摘要：【中文】本发明公开一种可快速植入型缓释微针贴片及其制备方法。本发明首先公开了可快速植入型缓释微针，包括针尖、中间层、针体和基底；所述针尖由包含生物可降解不溶于水的高分子材料基质形成；所述中间层由包含亲水性材料基质形成；所述针体和基底由包含生物兼容性高分子材料基质形成。本发明还公开了上述微针的制备方法。本发明微针或微针贴片用生物可降解不溶于水的高分子材料制作针尖，用亲水性材料制作中间层，用生物兼容性高分子材料制作针体和基底，形成针尖难溶于水的多层微针，作用于皮肤后，吸收水分，使针尖与针体和基底在1h内快速分离，基底被揭后，针尖留在皮内，用药者不需长时间贴敷微针贴片，就能保证药物在体内长效释放。 【EN】The invention discloses a rapidly implantable sustained-release microneedle patch and a preparation method thereof. The invention firstly discloses a rapid implantable slow release microneedle, which comprises a needle point, a middle layer, a needle body and a substrate; the needle tip is formed by a matrix containing biodegradable water-insoluble high polymer materials; the intermediate layer is formed from a matrix comprising a hydrophilic material; the needle body and the base are formed of a matrix comprising a biocompatible polymeric material. The invention also discloses a preparation method of the microneedle. The micro-needle or the micro-needle patch is characterized in that a needle point is made of biodegradable water-insoluble high polymer material, a middle layer is made of hydrophilic material, a needle body and a substrate are made of biocompatible high polymer material to form a multi-layer micro-needle with the needle point difficult to dissolve in water, the multi-layer micro-needle acts on the skin and absorbs water to enable the needle point, the needle body and the substrate to be quickly separated within 1 hour, after the substrate is uncovered, the needle point is remained in the skin, and a user can ensure the long-term release of a medicament in the body without applying the micro-needle.

摘要：【中文】本发明公开一种可植入型两段式微针贴片及其制备方法。本发明首先公开了可植入型两段式微针，包括上段针尖和下段一体式基座；上段针尖由包含生物可降解不溶于水的高分子材料基质形成；所述下段一体式基座由包含水溶性高分子材料基质形成。本发明还公开了上述微针的制备方法。本发明微针用生物可降解不溶于水的高分子材料制作上段针尖，用水溶性高分子材料制作下段一体式基座，形成针尖难溶于水、基座易溶于水的两段式微针，作用于皮肤后，下段一体式基座吸收皮肤内的水分快速溶解，实现快速分离，上段针尖会被嵌入皮内，用药者不需长时间贴敷微针，就能保证药物在体内长效释放。同时下段一体式基座为水溶性高分子材料，避免了医疗垃圾的产生。 【EN】The invention discloses an implantable two-section microneedle patch and a preparation method thereof. The invention discloses an implantable two-section type microneedle, which comprises an upper section needle point and a lower section integrated base; the upper section of the needle tip is formed by a biodegradable water-insoluble high polymer material matrix; the lower integrated susceptor is formed of a matrix comprising a water-soluble polymer material. The invention also discloses a preparation method of the microneedle. The microneedle is characterized in that an upper section of needle point is made of biodegradable water-insoluble high polymer material, a lower section of integrated base is made of water-soluble high polymer material, so that a two-section microneedle with the needle point being insoluble in water and the base being soluble in water is formed, after the microneedle acts on skin, the lower section of integrated base absorbs water in the skin to be quickly dissolved, the rapid separation is realized, the upper section of needle point can be embedded into the skin, and a user can ensure that the drug is released in vivo for a long time without pasting the microneedle for a long time. Meanwhile, the lower-section integrated base is made of water-soluble polymer materials, so that medical waste is avoided.

摘要：【中文】本发明公开一种可植入型缓释微针贴片及其制备方法。本发明首先公开了可植入型缓释微针包括针尖、针体和基底；所述针尖包括针尖中心层和针尖外层；所述针尖中心层由包含生物可降解不溶于水的高分子材料基质形成；所述针尖外层、针体和基底由包含水溶性高分子材料基质形成。本发明还公开了上述微针的制备方法和包含上述微针的微针贴片。本发明微针或微针贴片用高分子材料制作针尖中心层，用水溶性高分子材料制作基底、针体和针尖外层，形成针尖中心层难溶于水的微针或微针贴片，作用于皮肤后，吸收皮肤的水分，使基底和针体与针尖在0.5‑2h内快速分离，基底被揭下后，针尖会被留在皮内，用药者不需长时间贴敷，就能保证药物在体内长效释放。 【EN】The invention discloses an implantable sustained-release microneedle patch and a preparation method thereof. The invention firstly discloses an implantable slow-release micro-needle, which comprises a needle point, a needle body and a substrate; the needle tip comprises a needle tip central layer and a needle tip outer layer; the needle tip central layer is formed by a biodegradable water-insoluble high polymer material matrix; the needle tip outer layer, the needle body and the base are formed by a matrix containing a water-soluble high polymer material. The invention also discloses a preparation method of the microneedle and a microneedle patch containing the microneedle. The microneedle or microneedle patch is characterized in that a microneedle central layer is made of a high polymer material, a substrate, a needle body and a microneedle outer layer are made of a water-soluble high polymer material to form the microneedle or microneedle patch, wherein the microneedle or microneedle patch is insoluble in water in the microneedle central layer, and after the microneedle or microneedle patch acts on skin, the water of the skin is absorbed, so that the substrate, the needle body and the microneedle are quickly separated within 0.5-2h, the microneedle can be remained in the skin after the substrate is removed, and a user can ensure that a medicament is released in vivo for a long time without applying for a long time.

摘要：【中文】本发明公开一种加速聚乙烯醇可溶性微针成型和速溶给药的方法及制备的微针。本发明首先公开了加速聚乙烯醇可溶性微针成型和速溶给药的方法包括将至少一种水溶性二价无机盐或其水合物，或海藻酸钠与聚乙烯醇组合使用。本发明还提供了上述方法制备的微针。本发明在制备聚乙烯醇可溶性微针时通过在聚乙烯醇中添加至少一种水溶性二价无机盐或其水合物或海藻酸钠，使得聚乙烯醇结晶度降低，结构规整性被破坏，聚乙烯醇链段活性增强，从而加速聚乙烯醇可溶性微针成型、实现速溶给药以及提高针体耐湿稳定性，同时保持了良好的微针基底柔韧性及针尖机械强度。另外，本发明方法简单、快速，便于大规模生产，拓宽了聚乙烯醇在可溶性微针领域的应用。 【EN】The invention discloses a method for accelerating the forming and instant dosing of polyvinyl alcohol soluble microneedles and microneedles prepared by the same. The invention firstly discloses a method for accelerating the forming and instant administration of polyvinyl alcohol soluble microneedles, which comprises the step of using at least one water-soluble divalent inorganic salt or hydrate thereof, or sodium alginate and polyvinyl alcohol in combination. The invention also provides the microneedle prepared by the method. When the polyvinyl alcohol soluble microneedle is prepared, at least one water-soluble divalent inorganic salt or hydrate thereof or sodium alginate is added into polyvinyl alcohol, so that the crystallinity of the polyvinyl alcohol is reduced, the structural regularity is damaged, and the activity of a polyvinyl alcohol chain segment is enhanced, thereby accelerating the forming of the polyvinyl alcohol soluble microneedle, realizing instant administration, improving the moisture-resistant stability of a needle body, and simultaneously keeping good flexibility of a microneedle substrate and good mechanical strength of a needle point. In addition, the method is simple and rapid, is convenient for large-scale production, and widens the application of the polyvinyl alcohol in the field of soluble microneedles.