CAJ | 학술논문

为了优化和验证葛根芩连注射剂中葛根素、黄芩苷、盐酸小檗碱3种成分的高效液相色谱（HPLC）测定方法，选用Kromsil ODS（250 mm ×4.6 mm ，5μm）色谱柱，流动相分别为甲醇水（30∶70，V/V ）、甲醇水磷酸（40∶60∶0.2，V/V ）、乙腈水磷酸二氢钾（32∶68∶0.3，V/V ），检测波长分别为251、280、348 nm ，柱温25℃，流速1.0 mL/min。结果显示，葛根素在0.7～4.2μg/mL有良好的线性关系，平均回收率为98.8％；黄芩苷在4.3～25.8μg/m L有良好的线性关系，平均回收率为95.3％；盐酸小檗碱在4.0～24.0μg/m L有良好的线性关系，平均回收率为96.4％。葛根芩连注射剂中葛根素、黄芩苷、盐酸小檗碱含量分别为2.086、2.573、6.836 m g/m L ，且批内变异系数均小于2％，批间变异系数均小于3％，符合检测要求。表明优化后的 HPLC法准确、简便、快速，可用于葛根芩连注射剂的质量控制和评价。
위료우화화험증갈근금련주사제중갈근소、황금감、염산소벽감3충성분적고효액상색보（HPLC）측정방법，선용Kromsil ODS（250 mm ×4.6 mm ，5μm）색보주，류동상분별위갑순수（30∶70，V/V ）、갑순수린산（40∶60∶0.2，V/V ）、을정수린산이경갑（32∶68∶0.3，V/V ），검측파장분별위251、280、348 nm ，주온25℃，류속1.0 mL/min。결과현시，갈근소재0.7～4.2μg/mL유량호적선성관계，평균회수솔위98.8％；황금감재4.3～25.8μg/m L유량호적선성관계，평균회수솔위95.3％；염산소벽감재4.0～24.0μg/m L유량호적선성관계，평균회수솔위96.4％。갈근금련주사제중갈근소、황금감、염산소벽감함량분별위2.086、2.573、6.836 m g/m L ，차비내변이계수균소우2％，비간변이계수균소우3％，부합검측요구。표명우화후적 HPLC법준학、간편、쾌속，가용우갈근금련주사제적질량공제화평개。
In order to establish a simple HPLC method for determining the content of three virtual components in Gegenqinlian injection ,Kromsil ODS column(250 mm × 4.6 mm ,5 μm) was used . The HPLC system for puerarin ,baicalin ,berberine used the mobile phase composed of methanol-water(30∶70 ,V/V ) ,methanol-water-phosphoric acid(40∶60∶0.2 ,V/V ) and acetonitrile-water-potassium dihydrogen phosphate (32∶68∶0.3 ,V/V ) ,respectively ,with a flow rate of 1.0 mL/min and the column temperature was maintained at 25 ℃ .The detection wavelength was set at 251 nm , 280 nm and 348 nm ,respectively .The results showed that the puerarin calibration curve was linear in the range of 0.7 -4.2 μg/mL with the average recoveries was 98.8% .The calibration curve of baicalin was linear in the range of 4.3 -25.8 μg/mL with the average recoveries was 95.3% .The calibration curve of berberine was linear in the range of 4.0-24.0 μg/mL with the average recoveries is 96.4% .The content of puerarin ,baicalin and berberine was controlled as qualified more than 2.086 mg/mL ,2.573 mg/mL and 6.836 mg/mL ,with CV for within-run assays was less than 2% and CV for between-run assays was 3% ,respectively .This method was accurate ,convenient and quick .It can be used for Gegenqinlian injection quality control .