药学学报

Delivery approach	Material	Manufacturing method	Application	Advantage	Disadvantage	Ref.
"Poke and patch"	Silicon, stainless steel, acrylic	Micro-molding, lithography, etching, laser engraving, micro-milling, 3D printing	Skin pre-treatment	High mechanical, mature preparation technology, sustained drug delivery capability	Two application process, pores of the skin close quickly, no accurate dosing, sharp waste disposal	[10, 11]
"Coat and poke"	Stainless steel, titanium, polymer	Dip-coating, gas-jet drying, spray coating, electro-hydrodynamic atomization, piezoelectric inkjet printing	Influenza vaccine, biosensing applications, protein delivery	Rapid drug release, high mechanical strength, precise dosing, enhanced drug stability, no cold chain required, no risk reuse	Low drug loading capacity, single-use only, limited material compatibility, infection risk	[12-16]
"Poke and flow"	Silicon, metal, glass, ceramic, polymers	Laser-cutting method, 3D printing, stereo lithography, blowing air, drawing lithography	Drug delivery, mRNA delivery, cell therapy, glucose monitoring	Delivering high-dose drugs, controllable delivery rate, mechanically robust	Risk of clogging, complex two-component device, cold-chain storage and transportation	[17-21]
"Poke and release"	PVP, PVA, PLGA	Casting, drawing lithography, droplet-born air blowing, centrifugal lithography, 3D printing	Skin disease, chronic pain, lidocaine, vaccine	Controllable drug release, high biocompatibility, high drug loading, no sharp waste, no requirement for cold-chain storage	Poor mechanical strength, temporary foreign body reaction, drugs affect needle strength	[22-24]
"Poke and swell"	Chitosan, PVA, PLGA	Micro-molding, casting, electrospinning, 3D printing	Anti-scarring, drug delivery, sampling and sensing	No residual in skin, potential for sustained or controlled release, high drug loading capacity, biocompatible materials used	Limited range of swelling materials	[25-29]

Delivery approach	Material	Manufacturing method	Application	Advantage	Disadvantage	Ref.
"Poke and patch"	Silicon, stainless steel, acrylic	Micro-molding, lithography, etching, laser engraving, micro-milling, 3D printing	Skin pre-treatment	High mechanical, mature preparation technology, sustained drug delivery capability	Two application process, pores of the skin close quickly, no accurate dosing, sharp waste disposal	[10, 11]
"Coat and poke"	Stainless steel, titanium, polymer	Dip-coating, gas-jet drying, spray coating, electro-hydrodynamic atomization, piezoelectric inkjet printing	Influenza vaccine, biosensing applications, protein delivery	Rapid drug release, high mechanical strength, precise dosing, enhanced drug stability, no cold chain required, no risk reuse	Low drug loading capacity, single-use only, limited material compatibility, infection risk	[12-16]
"Poke and flow"	Silicon, metal, glass, ceramic, polymers	Laser-cutting method, 3D printing, stereo lithography, blowing air, drawing lithography	Drug delivery, mRNA delivery, cell therapy, glucose monitoring	Delivering high-dose drugs, controllable delivery rate, mechanically robust	Risk of clogging, complex two-component device, cold-chain storage and transportation	[17-21]
"Poke and release"	PVP, PVA, PLGA	Casting, drawing lithography, droplet-born air blowing, centrifugal lithography, 3D printing	Skin disease, chronic pain, lidocaine, vaccine	Controllable drug release, high biocompatibility, high drug loading, no sharp waste, no requirement for cold-chain storage	Poor mechanical strength, temporary foreign body reaction, drugs affect needle strength	[22-24]
"Poke and swell"	Chitosan, PVA, PLGA	Micro-molding, casting, electrospinning, 3D printing	Anti-scarring, drug delivery, sampling and sensing	No residual in skin, potential for sustained or controlled release, high drug loading capacity, biocompatible materials used	Limited range of swelling materials	[25-29]

微针在经皮给药中的应用: 聚焦递送机制与前沿进展

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孔佩佩 ¹ , 左池靖 ¹^,²^,³ , 罗文慧 ¹^,² , 张静 ¹^,³^,⁴ , 刘欢欢 ¹^,²^,⁵^,⁶^,^* , 彭灿 ¹^,²^,³^,⁴^,⁵^,^*

药学学报 | 综述 2026,61(7): 2398-2406

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药学学报 |综述 2026 , 61 (7) : 2398 -2406

微针在经皮给药中的应用: 聚焦递送机制与前沿进展

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孔佩佩¹, 左池靖¹^,²^,³, 罗文慧¹^,², 张静¹^,³^,⁴, 刘欢欢¹^,²^,⁵^,⁶^,^*, 彭灿¹^,²^,³^,⁴^,⁵^,^*

作者信息

¹安徽中医药大学药学院, 安徽合肥 230012

²安徽中医药大学新安医学与中医药现代化研究所, 安徽合肥 230012

³安徽中医药大学安徽省现代中药产业共性技术研究中心, 安徽合肥 230012

⁴省部共建安徽道地中药材品质提升协同创新中心, 安徽合肥 230012

⁵药物制剂技术与应用安徽省重点实验室, 安徽合肥 230012

⁶安徽省活性天然产物重点实验室, 安徽合肥 230012

通讯作者:

刘欢欢, Tel: 18326612112, E-mail: huanhuanliu2016@ahtcm.edu.cn

彭灿, Tel: 86-551-68129155, E-mail: pengcanking@hotmail.com

作者简介:

作者贡献:

孔佩佩负责文献检索及文稿撰写; 左池靖负责文章选题与写作思路的指导; 罗文慧、张静、刘欢欢负责提供修改意见; 彭灿负责项目设计、基金申请及论文终审。

The application of microneedles in transdermal drug delivery: Focus on delivery mechanisms and recent advances

Pei-pei KONG¹, Chi-jing ZUO¹^,²^,³, Wen-hui LUO¹^,², Jing ZHANG¹^,³^,⁴, Huan-huan LIU¹^,²^,⁵^,⁶^,^*, Can PENG¹^,²^,³^,⁴^,⁵^,^*

Affiliations

¹School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China

²Center for Xin′an Medicine and Modernization of Traditional Chinese Medicine of IHM, Anhui University of Chinese Medicine, Hefei 230012, China

³Generic Technology Research Center for Anhui TCM Industry, Anhui University of Chinese Medicine, Hefei 230012, China

⁴MOE-Anhui Joint Collaborative Innovation Center for Quality Improvement of Anhui Genuine Chinese Medicinal Materials, Hefei 230012, China

⁵Anhui Province Key Laboratory of Pharmaceutical Preparation Technology and Application, Hefei 230012, China

⁶Anhui Provincial Key Laboratory of Bioactive Natural Products, Hefei 230012, China

出版时间: 2026-07-12 doi: 10.16438/j.0513-4870.2025-0950

文章导航

摘要

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本研究聚焦于微针在经皮给药领域的创新应用, 旨在探讨其突破皮肤屏障限制的深层机制并综述前沿进展。近年来, 经皮给药研究更多关注微针的机制优化与材料创新, 本综述从微针的“刺穿和贴敷”和“涂覆和刺穿”等5种递送机制分析, 明晰原理、优点与现存挑战, 同时结合眼科疾病、皮肤病、癌症、自身免疫性疾病及慢性代谢性疾病等领域应用案例, 在药物输送效率和健康监测方面展现出广阔的应用前景。未来需攻克规模化生产、长期安全性验证及个体化治疗等关键问题, 加速临床转化进程。

关键词

微针 / 经皮给药 / 递送机制 / 应用 / 生物技术药物

Abstract

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This study focuses on the innovative applications of microneedles in transdermal drug delivery, aiming to explore their underlying mechanisms for overcoming skin barrier limitations and summarise cutting-edge advances. Recent transdermal delivery research has increasingly emphasised mechanism optimisation and material innovation for microneedles. This review analyses five delivery mechanisms — including "poke and patch" and "coat and poke" — clarifying their principles, advantages, and existing challenges. By examining application cases across ophthalmic disorders, dermatology, oncology, autoimmune diseases, and chronic metabolic conditions, it demonstrates broad prospects for drug delivery efficiency and health monitoring. Future efforts must address critical challenges including scalable production, long-term safety validation, and personalised treatment approaches to accelerate clinical translation.

Key words

microneedle / transdermal drug delivery / delivery mechanism / application / biotechnology drug

引用本文

孔佩佩, 左池靖, 罗文慧, 张静, 刘欢欢, 彭灿. 微针在经皮给药中的应用: 聚焦递送机制与前沿进展. 药学学报, 2026 , 61 (7) : 2398 -2406 . DOI: 10.16438/j.0513-4870.2025-0950

Pei-pei KONG, Chi-jing ZUO, Wen-hui LUO, Jing ZHANG, Huan-huan LIU, Can PENG. The application of microneedles in transdermal drug delivery: Focus on delivery mechanisms and recent advances[J]. Acta Pharmaceutica Sinica, 2026 , 61 (7) : 2398 -2406 . DOI: 10.16438/j.0513-4870.2025-0950

正文

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经皮给药系统(transdermal drug delivery system, TDDS) 凭借其非侵入性、规避肝脏首过代谢、维持稳定血药浓度及提升患者依从性等优势, 已成为药物递送领域的重要研究方向。然而, 皮肤的角质层(stratum corneum, SC) 作为天然的物理屏障, 由紧密排列的角质细胞(“砖块”) 和富含脂质的细胞间基质(“灰浆”) 构成, 对亲水性药物和分子质量 > 500 Da的大分子药物构成双重渗透障碍^[1]。此外, 不同个体间SC厚度、脂质组成及皮肤含水量等差异, 也限制了TDDS的实际应用^[2]。

尽管一些药物采用局部给药或透皮贴剂的形式, 但多数大分子药物仍需依赖皮下注射来实现向皮肤的输送。在过去的十年里, 相关研究使用物理促渗技术(离子电渗^[3]、电穿孔^[4]、超声促渗技术^[5]及化学促渗剂等), 这些方法能在一定程度改善渗透, 但普遍存在皮肤刺激、操作复杂或成本高昂等局限性因素。因此, 开发一种无需皮下注射, 却能高效输送药物的新型给药方式至关重要。

微针(microneedles, MNs) 作为经皮给药的第三代增强策略, 是由数百至数千根的微米级针尖组成的阵列结构, 针体直径通常小于300 μm, 长度500~1 000 μm, 这种微小尺寸使其能穿透角质层, 在皮肤表层形成微通道, 但不会触及深层神经和血管, 具有微创、快速、无痛等特点^[6]。通过设计不同结构和材料, 微针还能实现药物的可控释放, 例如可溶微针依靠材料降解速度控制释药时间, 空心微针精准控制注射量。应用范围已经超越了其传统医学领域, 扩展至疾病管理、免疫治疗、诊断和美容等方面。

目前, 已有大量研究从材料学和药理学角度分别探讨了微针构建中关键的基质材料与药物-载体相互作用^{[7, 8]}, 但没有从药物释放机制角度深入研究, 本文将从微针递送的机制、应用领域与前沿突破、当前面临的挑战等方面进行阐述, 旨为微针技术的进一步研究和临床转化提供相关参考。

1　递送机制

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微针用于药物递送的概念最早由Gerstel和Place 1976年在美国专利中提出^[9]。它的机制实际上是由微针穿透皮肤角质层到达皮肤特定深度, 形成微小孔道, 图1), 下面详细阐述了每种策略概况, 并将各类微针在制备材料、制备工艺、应用案例及优缺点总结于表1^[10-29]。

1.1　刺穿和贴敷

固体微针的“刺穿和贴敷”(poke and patch) 是一种分两步的经皮递送策略。微针物理穿刺形成直径1~10 μm、深度 < 200 μm的暂时性微通道, 随后在微针处理后的皮肤区域, 涂敷药物制剂或贴附含有药物的透皮贴片, 依赖被动扩散进入皮肤, 实现经皮递送^[30](图1A)。

这种方法的优点在于技术相对简单—不需要装载或包衣, 但最主要的限制是两步给药操作, 且难以精确控制再次敷用的药物剂量(表1)。此外, 皮肤的自愈机制导致30 min内约25%通道闭合, 6 h内基本完全闭合, 这可能导致药物输送提前中断^[31]。虽然使用封闭贴剂可以将通道开放时间延长, 但这会增加皮肤感染的风险。现有研究表明, 可通过增加针密度、优化微针制备材料、药物等途径, 延缓微通道的闭合速度, 从而为药物递送争取更充足的时间^[32]。

1.2　涂覆和刺穿

“涂覆与刺穿”(poke and flow) 法是将药物直接涂覆于针体表面, 当微针刺入皮肤后, 聚乙烯醇(polyvinyl alcohol, PVA) 等水溶性涂层在组织间液中的快速溶解特性, 促使药物迅速释放^[33](图1B)。相较于其他策略, 在采用温和的浸涂或喷涂工艺时, 主要优势在于能最大程度地保护生物活性分子的稳定性, 已被应用于疫苗、激素及其他大分子的递送。不过, 该方法面临单位面积载药量受限, 涂层分布不均匀及剂量无法精确等问题。针对上述问题, 近年研究通过复合涂层技术和结构设计方面进行改进, 研究者们采用真空成型工艺或逐层组装技术制备出剂量可控的微针^{[34, 35]}。或者将多孔聚合物涂覆在微针贴片上, 从而改善浸涂/喷涂工艺的分布不均问题^[36]。

在涂覆-刺穿方法的基础上, 发展出现了核壳微针, 这种微针利用不同材料层之间的降解差异性来递送药物。例如, Ryu等^[37]开发了聚乳酸-羟基乙酸共聚物[poly (lactic-co-glycolic acid), PLGA] 微胶囊(结构: 藻酸盐外壳-壳聚糖中间层-PLGA核心), 结果表明, 用壳聚糖涂层的微针表现出较低的初始突释和对亲水性药物的持续释放。除此之外, 涂层厚度、材料性质、药物特性及微针几何结构(如针尖形状、尺寸) 均会影响其释放速率和递送效率。

1.3　刺穿和流动

“刺穿和流动”(poke and flow) 方法的构想是通过中空腔道直接输注药液, 模拟皮下注射过程, 穿刺后, 借助外部机械压力系统(活塞、弹簧或液压装置) 将液体药物直接注入皮肤浅层(图1C)。这种封闭式输注途径降低了药物暴露污染的风险, 有利于保护DNA疫苗、单克隆抗体等易降解生物制剂的活性, 且剂量控制精度达± 5% (0.1~100 μL), 明显优于传统注射器, 为胰岛素等需精准给药的疗法提供新方案。

这种方法克服了固体微针的剂量限制, 能够满足蛋白质、mRNA和抗体药物大剂量输送, 甚至可用于间质液(interstitial fluid, ISF) 原位提取与分析。有报道研究葡萄糖试纸上搭载纸基传感器, 中空微针作为导管, 在毛细管作用力下, 将ISF垂直引流至试纸上, 依据颜色变化读取血糖浓度。用户仅需手指按压即可完成穿刺-吸收-检测全流程, 适用于日常生活中的实时血糖监测^[38]。这种设计策略也可扩展至其他传感器或可穿戴传感设备上。更有研究通过模仿麦穗的孔道及互联管道, 制造出能实现正向给药和反向提取微量样液的双重功能多孔微针, 实现了给药和取样一体化的架构^[39]。

然而, 高黏度药液堵塞、内腔精密加工与工艺复杂, 以及外部压力装置的便携性问题仍需解决。NanoPass公司开发的MicronJet600, 将给药针孔移至针体侧面, 结合注射后撤回机制, 使堵塞率降低至5%以下^[40]。

1.4　刺穿和释放

“刺穿和释放”(poke and release) 递送机制是使用可生物降解的聚合物或糖类等生物相容性材料作为基质, 将药物直接包埋于针体中, 刺入皮肤后, 针尖接触组织间质液, 基质材料会溶解或降解, 同步释放包埋药物(图1D)。相较于最初的策略, 这种方法的改进是通过调控基质材料的溶解速率来控制药物释放。比如, 亲水性聚合物(如透明质酸) 通过缓慢溶解实现控释; 疏水性聚合物(如PLGA) 通过降解速率调控释放; 生物响应性材料可智能释放药物。由于材料具有生物可降解性, 针体在体内完全降解, 无需移除, 不产生锐器废弃物和感染风险, 如PLGA微针通过酶解代谢为无害产物CO₂和H₂O^[41]。然而, 该方法的应用受到皮肤湿度、材料特性矛盾及针体机械强度与药物活性矛盾等方面的限制。

对于可溶性微针机械强度低, 固体微针尖端残存皮肤等问题, 研究人员在机制基础上设计了可分离微针, 采用分层设计, 实现针尖-基座物理分离。比如治疗脱发时, 载有的谷氨酸微针针尖迅速从其基底分离并进入皮肤。滞留在皮下充当皮肤内的药物储存罐, 逐渐释放治疗药^[42]。表明这种微针能够以更低的剂量频率促进毛发再生。

1.5　刺穿-膨胀

作为“刺穿和贴敷”(poke and swell) 方法的替代方案, 研究人员主要开发了水凝胶微针, 其核心是利用吸水膨胀特性来实现药物递送和生物传感功能, 由交联网络结构和亲水基团的聚合物构成, 例如泊洛沙姆、含苯硼酸/丙烯酰胺的丝素蛋白等软性材料。在干燥状态下, 这些微针具备足够的机械强度穿透角质层, 一旦插入皮肤, 微针吸收组织间液, 其内部的亲水基团与水分子相互作用, 导致聚合物链之间的间距增大, 从而使微针发生溶胀, 逐渐形成多孔网络结构, 但不完全降解, 药物通过扩散作用持续释放数小时至数天(图1E)。

药物的释放速率通过调整聚合物的交联密度来控制, 交联密度越高, 药物释放速率越慢, 反之亦然^[43]。Zhao等^[44]通过将明胶与四臂PEG-SG交联, 构建了不同交联度的复合水凝胶微针, 证实了高交联密度延长降解时间, 达到72 h持续释放。

与其他方法相比, 水凝胶微针依从性更佳、载药量提高、药物扩散不易受压缩皮肤组织阻挡。但研究发现水凝胶微针存在机械强度不够、无法保持活性等缺点。因此, 研究人员在水凝胶微针的基础上, 添加适当比例的冷冻保护剂, 利用逐步低温成型工艺制备了冷冻微针。Zheng等^[45]构建了用于重建毛囊的冷冻微针, 其传递的嵌入类器官最终可以重建成熟毛囊, 并以仿生的形式突破皮肤表面, 从而维持头发再生的细胞活力。

在实际使用过程中, 该类型微针与皮肤组织的黏附性差, 在使用过程中易于脱落这一现象, Fu等^[46]受章鱼触手的启发, 设计一种带吸盘结构的黏附型微针, 牢固地吸附于肿瘤组织表面, 与传统微针相比较, 其剥离强度和黏附性能优异。

2　微针给药系统在多种疾病中的应用

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2.1　眼科疾病

常规的眼药水、眼膏等方式因操作简便、非侵入性而被经常使用, 但渗透效果较差, 需要多次给药。微针通过物理穿透角膜/巩膜屏障, 为青光眼、眼内炎症及新生血管性眼病提供了突破性解决方案。Kim等^[47]采用微针给药技术, 经巩膜输送两种抗青光眼药物来治疗青光眼, 结果证明, 与滴眼药水相比, 微针给药方式比滴眼药水效果突出, 且剂量显著降低。Roy等^[48]进一步验证了微针对眼部深层组织药物递送的优势。他们使用微针巩膜贴片递送曲安奈德, 应用5 min即可显著提升眼后段组织的药物浓度。

针对需长期治疗的眼后段疾病, Wu等^[49]设计的搭载PLGA纳米粒的双层可降解微针, 将纳米粒精准富集于尖端, 穿透巩膜后3 min内溶解, 并持续释放蛋白药物超过2个月, 突破了抗VEGF疗法需每月注射的难题。Kong等^[50]制备了新型负载纳米酶的冷冻微针, 它能够可控地递送纳米酶以治疗角膜炎, 纳米酶在酸性条件下催化H₂O₂产生羟基以杀灭细菌, 冷冻过程可以大大提高微针的机械强度。但目前大多数眼用微针研究正处在动物实验阶段, 没有经过确切的临床试验来验证, 尚需要进一步研究。

2.2　皮肤病

皮肤微针治疗是一种微创技术, 通过在表皮和真皮层制造可控的微损伤, 激活皮肤创伤修复级联反应(包括炎症期、增殖期、重塑期), 促进胶原蛋白、弹性蛋白合成及血管生成, 从而改善皮肤质地、疤痕和衰老问题^[51-53]。

2.2.1　抗衰老与皱纹改善

通过刺激胶原再生, 显著减少鱼尾纹、法令纹, 提升皮肤弹性。Shin等^[54]开发的双重抗皱微针贴片, 以透明质酸为骨架, 协同负载乙酰八肽-3、L-抗坏血酸2-葡萄糖苷及抗皱复合物构成, 能显著改善眼部皱纹深度、提升皮肤弹性及眼周紧致度(P < 0.05), 水分流失减少, 为美容行业提供新技术。Yang等^[55]开发一种可分离微针递送成纤维细胞生长因子或胶原蛋白, 专门针对紫外线导致的色斑、肤色不均等皮肤光老化损伤问题^[56]。这些研究利用微针将难以渗透的大分子或复合成分高效递送至真皮层, 超过传统涂抹式护肤品的功效。

2.2.2　疤痕修复与伤口愈合

微针递送生长因子(如表皮生长因子、成纤维细胞生长因子) 能够刺激细胞增殖分化, 加速疤痕修复进程。Yang等^[57]采用分层结构设计: 射干多糖作为基底负载云南白药的双功能微针贴片, 可在6 min内快速溶解释放止血成分; 同时尖端负载的生长因子缓慢释放, 用于后续长达7天的伤口修复, 这种先止血、后修复的设计, 正好符合伤口愈合的生理过程。

2.2.3　痤疮

寻常痤疮是一种由痤疮丙酸杆菌引起的普遍炎症性皮肤病, 通常用抗生素和乳膏治疗。为了提高这些传统药物的疗效和降低毒性, Xiang等^[58]提出了一种非抗生素的治疗策略, 合成了锌卟啉的金属有机框架和氧化锌的复合微针(图2)。该复合材料在超声波作用下能显著提高声催化性能, 迅速产生活性氧来杀灭痤疮丙酸杆菌, 抗菌效率达到99.73%, 并释放的锌离子调节金属硫蛋白(Mt 1、Mt 2) 和DNA复制相关基因, 维持细胞中的锌稳态并促进皮肤修复, 为痤疮治疗提供了一种高效新策略。需注意的是不同皮肤状态及患者个体差异可能影响治疗效果, 因此针对不同类型皮肤或病症的微针设计与应用需进一步深入探索。

2.2.4　生发

临床上常用的米诺地尔(minoxidil, MXD) 酊剂, 虽有一定的疗效, 但难以触达毛囊深处。Chen等^[59]提出一种结合载有MXD纳米结构脂质体(MCD-NLC-MN) 和低温大气等离子体的微针贴片多协同疗法, 高效递送MXD至毛囊深处, 促进毛囊周围血管舒张, 重塑毛囊微环境, 加速毛发生长。在一项纳入8项随机对照试验(472例AGA患者) 表明, 与单独使用5% MXD溶液相比, 微针联合MXD可显著提升毛发数量, 并且微针在深度 < 1 mm且治疗12周效果更优^[60]。

但该疗法没有在不同严重程度、不同类型脱发患者的适用性来作研究, 仍需更多临床研究验证, 未来可以将微针联合低能量激光、干细胞疗法或药物等生发手段, 为脱发治疗提供一种有效的新方法。

2.3　癌症

微针通过无创穿透角质层, 实现局部药物递送, 适用于浅表肿瘤(如黑色素瘤、乳腺癌) 的靶向治疗。

2.3.1　黑色素瘤

化疗仍然是大多数癌症患者的基础治疗方法, 其单一疗法常显不足, 这促使了化疗-光热疗法(photothermal therapy, PTT) 或化疗-光动力疗法(photodynamic therapy, PDT) 等协同疗法的发展。Dong等^[61]开发一种负载硝普钠和Fe²⁺的多功能微针, 可通过PTT-气体协同作用有效杀伤肿瘤细胞。Huang等^[62]开发一种pH响应性溶解微针, 在肿瘤酸性环境下降解, 633 nm光照激活偶联的原卟啉Ⅸ产生活性氧进行PDT, 化疗-PDT联合抑制黑色素瘤生长, 并将全身毒性降至最低。Wang等^[63]报道的可自降解透明质酸与pH敏感型右旋糖酐纳米颗粒整合, 并共载抗PD-1抗体和葡萄糖氧化酶, 制备出一种可自解离的微针贴片, 联合递送抗PD-1和抗CTLA-4显示出在B16-F10小鼠黑色素瘤模型中显著协同效应。这些研究表明, 微针通过局部联合用药克服单一疗法的局限性。

2.3.2　乳腺癌

雌激素受体阳性(ER⁺) 乳腺癌是临床中最常见的亚型, 约占所有乳腺癌病例的70%~80%。目前对于晚期或转移性ER⁺乳腺癌患者, 2021年ESMO指南推荐的一线治疗方案是内分泌治疗联合细胞周期蛋白依赖性激酶4/6抑制剂(CDK4/6), 但耐药与毒性问题突出^[64]。

新兴的蛋白降解靶向嵌合体(proteolysis-targeting chimera, PROTAC) 技术通过降解致癌靶蛋白, 展现出突破性潜力, 解决传统口服PROTAC存在溶解性差、靶向效率低、肝毒性显著及半衰期短等问题。Cheng等^[65]利用pH敏感胶束制备的可降解微针贴片, 同步装载PROTAC中分子ERD308和CDK4/6抑制剂Palbociclib。微针直接作用于肿瘤部位, 使药物滞留率达87.7%, 肿瘤缩小80%以上。值得注意的是, 这种局部给药方式有效规避口服PROTAC的肝毒性和全身性不良反应, 证明了微针贴片递送PROTAC治疗癌症的可行性, 为开发更有效、更安全的癌症疗法提供了新思路。

综上, 癌症微针疗法的关键在于“协同增效”。当前研究主要集中在动物模型, 未来挑战在于如何确保局部治疗能有效预防远处转移及能穿透更深组织的微针系统, 将是未来的重点研究方向。

2.4　自身免疫性疾病

类风湿性关节炎(rheumatoid arthritis, RA) 是一种全身性自身免疫性疾病, 表现为关节僵硬和肿胀, 其特征在于功能失调的抗瓜氨酸化蛋白抗体和类风湿因子^[66]。利用病毒载体递送促凋亡基因PUMA已被证实是治疗类风湿性关节炎的有效的凋亡疗法^[67]。研究报道了可溶解微针递送PUMA质粒, 有效缓解软骨损伤和骨侵蚀^[68]。Zheng等^[69]采用载有蜂毒的微针与黏性透皮贴片联合给药, 其协同效应显著增强了RA治疗效果。

2.5　心血管疾病

心血管疾病(cardiovascular disease, CVD) 的发病率和病死率均居全球前列, 每年导致约1980万人死亡, 占全球总死亡人数的31%。其中, 心肌梗死的死亡率最高, 心肌梗死后需要长期释放药物帮助心肌修复。Huang等^[70]研究开发了一种装载药物的可分离微针药物洗脱球囊。该团队首次在导管内轴植入近红外环形激光器, 在半年内持续释放紫杉醇, 有效预防晚期管腔再狭窄。为解决心肌梗死后的心肌修复问题, 负载姜黄素和SDF-1α的微针能够抑制炎症, 促进血管生成^[71]。而Tang等^[72]开发的聚乙烯醇微针心肌贴片通过促进干细胞分泌VEGF和IGF-1, 激活Akt通路, 改善LVEF和心脏功能。此外, Huang等^[73]还利用明胶甲基丙烯酰微针递送siRNA, 有效缓解心肌缺血再灌注损伤。表明不同材料与功能设计的微针贴片进一步丰富了CVD的治疗手段, 为未来临床应用提供了广阔前景。

2.6　慢性代谢病

糖尿病与肥胖等慢性代谢病, 常常因为传统给药效率低、控释差而疗效受限。治疗的重点不仅在于给药, 更在于监测、反馈与智能调控。微针技术通过可调释放、光控开关、实时监测响应等方面, 为临床治疗带来突破。

2.6.1　糖尿病

传统聚合物MNs载药能力低、药效作用时间短的问题, Liu等^[74]采用循环冻融技术开发了可调空腔体积的中空微针。在糖尿病大鼠模型中, 给药后14 h仍能产生显著降血糖效果, 且无低血糖风险, 证明高剂量药物长效降糖的潜力。

Dai等^[75]为解决传统胰岛素生物利用度低和控释能力不足的问题, 用近红外光来控制胰岛素的“开关”控制, 以热敏微凝胶复合材料制备的可溶性微针。体内、外实验均证实单贴片经两次短暂照射即可维持糖尿病大鼠正常血糖水平超过6 h, 为构建基于连续血糖监测的闭环、按需胰岛素输送系统提供了重要技术基础。

智能技术在医疗辅助的应用日益广泛, 智能手表等物联网传感器能够实时监测血糖、心率及体温等数据, 经AI分析生命体征。如果检测到异常, 自动调整胰岛素剂量^[76]。Huang等^[77]开发一种集成电子/流体微针贴片, 结合嵌入式电路与手机APP, 实现实时血糖监测、预警及智能给药, 动物实验显示连续3天监测精度误差 < 18%, 推动了血糖管理的实时性、智能化和个性化, 为人工胰腺的临床转化奠定技术基础。

已完成的临床试验(NCT02682056), 评估生物相容性聚合物/金属微针贴片在15例7~18岁糖尿病儿童(平均年龄16.8岁) 中的血糖监测效率^[78]。4 h同步采样对比发现, 微针贴片疼痛评分为11.2, 显著低于静脉导管(26.8) 但高于采血针(4.4), 同时参与者在整个研究期间未观察到任何不良反应, 结果表明微针贴片可实现无创、连续血糖监测, 其准确性与传统方法相当, 疼痛及心理负担显著低于静脉穿刺, 更适用于儿童长期血糖管理。

2.6.2　肥胖

在肥胖治疗中, 微针主要是通过局部给药, 诱导白色脂肪“棕色化”, 从而促进能量消耗。研究人员分别利用微针将罗格列酮或琥珀酸递送至皮下脂肪组织, 成功诱导白色脂肪细胞向产热的棕色/米色脂肪细胞转化, 在降低肥胖小鼠体重的同时, 有效规避了口服给药可能带来的全身性不良反应^{[79, 80]}。

从动物模型到初步临床验证, 其在糖尿病和肥胖管理中的安全性与有效性已得到初步证实。但在长期安全性及规模化生产方面仍存挑战, 需要更多的临床试验来验证, 加速技术革新与推广应用。

3　总结与展望

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微针经皮给药技术正逐步从单一递送工具过渡到诊疗一体化的智能平台, 具有无痛微创、规避首过效应和精准局部给药的优势, 突破皮肤屏障限制, 展现巨大的发展潜力。本文阐释了递送机制、优势与局限, 并综述在六大领域的前沿进展, 展现其精准、高效的临床价值。

然而, 在临床转化时仍有许多限制因素: ①皮肤/眼部结构、厚度的个体差异, 可能导致微针穿刺深度与药物递送效率的波动。②大规模生产的一致性与成本控制: 聚合物浇筑时物料黏度波动, 使微针密度不均、针尖缺损等; 自动化检测对细微缺陷识别率不足; 高精度生产设备投入高; 医用级聚合物原材料成本高。③长期及反复应用可能引发的慢性炎症、皮肤屏障损伤及材料降解产物的体内行为等安全性问题及缺少统一的质量标准。

基于当前研究现状, 未来突破方向应着重关注: ①开发出能够根据组织微环境自适应调节长度、形态与力学性能的“智能微针”; ②开发更耐用的模具材料、基于机器视觉、光谱分析等技术快速质检方法; ③设计严谨、大样本、长周期的前瞻性临床试验, 并建立一套涵盖材料、性能、功效与安全性的国际标准化评价体系。最终, 通过工艺优化、智能设计、临床验证与标准共建的多路径协同, 使微针实现真正意义上的临床转化与产业升级。

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2026年第61卷第7期

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doi: 10.16438/j.0513-4870.2025-0950

接收时间：2025-08-14
首发时间：2026-09-21
出版时间：2026-07-12

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收稿日期：2025-08-14
修回日期：2026-01-07

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¹安徽中医药大学药学院, 安徽合肥 230012

²安徽中医药大学新安医学与中医药现代化研究所, 安徽合肥 230012

³安徽中医药大学安徽省现代中药产业共性技术研究中心, 安徽合肥 230012

⁴省部共建安徽道地中药材品质提升协同创新中心, 安徽合肥 230012

⁵药物制剂技术与应用安徽省重点实验室, 安徽合肥 230012

⁶安徽省活性天然产物重点实验室, 安徽合肥 230012

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刘欢欢, Tel: 18326612112, E-mail: huanhuanliu2016@ahtcm.edu.cn

彭灿, Tel: 86-551-68129155, E-mail: pengcanking@hotmail.com

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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Delivery approach	Material	Manufacturing method	Application	Advantage	Disadvantage	Ref.
"Poke and patch"	Silicon, stainless steel, acrylic	Micro-molding, lithography, etching, laser engraving, micro-milling, 3D printing	Skin pre-treatment	High mechanical, mature preparation technology, sustained drug delivery capability	Two application process, pores of the skin close quickly, no accurate dosing, sharp waste disposal	[10, 11]
"Coat and poke"	Stainless steel, titanium, polymer	Dip-coating, gas-jet drying, spray coating, electro-hydrodynamic atomization, piezoelectric inkjet printing	Influenza vaccine, biosensing applications, protein delivery	Rapid drug release, high mechanical strength, precise dosing, enhanced drug stability, no cold chain required, no risk reuse	Low drug loading capacity, single-use only, limited material compatibility, infection risk	[12-16]
"Poke and flow"	Silicon, metal, glass, ceramic, polymers	Laser-cutting method, 3D printing, stereo lithography, blowing air, drawing lithography	Drug delivery, mRNA delivery, cell therapy, glucose monitoring	Delivering high-dose drugs, controllable delivery rate, mechanically robust	Risk of clogging, complex two-component device, cold-chain storage and transportation	[17-21]
"Poke and release"	PVP, PVA, PLGA	Casting, drawing lithography, droplet-born air blowing, centrifugal lithography, 3D printing	Skin disease, chronic pain, lidocaine, vaccine	Controllable drug release, high biocompatibility, high drug loading, no sharp waste, no requirement for cold-chain storage	Poor mechanical strength, temporary foreign body reaction, drugs affect needle strength	[22-24]
"Poke and swell"	Chitosan, PVA, PLGA	Micro-molding, casting, electrospinning, 3D printing	Anti-scarring, drug delivery, sampling and sensing	No residual in skin, potential for sustained or controlled release, high drug loading capacity, biocompatible materials used	Limited range of swelling materials	[25-29]

Delivery approach

Material

Manufacturing method

Application

Advantage

Disadvantage

Ref.

"Poke and patch"

Silicon, stainless steel, acrylic

Micro-molding, lithography, etching, laser engraving, micro-milling, 3D printing

Skin pre-treatment

High mechanical, mature preparation technology, sustained drug delivery capability

Two application process, pores of the skin close quickly, no accurate dosing, sharp waste disposal

[10, 11]

"Coat and poke"

Stainless steel, titanium, polymer

Dip-coating, gas-jet drying, spray coating, electro-hydrodynamic atomization, piezoelectric inkjet printing

Influenza vaccine, biosensing applications, protein delivery

Rapid drug release, high mechanical strength, precise dosing, enhanced drug stability, no cold chain required, no risk reuse

Low drug loading capacity, single-use only, limited material compatibility, infection risk

[12-16]

"Poke and flow"

Silicon, metal, glass, ceramic, polymers

Laser-cutting method, 3D printing, stereo lithography, blowing air, drawing lithography

Drug delivery, mRNA delivery, cell therapy, glucose monitoring

Delivering high-dose drugs, controllable delivery rate, mechanically robust

Risk of clogging, complex two-component device, cold-chain storage and transportation

[17-21]

"Poke and release"

PVP, PVA, PLGA

Casting, drawing lithography, droplet-born air blowing, centrifugal lithography, 3D printing

Skin disease, chronic pain, lidocaine, vaccine

Controllable drug release, high biocompatibility, high drug loading, no sharp waste, no requirement for cold-chain storage

Poor mechanical strength, temporary foreign body reaction, drugs affect needle strength

[22-24]

"Poke and swell"

Chitosan, PVA, PLGA

Micro-molding, casting, electrospinning, 3D printing

Anti-scarring, drug delivery, sampling and sensing

No residual in skin, potential for sustained or controlled release, high drug loading capacity, biocompatible materials used

Limited range of swelling materials

[25-29]