新生戒毒胶囊的毒理学实验研究

目的研究新生戒毒胶囊的毒理作用，以确保临床用药的安全性。方法①急性毒性试验：以最大给药体积的新生戒毒胶囊予小鼠1d内灌胃给药3次后，连续观察7d。②长期毒性试验：大鼠80只随机分为4组，每组20只，分别给予新生戒毒胶囊5g／kg（高剂量组）、3g／kg（中剂量组）、100mg／kg（低剂量组）或等量的生理盐水灌胃，连续12周，停药后进行血常规，血清尿素氮（BUN）、肌酐，血清丙氨酸转氨酶、天门冬氨酸转氨酶检查，其内脏接受病理检查。结果急性毒性试验测得新生戒毒胶囊的最大耐受量为生药量240g／kg，为成人临床每日用量的240倍：长期毒性试验表明，三个剂量组血液学检查、肝肾功能测定、主要脏器系数等各项指标与对照组比较差异均无统计学意义；主要脏器病理检查未见异常。结论新生戒毒胶囊临床剂量口服安全，无蓄积毒性。

Toxicity of Xinshengjiedu capsule: experiment with mice and rats

Objective To study the toxicology of Xinshengjiedu capsule so as to guarantee the safety of clinical . Methods Pretest failed to detect the median lethal dose （LD50） of oral administration of Xinshengjiedu capsule. Xinshengjiedu capsule was administered orally at the dosage of crude drug 2.0 g/ml and the volume of 0.8 ml/（20 g body weight, d） given in 3 doses, and were observed for 7 d. Eighty Wistar rats were divided into 4 equal groups undergoing gastric perfusion of Xinshengjiedu capsule at the dosage of 100 mg/kg （low dosage group）, 3 g/kg （moderate dosage group）, or 5 g/kg （high dosage group） respectively, or normal saline （control group） for 12 weeks. Body weight was measured once a week, the general status, hair, eating, activity, etc, were observed. Blood samples were collected after the cease of drug administration to undergo blood routine examination, alanine transaminase, aspartate aminotransferase, blood urea nitrogen, and creatinine. Then except 10 rats in the control and high dosage group each the other rats were killed with their viscera taken out to undergo pathological examination. Results The maximal dosage given was more than 240 g/kg, 240 times the dosage used in clinic practice for an adult. There were no significant differences in blood routine testes, blood chemical analysis, organ coefficient, and pathological examination among the 3 different dosage groups. Conclusion Without distinct toxicity, Xinshengjiedu capsule can be considered as safe in clinical application.