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目的:观察养心草安神颗粒连续给药对大鼠的长期毒性反应及恢复情况,来评价长期服药的安全性,并为临床用药安全提供毒理学依据。方法:将成人临床拟用日剂量的80、40、20倍作为高、中、低剂量组,同溶媒对照组一起,对SD大鼠进行13周的给药期和2周的恢复期观察,测定大鼠的体质量、摄食饮水量、血液学指标、血液生化学指标、脏器系数及脏腑组织病理学检查。结果:给药期,各剂量组大鼠表现出活动倦怠,恢复期逐渐恢复正常;与溶媒对照组比较血液学指标、血液生化学指标和脏器系数均无统计学差异(P>0.05),脏腑组织病理切片未见药物导致毒性病理学改变。结论:长期服用养心草安神颗粒对大鼠无显著毒性反应和延迟毒性反应,临床给药量安全。
OBJECTIVE: To observe the long-term toxicity and recovery of Yang Xin Cao Anshen Granules in rats, to evaluate the safety of long-term administration and to provide toxicological basis for clinical drug safety. Methods: 80, 40 and 20 times of daily dosage of adults were used as the high, medium and low dose groups, with the vehicle control group, the SD rats were administered for 13 weeks and 2 weeks of recovery observed, The body weight, water intake, hematological indexes, blood biochemical indexes, viscera coefficient and visceral histopathological examination of rats were determined. Results: During the administration period, the rats in each dose group showed activity burnout and returned to normal gradually. Compared with the vehicle control group, the hematological indexes, blood biochemical indexes and organ coefficients showed no significant difference (P> 0.05) Visceral histopathology no drug induced pathological changes. Conclusion: Long-term use of Yang Xin Cao Anshen granule no significant toxic reaction and delayed toxicity in rats, the clinical dose safe.