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目的:综合评价抗骨质疏松产品——鹿骨瓜子肽胶囊。方法:抗骨质疏松实验采用新生SD大鼠成骨细胞体外培养法,测定MTT,ALK和矿化骨结节;安全性毒理学评价采用急性毒性、微核实验、精子畸变,Ames实验以及30d喂养实验;进行稳定性加速实验,观察感官、微生物、重金属、崩解时限、水分、灰分以及鹿骨瓜子肽含量。结果:鹿骨瓜子肽对新生SD大鼠成骨细胞有明显增殖作用,ALK活性增强、矿化骨结节数量增多;鹿骨瓜子肽胶囊无毒、无诱变、无致突变;每100g含多肽≥8.0g,保质期为24个月,微生物、重金属、崩解时限、水分、灰分均符合国家标准和企业质量标准。结论:鹿骨瓜子肽胶囊是一种安全、有效,质量可控,增加骨密度、防治中老年人骨质疏松症的健康产品。
Objective: To evaluate the anti-osteoporosis product - deer bone melon capsule. Methods: anti-osteoporosis experiment using newborn SD rat osteoblast cultured in vitro, MTT, ALK and mineralized bone nodules; safety toxicology evaluation using acute toxicity, micronucleus test, sperm test, Ames test and 30d Feeding experiments; Stabilization accelerated experiments were conducted to observe the sensory, microbial, heavy metals, disintegration time, moisture, ash and deer bone melon seeds content. Results: The deer bone melon peptide had obvious proliferation effect on newborn SD rat osteoblasts, ALK activity increased, the number of mineralized bone nodules increased; deer bone melon seeds capsule non-toxic, no mutation, no mutation; per 100g containing peptide ≥ 8.0g, shelf life of 24 months, microorganisms, heavy metals, disintegration time, moisture, ash are in line with national standards and enterprise quality standards. Conclusion: The deer bone melon seed capsule is a safe, effective, quality control, increase bone mineral density, prevention and treatment of osteoporosis in the elderly health products.