盐酸美西律栓剂的制备及质量控制  

Preparation and Quality Control of Mexiletine Hydrochloride Suppository

作　　者：金伟华[1] 陈华[1] 张明[1] 于波涛[1] 蒲志强[1] 杨迎[2] 

机构地区：[1]成都军区总医院药剂科,四川成都610083 [2]泸州医学院药学系,四川泸州646000

出　　处：《解放军药学学报》2017年第3期247-249,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的制备盐酸美西律栓剂,研究栓剂的质量控制方法。方法采用热熔法制备盐酸美西律栓剂,按照《中国药典》2015年版控制栓剂质量,采用HPLC法测定栓剂中盐酸美西律的含量。结果制备的盐酸美西律栓剂为浅黄色圆锥形固体,盐酸美西律在0.1062~0.5308 mg·ml^(-1)浓度范围内,呈良好的线性关系,回归方程为A=117.95C-10.5677(r=0.9999),低、中、高3个浓度的样品回收率分别为99.86%、100.43%、101.01%,RSD=0.63%(n=9)。结论本制剂制备工艺可行,质量控制方法可靠。Objective To prepare a mexiletine hydroehloride suppository and to establish a method for quality control of the suppository.Methods A mexiletine hydrochloride suppository was prepared with heat- ing method.The quality of this suppository was controlled according to Chinese Pharmacopoeia（2015 edi- tion）.The mexiletine hydrochloride was determined by HPLC.Results The prepared mexiletine hydrochlo- ride suppository was light yellow and conical.Mexiletine hydrochloride presented good linearity within the range of 0.1062--0.5308 mg ·ml^-1.The regression equation was A =117.95C --10.5677（ r =0.9999）.The recovery of low, medium and high concentrations of mexiletine hydrochloride was 99.86%, 100.43% and 101.01% respectively, RSD = 0.63 % （ n = 9）. Conclusion This preparation technology is feasible, and the quality is stable and controllable.

关 键 词：盐酸美西律 栓剂 质量控制 HPLC 

分 类 号：R944.23[医药卫生—药剂学]