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机构地区:[1]海军医学研究所,上海200433
出 处:《海军医学杂志》2002年第4期291-293,共3页Journal of Navy Medicine
摘 要:目的 :对速效抗晕胶囊 (QAAMC)的毒理与人体药效学试验进行安全性评价。方法 :ICR小鼠急性LD50 试验 ,Wistar大鼠长期毒性试验以及舰艇人员海上试验。结果 :以苯丙胺计 ,QAAMC的LD50 =(112 .14± 6 .10 )mg/kg ,相当于临床推荐剂量 (苯丙胺 0 .0 83mg/kg)的 1346倍 ;长期服用剂量≤ 2 5 5mg/kg对大鼠不产生毒性作用 ,但剂量达 5 10mg/kg(临床剂量的 12 4 .4倍 )时可致动物兴奋反应、食欲降低和体重下降 ;经 36 5名舰艇人员海上试验证明 ,其抗晕船效果达 91.5 1% ,兴奋反应发生率 31.73%。结论 :QAAMC具有显著的抗晕船效果 ,按临床推荐剂量 (2 5 5mg/人 )长期服用 ,在体内不会产生蓄积作用 ,但少数人 (31.73% )Objective: To conduct safety evaluation of Quick acting Anti motion Capsules(QAAMC) for animal toxicology and human drug efficacy. Methods: Acute LD 50 test of QAAMC was used in ICR mice and chronic toxicological test in Wistar rats. The naval ship crew accepted drug efficacy tests on the sea. Results: Acute LD 50 dose of Amphetamine Sulfate in QAAMC was 112.14±6.10 mg/kg, 1 346 times as much as the clinical dose (0.083 mg/kg) in human body. Chronic toxicological study showed that evident toxicity and side effect of QAAMC were not found in oral dose of 255 mg/kg for long time. However, QAAMC of 510 mg/kg (124.4 times the clinical dose) would give rise to excitation, a poor appetite and weight loss in some rats. Drug efficacy test reveals that anti seasickness efficacy rate was 91.51%(P<0.05). Incidence of an excitation was only 31.73%. Conclusion: Our study shows anti seasickness efficacy of QAAMC was significant. Taking its clinical dose of 255 mg per person for a long time might not result in accumulation in vivo. However, some persons (31.73%) might have excitatory response.
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