Abstract: To evaluate the clinical safety of the anti-cough powder, one of the traditional Chinese patent medicines collected in Chinese Veterinary Pharmacopoeia, from the perspective of modern pharmacology, we were commissioned by the Office of China Pharmacopoeia to make studies on the toxicology of the anti-cough powder. In the present study, we examined the acute toxicity of anti-cough powder in mice by intragastric administration and assessed its long-term toxicity in rats by recording the amount of hydroposia and feeds-foraging per day and body weight per week, measuring hematologic and blood biochemical indexes after administration for 24 hours and withdrawal for 2 weeks, and making pathological section after intragastric administration for 4 weeks in rats with low (7 g/kg) and high (14 g/kg) dosage groups. Our results showed that the medial lethal dose (LD50) of anti-cough powder is above 120 g/kg; during 4 weeks intragastric administration, the rats’ body weight, amount of hydroposia and feeds-foraging of each dosage group showed no significant difference compared to the control group（P＞0.05）; blood biochemical indicators such as urea nitrogen, creatinine, blood glucose and hematologic indexes such as white cell, red cell and hemoglobin had no significant difference compared to the control group as well（P＞0.05）; tissue sections of main organs such as heart, lung, spleen, liver and kidney were observed no abnormality. Taken together, these above results indicated that the anti-cough powder has a lower toxicity and its clinical medication is safe.

Key words: anti-cough powder; toxicology; acute toxicity; long-term toxicity