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中国精品科技期刊2020
冷京京,涂伟,赵璠,等. 马鹿骨胶囊增加骨密度性能及安全性评价[J]. 食品工业科技,2023,44(21):379−385. doi: 10.13386/j.issn1002-0306.2022110137.
引用本文: 冷京京,涂伟,赵璠,等. 马鹿骨胶囊增加骨密度性能及安全性评价[J]. 食品工业科技,2023,44(21):379−385. doi: 10.13386/j.issn1002-0306.2022110137.
LENG Jingjing, TU Wei, ZHAO Fan, et al. Bone Density Improvement Function and Safety Evaluation of the Malugu Capsule[J]. Science and Technology of Food Industry, 2023, 44(21): 379−385. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2022110137.
Citation: LENG Jingjing, TU Wei, ZHAO Fan, et al. Bone Density Improvement Function and Safety Evaluation of the Malugu Capsule[J]. Science and Technology of Food Industry, 2023, 44(21): 379−385. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2022110137.

马鹿骨胶囊增加骨密度性能及安全性评价

Bone Density Improvement Function and Safety Evaluation of the Malugu Capsule

  • 摘要: 为了测定马鹿骨胶囊增加骨密度的性能及其安全性,本试验将大鼠分为假手术组、模型对照组(卵巢切除模型)、高剂量碳酸钙组以及马鹿骨胶囊不同剂量的三个组(200、400和1200 mg/kg·bw)连续灌胃90 d,试验后测定大鼠左股骨骨密度和右股骨骨钙含量,以评价马鹿骨胶囊增加骨密度的性能。其次,以15 g/kg·bw剂量的马鹿骨胶囊进行大鼠急性毒性试验,并开展遗传毒性试验和大鼠4周喂养试验以测定马鹿骨胶囊的安全性。试验结果显示,马鹿骨胶囊三个剂量组的体重与模型对照组无显著性差异(P>0.05)。马鹿骨胶囊三个剂量组的左股骨骨密度分别为0.6651、0.6560、0.6605 g/cm3,显著高于模型对照组0.6307 g/cm3P<0.05)。安全性评价结果表明,马鹿骨胶囊对大鼠的急性经口MTD大于15 g/kg·bw,判定为无毒级别。遗传毒性试验均为阴性结果。大鼠4周喂养试验中,健康状况、生化和血液学指标及器官组织形态均未见异常变化。综上所述,马鹿骨胶囊具有增加骨密度的功能且安全性良好。

     

    Abstract: 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.

     

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