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目的:考察青蒿素哌喹片(ATQ)对恒河猴单次经口给药可能产生的的毒性反应,评价其安全性。方法:采用近似致死量法进行实验。对恒河猴单次经口给予青蒿素哌喹片,给药剂量为168,377,849,1 910,4 296 mg·kg~(-1),每个剂量1只动物,观察14 d内恒河猴的毒性反应和死亡情况,求得ATQ对恒河猴的近似致死剂量范围,称量体重、摄食量,检测血液学及血液生化学,对所有恒河猴解剖并进行大体病理观察。结果:所有恒河猴14 d内未出现死亡。4 296,1 910 mg·kg~(-1)剂量ATQ可使恒河猴出现呕吐及摄食减少,其中4 296 mg·kg~(-1)剂量组恒河猴体重减轻。结论:ATQ对恒河猴单次经口给药的近似致死剂量大于4 296 mg·kg~(-1)(相当于临床剂量的257倍)。
Objective: To investigate the toxicity of artemisinin and piperaquine tablet (ATQ) on the single oral administration of rhesus monkeys to evaluate its safety. Methods: Approximate lethal dose method for experiments. The rhesus monkeys were treated with a single oral administration of artemisinin and pirafeachin tablets at a dose of 168,377,849,1 910,4 296 mg · kg -1 for 1 d. The lethal dose range of ATQ on rhesus monkeys was obtained. Body weight, food intake, hematology and blood biochemistry were measured. All rhesus macaques were dissected and gross pathology was observed. Results: All rhesus monkeys did not die within 14 days. 4 296,1 910 mg · kg -1 dose of ATQ can cause vomiting and decreased feeding in rhesus monkeys, 4 296 mg · kg -1 dose group rhesus monkey weight loss. CONCLUSIONS: The approximate lethal dose of ATQ for single oral administration to rhesus monkeys is greater than 4 296 mg · kg -1 (equivalent to 257 times the clinical dose).