CN105963660A - 一种治疗类风湿性关节炎的中药制剂 - Google Patents

一种治疗类风湿性关节炎的中药制剂 Download PDF

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CN105963660A
CN105963660A CN201610378888.1A CN201610378888A CN105963660A CN 105963660 A CN105963660 A CN 105963660A CN 201610378888 A CN201610378888 A CN 201610378888A CN 105963660 A CN105963660 A CN 105963660A
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姜海
杨柳
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Heilongjiang University of Chinese Medicine
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Abstract

本发明提供了一种治疗类风湿性关节炎的中药制剂及其制备方法,所述中药制剂是由苍耳子、独活、海风藤、威灵仙、桑枝、桂枝、干姜、当归、川芎、续断、熟地、生地、黄芩和甘草等通过乙醇回流提取与超微粉碎相结合的工艺制备而成。诸药味合用共奏祛风通络、活血补肾、清热解毒之功,对类风湿性关节炎有显著疗效。

Description

一种治疗类风湿性关节炎的中药制剂
技术领域
本发明涉及一种治疗类风湿性关节炎的中药制剂,属中药应用领域。
背景技术
类风湿性关节炎常以小关节起病,多为对称性,先影响关节滑膜,然后侵袭关节软骨和骨组织,导致关节结构破坏,使关节畸形、功能丧失,是一种多系统自身免疫性疾病。
目前,在西医领域,治疗类风湿性关节炎的药物较多,基本可分为非甾体抗炎药、SAARD、糖皮质激素、生物制剂4种,配合利用可有效控制病情,但长期使用有一定不良反应。
在中医领域,类风湿性关节炎属于“痹症”范畴,《内经》曰:“风、寒、湿三气杂至,合而为痹。”风、寒、湿三邪入侵肌肤,留滞不去,以致气血凝滞,不通则痛,气血运行不畅,经脉失养,则关节屈伸不利,湿邪留滞关节,多有肿胀、僵硬、麻木等,若患病日久,反复发作,致肝肾亏损,阳气虚弱。从中医的辨证论治理论出发治疗类风湿性关节炎往往能获得较好的疗效,且不良反应较小。近年来,以中药为主要成分治疗类风湿类关节炎的研究较多。例如,中国专利CN201110324199.X公开了一种治疗类风湿性关节炎的中药配方,由青风藤、丁公藤、雪上一枝蒿、雷公藤、络石藤、石楠叶等二十几味中药材。但是使用的药材较多,后期生产过程中质量控制较为困难。又如,中国专利CN201110337926.6公开了一种治疗风湿、类风湿性关节炎和颈肩腰腿痛的外用膏药,采用马钱子、川乌、草乌、土元、肉桂、白芥子、荜拨、三七、乳香、没药、血竭、细辛、全虫、蜈蚣、乌梢蛇、白花蛇、地龙、公丁香、威灵仙、干姜、当归、川芎、红花、透骨草、寻骨风、青风藤、海风藤、鸡血藤、羌活等多味药物配制而成,但是方中大量使用了马钱子、川乌、草乌等有毒中药以及寻骨风等富含马兜铃酸的限用中药,长期使用容易对人体产生其它有害影响。为此,本发明提出了一种配伍合理、疗效明确、药效显著的治疗类风湿性关节炎的中药制剂。
发明内容
本发明提供了一种治疗类风湿性关节炎的中药制剂及其制备方法。
为实现上述目的,一方面,本发明提供了一种治疗类风湿性关节炎的中药制剂。所述中药制剂由以下重量份的原料药制成:
苍耳子20-30份、独活20-30份、海风藤10-20份、威灵仙10-20份、桑枝10-20份、桂枝10-20份、干姜10-20份、当归8-15份、川芎8-15份、续断8-15份、熟地8-15份、生地8-15份、黄芩8-15份、甘草8-15份。
在本发明的一个优选的实施方案中,所述中药制剂由以下重量份的原料药制成:
苍耳子25-30份、独活25-30份、海风藤10-15份、威灵仙15-20份、桑枝10-15份、桂枝10-15份、干姜10-15份、当归8-10份、川芎8-10份、续断10-15份、熟地12-15份、生地8-10份、黄芩12-15份、甘草12-15份。
在本发明的另一个优选的实施方案中,所述中药制剂由以下重量份的原料药制成:
苍耳子28份、独活25份、海风藤12份、威灵仙15份、桑枝10份、桂枝12份、干姜15份、当归10份、川芎10份、续断15份、熟地12份、生地8份、黄芩12份、甘草15份。
在本发明的另一个优选的实施方案中,所述中药制剂为口服液、片剂或胶囊剂。
另一方面,本发明提供了所述中药制剂的制备方法:
所述中药制剂是由以下步骤制备而成:
(1)按重量份称取苍耳子、独活、海风藤、威灵仙、桑枝、桂枝、干姜、当归、川芎、续断、熟地、生地、黄芩、甘草,去除杂质,洗净,晾干,粉碎,备用;
(2)将以上各原料粉末混合均匀,加入8-12倍量浓度为75-90%的乙醇溶液回流提取3-4次,每次提取2.5-4h,过滤,合并滤液,减压浓缩至稠膏,将所得稠膏置于50-60℃下烘干至恒重,将所得干膏进行超微粉碎,粉碎后过200-300目筛,备用;
(3)将步骤(2)所得的干膏粉混合,加入适量的辅料,制成药学上可接受的剂型。
另一方面,本发明提供了所述中药制剂在制备治疗类风湿性关节炎的药物中的应用。
本发明中药制剂的方中以苍耳子、独活祛风除湿止痛为君药,以海风藤、威灵仙、桑枝通利关节为臣药,辅以桂枝、干姜温阳散寒,当归、川芎补血活血,续断、熟地补肾益精,生地、黄芩清热凉血、解毒燥湿,甘草调和诸药,诸味合用共奏祛风通络、活血补肾、清热解毒之功。同时,在制备方法中将各原料提取后所得的干膏粉进行超微粉碎,大大有利于各成分在体内的吸收利用。
具体实施方式
通过以下实施方式进一步详细说明本发明的技术方案。需要指出的是,以下说明仅仅是对本发明要求保护的技术方案的举例说明,并非对这些技术方案的任何限制。本发明的保护范围以所附权利要求书记载的内容为准。
实施例1:
所述中药制剂由以下重量份的原料药制成:
苍耳子28份、独活25份、海风藤12份、威灵仙15份、桑枝10份、桂枝12份、干姜15份、当归10份、川芎10份、续断15份、熟地12份、生地8份、黄芩12份、甘草15份;
制备方法为:
(1)按重量份称取苍耳子、独活、海风藤、威灵仙、桑枝、桂枝、干姜、当归、川芎、续断、熟地、生地、黄芩、甘草,去除杂质,洗净,晾干,粉碎,备用;
(2)将以上各原料粉末混合均匀,加入10倍量浓度为85%的乙醇溶液回流提取3次,每次提取3.5h,过滤,合并滤液,减压浓缩至稠膏,将所得稠膏置于55℃下烘干至恒重,将所得干膏进行超微粉碎,粉碎后过200目筛,备用;
(3)将步骤(2)所得的干膏粉加入适量硬脂酸镁混合均匀,用75%乙醇溶液制软材,过16目筛制粒,将湿颗粒于55℃干燥,整粒,装入胶囊壳中,即得胶囊剂。
实施例2:
所述中药制剂由以下重量份的原料药制成:
苍耳子25份、独活30份、海风藤10份、威灵仙20份、桑枝10份、桂枝12份、干姜10份、当归8份、川芎8份、续断12份、熟地15份、生地8份、黄芩12份、甘草12份;
制备方法为:
(1)按重量份称取苍耳子、独活、海风藤、威灵仙、桑枝、桂枝、干姜、当归、川芎、续断、熟地、生地、黄芩、甘草,去除杂质,洗净,晾干,粉碎,备用;
(2)将以上各原料粉末混合均匀,加入12倍量浓度为80%的乙醇溶液回流提取3次,每次提取3h,过滤,合并滤液,减压浓缩至稠膏,将所得稠膏置于60℃下烘干至恒重,将所得干膏进行超微粉碎,粉碎后过200目筛,备用;
(3)将步骤(2)所得的干膏粉加入适量硬脂酸镁混合均匀,用75%乙醇溶液制软材,过16目筛制粒,将湿颗粒于55℃干燥,整粒,装入胶囊壳中,即得胶囊剂。
实施例3:
所述中药制剂由以下重量份的原料药制成:
苍耳子20份、独活22份、海风藤15份、威灵仙15份、桑枝20份、桂枝10份、干姜12份、当归12份、川芎12份、续断15份、熟地12份、生地10份、黄芩10份、甘草9份;
制备方法为:
(1)按重量份称取苍耳子、独活、海风藤、威灵仙、桑枝、桂枝、干姜、当归、川芎、续断、熟地、生地、黄芩、甘草,去除杂质,洗净,晾干,粉碎,备用;
(2)将以上各原料粉末混合均匀,加入9倍量浓度为90%的乙醇溶液回流提取3次,每次提取4h,过滤,合并滤液,减压浓缩至稠膏,将所得稠膏置于55℃下烘干至恒重,将所得干膏进行超微粉碎,粉碎后过200目筛,备用;
(3)将步骤(2)所得的干膏粉加入适量硬脂酸镁混合均匀,用75%乙醇溶液制软材,过16目筛制粒,将湿颗粒于55℃干燥,整粒,装入胶囊壳中,即得胶囊剂。
临床试验
自2013年1月至2015年10月共收集类风湿性关节炎病例147例,均为门诊患者,其中男性59例,女性88例,年龄在14-76岁之间,平均年龄为37岁,病程为1年-12年,平均5年。
诊断标准
类风湿性关节炎符合1987年美国风湿病协会修订的类风湿性关节炎的诊断标准,并参照1988年全国中西医结合风湿病学术会议拟定的诊断标准。
治疗方法
以实施例1制得的胶囊为治疗药物,每日三次,每次3-6例,45天为一个疗程。妇女经期停用。
疗效标准
显效:症状消失、关节功能恢复;
有效:症状减轻,关节活动障碍有所改善;
无效:症状无减轻,关节障碍无改变。
治疗结果
147例患者中显效89例,有效53例,无效5例,总有效率96.6%。
以上所述仅为本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原料的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。

Claims (7)

1.一种治疗类风湿性关节炎的中药制剂,其特征在于,所述中药制剂由以下重量份的原料药制成:
苍耳子20-30份、独活20-30份、海风藤10-20份、威灵仙10-20份、桑枝10-20份、桂枝10-20份、干姜10-20份、当归8-15份、川芎8-15份、续断8-15份、熟地8-15份、生地8-15份、黄芩8-15份、甘草8-15份。
2.根据权利要求1所述的中药制剂,其特征在于,所述中药制剂由以下重量份的原料药制成:
苍耳子25-30份、独活25-30份、海风藤10-15份、威灵仙15-20份、桑枝10-15份、桂枝10-15份、干姜10-15份、当归8-10份、川芎8-10份、续断10-15份、熟地12-15份、生地8-10份、黄芩12-15份、甘草12-15份。
3.根据权利要求1所述的中药制剂,其特征在于,所述中药制剂由以下重量份的原料药制成:
苍耳子28份、独活25份、海风藤12份、威灵仙15份、桑枝10份、桂枝12份、干姜15份、当归10份、川芎10份、续断15份、熟地12份、生地8份、黄芩12份、甘草15份。
4.根据权利要求1所述的中药制剂,其特征在于,所述中药制剂为口服液、片剂或胶囊剂。
5.根据权利要求1-3中任一项所述的中药制剂,其特征在于,所述中药制剂是由以下步骤制备而成:
(1)按重量份称取苍耳子、独活、海风藤、威灵仙、桑枝、桂枝、干姜、当归、川芎、续断、熟地、生地、黄芩、甘草,去除杂质,洗净,晾干,粉碎,备用;
(2)将以上各原料粉末混合均匀,加入8-12倍量浓度为75-90%的乙醇溶液回流提取3-4次,每次提取2.5-4h,过滤,合并滤液,减压浓缩至稠膏,将所得稠膏置于50-60℃下烘干至恒重,将所得干膏进行超微粉碎,粉碎后过200-300目筛,备用;
(3)将步骤(2)所得的干膏粉混合,加入适量的辅料,制成药学上可接受的剂型。
6.一种根据权利要求1-3中任一项所述的中药制剂的制备方法,其特征在于,所述中药制剂是由以下步骤制备而成:
(1)按重量份称取苍耳子、独活、海风藤、威灵仙、桑枝、桂枝、干姜、当归、川芎、续断、熟地、生地、黄芩、甘草,去除杂质,洗净,晾干,粉碎,备用;
(2)将以上各原料粉末混合均匀,加入8-12倍量浓度为75-90%的乙醇溶液回流提取3-4次,每次提取2.5-4h,过滤,合并滤液,减压浓缩至稠膏,将所得稠膏置于50-60℃下烘干至恒重,将所得干膏进行超微粉碎,粉碎后过200-300目筛,备用;
(3)将步骤(2)所得的干膏粉混合,加入适量的辅料,制成药学上可接受的剂型。
7.根据权利要求1-3中任一项所述中药制剂在制备治疗类风湿性关节炎的药物中的应用。
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