CN114146139A - 促进骨折愈合的中药提取物及其制备方法和应用 - Google Patents
促进骨折愈合的中药提取物及其制备方法和应用 Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供促进骨折愈合的中药提取物及其制备方法和应用,涉及中药技术研究领域;该中药提取物的药物原料包括8‑10份酒萸肉、8‑10份杜仲、8‑12份补骨脂、5‑8份仙人掌、8‑10份红花、5‑8份丹参、5‑8份酒黄精和8‑10份自然铜,将这些药物原料先后经过两次醇提和两次水提后并经浓缩、干燥后制得中药提取物,并将其运用于所有的骨折症状中;该中药提取物的原料来源丰富、所需药味少、获取便利且均为天然药物,无毒副作用;通过将这些原料依次进行两次醇提和两次水提,能够将原料中的水溶性和醇溶性有效成分充分提取出,进而提高提取物中有效药用成分含量,使制备的中药提取物能够进一步促进骨折愈合,缩短骨折愈合时间,减轻患者骨折术后疼痛及肿胀疗效较好。
Description
技术领域
本发明涉及中药技术研究领域,特别是促进骨折愈合的中药提取物及其制备方法和应用。
背景技术
骨折是指骨的连续性及完整性失去,同时也包括局部软组织与血管的损伤。骨折后人体会激发复杂的细胞信号网络去修复损伤和恢复功能,最终恢复骨的正常结构与功能。骨损伤包括三个连续的过程:炎症、修复、重建,骨折发生后,骨折断端产生血肿,血管活性物质、炎症因子、生长因子从血肿中释放出来;巨唆细胞及其它的免疫细胞募集于骨折断端清除坏死的组织,同时周围组织释放的生长因子、趋化因子等使募集于骨折断端处,进而向造骨原始细胞及成骨细胞分化。成熟的成骨细胞释放细胞外基质形成未成熟的编织骨,细胞外基质、成骨细胞、新形成的血管及未成熟的编织骨形成骨痂充填在骨折断端,在不同细胞信号通路的管理下成骨细胞与破骨细胞协同作用下实现骨痂的改造,与此同时,依据定律骨豁能够承受骨组织的机械应变,并且具有适应这些功能需求的能力,实现骨的改造与重建。
目前,骨折患者多数采用打夹板、石膏固定和手术牵引等方式治疗,经过良好的复位和固定后,骨折一般在半年以上得以治愈,由于恢复期较长,骨折患者将长期行动不便,丧失劳动能力,造成的损伤巨大。目前,配合治疗骨折主要有一些中药复方,如云南白药、七厘散、跌打丸等。这些复方药味较多,有的甚至几十味药材,成分复杂,服用剂量大、纯度不高;且由于多味药材采收季节和地点难以统一,若需集齐所需药材,往往需要将已收集的药材进行长时间放置,而部分药材在长时间放置中会导致药性失效,结果造成药物质量不稳定、效果不佳、成本高等缺点。
发明内容
本发明的目的在于提供促进骨折愈合的中药提取物及其制备方法和应用,该中药提取物的原料来源丰富、所需药味少、获取便利且均为天然药物,无毒副作用;通过将这些原料依次进行醇提和水提操作,进一步提高提取物中有效药用成分含量,使制备的中药提取物有明显的促进骨折愈合作用,缩短骨折愈合时间,减轻患者骨折术后疼痛及肿胀,提高骨折疗效。
本发明的目的是通过以下技术方案来实现的:
促进骨折愈合的中药提取物,该中药提取物由原料药依次经过醇提和水提所得;
按重量份计,所述原料药包括8-10份酒萸肉、8-10份杜仲、8-12份补骨脂、5-8份仙人掌、8-10份红花、5-8份丹参、5-8份酒黄精和8-10份自然铜;所述酒萸肉为山茱萸炮制所得;所述酒黄精为黄精炮制所得。
优选的,按重量份计,所述原料药包括10份酒萸肉、8份杜仲、10份补骨脂、7份仙人掌、8份红花、6份丹参、5份酒黄精和10份自然铜。
该促进骨折愈合的中药提取物的制备方法,包括如下步骤:
S1将所述原料药粉碎,其后向碎料中加入8倍所述原料药重量的95%乙醇,回流提取1.5-2h,过滤,得到第一次滤渣和第一次滤液;
S2向所述第一次滤渣中再加入6倍所述原料药重量的95%乙醇回流提取1.5-2h,过滤,得到第二次滤渣和第二次滤液;
S3向所述第二次滤渣中加入10倍所述原料药重量的水浸泡,并进行蒸馏,其次将蒸馏后的固液混合物煎煮40~60min后过滤,得到第三次滤渣和第三次滤液;
S4向所述第三次滤渣中加入10倍所述原料药重量的水浸泡,并煎煮40~60min后过滤,得到第四次滤渣和第四次滤液;
S5将所述第一次滤液、第二次滤液、第三次滤液和第四次滤液合并,并在60-70℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。上述制备方法中,先向药物原料中加入乙醇,因酒黄精和酒萸肉中已经含有乙醇,因此此处的乙醇添加量相应减少,通过两次醇提能够有效的将药物原料中的醇溶性物质(如游离黄酮类、萜类、挥发油,生物碱等)充分提取出,进而提高有效药用成分的含量,同时因酒精本身具有行血活络的功效,易于吸收和发散,能增强中药提取物祛风活血、止痛散淤的功能;其次,再经过两次水提操作,能够将药物原料中的水溶性物质(如糖类,苷类鞣质,黄酮苷类等)提出来,进而确保药物原料中的醇溶性和水溶性药物成分均能充分提取出,有效确保该中药提取物的药用价值。
该促进骨折愈合的中药提取物可运用于开发性骨折、非开发性骨折、成旧性骨折、粉碎性骨折、骨裂、跌打、扭伤、骨折不愈合、延迟愈合等各种症状。
本发明的有益效果是:
酒萸肉:酸、涩、微温,酒萸肉由山茱萸与黄酒炮制所得;山萸肉补益肝肾,涩精止汗,用于肝肾不足之腰酸遗精、头晕目眩等症;而炮制后的山茱萸,补益肝肾效果增强,活血通络,涩精固脱,用于眩晕耳鸣、腰膝酸痛、阳痿遗精等症。
杜仲:甘、温,补肝肾,强筋骨,去关节湿淫、治腰膝酸痛,腿足拘挛。杜仲能增强肾上腺皮质的功能,激活机体特异性的免疫功能反应,具有双相调节细胞免疫功能的作用;杜仲水提液有促进骨折断端矿物质沉积、提高骨密度,促进骨折愈合的作用。杜仲含药血清能够促进骨髓间充质干细胞成骨分化。
酒黄精:酒黄精为黄精与黄酒炮制所得;黄精具有补气养阴,健脾,润肺,益肾的作用,是很好的补益药;但因生黄精具有麻味,生品服用时,口舌麻木,刺激咽喉,接触过生黄精或其汁液的皮肤会产生瘙痒的感觉,久闻其生味,有刺目之感,难以用于临床;黄精经过炮制后,其刺激性及副作用消除,糖性变浓裂,口感好,利于口服,且经炮制后转变药性,利于有效成分积累,其黏液质被破坏并去掉,使其滋而不腻,同时使黄精药效增强,具有补肾益血,活血通络,润肺生津、止痛散淤之功效。
补骨脂:辛、苦、温;补肾壮阳、固精缩尿、治腰膝酸软冷痛的功效,补骨脂有效成分补骨脂素及异补骨脂素具有促进骨髓间充质千细胞成骨分化的作用。
仙人掌:味苦,性寒,行气活血,清热解毒,消肿止痛,健脾止泻,安神利尿,改善胃肠功能,溶解血栓,消肿生肌,加快脂肪分解速度,调节血脂、降血糖、降血压、抗肿瘤、抗病毒等。
红花:辛,温,归心、肝经,具有活血通经,祛瘀止痛的作用,红花及提取物有抗凝血、抑制血栓形成;羟基红花黄色素A能够抑制地塞米松诱导的BMSCs成脂分化,在股骨头坏死中起到作用。
丹参:丹参性苦,微寒,有活血化瘀通络止痛功效;丹参能增加毛细血管的生成数量,改善和增加骨折局部的血液供应;促进成骨细胞与破骨细胞的修复功能;促使成纤维细胞的蛋白质合成旺盛,胶原纤维增多且密集;加速对基质钙化,更好地满足新骨形成对钙的需要;增加生长因子的含量,促进骨折的愈合。
自然铜:自然铜能提供骨折愈合必须的多种微量元素、促进胶原纤维形成和钙磷的沉积、增强多种酶的活性;同时其能够提高骨痂中微量元素Fe、Ca的含量,从而增加骨痂的生长。
综上,酒萸肉为补肝肾、活血之要药,杜仲具有补肝肾、强筋骨的功效,酒黄精具有补肾益血,活血通络,润肺生津、止痛散淤,故三者为君药;补骨脂性温,具有促进成骨分化,仙人掌性寒,具有活血止痛、消肿生肌之功效,二者共为臣药,能平衡二药的药性,以达生骨活血祛瘀之功效;丹参性苦,微寒,有活血化瘀通络止痛功效;红花性辛,温,有活血通经,消肿止痛之功效,二者共同作为佐药,二药相辅祛瘀生新,活血通络,祛瘀生新;自然铜补充微量元素,促进骨痂生长,其为使药。通过将上述中药进行提取制得的中药提取物,能够活血化瘀、消肿止痛、补益肝肾、强筋壮骨、益气养血,促进骨折愈合,改善患者的骨痂生长情况并提高血清ALP、血磷、血钙含量。
具体实施方式
下面结合实施例进一步详细描述本发明的技术方案,但本发明的保护范围不局限于以下。
一、实施例和对比例
实施例1
S1按照2015版中国药典所述方法制备酒黄精和酒萸肉;
S2按重量份计,取8份酒萸肉、8份杜仲、12份补骨脂、8份仙人掌、10份红花、5份丹参、5份酒黄精和10份自然铜进行粉碎,过40目,其后向碎料中加入528份95%乙醇,浸泡1h,其后回流提取1.5h,过滤,得到第一次滤渣和第一次滤液;
S3向所述第一次滤渣中再加入396份的95%乙醇回流提取1.5h,过滤,得到第二次滤渣和第二次滤液;
S4向所述第二次滤渣中加入660份的水浸泡,并蒸馏30min,蒸馏温度为78℃,其次将蒸馏后的固液混合物煎煮40min后过滤,得到第三次滤渣和第三次滤液;
S5向所述第三次滤渣中加入660份的水浸泡,并煎煮40min后过滤,得到第四次滤渣和第四次滤液;
S6将第一至第四次滤液合并、并在60℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。服用方法,每次0.8g,3次/d;30天为一疗程。
实施例2
S1按照2015版中国药典所述方法制备酒黄精和酒萸肉;
S2按重量份计,取10份酒萸肉、10份杜仲、8份补骨脂、5份仙人掌、8份红花、8份丹参、8份酒黄精和8份自然铜进行粉碎,过40目,其后向碎料中加入520份95%乙醇,浸泡1h,其后回流提取2h,过滤,得到第一次滤渣和第一次滤液;
S3向所述第一次滤渣中再加入390份的95%乙醇回流提取2h,过滤,得到第二次滤渣和第二次滤液;
S4向所述第二次滤渣中加入650份的水浸泡,并蒸馏30min,蒸馏温度为78℃,其次将蒸馏后的固液混合物煎煮60min后过滤,得到第三次滤渣和第三次滤液;
S5向所述第三次滤渣中加入650份的水浸泡,并煎煮60min后过滤,得到第四次滤渣和第四次滤液;
S6将第一至第四次滤液合并、并在70℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。服用方法,每次0.8g,3次/d;30天为一疗程。
实施例3
S1按照2015版中国药典所述方法制备酒黄精和酒萸肉;
S2按重量份计,取9份酒萸肉、9份杜仲、10份补骨脂、7份仙人掌、9份红花、6份丹参、6份酒黄精和9份自然铜进行粉碎,过40目,其后向碎料中加入520份95%乙醇,浸泡1h,其后回流提取1.8h,过滤,得到第一次滤渣和第一次滤液;
S3向所述第一次滤渣中再加入390份的95%乙醇回流提取1.8h,过滤,得到第二次滤渣和第二次滤液;
S4向所述第二次滤渣中加入650份的水浸泡,并蒸馏30min,蒸馏温度为78℃,其次将蒸馏后的固液混合物煎煮50min后过滤,得到第三次滤渣和第三次滤液;
S5向所述第三次滤渣中加入650份的水浸泡,并煎煮50min后过滤,得到第四次滤渣和第四次滤液;
S6将第一至第四次滤液合并、并在65℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。服用方法,每次0.8g,3次/d;30天为一疗程。
实施例4
S1按照2015版中国药典所述方法制备酒黄精和酒萸肉;
S2按重量份计,取10份酒萸肉、8份杜仲、10份补骨脂、7份仙人掌、8份红花、6份丹参、5份酒黄精和10份自然铜进行粉碎,过40目,其后向碎料中加入512份95%乙醇,浸泡1h,其后回流提取2h,过滤,得到第一次滤渣和第一次滤液;
S3向所述第一次滤渣中再加入384份的95%乙醇回流提取2h,过滤,得到第二次滤渣和第二次滤液;
S4向所述第二次滤渣中加入640份的水浸泡,并蒸馏30min,蒸馏温度为78℃,其次将蒸馏后的固液混合物煎煮50min后过滤,得到第三次滤渣和第三次滤液;
S5向所述第三次滤渣中加入640份的水浸泡,并煎煮50min后过滤,得到第四次滤渣和第四次滤液;
S6将第一至第四次滤液合并、并在70℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。服用方法,每次0.8g,3次/d;30天为一疗程。
对比例1
S1按照2015版中国药典所述方法制备酒黄精和酒萸肉;
S2按重量份计,取9份杜仲、10份补骨脂、7份仙人掌、6份丹参、6份酒黄精和9份自然铜进行粉碎,过40目,其后向碎料中加入376份95%乙醇,浸泡1h,其后回流提取1.8h,过滤,得到第一次滤渣和第一次滤液;
S3向所述第一次滤渣中再加入282份的95%乙醇回流提取2h,过滤,得到第二次滤渣和第二次滤液;
S4向所述第二次滤渣中加入470份的水浸泡,并蒸馏30min,蒸馏温度为78℃,其次将蒸馏后的固液混合物煎煮50min后过滤,得到第三次滤渣和第三次滤液;
S5向所述第三次滤渣中加入470份的水浸泡,并煎煮50min后过滤,得到第四次滤渣和第四次滤液;
S6将第一至第四次滤液合并、并在70℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。服用方法,每次0.8g,3次/d;30天为一疗程。
对比例2
S1按照2015版中国药典所述方法制备酒黄精和酒萸肉;
S2按重量份计,取10份酒萸肉、8份杜仲、10份补骨脂、7份仙人掌、8份红花、6份丹参、5份酒黄精和10份自然铜进行粉碎,过40目,其后向碎料中加入512份95%乙醇,浸泡1h,其后回流提取2h,过滤,得到第一次滤渣和第一次滤液;
S3向所述第一次滤渣中再加入384份的95%乙醇回流提取2h,过滤,得到第二次滤渣和第二次滤液;
S6将第一至第二次滤液合并、并在70℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。服用方法,每次0.8g,3次/d;30天为一疗程。
对比例3
S1按照2015版中国药典所述方法制备酒黄精和酒萸肉;
S2按重量份计,取10份酒萸肉、8份杜仲、10份补骨脂、7份仙人掌、8份红花、6份丹参、5份酒黄精和10份自然铜进行粉碎,过40目,加入640份的水浸泡,其后煎煮50min后过滤,得到第一次滤渣和第一次滤液;
S3向所述第一次滤渣中加入640份的水浸泡,并煎煮50min后过滤,得到第二次滤渣和第二次滤液;
S4将第一、二次滤液合并、并在70℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。服用方法,每次0.8g,3次/d;30天为一疗程。
对比例4
云南红药胶囊(云南植物药业公司,0.25g/粒)3粒/次,3次/d,口服。30天为一疗程。
二、试验
1.检测实施例1-4制备的中药提取物的急性口服毒性
取体重相近的小白鼠采用常规的急性毒性试验方法进行检测,检测结果如表1所示:
表1
组别 | 急性口服毒性LD(mg/kg b.wt) |
实施例1 | >12000(无毒) |
实施例2 | >12000(无毒) |
实施例3 | >12000(无毒) |
实施例4 | >12000(无毒) |
结论:从表1可知,本发明中的中药提取物的安全性毒理学评价为无毒级,无毒副作用。
2.骨痂和骨折线评分试验
取体重相近的家兔80只并随机分成8组,包括4组对比组和4组发明组,每组10只,各组家兔于造模前进行称重并标号,造模时用0.3%戊巴比妥钠按30mg/kg家兔体重,耳缘静脉注射麻醉。在无菌条件下,用钢锯行左桡骨中段横断3mm缺损手术,术后不作任何固定,用生理盐水冲洗切口,逐层缝合切口。术后当天便按剂量设计分别耳缘静脉注射生理盐水或受试药物,每天两次,发明组按0.3克/千克注射,对比组按0.3克/千克注射。给药后第14和28天将每组中的10只家兔均拍摄X光,对骨痂和骨折线评分,评分标准如下:
0分,骨折断端清楚,无骨膜反应,无骨痂可见;
1分,骨折断端边缘趋向模糊,骨膜轻度反应,无骨痂可见;
2分,断端边缘模糊,骨膜反应浅淡,骨痂少量,密度较淡,边缘不整齐;
3分,断端边缘仍可见,但接近消失,骨膜反应较深,骨痂量增多,但尚未填满缺损,密度增深,边缘较清;4分,断端边缘完全消失,骨膜反应密度近似骨影,骨痂填满缺损,与骨皮质密度相同并相互连接。
评分时,评分结果为每组10只家兔的平均值,评分结果如表2所示:
表2
结论:
通过表2可知:发明组中的四组药物相较对比组中的药物而言,其在14天或者18天时,评分结果均更高,发明组中的药物在14天时,已经普遍达到2分的标准,在第28天时,已经普遍达到4分的标注,显示其在促进骨痂生长方面具有积极的效果;而对比例1-3的药物因未按照本发明中的配方、配比或者制备方法制备,相较发明组的药物而言,分数明显较低,而对比例4中的云南红药胶囊虽然较对比例1-3中的评分高,但是其相较发明组而言较差,进而证明本发明中的配方、配比以及制备方法具有显著的进步。
以上仅是本发明的优选实施方式,应当理解本发明并非局限于本文所披露的形式,不应看作是对其他实施例的排除,而可用于各种其他组合、修改和环境,并能够在本文构想范围内,通过上述教导或相关领域的技术或知识进行改动。而本领域人员所进行的改动和变化不脱离本发明的精神和范围,则都应在本发明所附权利要求的保护范围内。
Claims (4)
1.促进骨折愈合的中药提取物,其特征在于,该中药提取物由原料药依次经过醇提和水提所得;
按重量份计,所述原料药包括8-10份酒萸肉、8-10份杜仲、8-12份补骨脂、5-8份仙人掌、8-10份红花、5-8份丹参、5-8份酒黄精和8-10份自然铜;
所述酒萸肉为山茱萸炮制所得;所述酒黄精为黄精炮制所得。
2.根据权利要求1所述的促进骨折愈合的中药提取物,其特征在于,按重量份计,所述原料药包括10份酒萸肉、8份杜仲、10份补骨脂、7份仙人掌、8份红花、6份丹参、5份酒黄精和10份自然铜。
3.根据权利要求1所述的促进骨折愈合的中药提取物的制备方法,其特征在于,包括如下步骤:
S1将所述原料药粉碎,其后向碎料中加入8倍所述原料药重量的95%乙醇,回流提取1.5-2h,过滤,得到第一次滤渣和第一次滤液;
S2向所述第一次滤渣中再加入6倍所述原料药重量的95%乙醇回流提取1.5-2h,过滤,得到第二次滤渣和第二次滤液;
S3向所述第二次滤渣中加入10倍所述原料药重量的水浸泡,并进行蒸馏,其次将蒸馏后的固液混合物煎煮40~60min后过滤,得到第三次滤渣和第三次滤液;
S4向所述第三次滤渣中加入10倍所述原料药重量的水浸泡,并煎煮40~60min后过滤,得到第四次滤渣和第四次滤液;
S5将所述第一次滤液、第二次滤液、第三次滤液和第四次滤液合并,并在60-70℃下减压浓缩、真空干燥,制得固体药剂,即为所述中药提取物。
4.根据权利要求1所述的促进骨折愈合的中药提取物的应用,其特征在于,运用于各种骨折症状。
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