CN116899093A - 一种新型膏药微针贴片及其制备方法 - Google Patents
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Abstract
本发明提供一种新型膏药微针贴片及其制备方法,包括针部、基体部、多孔薄膜和膏药贴片,所述基体部为片状基体,所述针部由多个呈列阵排布的针体组成,透过多孔薄膜且固定在基体部的其中一个面上,所述膏药贴片贴附于基体部的另一面上。本发明结合了膏药贴片和微针贴片各自的优势,既可以解决膏药贴片皮肤渗透性差和药物利用率低的问题,有解决了微针贴片载药量少的问题。
Description
技术领域
本发明涉及医疗器械技术领域,具体涉及一种新型膏药微针贴片及其制备方法。
背景技术
微针贴片是一种新型给药方法,其针部可刺入皮肤表皮层或真皮层上部,将药物输送至皮肤内。相对于注射给药,微针贴片给药具有微创、微痛、不出血等优点;相对于口服给药,微针贴片给药可避免肝脏的“首代”效应;相对于透皮给药,微针贴片可克服角质层对药物传输的阻碍,提高药物利用率。目前,微针贴片已被用于输送小分子、大分子、生物制剂等活性物质至体内,可显著提高其利用率。
但现有技术中,微针贴片针部的尺寸较小,针尖直径小于50微米,长度小于1500微米,载药量较小,相较于膏药贴来说,膏药贴的药物作用于皮肤,具有使用方便、患者耐受性好、延展性好、载药量大等优点,但膏药贴中的药物输送会被皮肤上的角质层所阻碍,导致其药物利用率低。因此,急需研制出一种结合了膏药贴片和微针贴片各自优势的新型给药贴片。
发明内容
本发明要解决的技术问题是提供一种新型膏药微针贴片及其制备方法,结合了膏药贴片和微针贴片各自的优势,既可以解决膏药贴片皮肤渗透性差和药物利用率低的问题,有解决了微针贴片载药量少的问题。
为解决上述技术问题,本发明的实施例提供一种新型膏药微针贴片,包括针部、基体部、多孔薄膜和膏药贴片,所述基体部为片状基体,所述针部由多个呈列阵排布的针体组成,透过多孔薄膜且固定在基体部的其中一个面上,所述膏药贴片贴附于基体部的另一面上。
其中,所述多孔薄膜上设有第一网状镂空,所述针体的尾部位于网状镂空的网格线上;所述基体部上设有第二网状镂空,所述第二网状镂空区域与第一网状镂空区域部分重合。
进一步,所述第一网状镂空为单一或阵列的圆形、正方形、六边形的一种。
其中,所述针体的长度为300~1000微米,针体密度为150~1000针/cm2。
其中,所述针部和基体部的制备材料均选用可溶性高分子聚合物。
进一步,所述可溶性高分子聚合物为透明质酸钠、明胶、聚乙烯醇、聚乙烯吡咯烷酮、壳聚糖、环糊精、海藻酸钠中的一种或多种混合,所述可溶性高分子聚合物均可在人体体表组织液中所溶解。
其中,所述多孔薄膜为纱布或棉柔巾。
优选的,所述多孔薄膜上暴露出的膏药部分可选择贴附离形纸以便储存备用。
本发明的实施例还提供一种新型膏药微针贴片的制备方法,包括以下步骤:
S1、制备具有镂空的多孔薄膜:根据设计将薄膜上对应区域去除,制备具有网状镂空的多孔薄膜;
S2、制备膏药微针贴片模具:采用3D打印技术或微铣削技术制备微针阳模具,往微针阳模具内注入PDMS,翻模制得具有针状微孔的PDMS模具,然后将步骤S1制备的具有网状镂空的多孔薄膜平铺于PDMS模具上,制成膏药微针贴片模具;
S3、制备网状镂空微针贴片模具:配置可溶性高分子聚合物溶液,将可溶性高分子聚合物溶液浇铸在步骤S2制备的膏药微针贴片模具上,然后经真空、离心、超声处理后,使可溶性高分子聚合物溶液透过多孔薄膜进入膏药微针贴片模具的针状微孔中,在多孔薄膜的一侧形成针部,并在多孔薄膜的另一侧形成具有第二网状镂空的基体部,干燥使可溶性高分子聚合物溶液固化,得到网状镂空微针贴片模具;
S4、制备膏药微针贴片:将膏药贴附于步骤S3制备的网状镂空微针贴片模具的多孔薄膜上,将网状镂空微针贴片模具脱模,得到膏药微针贴片。
其中,制备加工过程中需在无菌环境下进行。
本发明上述技术方案的有益效果如下:
本发明利用膏药微针贴片结合了膏药贴片和微针贴片各自的优势,通过微针贴片上的可溶性针体可以解决膏药贴片皮肤渗透性差和药物利用率低的问题,利用膏药贴上附着大量药物储备解决了微针贴片载药量少的问题,且多孔薄膜上的镂空区域也方便使膏药贴和微针贴片贴合。
附图说明
图1为本发明的结构示意图;
图2为本发明的截面结构示意图;
图3为本发明中制备方法的流程示意图;
图4为本发明中实施例1膏药贴片和膏药微针贴片药物渗透量与时间关系的曲线图;
图5为本发明中实施例2膏药贴片和膏药微针贴片药物渗透量与时间关系的曲线图。
附图标记说明:1、针部;2、多孔薄膜;3、基体部;4、膏药贴片;5、第一网状镂空。
具体实施方式
为使本发明要解决的技术问题、技术方案和优点更加清楚,下面将结合附图及具体实施例进行详细描述。
如图1、图2所示,本发明的实施例提供一种新型膏药微针贴片,包括针部1、基体部3、多孔薄膜2和膏药贴片4,所述基体部3为片状基体,所述针部1由多个呈列阵排布的针体组成,透过多孔薄膜2且固定在基体部3的其中一个面上,所述膏药贴片4贴附于基体部3的另一面上。所述针体1的形状为顶部带有尖刺部的针体结构,针体的具体结果不做限制,包括但不限于圆锥形针体、棱锥形针体、圆柱形针体等结构。本发明中,所述针部1的长度为300~1000微米,针密度为150~1000针/cm2,针部1采用可溶性高分子聚合物作为基质材料,该可溶性高分子聚合物为透明质酸钠、明胶、聚乙烯醇、聚乙烯吡咯烷酮、壳聚糖、环糊精、海藻酸钠中的一种或多种混合。针部的微针刺穿角质层后,在皮肤表面形成孔洞,可溶性高分子聚合物经皮肤皮下组织液溶解后,为膏药贴片上的药物扩散至体内提供通道,膏药贴上的药物通过孔洞提供的通道在体内进行扩散释放,药物分子穿过角质层屏障,经皮下组织吸收进入人体,使得药物通过经皮途径可以更加容易、快速、高效扩散至体内,而不是通过微针将药物输送至皮肤内。可溶性高分子聚合物溶液所制成的微针无需像其他微针那样形成微孔道递送药物后再移出针体,同时不重复使用针体也避免了交叉感染的风险;在保证药物生产过程中的稳定性,使用可溶性高分子聚合物作为针体的材料也避免创口感染,安全可靠性高。
本发明中膏药贴片3包括但不限于跌打损伤贴、退烧贴等市场上已有膏药贴。
所述多孔薄膜2上设有第一网状镂空5,所述针体1的尾部位于第一网状镂空5的网格线上,第一网状镂空5为单一或阵列的圆形、正方形、六边形等。所述多孔薄膜2为纱布或棉柔巾。采用多孔薄膜作为针部的连接体,能提高针部与基体部之间的结合度,能将针部利用基体部固定在多孔薄膜上,同时能促进针体全部刺进人体皮肤内层,进而在针体溶解时膏药贴中的药物经镂空区域域渗透进皮肤并向四周扩散,通过微针刺出的针孔进入皮肤内层,进一步提高药物利用率。具有网状镂空的多孔薄膜能够帮助膏药贴加快药物递送,膏药贴本身附着大量药物储备也解决了原本的微针贴片载药量少的问题,扩大微针状态下载药量的范围。所述基体部为具有镂空的片状基体,设有第二网状镂空,所述第二网状镂空区域与第一网状镂空区域完全或大部分重合,其作用是为了能让针部的微针固定于多孔薄膜上,且能够让贴片膏药通过重合的镂空部分作用于皮肤上。
实施例中,膏药贴上暴露于镂空部位的区域可选择贴附离型纸,以便储存备用。
采用本发明所公开的膏药微针贴片对人体药物渗透率的速度进行对比实验。针对表层皮肤问题,例如银屑病,黄褐斑等皮肤病,将药物输送至表层皮肤,其针长为300微米,实验结果如图4所示,膏药微针贴片中药物在皮肤中的渗透量明显高于普通膏药贴片。
针对非表层皮肤的问题,例如疼痛、糖尿病等,将药物输送至真皮层,并通过皮肤内的毛细血管输送至全身,其针长需要在300微米至1000微米,本实施例为900微米,可以在真皮层形成孔洞,并促进药物在真皮层内的传输,实验结果如图5所示,膏药微针贴片中药物在皮肤中的渗透量明显高于膏药。
如图3所示,本发明的实施例还提供一种新型膏药微针贴片的制备方法,包括以下步骤:
S1、制备具有镂空的多孔薄膜:根据设计经冲压、裁剪等处理方法,将多孔薄膜上刻出单一或阵列的圆形、正方形、六边形等镂空形状,制备出具有网状镂空的多孔薄膜;
S2、制备膏药微针贴片模具:通过3D打印技术或微铣削制备微针阳模具,将微针阳模具放置底面平整的容器中,在容器中倒入PDMS直至淹没阳模具,翻模制得具有针状微孔的PDMS模具,接着将步骤S1制备的具有网状镂空图案的多孔薄膜平铺于PDMS阴模具上,制成膏药微针贴片模具;
S3、制备网状镂空微针贴片模具:将透明质酸钠配置成质量分数10%的溶液,然后将溶液浇铸至在步骤S2制备的膏药微针贴片模具上,接着将膏药微针贴片模具置于真空环境中,经真空、离心、超声处理后,使可溶性高分子聚合物溶液透过多孔薄膜进入膏药微针贴片模具的针状微孔中,在多孔薄膜的一侧形成针部,并在多孔薄膜的另一侧形成具有第二网状镂空的基体部,使微针能够通过基体部固定在多孔薄膜上,接着将膏药微针贴片模具置于高温环境中干燥透明质酸钠溶液,得到图案化微针贴片模具;
S4、制备膏药微针贴片:将膏药贴附于步骤S3制备的图案化微针贴片模具的多孔薄膜上,将图案化微针贴片模具翻模,得到膏药微针贴片。
以上所述是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明所述原理的前提下,还可以作出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (8)
1.一种新型膏药微针贴片,其特征在于,包括针部、基体部、多孔薄膜和膏药贴片,所述基体部为片状基体,所述针部由多个呈列阵排布的针体组成,透过多孔薄膜且固定在基体部的其中一个面上,所述膏药贴片贴附于基体部的另一面上。
2.根据权利要求1所述的新型膏药微针贴片,其特征在于,所述多孔薄膜上设有第一网状镂空,所述针体的尾部位于网状镂空的网格线上;所述基体部上设有第二网状镂空,所述第二网状镂空区域与第一网状镂空区域有重合。
3.根据权利要求2所述的新型膏药微针贴片,其特征在于,所述第一网状镂空为单一或阵列的圆形、正方形、六边形的一种。
4.根据权利要求1所述的新型膏药微针贴片,其特征在于,所述针体的长度为300~1000微米,针体密度为150~1000针/cm2。
5.根据权利要求1所述的新型膏药微针贴片,其特征在于,所述针部和基体部的制备材料均选用可溶性高分子聚合物。
6.根据权利要求5所述的新型膏药微针贴片,其特征在于,所述可溶性高分子聚合物为透明质酸钠、明胶、聚乙烯醇、聚乙烯吡咯烷酮、壳聚糖、环糊精、海藻酸钠中的一种或多种混合。
7.根据权利要求1所述的新型膏药微针贴片,其特征在于,所述多孔薄膜为纱布或棉柔巾。
8.一种新型膏药微针贴片的制备方法,其特征在于,包括以下步骤:
S1、制备具有镂空的多孔薄膜:根据设计将薄膜上对应区域去除,制备具有网状镂空的多孔薄膜;
S2、制备膏药微针贴片模具:采用3D打印技术或微铣削技术制备微针阳模具,往微针阳模具内注入PDMS,翻模制得具有针状微孔的PDMS模具,然后将步骤S1制备的具有网状镂空的多孔薄膜平铺于PDMS模具上,制成膏药微针贴片模具;
S3、制备网状镂空微针贴片模具:配置可溶性高分子聚合物溶液,将可溶性高分子聚合物溶液浇铸在步骤S2制备的膏药微针贴片模具上,然后经真空、离心、超声处理后,使可溶性高分子聚合物溶液透过多孔薄膜进入膏药微针贴片模具的针状微孔中,在多孔薄膜的一侧形成针部,并在多孔薄膜的另一侧形成具有第二网状薄膜镂空的基体部,干燥使可溶性高分子聚合物溶液固化,得到网状镂空微针贴片模具;
S4、制备膏药微针贴片:将膏药贴附于步骤S3制备的网状镂空微针贴片模具的多孔薄膜上,将网状镂空微针贴片模具脱模,得到膏药微针贴片。
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