左旋盐酸苯环壬酯片的含量及溶出度测定方法  

Determination of the content and dissolution of left-levophencynonate hydrochloride tablets

作　　者：孙建绪[1] 林丏博[2] 贾丽华[3] 仲伯华[1] 高永良[1] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850 [2]辽宁医学院,锦州121001 [3]解放军307医院,北京100071

出　　处：《中国药物应用与监测》2008年第5期10-12,共3页Chinese Journal of Drug Application and Monitoring

基　　金：国家自然科学基金重大项目(203900508)

摘　　要：目的:测定左旋盐酸苯环壬酯片的含量及溶出度。方法:采用溶剂萃取酸性色素比色法(BCG法)测定含量,λmax=414nm。溶出度以桨法测定,转速50r·min-1,溶出介质为250mL0.1mol·L-1盐酸溶液。结果:当左旋盐酸苯环壬酯浓度为2.0～10.0μg·mL-1时,浓度与吸光度呈良好线性,回归方程:Y=0.0935X+0.0021,R2=1(n=3),回收率为(98.76±1.55)%,RSD=1.57%(n=5)。片剂30min取样,主药溶出80%以上。结论:该方法简便、快捷、准确,与HPLC法含量测定结果基本一致,为该制剂的溶出度测定及片剂半成品快速测定提供了方法学依据。Objective：To determine the content and dissolution of left-levophencynonate hydrochloride tablets（L-LPC）.Methods：A solvent extraction-acid dye spectrophotometry method was used,with the detection wavelength was 414 nm.An oar method was used to study the dissolution of L-LPC tablets,the rotative speed was 50 r·min^-1 and the dissolution medium was 250 mL of hydrochloric acid solution（0.1 mol·L^-1）.Results：The linear range of the standard curve was 2.0 ～ 10.0 μg · mL^-1,and the regression equation was Y = 0.093 5X ＋ 0.002 1,R2 = 1（n = 3）.The average recovery of the assay was（98.76 ± 1.55）%,RSD = 1.57%（n = 5）.The drug dissolution rate was over 80% at 30 min.Conclusion：This method is convenient,accurate and specific for dissolution determination of L-LPC tablets and provided basis for fast determination of semi-product.

关 键 词：左旋盐酸苯环壬酯片 酸性色素比色法 溶出度 

分 类 号：R927[医药卫生—药学]