短棒状杆菌外用制剂安全性的评价  

Evaluation in safety for external application of Corynebactrium parvum preparation

作　　者：杨琳[1] 白春杰[1] 闫素志[1] 丰沧玉[1] 王桂荣[1] 

机构地区：[1]长春生物制品研究所,长春130062

出　　处：《微生物学免疫学进展》2006年第4期23-26,共4页Progress In Microbiology and Immunology

摘　　要：研究短棒状杆菌外用剂型,为体外用药开辟新途径。将短棒状杆菌接种在适宜培养基上,连续扩增传代,培养终液稀释成不同浓度。依照新药管理办法,在动物体内进行各种安全性试验。结果显示:经急性毒性试验、长期毒性试验、生殖毒性试验,皮肤光敏试验、局部刺激试验等测定,在动物体内未见到毒性反应。该试验为短棒状杆菌外用制剂的开发提供了安全性依据。To develop the Corynebactrium parvum preparation on external application and investigate related advanced development. Corynebactrium parvum was inoculated in a proper culture medium and passaged in succession. Safety tests were performed in mice and rabbit by using diluted culture fluid according to requirements in relation to development of the new medicine. The results showed that the tests did not bave toxic effect on endurance limit,long toxigenicity, reproductive function,ray radiation injury and local stimulation. It provided a safe basis for external application of Corynebactrium parvum preparation.

关 键 词：短棒状杆菌 外用给药 安全性 

分 类 号：R927[医药卫生—药学]