【摘要】 目的　苦豆碱是从宁夏产药用植物苦豆子中提取出来的一类新药 ,目前尚无合适的检测方法用于苦豆碱片的含量测定。由于辅料的干扰 ,用于测定纯苦豆碱的紫外分光光度法不能用于片剂的含量测定。本文拟建立反相高效液相紫外色谱法测定苦豆碱片中苦豆碱的含量。方法　色谱条件 :ODS柱 ,流动相为甲醇 -水 -三乙胺 ( 3∶97∶0 1V V) ,流速 1 0mL·min- 1 ,检测波长为 2 0 5nm。结果　在 2 0～ 12 0 μg·mL- 1 浓度范围内 ,回归方程为A =1 6 92 0C + 1 74 5 5 (r2 =0 9999,n =5 )。80 ,10 0及 12 0 μg·mL- 1 三种浓度的回收率分别为 10 1 2± 1 4 4 % ,10 0 5± 0 75 %和 10 0 7± 1 10 % (n =3) ,相应的日内及日间精密度为 0 80～ 1 98%。三批样品的相对标示百分含量为 10 1 5 9± 1 38% ,98.4 6± 0 2 3%and 99.4 1± 1 0 9% (n =3)。结论苦豆碱高效液相色谱法的建立 ,排除了辅料对苦豆碱含量测定时的干扰 ,为一类新药苦豆碱片的质量控制提供了一种新的、有效的方法。更多还原

【Abstract】 Aim To develop a reverse phase HPLC method for the determination of aloperine, an alkaloid that is newly extracted from Sophora alopecuraides and has shown wide pharmacological effects including antibacterial and antiinflammatory actions. Methods The samples were analyzed on a ODS column with methanol water triethylamine (3∶97∶0 1 V/V) as a mobile phase. The flow rate was 1 0 mL·min -1 , and UV detection wavelength 205 nm. Results Linear regression equation was A=1 6920C+1 7455 (r 2=0 9999, n =5) in concentratins ranging from 20 to 120 μg·mL -1 . The recoveries were 101 2±1 46 % at 80 μg·mL -1 , 100 5±0 75% at 100 μg·mL -1 , and 100 7±1 10% at 120 μg·mL -1 , respectively, and the precisions of aloperine within or between run were from 0 80% to 1 98% ( n =5). The relative contents of aloperine in three lots of tablets were 101 59±1 38%, 98 46±0 23%, and 99 41±1 09% ( n =3). Conclusion The newly developed reverse phase HPLC method is simple and useful for daily assay of aloperine tablets and can overcome the interference from excipient and other alkaloids in titration and UV detection.更多还原