一种皮肤黏膜消毒剂的毒理学评价

为研究醋酸氯已定复方皮肤黏膜消毒剂的毒性,采用动物试验法进行了毒理学评价。结果,以醋酸氯己定为评价剂量,该消毒剂对小鼠急性经口LD50>20 g/kg体重,属实际无毒;该药原液对家兔皮肤和眼睛黏膜均无刺激性;阴道黏膜刺激试验中,三只家兔阴道黏膜经病理组织学检查发现,均有不同程度的充血、水肿、白细胞浸润和组织变形,刺激反应平均积分为1.9,有极轻度刺激性。亚急性毒性试验3个剂量组大鼠给药28 d后,10项血液生化指标和6项血液指标测定结果与正常对照组比较均无显著性改变,病理组织学检查10个脏器末见明显异常。3个剂量诱导PCE微核细胞率与阴性对照组比较无显著性差异(P>0.05),对小鼠骨髓PCE无诱变作用。结论,该消毒剂属实际无毒,亚急性毒性评价无异常改变,对家兔阴道黏膜有轻度刺激性。

TOXICOLOGICAL EVALUATION OF A SKIN-MUCOSA DISINFECTANT

In order to study the toxicity of compound chlorhexidine acetate disinfectant for skin and mucosa,animal test method was used for toxicological evaluation.Results: Using chlorhexidine acetate as the evaluating dosage,the mouse acute oral LD_(50) of the disinfectant was >20 g/kg body weight,which practically belongs to nontoxic category.The stock solution of the disinfectant was non-irritating to rabbit skin and eye mucous membrane.In vaginal mucosa irritation test,histopathological examination of vaginal mucosa of 3 rabbits found various degrees of congestion,edema,leukocyte infiltration and distortion of tissue.The average irritation score was 1.9 which meant mild irritation.In subacute toxicity test,28 days after the rats of 3 dosage groups received the drug,the results of measurement of 10 blood biochemical indices and 6 hematological indices did not show significant change as compared with those of the normal control group.Histopathological examination of 10 organs did not find significant abnormality.The percentrges of PCE with micronucleus induced by 3 dosages showed no significant difference as compared with that of the negative control group(P>0.05),indicating no mutagenic effect on mouse bone marrow PCE.Conclusion: The disinfectant belongs to practically nontoxic category and did not show abnormal change in subacute toxicity evaluation.It was slightly irritating to rabbit vaginal mucous membrane.