目的 比较不同指标预测葛根注射液稳定性的差异 ,为稳定性评价指标选择的必要性提供实验依据。方法 采用经典恒温加速试验法预测稳定性 ,注射液中葛根总黄酮与葛根素的含量测定分别采用紫外分光光度法与HPL C法。结果 注射液中有效部位总黄酮与有效成分葛根素的降解符合一级反应规律 ,分别以二者为指标的 t2 5℃0.9为 0.63 a和 1.82 a。结论 不同类型的稳定性评价指标对制剂的稳定性预测结果存在较大影响 ,提供充分的稳定性评价指标选择依据是必要的。

Object To compa re the stabi li ty of PU ERARIN IN JECTION as predicted by the change of total Puerarin flavo noids and kako nein in the prepa ration during stabili ty test, to provide an ex ample showing the importance for the proper choice of stabi li ty index based upon different activ e principles present in the preparatio n. Methods The stability of the prepa ration under study were tested by the classical accelerated iso thermal method and the change of total Puerarinf lavonoids and kakonein were determined by UV and HPLC. Results The deg radation of both active principles follow ed the fi rst order reactio n. The t25℃ 0. 9 w ere 0. 63 a and 1. 82 a respectiv ely. Conclusion The stabili ty o f PUERARIN IN JECTION will show di fferent v alues w hen based upon ei ther single ing redient , sugg esting the necessi ty to provide a logical basis fo r the determina tion o f stability index.