盐酸美西律乳膏的研制  

Preparation of Mexiletine Hydrochloride Cream

作　　者：金伟华[1] 蒲志强[1] 陈华[1] 于波涛[1] 王凯 

机构地区：[1]成都军区总医院药剂科,四川成都610083 [2]成都医学院药学系,四川成都610083

出　　处：《中国医药工业杂志》2017年第9期1351-1354,共4页Chinese Journal of Pharmaceuticals

摘　　要：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。The cream loaded with mexiletine hydrochloride for topical analgesia was prepared to avoid liver damages and gastrointestinal adverse reactions after oral administration. An HPLC method was established for the determination of mexiletine hydrochloride. The determination was performed on a YMC-Triart C18 column with the mobile phase of methanol ： 0.1 mol/L sodium acetate solution （51 ： 49） at the flow rate of 1 ml/min, column temperature of 30 ℃ and detection wavelength of 262 nm. Mexiletine hydrochloride presented good linearity in the range of 0.1-0.5 mg/ml. The recoveries of low, medium and high concentrations of mexiletine hydrochloride were 101.76 %, 101.23 % and 101.62 % , with RSDs of 0.38 % （n=9）. The results of pain sensitivity test of 6 healthy volunteers showed that the cream had the effect of relieving pain, and drug concentration in cream was positively correlated with the degree of pain relief.

关 键 词：盐酸美西律 乳膏 含量测定 疼痛敏感性试验 体外透皮 

分 类 号：R944.21[医药卫生—药剂学]