CN114042131A - 一种治疗甲真菌病的药液及其制备方法及应用 - Google Patents
一种治疗甲真菌病的药液及其制备方法及应用 Download PDFInfo
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Abstract
本发明涉及一种治疗甲真菌病的药液及其制备方法及应用,所述治疗甲真菌病的药液的原料组分包括:杀菌剂,鸦胆子油,植物复合提取物,冰醋酸,薄荷醇和乳化剂。本发明的治疗甲真菌病的药液杀菌能显著杀灭大肠杆菌、金黄色葡萄球菌和白色念珠菌,有效治疗甲真菌病,且与现有技术相比,具有安全有效、无毒副作用、便捷、成本低,除此以外,本发明原料易得,制备方法简单,便于制备,成本相对低廉,适合推广应用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗甲真菌病的药液及其制备方法及应用。
背景技术
甲真菌病又称甲癣,俗称“灰指甲”,是指皮癣菌侵犯甲板或甲下所引起的疾病。甲真菌病是由皮癣菌、酵母菌及非皮癣菌等真菌引起的甲感染。甲真菌常见二型:①真菌性白甲(浅表性白色甲真菌病),此型病损局限于甲面一片或其尖端;②甲下真菌病又分远端侧位型、近端甲下型及浅表白色型,此型病变从甲的两侧或远端开始,继而甲板下发生感染。
目前市面上治疗甲真菌病的药物较多,但治疗效果都不太明显,或者容易复发。
近年来,脂质体作为一种新型药物传递系统,其作为抗肿瘤药物、抗寄生虫药物、抗菌药物、抗结核药物、激素类药物、基因治疗药物的载体时有着广泛的应用。特别是脂质体抗肿瘤药物的研究和不断开发上市,为人类最终攻克癌症这一威胁人类生命安全的疾病提供了有利的武器。
因此,需要开发一款新的药物用于治疗甲真菌病,尤其是可以减少复发,是具有十分重要现实意义的。
发明内容
本发明的目的在于,提供一种缓解手部皮炎症状的可添加于护肤品中的治疗甲真菌病的药液,能够有效治疗甲真菌病,安全有效、无毒副作用、成本低。
本发明的技术方案为:
一种治疗甲真菌病的药液,所述治疗甲真菌病的药液包括以下原料组分:杀菌剂,鸦胆子油,植物复合提取物,冰醋酸,薄荷醇、乳化剂和水凝胶剂。
优选的,按重量份计,原料组分包括:杀菌剂0.01~2.5份,鸦胆子油0.01~1.0份,植物复合提取物0.05~1.5份,冰醋酸5~30份,薄荷醇0.005~0.5份,乳化剂0.01~8.0份,水凝胶剂:0.5~5份。
优选的,按重量份计,原料组分包括:杀菌剂2.5份,鸦胆子油0.5份,植物复合提取物1.0份,冰醋酸30份,薄荷醇0.3份,乳化剂6份,水凝胶剂0.8份。
优选的,所述杀菌剂选自苯扎氯铵、苯扎溴铵、醋酸氯己定、盐酸聚六亚甲基胍中的一种或几种。
优选的,所述鸦胆子油的提取方法为:将鸦胆子粉碎后过20-40目筛,加入石油醚浸泡12-24小时,按石油醚体积:鸦胆子药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取2-4次,每次0.5-1.5h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油。
优选的,所述植物复合提取物为鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物。
优选的,所述鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物的添加量之比为3:5:4:8:2:6;优选的,所述黄柏提取物其提取方法为:将黄柏粉碎过60-80目筛,加入80%乙醇浸泡10-20小时,按乙醇体积∶黄柏药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取1-3次,每次1-3h,合并各次提取液,应用旋转薄膜浓缩仪减压浓缩到无醇味,即得所述黄柏提取物。
优选的,所述乳化剂选自大豆磷脂、二硬脂酰磷脂酰乙醇胺、泊洛沙姆127和泊洛沙姆407中的一种或几种。
优先的,所述水凝胶剂选自壳聚糖、透明质酸、海藻酸钠和明胶中的一种或几种。
一种所述治疗甲真菌病的药液的制备方法,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀形成混合溶液;
(5)将乳化剂和水凝胶剂分别依次加入步骤(4)的得到的混合溶液中,用漩涡振荡器振荡5-10min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
所述治疗甲真菌病的药液可以应用在制备治疗甲真菌病药物中。
所述治疗甲真菌病的药液还可以应用在制备抗菌剂中,用于杀灭大肠杆菌、金黄色葡萄球菌、白色念珠菌和皮肤癣菌。优选的,可以制成皮肤抗菌液。
本发明将鸦胆子油包埋在脂质体微粒中,脂质体作为载体具有能增加与癌细胞的亲和力,克服耐药性,增加药物被癌细胞的摄取量,降低用药剂量,提高疗效,降低毒性的特点。脂质体具有以下几方面特点,①靶向性:脂质体进入体内可被网状内皮系统的巨噬细胞作为外界异物而药物能充分向靶组织靶细胞透过;④降低药物毒性:药物被脂质体包封后,主要被网状内皮系统的巨噬细胞所吞噬而摄取,浓集于肝、脾等组织而使药物在心、肾中的累积量比游离药物低得多,因此如将对心肾有毒性的药物或对正常细胞有毒性的抗癌药物包封成脂质体,可明显降低药物的毒性;⑤天然无毒并具生物可降解性。
本发明中鸦胆子油的制备方法:分别称取卵磷脂、胆固醇,置于圆底烧瓶中,加入乙醚使之溶解,在40℃下减压旋转蒸发除去乙醚,在瓶壁上形成一层均匀薄膜。加入磷酸盐缓冲液(pH值=6.8),即得空白脂质体乳状液。再将鸦胆子油加入空白脂质体乳状液中用均质机乳化得到小单室鸦胆子油脂质体。用超声仪超声后,将通过0.45μm的微孔滤膜过滤得到粒径均匀的鸦胆子油脂质体。
2.温敏凝胶优势及制备方法
温敏性水凝胶是一类具有温度依赖性的水凝胶,温敏性水凝胶在低温时呈溶液状态,当温度接近相转变温度时,溶液转变为凝胶状态。水凝胶是一种以共价键或非共价键交联而形成的具有三维网络结构的高分子材料,能够吸收并保存大量水分,可以防止指甲部位的干燥,显著的软化角质,从而有利于有效成分的渗透。
泊洛沙姆是一种温敏性合成聚合物,随着温度改变能够实现溶胶-凝胶转变,但其相对分子质量低,水凝胶结构很难长期保持。本研究以泊洛沙姆为基体,通过与海藻酸钠溶液混合制备了温敏性海藻酸钠/泊洛沙姆复合水凝胶。
海藻酸钠具有良好的生物相容性、亲水性和生物降解性,已被用于伤口敷料、关节软骨修复和药物缓释等方面。海藻酸钠能够在极其温和的条件下快速形成凝胶,本研究为降低泊洛沙姆温敏水凝胶的溶胶-凝胶转变浓度。
壳聚糖具有抗菌活性、易改性和生物降解等优良特性,已被应用于伤口敷料、组织修复、药物缓释等方面。
制备方法:称取一定质量比(0.3:0.5:1,0.2:0.6:1,0.3:0.7:1,0.5:0.6:1)的壳聚糖、海藻酸钠和泊洛沙姆于血清瓶中,加入去离子水,用漩涡振荡器振荡5-10min,在4℃下溶解24h,制得温敏性复合水凝胶样品。
本发明中的植物复合提取物由鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物组成。
艾叶水提物及艾叶挥发油具有较为明显的抗菌、杀虫作用。艾叶的主要药物活性成分有挥发油、黄酮类化合物、鞣质类化合物、多糖类化合物、三萜类化合物、微量元素及绿原酸等。有研究表明,艾叶挥发油具有抗菌(细菌和真菌)和抗病毒的作用,艾叶黄酮具有抗氧化和抑菌的作用。艾叶挥发油中的桉树脑和4-松油烯醇对青霉、疫霉、黑曲霉、链格孢、粉红聚端孢5种真菌均具有抑菌活性,其抑菌活性随艾叶挥发油浓度的增加而增强。刘萍等进行艾叶水煎液体外抑菌实验研究的结果证明,艾叶水煎液与复方艾叶水提液对阴道炎的5种常见致病菌(白念珠菌、肺炎双球菌、大肠埃希菌、表皮葡萄球菌和金黄色葡萄球菌)均具有明显的抗菌作用。
鸡冠花提取物对红色毛癣菌、须癣毛癣菌、犬小孢子菌、絮状表皮癣菌均具有抑制作用,其水提取物的作用强于70%乙醇提取物。
高良姜提取物:挥发油皮肤癣菌(红色毛癣菌、石膏样毛癣菌、猴毛癣菌、絮状表皮癣菌、犬小孢子菌、羊毛状小孢子菌、石膏样小孢子菌、断发毛癣菌,大脑状毛癣菌、无色红毛癣菌、白色念株菌)大肠杆菌、肠球菌、金黄色葡萄球菌、肺炎链球菌。
研究表明,从广藿香中提取的广藿香酮和广藿香醇,能产生抗真菌、抗炎的药理作用,抑制人体皮肤众多的典型细菌真菌的滋生繁殖,增强机体抵抗力。广藿香叶挥发油能够抑制炎症组织前列腺素E2合成,减少炎症组织中脂质过氧化产物戊二醛堆积,降低一氧化氮含量,达到抗炎效果。广藿香水提物能够抑制促炎因子表达,从而抑制以血管扩张、组织液渗出、水肿为主的急性炎症及以组织增生为主的慢性炎症症状,具有良好的消炎止痛作用。
有研究显示,氧化苦参碱与蛇床子提取物体外联用,对金黄色葡萄球菌具有较好的协同抑制作用。另有研究显示,氧化苦参碱对于大肠埃希菌也具有较好的抑制作用,且其作用具有剂量依赖性。张丰川等对于苦参不同制剂进行体外抑菌研究时发现,氧化苦参碱对对马拉色菌株具有抑制作用。另有研究显示,氧化苦参碱可以通过抑制JAK-STAT信号通路的活化,抑制细菌对JAK2的激活作用,从而对浓毒症大鼠肺损伤性疾病有明显的抑制作用。
本发明的有益效果为:
本发明所述的治疗甲真菌病的药液,通过将包括杀菌剂,鸦胆子油,植物复合提取物,冰醋酸,薄荷醇、乳化剂和水凝胶剂等原料进行复配,使得各原料之间相互作用而产生了协同。测试结果表明,本发明的治疗甲真菌病的药液杀菌能显著杀灭大肠杆菌、金黄色葡萄球菌、白色念珠菌和皮肤癣菌,有效治疗甲真菌病,且与现有技术相比,具有安全有效、无毒副作用、便捷、成本低,除此以外,本发明原料易得,制备方法简单,便于制备,成本相对低廉,适合推广应用。
将检测,本发明所述的治疗甲真菌病的药液对红色毛癣菌、须癣毛癣菌、絮状表皮癣菌、絮状小孢子菌的的杀菌效果接近对白色念珠菌的杀菌效果,杀菌率均可达90%。
附图说明
图1显示典型病例1的患者使用本发明治疗甲真菌病的药液前后对比图;
图2显示典型病例2的患者使用本发明治疗甲真菌病的药液前后对比图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面将对本发明的技术方案进行详细的描述。显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所得到的所有其它实施方式,都属于本发明所保护的范围。
在一些具体的实施例中,所述治疗甲真菌病的药液包括以下原料组分,按重量百分比计,原料组分包括:所述治疗甲真菌病的药液包括以下原料组分:杀菌剂0.01~2.5%,鸦胆子油0.01~1.0%,植物复合提取物0.05~1.0%,冰醋酸5~30%,薄荷醇0.005~0.5%,乳化剂0.01~8.0份,水凝胶剂:0.5~5份,余量为水;
杀菌剂选自苯扎氯铵、苯扎溴铵、醋酸氯己定、盐酸聚六亚甲基胍中的一种或几种;
鸦胆子油的提取方法为:将鸦胆子粉碎后过20-40目筛,加入石油醚浸泡12-24小时,按石油醚体积:鸦胆子药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取2-4次,每次0.5-1.5h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油。
所述乳化剂选自大豆磷脂、二硬脂酰磷脂酰乙醇胺、泊洛沙姆127和泊洛沙姆407中的一种或几种;
优先的,所述水凝胶剂选自壳聚糖、透明质酸、海藻酸钠和明胶中的一种或几种。
一种所述治疗甲真菌病的药液的制备方法,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀形成混合溶液;
(5)将乳化剂和水凝胶剂分别依次加入步骤(4)的到的溶液中,用漩涡振荡器振荡5-10min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
以下实施例中以1重量份代表1g。
实施例1
本实施例提供了一种治疗甲真菌病的药液包括以下原料组分:杀菌剂2.5份,所述杀菌剂为苯扎氯铵,鸦胆子油0.01份,植物复合提取物1.0份,冰醋酸30份,薄荷醇0.5份,乳化剂0.01份,水凝胶剂0.8份;所述乳化剂为大豆磷脂,所述水凝胶剂为壳聚糖和透明质酸;
所述鸦胆子油的提取方法为:将鸦胆子粉碎后过20-40目筛,加入石油醚浸泡12-24小时,按石油醚体积:鸦胆子药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取2-4次,每次0.5-1.5h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油;
所述治疗甲真菌病的药液的制备方法,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀,形成混合溶液;
(5)将乳化剂和水凝胶剂分别依次加入步骤(4)的得到的混合溶液中,用漩涡振荡器振荡10min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
实施例2
本实施例提供了一种治疗甲真菌病的药液包括以下原料组分:
杀菌剂2.5份,杀菌剂为苯扎溴铵,鸦胆子油0.01份,植物复合提取物0.05份,冰醋酸5份,薄荷醇0.005份,乳化剂1.0份;水凝胶剂0.8份,乳化剂为二硬脂酰磷脂酰乙醇胺,所述水凝胶剂为壳聚糖和海藻酸钠;
鸦胆子油的提取方法为:将鸦胆子粉碎后过20-40目筛,加入石油醚浸泡12-24小时,按石油醚体积:鸦胆子药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取2-4次,每次0.5-1.5h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油;
植物复合提取物为鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物,鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物的添加量之比为3:5:4:8:2:6;优选的,所述黄柏提取物其提取方法为:将黄柏粉碎过60-80目筛,加入80%乙醇浸泡10-20小时,按乙醇体积∶黄柏药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取1-3次,每次1-3h,合并各次提取液,应用旋转薄膜浓缩仪减压浓缩到无醇味,即得所述黄柏提取物;
治疗甲真菌病的药液的制备方法,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀,形成混合溶液;
(5)将乳化剂和水凝胶剂依次加入步骤(4)得到的混合溶液中,用漩涡振荡器振荡5-10min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
实施例3
本实施例提供了一种治疗甲真菌病的药液包括以下原料组分:
杀菌剂2.0份,杀菌剂为盐酸聚六亚甲基胍,鸦胆子油0.5份,植物复合提取物0.5份,冰醋酸18份,薄荷醇0.3份,乳化剂6份,水凝胶剂1.0份;所述乳化剂为泊洛沙姆127,所述水凝胶剂为壳聚糖;
鸦胆子油的提取方法为:将鸦胆子粉碎后过20-40目筛,加入石油醚浸泡12-24小时,按石油醚体积:鸦胆子药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取2-4次,每次0.5-1.5h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油;
植物复合提取物为鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物,鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物的添加量之比为3:5:4:8:2:6;优选的,所述黄柏提取物其提取方法为:将黄柏粉碎过60-80目筛,加入80%乙醇浸泡10-20小时,按乙醇体积∶黄柏药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取1-3次,每次1-3h,合并各次提取液,应用旋转薄膜浓缩仪减压浓缩到无醇味,即得所述黄柏提取物;
治疗甲真菌病的药液的制备方法,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀,形成混合溶液;
(5)将乳化剂和水凝胶剂分别依次加入步骤(4)的得到的混合溶液中,用漩涡振荡器振荡5-10min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
实施例4
本实施例提供了一种治疗甲真菌病的药液包括以下原料组分:
杀菌剂2.5份,杀菌剂为盐酸聚六亚甲基胍,鸦胆子油0.5份,植物复合提取物1.0份,冰醋酸30份,薄荷醇0.3份,乳化剂6份,水凝胶剂0.8份;所述乳化剂为泊洛沙姆407,所述水凝胶剂为壳聚糖和海藻酸钠;
鸦胆子油的提取方法为:将鸦胆子粉碎后过30目筛,加入石油醚浸泡36小时,按石油醚体积:鸦胆子药材重量比例为6.5∶1,在65℃水浴锅中回流提取3次,每次1.0h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油;
植物复合提取物为鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物,鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物的添加量之比为3:5:4:8:2:6;优选的,所述黄柏提取物其提取方法为:将黄柏粉碎过60目筛,加入80%乙醇浸泡20小时,按乙醇体积∶黄柏药材重量比例为6.5∶1,在70℃水浴锅中回流提取3次,每次3h,合并各次提取液,应用旋转薄膜浓缩仪减压浓缩到无醇味,即得所述黄柏提取物;
治疗甲真菌病的药液的制备方法,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀,形成混合溶液;
(5)将乳化剂和水凝胶剂依次加入步骤(4)的得到的混合溶液中,用漩涡振荡器振荡7min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
实施例5
本实施例提供了一种治疗甲真菌病的药液包括以下原料组分:
杀菌剂2.0份,杀菌剂为盐酸聚六亚甲基胍,鸦胆子油0.5份,植物复合提取物0.5份,冰醋酸18份,薄荷醇0.3份,乳化剂6份,水凝胶剂1份;所述乳化剂为泊洛沙姆407,所述水凝胶剂为海藻酸钠;
鸦胆子油的提取方法为:将鸦胆子粉碎后过40目筛,加入石油醚浸泡24小时,按石油醚体积:鸦胆子药材重量比例为10∶1,在60℃水浴锅中回流提取4次,每次0.5h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油;
植物复合提取物为鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物,鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物的添加量之比为3:5:4:8:2:6;优选的,所述黄柏提取物其提取方法为:将黄柏粉碎过80目筛,加入80%乙醇浸泡10小时,按乙醇体积∶黄柏药材重量比例为3∶1,在60℃水浴锅中回流提取1次,每次1h,合并各次提取液,应用旋转薄膜浓缩仪减压浓缩到无醇味,即得所述黄柏提取物;
治疗甲真菌病的药液的制备方法,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀,形成混合溶液;
(5)将乳化剂和水凝胶剂分别依次加入步骤(4)的得到的混合溶液中,用漩涡振荡器振荡5min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
试验一:杀菌性能(样品为实施例4的药液)
通过抑菌试验检测本发明的治疗甲真菌病的药液对白色念珠菌、大肠杆菌和金黄色葡萄球菌的杀菌效果,以及实施例4的药液皮肤癣菌的杀菌效果,结果如下表1-3:
表1对白色念珠菌的杀菌效果
表2对大肠杆菌和金黄色葡萄球菌的杀菌效果
表3实施例4的药液对皮肤癣菌的作用效果
试验二:临床评价(样品为实施例4)
以甲真菌病患者作为对象,用实施例4获得的药液实施临床试验,典型病例如下:
1、李某,47岁,女,病程10年。左1、3、4、5趾甲;右1、2、4、5趾甲增厚,变色。使用本发明实施例4得到的治疗甲真菌病的药液涂抹患处,1次/周,每次90-120分钟;三个月后,基本恢复正常,如图1所示,其中上图为使用本发明的药液前的状况,下图为使用本发明的药液三个月后的状况。
范某,32岁,男,病程10年余,左1,3趾甲;右1,2,3趾甲增厚变色。使用本发明实施例4得到的治疗甲真菌病的药液涂抹患处,1次/周,每次90-120分钟;三个月后,基本恢复正常,如图2所示,其中上图为使用本发明的药液前的状况,下图为使用本发明的药液三个月后的状况。
通过上述试验检测,本发明中获得的药液对皮肤癣菌和白念珠菌的具有体外抗菌活性,该药液具有很强的杀菌作用,临床评价试验说明该药液具有优异的治疗甲真菌病作用。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (10)
1.一种治疗甲真菌病的药液,其特征在于,所述治疗甲真菌病的药液包括以下原料组分:杀菌剂,鸦胆子油,植物复合提取物,冰醋酸,薄荷醇、乳化剂和水凝胶剂。
2.根据权利要求1所述的治疗甲真菌病的药液,其特征在于,按重量份计,原料组分包括:杀菌剂0.01~2.5份,鸦胆子油0.01~1.0份,植物复合提取物0.05~1.0份,冰醋酸5~30份,薄荷醇0.005~0.5份,乳化剂0.01~8.0份,水凝胶剂:0.5~5份。
3.根据权利要求1所述的治疗甲真菌病的药液,其特征在于,按重量份计,原料组分包括:杀菌剂2.5份,鸦胆子油0.5份,植物复合提取物1.0份,冰醋酸30份,薄荷醇0.3份,乳化剂6份,水凝胶剂0.8份。
4.根据权利要求1所述的治疗甲真菌病的药液,其特征在于,所述杀菌剂选自苯扎氯铵、苯扎溴铵、醋酸氯己定、盐酸聚六亚甲基胍中的一种或几种;所述植物复合提取物为鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物。
5.根据权利要求1所述的治疗甲真菌病的药液,其特征在于,所述鸦胆子油的提取方法为:将鸦胆子粉碎后过20-40目筛,加入石油醚浸泡12-24小时,按石油醚体积:鸦胆子药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取2-4次,每次0.5-1.5h,合并各次提取液,水浴加温挥散至无石油醚味,即得所述鸦胆子油。
6.根据权利要求1所述的治疗甲真菌病的药液,其特征在于,所述鸡冠花提取物、广藿香提取物、艾叶水提物、高良姜提取物、苦参提取物和黄柏提取物的添加量之比为3:5:4:8:2:6;优选的,所述黄柏提取物其提取方法为:将黄柏粉碎过60-80目筛,加入80%乙醇浸泡10-20小时,按乙醇体积∶黄柏药材重量比例为3-10∶1,在60-70℃水浴锅中回流提取1-3次,每次1-3h,合并各次提取液,应用旋转薄膜浓缩仪减压浓缩到无醇味,即得所述黄柏提取物。
7.根据权利要求1所述的治疗甲真菌病的药液,其特征在于,所述乳化剂选自大豆磷脂、二硬脂酰磷脂酰乙醇胺、泊洛沙姆127和泊洛沙姆407中的一种或几种。
8.根据权利要求1所述的治疗甲真菌病的药液,其特征在于,所述水凝胶剂选自壳聚糖、透明质酸、海藻酸钠和明胶中的一种或几种。
9.一种权利要求1-8任一项所述治疗甲真菌病的药液的制备方法,其特征在于,具体步骤为:
(1)将杀菌剂溶于水中,形成杀菌剂水溶液;
(2)将薄荷醇溶于冰醋酸中,形成薄荷醇溶液;
(3)将鸦胆子油溶于乳化剂中,形成鸦胆子油溶液;
(4)将步骤(1)得到的杀菌剂水溶液、步骤(2)得到的薄荷醇溶液和步骤(3)得到的鸦胆子油溶液进行混合并搅拌,混合均匀,过滤,加入植物复合提取物,搅拌使溶解均匀形成混合溶液;
(5)将乳化剂和水凝胶剂分别依次加入步骤(4)的得到的混合溶液中,用漩涡振荡器振荡5-10min,在4℃冰箱中充分溶胀,即得所述治疗甲真菌病的药液。
10.权利要求1-8任一项所述治疗甲真菌病的药液在制备治疗甲真菌病药物中的应用。
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