人参茸芝胶囊的急性毒性实验研究

Acute toxicity test of Renshen Rongzhi capsules

目的研究人参茸芝胶囊的急性毒性,评价人参茸芝胶囊的安全性。方法根据中药、天然药物急性毒性实验技术指导原则,将60只小鼠按体质量随机分为给药组和空白对照组,禁食不禁水12 h后,给药组将人参茸芝胶囊以最大浓度(2.2 g·m L-1),最大体积(40 m L·kg-1)灌胃给药,空白对照组以等容积的蒸馏水灌胃给药,连续14 d观察小鼠体质量、行为活动以及死亡情况。14 d后处死所有小鼠,观察小鼠心、肝、肾、脑等脏器是否正常。结果给药组小鼠无1例死亡,与对照组比较,给药组小鼠的体质量变化和进食量无显著差异,行为活动无异常。尸解后未见给药组小鼠的脏器异常。小鼠的人参茸芝胶囊的半数致死量(LD50)未测得,最大耐受量(MTD)为88 g·kg-1。结论从药物急性毒性研究结果来看,人参茸芝胶囊是一个安全的剂型。

ABSTRACT:Objective To investigate the acute toxicity and evaluate the safety of Renshen Rongzhi capsule.Methods According to the technical guidelines for the acute toxicity experiment on traditional Chinese medicine and natural medicine, 60 mice were randomly divided into treatment group and control group. After fasting but not restraining water for 12 h, Renshen Rongzhi capsule at a maximum concentration (2.2 g?mL?1) and maximum capacity (40 mL?kg?1) were given ig in the treatment group, while distilled water to the control group. After administration, mice were free to forage and water for 14 d and the body weight and behavioral events and circumstances of the death were recorded, after 14 d, all animals were killed and autopsied. Then the internal organs were observed, which included heart, liver, kidney, and brain.Results The mortality was 0 in the treatment group. Compared with the treatment group, the changes of the food intake and the body weight were not significantly different in the treatment group. The general conditions of animals were not abnormal in the treatment group. After the gross anatomy, the appearance of organ showed no abnormality. The LD50of mice Renshen Rongzhi capsule could not be measured, the maximum tolerance dosage (MTD) was 88 g?kg-1, respectively.Conclusion Based on the medicinal toxic experimental results, Renshen Rongzhi capsule is a kind of safe form.