This invention discloses an 8–18 nm covalently bonded pH-responsive
biomass active pharmaceutical ingredient (API), its preparation method, and its applications. The API has a three-layer covalently bonded core-shell structure, is free of free small molecules, and exhibits excellent
structural stability. It is prepared from bamboo-derived
biomass raw materials such as modified
bile acid-bamboo
flavonoid cocrystal complex, modified bamboo polysaccharides, and
galactose oligosaccharides. The product has a particle size of 8–18 nm, a PDI < 0.21, a
Zeta potential of -8.0 to -11.0 mV, and possesses pH-targeted
drug release characteristics within the renal
lesion microenvironment. Under normal physiological conditions, the
drug leakage rate is less than 3.2%, and the
in vivo biodegradation rate exceeds 99.1% within 72 hours. It exhibits no tissue accumulation and high safety. This invention targets the common
pathological features of renal
oxidative stress, chronic
inflammation, and
immune dysregulation in viral renal failure and renal
cancer, exerting therapeutic effects through
antioxidant, anti-inflammatory, renal tubular barrier repair, and
immune regulation mechanisms. This invention employs a room-temperature pure aqueous
phase reaction combined with a two-stage
ultrafiltration process, ensuring mild conditions, batch stability, and suitability for industrial
mass production.