CN105663789A - 一种用于治疗风湿性关节炎的中药组合物及其制备方法和应用 - Google Patents
一种用于治疗风湿性关节炎的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明提供了一种用于治疗风湿性关节炎的中药组合物,它由如下重量份数的原料制备得到:珠子参25份、长春七18份、一箭球15份、走马风20份、樗叶花椒10份、当归25份、丹参25份、白术10份、钩藤10份、党参18份、络石藤25份、天麻20份、甘草10份,通过益气养血,祛风除湿,搜风通络、化痰祛淤达到治疗风湿性关节炎的目的,并公开了制备方法和用途。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种用于治疗风湿性关节炎的中药组合物及其制备方法和应用。
背景技术
风湿性关节炎(rheumatoidarthritis)是一种常见的急性或慢性结缔组织炎症。可反复发作并累及心脏。临床以关节和肌肉游走性酸楚、重著、疼痛为特征。属变态反应性疾病。是风湿热的主要表现之一,多以急性发热及关节疼痛起病。
风湿在医学上是指关节及其周围软组织不明原因的慢性疼痛。风湿性疾病则指一大类病因各不相同但共同点为累及关节及周围软组织,包括肌、韧带、滑囊、筋膜的疾病。关节病变有疼痛外尚伴有肿胀和活动障碍,呈发作与缓解交替的慢性病程。由于患者的血液循环不通畅,导致肌肉或者组织所需要的营养无法通过血液循环来输送,致使患者肌肉缺少营养而加速老化变得僵硬,严重的会导致患者肌肉和血管萎缩,部分患者且可出现关节致残和内脏功能衰竭。目前国内临床常用非甾类抗炎药等药物治疗,都是化学药品,副作用大,安全性日益受到人们关注。为此,需要开发出更多安全有效治疗风湿性关节炎药物满足临床治疗的需要。中药已经在风湿性关节炎用药市场占有重要地位,因为中药副作用小,疗效确切,适用于长期用药,适应了风湿性关节炎容易复发的特点,临床应用非常广泛。人们迫切需要一种行之有效、己被大多数人证实能起良好效果的治疗风湿性关节炎的中药组合物。
发明内容
发明目的:为了解决上述问题,本发明的目的在于提供一种用于治疗风湿性关节炎的中药组合物及其制备方法和应用。
技术方案:本发明的目的是通过如下的方案实现的:
一种用于治疗风湿性关节炎的中药组合物,它由如下重量份数的原料制备得到:珠子参25份、长春七18份、一箭球15份、走马风20份、樗叶花椒10份、当归25份、丹参25份、白术10份、钩藤10份、党参18份、络石藤25份、天麻20份、甘草10份。
上述用于治疗风湿性关节炎的中药组合物,所述原料经提取后添加辅料制成口服液、片剂、胶囊或颗粒剂。
上述用于治疗风湿性关节炎的中药组合物,所述辅料为糊精、乳糖、淀粉、蔗糖、葡萄糖、微晶纤维素、甘露糖、甲基纤维素、羟丙基纤维素、羧甲基纤维素和甜菊苷的一种或几种。
上述用于治疗风湿性关节炎的中药组合物的制备方法,其特征在于,它包括如下步骤:取上述药材合并,加水煎煮两次,合并煎液,减压浓缩至65℃时相对密度为1.15-1.20的浸膏,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65℃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,或将浓缩液喷雾干燥,添加辅料制成胶囊剂、片剂、颗粒剂。
上述用于治疗风湿性关节炎的中药组合物的制备方法,步骤中,煎煮条件为:第一次加水为药材重量的8-12倍量,煎煮1-2h,第二次加水为药材重量的6-10倍量,煎煮1-2h。
上述用于治疗风湿性关节炎的中药组合物的制备方法,步骤中,喷雾干燥条件为:进风温度为100-120℃,出风温度为80-90℃,物料温度为70-90℃,雾化压力为0.2-0.4兆帕,喷雾速度为5-10ml/s。
上述用于治疗风湿性关节炎的中药组合物在制备治疗风湿性关节炎的药物中的应用。
珠子参来源于五加科,人参属,假人参亚属植物珠子参PanaxpseudoginsengWall.var.major(Burkill)H.L.Li的干燥根状茎,补肺,养阴,活络,止血。用于气阴两虚,烦热口渴,虚劳咳嗽,跌扑损伤,关节疼痛,咳血,吐血,外伤出血。
长春七为伞形科植物岩风、条风和灰毛岩风的根,多年生草本,常全株被灰色短柔毛。根颈较长化,上端存留多数枯萎叶鞘。木质呈小灌木状;根可入药,具有辛温解表,祛风活络的功效。拉丁学名:LibanotisspodotrichomaK.T.Fu,发表散寒,祛风活络。用于感冒,咳嗽,头痛,牙痛,风湿关节疼痛,跌打损伤。本发明以全草入药。
一箭球为莎草科水蜈蚣属植物单穗水蜈蚣KyllingamonocephalaRottb.,以全草入药,清热化痰,发汗退热,消肿解毒。用于感冒发热,疟疾、痢疾,百日咳,跌打损伤,皮肤瘙痒,蛇虫咬伤等症。
走马风,拉丁学名为Blumealaciniata(Roxb.)DC.,是菊科多年生草本植物六耳铃的全草入药的名称。主要分布在我国的广东、广西及西南部等地。味辛、苦,性微温,具有祛风除湿,通经活络的功效。临床上用于风湿骨痛,头痛,跌打肿痛,湿疹及毒蛇咬伤等症。
樗叶花椒为芸香科花椒属植物樗叶花椒ZanthoxylumailanthoidesSieb.etZucc.,以根、树皮、果实和叶入药。根春秋采挖;树皮5月采收晒干;果实10~11月采收阴干;叶夏秋采集。根:祛风通络,活血散瘀,解蛇毒。外用治跌打肿痛,风湿关节痛。树皮:祛风湿,通经络。用于腰膝疼痛,顽痹,疥癣等症。果实:温中,除湿,止痛,杀虫。可代花椒用。为芳香健胃,驱风药。治中暑腹脘冷痛吐泻,并能驱蛔虫。叶:外用治毒蛇咬伤肿痛及外伤出血。本发明以树皮入药。
有益效果:
中医学认为人体感受风、寒、湿邪而致风湿性关节炎,表现为身痛或身重、关节疼痛,屈伸不利,从中医理论看,本方中珠子参、长春七、一箭球、走马风、樗叶花椒益气养血,为君药,当归、丹参、白术、钩藤、党参、络石藤、天麻草活血化瘀、祛风除湿为臣药,甘草调和诸药,为佐使药,诸药相合,共奏益气养血,祛风除湿,搜风通络、化痰祛淤作用,用于治疗风湿性关节炎。
具体实施方式
以下通过实施例形式,对本发明的上述内容再作进一步的详细说明,但不应将此理解为本发明上述主题的范围仅限于以下的实例,凡基于本发明上述内容所实现的技术均属于本发明的范围。
1、制备实施例
实施例1:取珠子参25g、长春七18g、一箭球15g、走马风20g、樗叶花椒10g、当归25g、丹参25g、白术10g、钩藤10g、党参18g、络石藤25g、天麻20g、甘草10g药材合并,加水煎煮两次,第一次加水为药材重量的8倍量,煎煮1h,第二次加水为药材重量的6倍量,煎煮1h,合并煎液,0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.10,加95%(v/v)乙醇使含醇量达85%(v/v),搅拌,静置24小时,滤液减压回收乙醇并浓缩,滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30,喷雾干燥(条件为进风温度为120℃,出风温度为100℃,物料温度为90℃,雾化压力为0.4兆帕,喷雾速度为10ml/s。),加入淀粉,混合均匀,用适量80%(v/v)乙醇润湿,制软材,过30目筛制粒,于70~80℃干燥,用60目筛整粒,压片,包糖衣,分装,外包装,送检合格,得片剂。
实施例2:取珠子参25g、长春七18g、一箭球15g、走马风20g、樗叶花椒10g、当归25g、丹参25g、白术10g、钩藤10g、党参18g、络石藤25g、天麻20g、甘草10g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1.5h,第二次加水为药材重量的8倍量,煎煮1.5h,合并煎液,0.07MPa、60-70℃下减压浓缩至65℃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24小时,滤液减压回收乙醇并浓缩,滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25,喷雾干燥(条件为进风温度为100℃,出风温度为80℃,物料温度为80℃,雾化压力为0.2兆帕,喷雾速度为5ml/s。),加入糊精等,干法制粒,过60目筛,装入1号胶囊即可得胶囊剂。
实施例3:取珠子参25g、长春七18g、一箭球15g、走马风20g、樗叶花椒10g、当归25g、丹参25g、白术10g、钩藤10g、党参18g、络石藤25g、天麻20g、甘草10g药材合并,加水煎煮两次,第一次加水为药材重量的12倍量,煎煮2h,第二次加水为药材重量的10倍量,煎煮2h,合并煎液,0.07MPa、60-70℃下减压浓缩至65℃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24小时,滤液减压回收乙醇并浓缩,滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25,喷雾干燥(条件为进风温度为110℃,出风温度为85℃,物料温度为85℃,雾化压力为0.3兆帕,喷雾速度为7.5ml/s。),加入上述β-环糊精包合物,粉碎,再加入适当乳糖,用适量80%(v/v)乙醇润湿,制软材,过14目筛制粒,50-80℃干燥,60目整粒,得颗粒剂。
实施例4:取珠子参25g、长春七18g、一箭球15g、走马风20g、樗叶花椒10g、当归25g、丹参25g、白术10g、钩藤10g、党参18g、络石藤25g、天麻20g、甘草10g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1.5h,第二次加水为药材重量的8倍量,煎煮1.5h,合并煎液,0.07MPa、60-70℃下减压浓缩至65℃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24小时,滤液减压回收乙醇并浓缩,滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25,加水及蔗糖,制备成口服液。
2.本发明治疗风湿性关节炎的实验研究
2.1样品的制备:按口服液实施例方法制备,制备成口服液20支。
2.2给药剂量:每日每只20g小鼠灌胃,低剂量、中剂量和高剂量分别为5g生药量/kg、10g生药量/kg和20g生药量/kg。
2.3仪器与试剂
DKZ-2型电热恒温水浴箱(上海精宏实验设备有限公司),8452A型紫外分光光度计(美国惠普公司);TG328A型电光分析天平(上海天平仪器厂)。冰醋酸(上海试剂四厂,批号:090402)阿司匹林片,南京制药厂,批号20100216
2.3动物昆明种小鼠210只,雌性,体重(20.1±2.4)g,由南京中医药大学实验动物中心提供(SYXK(苏)2000-0053)。
2.4镇痛作用(热板法)实验
2.4.1分组及给药将50只小鼠随机分5组,即阴性对照组、阳性对照组、本发明大、中、小剂量组,每组均为10只;次日灌胃给药,连续7d,本发明大、中、小剂量;阳性对照组给阿司匹林片,剂量为20g·kg-1·d-1;阴性对照组灌胃0.9%氯化钠溶液,容积均为每只2ml,停药24h后进行镇痛作用(热板法)实验。
2.4.2将水浴槽加满水,使水面接触热板,调节恒温装置使水温控制在55±0.5℃,加热后作为热刺激,用秒表记录小鼠自投入热板至出现舔足的时间(s)作为该鼠的痛阈值(测2次,以平均值不超过60秒者为合格),于给药第三天后1h,再测每只痛阈值。
2.5镇痛作用(扭体法)实验
2.5.1分组及给药将50只小鼠随机分5组,即阴性对照组、阳性对照组、本发明大、中、小剂量组,每组均为10只;次日灌胃给药,连续7d,本发明大、中、小剂量分别为40,20,10g·kg-1·d-1(相当生药);阳性对照组给阿司匹林片,剂量为20g·kg-1·d-1;阴性对照组灌胃0.9%氯化钠溶液,容积均为每只2ml,停药24h后进行镇痛作用(扭体法)实验。
2.5.2第3天给药后1小时,每鼠腹腔注射0.6%冰醋酸0.1ml/10g,记录注射致痛剂后10min内各鼠扭体次数,比较组间差异。
表1本发明对小鼠镇痛作用的影响(x±s)
与阴性对照组比较,*1P<0.01,*2P<0.05
2.6肉芽组织增生试验
2.6.1分组及实验将50只小鼠随机分5组,即模型组、阳性对照组、本发明大、中、小剂量组,每组均为10只,采用棉球腋下埋藏法造模。
2.6.2给药次日灌胃给药,连续7d,本发明大、中、小剂量;阳性对照组同前;模型组灌胃0.9%氯化钠溶液,容积均为每只2ml,于末次给药后30min,将动物处死,将棉球肉芽组织取出,在60℃烤箱中烘干称重。以棉球肉芽组织干重减去棉球质量,即为肉芽组织净重。
表2本发明对小鼠腋下棉球埋藏诱发肉芽组织增生的影响(x±s)
与阴性对照组比较,*1P<0.01,*2P<0.05
2.7实验结论
2.7.1本发明大中剂量给药组能提高小鼠痛阈值和减少醋酸所致小鼠扭体次数,与阴性对照组比较,有显著性差异(P<0.05或P<0.01),表明本发明有明显的镇痛作用。大小剂量给药组能减轻肉芽组织重量,对棉球腋下埋藏诱发肉芽组织增生有明显的抑制作用,与阴性对照组比较有显著性差异(P<0.01,P<0.05),表明本发明有明显的抗炎作用。综上,本发明对风湿性关节炎具有一定的治疗作用。
Claims (7)
1.一种用于治疗风湿性关节炎的中药组合物,其特征在于,它由如下重量份数的原料制备得到:珠子参25份、长春七18份、一箭球15份、走马风20份、樗叶花椒10份、当归25份、丹参25份、白术10份、钩藤10份、党参18份、络石藤25份、天麻20份、甘草10份。
2.根据权利要求1所述的用于治疗风湿性关节炎的中药组合物,其特征在于,所述原料经提取后添加辅料制成口服液、片剂、胶囊或颗粒剂。
3.根据权利要求2所述的用于治疗风湿性关节炎的中药组合物,其特征在于,所述辅料为糊精、乳糖、淀粉、蔗糖、葡萄糖、微晶纤维素、甘露糖、甲基纤维素、羟丙基纤维素、羧甲基纤维素和甜菊苷的一种或几种。
4.权利要求1所述的用于治疗风湿性关节炎的中药组合物,其特征在于,制备方法包括如下步骤:取上述药材合并,加水煎煮两次,合并煎液,减压浓缩至65℃时相对密度为1.15-1.20的浸膏,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65℃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,或将浓缩液喷雾干燥,添加辅料制成胶囊剂、片剂、颗粒剂。
5.根据权利要求4所述的用于治疗风湿性关节炎的中药组合物,其特征在于,制备方法步骤中,煎煮条件为:第一次加水为药材重量的8-12倍量,煎煮1-2h,第二次加水为药材重量的6-10倍量,煎煮1-2h。
6.根据权利要求4所述的用于治疗风湿性关节炎的中药组合物,其特征在于,制备方法步骤中,喷雾干燥条件为:进风温度为100-120℃,出风温度为80-90℃,物料温度为70-90℃,雾化压力为0.2-0.4兆帕,喷雾速度为5-10ml/s。
7.权利要求1所述用于治疗风湿性关节炎的中药组合物在治疗风湿性关节炎的药物中的应用。
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