关键词: 氨酚那敏三味浸膏胶囊, 肝脏毒性实验, 解热, 镇痛

Abstract:

AIM: To investigate the hepatic toxicity and pharmacodynamic effects of paracetamol and chlorphenamine maleate with three herb extracts capsules. METHODS: Fixed dose toxicity test and two-week feeding toxicity test were applied to observe the degree of toxic injury in rats; the analgesic effect was investigated by hot plate method, and the fever model in rats was induced by yeast, and the body temperature of the rats was measured to investigate the antipyretie effects of the products. RESULTS:There was no death within one week after oral administration of 10 000 mg/kg; In the two-week feeding toxicity test, edial and high dose group (equivalent to the human maximum daily dose of 3, 9 times) increased the serum levels of AST, ALT, ALP, total bile acid levels, decrease CYP1A2, CYP3A4 expression of mRNA in rat liver tissues, a week after stopping, the above indexes were improved. Each three herb extracts capsules group (124.81, 249.62, 499.24 mg/kg) could lower the body temperature of yeast-induced febrile rats; hot-plate test results showed that 1.75 g/kg, 3.50 g/kg and 7.00 g/kg of herb extracts capsules increased the pain thresholds for 1 and 2 hour. CONCLUSION: The drug has no severe acute toxic risk in human, the human maximum daily dose of medication for two weeks cause no obvious toxicity to the animal body; the human maximum daily dose of 9 times two weeks have influence on animal liver function, mainly caused by acetaminophen, but it can be recovered after stopping medication for a week. And the products have better effects on relieving fever and analgesia.

Key words: paracetamol and chlorphenamine maleate with three herb extracts capsules, hepatic toxicity test, relieving fever, analgesia