鼻渊灵颗粒的稳定性考察

Stability of Biyuanling Granules

目的:考察鼻渊灵颗粒中黄芩苷的稳定性,并预测其有效期。方法:采用反相高效液相色谱法测定鼻渊灵颗粒中黄芩苷的含量:色谱柱为Diamonsil ODS C_(18)(200 mm×4.6 mm,5μm),流动相为甲醇-水磷酸(53:47:0.2),检测波长为274 nm;采用经典恒温加速试验法考察药物的稳定性,并计算其有效期。结果:该制剂中黄芩苷在25℃下分解常数K=4.592×10^(-6)h^(-1),有效期t_(0.9)=2.62 a。结论:本方法科学、合理,可用于鼻渊灵颗粒的稳定性考察。

OBJECTIVE： To study the stability of Baicalin in Biyuanling granules and predicate its validity duration. METHODS： The content of Baicalin in Biyuanling granules was determined by RP-HPLC on Diamonsil ODS C18 chromatographic column（200 mm×4.6 mm, 5μm） with methanol -waterphosphoric acid（53 ： 47 ： 0.2） used as mobile phase. The detective wavelength was set at 274 nm. The stability of Baicalin in Biyuanling granules was determined by classical accelerated test process in constant temperature and its validity duration was computed. RESULTS： The disintegration constant of Baicalin at 25℃ was K = 4. 592× 10^-6 h^-1, and the validity duration was t 0.9 = 2.62 years. CONCLUSION： The method developed in this study was proved to be scientific, reasonable and suitable for the study of the stability of Biyuanling granules.