Abstract: AIM: To evaluate the antitussive effects of total alkaloid agent extracted from Papaver somniferum L.on acute tracheitis and bronchitis of which the syndrome is counterflow ascent of lung qi according to traditional Chinese medicine (TCM).METHODS: Random principle, double blind method, control group applied with placebo and add-on design were adopted in all trials. 89 patients with acute tracheitis and bronchitis whose syndrome is counterflow ascent of lung qi according to TCM took part in the trial.Among them 45 were in the treatment group treated with total alkaloid agent extracted from Papaver somniferum L.and 44 were in the control group treated with placebo.RESULTS: The rate of obvious coughing in treatment group and control group were 75.56 % and 77.27 %(P=0.8487), respectively.The cough alleviation time were 19.55±18.57 h and 25.27±19.60 h(P=0.1993), respectively.The cough disappear rate of the third day were 33.33 % and 36.36 %(P=0.7642) respectively. The average mark value drcreased were 3.53 and 4.16(P=0.2786), respectively.CONCLUSION: The total alkaloid agent extracted from Papaver somniferum L.has no significant antitussive effect on moderate and severe cough on the ground that the patients with acute tracheitis and bronchitis whose syndrome is counterflow ascent of lung qi according to TCM has been treated with cefaclor sustained release capsules simultaneously.

Key words: total alkaloid agent extracted from Papaver somniferum L., acute tracheitis and bronchitis, antitussive, exploratory clinical trial