摘要
目的 评价骨碎补总黄酮的安全性 ,给临床实验提供依据 ,从而保证临床用药安全。方法 ①小鼠灌胃最大耐受量测定 :2 0只NIH小鼠给予 0 40 g·mL 1骨碎补总黄酮溶液 3 0mL·kg 1,分 2次 (8∶3 0 ,16∶3 0 )灌胃给药 ,观察其饮食、活动、精神状态、皮毛肤色、大小便及体重变化。②大鼠灌胃最大耐受量测定 :2 0只Wistar大鼠灌胃给予 0 40g·mL 1骨碎补总黄酮溶液 3 0mL·kg 1,分 2次 (8∶3 0 ,16∶3 0 )给药 ,观察其饮食、活动、精神状态、皮毛肤色、体重、摄食量变化及大小便。③小鼠腹腔注射给药急性毒性实验 (LD50 ) :设置 7个浓度的药液进行腹腔注射 ,一次给药后观察 7d。结果 小鼠、大鼠灌胃给药后 ,其饮食、活动、精神状态等体征均无异常变化 ,体重变化在正常范围内 (P >0 0 5 )。小鼠急性毒性实验 ,尸检可见动物腹腔内有少量残留药液 ,重要脏器未见明显病理变化 ,总黄酮LD50 =5 99g·kg 1。结论 骨碎补总黄酮急性毒性实验未显示毒性作用 ,预期临床应用安全性良好。
Objective To provide evidence for clinical trial and to evaluate the safety of total flavonoids from rhizome of drynariae. Methods The maximum tolerance of gastrogavage in mice: twenty mice were fed 30 mL·kg -1 with the total flavonoids solution (0.40 g·mL -1) by gastrogavage, the bite and sup, activity, psychosis, coat and skin, urine and faeces, and body weight were observed.The maximum tolerance of gastrogavage in rats: twenty rats were given the same dose total flavonoids solution, and the same observation were done.The acute toxicity trial in mice, LD 50 was carried out by abdominal injection with 7 dosage groups, and the mice were observed for 7 days after one injection. Results The mice and rats had no abnormal changes in bite and sup, activity, psychosis, coat and skin, urine and faeces, and body weight.There were no significant changes(P>0.05).Only a little remain of the fed sample was found in the abdomen anatomizing.And there were no remarkable pathological changes in all organs.The median lethal dose of the total flavonoids was 5.99 g·kg -1. Conclusion There are no abnormal changes in the acute toxicity trial with total flavonoids from rhizome of drynariae, and the flavonoids are safe in clinical use.
出处
《医药导报》
CAS
2005年第1期12-14,共3页
Herald of Medicine
基金
国家"九.五"科技攻关重大疾病课题 (基金编号 :96 90 6 0 9 0 4)。
关键词
骨碎补总黄酮
毒性实验
急性
最大耐受量
半数致死量
Total flavonoids from rhizome of drynariae
Acute toxicity trial
Maximum tolerance
Median lethal dose
