CN108310070A - 一种治疗疼痛的中药组合物及其制备方法 - Google Patents
一种治疗疼痛的中药组合物及其制备方法 Download PDFInfo
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Abstract
一种治疗疼痛的中药组合物及其制备方法,所述中药组合物主要由以下中药原料药制成;川芎、制乳香、制没药、酒制大黄、补骨脂、白芷、红花、土鳖、细辛、羌活、独活、伸筋草和海风藤。本发明还包括所述中药组合物的制备方法。本发明中药组合物主要应用于闭合性的骨外伤、软组织损伤、陈旧性损伤、风湿骨痛以及不明原因的疼痛或疼痛反复发作的外用治疗。本发明外用药物疗效显著,镇痛快速,作用稳定,无毒副作用,无并发症和后遗症;本发明的制备工艺简单,操作便捷,保持药物活性强。
Description
技术领域
本发明涉及一种药物组合物及其制备方法,具体涉及一种治疗疼痛的外用中药组合物及其制备方法。
背景技术
疼痛已被现代医学列为继呼吸、脉搏、血压、体温之后的第五大生命体征。疼痛是包括机体接受内、外环境刺激后,致痛物质从组织产生和释放、疼痛感受器的致敏、痛觉信息的传导和感觉中枢的感知,并最终进入意识阶段的一个非常复杂的过程。疼痛不仅影响生活质量,有人还会由于长期疼痛得不到有效治疗而产生心理疾病。很多疼痛病人由于不及时治疗,长期的局部疼痛会形成复杂的疼痛综合症或中枢性疼痛,使普通的疼痛变得愈发剧烈和难以治疗,导致机体各***功能失调、免疫力降低而诱发各种并发症,甚至致残或危及病人的生命。所以,疼痛患者应该及时治疗疼痛。
从西医角度看,一般认为急性疼痛是无菌性炎症引起的,通过对局部痛点打封闭针或激素类药物就可以快速解决疼痛问题。该方法虽然可以迅速将无菌性炎症清除,缓解疼痛,使病情好转,但其价格昂贵,最易造成机体不可逆的神经损伤。口服止痛药物多用于慢性疼痛治疗,包括阿片类药物、非甾体类药物、周围神经营养药物、抗惊厥类药物、抗抑郁类药物等,这类药物长期使用会引起机体过敏性反应,损害胃粘膜,导致肝肾功能异常,有些甚至掩盖病情造成误诊,且大多数具有耐受性和成瘾性。因此,开发一种快速镇痛、安全有效、且无成瘾性、价格低廉的药物将为广大疼痛患者带来福音。
我国中医在治疗疼痛方面有几千年的临床经验,认为引起疼痛的原因不外乎经络闭阻、痰湿阻滞、气血逆乱等,尤其是以经络气血失调为根本原因。
体外治疗法是中医临床最常使用的方法之一。在中医典籍《医学源流论·薄贴论》中就提出:“若其病既有定所,在于皮肤筋骨之间,可按而得之者,用膏贴之,闭塞其气,使药性从毛孔而入,其腠理通经贯络,或提而出之或攻而散之,较之服药有力”。即认为中药外用治疗病位固定,经络不通之病效果优于内服。中药外用膏剂有效成分经皮肤组织吸收后,就近作用于疼痛局部,可有效避免口服经消化道吸收所遇到的多环节灭活作用,也没有西药止痛药常出现的恶心、便秘、多汗、成瘾,甚至引起消化性溃疡以及肝肾功能损害等副作用的发生。
CN104274546A公开了一种外用中药组合物、外用中药制剂及其制备方法和应用,该中药组合物原料组分为:白芥子30~70份、甘遂15~60份、清风藤60~180份、延胡索30~70份和细辛15~60份。虽然该中药组合物具有止痛、抗炎、消肿和镇痛的功效,采用敷灸的方法进行治疗,但敷后皮肤会起泡,或使局部皮肤充血潮红,在临床使用时也具有局限性,操作不方便。
CN104606324A公开了一种中药组合抗疼痛药及其制备方法,其配方包括马钱子,地龙,透骨草,僵蚕,汉防己,威灵仙,当归,生大黄,泽兰,乳香,没药,申姜,王不留行,细辛,刺五加皮,豨莶草,功劳叶,蜈蚣,丝瓜络,麻黄等;其制备方法是取麻油2000毫升置锅内,将以上各味药放入锅内炸枯去渣,炼油滴水成珠,下樟丹1000克,搅匀即成。但是,该中药组合物经过油炸后有效成分会损失,且加入樟丹会产生毒副作用,药效难以保证。
CN105456977A公开了一种治疗颈肩腰腿疼痛膏药,制川乌 200 份、制草乌 200份、干姜 300 份、川芎 200份、红花 200 份、白芥子 500 份、制乳香 300 份、制没药 300份、肉桂 200 份、川椒 200 份、黑胡椒 200份、伸筋草 300 份、透骨草 300 份、土元 200份、全蝎 200 份、乌梢蛇 150 份、地龙 150 份、当归 300份、丹参 300 份、怀牛膝 300份、续断 200 份、炒杜仲 200 份、羌活 200 份、独活 200 份、地风 300 份、年见 300 份、鸡血藤 300 份、青风藤 300 份、海风藤 300 份、雷公藤 200 份、小茴香 200 份、薏仁600份、威灵仙 200 份、防风 200 份、防己 200 份、苍术300 份、五加皮 500 份。但是,该膏药配方复杂,操作繁琐,并加入了樟丹,毒副作用难以避免,药效难以控制。
发明内容
本发明所要解决的技术问题是,克服现有技术存在的上述缺陷,提供一种具有活血化瘀,消肿止痛,祛风除湿,通经活络的功效,疗效显著,镇痛快速,作用稳定,无毒副作用,无并发症和后遗症,使用方便,价格低廉的治疗疼痛的中药组合物。
本发明进一步要解决的技术问题是,克服现有技术存在的上述缺陷,提供一种工艺简单、操作便捷和保持药物活性高的治疗疼痛的中药组合物的制备方法。
本发明解决其技术问题所采用的技术方案如下:一种治疗疼痛的中药组合物,主要由以下中药原料药制成:川芎、制乳香、制没药、酒制大黄、补骨脂、白芷、红花、土鳖、细辛、羌活、独活、伸筋草和海风藤。
本发明所使用的制乳香、制没药、酒制大黄可市购也可参照2015版中国药典通则0213进行炮制。所述制乳香的炮制方法为:取净乳香,采用醋炙法至表面光亮,每100kg乳香,用醋5kg;所述制没药的炮制方法为:取净没药,采用醋炙法至表面光亮,每100kg没药,用醋5kg,本品炮制后为不规则小块状或类圆形颗粒状,表面棕褐色或黑褐色,有光泽,具特异香气,略有醋香气,味苦而微辛;所述酒制大黄的炮制方法为:取大***,采用酒炙法炒干,本品形如大***,表面深棕黄色,有的可见焦斑,微有酒香气。
具体地,各原料的功效如下:川芎味辛,性温,归肝、胆、心包经,功效:活血行气,祛风止痛,用于胸痹心痛,胸胁刺痛,跌扑肿痛,头痛风湿痹痛;补骨脂味辛、苦,性温,归肾、脾经,功效:温肾助阳,纳气平喘,温脾止泻,外用消风祛斑;乳香味辛、苦,性寒,归心、肝、脾经,功效:活血定痛,消肿生肌,用于胸痹心痛,胃脘疼痛,风湿痹痛,筋脉拘挛,跌打损伤,痈肿疮疡;没药味辛、苦,性平,归心、肝、脾经,功效:散瘀定痛,消肿生肌,用于胸痹心痛,胃脘疼痛,风湿痹痛,跌打损伤,痈肿疮疡;大黄味苦,性寒,归脾、胃、大肠、肝、心包经,功效:泻下攻积,清热泻火,凉血解毒,逐瘀通经,利湿退黄,酒大黄善清上焦,血分热毒,用于治疗目赤咽肿、齿龈肿痛;白芷味辛,性温,归胃、大肠、肺经,功效:解表散寒,祛风止痛,宣通鼻窍,燥湿止带,消肿排脓,用于感冒头痛,眉棱骨痛,鼻塞流涕,鼻鼽,鼻渊,牙痛,带下,疮疡肿痛;红花味辛,性温,归心、肝经,功效:活血通经,散瘀止痛,用于恶露不行,胸痹心痛,瘀滞腹痛,胸胁剌痛,跌扑损伤,疮疡肿痛;土鳖味咸,性寒,有小毒,归肝经,功效:破血逐瘀,续筋接骨,用于跌打损伤,筋伤骨折,血瘀经闭;细辛味辛,性温,归心、肺、肾经,功效:解表散寒,祛风止痛,通窍,温肺化饮,用于风寒感冒,头痛,牙痛,鼻塞流涕,鼻鼽,鼻渊,风湿痹痛,痰饮喘咳;羌活味辛、苦,性温,归膀胱、肾经,功效:解表散寒,祛风除湿,止痛,用于风寒感冒,头痛项强,风湿痹痛,肩背酸痛;独活味辛、苦,性微温,归肾、膀胱经,功效:祛风除湿,通痹止痛,用于风寒湿痹,腰膝疼痛,少阴伏风头痛,风寒挟湿头痛;伸筋草味微苦、辛,性温,归肝、脾、肾经,功效:祛风除湿,舒筋活络,用于关节酸痛,屈伸不利;海风藤味辛、苦,性微温,归肝经,功效:祛风湿,通经络,止痹痛,用于风寒湿痹,肢节疼痛,筋脉拘挛,屈伸不利;黄酒味苦、甘、辛,性大热,入足厥阴肝、足少阳胆经,功效:行经络而通痹塞,温血脉而散凝瘀,善解凝郁,最益肝胆,主行药势,有百邪恶毒、通经络、行血脉、脾胃、养皮肤、散湿气、扶肝、除风下气、活血、利小便。
本发明治疗疼痛的中药组合物配方是遵循中医理论之理、法、方、药原则,按君、臣、佐、使之举方。选土鳖、红花活血化瘀,通经止痛谓之君;制乳香、制没药活血生肌,消肿止痛,川芎活血行气,祛风止痛,酒制大黄逐淤通络解毒为臣;选羌活、独活祛风湿止痛,细辛、白芷散寒祛风止痛,补骨脂祛风温阳,伸筋草、海风藤祛风除湿,通络止痛为佐;选辅料黄酒调和诸药,引药入径,直达病所为使;全方合用,共奏活血化瘀,消肿止痛,祛风除湿,通筋活络之功。
优选地,所述治疗疼痛的中药组合物中,各中药原料药的重量份为:川芎20~100份、制乳香20~80份、制没药20~80份、酒制大黄20~150份、补骨脂20~150份、白芷20~100份、红花10~100份、土鳖10~100份、细辛5~50份、羌活20~100份、独活20~100份、伸筋草20~120份、海风藤20~120份。
优选地,所述治疗疼痛的中药组合物中,各中药原料药的重量份为:川芎25~60份、制乳香25~60份、制没药25~60份、酒制大黄25~100份、补骨脂25~100份、白芷25~80份、红花15~80份、土鳖15~80份、细辛8~30份、羌活25~80份、独活25~80份、伸筋草25~80份、海风藤25~80份。
更优选地,所述治疗疼痛的中药组合物中,各中药原料药的重量份为:川芎30份、制乳香30份、制没药30份、酒制大黄30份、补骨脂30份、白芷30份、红花20份、土鳖20份、细辛10份、羌活30份、独活30份、伸筋草30 份、海风藤30份。
进一步,所述治疗疼痛的中药组合物的剂型包括按照传统制药工艺制成的膏剂、粉剂、贴剂、酊剂、软膏剂或喷雾剂。
进一步,所述膏剂、贴剂、酊剂、软膏剂或喷雾剂含有医学上允许使用的辅料。
优选地,所述膏剂的辅料为黄酒。
优选地,所述辅料黄酒的酒精浓度为13°~15°。
优选地,所述中药原料药与辅料黄酒的质量比为1:1~5(更优选1:1.1~3.0,更进一步优选1:1.1~2.0)。
优选地,本发明所述中药原料为中药饮片。
本发明进一步解决其技术问题所采用的技术方案如下:一种治疗疼痛的中药组合物膏剂的制备方法:将所述中药原料药分别干燥,粉碎,过筛,得中药原料粉,将各中药原料药粉混合后,再与辅料黄酒混合,静置,即成。本发明药物的制备方法未经特殊加工,将配方中所述中药原料经干燥,粉碎,过筛,混合后,直接加入辅料黄酒,可保护药物的有效成分,使之损耗降到最低,能充分被皮肤组织吸收,在有效疗程内药到病除。
优选地,所述干燥的温度为65~75℃,时间为30~40min。
优选地,所述过筛的目数为50~100目。
优选地,各中药原料药粉混合的时间为15~30min。
优选地,与辅料黄酒混合的时间为20~40min。
优选地,所述静置的时间为20~48h。
本发明治疗疼痛的中药组合物膏剂的使用方法,本发明治疗疼痛的中药组合物膏剂供外用:将所述膏剂均匀涂擦于患处,涂擦的厚度为1~2mm,涂擦面积≥痛处面积的2倍,每12~24h更换一次,有效疗程为5~15天。
本发明治疗疼痛的中药组合物的应用范围:可应用于闭合性的骨外伤,软组织损伤,陈旧性损伤,风湿骨痛以及不明原因的疼痛或疼痛反复发作的治疗。可治疗的疼痛,具体有踝关节挫伤或骨折、膝关节炎或积水、半月板陈旧性损伤、腰颈椎骨质增生和腰椎间盘突出所引起的疼痛。
本发明治疗疼痛的外用药物使用时的注意事项:本发明产品仅限外用,不可内服;孕妇慎用;痛处表皮有伤口或溃疡者禁用。
本发明产品的有益效果如下:
(1)本发明产品在临床使用中,具有活血化瘀,消肿止痛,祛风除湿,通经活络的功效,疗效显著,镇痛快速,作用稳定,无毒副作用,无并发症和后遗症,使用方便,价格低廉;据2015年12月至2016年12月期间,对不同原因所致的疼痛进行分类,并结合临床诊断,对516例患者应用本发明治疗疼痛的外用药物的疗效进行统计,本发明治疗疼痛的外用药物对于踝关节挫伤或骨折和腰颈椎骨质增生使用有效率高达100%,对于膝关节炎或积水、半月板陈旧性损伤和腰椎间盘突出的有效率高达97%以上;
(2)本发明治疗疼痛的外用药物经人体皮肤组织吸收后,生物利用率高,能促进受伤的周围软组织、骨膜、骨质的快速修复,从而尽早解除疼痛,改善痛处功能障碍。
(3)本发明治疗疼痛的外用药物的制备工艺简单,操作便捷,保持药物活性强。
具体实施方式
下面结合实施例和部分病例对本发明作进一步说明。
本发明实施例所使用的各中药原料为市购中药饮片;本发明所使用的黄酒的酒精浓度为14°;本发明实施例所使用的原料如无特殊说明,均通过常规商业途径获得。
一种治疗疼痛的外用药物实施例1~3
一种治疗疼痛的外用药物实施例1~3的原料组分及配比如表1所示:
表1 一种治疗疼痛的外用药物实施例1~3的原料组分及配比表
一种治疗疼痛的外用药物的制备方法实施例1~3
分别按照表1实施例1~3各原料组分及配比准确称取,将所述中药原料分别在70℃下,干燥35min,粉碎,过60目筛,得中药原料粉,将各中药原料粉混合20min后,再与辅料黄酒混合30min,静置24h,得治疗疼痛的外用药物膏剂1~3。
一种治疗疼痛的外用药物的使用方法实施例1~3
将所得治疗疼痛的外用药物膏剂1~3分别均匀涂擦于患处,涂擦的厚度为1~2mm,涂擦面积为痛处面积的2倍,每24h更换一次,有效疗程为5~15天。
一种治疗疼痛的外用药物的应用实施例1~3
将所得治疗疼痛的外用药物膏剂1~3应用于踝关节挫伤或骨折、膝关节炎或积水、半月板陈旧性损伤、腰颈椎骨质增生和腰椎间盘突出所引起的疼痛治疗。
本发明治疗疼痛的外用药物的临床效果评价:
(1)临床病例疗效统计:
于2015年12月至2016年12月期间,对不同原因所致的疼痛进行分类,并结合临床诊断,对516例患者(其中,男性327例,女性189例,年龄为13~67岁,最长病程为25年,疗程为15~30天)应用本发明治疗疼痛的外用药物膏剂1的疗效,按照临床观察诊断和疗效判断标准进行了***性的观察和统计。所述疗效判断标准如下:治愈标准:疼痛消失,无肿胀,无功能障碍,停药后12个月未复发;显效标准:疼痛缓解,其它症状好转,停药后复发;好转标准:用药时疼痛减轻,停药后疼痛无明显好转;无效标准:用药15天后疼痛无明显改善;治愈、显效、好转均属有效。结果如表2所示。
表2 本发明治疗疼痛的外用药物膏剂1的临床观察疗效统计表
由表2可知,516例临床观察疗效基本在97%及以上,说明本发明治疗疼痛的外用药物在治疗疼痛方面具有良好的临床效果,能有效治疗踝关节挫伤或骨折、膝关节炎或积水、半月板陈旧性损伤、腰颈椎骨质增生和腰椎间盘突出所引起的疼痛,能快速镇痛,且疗效稳定,能在有效疗程内快速解除疼痛,改善功能障碍,值得在临床应用上推广。
(2)典型病例及疗效:
病例1:黄某,女,37岁。2017年5月因左踝关节扭伤致疼痛难忍,随后肿胀不能行走,局部皮肤发紫;某医院经X光照片后,疑踝关节多处骨折,并建议先石膏固定,待局部肿胀好转后,再照片复查,考虑骨科手术;患者未接受医院手术方案,而采用本发明治疗疼痛的外用药物膏剂1外敷,1h后疼痛锐减,3天后肿胀部位瘀血紫色大有好转,5天后疼痛肿胀基本消失,仅行走时稍有痛感,续用15天完全康复,行走无碍,停止治疗;一月后到某医院X光照片复查,提示局部有少许骨痂呈现;6个月后随访无异常反应。
病例2:刘某,男,42岁。2017年9月,因腰部受重力损伤而造成椎间盘突出,运动受限,动则疼痛难忍,随即到某医院行牵引术加外敷本发明治疗疼痛的外用药物膏剂1,6h后疼痛缓解,5天后未用牵引术疼痛大减,并能起床行走,续用15天完全康复。
病例3:钱某,男,60岁。左膝关节酸痛3年,上下楼梯时疼痛加重,伴乏力,肿胀不明显,后经某医院CT扫描诊断:左膝半月板破损(外),建议手术治疗,后使用本发明治疗疼痛的外用药物膏剂2外敷15天,疼痛基本消失,运动无碍,续用此膏剂30天,随访两年未复发。
病例4:赵某,男,45岁。5年前经某医院诊断为颈椎骨质增生,经中西药内服、理疗、外贴膏药等屡治无效;近1年自觉颈部酸胀不适,低头运动时胀痛难受,伴头昏目胀,右手指尖麻木,时有胸闷欲呕,身体日逐消瘦,体力不支;后经本发明治疗疼痛的外用药物膏剂3外敷15天后,疼痛明显好转,各项症状明显减轻;续用一月后各项症状消失,后经某医院CT扫描,其结果提示:椎体各段无异常改变。
Claims (10)
1.一种治疗疼痛的中药组合物,其特征在于:主要由以下中药原料药制成;川芎、制乳香、制没药、酒制大黄、补骨脂、白芷、红花、土鳖、细辛、羌活、独活、伸筋草和海风藤。
2.根据权利要求1所述治疗疼痛的外用药物,其特征在于:所述中药原料药的重量份为:川芎20~100份、制乳香20~80份、制没药20~80份、酒制大黄20~150份、补骨脂20~150份、白芷20~100份、红花10~100份、土鳖10~100份、细辛5~50份、羌活20~100份、独活20~100份、伸筋草20~120份、海风藤20~120份。
3.根据权利要求1所述治疗疼痛的中药组合物,其特征在于:所述中药原料和辅料黄酒的质量比为1:1.1~3.0;所述各中药原料药的重量份为:川芎25~60份、制乳香25~60份、制没药25~60份、酒制大黄25~100份、补骨脂25~100份、白芷25~80份、红花15~80份、土鳖15~80份、细辛8~30份、羌活25~80份、独活25~80份、伸筋草25~80份、海风藤25~80份。
4.根据权利要求1所述治疗疼痛的中药组合物,其特征在于:所述中药原料和辅料黄酒的质量比为1:1.1~2.0;所述各中药原料的重量份为:川芎30份、制乳香30份、制没药30份、酒制大黄30份、补骨脂30份、白芷30份、红花20份、土鳖20份、细辛10份、羌活30份、独活30份、伸筋草30 份、海风藤30份。
5.根据权利要求1~4之一所述治疗疼痛的中药组合物,其特征在于:所述治疗疼痛的中药组合物的剂型包括按照传统制药工艺制成的膏剂、粉剂、贴剂、酊剂、软膏剂或喷雾剂。
6.根据权利要求5所述治疗疼痛的中药组合物,其特征在于:所述膏剂、贴剂、酊剂、软膏剂或喷雾剂含有医学上允许使用的辅料。
7.根据权利要求6所述治疗疼痛的中药组合物,其特征在于:所述膏剂的辅料为黄酒。
8.根据权利要求7所述治疗疼痛的中药组合物,其特征在于:所述黄酒的酒精浓度为13°~15°。
9.根据权利要求8所述治疗疼痛的中药组合物,其特征在于:所述中药原料药与辅料黄酒的质量比为1:1~5。
10.一种如权利要求9所述治疗疼痛的中药组合物的制备方法,其特征在于:将所述中药原料分别干燥,粉碎,过筛,得中药原料粉,将各中药原料粉混合后,再与辅料黄酒混合,静置,即成。
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CN114209444A (zh) * | 2021-12-23 | 2022-03-22 | 山东第一医科大学附属省立医院(山东省立医院) | 一种急性痛风治疗包 |
CN114209444B (zh) * | 2021-12-23 | 2024-05-10 | 山东第一医科大学附属省立医院(山东省立医院) | 一种急性痛风治疗包 |
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