Formula optimization,content determination,and therapeutic effect analysis of terbinafine hydrochloride spray
Wang Lei
Wang Hongying
Xu Xiaoyi
Lin Degui
Guo Changlin
Chen Huangshi
Zhao Qiang
Zhang Wei
Abstract：The research aims to prepare terbinafine hydrochloride(TNH)spray and conduct quality control on it.The orthogonal experiment was adopted to optimize the formula of TNH spray,and the content of TNH spray was determined by high performance liquid chromatography(HPLC).The therapeutic effect of this spray on skin tinea was also investigated.The results show that the optimal formula of TNH spray was:1.5 g/100 mL of propylene glycol(PG),8 g/100 mL of polyethylene glycol(PEG),and 0.2 g/100 mL of anhydrous sodium acetate(SA).The light transmittance(T value)of the three batches of TNH sprays prepared according to the optimal formula was 98.8%,98.2%,and 98.6%respectively.The pH values were all qualified,and the stability was all grade 3.The HPLC determination range was within 0.058 8～0.196 0 g/L.The linear regression equation was Y=26 557 391 X-31 461(r2=0.999 4).The relative standard deviation(RSD value)of the precision test was 1.18%,and the solution was stable within 24 hours after preparation.The average recovery rate was 104.82%,the RSD value of the recovery rate was 1.56%,and the content determination values of the TNH spray in three consecutive batches were 100.2%,102.0%,and 101.9%respectively.The average cured area of TNH spray on SD rats with skin tinea reached 1.4 cm2,and the cure rate was 74%.Research shows that the TNH spray formula optimized by orthogonal experiments meets its quality requirements.The HPLC method has good precision,high accuracy and repeatability,and can effectively control its quality.The TNH spray has a relatively good effect in treating skin tinea.
Keywords：Terbinafine hydrochlorideSpraySkin fungal infectionFormula optimization
Publication Date：2025-10-15
Online Publishing Date：2025-11-24(First online date of this platform, not the publication date of the document)
Pages：5( 18-22 )