的清膏,然后干燥、研末和消毒后备用;
C、①按照传统制备中药胶囊剂的方法,将B中研磨好的细末过筛后,加入适量的微粉硅胶、微晶纤维素和淀粉混合均匀,然后制备成胶囊剂(其胶囊锁合后总长度为23.3mm,药粉容量0.4~0.5g/粒),②继而抛光、消毒,分装密封即可。
一种可有效治疗痛风的胶囊剂药物及其制备方法,其特征在于,所述服用方法为:将制备好的胶囊剂药物以每日三次服用,早中晚各服一次,给药量2.5g(5粒)/次,饭后温开水送服。(用药期间忌烟、酒、生葱、生蒜、辛辣刺激性食物)。25天为一个疗程,服药3~7个疗程后,临床症状及体征消失,功能活动恢复正常。
本发明组方中的各原料中药在中国药典、中国辞典以及其中华本草中均有详细的记载。本发明选用其中最常见的中药为原料,充分发挥各组分的药理功效:
制川乌,性味:味辛、苦、性热,具有祛风除湿、温经止痛之功效,用于治疗风寒湿痹、关节冷痛、寒疝作痛及麻醉止痛;
薏苡仁,性味:甘、淡、微寒,具有利湿健脾、舒筋除痹、清热排脓之功效,用于治疗水肿、脚气、小便淋沥、湿温病、泄泻带下、风湿痹痛、筋脉拘挛、肺痈、肠痈、扁平疣等症;
木防己,性味:味苦、辛、性寒,具有祛风除湿、通经活络、解毒消肿之功效,用于治疗风湿痹痛、水肿、小便淋痛、闭经、跌打损伤、咽喉肿痛、疮疡肿毒、湿疹、毒蛇咬伤;
蚕砂,性味:温、甘、辛,具有祛风湿、和中化浊之功效,用于治疗风湿痹痛、肢体不遂、皮肤顽麻、风疹瘙痒、湿浊内阻的腹痛吐泻转筋、闭经、崩漏等症;
滑石,性味:甘、淡、寒,具有利尿通淋、清热解暑、祛湿敛疮之功效,用于治疗热淋、石淋、尿热涩痛、暑湿烦渴、湿热水泻,外治湿疹、湿疮、痱子,还用于小便不利、淋沥涩痛;
黄柏,性味:苦、寒,具有清热燥湿、泻火解毒、除骨蒸清虚热之功效,用于治疗湿热泻痢、黄疸、带下、热淋、脚气、痿辟、骨蒸劳热、盗汗、遗精、疮疡肿毒、湿疹瘙痒;
苍术,性味:辛、苦、温,具有燥湿健脾、去风湿之功效,用于治疗脾为湿困引起的运化失调、食欲不振、呕恶烦闷、腹胀泄泻、关节肢体疼痛;
桑枝,性味:味微苦、性平,具有祛风湿、利关节之功效,用于治疗风湿痹病、肩臂、关节酸痛麻木;
独活,性味:味辛、苦、性微温,具有祛风除湿、痛痹止痛之功效,用于治疗风寒湿痹、要洗疼痛、少阴伏风头痛、风寒挟湿头痛等症;
海风藤,性味:味辛、苦、性微温,具有祛风湿、通经络、止痹痛之功效,用于治疗风寒湿痹、肢节疼痛、筋脉拘挛、屈伸不利;
五加皮,性味:辛、苦、温,具有祛风湿、补肝肾、强筋骨之功效,用于治疗风湿痹痛、筋骨痿软、小儿行迟、体虚乏力、水肿、脚气等症;
牛膝,性味:苦、酸、性平,具有补肝肾、强筋骨、活血通经、引敌国(火)下行、利尿通淋之功效,用于治疗腰膝酸痛、下肢痿软、血滞经闭、痛经、产后血瘀腹痛、徵瘕、胞衣不下、热淋、血淋、跌打损伤、痈肿恶疮、咽喉肿痛;
赤芍,性味:味苦、性微寒,具有清热凉血、散瘀止痛之功效,用于治疗热人营血、温毒发斑、吐血衄血、目赤肿痛、肝郁胁痛、经闭痛经、瘾瘕腹痛、跌扑损伤、痈肿疮疡;炒赤芍:炒后药性偏于缓和、活血止痛而不伤中,可用于瘀滞疼痛;酒赤芍:以活血散瘀力胜、清热凉血作用较弱,多用于闭经或痛经、跌打损伤;
防风,性味:味辛、甘、性微温,具有祛风解表、胜湿止痛、止痉定搐之功效,用于治疗外感表证、风疹瘙痒、风湿痹痛、破伤风等病症;
秦艽,性味:味辛、苦、性平,具有祛风湿、清湿热、止痹痛、退虚热之功效,用于治疗风湿痹痛、中风半身不遂、筋脉拘挛、骨节酸痛、湿热黄疸、骨蒸潮热、小儿疳积发热;
大黄,性味:苦、性寒,具有攻积滞、清湿热、泻火、凉血、祛瘀、解毒之功效,用于治疗实热便秘、热结胸痞、湿热 泻痢、黄疸、淋病、水肿腹满、小便不利、目赤、咽喉肿痛、口舌生疮、胃热呕吐、吐血、咯血、衄血、便血、尿血、蓄血、经闭、产后瘀滞腹痛、癥瘕积聚、跌打损伤、热毒痈疡、丹毒、烫伤等症;
乳香,性味:辛、苦、温,具有活血行气止痛、消肿生肌之功效,用于治疗胸痹心痛、胃脘疼痛、痛经经闭、产后瘀阻、症瘕腹痛、风湿痹痛、筋脉拘挛、跌打损伤、痈肿疮疡;
甘草,性味:甘、平,具有益气补中、缓急止痛、润肺止咳、泻火解毒、调和诸药之功效,用于治疗倦怠食少、肌瘦面黄、心悸气短、腹痛便溏、四肢挛急疼痛、脏躁、咳嗽气喘、咽喉肿痛、痈疮肿痛、小儿胎毒及药物、食物中毒。
本发明药物是基于中医治疗痛风的原则,从依据痛风的病理机制及药理作用认为:就痛风,本发明所提供的药物中的各原料中药药效共奏,对上述疾病有很好的治疗效果。
具体实施方式
本发明就是针对上述痛风的治疗而提出的一种中药配方,采用该配方制备的药物药效好,见效快,是一个很好的中药组方,特别适合临床使用。下面结合本发明的具体实施方式作进一步详细的描述:
实施例1:
一种可有效治疗痛风的胶囊剂药物,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌35g、薏苡仁280g、木防己95g、蚕砂120g、滑石200g、黄柏120g、苍术80g、桑枝120g、独活95g、海风藤118g、五加皮80g、牛膝120g、赤芍118g、防风95g、秦艽95g、大黄118g、乳香52g、甘草118g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
实施例2:
一种可有效治疗痛风的胶囊剂药物,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌40g、薏苡仁320g、木防己105g、蚕砂140g、滑石230g、黄柏140g、苍术90g、桑枝140g、独活105g、海风藤130g、五加皮90g、牛膝140g、赤芍130g、防风105g、秦艽105g、大黄130g、乳香60g、甘草130g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
实施例3:
一种可有效治疗痛风的胶囊剂药物,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌45g、薏苡仁350g、木防己120g、蚕砂160g、滑石260g、黄柏160g、苍术100g、桑枝160g、独活120g、海风藤150g、五加皮100g、牛膝160g、赤芍150g、防风120g、秦艽120g、大黄150g、乳香70g、甘草150g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
典型病例:
经临床诊断治疗痛风患者共1398例,年龄为54岁以上的840例,只有558例为54岁以下。1398例患者中临床症状体征消失,功能活动恢复正常的有961例,有效的367例,无效的70例。总有效率达95%。
Claims (3)
1.一种可有效治疗痛风的胶囊剂药物,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌15~45g、薏苡仁100~350g、木防己50~120g、蚕砂100~160g、滑石100~260g、黄柏80~160g、苍术30~100g、桑枝100~160g、独活30~120g、海风藤60~150g、五加皮50~100g、牛膝50~160g、赤芍60~150g、防风30~120g、秦艽30~120g、大黄30~150g、乳香30~70g、甘草30~150g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
2.根据权利要求1所述的可有效治疗痛风的胶囊剂药物,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌18~40g、薏苡仁115~320g、木防己56~105g、蚕砂115~140g、滑石115~230g、黄柏90~140g、苍术36~90g、桑枝115~140g、独活36~105g、海风藤70~130g、五加皮56~90g、牛膝56~140g、赤芍70~130g、防风36~105g、秦艽36~105g、大黄36~130g、乳香36~60g、甘草36~130g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
3.根据权利要求1至2所述的可有效治疗痛风的胶囊剂药物,其特征在于,所述药物的各个组分及质量份比如下所示:
制川乌35g、薏苡仁280g、木防己95g、蚕砂120g、滑石200g、黄柏120g、苍术80g、桑枝120g、独活95g、海风藤118g、五加皮80g、牛膝120g、赤芍118g、防风95g、秦艽95g、大黄118g、乳香52g、甘草118g,辅料:微粉硅胶、微晶纤维素和淀粉适量。
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