摘要
目的:建立同时测定乐脉分散片中丹酚酸B、丹参酮ⅡA与阿魏酸含量的方法并考察三者的溶出特点。方法:采用HPLC同时测定丹酚酸B、丹参酮ⅡA与阿魏酸含量,色谱条件为AlltimaTMODS C18色谱柱(4.6 mm×150 mm,5μm),流动相乙腈-0.5%冰乙酸梯度洗脱,流速1.0 mL·min-1,检测波长分别为320(0～10 min),286(10～20 min),270(20～30 min)nm,柱温30℃,进样量20μL。采用小杯法测定体外溶出度,以0.1 mol·L-1HCl为溶出介质,转速50 r·min-1,取样时间60min,考察不同时间内丹酚酸B、丹参酮ⅡA与阿魏酸的累计释放度,通过相似因子(f2)法对各成分的溶出度曲线进行相似性比较。结果:丹酚酸B、丹参酮ⅡA、阿魏酸的线性范围分别为30.15～301.48,0.15～1.52,0.66～6.55 mg·L-1。以丹酚酸B为参比,乐脉分散片中丹参酮ⅡA与阿魏酸的f2分别为70.35,82.49。结论:乐脉分散片中丹酚酸B、丹参酮ⅡA与阿魏酸具有相似的溶出特点。
Objective： To establish a method for simultaneous determination of salviamolic acid B, tanshinone II A and ferulic acid from Lemai dispersible tablets, then investigate in vitro dissolution characteristics of these three ingredients. Method： HPLC was adopted to determine the contents of salviamolic acid B, tanshinone IIA and ferulic acid, chromatographic conditions were as follows： AlhimaTM ODS Cls column （4.6 mmx 150 mm, 5 μm） , mobile phase of acetonitrile-0.5% acetic acid gradient elution, flow rate 1.0 mL ·min-1, detection wavelength of 320 （0-10 min）, 286 （10-20 min）, 270 （20-30 min） nm, column temperature at 30 ℃, injection volume 20 μL. In vitro dissolution was determined by small cup method, with 0. 1 mol ·L^-1 HC1 as dissolution medium, rotate speed was 50 r·min^-1and dissolving time was 60 min, accumulative dissolution of salviamolic acid B, tanshinone 11 A and ferulic acid within different times were calculated, resemblance of release curves were compared with similarity factors （f2） method. Result： Linear range of salviamolic acid B, tanshinone II A and ferulic acid were 30. 15-301.48, 0.15-1.52 and 0.66-6.55 mg ·L^-1, respectively. Compared with salviamolic acid B, f2 of tanshinone II A and ferulic acid were 70.35 and 82.49, respectively. Conclusion： Dissolution of salviamolic acid B, tanshinone II A had similar characteristics with ferulic acid in Lemai dispersible tablets.
出处
《中国实验方剂学杂志》
CAS
北大核心
2013年第19期50-53,共4页
Chinese Journal of Experimental Traditional Medical Formulae
关键词
乐脉分散片
丹酚酸B
丹参酮ⅡA
阿魏酸
溶出度
相似因子
Lemai dispersible tablets
salviamolic acid B
tanshinone II A
ferulic acid
dissolution
similarity factor
