CN104435020A - 一种改善皮肤质量的组合物及其用途 - Google Patents
一种改善皮肤质量的组合物及其用途 Download PDFInfo
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Abstract
本发明提供了一种改善皮肤质量的组合物,它是由如下重量配比的原料制备而成的药物制剂:美洲大蠊提取物4~16份、马齿苋提取物8~24份。本发明还提供了该组合物的用途。本发明提供的组合物治疗湿疹效果良好,能够有效抑制湿疹皮肤水分丢失、减轻炎症反应、减轻皮肤溃烂、炎症等病理损伤,具有较好的应用前景。
Description
技术领域
本发明涉及一种改善皮肤质量的组合物及其用途。
背景技术
湿疹是由多种复杂的内、外因素引起的一种具有多形性皮损和易有渗出倾向的皮肤炎症性反应。本病病因复杂,多难以确定,病情易反复,可迁延多年不愈。湿疹的发生率高,因此它的治疗是当前国内外学者极为关注的问题,但目前尚无满意的治疗方法。以往的治疗常用的组胺药、镇静药、钙剂、皮质类固醇激素等,多数只能达到近期疗效,但不能制止复发。近年来,中医药在湿疹的治疗上显示了一定的优势。
美洲大蠊是传统的中药材,其性寒味咸,有散瘀、消积、解毒、利水、消肿等功效。美洲大蠊提取物具有抗炎、消肿、促进细胞增殖和新生肉芽组织增长,加速病损组织修复,加快坏死组织脱落,提高机体免疫功能等作用。近年来对美洲大蠊的药理研究越来越多,其临床引用也越来越广泛。
马齿苋为马齿苋科马齿苋属植物,为药食两用植物,具有清热解毒,凉血止血的功能。现代药理研究证明马齿苋具有抗菌、降血脂、抗衰老、松弛肌肉、抗炎、镇痛以及促进伤口愈合等作用。
目前还未见美洲大蠊提取物联合马齿苋提取物用于治疗皮肤湿疹的报道。
发明内容
本发明提供了一种改善皮肤质量的组合物,它是由含有下述原料制备而成的制剂:美洲大蠊提取物、马齿苋提取物。
优选地,它是由下述重量配比的原料制备而成的药物制剂:美洲大蠊提取物4~16份、马齿苋提取物8~24份。
最优选的,它是由下述重量配比的原料制备而成的药物制剂:美洲大蠊提取物12份、马齿苋提取物20份。
本发明所述美洲大蠊提取物,满足WS3-B-3674-2000(Z)中对“康复新液”的限定标准即可,每1ml含总氨基酸不得低于0.72mg,如市售康复新液。
或者,满足WS3-B-3674-2000(Z)中对“美洲大蠊Perip leneta ameri Cana干燥虫体的提取物”的限定标准亦可,按照干燥品计算,含总氨基酸不得少于7.0%,如市售的康复新。康复新液是由康复新液制备而成的溶液。另外,也可以使用目前常见的美洲大蠊提取物制备方法进行制备,例如:
称取美洲大蠊药材,加70~90%v/v乙醇回流提取,合并提取液,回收乙醇、浓缩后,加水沉淀,静置,收集上清液,减压浓缩、干燥即得。本发明提供的一个具体实施方式中,用于回流提取的乙醇浓度为85%,当然,考虑到配液时的误差,亦可使用80%~90%v/v的乙醇。
本发明所述马齿苋提取物即为干燥的马齿苋水提物,即将马齿苋加水提取后,浓缩、干燥即得。
上述的马齿苋饮片的水提取方法为浸提、煎煮、回流或/和超声提取。
上述组合物是由美洲大蠊提取物、马齿苋提取物为活性成分,加上药学或化妆品中常用的辅料或辅助性成分制备而成的制剂。
本发明所述药学上可接受的辅料,是指除活性成分以外包含在剂型中的物质,包括但不仅限于填充剂(稀释剂)、润滑剂(助流剂或抗粘着剂)、分散剂、湿润剂、粘合剂、调节剂、增溶剂、抗氧剂、抑菌剂、乳化剂、崩解剂等。粘合剂包含糖浆、阿拉伯胶、明胶、山梨醇、黄芪胶、纤维素及其衍生物(如微晶纤维素、羧甲基纤维素钠、乙基纤维素或羟丙甲基纤维素等)、明胶浆、糖浆、淀粉浆或聚乙烯吡咯烷酮等;填充剂包含乳糖、糖粉、糊精、淀粉及其衍生物、纤维素及其衍生物、无机钙盐(如硫酸钙、磷酸钙、磷酸氢钙、沉降碳酸钙等)、山梨醇或甘氨酸等;润滑剂包含微粉硅胶、硬脂酸镁、滑石粉、氢氧化铝、硼酸、氢化植物油、聚乙二醇等;崩解剂包含淀粉及其衍生物(如羧甲基淀粉钠、淀粉乙醇酸钠、预胶化淀粉、改良淀粉、羟丙基淀粉、玉米淀粉等)、聚乙烯吡咯烷酮或微晶纤维素等;湿润剂包含十二烷基硫酸钠、水或醇等;抗氧剂包含亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、二丁基苯酸等;抑菌剂包含0.5%苯酚、0.3%甲酚、0.5%三氯叔丁醇等;调节剂包含盐酸、枸橼酸、氢氧化钾(钠)、枸橼酸钠及缓冲剂(包括磷酸二氢钠和磷酸氢二钠)等;乳化剂包含聚山梨酯-80、脂肪酸山梨坦、普流罗尼克F-68,卵磷酯、豆磷脂等;增溶剂包含吐温-80、胆汁、甘油等。
所述药学上可接受的辅助性成分,它具有一定生理活性,但该成分的加入不会改变上述化合物或衍生物在疾病治疗过程中的主导地位,而仅仅发挥辅助功效,这些辅助功效仅仅是对该成分已知活性的利用,是医药领域惯用的辅助治疗方式。若将上述辅助性成分与本发明化合物配合使用,仍然应属于本发明保护的范围。
上述的制剂为液体制剂、固体制剂、半固体制剂、气体制剂。
上述制剂为水凝胶贴剂、液体敷料、泡沫材料贴剂、膜剂、压敏胶。
本发明还提供了上述组合物在制备改善皮肤质量的药物或者化妆品中的用途。
本发明还提供了上述的组合物在制备治疗湿疹的药物或化妆品中的用途。
进一步地,所述药物是抑制湿疹皮肤水分丢失,减轻炎症反应、减轻皮肤溃烂的药物。
本发明提供的组合物改善皮肤质量,治疗湿疹、抑制湿疹皮肤水分丢失、减轻炎症反应、减轻皮肤溃烂、炎症等病理损伤效果良好,具有较好的应用前景。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
本发明中,美洲大蠊提取物的制备方法:称取美洲大蠊药材,分别加7倍量、5倍量和3倍量85%v/v乙醇回流提取3次,每次2小时,过滤,合并滤液,减压回收至适当体积,加水沉淀,静置过夜,收集上清液,减压浓缩、干燥即得。
马齿苋提取物的制备方法:称取马齿苋药材,分别加8倍量、10倍量和12倍量水提取3次,每次2小时,过滤,合并滤液,减压浓缩、干燥即得。
实施例1 本发明水凝胶贴剂的制备
1、原辅料构成
原料:美洲大蠊提取物1.2g、马齿苋提取物2.0g;
辅料:二羟基氨基醋酸铝15g、NP-700 35g、甘油30g、冰片25g、PVP k30 15g。
2、制备方法
在带有强力搅拌装置的1000mL玻璃烧瓶中,将处方量的药物和交联剂二羟基氨基醋酸铝溶解于保湿剂甘油、促渗剂和纯化水的混合溶液中,加入处方量的水凝胶基质材料NP-700,充分搅拌,使其混合均匀;再将混合均匀的处方量的pH调节剂酒石酸、增黏剂PVP k30和注射用水加入其中,搅拌,使其混合均匀。再将上述含药水凝胶基质材料采用刮涂工艺,涂布在经过疏水化处理的无纺布上,控制涂布厚度为(1.5±0.1)mm。与防黏纸复合后,置于60℃烘箱中干燥1h,调节含水量至所需程度,冷却后分切、密封即得。
实施例2 本发明液体敷料的制备
1、原、辅料构成
原料:美洲大蠊提取物1.2g、马齿苋提取物2.0g;
辅料:甲壳素30g、冰片25g、胶原蛋白40g。
2、制备方法
将上述药物与辅料混合均匀后,加入蒸馏水定容到100ml混匀即可。先将甲壳素、胶原蛋白和蒸馏水加热溶解,加热温度为80~100℃,再加入无机酸、甲醛和发泡剂共混搅拌;将共混溶液加热成型,热成型的温度为60~90℃,热成型的时间为4~12小时;最后将热成型的产品进行清洗,即得。
实施例3 本发明泡沫材料贴剂的制备
1、原、辅料构成
原料:美洲大蠊提取物1.2g、马齿苋提取物2.0g;
辅料:甲壳素30g、聚乙烯醇30g。
2、制备方法
先将甲壳素、聚乙烯醇和蒸馏水加热溶解,加热温度为80~100℃,将药物混合均匀后加入熔融的辅料中,共混搅拌;将共混溶液加热成型,热成型的温度为60~90℃,热成型的时间为4~12小时;最后将热成型的产品进行清洗,即得。
实施例4 本发明膜剂的制备
1、原、辅料构成
原料:美洲大蠊提取物1.2g、马齿苋提取物2.0g;
辅料:聚乙烯醇40g、冰片20g、甘油15g、CMC-Na 15g。
2、制备方法
先将聚乙烯醇加热溶解于甘油中,加热温度为80~100℃,将冰片研细后与药物细粉及CMC-Na充分混合成药浆后加入熔融的辅料中,共混搅拌。然后用涂膜机涂膜成所需要的厚度,烘干后根据主药含量计算出单位剂量膜的面积,剪切成单剂量的小格,包装即得。
实施例5 本发明压敏胶的制备
1、原、辅料构成
原料:美洲大蠊提取物1.2g、马齿苋提取物2.0g;
辅料:SIS热塑性弹性体25g、C5树脂15g、矿物油10g丙烯酸树脂10g、聚乙二醇15g、二苯胺5g。
2、制备方法
先通过密炼方式预先将SIS型热塑性弹性体、丙烯酸树脂等进行物理共混,在熔融状态下加入药物及其它组成成分混合均匀制得。
以下通过具体药效学实验证明本发明的有益效果
试验例1 本发明组合物对大鼠湿疹的治疗效果
一、实验材料、仪器
1、受试物
(1)美洲大蠊提取物。
(2)马齿苋提取物。
2、化学试剂
(1)2%戊巴比妥钠溶液,配制方法:用电子天平准确称取2g戊巴比妥钠固体,装于烧杯中,加入98ml生理盐水,搅拌溶解即得。
(2)碘伏。
(3)70%消毒酒精
(4)8%的硫化钠-乙醇溶液:配制方法:用电子天平准确称取8gNa2S固体,装于烧杯中,加入100ml70%的乙醇,搅拌溶解机得。
(5)生理盐水。
(6)2,4-二硝基氯苯。
3、实验动物
SD大鼠:体重185~245g,由成都达硕生物科技有限公司提供,实验动物许可证号:scxkc(111)2008-24。
4、实验仪器
(1)电子天平。
(2)电热恒温水浴锅。
(3)酶标仪。
(4)离心机。
二、统计学方法
用SPSS 17.0软件进行统计分析。数据以均数±标准差()表示,组间采用单因素方差分析,方差齐者组间进行LSD检验,方差不齐者进行Tamhane’s T2检验。
三、组合物最佳比例筛选
1、药物配比
为全面有效地对初选方剂进行最佳药物配伍和最佳剂量配比关系的筛选,并尽量减少试验次数,本试验采用均匀设计法进行分组设计。本方由2种中药提取物组成,根据药物属性和经验剂量关系,均取相同剂量,采取药物组合和剂量配比研究的试验设计和评价方法,以0.4为下降梯度,同时另设空白对照组和阳性药物对照组。各剂量配比组药物的具体比例关系见表1。各组药物最终的给药浓度一致。
表1 两种提取物比例
2、实验动物分组及湿疹模型的制备
200只SPF级SD大鼠按体重随机分为:模型组(MD组)、阳性组(复方黄柏液组)组合物1~18组,每组10只,雌雄各半。
除正常组外其余各组大鼠均于第1天于后背部剪毛约2cm×3cm并涂5%的2,4-二硝基氯苯(DNCB)30μl于皮肤首次致敏,7d后在大鼠右耳内侧涂0.2%DNCB50μl激发,以后每隔3d激发1次,连续5次。于第4、5次激发后24、36、72h观察大鼠右耳较左耳壳明显红肿,并出现渗出和结痂,表明造模成功。
3、给药
自造模当天开始按组别、剂量涂抹给药,模型组大鼠皮肤涂抹纯净水,连续30天。
4、检测指标
4.1、TEWL检测
面部经皮水份丢失(Trans-epidermal water lose),经皮水份丢失的数值越低,皮肤的保护性屏障功能就越好;其数值越高,皮肤的屏障功能就越差。检测条件:温度(25±0 5)℃,相对湿度(60%±5%)。
4.2、皮肤IFN-γ和IL-4含量测定
末次给药后,断颈处死大鼠,剪取给药处皮肤,Elisa法测定各实验组大鼠皮肤IFN-γ和IL-4含量。
4.3皮肤病理损伤指数监测
剪取适当大小皮肤,10%的中性甲醛固定,组织脱水,石蜡包埋切片,HE染色,显微镜下观察各实验组大鼠皮肤病理损伤,其结果以损伤指数计。
5、实验结果
5.1各实验组大鼠TEWL比较 结果见表2。
表2 各实验组大鼠TEWL
注:与模型组比较,**P<0.01,*P<0.05;与黄柏洗液组比较,△△P<0.01,△P<0.05
由表2可知,与模型组比较,组合物1~6、8~15组大鼠皮肤的TEWL均有显著减小(P<0.05),其中,组合物7组有极显著减小(P<0.01);与黄柏洗液组比较,组合物7组大鼠TEWL有显著减小(P<0.05)。表明各比例组合物均能有效抑制湿疹大鼠皮肤水分丢失,进而有效维护皮肤屏障功能,其中以组合物7效果最佳。
5.2各实验组大鼠IFN-γ和IL-4含量比较 结果见表3。
表3 各实验组大鼠IFN-γ和IL-4含量
注:与模型组比较,**P<0.01,*P<0.05;与黄柏洗液组比较,△△P<0.01,△P<0.05
由表3可知,与模型组比较,组合物1~6、8~15组大鼠IFN-γ含量均有显著升高(P<0.05),其中,组合物7组有极显著升高(P<0.01);与黄柏洗液组比较,组合物1~6、8~18组大鼠IFN-γ含量均有显著升高(P<0.05),其中,组合物7组有极显著升高(P<0.01)。与模型组比较,组合物1~5、8~15组大鼠IL-4含量均有显著降低(P<0.05),组合物6和7均有极显著降低(P<0.01);与黄柏洗液比较,组合物3~6、8~18组大鼠IL-4含量均有显著降低(P<0.05),其中,组合物7组有极显著降低(P<0.01),表明各药物组合物均能降低湿疹大鼠皮肤炎症反应,其中以组合物7效果最佳。
5.3各实验组大鼠皮肤病理损伤指数比较 结果见表4。
表4 各实验大鼠皮肤病理损伤指数
注:与模型组比较,**P<0.01,*P<0.05;与黄柏洗液组比较,△△P<0.01,△P<0.05
由表4可知,与模型组比较,组合物1~6、8~15组大鼠皮肤病理损伤指数均有显著减小(P<0.05),其中,组合物7组有极显著减小(P<0.01);与黄柏洗液组比较,组合物7组大鼠TEWL有显著减小(P<0.05)。表明各比例组合物均能有效治疗湿疹大鼠皮肤病理损伤,进而有效维护皮肤屏障功能,其中以组合物7效果最佳。
6、实验结论
美洲大蠊提取物和马齿苋提取物各种比例组合物对大鼠湿疹均具有良好的治疗作用,主要体现在:均能有效抑制湿疹大鼠皮肤水分丢失、减轻炎症反应、减轻皮肤溃烂、炎症等病理损伤,其中以药物组合物7,即美洲大蠊提取物:马齿苋提取物=1.2:2.0具有最佳效果。
综上,美洲大蠊提取物和马齿苋提取物能够有效地改善皮肤质量,治疗湿疹、抑制湿疹皮肤的水分丢失、减轻炎症反应、减轻皮肤溃烂、炎症等病理损伤。本发明提供的制剂具有良好的治疗、预防效果,应用前景广阔。
Claims (10)
1.一种改善皮肤质量的组合物,其特征在于:它是由含有下述重量配比的原料制备而成的制剂:
美洲大蠊提取物4~16份、马齿苋提取物8~24份。
2.根据权利要求1所述的组合物,其特征在于:它是由下述重量配比的原料制备而成的药物制剂:
美洲大蠊提取物4~16份、马齿苋提取物8~24份。
3.根据权利要求2所述的组合物,其特征在于:它是由下述重量配比的原料制备而成的药物制剂:
美洲大蠊提取物12份、马齿苋提取物20份。
4.根据权利要求1~3任意一项所述的用途,其特征在于:所述美洲大蠊提取物,每1ml含总氨基酸不得低于0.72mg;或者,所述美洲大蠊提取物,按照干燥品计算,含总氨基酸不得少于7.0%;所述马齿苋提取物为干燥的马齿苋水提物。
5.根据权利要求4所述的用途,其特征在于:所述美洲大蠊提取物为康复新液或康复新。
6.根据权利要求1~5任意一项所述的用途,其特征在于:所述美洲大蠊提取物采用如下方法制备:
称取美洲大蠊药材,加70~90%v/v乙醇回流提取,合并提取液,回收乙醇、浓缩后,加水沉淀,静置,收集上清液,减压浓缩、干燥即得。
7.根据权利要求4所述的组合物,其特征在于:所述的马齿苋的水提取方法为浸提、煎煮、回流或/和超声提取。
8.根据权利要求1~3任意一项所述的组合物,其特征在于:所述的制剂为水凝胶贴剂、液体敷料、泡沫材料贴剂、膜剂、压敏胶。
9.权利要求1~8任意一项所述的组合物在制备改善皮肤质量、治疗湿疹的药物或者化妆品中的用途。
10.根据权利要求9所述的用途,其特征在于:所述药物是抑制湿疹皮肤水分丢失,减轻炎症反应、减轻皮肤溃烂的药物。
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