泰乐菌素注射液的毒性试验研究

STUDY ON THE TOXICITY TESTS OF TYLOSIN INJECTION

为提供泰乐菌素注射液的毒理学评价资料.本试验采用改良Karber法测定小鼠LD以剂量递增法测定小鼠蓄积性和耐受性。分别以剂量230、90、40 mg/kg为3个试验组,设阴性和阳性组对照进行小鼠骨髓微核试验;分别以剂量380、190、90mg/kg为3个剂量组,设阴性和阳性对照组进行小鼠精子畸形试验。结果表明:其LD50为448.75 mg/kg,蓄积系数大于5.3,无明显蓄积毒性和耐受性(P>0.05),小鼠骨髓微核试验和精子畸形试验结果,均为阴性。

In order to provide some scientific data for safe toxicological evalutation of Ty-losin injection, this paper determines LD50by improved Karber method, accumulative toxicity test and tolerance test by progressive dose increase method,bone marrow micronucleus test with 3 experimental groups at dosage of 230,90 or 40 mg/kg respectively and positibve and negative control groups, spermatogenic malformation test with 3 experimental groups at dosage of 380,190 or 90 mg/kg/day respectively and positive and negative control groups. Experimental animals used in these 5 tests are mice. The data are 448. 75 mg/kg(LD50) and over 5. 3 (accumulative coefficient). The other 3 resulrs are all negative.