| Objective:To observe the treatment effects and safety of Tibetan Bone Capsule applied to treat osteoporosis and fracture.Methods:①According to the effects and main functions of Tibetan Bone Capsule and in accordance with the request of the new Chinese guide principles for the pharmacological and toxicological research,with a customized instrument,amodel of closed femur fracture was built to judge the extent of the bone healing through two indicators,the healing time and thick of callus slice in fracture location.②Analyzing the Capsule's functions of blood-activating and stasis-dissolving with hemorheological methods.③Observing the drug's efficacy of relieving pains induced by body-writhing method and hot plate method.④Evaluating the drug's anti-inflammatory effect by its influence on histamine-induced capillary permeability in the skin of mice and carrageenan-induced mice foot swelling.⑤Reflecting the drug's efficacy on preventing osteoporosis by the changes in bone mineral density and blood calcium(Ca),serum alkaline phosphatase(AKP)and other constituents.⑥Measuring the drug's safety by acute toxic experiments and long term toxic experiments.Results:①Tibetan Bone Capsule can improve the formation of the little bone beam and callus density in callus slice histomorphometry.②The drug can increase the pain threshold caused by the hotplate method and can reduce the number of reactive mice which gain pain from acid injury and body writhing. The drug has remarkably analgesic effect and can increase the rate of analgesia.③The capsule can significantly improve all the hemorheological indicators of the acute blood stasis model caused by cold adrenergic stimulation to the adult mice, suggesting that the capsule plays a good role in activating blood and dissolving blood stasis.④After Evans blue saline solution being administered through tail vein,the capsule can increase the mice's peritoneal dye infiltration and can inhibit carrageenan-induced foot swelling of the adult mice, suggesting it has significant anti-inflammatory effects.⑤The drug can increase(70mg/kg.d) femur bone density of the adult mice osteoporosis model induced by acetic acid,and it can increase serum calcium(Ca) levels and lower serum alkaline phosphatase(AKP) of the mice model,suggesting the drug plays a role in anti-osteoporosis.⑥Acute toxicity test with the animal cannot detect LD50.In the drug test,obvious acute toxic response could not be found after the highest oral dose 1400 times higher than that of the clinical using.Long-term experiments showed that being continuously oral using for six months among the adult mice,no obvious toxic case had been found.Conclusion:Tibetan Bone Capsule can improve the healing quality of fracture and at the same time play a important role in anti-osteoporosis.Its therapeutic dose is safe and efficacious.
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