Objective: To investigate the therapeutic efficacy of Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma on nude mice with bone metastasis of breast cancer and its mechanism. Method: Nude mice were randomly divided into normal group

model group

zoledronate group and Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma group. Except for normal group

MDA-MB-231BO cells were injected into the left ventricle to create the model of bone metastasis of breast cancer. Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma group nude mice were orally administered with Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma. Normal group

model group and zoledronate group nude mice were orally administered with physiological saline

and zoledronate was injected into the abdominal cavity in zoledronate group. The degree of bone metastases was evaluated. Bone mineral density (BMD)

bone volume (BV)

range of interests (ROI) and total volume (TV) were evaluated by micro-CT. Osteoclasts in bone metastasis were evaluated by tartrate resistant acid phosphatase dye (TRAP). Transforming growth factor-β1(TGF-β1)

drosophila mothers against decapentaplegic protein 3 (Smad3)

Smad4

Glioma-associated oncogene homologue 2 (Gli2) and Parathyroid hormone-related protein (PTHrP) in bone metastasis tissues were evaluated by Western blot. Result: The degree of bone metastases

BMD and BV/TV in Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma group were higher than those of model group (P<0.01). The number of TRAP (+) cells in Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma group was lower than that of model group (P<0.01). The expression of TGF-β1

Smad3

Gli2 and PHTrP protein expressions of bone metastases tissues in Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma group were lower than those of model group (P<0.01)

and the expression of Smad4 in Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma group was higher than that of model group (P<0.05). Conclusion: Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma has a therapeutic effect on soluble osseous injury in nude mice with bone metastasis of breast cancer

and the mechanisms of action may be that Aconiti Lateralis Radix Praeparata-Atractylodis Macrocephalae Rhizoma could up-regulate Smad4

down-regulate TGF-β1

Smad3

Gli2 and PTHrP

and regulate TGF-β1/Smads/Gli2/PTHrP signaling pathway.