含薄荷醇的乳膏剂薄荷清馨膏的安全性研究OA

The safety of Menthol Fresh Cream,a topical formulation containing menthol,was systematically evaluated with respect to neurotoxicity,skin irritation,skin sensitization,acute oral toxicity,and phototoxicity.Zebrafish models were employed to assess potential neurotoxicity and sensitization.The results showed no adverse effects on peripheral motor nerve development or behavioral responsiveness.At concentrations≤0.025%,no significant effects on the central nervous system were observed,and no sensitization potential was detected at concentrations≤0.125%.Mammalian studies were conducted to assess acute oral toxicity,phototoxicity,repeated-dose skin irritation,skin sensitization,and photoallergic potential.The acute oral LD50 exceeded 5 000 mg/kg,indicating that the product is practically non-toxic.No evidence of phototoxicity,skin irritation,skin sensitization,or photoallergic reactions was observed in these studies.In addition,a human occlusive patch test was performed to assess product safety in humans.No adverse skin reactions were observed in any of the 30 participants,demonstrating good skin compatibility.Overall,Menthol Fresh Cream,which provides cooling and soothing effects,exhibits no significant neurotoxicity or dermal toxicity at typical use concentrations.The product shows no sensitization or irritation potential and demonstrates a high level of safety for topical human use.