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健骨软胶囊毒理学安全性评价
引用本文:游剑,龚建平,范玫玫,简晖,侯莉,魏惠珍,饶小勇. 健骨软胶囊毒理学安全性评价[J]. 江西中医学院学报, 2010, 22(3): 51-53
作者姓名:游剑  龚建平  范玫玫  简晖  侯莉  魏惠珍  饶小勇
作者单位:中药固体制剂制造技术国家工程研究中心,南昌,330006
基金项目:2009年江西省火炬计划项目 
摘    要:目的:对健骨软胶囊的食用安全性进行食品毒理学安全性评价和研究。方法:进行小鼠经口急性毒性试验、Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验。结果:健骨软胶囊小鼠经口MTD(25g/kg,属无毒级;Ames试验、骨髓微核试验及小鼠精子畸形试验表明该样品无致突变作用,对雄性生殖细胞无遗传毒性。结论:健骨软胶囊属无毒级物质,对体细胞无致诱变及突变作用。

关 键 词:健骨软胶囊  毒理学安全性  评价

Toxicology and Safety Assessment of Jiangu soft gelatin capsule
Affiliation:YOU Jian,GONG Jian-ping,FAN Mei-mei,et al. (National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine,Nanchang 330006)
Abstract:Objective:To evaluate and study the toxicological safety of Jiangu soft gelatin capsule. Methods:Acute toxicity test,Ames test,bone marrow micronucleus test,sperm malformation test were conducted. Results:Jiangu soft gelatin capsule with the dose of MTD﹥25 g/kg showed to be non-toxic on the mice. Ames test and bone marrow micronucleus test and sperm malformation test showed Jiangu soft gelatin capsule was safe without mutagenesis. No toxicity was observed in sperm shape abnormality test in mice. Conclusion:Jiangu soft gelatin capsule is a non-toxic and non-mutating drug for the body cell.
Keywords:Jiangu soft gelatin capsule  Toxicology and safety  Assessment
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