目的：观察益欣康泰胶囊较大剂量、较长疗程给动物灌服后所产生的毒性反应及停药后动物的恢复情况，综合评价该药物的安全性，为临床验证提供依据。方法：给ＳＤ大鼠灌服益欣康泰胶囊２００ｇ、１５０ｇ、１００ｇ（生药）／ｋｇ（分别相等于临床成人拟日服剂量的１１７、７０、４７ 倍），连续９０ 天。分别于给药后４５ 天、９０ 天及停药后１０ 天，测定动物血液学、血清生化学的相关指标，同时观察药物对幼年大鼠体重增长的影响以及对动物２４ｈ 饮食变化，测定动物器官指数的变化以及对重要器官的组织形态学观察。结果：益欣康泰胶囊对动物的血液学、血清生化学指标无明显毒性损害；中、低剂量对幼年大鼠的体重增长有明显的促进作用；增加动物的饮食量；对动物器官指数无明显毒性损害；组织形态学观察结果亦表明，对动物的重要器官无明显毒性损害。结论：益欣康泰胶囊是一种毒副作用低、安全性较大的药物，可以提供临床使用 OBJECTIVE: To observe the toxicity of Yixin Kangtai capsules after a large dose, long course of treatment, and animal recovery after drug withdrawal, and to evaluate the safety of the drug comprehensively, so as to provide a basis for clinical validation. METHODS: Sprague-Dawley rats were given Yixin Kangtai capsules 200g, 150g, 100g (crude drug)/kg (equal to 117, 70, and 47 times the dose of the intended adult daily dose) for 90 consecutive days. . The relevant indexes of hematology and serum biochemistry were measured at 45 days, 90 days after drug administration and 10 days after drug withdrawal. The effects of drugs on weight gain of juvenile rats and 24 h dietary changes in animals were measured. Animal organs were measured. Changes in indices and histological observations of vital organs. RESULTS: There was no obvious toxicity damage to animal’s hematology and serum biochemical indexes of Yixin Kangtai Capsule; Medium and low dose had a significant role in promoting weight gain of young rats; Increased animal dietary intake; No obvious animal organ index Toxic damage; Histomorphological observations also showed no significant toxic damage to the vital organs of the animals. Conclusion: Yixin Kangtai Capsules is a kind of drug with low toxicity and high safety, which can provide clinical use