咽康口服液急性毒性和长期毒性试验研究

Experimental Study on Acute Toxicity and Long- Term Toxicity of Yankang Oral Liquid

目的探讨咽康口服液的急性毒性和长期毒性,为临床安全用药提供科学依据。方法急性毒性试验,在无法测定半数致死量(LD50)的基础上,以最大给药体积剂量(1.0 g/m L)给予小鼠炎康口服液,24 h内灌胃给药3次,连续观察7 d。长期毒性试验,将大鼠随机分为对照组及低、中、高[0.5,2.5,5.0 m L/(kg·d)]剂量组,给药量分别相当临床患者用药量的1,5,10倍;30 d后每组随机处死雌雄大鼠各5只,取尾静脉血测定血液流变学和血液生化学主要指标,对心、肝、肾、肺作组织病理学检查。结果急性毒性试验时小鼠灌胃最大耐受量至少相当于临床1次治疗量的300倍,且未见毒性反应。长期毒性试验时各剂量组大鼠的体重和血液流变学、血液生化学主要指标与对照组无明显差异,心、肝、肾、肺组织病理学检查均未见明显病理改变。结论咽康口服液临床应用安全。

Objective To study the acute toxicity and long-term toxicity of Yankang Oral Liquid in order to provide the scientific basis for its clinical safe use. Methods The acute toxicity test：on the basis of unable determining LD50,the maximum volume dose（1. 0 g/mL） was given to mice by intragastric gavage for 3 times within 24 h,and 7 d continuous observation was conducted;the long-term toxicity test：the rats were randomly divided into the control group,low,middle and high dose[0. 5,2. 5,5 mL/（kg·d）] groups respectively,the dose amount was equivalent to 1,5,10 times of clinical patients dosage. 5 male and female rats in each group were randomly killed af-ter 30 d. The tail venous blood was collected for determining the hemorheology and blood biochemical major indicators. The heart,liver, kidneys and lungs were performed the histopathological examination. Results The acute toxicity test indicated that the maximum tol-erance amount by gavage was at least equivalent to 300 times of clinical once treatment amount and had no toxic reactions. In the long-term toxicity test,the major indicators of body weight,hemorheology and blood biochemical in each dose group had no statistically significant differences with the control group,no obvious histopathological changes were found in the heart,liver,kidneys and lungs. Conclusion Yankang Oral Liquid is safe in clinical application.