关键词: 经典名方, 两地汤, 两地颗粒, 单次给药, 重复给药

Abstract: Objective To investigated the toxicity of Liangdi Granules, a modern dosage form of the classical prescription Liangdi decoction, through single administration and repeated administration in SD rats, and to evaluate safety. Method Single dose toxicity test: the test was carried out by the maximum dose method. 20 female rats were randomly divided into vehicle control group ( pure water) and 48 g / kg dose group of Liangdi granules, with 10 rats in each group. After intragastrically administered, the toxicity and death of rats were investigated for 14 days. Repeated administration toxicity test: 84 female SD rats were randomly divided into vehicle control group ( pure water) and 3, 6 and 12 g / kg dose group of Liangdi granules, with 21 rats in each group. Rats were administrered continuously for 26 weeks, and recovered for 4 weeks. The test items included clinical observation, body weight, food intake, hematology, coagulation, serum biochemistry and histopathological examination. Result There was no obvious toxic reaction in SD rats at a single dose of 48 g / kg. SD rats were given Liangdi Granules by intragastric administration for 26 weeks. There were no toxic reactions related to the test article in body weight, food intake, hematology, coagulation, serum biochemistry and histopathological examination of rats in each dose group. Conclusion The Liangdi granules has no acute toxicity to SD rats, and the NOAEL is 12 g / kg in the repeated administration toxicity test.

Key words: classical formulas, Liangdi decoction, Liangdi granules, single administration, repeated administration