复方白头翁结肠靶向片的稳定性考察

Stability Investigation of Compound Baitouweng Colon Targeting Tablet

目的:考察复方白头翁结肠靶向片的稳定性。方法:采用HPLC测定白头翁皂苷B4的含量,按2010年版《中国药典》中方法考察复方白头翁结肠靶向片的外观性状、脆碎度、释放度、质量差异;采用经典恒温试验计算制剂的有效期。结果:样品经高温、高湿、强光照射、加速试验后,各项指标均无明显变化。结论:复方白头翁结肠靶向片在室温(25℃)条件下,有效期为2.69年。

Objective： To investigate stability of compound Baitouweng colon targeting tablet. Method： The content of anemoside B4 was determined by HPLC, appearance characteristics, friability, release and weight variation of compound Baitouweng colon targeting tablet were investigated according to methods from the 2010 edition of Chinese Pharmacopoeia, Validity period of this preparation was determined by classical isothermal test. Result： After high temperature, high humidity, high light, acceleration tests, there was no significant change of each indicators in sample. Conclusion： Validity period of this product was 2. 69 years at room temperature （25℃） conditions.