Bone Density Improvement Function and Safety Evaluation of the Malugu Capsule

In order to evaluate the bone density improvement function and safety of the Malugu capsule, rats were divided into sham surgery group, model control group (oophorectomy model), high-dose calcium carbonate group (positive control), and groups with different doses of Malugu capsule (200, 400 and 1200 mg/kg·bw) by 90 days of gavage administration. The bone mineral density of the left femur and the calcium content of the right femur was measured to evaluate the performance of the Malugu capsule in increasing bone density. The acute toxicity test of the Malugu capsule at the dose of 15 g/kg·bw was carried out. Moreover, the genotoxicity test and 4-week feeding test of rats were also performed to evaluate the safety of the Malugu capsule. The results showed that there was no significant difference in body weight of rats among the groups of Malugu capsule treatment compared with the model control group (P>0.05). The bone mineral density of the left femur in the three doses of Malugu capsule groups were 0.6651, 0.6560 and 0.6605 g/cm³, respectively, which was significantly higher than that of 0.6307 g/cm³ (P<0.05) in the model control group. The safety evaluation results showed that the acute oral MTD of the Malugu capsule for rats was higher than 15 g/kg·bw, which could be classified as non-toxic. Moreover, the result of the genotoxicity test of the Malugu capsule was negative. Finally, no abnormal changes in health status, biochemical, hematological indicators, and organ tissue morphology of rats were observed in the 4-week feeding tests. In conclusion, the Malugu capsule has the function of increasing bone mineral density without safety issues.