As the dominant oral solid dosage form,tablets are facing core demands for consistent quality and high production efficiency in the era of Pharmaceutical Industry 4.0. Against the backdrop of continuous advancement of generic drug consistency evaluation and transformation toward intelligent manufacturing,the deep integration of Quality by Design (QbD) and Process Analytical Technology (PAT) is promoting a paradigm shift in tablet quality control from traditional end-product testing to full-chain real-time predictive control. This paper systematically reviews key technological advances across the whole tablet production chain driven by the integration of QbD and PAT,including intelligent responsive excipients and molecular simulation-assisted formulation design,continuous granulation-drying integrated systems with multi-scale online monitoring,microstructure regulation and AI-driven optimization of tableting processes,and intelligent monitoring systems for nano-coating materials. The principles,current applications,and bottlenecks of key technologies in each segment are analyzed. Challenges such as multi-modal data fusion,digital twin model verification,and economic viability of green processes are discussed. Future development directions,including blockchain traceability,biomimetic coating materials,self-learning digital twins and carbon-neutral manufacturing,are further prospected. This review holds that constructing a closed-loop intelligent manufacturing system integrating tablet design,monitoring and optimization is not merely technical integration,but a paradigm shift in pharmaceutical philosophy from compliance by testing to.
| 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 |