某中药育发液外用的毒理学研究  

A toxicological study of a herbal pilatory for external use

作　　者：孟真[1] 郑云燕[1] 严峻[1] 傅剑云[1] 朱周靓[1] 张世鑫[1] 周忭 MENG Zhen;ZHENG Yun-yan;YAN Jun;FU Jian-yun;ZHU Zhou-jing;ZHANG Shi-xin;ZHOU Bian(Zhejiang Provincial Center for Disease Control and Prevention,Hangzhou,Zhejiang 310051,China)

机构地区：[1]浙江省疾病预防控制中心,浙江杭州310051

出　　处：《预防医学》2019年第5期465-469,473,共6页CHINA PREVENTIVE MEDICINE JOURNAL

摘　　要：目的评估某中药育发液外用的安全性。方法采用急性眼刺激试验检测中药育发液的眼刺激性;采用皮肤刺激试验、皮肤变态反应试验和皮肤光毒性试验检测中药育发液的皮肤毒性;采用鼠伤寒沙门菌回复突变试验(Ames试验)和CHL细胞染色体畸变试验检测中药育发液对原核细胞和真核细胞遗传物质的诱变性。结果急性眼刺激试验结果显示,家兔眼部涂抹育发液原液后,结膜表现为充血和水肿,最高积分为2 (24 h);角膜混浊,最高积分为1 (24 h);眼部症状72 h内恢复正常,积分降至0。育发液对家兔的多次皮肤刺激试验结果为无刺激性;对豚鼠皮肤的致敏率为0;对豚鼠皮肤无光毒性作用。在添加和未添加代谢活化系统条件下,与阴性对照组相比,育发液各剂量组鼠伤寒沙门菌回变菌落数均未出现异常增多,均未引起CHL细胞染色体畸变率增加(P>0.05)。结论在本实验条件下未观察到该中药育发液的皮肤毒性和遗传毒性,对眼有轻度刺激性但作用可逆,因此其外用安全性可以接受。Objective To evaluate the safety of a herbal pilatory for external use.Methods An acute eye irritation test were employed to detect the eye irritation of the herbal pilatory;a skin irritation test,a skin sensitization test and a skin phototoxicity test were employed to detect the dermal toxicity;Salmonella typhimurium reverse mutation assay(Ames test)and chromosome aberration test in CHL cells were employed to detect the effects of the pilatory on gene mutation and chromosome aberration in prokaryotic and eukaryotic cells.Results When the eyes of rabbits exposed to the pilatory without rinse during the first 24 hours,the conjunctiva showed congestion and edema with the highest score of 2,corneal opacity was observed with the highest score of 1;however,these symptoms returned to normal within 72 hours,with the score reduced to 0.No irritation to the skin of rabits was found after exposed to the pilatory for fourteen days,no skin sensitization was introduced by Buehler test and no skin phototoxicity on guinea pigs was detected.There was no abnormal growth of reverse mutation colonies induced by the pilatory under S9 acitivation or not.There was no statistically significant rise of chromosome aberration rate in the exposed CHL cells compared to the control groups(P>0.05).Conclusion Under the condition,the herbal pilatory showed mild and reversible irritation to eyes,while no dermal toxicity and genetic toxicity were observed.The safety of the herbal pilatory for external use is acceptable.

关 键 词：中药育发液 安全性 眼刺激性 皮肤毒性 遗传毒性 

分 类 号：R285[医药卫生—中药学]