用于刺激响应性和持续控制释放活性药物成分的纳米颗粒与水凝胶载体
Nanoparticulate and Hydrogel Vehicles for Stimuli-Responsive and Sustained Controlled Release of Active Pharmaceutical Ingredients
许多药物靠全身被动分布到达病灶，剂量受健康组织耐受度限制，导致血药浓度在毒性高峰和无效低谷间波动。本综述聚焦纳米颗粒载体（脂质体、脂质纳米颗粒、聚合物、无机和仿生载体）与水凝胶（天然、合成、超分子及微凝胶组装）以及二者结合形成的杂化结构，后者由凝胶提供局部滞留、纳米颗粒提供载荷保护和胞内递送。文章按“疾病线索、传感化学、载体结构、释放机制与动力学、给药途径、临床成熟度”这一链条组织文献（重点2022–2026年），指出决定释放行为的并非载体化学本身，而是被释放物种的身份及限速转运步骤。文中还讨论了CMC复杂性、监管碎片化、抗PEG免疫原性和临床前与临床疗效不匹配等转化障碍。
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摘要Abstract
Most active pharmaceutical ingredients (APIs) reach their target by passive systemic distribution, so the dose required for efficacy at the lesion is set by what healthy tissue can tolerate; conventional dosage forms consequently produce pharmacokinetic profiles that oscillate between toxic peaks and sub-therapeutic troughs. Nanoparticulate carriers (liposomes, lipid nanoparticles, polymeric and inorganic systems, and biomimetic carriers) and hydrogels (natural, synthetic, supramolecular, and microgel-assembled) have emerged as the dominant strategies to address this, increasingly combined as hybrid nanoparticle-hydrogel constructs in which the gel provides locoregional retention and the nanoparticles provide cargo protection, intracellular delivery and stimuli responsiveness. Stimuli-responsive chemistries (pH, redox, enzyme, ROS, hypoxia, temperature, light, magnetic, ultrasound, glucose, and multi-stimuli logic) translate the molecular signatures of a disease into spatiotemporally controlled cargo release. This narrative review consolidates the state of the art (prioritizing 2022-2026) and departs from the conventional carrier-type survey in one respect: the literature is read along an explicit chain-disease cue, sensing chemistry, carrier architecture, release mechanism and kinetics, administration route, and clinical readiness-which exposes a variable that classification by carrier type conceals. Across all three material classes, what governs release behavior is not primarily the carrier chemistry but the identity of the released species (dissolved drug, drug from an embedded nanoparticle, an intact nanoparticle, and a matrix fragment) and the transport step that limits it. This is why power-law exponent analysis developed for dissolved drug fits particulate release poorly, why statistical goodness-of-fit cannot by itself establish a release mechanism, and why carrier class predicts clinical readiness less well than administration route and regulatory product type. Translational hurdles-CMC complexity, regulatory fragmentation, anti-PEG immunogenicity, and the structural mismatch between preclinical promise and clinical efficacy-are critically appraised in light of previously reported <1% delivery efficiency analysis. This review identifies converging strategies that could move stimuli-responsive controlled release from an aspirational outcome to a routine clinical reality.