Abstract:The Chinese herb, Gu‐Sui‐Bu (GSB) (Drynaria fortunei J. Sm.) has been anecdotally reported to enhance bone healing. We had previously confirmed in vitro the efficacy and safety of GSB in bone healing, and showed that it influenced both osteoblast and osteoclast activity. For clinically useful application of these bone regenerative effects, a satisfactory delivery system for GSB is required. In this study, we determined the optimal concentration of GSB for regenerative activity in rat bone cells via MTT, alkaline phosphatase (ALP), nodule formation and TRAP assays, and designed and tested a GSB‐rich bone composite material. The composite was fabricated by mixing a biodegradable GGT composite, containing genipin cross‐linked gelatin and tricalcium phosphate, with the predetermined concentration of GSB (GGT‐GSB). Neonatal rat calvarial culture and animal implantation were employed to evaluate and compare in vitro and in vivo the potential of GGT‐GSB and GGT in regeneration of defective bone tissue. The most effective concentration of GSB was 100 μg/mL, which significantly increased osteoblast numbers, intracellular ALP levels and nodule numbers, without influencing osteoclast activity. In vitro and in vivo tests also showed that GGT‐GSB accelerated bone regeneration compared to GGT. GGT‐GSB thus has great potential for improved bone repair. © 2007 Wiley Periodicals, Inc. J Biomed Mater Res, 2008