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[目的]对通脉糖眼明胶囊进行急性毒性评价,确定临床用药安全剂量,保证临床用药安全。[方法]依据《中药新药研究技术要求》及《中药新药药理研究指南》设计试验,给予小鼠以通脉糖眼明胶囊最大浓度、最大容积灌胃给药,观察小鼠急性毒性反应,确定通脉糖眼明胶囊半数致死量(LD_(50))或最大给药量。[结果]试验中未测得LD_(50),小鼠最大给药量折合生药112.104 g/(kg·d),相当于成人临床用药量的260倍。[结论]中药复方“通脉糖眼明胶囊”急性毒性甚小,临床常用药物剂量安全可靠。
[Objective] To evaluate the acute toxicity of Tongmaisuanming Capsule and determine the safe dose of clinical medication to ensure the safety of clinical medication. [Method] According to the design requirements of “Technical Requirements of New Drug Research of Chinese Materia Medica” and “Guidebook of Pharmacological Study of New Drugs of Chinese Materia Medica”, the mice were given intragastric administration with the maximum concentration and the maximum volume of Tongmai Tangyanming capsules. The acute toxicity reaction was observed in mice. Tongmai sugar eye capsules half the lethal dose (LD_ (50)) or the maximum dose. [Results] The LD_ (50) was not measured in the experiment. The maximum dose of the drug in mice was equivalent to 112.104 g / (kg · d) of crude drug, equivalent to 260 times of the clinical dose in adults. [Conclusion] The traditional Chinese medicine compound “Tongmai sugar eye capsules” acute toxicity is very small, safe and reliable dose of commonly used drugs in clinical practice.