CN101810685B - 一种治疗膝关节炎症的中药组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗膝关节炎症的中药组合物及其制备方法,中药组合物的内服药物为:当归,川芎,秦艽,三七,徐长卿,红花,怀牛膝,桂枝,鸡血藤,黑皮跌打,小茴香,虎杖,乌梢蛇,防风,伸筋草,骨碎补,杜仲,老鹳草,白芍;外用药物为:没药,乳香,续断,羌活,红花,三七,天麻,小茴香,制川乌,蝎子,透骨草。本发明的中药制剂安全,毒副作用小,治愈时间短,治愈后不易复发;且具有药剂易于制造,成本低廉等优点。
Description
技术领域
本发明涉及含有来源于植物、动物或矿物组份的医用配制品及其制备方法,特别涉及一种治疗膝关节炎症的中药组合物及其制备方法。
背景技术
《素问·五脏生成篇》曰:“足受血能步行,掌受血能握,指受血能摄。”肝主筋,脾主肌肉四肢,关节功能维持与肝脾、气血、荣卫密切相关。“肢体损于外,则气血伤于内,荣卫有所不贯”滑膜损伤,渗出水液,湿邪滞留。所以产生膝关节炎,滑膜炎等常见的膝关节炎症。关节炎是一种常见的以关节组织慢性炎症为主要表现的自身免疫性疾病。
病变关节主要表现为炎症细胞浸润,滑膜增生、血管翳形成以及由此引发的软骨和骨的损伤。关节炎属中医学“痹病”范畴。《内经》认为,素体气血亏虚,风、寒、湿三气杂合乘虚入侵人体,流注筋骨血脉,搏结于关节,是痹病的主要病因病机。所以,风寒湿热之邪只是本病发生的外部条件,而气血不足,营卫失调才是本病的内在因素。治疗本病当以祛风散寒除湿,益气活血通络为大法。
膝部有许多与关节活动和肌腱滑动结构有关的滑囊,有的与关节相通,有的则孤立存在,最易患病的滑囊是髌前滑囊,髌下滑囊腓肠肌、膝部遭受长期的外力磨擦或压迫,均可导致滑膜充血、水肿及浆液渗出,形成急性的滑囊积液、囊壁增厚和关节粘连等病理改变。膝关节囊的滑膜层血运丰富,分布范围较大,是膝关节的重要结构之一。
滑膜细胞能分泌滑液,保持关节面的润滑。膝关节滑膜炎的发生多是由于膝关节急性创伤,或是由于慢性劳损、骨质增生以及风湿因素而导致的滑膜无菌性炎症。其病理改变主要有二:一是病区域滑膜的血管扩张、充血,血浆、红细胞、白细胞等外渗,产生大量渗出液;二是滑膜细胞活跃增生,细胞分泌异常旺盛,产生大量黏液素,关节腔积液,关节压力增高,阻碍淋巴系统循环,使关节内酸性代谢产物堆积,如此长时间存留,可加重滑膜炎症使病情恶性循环。
后期则滑膜增厚,黏连,关节软骨萎缩,导致膝关节功能障碍。膝关节诸多炎症均属中医“膝部伤筋”范畴,由于膝部外伤劳损,气血瘀滞,水湿停着,经络不通所致,祖国医学认为肝肾亏虚,筋骨失养,腠理空虚,风寒杂至,凝滞血脉,血不荣筋,筋脉挛急,要强筋骨、补肝肾,使局部血管扩张,血运增强,代谢增强,免疫力提高,从而使疼痛缓解,促进瘀血的吸收,起到舒筋活络、固本祛邪、消肿止痛的作用。
中医认为,风、寒、湿、热等外邪侵袭人体,闭阻经络,气血不能畅行,引起筋骨、关节等酸痛、麻木、重着、伸屈不利,甚或关节肿大灼热,以致不通则痛。对于这个人体最大的关节,单纯的中药内服是不可取的,必须多种手法结合治疗,才能达到事半功倍的效果,其中按摩,针灸,热敷都是不错的选择。
针灸治疗是一种绿色疗法,且起效迅速,预后理想,其疗效是肯定的,这将会给患者带来新的希望。治疗膝关节骨性关节炎常针刺内外膝眼、鹤顶、阴陵泉、血海、梁丘、足三里等穴,以疏通经络,活血行气,消肿止痛。
《灵枢·九针十二原》云:凡用针者,虚则实之。实则虚之,满则泻之,宛陈则除之。膝关节在上述某种因素的影响下,造成膝关节周围经络阻滞,气血运行不畅,瘀于局部而成肿胀,积液一旦生成则又会进一步阻碍气血运行,而长时间的积液刺激会导致膝关节滑膜增生,长时间的活动受限和气血循行阻滞也会导致下肢肌肉萎缩,而针灸则有斩关夺隘之功,可直接开门驱邪,把宛陈之积液排除体外,再有经络气血得温则行,遇寒则凝,故针灸之力又可开闭,掘塞,疏通经络,使气血运行得畅,故其病自可痊愈。
发明内容
本发明所要解决的技术问题在于,提供一种治疗膝关节炎症的中药组合物及其制备方法。本发明中药组合物能够强筋骨、补肝肾,使局部血管扩张,血运增强,代谢增强,免疫力提高,从而使疼痛缓解,促进瘀血的吸收,起到舒筋活络、固本祛邪、消肿止痛。
为解决上述技术问题,本发明提供了一种治疗膝关节炎症的中药组合物,由内服药物和外用药物组成,内服药物为蜜炼丸剂、胶囊剂或粉剂,外用药物为擦剂;
其中,所述蜜炼丸剂的制作过程为:当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,乌梢蛇2条,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g,把药材加水浸泡30分钟至1小时,加热煮沸45分钟,过滤,滤液备用;滤渣加水,第二次加热,煮沸30分钟,再过滤,滤液备用;将两次滤液合在一起,加热浓缩至糊状,放入烘箱,控制在75℃,烘干后冷却成粉末状与蜂蜜混和在一起搓成细条;以每5g为一丸蜡封蜡封包装;
其中,所述胶囊剂的制作过程为:取乌梢蛇2条放入10倍量乙醇中,加热回流提取30分钟~45分钟,提取活性成份,将提取液静置;取当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g加水加热回流提取3次,每次30分钟~45分钟,将3次提取液合并静置;将上述两种提取液合并,减压回收乙醇并浓缩至药液浓度为0.8g生药/mL,抽滤后,滤液的相对密度为20℃时1.07;上述滤液经体积为10L的大孔吸附树脂柱吸附;吸附之后用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的乙醇洗脱,收集乙醇洗脱液,去除乙醇溶剂,得到组份药粉,装入胶囊制为胶囊剂;每粒胶囊装0.3g;
其中,所述粉剂中成药的制作过程为:当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,乌梢蛇2条,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g,上述组份按配比混合,投入粉碎机粉碎成细粉,细粉过筛后放入耐酸碱浸渍锅内,在常温下,与乙醇共同浸渍10~20天,将浸渍好的液体及药渣进行压榨过滤,分离后取滤液,加热浓缩至糊状,放入烘箱,控制在100℃,烘干后冷却,粉碎后以每袋4~6g包装;
其中,所述外用擦剂的制备方法包括:将天麻1000g、小茴香1000g、制川乌50g和蝎子3条用乙醇浸泡,后60~85℃热提取3次,每次1小时,所用乙醇为蝎子、小茴香、制川乌和天麻四种药材的总重量的10倍量;加热浓缩乙醇提取液,浓缩至相对密度为1.06的浓缩液,静置备用;将其余组份没药1000g,乳香1000g,续断1000g,红花1000g,三七1000g,透骨草1000g按配比混合,投入粉碎机粉碎成细粉,细粉过筛后放入耐酸碱浸渍锅内,在常温常压下,与乙醇共同浸渍10~15天,将浸渍好的液体及药渣进行压榨过滤,分离后取滤液,然后与前述浓缩液混和;将所述混和液加热浓缩至糊状,放入烘箱80℃烘干后冷却,与羌活1000g混和研磨成细粉状,掺入凡士林制成擦剂。
本发明中药组合物采用纯中药配制而成,具有疗效确切、安全、无明显毒副作用等特点,具有强筋骨、补肝肾,使局部血管扩张,血运增强,代谢增强,免疫力提高,从而使疼痛缓解,促进瘀血的吸收,起到舒筋活络、固本祛邪、消肿止痛的作用。本发明采用补肾壮骨、活血化瘀作用的中药对膝关节有一定疗效,可改善局部动脉供血功能障碍,增强局部血流量,促进骨小梁再生形成,囊状改变缩小,硬化骨吸收,软骨部位修复,血脉通畅肌肉萎缩恢复与现有技术相比教,本技术具有给药方便,药剂易于制造,成本低廉等优点。本发明采用不同药性的中药材,进行了科学配伍,能达到理想的治疗效果,配合针灸,按摩,推拿等方式使用事半功倍;且安全,毒副作用小,使用方便,治愈时间短,治愈后不易复发。能创造较好的社会价值及经济利益。
具体实施方式
膝关节炎症属中国传统医学“痹证”、“鹤膝风”等范畴,本病初期为外伤瘀血内停经脉受阻(急性)或风、寒、湿、邪三气杂合(慢性)瘀血内阻,气血不得畅行,阳气不得敷布,水湿停聚流注关节,湿郁而化热,湿热相搏,瘀滞积液所致,故治疗上以活血化瘀、清热利湿、舒筋通络、消肿止痛为主。中药治疗本病,应从两方面着手:一是解决关节瘀血,二是抑制滑膜异常分泌,这是治疗本病的关键所在。
《素问·五脏生成篇》曰:“足受血能步行,掌受血能握,指受血能摄。”肝主筋,脾主肌肉四肢,关节功能维持与肝脾、气血、荣卫密切相关。“肢体损于外,则气血伤于内,荣卫有所不贯”滑膜损伤,渗出水液,湿邪滞留。施治采取益气调荣卫,利水湿强筋骨。膝关节炎症多由慢性劳损或损伤所致,也有因急性滑膜炎处理不当而成慢性状态。多见体质多湿者,临床以关节积液、肿胀、伸屈困难、疼痛不剧烈为主要表现,属中医学痹证夹湿范畴。关节运动靠肌肉牵拉,靠滑膜分泌滑液润滑,而肌肉、筋骨、滑液又靠气血濡养。
因此适当的穴位注射及手法按摩可起到活血化瘀、舒筋通络,消肿止痛作用,可改善血液循环,促进细胞代谢及渗出液吸收的作用。另外,局部固定制动使患膝得以休息,减少不良刺激,加速滑膜修复;膝关节解剖复杂,关节功能活动要求高,滑膜的退变、肥厚、黏连、纤维化、挛缩等,往往导致股四头肌的挛缩,关节功能活动障碍,甚至强直、僵硬。因此,及早行股四头肌及膝关节功能锻炼也是治疗本病的关键。
股四头肌功能锻炼,可有效防止关节周围黏连,肌肉萎缩,增加局部血液循环,加速新陈代谢,从而有利于膝关节滑膜及其软骨的营养和修复,消除局部炎症,有利于渗出液的吸收,促进肿胀消退。诸法合用,即可解除关节滑膜炎症,消除关节积液,促进关节功能改善,达到标本兼治之功。当膝关节直接受到暴力打击或受到间接暴力造成膝关节扭伤,长期的负重慢性劳损,或肢体本身力学紊乱,剧烈运动或超强度的训练,不正确的活动姿势,粗暴的治疗手法或关节手术等均可触及或伤及滑膜而产生独特的炎症反应,造成滑膜损伤充血、肿胀,滑膜细胞产生大量滑液,而至关节内积液。
关节炎是一种常见的以关节组织慢性炎症为主要表现的自身免疫性疾病。病变关节主要表现为炎症细胞浸润,滑膜增生、血管翳形成以及由此引发的软骨和骨的损伤。类风湿关节炎属中医学“痹病”范畴。《内经》认为,素体气血亏虚,风、寒、湿三气杂合乘虚入侵人体,流注筋骨血脉,搏结于关节,是痹病的主要病因病机。所以,风寒湿热之邪只是本病发生的外部条件,而气血不足,营卫失调才是本病的内在因素。治疗本病当以祛风散寒除湿,益气活血通络为大法。
方中以桂枝、防风、散寒除湿,以消除外来之邪,疏通经络;以当归、川芎活血化瘀、消除瘀滞,疏通经脉;以当归、白芍扶正益气养血,使正气内存,病邪渐退;从现代医学角度来看,本方具有消炎、镇痛、调节免疫之功能。其中当归、川芎、桂枝、具有改善局部微循环,抑制体液免疫、消除局部炎症;而当归等能调节细胞免疫功能。诸药合用,标本兼治,既注重整体宏观调整,又重视局部微观治疗,具有辨证与辨病,局部与整体相结合的特点,故能取得较好的临床疗效。方中鸡血藤、红花、当归、川芎、乳香、没药、老鹳草、透骨草活血化瘀,祛除瘀血,促进瘀血吸收;桂枝有温阳化气利水、消肿之功;白芍清热利水渗湿,消除积液,抑制滑膜异常分泌的作用;伸筋草、续断舒筋通络止痛,达通则不痛之效。徐长卿滋阴养血;黑皮跌打清心活血,使补而不滞;白芍、小茴香和三七能散瘀血、破血通经;川芎擅疏通,上行头目,下行血海,为血中气药,为止痛圣药;当归补血润燥,通经化瘀;怀牛膝、益气敛阴,助补气生阴之力;秦艽滋阴润燥、清热除烦;红花载药上行,使药力上行,可行气血,使诸药滋而不腻,补不留瘀;乌梢蛇以毒化瘀;制川乌破血化瘀;诸药合用补行兼施,共奏益气滋阴养血,行气活血止痛,去腐生肌,囊状改变缩小,硬化骨吸收,软骨部位修复,血脉通畅肌肉萎缩恢复之功。
当归:其味甘而重,故专能补血,其气轻而辛,故又能行血,补中有动,行中有补,诚血中之气药,亦血中之圣药。大约佐之以补则补,故能养营养血,补气生精,安五脏,强形体,益神志,凡有形虚损之病,无所不宜。佐之以攻则通,故能祛痛通便,利筋骨,治拘挛、瘫痪、燥、涩等证。营虚而表不解者,佐以柴、葛、麻、桂等剂,大能散表卫热,而表不敛者,佐以大黄之类,又能固表。惟其气辛而动,故欲其静者当避之,性滑善行,大便不固者当避之。凡阴中火盛者,当归能动血,亦非所宜,阴中阳虚者,当归能养血,乃不可少。
三七性甘味微苦,性温,归肝、胃经以根、根状茎入药。是名贵中药材,生用可止血化瘀、消肿止痛,具有良好的止血功效、显著的造血功能;能加强和改善冠脉微循环,三七入药历史悠久,作用奇特被历代医家视为药中之宝,故有“金不换”之说法。三七“味微甘而苦,颇似人参之味。”“凡杖扑伤损,瘀血淋漓者,随即嚼烂罨之即止,青肿者即消散。若受杖时,先服一、二钱,则血不冲心,杖后尤宜服之,产后服亦良。大抵此药气温,味甘微苦,及阳明、厥阴血分之药,故能治一切血病”。《本草求真》记载:“三七,世人仅知功能止血止痛。殊不知痛因血瘀而疼作,血因敷散而血止。三七气味苦温,能于血分化其血瘀。”
川芎辛,温。入肝、胆经。行气开郁,法风燥湿,活血止痛。治风冷头痛旋晕,胁痛腹疼,寒痹筋挛,经闭,难产,产后瘀阻块痛,痈疽疮疡。用于月经不调,经闭痛经,瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。《本经》载其:主中风入脑头痛,寒痹,筋挛缓急,金创,妇人血闭无子。《别录》载其:″除脑中冷动,面上游风去来,目泪出,多涕唾,忽忽如醉,诸寒冷气,心腹坚痛,中恶,卒急肿痛,胁风痛,温中内寒。″是行气化瘀的良药。
虎杖微苦,微寒。归肝、胆、肺经。功能清热解毒,利胆退黄,祛风利湿,散瘀定痛,止咳化痰。用于关节痹痛,湿热黄疸,经闭,癓瘕,咳嗽痰多,水火烫伤,跌扑损伤,痈肿疮毒。《医林纂要》载其:坚肾,强阳益精,壮筋骨,增气力。敷跌伤折损处,可续筋接骨。
白芍入肝、脾经,养血柔肝,缓中止痛,敛阴收汗。治胸腹胁肋疼痛,泻痢腹痛,自汗盗汗,阴虚发热,月经不调,崩漏,带下,妇人血闭不通,消瘀血,能蚀脓,益女子血。《日华子本草》:治风、补劳,主女人一切病,并产前后诸疾,通月水,退热,除烦,益气,天行热疾,瘟瘴,惊狂,妇人血运,及肠风,泻血,痔瘘。发背,疮疥,头痛,明目,目赤努肉。赤色者多补气,白者治血。
红花性温,味辛。功能主治应用于活血通径、散瘀止痛。用于经闭、痛经、恶露不行、症瘕痞块、跌打损伤。《本草汇言》:红花,破血、行血、和血、调血之药也。主胎产百病因血为患,或血烦血晕,神昏不语;或恶露抢心,脐腹绞痛;或沥浆难生,;或胞衣不落,子死腹中,是皆临产诸证,非红花不能治。若产后血晕、口噤指搦;或邪入血室,谵语发狂;或血闷内胀,僵仆如死,是皆产后诸证,非红花不能定。凡如经闭不通而寒热交作,或过期腹痛而紫黑淋漓,或跌扑损伤而气血瘀积,或疮疡痛痒而肿溃不安,是皆气血不和之证,非红花不能调。
怀牛膝药效高,李时珍说它:滋补之功,如牛之力。牛膝气味苦酸平,主治寒湿痿痹、四肢拘挛,膝痛不可屈伸,逐血气,伤热火烂,久服轻身耐老。1.其中所含生物碱,具有良好的降压作用。2.所含的脱皮甾酮能改善肝功能,降低血浆胆固醇,有增强细胞活性的作用。3.富含牛膝多糖有明显的增强体液免疫功能作用。4.对人体因缺乏锌、锰所导致内分泌功能低下或腺体萎缩,生长缓慢、阳痿、不孕、习惯性流产等病理变化有较好的疗效。5.具有抗炎与镇痛作用。6.具有将胆囊、肾脏、膀胱、尿道的结石化解并排出体外的功能。7.其有效成分有一定的兴奋子宫、抗衰老作用。8.利尿、解痉作用。所以它的一味活血化瘀健体的良药。
桂枝辛、甘,温。归心、肺、膀胱经。功效发汗解肌,温经通脉,助阳化气,散寒止痛。其有效成分是桂皮油。其作用是扩张血管,调节血液循环,使血液流向体表,发汗解肌,温通经脉,助阳化气,平冲降气。用于风寒感冒,脘腹冷痛,血寒经闭,关节痹痛,痰饮,水肿,心悸,奔豚。《本草别说》载其:仲景《伤寒论》发汗用桂枝。桂枝者,枝条,非身干也。取其轻薄而能发散。今又有一种柳桂,乃桂之嫩小枝条也,尤宜人治上焦药用也。
鸡血藤性苦、甘,温。归肝、肾经,补血,活血,通络。用于月经不调,血虚萎黄,麻木瘫痪,风湿痹痛活血舒筋;养血调经,《本草纲目拾遗》载其能医手足麻木;肢体瘫痪;风湿痹痛;鸡血藤内服是治疗血淤不散,养血化淤活血的良药。
乌梢蛇祛风,通络,止痉。用于风湿顽痹,麻木拘挛,中风口眼歪斜,半身不遂,抽搐痉挛,破伤风,麻风疥癣,瘰疬恶疮。眼镜蛇、蝮蛇均为有毒蛇,祛风湿、通经络作用较强,乌梢蛇与二者同用,其效尤佳。用于风湿痹痛或类风湿关节炎、类风湿性脊柱炎等。乌梢蛇1条,切片煮汤。加猪脂、盐、姜少许调味,饮汤吃肉。乌梢蛇有祛风除湿和解毒作用,对于荨麻疹、湿疹脓疮也有一定预防或治疗效果。本方和以煮作汤羹,尤宜于食用。
防风味辛、甘,性微温。归膀胱、肝、脾经。祛风解表,胜湿止痛,止痉。外感表证,风疹瘙痒,风湿痹痛,破伤风。用于感冒头痛,风疹瘙痒。治风寒表证,头痛身痛、恶风寒者,常配伍荆芥、羌活、独活等;治外感风湿,头痛如裹、身重肢痛者,与羌活、藁本等同用;治风疹瘙痒,多配伍苦参、荆芥、当归等。用于风湿痹痛。适用于风寒湿痹,肢节疼痛、筋脉挛急者,常配合羌活、桂枝、姜黄。
老鹳草苦、为辛,平。归肝、肾、大肠经,功能主治祛除风湿。用于风湿痹痛。肢体麻木、关节不利等症,单用有效,水煎服或熬膏用;如配伍桂枝、当归、红花、芍药等药,能增强活血通络止痛等作用。
制川乌辛、苦,热;有大毒。归心、肝、肾、脾经。祛风除湿,温经止痛。用于风寒湿痹、关节疼痛、心腹冷痛、寒疝作痛。多在炮制后用。一般在中药的配方里,川乌的用量多为15-30g。剂量最好不要超过60g。
伸筋草微苦、辛,温。归肝、脾、肾经。祛风除湿,舒筋活络。用于关节酸痛,屈伸不利。微苦、辛,温。归肝、脾、肾经。祛风除湿,舒筋活络。用于关节酸痛,屈伸不利。生草药性备要》:(伸筋草)“消肿,除风温。浸酒饮,舒筋活络。其根治气结疼痛,损伤,金疮内伤,去痰止咳,治疮疽卒手足。”
透骨草甘,辛,温。入肺、肝经。功能主治祛风除湿,解毒止痛。用于风湿关节痛;外用治疮疡肿毒。配伸筋草,治肝肾不足,筋骨失养,屈伸不利,肢体麻木,筋骨挛缩,有伸筋透骨之效。配鸡血藤,补肝益肾,活血止痛,久痹属虚者最为相宜。
骨碎补苦,温。归肾、肝经。补肾强骨,续伤止痛。用于肾虚腰痛,耳鸣耳聋,牙齿松动,跌扑闪挫,筋骨折伤;外治斑秃,白癜风。补肾,活血,止血。治肾虚久泻及腰痛,风湿痹痛,齿痛,耳鸣,跌打闪挫、骨伤,阑尾炎,斑秃,鸡眼。《药性论》:″主骨中毒气,风血疼痛,五劳六极,手不收,上热下冷。″《本草正》:″疗骨中邪毒,风热疼痛,或外感风湿,以致两足痿弱疼痛。
杜仲补肝肾,强筋骨,安胎。治腰脊酸疼,足膝痿弱,小便余沥,阴下湿痒,胎漏欲堕,胎动不安,高血压。《本经》:″主腰脊痛,补中益精气,坚筋骨,强志,除阴下痒湿,小便余沥。″《别录》:主脚中酸痛,不欲践地。《药性论》:″治肾冷臀腰痛,腰病人虚而身强直,风也。腰不利加而用之。″
小茴香散寒止痛,理气和胃。活血、利气、止痛。用于胸胁院腹疼痛、经闭痛经、产后瘀阻、跌扑肿痛。用于寒疝腹痛,睾丸偏坠,痛经,少腹冷痛,脘腹胀痛,食少吐泻,睾丸鞘膜积液。盐小茴香暖肾散寒止痛。桂枝用于外感风寒表证,不论有汗、无汗均可应用.表虚有汗者,常与白芍、生姜、大枣等同用,以调和营卫,如桂枝汤.表实无汗者,常与麻黄等相须为用,以增强发汗解表之功,如麻黄汤.用于风湿痹痛、胃寒腹痛、经闭、痛经.风湿痹痛,肩臂肢节冷痛,常与附子、生姜、甘草等同用,以温经散寒止痛,如桂枝附子汤.胃寒腹痛,喜温喜按,常与饴糖、白芍、生姜等同用,共奏温中散寒之功,如小建中汤.血寒瘀滞,经闭腹痛或痛经,常与当归、川芎、吴茱萸等同用,以温经散寒,活血通经,如温经汤.心悸脉结代,常与炙甘草、人参等同用,如炙甘草汤.
续断,中药名,为川续断科多年生草本植物川续断的根,因能“续折接骨”而得名。秋季采挖,除去根头及须根,用微火烘至半干,堆置“发汗”至内部变绿色时,再烘干。《滇南本草》:“补肝,强筋骨,定经络,止经中(筋骨)酸痛,安胎,治妇人白带,生新血,破瘀血,落死胎,止咳嗽咳血,治赤白便浊。”
天麻性平,味甘。平肝息风止痉。用于治疗头痛眩晕、肢体麻木、小儿惊风、癫痫抽搐、破伤风等病症。用量3~9g。天麻是一味常用而较名贵的中药,临床多用于头痛眩晕、肢体麻木、小儿惊风、癫痫、抽搐、破伤风等症。由于天麻对肝阳上亢引起的头痛、眩晕等效果显著,故常被人当成“补药”服用。一见眩晕,不分体质虚实,气血盛衰,就妄用天麻,其结果就可能出现以上患者一样的不良反应。服用天麻出现的常见不良反应有:头晕、恶心、胸闷、皮肤丘疹伴瘙痒等,个别会出现面部或全身浮肿,甚至脱发现象。不仅单用天麻会发生这类反应,有的人服了含天麻的汤剂如半夏白术天麻汤等、中成药如天麻丸、天麻蜜环菌糖衣片后,同样会出现对天麻过敏的症状。
羌活性辛、味苦,温。归膀胱、肾经。功能主治散寒,祛风,除湿,止痛。用于风寒感冒头痛,风湿痹痛,肩背酸痛。用于风寒感冒,头痛身疼。本品辛温,气雄而散,发表力强,主散太阳经风邪及寒湿之邪,有散寒祛风、胜湿止痛之功,故善治风寒湿邪袭表,恶寒发热、肌表无汗、头痛项强、肢体酸痛者,常与桃仁、羌活、威灵仙、川芎等药同用,如九味羌活汤;若寒湿偏重,头痛身重者,可配伍独活、稿本、川芎等药,如羌活胜湿汤。羌活气味浓烈是制造滴丸剂良好的挥发油。
蝎子是传统的药用动物,也是我国市售商品药材的主要来源。中医以完整的干燥体入药,称为“全蝎”或“全虫”。蝎子中含有蝎毒素,其化学性质和药理作用与蛇毒成分中的神经毒相似;此外还含有三甲苯、甜菜硷、牛黄酸、软脂酸、硬脂酸、胆甾醇、卵磷脂及铵盐等,其性平、味腥,有毒,有祛法风、止痉、通络、解毒功能,可治惊风抽搐、癫痫、中风、半身不遂、口眼歪斜、偏头痛、破伤风、淋巴结核和风疹疮肿等症。医药研究表明,蝎子对心脑血管疾病和多种类型的癌症也有一定的疗效,对预防许多慢性病有显著的效果。目前,用蝎毒素配成的中药已达60余种。蝎子具有很高的药用价值,是目前需求量较大的贵重药材。蝎子还是高级宴席中招待贵宾的名贵佳菜。此外,蝎子还可做成食疗珍品。养殖蝎子如果能提取其虫毒的话则经济价值更高。发展人工养蝎,投资少,饲养技术不难,既能解决全蝎药源紧缺的矛盾,又是一项农村致富的养殖业。
没药散血去瘀,消肿定痛。治跌打损伤、金疮、筋骨、心腹诸痛、症瘕、经闭、痈疽肿痛、痔漏、目障。苦,辛,平。①《药性论》:“味苦辛。”②《海药本草》:“味苦辛,温,无毒。”③《开宝本草》:“味苦,平,无毒。”入肝、脾、心、肾经。①《本草经疏》:“入足厥阴经。”②《本草新编》:“入脾、肾二经。”③《本草求真》:“入心、肝。”配乳香,活血散瘀、行气舒筋;配穿山甲,活血散瘀、消肿止痛。配血竭,活血散瘀、止痛。配雄黄,消肿生肌、燥湿解毒。
乳香辛苦,温。调气活血,定痛,追毒。治气血凝滞、心腹疼痛,痈疮肿毒,跌打损伤,痛经,产后瘀血刺痛。《别录》:疗风水毒肿,去恶气。疗风瘾疹痒毒。《本草拾遗》:疗耳聋,中风口噤,妇人血气,能发酒,理风冷,止大肠泄游,疗诸疮令内消。治跌扑折伤筋骨:乳香,真没药各一钱五分,当归尾,红花、桃仁各三钱。水煎服。
黑皮跌打为番荔枝科植物黑风藤的根、藤。性温,味甘。通经络,强筋骨,健脾温中。治跌打损伤,风湿性关节炎,类风湿性关节痛,感冒,月经不调。治风湿骨痛:黑皮跌打配吊吊香、芦子藤、当归、芸香草,泡酒服。.
秦艽是龙胆科多年生草本植物,是治风湿关节痛、结核病潮热、黄疸等症的主药之一。在青海尤以黄南产的秦艽质量最佳。是中国重要的传统中药之一,始载于《神农本草经》,列为中品,“秦艽主寒热邪气,寒湿风痹,肢节痛、下水、利小便。”用于风湿痹痛。秦艽功能祛风湿、舒筋络,常用于风湿痹痛、关节拘挛、手足不遂等症。本品药性润而不燥,无论寒湿、湿热、痹证新久,皆可应用。在配伍方面常与防风、羌活、独活、桑枝等同用。此外,本品还常与祛风解表药同用,治疗表证肢体酸痛之症。
徐长卿性能:性温,味辛;疏风解热,行气活血。徐长卿配伍安息香徐长卿祛风散寒、除湿止痛;安息香行气活血止痛.二者伍用,有祛风活血、散寒止痛之功效,用於治疗′恶疮心痛、闷绝欲死′者.味辛,性温.入肝、胃经.功能:镇痛、止咳、利水消肿、活血解毒.主治:胃痛、牙痛、风湿疼痛、经期腹痛、慢性气管炎、腹水、水肿、痢疾、肠炎、跌打损伤、湿疹、荨麻疹、毒蛇咬伤。
本发明蜜炼丸剂的制作过程为:当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,乌梢蛇2条,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g,把药材加水浸泡30分钟至1小时,加热煮沸45分钟,过滤,滤液备用;滤渣加水,第二次加热,煮沸30分钟,再过滤,滤液备用;将两次滤液合在一起,加热浓缩至糊状,放入烘箱,控制在75℃,烘干后冷却成粉末状与蜂蜜混和在一起搓成细条;以每5g为一丸蜡封包装。
本发明胶囊剂的制作过程为:取乌梢蛇2条放入10倍量乙醇中,加热回流提取30分钟~45分钟,提取活性成份,将提取液静置。取当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g加水加热回流提取3次,每次30分钟~45分钟,将3次提取液合并静置。将上述两种提取液合并,减压回收乙醇并浓缩至药液浓度为0.8g生药/mL,抽滤后,滤液的相对密度为20℃时1.07;上述滤液经体积为10L的大孔吸附树脂柱吸附;吸附之后用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的乙醇洗脱,收集乙醇洗脱液,去除乙醇溶剂,得到组份药粉,装入胶囊制为胶囊剂。每粒胶囊装0.3g。可以每12粒为一版。
本发明粉剂中成药的制作过程为:当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,乌梢蛇2条,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g所述组份按配比混合,投入粉碎机粉碎成细粉,细粉过筛后放入耐酸碱浸渍锅内,在常温下,与乙醇共同浸渍10~20天,将浸渍好的液体及药渣进行压榨过滤,分离后取滤液,加热浓缩至糊状,放入烘箱,控制在100℃,烘干后冷却,粉碎后以每袋4~6g包装。使用时可直接冲服。
本发明外用擦剂的制备方法包括:
将天麻1000g、小茴香1000g、制川乌50g和蝎子3条用乙醇浸泡,后60~85℃热提取3次,每次1小时,所用乙醇与蝎子、小茴香、制川乌和天麻四种药材的总重量的10倍量;加热浓缩乙醇提取液,浓缩至相对密度为1.06的浓缩液,静置备用;将其余所述组份没药1000g,乳香1000g,续断1000g,红花1000g,三七1000g,透骨草1000g按配比混合,投入粉碎机粉碎成细粉,细粉过筛后放入耐酸碱浸渍锅内,在常温常压下,与乙醇共同浸渍10~15天,将浸渍好的液体及药渣进行压榨过滤,分离后取滤液,然后与前述浓缩液混和;将所述混和液加热浓缩至糊状,放入烘箱80℃烘干后冷却,与羌活1000g混和研磨成细粉状,掺入凡士林制成擦剂。可直接涂抹于病患部位。
药理学毒性试验
1.皮肤刺激性试验
取家兔剃毛,用本发明外用药物擦剂进行诱导和激发接触试验,在24小时和48小时后观察试验家兔,均不见皮肤有红斑及水肿等现象,与阴性对照组无差异。结果表明,该贴剂对皮肤反应强度近于零,即无皮肤变态反应。
2.内服药物蓄积毒性试验报告
试验方法:选用20只健康小白鼠,雌、雄各10只,剂量设计每5天为一期,每期剂量分别为0.10LD50、0.15LD50、0.22LD50、0.34LD 50、0.50LD50,此样品的雌性、雄性小鼠的LD 50均为5000m份/k份BW(五个剂量为500、750、1100、1700、2500m份/k份BW)。每5天称体重一次,调整给药量,按0.1ml/10份BW经口灌胃。20天后,动物无死亡情况发生,试验结束,按递增剂量给受试物20天后,雌性、雄性动物均无死亡情况发生。
3.急性毒性试验
以本品内服药物临床日用量的300倍给白鼠口服投药,观察5日。结果所有动物健存,其活动、饮食、毛发、排泄物未发现异常,未见毒性反应。对白鼠破损皮肤进行刺激性试验,未见有刺激性反应和其它不良反应。
毒性试验证明,该药未有毒性作用和不良反应,临床应用安全可靠。
4.长期毒性实验:
本发明中药组合物对小鼠按7.69、19.18和43.21g生药/kg连续用药15周(1.0ml/100g体重,每天2次)及停药3周后,结果表明:本发明中药组合物对大鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响,脏器肉眼没有发现异样变化和组织学检查结果表明,用药15周及停药3周后,大鼠各脏器均无明显改变。说明本发明中药组合物对大鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
药理学实验说明:
试验目的:以非甾体抗炎药双氯芬酸钠为对照验证本研究药物的抗炎消炎效果。
试验材料:
1、药品:本发明实施例2的中药组合物丸剂、双氯芬酸钠(河南东泰制药有限公司)、生理盐水(安徽丰原药业股份有限公司)、弗氏完全佐剂(Sigma)。
2、试验动物:1)昆明种小鼠50只,雌、雄各半,体重在20±2g,由安徽省实验动物中心提供;2)SD大鼠50只,雌、雄各半,体重在180~200g,由安徽省实验动物中心提供。
3、仪器:软皮尺、注射器。
三、试验方法:
1、模型制备:
(1)将小鼠随机分为五组,编号1、2、3、4、5组,第1组为生理盐水组,第2组为双氯芬酸钠组,第3组为本发明低浓度组,第4组为本发明中浓度组,第5组为本发明高浓度组。测量每只小鼠的踝关节周长及表面温度。采用卵蛋白诱导为关节炎模型,方法如下:方法为用卵蛋白溶解于生理盐水,配成20,L的溶液,与等量弗氏佐剂混匀,注入动物背部皮下致敏,每次1mL,每周1次,连续3周致敏,末次注射后1周,于关节内注入5mg溶解的卵蛋白,24h后,测量小鼠的踝关节周长及表面温度。
(2)将大鼠随机分为五组,编号A、B、C、D、E组,A组为生理盐水组,B组为双氯芬酸钠组,C组为本发明低浓度组,D组为本发明中浓度组,E组为本发明高浓度组。测量每只大鼠的踝关节周长及足拓。制成佐剂型关节炎,方法如下:将充分乳化混匀的CFA(终质量浓度10g/L)用足跖部皮下注射法,一侧一次注入0.1mL。原发病变主要表现为致炎局部的炎性反应,续发病变一般于致炎后10~20d左右出现,20d左右达到高峰,此时测量每只大鼠的踝关节周长及足拓。
2、给药方法:
试验设置生理盐水对照组、双氯芬酸钠对照组、本发明组,本发明组又分三个剂量组,采用灌胃给药,将双氯芬酸钠配制成0.25g/ml,本发明配制成4.75g/ml、9.5g/ml、14.25g/ml,小鼠每次0.5ml,大鼠每次0.8ml,双氯芬酸钠与生理盐水组每日给药三次,本发明组每日给药六次,观察两天。
四、试验结果
表1药物对抗小鼠组踝关节炎症肿胀的观察结果
表2药物对抗大鼠组踝关节炎症肿胀的观察结果
五、结论
1、以双氯芬酸钠为对照测定本发明药物的抗炎疗效,试验结果表明,低浓度抗炎效果一般,中等浓度即能有效抗炎,过高浓度不能显著增加抗炎效果。
2、本研究药物抗炎起效不如双氯芬酸钠快,但效果持久且中等浓度有效率高于对照药双氯芬酸钠,这也是中成药制剂的特点之一。
临床药理药效:
1、临床资料150例患者,男132例,女18例;年龄最大74岁,最小21岁,30岁~50岁96例;病程1个月以内的62例,1个月~3个月45例,4个月~6个月28例,7个月~12个月9例,1年以上6例;有明显外伤史的125例,慢性劳损18例,原因不明7例;单侧136例,双侧14例;在150例患者中未经任何治疗98例,曾、行针灸、服药、理疗等治疗,无明显改善者65例。
2、治疗方法
2、1本发明外用药物各10g。共研细末,装布袋,水煎30min,敷膝,每日2次~3次,10d为1疗程。
2、2中药内服本发明内服药物组分各10g,水煎服,每日一剂(根据病情适当加减)。
3疗效分析
3、1疗效标准
痊愈:治疗1疗程后症状和体征全都消失,关节活动正常;好转:治疗1疗程后症状和体征及关节活动基本正常;无效:治疗1疗程后症状和体征及关节活动较治疗前无明显改善。
3、2治疗结果
150例患者中,痊愈113例,占75.33%;好转30例,占20%;无效7例,占4.67%。总有效率95.33%。病程与疗效关系见附表。
附表
| 病程 | 痊愈(%) | 好转(%) | 无效(%) | 合计 |
| 1个月以内 | 58(93.55) | 3(4.84) | 1(1.62) | 62 |
| 1个~3个月 | 34(75.56) | 10(22.23) | 1(2.21) | 45 |
| 4个~6个月 | 15(53.57) | 11(39.29) | 2(7.14) | 28 |
| 7个~12个月 | 4(44.44) | 4(44.44) | 1(11.11) | 9 |
| 1年以上 | 2(33.33) | 2(33.33) | 2(33.33) | 6 |
| 合计 | 113(75.32) | 30(20.02) | 7(4.66) | 150 |
根据临床功能显示本发明中药组合物滋补肝肾,活血化瘀,消肿止痛,用于风寒湿痹引起的关节疼痛,肿胀,手足不温,四肢麻木,肩臂腰腿疼痛,研究处方中各味药材的不同提取方法产物的镇痛、抗炎和抗凝血几个方面的作用,验证其与临床主治有关的药效学作用,并与原工艺制剂比较验证新工艺制剂的有效性。
典型病例:
例1、马某,男,32岁,就诊时自述因骑摩托车与汽车追尾十余里,膝关节撞击车尾保险杠,右膝部剧烈疼痛,拍片地异常,布洛芬口服及伤湿止痛膏外贴,疼痛略减轻,5天后发现膝部肿胀,活动受限,遂到我院就诊,诊断:创伤性右膝关节滑膜炎,内服药物与外用药物配合使用:
内服当归10g,川芎10g,秦艽10g,三七15g,徐长卿15g,红花10g,怀牛膝10g,桂枝10g,鸡血藤10g,黑皮跌打10g,小茴香10g,虎杖10g,乌梢蛇1条,防风10g,伸筋草10g,骨碎补10g,杜仲10g,老鹳草10g,白芍10g;
外用:没药15g,乳香10g,续断15g,羌活15g,红花10g,三七20g,天麻10g,小茴香10g,制川乌10g,蝎子3条,透骨草15g。经用上法治疗2疗程后而愈,至今未复发。
例2:封某,女,45岁,膝关节疼痛5年余,近一年来上、下楼、下蹲活动均感困难,近一月来伴关节肿胀、积液。西医诊断为“滑膜炎伴少量积液”,纳差,睡眠不佳、二便正常。刻诊,舌质暗红,舌尖边有瘀点,脉弦。辨证:患者肝肾亏损,加之风寒湿之邪侵入经络、日久气血阻滞,不通则痛。治宜祛风除湿,温通经络,行气活血,荣筋止痛。内服药物与外用药物配合使用:
内服当归15g,川芎15g,秦艽10g,三七15g,徐长卿15g,红花10g,怀牛膝10g,桂枝15g,鸡血藤10g,黑皮跌打10g,小茴香10g,虎杖10g,乌梢蛇1条,防风10g,伸筋草10g,骨碎补10g,杜仲10g,老鹳草15g,白芍10g;
外用:没药15g,乳香10g,续断15g,羌活15g,红花20g,三七20g,天麻10g,小茴香10g,制川乌10g,蝎子3条,透骨草10g。采用上述治疗2周,5天为一疗程,膝关节疼痛基本消失,活动自如,肿胀消失,1年后追访未见复发。
例3:程某,男,48岁。初诊。主诉:右膝肿胀睟痛无力7年,加重2年余。右膝肿胀睟痛7年,初起肿痛时有进退,近2年来肿痛持续不减,活动较多时疼痛加重,有外伤史。曾经中西医多方治疗,先后穿刺抽液达10余次(淡黄色液体)均无效。检查:右膝关节高度肿胀,皮色发亮,纹沟消失,触之饱满有波动,压痛明显,浮髌试验阳性,股四头肌萎缩。X线片显示骨关节间隙增宽(包括髌股关节),骨质无增生破坏。诊断:右膝关节创伤性滑膜炎(慢性)。治疗:内服药物与外用药物配合使用:
内服当归15g,川芎15g,秦艽10g,三七15g,徐长卿15g,红花10g,怀牛膝15g,桂枝10g,鸡血藤10g,黑皮跌打15g,小茴香15g,虎杖10g,乌梢蛇1条,防风10g,伸筋草10g,骨碎补10g,杜仲15g,老鹳草15g,白芍10g;
外用:没药15g,乳香10g,续断15g,羌活15g,红花20g,三七20g,天麻10g,小茴香10g,制川乌10g,蝎子2条,透骨草10g。嘱减少活动。二诊,肿胀下移至小腿中下段,膝部肿胀减退。原方继服7剂。三诊,患肢肿胀明显消退,浮髌试验不明显,压痛甚微。再进7剂。复查,肿胀、压痛完全消失,关节内积液吸收,恢复正常活动。唯股四头肌中度萎缩,嘱其加强锻炼。
实施例4:韩某,男,42岁。初诊主诉:右膝肿胀疼痛3年。院外曾数次穿刺抽吸(有时可吸出暗红色液体,有时吸不出),治疗无效。检查:右膝弥漫性肿胀,以髌上囊及髌周最为显著,触之有软组织增厚及海绵样感,内无结节样物,浮髌试验阳性,股四头肌明显萎缩,关节穿刺抽出咖啡样液体。X线片示胫骨平台轻度增生,无骨质破坏。诊断:色素绒毛结节性滑膜炎。治疗:卧床休息,内服当归15g,川芎15g,秦艽10g,三七15g,徐长卿15g,红花10g,怀牛膝15g,桂枝15g,鸡血藤10g,黑皮跌打10g,小茴香10g,虎杖15g,乌梢蛇1条,防风10g,伸筋草10g,骨碎补10g,杜仲15g,老鹳草15g,白芍10g;
外用:没药15g,乳香10g,续断15g,羌活15g,红花20g,三七20g,天麻10g,小茴香10g,制川乌10g,蝎子3条,透骨草10g。连续服药40剂,肿胀明显减轻,胀痛消失,积液吸收,浮髌试验阴性。与健膝对比,患膝稍膨大,触摸软组织增厚感存在,但无不适。随访2年未复发,已恢复正常工作。
本发明中药组合物采用纯中药配制而成,具有疗效确切、安全、无明显毒副作用等特点,具有强筋骨、补肝肾,使局部血管扩张,血运增强,代谢增强,免疫力提高,从而使疼痛缓解,促进瘀血的吸收,起到舒筋活络、固本祛邪、消肿止痛的作用。本发明采用补肾壮骨、活血化瘀作用的中药对膝关节有一定疗效,可改善局部动脉供血功能障碍,增强局部血流量,促进骨小梁再生形成,囊状改变缩小,硬化骨吸收,软骨部位修复,血脉通畅肌肉萎缩恢复与现有技术相比教,本技术具有给药方便,药剂易于制造,成本低廉等优点。本发明采用不同药性的中药材,进行了科学配伍,能达到理想的治疗效果,配合针灸,按摩,推拿等方式使用事半功倍;且安全,毒副作用小,使用方便,治愈时间短,治愈后不易复发。能创造较好的社会价值及经济利益。
Claims (1)
1.一种治疗膝关节炎症的中药组合物,其特征在于,由内服药物和外用药物组成,内服药物为蜜炼丸剂、胶囊剂或粉剂,外用药物为擦剂;
其中,所述蜜炼丸剂的制作过程为:当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,乌梢蛇2条,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g,把药材加水浸泡30分钟至1小时,加热煮沸45分钟,过滤,滤液备用;滤渣加水,第二次加热,煮沸30分钟,再过滤,滤液备用;将两次滤液合在一起,加热浓缩至糊状,放入烘箱,控制在75℃,烘干后冷却成粉末状与蜂蜜混和在一起搓成细条;以每5g为一丸蜡封包装;
其中,所述胶囊剂的制作过程为:取乌梢蛇2条放入10倍量乙醇中,加热回流提取30分钟~45分钟,提取活性成份,将提取液静置;取当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g加水加热回流提取3次,每次30分钟~45分钟,将3次提取液合并静置;将上述两种提取液合并,减压回收乙醇并浓缩至药液浓度为0.8g生药/mL,抽滤后,滤液的相对密度为20℃时1.07;上述滤液经体积为10L的大孔吸附树脂柱吸附;吸附之后用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的乙醇洗脱,收集乙醇洗脱液,去除乙醇溶剂,得到组份药粉,装入胶囊制为胶囊剂;每粒胶囊装0.3g;
其中,所述粉剂中成药的制作过程为:当归1000g,川芎1000g,秦艽1000g,三七1000g,徐长卿1000g,红花1000g,怀牛膝1000g,桂枝1000g,鸡血藤1000g,黑皮跌打1000g,小茴香1000g,虎杖1000g,乌梢蛇2条,防风1000g,伸筋草1000g,骨碎补1000g,杜仲1000g,老鹳草1000g,白芍1000g,上述组份按配比混合,投入粉碎机粉碎成细粉,细粉过筛后放入耐酸碱浸渍锅内,在常温下,与乙醇共同浸渍10~20天,将浸渍好的液体及药渣进行压榨过滤,分离后取滤液,加热浓缩至糊状,放入烘箱,控制在100℃,烘干后冷却,粉碎后以每袋4~6g包装;其中,所述外用擦剂的制 备方法包括:将天麻1000g、小茴香1000g、制川乌50g和蝎子3条用乙醇浸泡,后60~85℃热提取3次,每次1小时,所用乙醇为蝎子、小茴香、制川乌和天麻四种药材的总重量的10倍量;加热浓缩乙醇提取液,浓缩至相对密度为1.06的浓缩液,静置备用;将其余组份没药1000g,乳香1000g,续断1000g,红花1000g,三七1000g,透骨草1000g按配比混合,投入粉碎机粉碎成细粉,细粉过筛后放入耐酸碱浸渍锅内,在常温常压下,与乙醇共同浸渍10~15天,将浸渍好的液体及药渣进行压榨过滤,分离后取滤液,然后与前述浓缩液混和;将所述混和液加热浓缩至糊状,放入烘箱80℃烘干后冷却,与羌活1000g混和研磨成细粉状,掺入凡士林制成擦剂。
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| CN102397523B (zh) * | 2011-11-28 | 2013-03-13 | 吕会辰 | 一种治疗风湿、类风湿性关节炎和颈肩腰腿疼的药物 |
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