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制备了用于局部镇痛的盐酸美西律乳膏,并建立了HPLC法测定1含量。采用YMC-Triart C_(18)柱,以甲醇∶0.1 mol/L乙酸钠溶液(51∶49)为流动相,柱温30℃,检测波长262 nm。盐酸美西律在0.1~0.5 mg/ml范围内线性关系良好,低、中、高浓度样品的平均回收率为101.54%,RSD为0.38%(n=9)。6名健康志愿者的疼痛敏感性试验结果表明,盐酸美西律乳膏具有减轻疼痛的作用,并且其浓度与减轻疼痛程度呈正相关。以SD大鼠为模型的体外透皮试验表明,本品的释药特性符合Weibull方程。
A topical analgesic cream was prepared and the content of 1 was determined by HPLC. The mobile phase consisted of YMC-Triart C_ (18) column and methanol: 0.1 mol / L sodium acetate solution (51:49). The column temperature was 30 ℃ and the detection wavelength was 262 nm. The average recovery of mexiletine hydrochloride in the range of 0.1-0.5 mg / ml was 101.54% with RSD of 0.38% (n = 9). Pain sensitivity test results in six healthy volunteers showed that mexiletine hydrochloride cream had a pain-relieving effect and its concentration was positively correlated with the degree of pain relief. In vitro rat model of SD rats showed that the release characteristics of this product accord with Weibull equation.