CN114452354A - 一种用于伤口的中药组合物及其提取物和应用 - Google Patents
一种用于伤口的中药组合物及其提取物和应用 Download PDFInfo
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Abstract
本发明涉及一种用于伤口的中药组合物及其提取物和应用,由人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉制成,该中药组合物具有杀菌、促进伤口愈合的作用,且有效成分含量高,具有更优异的疗效。
Description
技术领域:
本发明属于中药技术领域,具体涉及一种伤口的中药组合物及其提取物和应用。
背景技术
身体受伤出现伤口是比较常见的事,对各种外伤,常常引起皮肤和软组织的损伤,严重时甚至断肢。伤口处理正确,能使其迅速愈合;反之,可能化脓感染,经久不愈,甚至因并发全身感染、气性坏疽、破伤风等危及生命。
伤口创伤愈合的基本过程包括急性炎症期→细胞增生期→瘢痕形成期→表皮及其它组织再生,愈合过程大致如下:1.急性炎症期:伤口的早期变化伤口局部有不同程度的组织坏死和血管断裂出血,数小时内便出现炎症反应,表现为充血、浆液渗出及白细胞游出,故局部红肿。白细胞以中性粒细胞为主,3天后转为以巨噬细胞为主。伤口中的血液和渗出液中的纤维蛋白原很快凝固形成凝块,有的凝块表面干燥形成痂皮,凝块及痂皮起着保护伤口的作用。2.细胞增生期:伤口收缩2-3天后伤口边缘的整层皮肤及皮下组织向中心移动,于是伤口迅速缩小,直到14天左右停止。3.瘢痕形成期:肉芽组织增生和瘢痕形成大约从第3天开始,从伤口底部及边缘长出肉芽组织,填平伤口。毛细血管大约以每日延长0.1-0.6mm的速度增长,其方向大都垂直于创面,并呈袢状弯曲。4.表皮及其他组织再生:创伤发生24小时以内,伤口边缘的表皮基底增生,并在凝块下面向伤口中心移动,形成单层上皮,覆盖于肉芽组织的表面,当这些细胞彼此相遇时,则停止前进,并增生、分化成为鳞状上皮。
传统中医药在治疗伤口愈合具有一定优势,如云南白药在治疗外伤已广被人们接受,因此,进一步挖掘开发中医药在外伤、伤口愈合的优势,已越来越被重视。CN112245497A公开了一种杀菌消炎、促进伤口愈合的中药制剂,该中药制剂包括硼砂、滑石、枯矾、虫牙药、雄黄、没药、蛋清、白芷、黄柏、冰片、密陀僧、三七、丹参、仙人掌和迷迭香,但是该组方采用了大量有毒的矿物药如雄黄、密陀僧,在实际应用不易控制其毒性,临床应用受到较大的限制。CN101019973A公开了一种创伤快速愈合散,包括象皮、珍珠粉、三七、穿山甲、鸡内金、乳香、没药、僵蚕、榆皮、熟石膏、龙骨、鹿骨、血竭,然而该处方采用了较多的动物药材,尤其还需采用穿山甲,因而,临床应用存在较大的局限。CN104739913A公开了一种加快伤口愈合的制剂、制备方法及其应用,包括以下药材制备而成:灯盏细辛和银杏,所述灯盏细辛和银杏的重量比例为1:0.9-1.1,所述药材分别为依次经过醇溶、浓缩、冻干和回溶处理的提取液。该组合物组方简单明确,具有加快伤口愈合的作用,但未能充分体现中医药的中医特点,缺少对整体的调整。
因此,尽管目前有较多的用于伤口愈合的中药产品,但是对于伤口的治疗上效果仍不理想,不能满足临床需求。
发明内容:
本发明的目的在于克服现有技术的不足,提供一种用于伤口的中药组合物及其提取物和应用,本发明的组合物及其提取物能抑菌消毒、并促进伤口愈合,且能够改善伤口周边区域的微循环,从而加快伤口的恢复。
本发明提供一种用于伤口的中药组合物,由以下重量份的原料药制成:人参9-15份玉竹10-15份葛根9-15份茯苓15-20份甘草9-15份蒲公英9-15份黄精12-18份小球藻粉30-50份。
优选地,所述原料的重量份为:人参10-12份玉竹10-12份葛根9-12份茯苓18-20份甘草10-12份蒲公英10-12份黄精13-15份小球藻粉40-50份。进一步优选,人参10份玉竹12份葛根12份茯苓18份甘草11份蒲公英11份黄精15份小球藻粉40份。
本发明还提供一种用于伤口的中药组合物,由以下重量份的原料经发酵制成:人参9-15份玉竹10-15份葛根9-15份茯苓15-20份甘草9-15份蒲公英9-15份黄精12-18份小球藻粉30-50份酵母10-30份。
优选地,所述原料的重量份为:人参10-12份玉竹10-12份葛根9-12份茯苓18-20份甘草10-12份蒲公英10-12份黄精13-15份小球藻粉40-50份酵母20-30份。进一步优选:人参10份玉竹12份葛根12份茯苓18份甘草11份蒲公英11份黄精15份小球藻粉40份酵母25份。
本发明采用中医益气养阴生肌,清热解毒的治法,使其在抗菌过程中,又能有效促进创面愈合,恢复组织再生。
其中人参性甘、微苦,微温。归脾、肺、心、肾经。功能与主治:大补元气,复脉固脱,补脾益肺,生津养血,安神益智。用于体虚欲脱,肢冷脉微,脾虚食少,肺虚喘咳,津伤口渴,内热消渴,气血亏虚,久病虚羸,惊悸失眠,阳痿宫冷。现代医学分析表明,人参含29种人参皂甙、16种氨基酸、12种无机元素、9种糖、7种维生素及黄酮类物质、甾醇、胆碱、酶等人体需要的营养素。目前研究表明人参中富含的皂苷具有广泛的活性,人参皂苷提取物对兔耳增生性瘢痕具有抑制作用,能够抑制伤口炎症,对糖尿病病足创面也具有修复作用。
玉竹性甘,微寒。归肺、胃经。功能与主治:养阴润燥,生津止渴。玉竹根茎含铃兰苦甙、铃兰甙、山柰酚甙、槲皮醇甙、皂甙、白屈菜酸、黏液质、门冬酰胺、葡萄糖、阿拉伯糖和甘露醇。尚含淀粉25.6%-30.6%及维生素A、维生素C。叶中含玉竹甙、胡萝卜素、维生素C及含C25-C32的醛类物质,主要是28碳醛。叶和根茎还含有吖丁啶-2-羧酸。
葛根:甘、辛,凉。归脾、胃经。具有解表退热,生津,透疹,升阳止泻功效。用于外感发热头痛、高血压颈项强痛、口渴、消渴、麻疹不透、热痢、泄泻。现代药理研究:含多种黄酮类成分,主要活性成分为大豆素(daidzein)、大豆甙(daidzin)、葛根素(puerarin)、葛根素-7-木糖甙(puerarin-7-xyloside)等。
茯苓:味甘、淡,性平。归心、肺、脾、肾经。具有利水渗湿功效用于水肿尿少,痰饮眩悸。现代药理研究:茯苓主要含有β-茯苓聚糖。另含三萜类茯苓酸、茯苓素等化学成分。茯苓具有抗菌、促进造血功能、镇静等药理作用。
甘草:性味甘,平。归脾,胃,心,肺经。具有补脾益气,清热解毒,祛痰止咳,调和诸药功效。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,缓解药物毒性。现代药理研究:主要成分有甘草酸、甘草甙等,甘草有抗炎和抗变态反应的功能。
蒲公英性寒,味苦、甘。苦,甘,寒。归肝,胃经。清热解毒,消肿散结,利尿通淋。用于乳痈、瘰疬、疔疮肿毒、咽痛、肺痈、肠痈、目赤、湿热黄疸、热淋涩痛。现代药理研究:蒲公英具有广谱的抗病原微生物作用,对于革兰氏(+)菌、革兰氏(-)菌、真菌、螺旋体和病毒均有不同程度的抑制作用;蒲公英外用及水煎剂内服均具有抗炎作用;蒲公英有抗氧化、抗肿瘤、保肝利胆作用;蒲公英有清除幽门螺旋杆菌感染和对胃粘膜损伤保护作用;有降血糖作用;蒲公英有调节脂质代谢和降血脂作用,能抑制血小板聚集;有增强巨噬细胞吞噬能力及抗体生成的作用。
黄精:甘,平,归脾,肺,肾经。其根茎含3种多糖,即黄精多糖甲、乙、丙,和3种低聚糖,即黄精低聚糖甲、乙、丙,以及赖氨酸等8种氨基酸。抗病原微生物作用体外试验表明:黄精含有抗菌物质,在试管内对抗酸菌有抑制作用,对于实验性结核病的豚鼠,在感染结核菌的同时给予黄精煎剂与感染后淋巴肿大再给药,均有显著的抑菌效果,且能改善健康状况,其疗效与异烟肼接近。黄精粗制剂及水抽出液,对革兰阴性伤寒杆菌和革兰阳性金黄色葡萄球菌均有抑制作用。
本发明进一步提供上述中药组合物的提取物制备方法:
将上述中药原料饮片分别粉碎至100-120目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入与药材重量1-3倍的水;
发酵:随后将20-30重量份酵母混合搅拌至上述药材中,20-23℃恒温发酵,发酵10-18天后停止发酵;
过滤:上述发酵液粗滤,再经过微孔过滤器,压力为0.2MPa,除去微粒、细菌、污染物等;
灭菌:将上述过滤液灭菌。
进一步优选加入1.5、2倍水,优选发酵12、14、15、16、17天,优选加入20、25、30重量份酵母。
本发明还提供上述中药组合物在制备治疗伤口愈合药物中的应用。
进一步优选用于制备治疗伤口愈合中改善微循环药物中的应用。
进一步优选用于制备治疗伤口愈合中抑菌药物中的应用,所述菌为细菌或真菌,进一步优选大肠杆菌、金黄色葡萄球菌、铜绿假胞菌以及白色念珠菌。
与现有技术相比,本发明的有益效果为:
1、本发明中药组合物:组方配伍科学合理,同时现代药理学研究也表明其具有抗炎、杀菌、促进伤口愈合的作用。
2、本发明中药组合物有效地提高有效成分含量,具有更优异的疗效。
3、本发明的中药组合物及其提取液,经指定的第三方检测机构的检测,对白色念珠球菌、大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌灭杀率高。
具体实施方式
实施例1:人参10g玉竹12g葛根12g茯苓18g甘草11g蒲公英11g黄精15g小球藻粉40g。将符合饮片标准的上述中药原料分别粉碎至100目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入与药材重量1.5倍的水。
发酵:随后将25g酵母混合搅拌至上述药材粉末中,22℃恒温发酵,发酵12天后停止发酵。
过滤:上述发酵液粗滤,再经过微孔过滤器,压力为0.2MPa。除去微粒、细菌、污染物等。
灭菌:将上述过滤液灭菌,灌装。
实施例2:人参12g玉竹12g葛根12g茯苓18g甘草10g蒲公英10g黄精18g小球藻粉40g。将符合饮片标准的上述中药原料分别粉碎至100目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入与药材重量2倍的水。
发酵:随后将30g酵母混合搅拌至上述药材粉末中,21℃恒温发酵,发酵10天后停止发酵。
过滤:上述发酵液粗滤,再经过微孔过滤器,压力为0.2MPa。除去微粒、细菌、污染物等。
灭菌:将上述过滤液灭菌,灌装。
实施例3:人参9g玉竹10g葛根12g茯苓20g甘草15g蒲公英15g黄精15g小球藻粉30g。将符合饮片标准的上述中药原料分别粉碎至100目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入与药材重量2倍的水。
发酵:随后将30g酵母混合搅拌至上述药材粉末中,23℃恒温发酵,发酵12天后停止发酵。
过滤:上述发酵液粗滤,再经过微孔过滤器,压力为0.2MPa。除去微粒、细菌、污染物等。
灭菌:将上述过滤液灭菌,灌装。
实施例4:人参10g玉竹10g葛根12g茯苓18g甘草12g蒲公英12g黄精15g小球藻粉30g。将符合饮片标准的上述中药原料分别粉碎至120目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入与药材重量1.5倍的水。
发酵:随后将30g酵母混合搅拌至上述药材粉末中,22℃恒温发酵,发酵12天后停止发酵。
过滤:上述发酵液粗滤,再经过微孔过滤器,压力为0.2MPa。除去微粒、细菌、污染物等。
成型:将过滤液浓缩后,加入聚乙烯醇以及壳聚糖制成涂膜剂。
实施例5:人参10g玉竹10g葛根15g茯苓18g甘草15g蒲公英12g黄精15g小球藻粉30g。将符合饮片标准的上述中药原料分别粉碎至120目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入与药材重量1.5倍的水。
发酵:随后将30g酵母混合搅拌至上述药材粉末中,23℃恒温发酵,发酵10天后停止发酵。
过滤:上述发酵液粗滤,再经过微孔过滤器,压力为0.2MPa。除去微粒、细菌、污染物等。
成型:将过滤液浓缩成膏,加入白凡士林、羊毛脂制成外用膏剂。
实施例6:人参10g玉竹12g葛根12g茯苓18g甘草11g蒲公英11g黄精15g小球藻粉40g。将符合饮片标准的上述中药原料分别粉碎至100目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入55%乙醇回流提取2次,每次1.5小时,过滤后合并提取液,然后浓缩回收除去乙醇,得浓缩液。
在初步的预研究中发现,将人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉经乙醇提取后,虽然具有促进伤口愈合的作用,但是作用仍有限。在研究中也发现,组方中的皂苷、多糖对创面愈合有较好的作用,然而中药的皂苷组分、结构多种多样,在进一步考虑伤口的愈合过程和本发明的中药组方以及筛选实验后,人参、黄精的皂苷、黄精多糖在创面的愈合中发挥重要的作用,而本发明发现采用酵母发酵后能够有效提高人参、黄精皂苷、黄精多糖的含量。以下实验是部分研究的展示:
实验例1
SD大鼠饲养1周后,称重后选取160-180g的大鼠,随机分成四组,每组8只大鼠,分为模型组、实施例1组、实施例3组、实施例6组。剃除大鼠背部及周围毛,用腹腔注射0.25%的戊巴比妥麻醉,固定后用生理盐水擦洗,局部消毒后,再用打孔器于背部正中两侧打3个孔,破坏部分肌肉表面筋膜以及深达肌筋膜,然后表面用凡士林纱布覆盖。实施例1、3、6组创面每天给予浸润提取液的无菌纱布覆盖创面,每天一次;模型组给予浸润生理盐水的无菌纱布覆盖创面,每天一次。一共用药14天。
观察比较各组创面愈合率:拍摄未用药前的创面图像,以及建模后第3、7、12、14天拍摄各组大鼠创面图像,再用图像分析软件(Image J)自动计算面积,创面愈合率(%)=(用药前创面面积-用药后创面面积)/用药前创面面积。实验结果如表1:
表1创面愈合率(%)比较
实验结果表明14天后各组创面基本修复,被新生表皮覆盖,模型组仍可观察到小块暗红色瘢痕,实施例6组发现仍有微小暗红色瘢痕,实施例3组有少许毛发覆盖,而实施例1组创口已基本覆盖毛发,同时实施例1组在用药7天时已大致愈合,在12天时伤口愈合并开始生长毛发。
实验例2
SD大鼠饲养1周后,称重后选取160-180g的大鼠,随机分成四组,每组8只,分为阴性对照组、模型组、实施例1组、实施例6组。采用实验例1方法造模、用药。在用药3天后,将各组大鼠麻醉,用枸橼酸钠抗凝管经腹主动脉取全血,制备含血小板血浆和贫血小板血浆,以ADP做为血小板聚集诱导剂,通过血小板聚集仪测定各组大鼠ADP诱导6min的血小板聚集率。实验结果如下:
表2血小板聚集率(%)
结果表明,本发明在改善血小板聚集相对未发酵中药具有更好的效果,能够改善微循环。
实验例3
含量测定:分别以人参中的人参皂苷Rh2以及黄精中的薯蓣皂苷为皂苷指标测定其含量。
黄精薯蓣皂苷HPLC含量测定方法:
色谱条件:C18色谱柱(250mm×4.6mm,5μm);流动相:水-乙腈(39︰61);流速:1.0mL/min;检测波长:200nm;柱温:30℃;进样量:20μL。
对照品溶液制备:称取薯蓣皂苷对照品10mg,加适量甲醇,涡旋溶解。然后将溶液转移至25mL容量瓶中,加甲醇摇匀定容至刻度,配制成0.4mg/mL的对照品溶液。
样品溶液制备:分别取实施例1、实施例6的样品,将其浓缩干燥后,取0.1g干粉加适量甲醇超声充分溶解,然后用0.22um的滤膜过滤至100ml容量瓶中,补加甲醇至刻度定容。
人参皂苷Rh2的HPLC含量测定方法:
色谱条件:C18色谱柱(250mm×4.6mm,5μm);流动相A为水(含0.1%甲酸),流动相B为乙腈,流动相按体积比A:B为45∶55;流速:1.0mL/min;检测波长:203nm;柱温:30℃;进样量:20μL。
对照品溶液制备:称取人参皂苷Rh2对照品10mg,加适量甲醇,涡旋溶解。然后将溶液转移至25mL容量瓶中,加甲醇摇匀定容至刻度,配制成0.4mg/mL的对照品溶液。
样品溶液制备:分别取实施例1、实施例6的样品,将其浓缩干燥后,取0.1g干粉加适量甲醇超声充分溶解,然后用0.22um的滤膜过滤至100ml容量瓶中,补加甲醇至刻度定容。
表3含量测定结果
实验例4
细菌定量杀灭实验,取实施例1的原液2ml测定,参照《消毒技术规范》(2002版)第二部分第2.1.1.7悬液定量测定,作用时间2min。分别测试对大肠杆菌、金黄色葡萄球菌、铜绿假胞菌以及白色念珠菌的作用。实验结果表明,本发明的中药组合物能有效抑制大肠杆菌、金黄色葡萄球菌、铜绿假胞菌以及白色念珠菌。
表4细菌杀灭实验
表5真菌杀灭实验
Claims (10)
1.一种用于伤口的中药组合物,其特征在于,由以下重量份的原料药制成:人参9-15份玉竹10-15份葛根9-15份茯苓15-20份甘草9-15份蒲公英9-15份黄精12-18份小球藻粉30-50份。
2.根据权利要求1所述的中药组合物,其特征在于,所述原料药的重量份为:人参10-12份玉竹10-12份葛根9-12份茯苓18-20份甘草10-12份蒲公英10-12份黄精13-15份小球藻粉40-50份。
3.根据权利要求1所述的中药组合物,其特征在于,所述原料药的重量份为:人参10份玉竹12份葛根12份茯苓18份甘草11份蒲公英11份黄精15份小球藻粉40份。
4.一种用于伤口的中药组合物,其特征在于,由以下重量份的原料经发酵制成:人参9-15份玉竹10-15份葛根9-15份茯苓15-20份甘草9-15份蒲公英9-15份黄精12-18份小球藻粉30-50份酵母10-30份。
5.根据权利要求4所述的中药组合物,其特征在于,所述原料的重量份为:人参10-12份玉竹10-12份葛根9-12份茯苓18-20份甘草10-12份蒲公英10-12份黄精13-15份小球藻粉40-50份酵母20-30份。
6.根据权利要求4所述的中药组合物,其特征在于,所述原料的重量份为:人参10份玉竹12份葛根12份茯苓18份甘草11份蒲公英11份黄精15份小球藻粉40份酵母25份。
7.根据权利要求4-6任一项所述的中药组合物的制备方法,其特征在于:其包括以下制备步骤:
将上述中药原料饮片分别粉碎至100-120目的细粉,依次按照人参、玉竹、葛根、茯苓、甘草、蒲公英、黄精、小球藻粉准确称重后混合均匀,然后加入与药材重量1-3倍的水;
发酵:随后将20-30重量份酵母混合搅拌至上述药材中,20-23℃恒温发酵,发酵10-18天后停止发酵;
过滤:上述发酵液粗滤,再经过微孔过滤器,压力为0.2MPa,除去微粒、细菌、污染物等;
灭菌:将上述过滤液灭菌。
8.根据权利要求6所述的制备方法制备得到的中药提取物。
9.根据权利要求1-6所述的中药组合物在制备治疗伤口愈合药物中的应用。
10.根据权利要求1-6所述的中药组合物在制备治疗伤口愈合改善微循环以及抑菌药物中的应用。
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