关键词: 蒲地蓝消炎口服液, SD 大鼠, 单次给药毒性, 多次给药毒性, 安全性

Abstract: Objective The non-clinical safety of Pudilan anti-inflammatory oral solution was reevaluated to provide reference for clinical application. Method Single dose toxicity: Forty SD rats were randomly divided into negative control group, 40. 04, 138. 60 and 295. 56 g / kg groups. Toxicity changes such as body weight and food intake were observed within 14 days after single administration. The 28-day dose toxicity: 160 SD rats were randomly divided into negative control group and 10. 01、32. 03、64. 06 g / kg groups. All rats were administered intragastrically once a day for 28 days with 4-weeks recovery phase. Test indicators included body weight, food intake, ophthalmology, clinical examination, histopathological and so on. Result Single dose toxicity: The 138. 60 g / kg group showed reduced activity and prone lying, and 7 / 10 animals died in the 295. 56 g / kg group. The maximal tolerance dose (MTD) of Pudilan anti-inflammatory oral solution was 138. 60 g / kg after a single administration. The 28-day dose toxicity: Except for hepatocyte hypertrophy in some animals of 32. 03 and 64. 06 g / kg groups, no abnormal changes related to drugs were observed in other groups. The no observed adverse effect level (NOAEL) was 64. 06 g / kg after 28 days of repeated administration. Conclusion The single dose toxicity and 28- day dose toxicity of SD rats showed that Pudilan anti-inflammatory oral liquid was safe and non-toxic in clinical administration cycle, which provided important reference information for clinical administration.

Key words: Pudilan anti-inflammatory oral liquid, SD rats, single dose toxicity, 28-day dose toxicity, safety