蛞蝓胶囊大鼠长期毒性实验研究

Experimental Study on Chronic Toxicity of Slug Capsule in Rats

关键词:  蛞蝓胶囊  毒性实验  长期毒性

Key words:  Slug capsule  chronic toxicity test  long term toxicity

摘要:

目的 观察大鼠对蛞蝓胶囊的长期毒性反应，为临床研究提供依据。方法 按照成人每日用量，将给药组大鼠分为低剂量组175.0 mg·kg^-1、中剂量组553.0 mg·kg^-1、高剂量组1 750.0 mg·kg^-1和对照组。连续灌胃给药26周，停药恢复4周，对一般情况进行观察，对体质量、进食量进行称量比较，对血液学指标、血液生化指标、尿常规进行检测，对脏器进行病理学检查和脏器系数比较。结果 给药组与对照组比较，大鼠的一般状况、行为活动、进食量、体质量变化、外周血象、尿常规指标、血液生化指标、脏器系数以及病理组织学等均无统计学差异。结论 蛞蝓胶囊大鼠长期毒性实验未见毒性反应，提示临床拟用剂量安全。

Abstract:

OBJECTIVE To observe the long term toxicity in rats after gavaging the administration of Slug capsule and to clarify the basis for clinical studies. METHODS According to the adult daily dose, the rats were randomly divided into four groups: low dose group (175.0 mg·kg^-1), middle dose group (553.0 mg·kg^-1), high dose (1 750.0 mg·kg^-1) group and control group. The medication administration teams were gavaged with Slug capsule for 26 weeks, the experimental rats were observed after the withdrawal of the drug for 4 weeks. The control group was given the same bulk of saline. the behavior and the general condition of experiment rats were observed, the chage of weight and food intake after giving Slug capsule were compared, the indexes of hematology, biochemistry and urine measured. The organ measure by pathology were measured and the index of organ was compared. RESULTS Compared with the control group, there were no significant difference in the outer appearance and behavior, body weight, organ coefficients, the indexes of hermatology and biochemistry in the drug taking groups. The pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug withdrawal. CONCLUSION Slug capsule has no obvious toxicity in rats for long-term administration. It infers that the doses drawn up in clinic will be safe.