Abstract:Objective: To establish a mice model of mammary gland hyperplasia, to observe the effects of Ruluotong on estradiol (E2), progesterone (P), visceral index,and pathologic changes of breast tissue in mammary gland of the model mice, and to study the mechanism of the actions. Method: Female mice were divided into blank control group,model control group,Ruluotong capsules high, midlle and low doses group (0.6,0.3,0.15 g·kg-1),Rukang tables group(0.53 g·kg-1). Model of mammary glands hyperplasia in mice was established by taking estradiol benzoate and progesterone. The treatment groups were given with different doses of Ruluotong capsules and Rukang pills for thirty days. The contents of E2, P of serum and visceral index were determined,pathologic changes of breast tissue were observed. Result: Ruluotong high,medlle and low doses could significantly decrease E2 level(P<0.01) of model serum and increase the P content of serum(P<0.05). Thymus index in the high dose group was markedly(P<0.01)and womb index was significantly increased(P<0.01). Pathomorphological investigation showed three doses of Ruluotong could significantly reduce lobular breast density and alveolar surface area(P<0.01),and increase lobular interstitial density(P<0.01). Pathological changes were mitigated by the capsules,with inhibition of mammary lobular hyperplasia,showing shrink in lobular size,narrowed acinar and duct. Conclusion: Ruluotong capsules can improve the pathological changes of the mammary gland hyperplasia by regulating proliferation of breast estrogen levels in mice to inhibit mammary gland hyperplasia of mice induced by estrogen effectively.