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目的通过动物长期毒性实验来研究辅助戒毒中药新生颗粒的安全性,为临床用药安全提供科学依据。方法按新生颗粒高、中和低3个剂量(59.84、29.92和14.96g原药材/kg体重)给SD大鼠连续灌服1个月并停药观察1周,观察期间大鼠的一般表现,测定血常规,血液生化的各项主要指标及动物体重,摄食量等。结果试验期间大鼠未见死亡,外观体征、行为活动、摄食、饮水、二便排泄正常。给药组体重增长和摄食量与对照组比较,差异无统计学意义(P>0.05);血常规和血液生化各项主要指标,动物的主要脏器指数与空白对照组相比,差异无统计学意义(P>0.05)。结论在本试验条件下,大鼠给予新生颗粒1个月后未见毒性反应,停药一周后观察未见延迟毒性反应。
OBJECTIVE: To study the safety of nascent particles of auxiliary drug-detoxification traditional Chinese medicine through animal long-term toxicity experiment and to provide a scientific basis for clinical drug safety. Methods SD rats were fed with three doses (59.84, 29.92 and 14.96g of crude drug / kg of body weight) of high, medium and low dose of neonatal granules continuously for 1 month and withdrawal for 1 week. The general performance, Determination of blood, blood biochemistry of the major indicators and animal body weight, food intake and so on. Results During the experiment, no death was observed in rats. Signs and behavior of appearance, behavior, food intake and drinking water were all excreted normally. There was no significant difference in body weight gain and food consumption between the two groups (P> 0.05). The main indexes of blood and blood biochemistry, the major organ index of animals were not statistically different from the blank control group Significance (P> 0.05). Conclusions Under the conditions of this experiment, no toxic reaction was observed in neonatal granule 1 month after the administration, and no delayed response was observed after one week of withdrawal.