CN108042622A - 一种治疗骨质增生、关节疼痛的中药组合物及其制备方法 - Google Patents
一种治疗骨质增生、关节疼痛的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供一种治疗骨质增生、关节疼痛的中药组合物及其制备方法,属于中药组合物制备技术领域。所述中药组合物由以下重量份的原料制备而成:当归20‑30份、五灵脂72‑83份、威灵仙150‑180份、制川乌60‑80份、制草乌31‑38份、土鳖虫50‑60份、透骨草74‑78份、防风83‑100份、白芥子90‑110份、黄芪70‑80份、羌活60‑70份、红花25‑38份、全蝎150‑160份。所述中药组合物经粉碎、提取、混合、制粒等步骤制备而成。本发明与普通西药治疗组相比,有效率达98.26%,疗效显著,无胃肠道不良反应。
Description
技术领域
本发明属于中药组合物制备技术领域,具体涉及一种治疗骨质增生、关节疼痛的中药组合物及其制备方法。
背景技术
骨质增生与外伤、劳损、风湿和不同原因的刺激有着密切的关系,其次风、寒、湿、热邪侵入机体,邪留于筋骨,经络瘀滞,使局部气血不畅,骨骼得不到气血供养而发生的增厚、变粗。《内经》指出:肝主筋、藏血,肾藏精,主骨生髓、髓又养骨,肾精不足,骨失所养;肝肾同源,精血互生,肝血不足,筋脉失养。骨软筋萎,势必则变。故而出现骨的变化而形成骨质增生。骨质增生的患者年龄发病主要集中在45-70岁之间,50-60岁发病率最高,本病病变部位多发生于颈椎、腰椎,其次胸椎、膝关节、踝关节和跟骨。骨质增生是一种常见、多发而又较顽固的病症,对人体危害很大,由于患者年龄、体质、病变部位不同,其临床表现及危害程度也有所不同,给患者带来不同程度的痛苦和生活工作的不便。患者的骨关节在骨刺的刺激下,活动时疼痛加剧,如果骨刺长在颈椎、腰椎等部位,还会压迫脊髓或脊神经,病人感到肢体麻木、眩晕、头痛、视力下降。个别严重者会部分或全部丧失劳动能力,生活不能自理。骨质增生发生在双膝关节者,下肢活动会受限,蹲下、站起会很困难。
西医对骨质增生、骨刺尚无有效治疗药物,通常采用对症处理,严重时进行手术治疗,但这些方法疗效均不理想,只治标不治本,且病情易复发。中医药在治疗骨质增生和骨刺方面有着自己的优势,已收载入《中华人民共和国卫生部药品标准——中药成方制剂》14册的穿龙骨刺片,用于治疗骨刺丧生疾病已有10余年上市历史,临床疗效确切,效果显著,但存在针对性不强,服用时间长见效慢、服用量大等弊端。
发明内容
本发明的目的是提供一种治疗骨质增生、关节疼痛的中药组合物及其制备方法,以克服上述不足。
为实现上述目的,本发明的技术解决方案是:
一种治疗骨质增生、关节疼痛的中药组合物,所述中药组合物由以下重量份的原料制备而成:当归20-30份、五灵脂72-83份、威灵仙150-180份、制川乌60-80 份、制草乌31-38份、土鳖虫50-60份、透骨草74-78份、防风83-100份、白芥子 90-110份、黄芪70-80份、羌活60-70份、红花25-38份、全蝎150-160份。
优选地,所述中药组合物由以下重量份的原料制备而成:当归23-26份、五灵脂75-80份、威灵仙160-170份、制川乌65-75份、制草乌33-36份、土鳖虫54-57 份、透骨草75-77份、防风86-94份、白芥子98-105份、黄芪74-78份、羌活62-67 份、红花28-35份、全蝎151-158份。
优选地,所述中药组合物由以下重量份的原料制备而成:当归25份、五灵脂 77份、威灵仙165份、制川乌70份、制草乌34份、土鳖虫56份、透骨草76份、防风90份、白芥子100份、黄芪77份、羌活65份、红花30份、全蝎155份。
优选地,所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过80-100目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加 6-8倍量水,煎煮2-3次,每次1-2h,合并提取液,过滤,减压浓缩成稠膏,加入上述粗粉混匀,即得活性成分。
优选地,所述减压浓缩的真空度为0.5-0.8MPa,温度为50-56℃。
优选地,所述稠膏的相对密度为1.21-1.24。
优选地,所述中药组合物丸剂的制备方法包括以下步骤:
将所述活性成分烘干,粉碎,过120-160目筛,加入辅料混合,制得浓缩丸。
优选地,所述辅料为聚乙二醇4000、硬脂酸、石蜡、乙基纤维素、微晶纤维素、黄酒、白醋。
所述辅料的添加方法包括以下步骤:
将所述活性成分烘干,粉碎,过120-160目筛,然后加入黄酒30-35份、白醋 24-28份混匀,灭菌后放置2-4h,再加入聚乙二醇400025-40份、硬脂酸13-18份、石蜡10-15份、乙基纤维素22-26份、微晶纤维素8-12份混合均匀,制得浓缩丸。
以下是本发明中药制剂的药物来源及主要功效:
当归:伞形科植物当归Angelica sinensis(Oliv.)Diels.的根。【性味归经】性温,味甘、辛。归肝经、心经、脾经。【功效与作用】补血活血、调经止痛、润肠通便。属补虚药下属分类的补血药。用于治血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡。
黄芪:豆科植物蒙古黄芪Astragalus membranaceus Bge.var.mongholicus(Bge.) Hsiao和膜荚黄芪A.membranaceus(Fisch.)Bge.的根。【性味归经】性微温,味甘。归脾经、肺经。【功效与作用】补气固表、利尿、托毒排脓、生肌。属补虚药下属分类的补气药。用于治疗气短心悸、乏力、虚脱、自汗、盗汗、体虚浮肿、慢性肾炎、久泻、脱肛、子宫脱垂、痈疽难溃、疮口久不愈合、小儿支气管哮喘、慢性乙型肝炎、慢性肾炎和病毒性心肌炎。补气宜炙用,止汗、利尿、托毒排脓生肌宜生用。
白芥子:十字花科植物芥Brassicajuncea(L.)Czern.et Cross.的成熟种子。【性味归经】性温,味辛。归肺经。【功效与作用】温肺豁痰利气、散结通络止痛。属化痰止咳平喘药下分类的温化寒痰药。用于治疗寒痰喘咳、胸胁胀痛、痰滞经络、关节麻木疼痛、痰温流注、阴疽肿毒。
红花:景天科植物红景天Rhodiola roseaL.的全草。【性味归经】性平,味甘、苦。归肺经、心经。【功效与作用】益气活血,通脉平喘。属补益药下分类的补气药。用于气虚血瘀,胸痹心痛,中风偏瘫,倦怠气喘。
五灵脂:鼯鼠科动物复齿鼯鼠Trogopterus xanthipes Milne-Edwards的粪便。【性味归经】性温,味咸、甘。归肝经。【功效与作用】活血止痛、化瘀止血、消积解毒。属活血化瘀药下属分类的活血止痛药。用于心腹血气诸痛、妇女经闭、产后瘀滞腹痛、崩漏下血、小儿疳积;外治蛇、蝎、蜈蚣咬伤。
威灵仙:毛茛科植物威灵仙Clematis chinensis Osbeck.、棉团铁线莲Clematishexapetala Pall.或东北铁线莲Clematis manshurica Rupr.的根及根茎。【性味归经】性温,味辛、咸。归膀胱经。【功效与作用】祛风除湿、通络止痛。属祛风湿病下属分类的祛风湿散寒药。用于风湿痹痛、肢体麻木、筋脉拘挛、屈伸不利、骨鲠咽喉。具有镇痛、抗疟,降血糖,利胆,增强食管蠕动,软化鱼骨刺,松弛咽、食道及肠平滑肌等作用。
川乌:为毛茛科植物乌头Aconitum carmichaelii Debx.的干燥母根。【性味归经】性热,味辛、苦,有大毒。归心经、肝经、肾经、脾经。【功效与作用】祛风除湿,温经止痛。属祛风湿药下属分类的祛风湿散寒药。用于风寒湿痹,关节疼痛,心腹冷痛,寒疝作痛及麻醉止痛。
草乌:毛茛科植物北乌头Aconitum kusnezoffii Reichb.的块根。【性味归经】性热,味辛、苦,有大毒。归心经、肝经、肾经、脾经。【功效与作用】祛风、除湿、散寒、止痛。属祛风湿药下分类的祛风湿散寒药。用于风寒湿痹、肢体关节冷痛、心腹冷痛。
土鳖虫:鳖蠊科昆虫地鳖Eupolyphaga sinensis Walker或冀地鳖Steleophagphancyi(Boleny)的雌虫全体。【性味归经】性寒,味咸,有小毒。归肝经。【功效与作用】破瘀血,续筋骨。属活血化瘀药下属分类的活血疗伤药。用于筋骨折伤、瘀血经闭、癥瘕痞块。
透骨草:全草均可入药Phryma leptostachya L.。【性味归经】味甘、辛,性温。归肺、肝经。【功效与作用】活血化瘀、利尿解毒、通经透骨,主风湿痹痛、筋骨挛缩、寒湿脚气、腰部扭伤、瘫痪、闭经、阴囊湿疹、疮疖肿毒。
羌活:伞形科植物羌活Notopterygium incisum Ting ex H.T.Chang或宽叶羌活Notopterygium,franchetii H.de Boiss.的干燥根茎和根。【性味归经】性温,味辛、苦。归膀胱经、肾经。【功效与作用】解表散寒,祛风除湿,止痛。属解表药下属分类的辛温解表药。用于风寒感冒,头痛项强,风湿痹痛,肩背酸痛。
全蝎:钳蝎科动物东亚钳蝎Buthus martensii Karsch的全体。【性味归经】性平,味辛,有毒。归肝经。【功效与作用】息风镇痉、攻毒散结、通络止痛。属平肝息风药下属分类的息风止痉药。用于小儿惊风、抽搐痉挛、中风口歪、半身不遂、破伤风、风湿顽痹、偏正头痛、疮疡、瘰疬。
防风:伞形科植物防风Saposhnikovia divaricata(Turcz.)Schischk.的根。【性味归经】性温,味甘、辛。归膀胱经、肝经、脾经。【功效与作用】发表、祛风、除湿。属解表药下分类辛温解表药。用于感冒、头痛、发热、无汗、风湿痹痛、四肢拘挛、皮肤风湿瘙痒、破伤风等症。
中医理论认为,药有个性之长,方有合群之用。本发明中药组合物中的原料药:五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎、防风、当归、黄芪、白芥子、红花具有活血化瘀、祛风除湿、益气补血之功效;其中当归、黄芪、白芥子、红花、防风具有益气活血、补气化寒之功效,能够改善血液循环,消除体内神经炎症,祛除体内寒气,补充气血供养;五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎具有活血止痛、化瘀、通经透骨之功效。综合以上诸药合理配伍,制成浓缩丸,使患者体内粘稠的血液得以运化,以达到新旧细胞的交换,从而使骨质增生、颈椎病、腰椎肩盘突出、坐骨神经痛、风湿类关节炎、肩周炎、强直性脊柱炎、腰肌劳损、股骨头坏死、骨质疏松、关节肿大变形症状消失。
本发明的有益效果是:
(1)本发明中药组合物各组分之间相互协同,通过辅料微晶纤维素、黄酒、白醋的添加,增加药物的横穿透力,使药物的活性成分直达病灶,具有促进中药组合物在体内崩解吸收,促进活血通络、降低药物寒性、散瘀活血和消肿止痛的作用。
(2)本发明中药组合物在体内溶解、吸收后,具有益气补血、促进血液循环的作用,且能够活血化瘀、祛风除湿、消肿止痛、补气化寒、通经透骨,有效的激发了体内的血液运行,对使骨质增生、颈椎病、腰椎肩盘突出、坐骨神经痛、风湿类关节炎、肩周炎、强直性脊柱炎、腰肌劳损、股骨头坏死、骨质疏松、关节肿大变形等起到了标本兼顾的作用。
(3)本发明与普通西药治疗组相比,有效率达98.26%,疗效显著,无胃肠道不良反应。
具体实施方式
为更好的理解本发明,现通过实施方式作进一步详细说明,以下实施例属于本发明的保护范围,但不限制本发明的保护范围。
在实施例中,所述的治疗骨质增生、关节疼痛的中药组合物,所述中药组合物由以下重量份的原料制备而成:当归20-30份、五灵脂72-83份、威灵仙150-180 份、制川乌60-80份、制草乌31-38份、土鳖虫50-60份、透骨草74-78份、防风 83-100份、白芥子90-110份、黄芪70-80份、羌活60-70份、红花25-38份、全蝎 150-160份。
所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过80-100目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加 6-8倍量水,煎煮2-3次,每次1-2h,合并提取液,过滤,减压浓缩成稠膏,所述减压浓缩的真空度为0.5-0.8MPa,温度为50-56℃,所述稠膏的相对密度为1.21-1.24,再加入上述粗粉混匀,即得活性成分;将所述活性成分烘干,粉碎,过120-160目筛,然后加入黄酒30-35份、白醋24-28份混匀,灭菌后放置2-4h,再加入聚乙二醇400025-40份、硬脂酸13-18份、石蜡10-15份、乙基纤维素22-26份、微晶纤维素8-12份混合均匀,制得浓缩丸。
实施例1
一种治疗骨质增生、关节疼痛的中药组合物,所述中药组合物由以下重量份的原料制备而成:当归23份、五灵脂83份、威灵仙170份、制川乌60份、制草乌 38份、土鳖虫54份、透骨草74份、防风100份、白芥子110份、黄芪70份、羌活67份、红花25份、全蝎151份。
所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过100目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加8倍量水,煎煮2次,每次2h,合并提取液,过滤,减压浓缩成稠膏,所述减压浓缩的真空度为0.7MPa,温度为50℃,所述稠膏的相对密度为1.22,再加入上述粗粉混匀,即得活性成分;将所述活性成分烘干,粉碎,过160目筛,然后加入黄酒30 份、白醋26份混匀,灭菌后放置2h,再加入聚乙二醇400028份、硬脂酸18份、石蜡12份、乙基纤维素22份、微晶纤维素12份混合均匀,制得浓缩丸。
实施例2
一种治疗骨质增生、关节疼痛的中药组合物,所述中药组合物由以下重量份的原料制备而成:当归20份、五灵脂80份、威灵仙150份、制川乌80份、制草乌 33份、土鳖虫50份、透骨草78份、防风94份、白芥子98份、黄芪80份、羌活 60份、红花38份、全蝎150份。
所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过80目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加7倍量水,煎煮2次,每次1.5h,合并提取液,过滤,减压浓缩成稠膏,所述减压浓缩的真空度为0.5MPa,温度为56℃,所述稠膏的相对密度为1.21,再加入上述粗粉混匀,即得活性成分;将所述活性成分烘干,粉碎,过140目筛,然后加入黄酒35 份、白醋24份混匀,灭菌后放置4h,再加入聚乙二醇400025份、硬脂酸16份、石蜡10份、乙基纤维素26份、微晶纤维素11份混合均匀,制得浓缩丸。
实施例3
一种治疗骨质增生、关节疼痛的中药组合物,所述中药组合物由以下重量份的原料制备而成:当归30份、五灵脂72份、威灵仙180份、制川乌65份、制草乌 31份、土鳖虫60份、透骨草75份、防风83份、白芥子90份、黄芪78份、羌活 70份、红花28份、全蝎160份。
所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过100目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加6倍量水,煎煮3次,每次1h,合并提取液,过滤,减压浓缩成稠膏,所述减压浓缩的真空度为0.8MPa,温度为55℃,所述稠膏的相对密度为1.24,再加入上述粗粉混匀,即得活性成分;将所述活性成分烘干,粉碎,过120目筛,然后加入黄酒32 份、白醋28份混匀,灭菌后放置3h,再加入聚乙二醇400040份、硬脂酸13份、石蜡15份、乙基纤维素24份、微晶纤维素8份混合均匀,制得浓缩丸。
实施例4
一种治疗骨质增生、关节疼痛的中药组合物,所述中药组合物由以下重量份的原料制备而成:当归26份、五灵脂75份、威灵仙160份、制川乌75份、制草乌 36份、土鳖虫57份、透骨草77份、防风86份、白芥子105份、黄芪74份、羌活 62份、红花35份、全蝎158份。
所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过80目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加7倍量水,煎煮2次,每次2h,合并提取液,过滤,减压浓缩成稠膏,所述减压浓缩的真空度为0.7MPa,温度为50℃,所述稠膏的相对密度为1.23,再加入上述粗粉混匀,即得活性成分;将所述活性成分烘干,粉碎,过120目筛,然后加入黄酒32 份、白醋27份混匀,灭菌后放置2h,再加入聚乙二醇400032份、硬脂酸17份、石蜡14份、乙基纤维素25份、微晶纤维素10份混合均匀,制得浓缩丸。
实施例5
一种治疗骨质增生、关节疼痛的中药组合物,所述中药组合物由以下重量份的原料制备而成:当归25份、五灵脂77份、威灵仙165份、制川乌70份、制草乌 34份、土鳖虫56份、透骨草76份、防风90份、白芥子100份、黄芪77份、羌活 65份、红花30份、全蝎155份。
所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过100目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加8倍量水,煎煮3次,每次1h,合并提取液,过滤,减压浓缩成稠膏,所述减压浓缩的真空度为0.6MPa,温度为50℃,所述稠膏的相对密度为1.24,再加入上述粗粉混匀,即得活性成分;将所述活性成分烘干,粉碎,过160目筛,然后加入黄酒35 份、白醋26份混匀,灭菌后放置2h,再加入聚乙二醇400038份、硬脂酸15份、石蜡13份、乙基纤维素23份、微晶纤维素11份混合均匀,制得浓缩丸。
对比例1
制备方法与实施例5相同,不同之处在于组份中缺少全蝎、威灵仙、黄芪、白芥子,辅料不含微晶纤维素、黄酒、白醋。
对比例2
制备方法与实施例5相同,不同之处在于组份中缺少全蝎、威灵仙、黄芪、白芥子。
对比例3
组份与实施例5相同,不同之处在于制备过程中辅料不含微晶纤维素、黄酒、白醋。
对比例4
采用中国专利“一种治疗颈腰椎骨质增生、腰椎间盘突出病的药物(专利号: ZL201410026888.6)”中实施例1的方法制备的药物。
临床治疗总结
1.一般资料
575例骨质增生、关节疼痛患者,男280例,女180例平均年龄(65.4±1.6) 岁,随机分为5组,每组115人。5组性别、年龄、病程等资料比较,差异无统计学意义(P>0.05),具有可比性。
2.诊断标准
参照《中医病症诊断疗效标准》中的有关诊断标准拟定,并辅以x线片或CT 扫描加以确诊。
3.治疗方法
治疗组:服用采用本实施例5方法制备的中药丸剂,每天早晚各一次,每次六克,疗程为30天。
对照组:服用采用对比例1-4所述的方法制备中药丸剂,每天早晚各一次,每次六克,疗程为30天。
4.评价方法
参照《临床疾病诊断依据治愈好转标准》拟定。
痊愈:临床症状完全消失,影像学改变消失或者明显改善;
显效:临床症状基本消失或者大部分明显改善,影像学明显改善;
有效:临床症状部分明显改善,影像学部分改善或无变化;
无效:临床症状和影像学均无变化。
5组患者治疗结果见下表。
由上表可见,治疗组服用实施例5的中药组合物,治愈人数明显高于对比例4,治疗骨质增生、关节疼痛的有效率达到98.26%。由对比例1-3可知,当本发明中缺少部分中药成分,或者部分辅料时,药物的疗效明显降低,这可能是全蝎、威灵仙、黄芪、白芥子,和辅料中的微晶纤维素、黄酒、白醋之间产生了协同作用,促进药物的药效。
5.典型病例
病例1
杨某,男,河北省邯郸市大名县南关人,67岁。腰、腿疼痛严重,行动不便3 年,曾用多种膏药贴敷,症状无明显减轻。于2015年10月28日确诊为腰椎间盘突出、风湿性关节炎,服用本发明药物5天,疼痛减轻,服用2个月后,腰腿不再疼痛,能自如行走。
病例2
黄某,女,河北省邯郸市大名县大街人,58岁。常年腰腿疼痛、阴雨天气加重已有2年,曾给予按摩、服药等治疗,症状无明显变化。于2017年2月3日确诊为风湿性骨头变形、膝关节增生,服用本发明药物5天,疼痛减轻,服用1个月后,病情大有好转,经过2个月的治疗后症状完全消失。
病例3
赵某,男,河北省邯郸市大名县万堤镇人,60岁。于2007年6月开始颈左侧、右肩、右臂及手指隐隐痛麻,时有时无,时轻时艰,后来逐渐加重,疼痛剧烈时如刀割电击,夜间尤甚,常常终夜难眠,多方治疗收效甚微。2008年9月求治,发现颈部活动尚可,唯姿势稍有不适,右臂就阵阵窜痛,令其旋肩举手,当手臂后旋时一阵剧痛,立即蹲下,出了一身冷汗。经拍片显示第5-7颈椎两侧有骨质增生,诊为神经根型颈椎病,服用本发明药物20天以后,疼痛减过半。二诊时,自述夜间虽痛但可以忍受住并能入睡,又服用本发明药物两个月后疼痛症状完全消失,此后未复发。
以上所述仅为本发明的实施例,并非因此限制本发明的专利范围,凡是利用本发明说明书内容所作的等效变换,或直接或间接运用在其它相关的技术领域,均同理包括在本发明的专利保护范围内。
Claims (8)
1.一种治疗骨质增生、关节疼痛的中药组合物,其特征在于,所述中药组合物由以下重量份的原料制备而成:当归20-30份、五灵脂72-83份、威灵仙150-180份、制川乌60-80份、制草乌31-38份、土鳖虫50-60份、透骨草74-78份、防风83-100份、白芥子90-110份、黄芪70-80份、羌活60-70份、红花25-38份、全蝎150-160份。
2.根据权利要求1所述的治疗骨质增生、关节疼痛的中药组合物,其特征在于,所述中药组合物由以下重量份的原料制备而成:当归23-26份、五灵脂75-80份、威灵仙160-170份、制川乌65-75份、制草乌33-36份、土鳖虫54-57份、透骨草75-77份、防风86-94份、白芥子98-105份、黄芪74-78份、羌活62-67份、红花28-35份、全蝎151-158份。
3.根据权利要求1所述的治疗骨质增生、关节疼痛的中药组合物,其特征在于,所述中药组合物由以下重量份的原料制备而成:当归25份、五灵脂77份、威灵仙165份、制川乌70份、制草乌34份、土鳖虫56份、透骨草76份、防风90份、白芥子100份、黄芪77份、羌活65份、红花30份、全蝎155份。
4.根据权利要求1所述的治疗骨质增生、关节疼痛的中药组合物,其特征在于,所述中药组合物活性成分的制备方法包括以下步骤:
将所述的五灵脂、威灵仙、制川乌、制草乌、土鳖虫、透骨草、羌活、全蝎粉碎成粗粉,过80-100目筛,备用;将防风、当归、黄芪、白芥子、红花煎煮,加6-8倍量水,煎煮2-3次,每次1-2h,合并提取液,过滤,减压浓缩成稠膏,加入上述粗粉混匀,即得活性成分。
5.根据权利要求4所述的治疗骨质增生、关节疼痛的中药组合物,其特征在于,所述减压浓缩的真空度为0.5-0.8MPa,温度为50-56℃。
6.根据权利要求4所述的治疗骨质增生、关节疼痛的中药组合物,其特征在于,所述稠膏的相对密度为1.21-1.24。
7.根据权利要求4所述的治疗骨质增生、关节疼痛的中药组合物,其特征在于:所述中药组合物丸剂的制备方法包括以下步骤:
将所述活性成分烘干,粉碎,过120-160目筛,加入辅料混合,制得浓缩丸。
8.根据权利要求7所述的治疗骨质增生、关节疼痛的中药组合物,其特征在于:所述辅料为聚乙二醇4000、硬脂酸、石蜡、乙基纤维素、微晶纤维素、黄酒、白醋。
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