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目的:益欣康泰胶囊为藏药复方制剂,实验采用给动物灌吸益欣康泰胶囊观察动物出现的毒性反应及死亡情况,评价药物的安全性。方法:测定益欣康泰对昆明种小鼠的最大耐受量(MTD)。结果:益欣康泰胶囊对昆明种小鼠的最大耐受量为2305g(生药)/kg,此剂量相当于临床成人拟日服剂量的1 081倍,未出现任何毒性反应及死亡现象。结论:益欣康泰胶囊口服安全、毒性低,可以用于临床验证使用
OBJECTIVE: Yixin Kangtai Capsule is a compound preparation of Tibetan medicine. The experiment used animals to infuse Yixing Kangtai Capsules to observe the toxicity and death of animals and evaluate the safety of the drug. Methods: The maximum tolerated dose (MTD) of Yixin Kangtai to Kunming mice was determined. RESULTS: The maximum tolerated dose of Yixin Kangtai capsule to Kunming mice was 2305g (crude drug)/kg. This dose was equivalent to 1,081 times of the dose expected to be taken in clinical adults without any toxic reaction and death. Conclusion: Yixin Kangtai Capsule is safe and has low oral toxicity and can be used for clinical verification.