CN108888724A - 一种用于防治痛风的中药制剂 - Google Patents
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Abstract
本发明公开了一种用于防治痛风的中药制剂,是以生地,山芋肉,泽泻,茯苓,山药,丹皮,黄芪,白茅根,补骨脂,桑枝,知母、黄柏,当归,丹参、炙乳香,炙没药,伸筋草,鸡血藤,苏木,怀牛膝,金樱子,锁阳,肉苁蓉,杜仲为原料药,按药剂学的常规工艺和辅料制备成内服制剂。临床试验统计数据表明,本发明的药物对于不同阶段的痛风并患者都具有明显的治疗效果;对于无症状高尿酸血症期也有很好的治疗作用,治愈率几乎是100%。另外,本发明采用药食同源、无毒无副作用的药材和食材为原料,长期或间断性服食服食,具有非常好的养生作用。
Description
技术领域
本发明涉及一种用于防治痛风的中药制剂,属于中药保健领域。
背景技术
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型糖尿病及心血管病等表现。痛风最重要的生化基础是高尿酸血症。正常成人每日约产生尿酸750mg,其中80%为内源性,20%为外源性尿酸,这些尿酸进入尿酸代谢池(约为1200mg),每日代谢池中的尿酸约60%进行代谢,其中1/3约200mg经肠道分解代谢,2/3约400mg经肾脏排泄,从而可维持体内尿酸水平的稳定,其中任何环节出现问题均可导致高尿酸血症。
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。临床表现如下:
1、急性痛风性关节炎:痛风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,可同时累及多个关节,表现为多关节炎。
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。多由恶性肿瘤及其放化疗(即肿瘤溶解综合征)等继发原因引起。
非甾体类抗炎药均可有效缓解急性痛风症状,为一线用药,秋水仙碱是治疗急性发作的传统药物。但这些药物对于胃肠道具有很大的伤害,也可引起骨髓抑制、肝损害、过敏和神经毒性等。对于间歇期和慢性期,目前临床应用的降尿酸药主要有抑制尿酸生成药和促进尿酸排泄药。根据降尿酸的目标水平在数月内调整至最小有效剂量并长期甚至终身维持。
发明内容
本发明的目的是提供一种用于防治痛风的中药制剂。
本发明一种用于防治痛风的中药制剂,是以生地,山芋肉,泽泻,茯苓,山药,丹皮,黄芪,白茅根,补骨脂,桑枝,知母、黄柏,当归,丹参、炙乳香,炙没药,伸筋草,鸡血藤,苏木,怀牛膝,金樱子,锁阳,肉苁蓉,杜仲为原料药,按药剂学的常规工艺和辅料制备成内服制剂。
本发明的药物组方中,以生地,山芋肉,泽泻,茯苓,山药,丹皮,黄芪,肉苁蓉为君药,生地滋阴,滋而不腻,适于长期服用,并不累及脾胃。山萸肉味酸涩微温,以其色红入血份以养肝肾。泽泻,茯苓味淡利湿祛浊。其中以生地,山芋肉,泽泻,茯苓,山药,丹皮,为宋代儿科鼻祖钱乙的《小儿药证直决》中的六味地黄汤,此方广泛用于滋补肝肾领域,儿童、成人均可使用,安全可靠,以生地易熟地加强滋阴效果,加上黄芪,肉苁蓉两味,黄芪扶正益气,肉苁蓉补肾强身,更增强了扶正祛邪的功能。以当归,炙乳香,炙没药,丹参为臣药,该四味为当代名医张锡纯的名方活络效灵丹的配方,取其活血化瘀,通络止痛,活血养血以养肾的功效。以白茅根,补骨脂,桑枝,知母,黄柏为佐,辅助君、臣药增强利湿清热,滋阴养肾的功效。知母、黄柏用于湿热泻痢,黄疸尿赤,热淋涩痛。骨蒸痨热,阴虚盗汗,肠燥便秘,配合补骨脂补肾壮阳、补脾健胃,增强养阴温阳的作用。以伸筋草,鸡血藤,苏木,怀牛膝,金樱子,锁阳,杜仲为使药,取伸筋草,鸡血藤强筋壮骨,抗风湿,养血补血为长,苏木活血祛瘀,消肿止痛,怀牛膝补益肝肾,强腰膝,活血引血下行,金樱子,锁阳温肾固涩,全方共奏滋补肝肾,滋阴潜阳,强健筋骨,提高免疫力的功能,以达到抗病防病的功能。
本发明的中药制剂中,各原料的重量配比为:生地28~35份,山芋肉19~22份,泽泻13~16份,茯苓13~16份,山药13~16份,丹皮13~16份,黄芪28~35份,白茅根19~22份,补骨脂13~16份,桑枝13~16份,知母13~16份,黄柏13~16份,当归13~16份,丹参28~35份,炙乳香7~11份,炙没药7~11份,伸筋草19~22份,鸡血藤19~22份,苏木13~16份,怀牛膝13~16份,金樱子13~16份,锁阳13~16份,肉苁蓉13~16份,杜仲13~16份。
优选配比:生地30~32份,山芋肉20~21份,泽泻14~15份,茯苓14~15份,山药14~15份,丹皮14~15份,黄芪30~32份,白茅根20~21份,补骨脂14~15份,桑枝14~15份,知母14~15份,黄柏14~15份,当归14~15份,丹参30~32份,炙乳香9~10份,炙没药9~10份,伸筋草20~21份,鸡血藤20~21份,苏木14~15份,怀牛膝14~15份,金樱子14~15份,锁阳14~15份,肉苁蓉14~15份,杜仲14~15份。
最佳配比:生地30份,山芋肉20份,泽泻15份,茯苓15份,山药15份,丹皮15份,黄芪30份,白茅根20份,补骨脂15份,桑枝15份,知母15份,黄柏15份,当归15份,丹参30份,炙乳香9份,炙没药9份,伸筋草20份,鸡血藤20份,苏木15份,怀牛膝15份,金樱子15份,锁阳15份,肉苁蓉15份,杜仲15份。
本发明的药物,可按药剂学的常规工艺和辅料制备成的内服制剂,如丸剂、片剂、颗粒剂、胶囊剂、口服液等等。
下面通过临床统计资料对发明药物治疗痛风的效果进行说明。
1.对象与方法
1.1试验物
采用本发明颗粒剂药物。规格:9g/袋。日服三次,每次9g。由仁和堂有限公司提供。
1.2受试对象,症属肾阴阳不足,尿酸高出正常范围,双脚肿痛的通风患者。
自2015-2018三年间,在甘肃酒泉地区观察了不同阶段的痛风病患者136例,年龄在45-70岁之间,男性。其中急性痛风性关节炎患者89例,间歇发作期患者47例。
2.治疗方法
每次1袋(9g),一日3次,温开水直接冲服。疗程:10天间为一周期,一般观察2个周期。
3.治疗结果
4.1急性痛风性关节炎
痊愈:66例,占74.2%;显效:18例,占20.2%;有效:5例,占5.6%;无效:0例。总有效率:100%。
4.2间歇发作期
痊愈:29例,占61.7%;显效:14例,占29.8%;有效:4例,占8.5%;无效:0例;总有效率:100%。
上述临床统计数据表明,本发明的中药制剂对于不同阶段的痛风并患者都具有明显的治疗效果。临床实验还表明,本发明的中药制剂对于无症状高尿酸血症期也有很好的治疗作用,治愈率几乎是100%。另外,本发明采用药食同源、无毒无副作用的药材和食材为原料,长期或间断性服食服食,具有非常好的养生作用。
具体实施方式
下面通过具体实施例对本发明用于防治痛风的中药制剂的原料配比、制备方法、以及用法用量做进一步说明。
实施例1、胶囊剂的制备
原料配方:生地30份,山芋肉20份,泽泻15份,茯苓15份,山药15份,丹皮15份,黄芪30份,白茅根20份,补骨脂15份,桑枝15份,知母15份,黄柏15份,当归15份,丹参30份,炙乳香9份,炙没药9份,伸筋草20份,鸡血藤20份,苏木15份,怀牛膝15份,金樱子15份,锁阳15份,肉苁蓉15份,杜仲15份;
制备工艺:按制备软胶囊剂剂的常规工艺和辅料制备成。规格:1.5g/粒。
用法用量:每次9g,一日3次,温开水直接冲服。疗程:10-30天为1疗程。
实施例2、颗粒剂的制备
原料配方:生地28份,山芋肉19份,泽泻13份,茯苓13份,山药13份,丹皮13份,黄芪28份,白茅根19份,补骨脂13份,桑枝13份,知母13份,黄柏13份,当归13份,丹参28份,炙乳香7份,炙没药7份,伸筋草19份,鸡血藤19份,苏木13份,怀牛膝13份,金樱子13份,锁阳13份,肉苁蓉13份,杜仲13份;
制备工艺:按制备颗粒剂的常规工艺和辅料制备成。规格:9g/袋。
用法用量:每次9g,一日3次,温开水直接冲服。疗程:10-30天为1疗程。
实施例3、水丸剂的制备
原料配方:生地35份,山芋肉22份,泽泻16份,茯苓16份,山药16份,丹皮16份,黄芪35份,白茅根22份,补骨脂16份,桑枝16份,知母16份,黄柏16份,当归16份,丹参35份,炙乳香11份,炙没药11份,伸筋草22份,鸡血藤22份,苏木16份,怀牛膝16份,金樱子16份,锁阳16份,肉苁蓉16份,杜仲16份。
制备工艺:按制备颗粒剂的常规工艺和辅料制备成。规格:15g/袋。
用法用量:每次15g,一日3次,温开水直接冲服。疗程:10-30天为1疗程。
实施例4、粉剂的制备
原料配方:生地30份,山芋肉20份,泽泻14份,茯苓14份,山药14份,丹皮14份,黄芪30份,白茅根20份,补骨脂14份,桑枝14份,知母14份,黄柏14份,当归14份,丹参30份,炙乳香9份,炙没药9份,伸筋草20份,鸡血藤20份,苏木14份,怀牛膝14份,金樱子14份,锁阳14份,肉苁蓉14份,杜仲14份。
制备工艺:按制备粉剂的常规工艺和辅料制备成。规格:15g/袋。
用法用量:每次15g,一日3次,温开水直接冲服。疗程:10-30天为1疗程。
实施例5、口服液的制备
原料配方:生地32份,山芋肉21份,泽泻15份,茯苓15份,山药15份,丹皮15份,黄芪32份,白茅根21份,补骨脂15份,桑枝15份,知母15份,黄柏15份,当归~15份,丹参32份,炙乳香10份,炙没药10份,伸筋草21份,鸡血藤21份,苏木15份,怀牛膝15份,金樱子15份,锁阳15份,肉苁蓉15份,杜仲15份。
制备工艺:按制备颗粒剂的常规工艺和辅料制备成。规格:20ml/瓶。
用法用量:每次20ml,一日3次,温开水直接冲服。疗程:10-30天为1疗程。
上述各实施例中,各原料的配比均以重量份计。
Claims (5)
1.一种用于防治痛风的中药制剂,是以生地,山芋肉,泽泻,茯苓,山药,丹皮,黄芪,白茅根,补骨脂,桑枝,知母、黄柏,当归,丹参、炙乳香,炙没药,伸筋草,鸡血藤,苏木,怀牛膝,金樱子,锁阳,肉苁蓉,杜仲为原料药,按药剂学的常规工艺和辅料制备成内服制剂。
2.如权利要求1所述一种用于防治痛风的中药制剂,其特征在于:所述各原料药按以下述重量份进行配比:生地28~35份,山芋肉19~22份,泽泻13~16份,茯苓13~16份,山药13~16份,丹皮13~16份,黄芪28~35份,白茅根19~22份,补骨脂13~16份,桑枝13~16份,知母13~16份,黄柏13~16份,当归13~16份,丹参28~35份,炙乳香7~11份,炙没药7~11份,伸筋草19~22份,鸡血藤19~22份,苏木13~16份,怀牛膝13~16份,金樱子13~16份,锁阳13~16份,肉苁蓉13~16份,杜仲13~16份。
3.如权利要求1所述一种用于防治痛风的中药制剂,其特征在于:生地30~32份,山芋肉20~21份,泽泻14~15份,茯苓14~15份,山药14~15份,丹皮14~15份,黄芪30~32份,白茅根20~21份,补骨脂14~15份,桑枝14~15份,知母14~15份,黄柏14~15份,当归14~15份,丹参30~32份,炙乳香9~10份,炙没药9~10份,伸筋草20~21份,鸡血藤20~21份,苏木14~15份,怀牛膝14~15份,金樱子14~15份,锁阳14~15份,肉苁蓉14~15份,杜仲14~15份。
4.如权利要求1所述一种用于防治痛风的中药制剂,其特征在于:生地30份,山芋肉20份,泽泻15份,茯苓15份,山药15份,丹皮15份,黄芪30份,白茅根20份,补骨脂15份,桑枝15份,知母15份,黄柏15份,当归15份,丹参30份,炙乳香9份,炙没药9份,伸筋草20份,鸡血藤20份,苏木15份,怀牛膝15份,金樱子15份,锁阳15份,肉苁蓉15份,杜仲15份。
5.如权利要求1所述一种用于防治痛风的中药制剂,其特征在于:所述内服制剂为茶剂、颗粒剂、软胶囊剂、丸剂、片剂、口服液。
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