白灵芝发酵普洱茶复合饮料对小鼠的急性毒性研究

Acute toxicology test of Ganoderma leucocontextum fermented Pu-erh tea compound beverage on mice

中文关键词:  白灵芝发酵普洱茶复合饮料  急性经口毒性  半数致死量(LD50)

英文关键词:Ganoderma leucocontextum fermented Pu-erh tea compound beverage  acute oral toxicity  median lethal dose

中文摘要:

      目的 评估白灵芝发酵普洱茶复合饮料的安全性。方法 以白灵芝发酵普洱茶复合饮料为研究对象, 基于前期预实验及相关研究, 将剂量设定为10000 mg/(kg·bw), 采用经典限量法, 选用健康的ICR小鼠作为实验模型, 经口灌胃给予受试物。实验严格遵循动物伦理与福利原则, 精确控制饲养环境的温度、湿度及光照周期, 以保障数据的准确可靠。结果 给予受试物后, 整个观察期内, 所有ICR小鼠均未出现中毒症状, 行为活动正常, 毛色光泽、精神饱满。定期精确测量小鼠体重, 增长趋势无明显异常, 且无死亡个体。经统计学分析, 该饮料对雄性和雌性ICR小鼠急性经口毒性的半数致死量(median lethal dose, LD50)值均大于10000 mg/(kg·bw), 95%可信限同样均大于10000 mg/(kg·bw)。结论 依据国际急性毒性剂量分级标准判定, 白灵芝发酵普洱茶复合饮料属实际无毒级。这表明在本次实验条件下, 该复合饮料急性经口摄入安全性高, 为后续产品开发与市场推广提供了关键的安全性数据支撑。

英文摘要:

      Objective To evaluate the safety of a composite beverage made from Ganoderma leucocontextum fermented Pu-erh tea compound beverage. Methods Using the Ganoderma leucocontextum fermented Pu-erh tea compound beverage as the study subject, based on preliminary experiments and related research, the dose was set at 10000 mg/(kg·bw). The classical limit method was employed, with healthy ICR mice selected as the experimental model, and the test substance was administered via oral gavage. The experiment strictly adhered to animal ethics and welfare principles, with precise control of environmental conditions including temperature, humidity and light cycles to ensure the accuracy and reliability of the data. Results After administration of the test substance, no signs of toxicity were observed in any of the ICR mice throughout the observation period. Their behavioral activity remained normal, with glossy fur and vigorous spirits. Regular precise measurements of mouse body weight showed no significant abnormalities in growth trends, and no deaths occurred. Statistical analysis revealed that the acute oral toxicity median lethal dose (LD50) values for both male and female ICR mice were greater than 10000 mg/(kg·bw), with 95% confidence intervals also exceeding 10000 mg/(kg·bw). Conclusion Based on international acute toxicity dose classification standards, the Ganoderma leucocontextum fermented Pu-erh tea compound beverage is classified as practically non-toxic. This indicates that under the experimental conditions of this study, the acute oral intake safety of this composite beverage is high, providing critical safety data support for subsequent product development and market promotion.