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作 者:范文彤 FAN Wentong(Quality Assurance Department,Tianjin Biochem Pharmaceutical Co.,Ltd.,Tianjin 300308,China)
机构地区:[1]天津生物化学制药有限公司品质部,天津300308
出 处:《中国医药科学》2020年第23期77-82,共6页China Medicine And Pharmacy
摘 要:目的通过对小鼠及大鼠进行急性毒性试验考察,得出小鼠及大鼠的最大耐受剂量,以期为临床药理学及临床安全用药提供试验数据支持与参考。方法小鼠在禁食后,灌胃3次,每次灌胃给药最大体积、最大浓度的海藻多糖,观察给药后小鼠行为活动及中毒症状、体重增长情况;大鼠在禁食后,灌胃3次,每次灌胃给药最大体积、最大浓度的海藻多糖,观察给药后大鼠中毒症状及有无死亡现象发生情况,据此测定各自的半数致死量(LD50)与最大耐受剂量。结果海藻多糖对小鼠及大鼠的LD50考察试验表明,半数致死量未能检测出,海藻多糖对小鼠及大鼠的最大耐受量考察试验表明,小鼠的最大耐受剂量应为6.0g/kg,相当于临床拟推荐剂量1.2g/(60kg·d)的300倍;大鼠的最大耐受剂量应为3.0g/kg,相当于临床剂量1.2g/(60kg·d)的150倍。结论海藻多糖在规定的安全剂量下服用,副作用较小,毒性较低。Objective Through an investigation of acute toxicity test of mice and rats, the maximum tolerance doses of mice and rats were obtained, so as to provide experimental data support and reference for clinical pharmacology and clinical safe medication. Methods After fasting, the mice were administered the maximum volume and concentration of algal polysaccharide by gavage for three times, and the behavior, toxic symptoms and weight gain of the mice after administration were observed. After fasting, the rats were administered the maximum volume and concentration of algal polysaccharide by gavage for three times, and the toxic symptoms and the occurrence of death among the rats after administration were observed. On these grounds, the respective 50% lethal dose(LD50) and maximum tolerance dose were determined. Results The LD50 investigation test of algal polysaccharide on mice and rats showed that the LD50 could not be detected, and the maximum tolerance investigation test of algal polysaccharide on mice and rats showed that the maximum tolerance dose of mice should be 6.0 g/kg, which is 300 times of the clinically recommended dose 1.2 g/(60 kg·d), while the maximum tolerance dose of rats should be 3.0 g/kg, which is 150 times of the clinical dose 1.2 g/(60 kg·d). Conclusion Algal polysaccharide has less side effect and lower toxicity when taken at the prescribed safe dose.
关 键 词:海藻多糖 急性毒性试验 半数致死量(LD50) 最大耐受量 推荐剂量 临床剂量
分 类 号:R273[医药卫生—中西医结合]
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