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皮肤外用桑白皮水提物安全性研究OACSTPCD

Safety Study of Water Extract from Mori Cortex for Skin Application

中文摘要英文摘要

目的 评估皮肤外用桑白皮水提物的安全性.方法 选取豚鼠进行皮肤急性毒性试验,观察豚鼠 14d内的体质量变化、毒性反应和死亡情况;进行皮肤致敏试验,观察 72h内皮肤致敏情况并评分.选取新西兰兔,采用自身对比法进行单次、多次皮肤刺激,观察72h内完整及破损皮肤刺激性反应并评分.结果 经低、中、高剂量(6.0,12.0,24.0 mg/mL)桑白皮水提物处理后,豚鼠均正常生长,完整皮肤、破损皮肤均未见急性毒性反应,且破损皮肤处结痂正常;各组豚鼠用药前及用药后 7,14 d的体质量无显著差异(P>0.05);未出现局部皮肤红斑、水肿或站立不稳、呼吸困难和过敏性休克等全身性症状,豚鼠未发生皮肤致敏反应.试验兔完整皮肤、破损皮肤均未出现刺激性反应.结论 在外用质量浓度不超过 24 mg/mL桑白皮水提物作用下,豚鼠无皮肤急性毒性、致敏性表现,试验兔无刺激性反应.

Objective To evaluate the safety of the water extract from Mori Cortex for skin application.Methods Forty guinea pigs were selected for acute skin toxicity test,and the changes in body mass,toxic reaction and mortality within 14 d were observed.Another thirty guinea pigs were selected for skin sensitization test,the sensitization degree within 72 h was observed and scored.Sixteen New Zealand rabbits were selected for single-and multiple-dose skin stimulation tests by the self-contrast method,the stimulation reactions of intact and damaged skin within 72 h were observed and scored.Results After the treatment of low-,medium-and high-doses water extract from Mori Cortex(6.0,12.0,24.0 mg/mL),guinea pigs grew normally,and no acute toxic reaction was observed in both intact and damaged skins,and the scabs on the damaged skin were normal.The body weight of guinea pigs in each group 7 d and 14 d after medication was similar to that before medication(P>0.05).No erythema or edema was observed at local skin of guinea pigs,and no systemic symptom(unstable standing,dyspnea,allergic shock)or skin sensitization reaction occurred.No stimulation reaction was observed in the intact and damaged skins of the test rabbits.Conclusion Water extract from Mori Cortex shows no acute skin toxicity or sensitization in guinea pigs or stimulation reaction in test rabbits when applied at a dose≤24 mg/mL.

钱明明;杨颖;王婷婷;王玺宁

江苏省连云港市食品药品检验检测中心,江苏 连云港 222000

药学

桑白皮水提物皮肤外用药急性毒性试验致敏试验刺激性试验安全性

water extract from Mori Cortexmedicine for skin applicationacute toxicity testsensitization teststimulation testsafety

《中国药业》 2024 (002)

52-55 / 4

江苏省市场监督管理局科技计划项目[KJ2022046].

10.3969/j.issn.1006-4931.2024.02.012

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