CN113713083A - 一种用于治疗脱发的药物组合 - Google Patents
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Abstract
本发明涉及一种用于治疗脱发的药物组合，作为药物制剂用于治疗相关脱发的疾病领域。本发明的主要活性成份为托法替布和环孢菌素A，本发明的组合物比其单一成份效果更好，起效时间快，生长出的毛发与正常的毛发相同，发质较硬。
Description
技术领域
本发明涉及一种用于治疗脱发的药物组合，作为药物制剂用于治疗相关脱发的疾病领域。
背景技术
脱发是一种常见的皮肤科疾病，随着人们生活和工作节奏的日益加快，国家有关部门颁布的健康指数显示其发病率已经高达30％。导致脱发的原因较多，一般可以分为雄激素性脱发，神经性脱发，内分泌脱发，症状性脱发等。目前治疗脱发和促进毛发再生的有效方法十分有限，一般方法为服用临床药物治疗和物理手术植发。这些治疗手段不仅昂贵而且给患者带来诸多不便。
将治疗脱发的有效成份融入日常使用的洗发水的方法治疗脱发和促进毛发生长，不仅使用方便而且经济实惠。专利CN107847428A公开了将枸橼酸托法替尼作为一种治疗脱发的药物，但其作为单一成份通过试验对比治疗脱发效果虽然有一定作用，但还是不非常明显；专利201510190767.X公开了将超高分子量γ-聚谷氨酸作为有效成份制备预防脱发和促进毛发生长的洗发水；这些公开的专利技术虽然有一定的防脱发效果，但是促进毛发再生的效果也还不是十分明显。专利CN106138058A公布了托法替尼与米诺地尔的组合物，效果比较好，但是由于米诺地尔的副作用较大，故临床应用有一定局限。
发明内容
基于上述问题，本发明所要解决的问题在于提供一种用于治疗脱发的药物组合。
本发明的技术方案如下：
一种用于治疗脱发的药物组合物，其特征在于其活性成份由的托法替尼与环孢菌素A组成的药物制剂；其中，托法替尼包括托法替尼自由碱和/或托法替尼盐。
根据权利要求1所述的用于治疗脱发的药物组合物，其特征在于，所述活性成分中，托法替尼自由碱及其盐中一种与环孢菌素A的质量百分比为10∶90～ 90∶10。
根据权利要求1或2所述的用于治疗脱发的药物组合，其特征在于，还包括载体基质，所述活性成分与载体介质的质量百分比为1∶99～15:85，所述载体基质包括水溶剂、醇类溶剂或洗发护发用品中的一种或两种以上。
根据权利要求3所述的用于治疗脱发的药物组合，其特征在于，所述活性成分与载体介质的质量百分比为3∶97～8∶92。
根据权利要求3所述的用于治疗脱发的药物组合，其特征在于，所述洗发护发用品包括乳膏、喷雾剂中的一种或两种以上。
根据权利要求3所述的用于治疗脱发的药物组合，其特征在于治疗发生在当所述毛囊处于中期休止期或晚期休止期
本发明提供的用于治疗脱发的药物组合，其活性成分包括托法替尼和环孢菌素 A，其中托法替尼是一种JAK抑制剂，可以与目标细胞(如真皮、表皮、真皮乳头细胞或毛囊细胞)的特异性蛋白活性位点选择性结合，抑制细胞通路信号的传递以及特性细胞因子的合成，从而减少毛发脱落疾病相关的症状；环孢菌素A 是一种钾离子通道开放剂能直接松弛血管平滑肌，有强大的小动脉扩张作用，使外周阻力下降，促进毛囊细胞的生长，从而使毛发再生；这两种物质的组合，使其协同作用于目标细胞的靶点蛋白和血管平滑肌，通过抑制细胞因子的合成和加快血液循环，以达到显著地促进毛发再生效果。
具体实施方式
下面通过一些实施例，对本发明的作进一步详细说明。
实施例1
处方：枸橼酸托法替布5g，环孢菌素10g，丙二醇100ml，乙醇300ml，苯氧乙醇1g，加水到1000ml，操作步骤：称取处方量的枸橼酸托法替布、环孢菌素，加入处方量的丙二醇和乙醇搅拌完全溶解，加纯化水至1000ml。
实施例2
处方：枸橼酸托法替布10g，环孢菌素10g，丙二醇100ml，乙醇300ml，苯氧乙醇1g，加水到1000ml，操作步骤：称取处方量的枸橼酸托法替布、环孢菌素，加入处方量的丙二醇和乙醇搅拌完全溶解，加纯化水至1000ml。
实施例3
处方：枸橼酸托法替布15g，环孢菌素10g，丙二醇100ml，乙醇300ml，苯氧乙醇1g，加水到1000ml，操作步骤：称取处方量的枸橼酸托法替布、环孢菌素，加入处方量的丙二醇和乙醇搅拌完全溶解，加纯化水至1000ml
实施例4
处方：枸橼酸托法替布10g，环孢菌素15g，丙二醇100ml，乙醇300ml，苯氧乙醇1g，加水到1000ml，操作步骤：称取处方量的枸橼酸托法替布、环孢菌素，加入处方量的丙二醇和乙醇搅拌完全溶解，加纯化水至1000ml
实施例5
处方：枸橼酸托法替布10g，环孢菌素20g，丙二醇100ml，乙醇300ml，苯氧乙醇1g，加水到1000ml，操作步骤：称取处方量的枸橼酸托法替布、环孢菌素，加入处方量的丙二醇和乙醇搅拌完全溶解，加纯化水至1000m
实施例6
实验对象：6周龄C57雄性小鼠，分成A组和B组，其中A组为施用了含有实施例1制得的制剂，B组是仅施用了空白辅料的对照组，每组小鼠选取5只作为实验对象。
操作过程：C57小鼠用三溴乙醇麻醉后，在背部抹上熔化的石蜡；待石蜡凝固后撕去背部毛发，露出皮肤；拔毛后第九天，注射环磷酰胺(20μg/g)；从给药当天开始，在小鼠背部皮肤抹药1次/2日；左侧涂抹40μl空白辅料，右侧涂抹含药制剂40μl；第21天处死小鼠，背部取材，切片，HE染色，封片。
实验结果如下：对比同等高倍或低倍视野下A组和B组毛囊数量。小鼠背部皮肤毛囊被染色成蓝色，相同面积下，蓝色的小点A组比B组明显多，表明给予含有实施例制剂后对小鼠有明显的促进毛囊增殖作用，对普通脱发、放化疗脱发、毛囊损伤有明显的改善效果。
Claims (8)
1.一种用于治疗脱发的药物组合物，其特征在于其活性成份由的托法替尼与环孢菌素A组成的药物制剂；其中，托法替尼包括托法替尼自由碱和/或托法替尼盐。
2.根据权利要求1所述的用于治疗脱发的药物组合物，其特征在于，所述活性成分中，托法替尼自由碱及其盐中一种与环孢菌素A的质量百分比为10∶90～90∶10。
3.根据权利要求1或2所述的用于治疗脱发的药物组合，其特征在于，还包括载体基质，所述活性成分与载体介质的质量百分比为1∶99～15:85，所述载体基质包括水溶剂、醇类溶剂或洗发护发用品中的一种或两种以上。
4.根据权利要求3所述的用于治疗脱发的药物组合，其特征在于，所述活性成分与载体介质的质量百分比为3∶97～8∶92。
5.根据权利要求3所述的用于治疗脱发的药物组合，其特征在于，所述洗发护发用品包括乳膏、喷雾剂中的一种或两种以上。
6.根据权利要求3所述的用于治疗脱发的药物组合，其特征在于治疗发生在当所述毛囊处于中期休止期或晚期休止期。
7.根据权利要求3所述的用于治疗脱发的药物组合，其特征在于治疗脱发的症状如：雄激素性脱发、休止期脱发、斑秃、头癣、全秃、少毛症、遗传性单纯稀毛症、前额纤维化脱发、瘢痕性脱发、毛发扁平苔癣、环形脱发、疤痕性脱发、非瘢痕性脱发、普秃或化疗引起的脱发。
8.根据权利要求1所述的用于治疗脱发的药物组合，其特征在于，托法替尼盐为托法替尼自由碱与下述酸中的一种反应后获得的：马来酸、酒石酸、枸缘酸、硫酸、磷酸、硝酸、盐酸。
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