直服颗粒是一种新型口服固体制剂，通过特殊制粒与包衣技术实现无水吞服，在改善用药依从性与提升剂量灵活性方面具有显著优势。该制剂的味觉掩蔽技术不仅能有效掩盖药物的不良味道，还可优化崩解与释药行为，进而实现口腔内迅速分散与顺滑吞咽，适用人群广泛。系统归纳直服颗粒的剂型特性、关键制备技术（包括湿法制粒、喷雾干燥、流化床包衣及双通道灌装等）、掩味策略（物理、化学及生物方法）以及药学与质量研究现状，并结合国内外已上市品种与在研案例，分析该制剂的技术优势与面临的挑战，提出药学研究与质量控制要点。目前制剂稳定性、规模化生产等方面的挑战，有望通过新型辅料的开发、连续生产技术的应用及质控方法的进一步完善得到解决，从而推动直服颗粒实现更广泛的应用。

Direct oral grunales are a novel oral solid dosage form that enables waterless ingestion through specialized granulation and coating technologies, offering significant advantages in improving medication adherence and enhancing dosage flexibility. The formulation's taste-masking technologies not only effectively mask the unpleasant flavors of drugs but also optimize disintegration and drug release profiles, thereby facilitating rapid dispersion in the oral cavity and smooth swallowing. Suitable for a wide range of people. This paper systematically reviews the formulation characteristics, key preparation technologies (including wet granulation, spray drying, fluidized bed coating, and dual-channel filling), taste-masking strategies (physical, chemical, and biological approaches), as well as the current status of pharmaceutical and quality research on direct-swallow granules. By examining marketed products and development candidates worldwide, it analyzes the technical advantages and challenges associated with this dosage form and propose key points for pharmaceutical research and quality control. Current challenges in areas such as formulation stability and large-scale production are expected to be addressed through the development of novel excipients, the application of continuous manufacturing technologies, and further refinement of quality control methodologies—thus promoting the broader adoption of direct-swallow granules.

R944

国家局药品监管科学体系建设重点项目（RS2024H001）