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目的:观察大鼠连续腹腔注射CA02脂质体产生的毒性反应与靶器官损害的可逆性。方法:设高、中、低剂量组和溶剂对照组,分别腹腔注射给予CA02脂质体注射液45.0,22.5,11.25 mg·kg~(-1)和等容量生理盐水(NS)对照品,通过对大鼠血液学、血液生物化学和病理靶向相关指标的观察,考察CA02脂质体对大鼠的毒性反应及程度。结果:连续腹腔注射CA02脂质体13周,动物全部存活,高剂量组大鼠PLT降低(P<0.01)、CREA降低(P<0.05)、TCHO升高(P<0.01)较溶剂对照组比较的差异有统计学意义,但停药4周后能恢复正常。中、小剂量组未见明显毒性反应。停药后各剂量组均未见迟缓性毒性发生。结论:大剂量[45.0 mg·(kg·d)~(-1)](相当于临床人用量的450.0倍)CA02腹腔注射对肾功能有一定的损害性,但为可逆性。
Objective: To observe the reversibility of toxicity and target organ damage caused by continuous intraperitoneal injection of CA02 liposome in rats. Methods: The high, medium and low dose groups and solvent control group were given intraperitoneal injection of CA02 liposomal injection of 45.0,22.5,11.25 mg · kg ~ (-1) and normal saline (NS) reference substance, by The hematology, blood biochemistry and pathology-related indicators of rats were observed to examine CA 02 liposomes on rats toxicity and extent. RESULTS: After continuous intraperitoneal injection of CA02 liposome for 13 weeks, the animals all survived. The PLT of rats in high dose group decreased (P <0.01), CREA decreased (P <0.05), TCHO increased (P <0.01) The difference was statistically significant, but returned to normal after 4 weeks of withdrawal. Medium and small dose groups showed no significant toxicity. After stopping the dose of each group were not delayed toxicity occurred. CONCLUSION: High-dose [45.0 mg · kg-1] (equivalent to 450.0 times of clinical dosage) intraperitoneal injection of CA02 has some renal damage but is reversible.