摘要
目的建立 1种HPLC法测定补骨脂注射液中补骨脂素和异补骨脂素的含量 ,并对注射液的稳定性进行研究。方法色谱柱为NucleodurC1 8柱 ( 2 5 0mm× 4.6mm ,5 μm) ,流动相为甲醇—1 %冰醋酸溶液 (5 0∶5 0 ) ,流速 0 .8mL/min ,检验波长为 2 95nm。结果补骨脂素回归方程为Y =91 2 0 8X - 1 4 4 5 0 4 ,r=0 .9995 ,线性范围为 2 .5～ 2 5 μg/mL ,平均回收率为 1 0 0 .5 0 % ,RSD为0 .96 % ,异补骨脂素回归方程为Y =7835 6X - 1 2 32 95 ,r =0 .9991 ,线性范围为 2 .5～ 2 5 μg/mL ,平均回收率为 1 0 0 .2 3% ,RSD为0 .96 %。结论HPLC法操作简便 ,准确 ,重现性好 ,可作为该制剂的质量控制方法 ;补骨脂注射液对光不稳定 。
Objective To establish a content measuring procedure by HPLC for the content measurement of psoralen and isopsoralen in Fructus Psoraleae Injection (FPI) and for the stability maintenance measurement of them in this injection. Methods HPLC was carried out in the column of Nucleodur C18 (250?mm × 4.6?mm, 5?μm),with CH 3OH 1%C 2H 4O 2 solution as the mobile phase (50∶50), the flowing rapidity being 0.8?mL?/min and the detecting wave length being 295?nm. Results The linear range of psoralen and isopsoralen were 2.5～25.0?μg?/mL respectively, with an averaged rate of 100.50%(RSD= 0.96 %) for the former and one of 100.23%(RSD= 0.96 %) for the latter in this injection. Conclusion HPLC can be used as a quality controlling method for Fructus Psoraleae Injection with such advantages as reliable, simplified and good reproducibility.
出处
《湖南中医学院学报》
2004年第3期12-13,18,共3页
Journal of Hunan College of Traditional Chinese Medicine
