鹿骨瓜子肽胶囊促进骨细胞增殖及其毒理稳定性研究

Effect of Deer bone and Seeds peptide capsule on osteoblasts proliferation,toxicology and stability

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 effect of Deer bone and Seeds peptide （DBS） capsule.Methods：In vitro anti-osteoporosis effect was evaluated by MTT reduction assay,and by detection of alkaline phosphatase （ALK） and mineralized nodes in osteoblasts from SD rats.The accelerated stability tests included determinations of appearance,microorganisms,heavy metals,disintegration time,and the contents of water,ash and DBS.Results：DBS capsule enhanced cell proliferation,ALK activity and the number of mineralized nodes in rat osteoblasts.Toxicological assessments showed that DBS capsule was completely not poisonous and had no potential of mutagenesis.The content of peptide was ≥8.0 g per 100 g in the capsule.The capsules＇ shelf life reached 24 months.All the indexes were conformed to match GB and the corporation quality standards,including those in microorganisms,heavy metals,disintegration,moisture barrier and ash.Conclusion：DBS capsule is an effective and safe product with controllable quality for enhancing bone mineral density,prevention and control of osteoporosis in middle-aged and senile people.