CN109288951A - 一种中药组合物、制剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种中药组合物、制剂及其制备方法,由五加皮、白凤仙花根、紫花地丁、大枫子、蓖麻根、无名异、青盐、白芷、天南星、透骨草、侧柏叶、象皮、番木鳖、毕拨、川乌、草乌、野芋头、桃仁、花椒、穿山甲、青皮、蟾酥、自然铜、藜芦、羌活、儿茶、乳香、没药、接骨木、苏木、土鳖虫、藤三七、红花、白公鸡血、麝香。该中药组合物可用于跌打损伤、骨折等骨伤病和风湿性疾病;其治疗时间短,疗效显著。
Description
技术领域
本发明涉及医学药物技术,具体为一种中药组合物、制剂及其制备方法。
背景技术
中医骨伤科学是医学科学的组成部分,是一门阐述防治人体损伤的学科。骨折是指骨小梁的连续性的中断或完整性受到破坏,骨折愈合是多种修复细胞和基因聚集的复杂过程。病人常为一个部位骨折,少数为多发性骨折,经过及时恰当处理,多数病人能恢复原来的功能,少数病人可留有不同程度的后遗症。中医学认为骨折愈合是一个祛瘀、生新、骨合的过程,并发展出“祛瘀接骨说”等理论,临床治疗骨折时也大多数选择具有活血化瘀或补益等功效的中药。
风湿性疾病是以关节痛、畏风寒为主症的临床症侯群。近年来,风湿、类风湿等骨伤疾病的患者逐年增多,成为人们常见病、多发病,中医认为其发病原因为外邪侵袭、淤血留滞、肝肾功能不足而阻闭经络,其痰瘀互结,交结于骨间所致。目前治疗这些骨伤疾病和风湿疾病的方法主要有理疗法、西医治疗和中医治疗,理疗法适用于病情较轻者,能暂时缓解病人痛苦,不易根治,西药治疗价格较贵,且有副作用,现有应用的中医治疗骨伤病的药物,往往疗程长,见效缓慢,疗效不十分明显,不易被人们接受。
发明内容
本发明的目的在于提出一种中药组合物、制剂及其制备方法,该中药组合物由多味中药制成,可用于跌打损伤、骨折等骨伤病和风湿性疾病;其治疗时间短,疗效显著。
为实现上述目的,本发明所采用的技术方案如下所述:
一种中药组合物,所述中药组合物由下述重量份数的原料制备而成:
进一步的,所述中药组合物由下述重量份数的原料制备而成:
本发明提供了一种所述的中药组合物的制备方法,包括以下步骤:
1)称取所述重量份的五加皮、紫花地丁、大枫子、白芷、天南星、透骨草、侧柏叶、番木鳖、荜拔、野芋头、青皮、羌活、儿茶、乳香、没药、接骨木、红花、白公鸡血置于煮锅中,加入适量凉水,烧开后文火煮1~2小时,出渣,药汤去沉淀后,加入所述重量份的青盐,重新熬煮至稠状,取出,阴干,粉碎并过100目筛,得粉状物1,备用;
2)称取所述重量份的白凤仙花根、蓖麻根、无名异、川乌、草乌、穿山甲、蟾酥、藜芦、苏木、土鳖虫、藤三七粉碎,用浓度为90-95wt%的乙醇水溶液回流提取三次,第一次用乙醇水溶液的量为原料药总重量的10倍,回流4小时,第二次用乙醇水溶液的量为原料药总重量的7倍,回流3小时,第三次用乙醇水溶液的量为原料药总重量的5倍,回流1小时,合并回流液,过滤,蒸除乙醇,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物2;
3)称取所述重量份的花椒、自然铜置于研磨机中,粉碎,研磨成细粉状,所述细粉为100-140目的细粉,即得粉状物3;
4)称取所述重量份的桃仁、麝香以及象皮粉碎,加入浓度为60wt%的乙醇,料液质量体积比为1:50,利用超声装置超声提取,超声频率为10-15kHz,温度为30-40℃,超声时间为30-60min,过滤,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物4;
5)将步骤1)制得的粉状物1、步骤2)制得的粉状物2、步骤3)制得的粉状物3以及步骤4)制得的粉状物4混合均匀,即得本发明所述的中药组合物。
本发明还提供了上述制备方法制得的中药组合物。
本发明还提供了一种治疗骨伤病和/或风湿类疾病的药物,包括上述的中药组合物及药学上可接受的辅料。
在本发明的一些具体实施方案中,所述的药物剂型为外用膏剂、凝胶剂、搽剂、气雾剂、酊剂或酒剂。
本发明还提供了一种治疗骨伤病和/或风湿类疾病的外用膏剂,所述药物包括重量份数比为0.5~3:1的上述中药组合物及辅料。
优选的,一种外用膏剂,所述辅料由重量份数比2:3.2:4:1.2为的烷基糖苷、椰油基甜菜碱、杜香萜烯和丙二醇混合而成。
上述优选药物制剂中,将杜香萜烯和丙二醇共同作为透皮剂时,二者能够在促进药物透过皮肤方面具有协同增效作用,尤其是杜香萜烯和丙二醇在本发明所述的比例范围内,协同增效作用显著增强。而选用的烷基糖苷,和椰油基甜菜碱协同作用,具有较好的乳化、渗透、铺展作用,可增加膏状体系的渗透性能,使得药物可以迅速铺展于被用物体表面,加快药效。
本发明还提供了上述中药组合物在制备治疗骨伤病和/或风湿类疾病药物中的应用。
在本发明的一些具体实施方案中,所述骨伤病包括跌打损伤、骨折、陈旧性骨折、筋骨扭伤或腰肌劳损。
本发明中药组合物及其制备的药物由五加皮、白凤仙花根、紫花地丁、大枫子、蓖麻根、无名异、青盐等30多味药物制成,各味中药协同配伍,具有活血止血,温中散寒,通窍止痛,消肿排脓,接骨续筋,对疏风解表,祛瘀通络,抗炎杀菌等功效。本发明药物协同作用,缩短治疗时间,对跌打损伤、骨折性骨伤病和风湿性疾病均有明显治疗效果。
中药来源:
五加皮:本品为五加科植物细柱五加Acanthopanax gracilistylus W.W.Smith的干燥根皮。
白凤仙花根:凤仙花科植物凤仙的根。
紫花地丁:本品为堇菜科植物紫花地丁Violayedoensis Makino的干燥全草。
大枫子:为大枫子科植物大风子的成熟种子。在本方中辅以大枫子、桃仁、羌活等药物具有祛风燥湿、消肿、抗菌止痒之功效。
蓖麻根:为大戟科植物蓖麻Ricinus communis L.的根。祛风解痉;活血消肿。
无名异:结核状的软锰矿石。
青盐:为一种结晶性石盐。
白芷:本品为伞型科植物白芷Angelica dahurica(Fisch.ex Hoffm.)Benth.etHook.f.或杭白芷Angelica dahurica(Fisch.ex Hoffm.)Benth.etHook.f.var.formosana(Boiss.)Shan etYuan的干燥根。
天南星:本品为天南星科植物天南星Arisaema erubescens(Wall.)Schott.、异叶天南星Arisaema heterophyllum Blume或东北天南星Arisaema amurense Maxim.的干燥块茎。
透骨草:大戟科地构叶属植物地构叶Speranskia tuberculata(Bunge)Baill.、凤仙花科草本植物凤仙花Impatiens balsamina L.、紫葳科角蒿属植物角蒿Incarvilleasinensis Lam.、豆科野豌豆属植物山野豌豆Vicia amoena Fisch.的全草和杜鹃花科白珠树属植物滇白珠Gaultheria yunnanensis(Franch.)Rehd.的全株。
侧柏叶:本品为柏科植物侧柏Platycladus orientalis(L.)Franco的干燥枝梢及叶。
象皮:象科动物亚洲象Elephas maximus L.的皮,以去毛的干燥皮入药。
番木鳖:本品为马钱科植物马钱Strychnos nuxvomica L.的干燥成熟种子。
毕拨:一种胡椒科、毕拨种、毕拨属植物。
川乌:本品为毛茛科植物乌头Aconitum carmichaeli Debx.的干燥母根。
草乌:本品为毛茛科植物北乌头Aconitum kusnezoffii Reichb.的干燥块根。
野芋头:天南星科芋属植物野芋Colocasia antiquorum Schott,以全草及块茎入药。
桃仁:本品为蔷薇科植物桃Prunus persica(L.)Batsch或山桃Prunus davidiana(Carr.)Franch.的干燥成熟种子。
花椒,为芸香科植物花椒的果皮。
穿山甲,本品为鲮鲤科动物穿山甲Manis pentadactyla Linnaeus的鳞甲。
青皮:本品为芸香科植物橘Citrus reticulataBlanco及其栽培变种的干燥幼果或未成熟果实的果皮。
蟾酥:本品为蟾蜍科动物中华大蟾蜍Bufo bufo gargarizans Cantor或黑眶蟾蜍B.melanostictus Schneider的干燥分泌物。
自然铜:本品为硫化物类矿物黄铁矿族黄铁矿。
藜芦:百合科藜芦属植物藜芦Veratrum nigrum L.,以根部或带根全草入药。
羌活:本品为伞形科植物羌活(背翅芹)Notopterygium incisum Ting exH.T.Chang或宽叶羌活Notopterygium forbesii Boiss.的干燥根茎及根。
儿茶:本品为豆科合欢属植物儿茶树Acacia catechu(L.f.)Willd.的去皮枝、干的干燥煎膏。
乳香:橄榄科乳香树属植物乳香树Boswellia carterii Birdw.[B.sacraFluek.]、药胶香树B.bhawdajiana Birdw.及野乳香树B.neglecta M.Moore等,以其树干皮部伤口渗出的油胶树脂入药。
没药:橄榄科没药属植物没药树Commiphora myrrha Engl.[C.molmol Engl.]及同属他种植物的树干皮部渗出的油胶树脂。
接骨木:忍冬科接骨木属植物接骨木Sambucus williamsii Hance,以全株入药。
苏木:本品为豆科云实属植物苏木Caesalpinia sappan L.的干燥心材。
土鳖虫:为鳖镰科昆虫地鳖及冀地鳖的干燥雌性全虫。
藤三七:落葵科藤三七Boussingaultia gracilis Miers.var.baselloidesBail.,以藤上块茎入药。
红花:本品为菊科植物红花Carthamus tinctorius L.的干燥花。
白公鸡血:雉科动物白公鸡的血。祛风活血,利关节,通经络。
麝香:本品为鹿科动物林麝Moschus berezovskii Flerov、马麝Moschussifanicus Przewalski或原麝Moschus moschiferus Linnaeus成熟雄体香囊中的干燥分泌物。
具体实施方式
下面结合实施例,对本发明一种中药组合物及其制剂、制法的具体实施方式作进一步描述。以下实施例仅用于更加清楚地说明本发明的技术方案,而不能以此来限制本发明的保护范围;有关技术领域的普通技术人员,在不脱离本发明的精神和范围的情况下,还可以做出各种变化和变型,因此所有等同的技术方案也属于本发明的范畴,本发明的专利保护范围应由各权利要求限定。
实施例1
该示例的中药组合物由下述重量份数的原料制成:
实施例2
该示例中的中药组合物由以下重量份的原料制成:
实施例3
该示例的中药组合物,由下述重量份数的原料制备而成:
制备方法包括以下步骤:
1)称取所述重量份的五加皮、紫花地丁、大枫子、白芷、天南星、透骨草、侧柏叶、番木鳖、荜拔、野芋头、青皮、羌活、儿茶、乳香、没药、接骨木、红花、白公鸡血置于煮锅中,加入适量凉水,烧开后文火煮1~2小时,出渣,药汤去沉淀后,加入所述重量份的青盐,重新熬煮至稠状,取出,阴干,粉碎并过100目筛,得粉状物1,备用;
2)称取所述重量份的白凤仙花根、蓖麻根、无名异、川乌、草乌、穿山甲、蟾酥、藜芦、苏木、土鳖虫、藤三七粉碎,用浓度为95wt%的乙醇水溶液回流提取三次,第一次用乙醇水溶液的量为原料药总重量的10倍,回流4小时,第二次用乙醇水溶液的量为原料药总重量的7倍,回流3小时,第三次用乙醇水溶液的量为原料药总重量的5倍,回流1小时,合并回流液,过滤,蒸除乙醇,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物2;
3)称取所述重量份的花椒、自然铜置于研磨机中,粉碎,研磨成细粉状,所述细粉为100目的细粉,即得粉状物3;
4)称取所述重量份的桃仁、麝香以及象皮粉碎,加入浓度为60wt%的乙醇,料液质量体积比为1:50,利用超声装置超声提取,超声频率为10kHz,温度为30℃,超声时间为60min,过滤,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物4;
5)将步骤1)制得的粉状物1、步骤2)制得的粉状物2、步骤3)制得的粉状物3以及步骤4)制得的粉状物4混合均匀,即得本发明所述的中药组合物。
实施例4
该示例的中药组合物,由下述重量份数的原料制备而成:
制备方法包括以下步骤:
1)称取所述重量份的五加皮、紫花地丁、大枫子、白芷、天南星、透骨草、侧柏叶、番木鳖、荜拔、野芋头、青皮、羌活、儿茶、乳香、没药、接骨木、红花、白公鸡血置于煮锅中,加入适量凉水,烧开后文火煮1~2小时,出渣,药汤去沉淀后,加入所述重量份的青盐,重新熬煮至稠状,取出,阴干,粉碎并过100目筛,得粉状物1,备用;
2)称取所述重量份的白凤仙花根、蓖麻根、无名异、川乌、草乌、穿山甲、蟾酥、藜芦、苏木、土鳖虫、藤三七粉碎,用浓度为90wt%的乙醇水溶液回流提取三次,第一次用乙醇水溶液的量为原料药总重量的10倍,回流4小时,第二次用乙醇水溶液的量为原料药总重量的7倍,回流3小时,第三次用乙醇水溶液的量为原料药总重量的5倍,回流1小时,合并回流液,过滤,蒸除乙醇,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物2;
3)称取所述重量份的花椒、自然铜置于研磨机中,粉碎,研磨成细粉状,所述细粉为140目的细粉,即得粉状物3;
4)称取所述重量份的桃仁、麝香以及象皮粉碎,加入浓度为60wt%的乙醇,料液质量体积比为1:50,利用超声装置超声提取,超声频率为15kHz,温度为40℃,超声时间为30min,过滤,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物4;
5)将步骤1)制得的粉状物1、步骤2)制得的粉状物2、步骤3)制得的粉状物3以及步骤4)制得的粉状物4混合均匀,即得本发明所述的中药组合物。
实施例5
一种中药组合物制备的外用膏剂,由下述重量份数的组分组成:
实施例3所述的中药组合物156份,烷基糖苷20份、椰油基甜菜碱32份、杜香萜烯40份以及丙二醇12份;
制备方法:将中药组合物及辅料加入适量纯净水混合搅拌均匀后,搅拌至稠膏状,即得外用膏剂。
实施例6
一种中药组合物制备的外用膏剂,由下述重量份数的组分组成:
实施例3所述的中药组合物222份,烷基糖苷25份、椰油基甜菜碱10份、杜香萜烯25份以及丙二醇14份;
制备方法:如实施例5所述的制备方法进行制备。
实施例7
一种中药组合物制备的外用膏剂,由下述重量份数的组分组成:
实施例4所述的中药组合物67份,烷基糖苷20份、椰油基甜菜碱42份、杜香萜烯32份以及丙二醇10份;
制备方法:如实施例5所述的制备方法进行制备。
对照实施例1
该示例的中药组合物,由下述重量份数的原料制备而成:
制备方法:按照实施例3所述的方法制备。
对照实施例2
实施例3所述的配方
制备方法:称取实施例3所述重量份的原料置于煮锅中,加入适量凉水,烧开后文火煮1~2小时,出渣,药汤去沉淀后,重新熬煮至稠状,取出,阴干,粉碎并过100目筛,即得中药组合物。
对照实施例3
一种中药组合物制备的外用膏剂,由下述重量份数的组分组成:
实施例3所述的中药组合物156份,烷基糖苷20份、椰油基甜菜碱32份以及丙二醇12份;
制备方法:将中药组合物及辅料加入适量纯净水混合搅拌均匀后,搅拌至稠膏状,即得外用膏剂。
对照实施例4
一种中药组合物制备的外用膏剂,由下述重量份数的组分组成:
实施例3所述的中药组合物156份,烷基糖苷20份、椰油基甜菜碱32份;
制备方法:将中药组合物及辅料加入适量纯净水混合搅拌均匀后,搅拌至稠膏状,即得外用膏剂。
试验例1本发明对大鼠骨折的影响
1.分组建模:取SPF级9-11周龄db/db大鼠(购自上海斯莱克实验动物有限责任公司)66只,其中55只腹腔注射10%水合氯醛3mL/kg对大鼠进行麻醉,待其完全被麻醉后,将其固定于无菌手术台,于左前肢处进行剪毛,用手术刀将皮肤切开,分离并去除肌肉及***,用骨钳将7组大鼠的桡骨造成骨折,空白对照组除外,将手术缝合线于伤口处逐层缝合切口,即造模完成,并观察其动态,手术期间用75%的医用酒精及时进行消毒并清理伤口。术后连续3d,腹腔注射4万单位的庆大霉素对骨折大鼠进行消炎杀菌,并对其伤口处用碘伏进行消毒。影像学检查实验大鼠手术后骨折情况,实验大鼠手术后通过X线摄片的定位观察证实所有大鼠的桡骨骨折部位造模成功,均可见桡骨断裂,骨量丢失,骨折线明显清晰,骨膜下出血及其周围***发生肿胀,桡骨损伤明显,骨折率为100%。造模成功的大鼠随机分为5组,动物分笼饲养,每笼11只;未手术的大鼠为空白组,其余5组为给药组。
2.给药:标准饲料饲养;将实施例1、实施例2、实施例3、对照实施例1的中药组合物加入适量水调制成膏剂,对给药组分别在患处涂抹实施例1、实施例2、实施例3、实施例5以及对照实施例1的膏剂,每日一次。
3.实验结果:
在给药30天后发现,给药组实施例1、实施例2、实施例3、实施例5骨折处胶原纤维与正常骨膜无明显差异,其中,实施例3、实施例5差异最小,无明显软骨细胞和编织骨形成骨性连接,编织骨基本转变成板层骨,而对照实施例1恢复较差,没有实施例1快。此外,给药组实施例3、实施例5在给药30天后,血清中钙、磷的含量明显高于对照组及实施例1。由钙和磷组成的磷灰石存在于骨骼中,是促进骨骼的重要因素,说明实施例3和实施例5对骨骼愈合的能力效果最好,可提高大鼠身体中钙的含量,增强钙能力的吸收,有效增加骨钙含量形成骨钙,加强钙元素吸收,促进骨骼的痊愈。
试验例2本发明膏剂对大鼠扭体反应的影响
取SPF级9-11周龄db/db大鼠(购自上海斯莱克实验动物有限责任公司)72只,雌雄各半,随机分成9组,空白组1组,对照组1组涂抹正红花油,给药组7组分别涂抹腹部给药(实施例1、实施例3、对照实施例1和对照实施例1-2的中药组合物加入适量水调制成膏剂,给予实施例1、实施例3、实施例5、对照实施例1-4制备得到的膏剂),均连续给药5d,1次/d。于末次给药后1h,每只腹腔注射0.6%冰醋酸溶液0.2ml,记录注射致痛剂后20min内各组大鼠扭体次数。
表1本发明膏剂对大鼠扭体次数的影响(平均值±s)
其中,*P<0.05,**P<0.01,与空白对照组相比。
结果如表1所示,本发明实施例1膏剂和对照正红花油效果相当,可明显(P<0.05)减少冰醋酸诱导的大鼠扭体次数。实施例3、实施例5以及对照实施例3-4的效果更佳。
试验例3本发明膏剂对大鼠耳郭肿胀的影响
取SPF级9-11周龄db/db大鼠(购自上海斯莱克实验动物有限责任公司)72只,雌雄各半,随机分成9组,空白组1组,对照组1组涂抹正红花油,给药组7组分别涂抹腹部给药(实施例1、、实施例3、对照实施例1和对照实施例1-2的中药组合物加入适量水调制成膏剂,给予实施例1、实施例3、实施例5、对照实施例1-4制备得到的膏剂),均连续给药5d,1次/d。于末次给药后1h,在大鼠左耳前后两面涂抹二甲苯0.05ml致炎,右耳作对照4h后将大鼠脱颈椎处死,用9mm直径打孔器直接在大鼠左右两耳同一部位打下圆耳片,称重。肿胀率计算:△肿胀率=(左耳片重量-右耳片重量)/右耳片重量。
表2本发明膏剂对大鼠耳郭肿胀的影响(平均值±s)
其中,*P<0.05,**P<0.01,与空白对照组相比。
结果如表2所示,本发明实施例1膏剂和对照正红花油效果相当,本发明膏剂可明显减少大鼠的耳郭肿胀率。实施例3、实施例5和对照实施例3-4的效果更佳。
试验例4本发明实施例膏剂的透皮效果
1试验药物:本发明实施例5和对照实施例3-4的中药膏剂。
2体外透皮实验
2.1离体鼠皮的制备:将6周龄db/db大鼠,断颈处死,用10wt%硫化钠溶液去毛,剥离腹部皮肤,除去皮下脂肪选取完整皮肤用生理盐水洗净,浸于生理盐水中,4℃保存备用。
2.2透皮实验方法:将备用的大鼠的皮肤固定在YB-P6智能透皮试验仪的扩散池与接受池之间,皮肤内层面向接受池。在接受池中充满乙腈作接受液(排除里面的气泡,使接受液与皮肤紧密接触),然后将实施例5和对照实施例3-4的液态药物充满整个扩散池。接受液温度维持30±0.5℃,电磁搅拌器转速维持在600rpm/min。分别在第1、2、4、6、8、10小时取0.5mL接收液,同时用乙腈将接受池补满。在同样的条件下,依次对上述3个样品做透皮实验。
3.色谱条件与***适用性试验:用十八烷基硅烷键合硅胶为填充剂;甲醇-水(25:75)为流动相;检测波长为284nm。理论板数按橙皮苷峰计算应不低于1000。
对照品溶液的制备:精密称取橙皮苷对照品适量,加甲醇制成每1ml含0.1mg的溶液,即得。
供试品溶液的制备:取实施例5和对照实施例3-4的中药膏剂2g,精密称定,置量瓶中,加甲醇300ml,超声处理30分钟,放冷,加甲醇至刻度,摇匀,滤过,精密量取续滤液2ml,置5ml量瓶中,加甲醇至刻度,摇匀,即得。
测定法:分别精密吸取对照品溶液与供试品溶液各1μl,注入液相色谱仪,测定,即得。以橙皮苷含量为基准进行判断,见表3。
表3不同实施例膏剂的透皮效果
由表3可知,实施例5所述膏剂所含橙皮苷浓度最高,本发明膏剂添加的杜香萜烯以及丙二醇具有协同增效的透皮作用。
典型病例
曾某,女45岁,自述膝关节疼痛多年,阴雨天加重,行走困难。经检查血沉加快,类风湿因子阳性,初步确诊为类风湿性关节炎。使用本发明实施例3制备的膏剂3天,疼痛症状明显减轻。
黄某:男,41岁,外出时摔倒,患者感觉剧痛难忍且不能自行站立,家人送至医院经X光检查显示为左腿粗隆间骨折,随后开始外敷实施例3膏剂治疗,24小时后可在床上坐起,疼痛消失。7天后拍X光片复查显示骨折处骨痂形成,又一个月后回访,患者可独立行走。
刘某:男,57岁,外出锻练时摔倒,经医院X光检查显示右腿股骨颈骨折,治疗开始外敷实施例5所述药物,用药5天,静养一周后可坐在床边活动患肢,无疼痛感。半个月后拍X光片复查,显示骨折处有大量骨痂形成。
元某,男,40岁,左侧股骨颈粉碎性骨折,右侧第5、6、7肋骨骨折,因外伤严重,迟迟没有做手术,西医治疗一个多月后伤势没有好转;随后开始使用本发明实施例5制得的膏剂,2个疗程(14d)后,疼痛感明显降低,继续治疗3个疗程康复痊愈,行走运动自如,正常工作。
董某,男,48岁,晨起后双手关节发紧,僵硬,活动后缓解,双手多个指关节红肿疼痛,气候恶劣时病情加重,经多年治疗无效。在关节涂抹本发明实施例5制备的膏剂1个疗程(7d)后,症状缓解,继续使用1个疗程后,症状消失,无疼痛,至今未复发。
上述数据对本发明的具体实施方式进行了详尽描述,但并非对本发明保护范围的限制,所属领域技术人员应该明白,在本发明的技术方案的基础上,本领域技术人员不需要付出创造性劳动即可做出的各种修改或变形仍在本发明的保护范围以内。
Claims (10)
1.一种中药组合物,其特征在于,所述中药组合物由下述重量份数的原料制备而成:
2.如权利要求1所述的中药组合物,其特征在于,所述中药组合物由下述重量份数的原料制备而成:
3.如权利要求1~2中任一项所述的中药组合物的制备方法,包括以下步骤:
1)称取所述重量份的五加皮、紫花地丁、大枫子、白芷、天南星、透骨草、侧柏叶、番木鳖、荜拔、野芋头、青皮、羌活、儿茶、乳香、没药、接骨木、红花、白公鸡血置于煮锅中,加入适量凉水,烧开后文火煮1~2小时,出渣,药汤去沉淀后,加入所述重量份的青盐,重新熬煮至稠状,取出,阴干,粉碎并过100目筛,得粉状物1,备用;
2)称取所述重量份的白凤仙花根、蓖麻根、无名异、川乌、草乌、穿山甲、蟾酥、藜芦、苏木、土鳖虫、藤三七粉碎,用浓度为90-95wt%的乙醇水溶液回流提取三次,第一次用乙醇水溶液的量为原料药总重量的10倍,回流4小时,第二次用乙醇水溶液的量为原料药总重量的7倍,回流3小时,第三次用乙醇水溶液的量为原料药总重量的5倍,回流1小时,合并回流液,过滤,蒸除乙醇,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物2;
3)称取所述重量份的花椒、自然铜置于研磨机中,粉碎,研磨成细粉状,所述细粉为100-140目的细粉,即得粉状物3;
4)称取所述重量份的桃仁、麝香以及象皮粉碎,加入浓度为60wt%的乙醇,料液质量体积比为1:50,利用超声装置超声提取,超声频率为10-15kHz,温度为30-40℃,超声时间为30-60min,过滤,浓缩至稠状,干燥,粉碎并过100目筛,制得粉状物4;
5)将步骤1)制得的粉状物1、步骤2)制得的粉状物2、步骤3)制得的粉状物3以及步骤4)制得的粉状物4混合均匀,即得本发明所述的中药组合物。
4.如权利要求3所述的制备方法制得的中药组合物。
5.一种治疗骨伤病和/或风湿类疾病的药物,其特征在于,包括权利要求1-2任一项或权利要求4所述的中药组合物及药学上可接受的辅料。
6.如权利要求5所述的药物,其特征在于,其剂型为外用膏剂、凝胶剂、搽剂、气雾剂、酊剂或酒剂。
7.一种治疗骨伤病和/或风湿类疾病的外用膏剂,其特征在于,所述药物包括重量份数比为0.5~3:1的权利要求1-2任一项或权利要求4所述的中药组合物及辅料。
8.如权利要求7所述的治疗骨伤病和/或风湿类疾病的外用膏剂,其特征在于,所述辅料由重量份数比2:3.2:4:1.2为的烷基糖苷、椰油基甜菜碱、杜香萜烯和丙二醇混合而成。
9.如权利要求1-2或者权利要求4-8中任一项所述的中药组合物在制备治疗骨伤病和/或风湿类疾病药物中的应用。
10.如权利要求9所述的应用,其特征在于,所述骨伤病包括跌打损伤、骨折、陈旧性骨折、筋骨扭伤或腰肌劳损。
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