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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 the stability of compound Pulsatilla colon targeting tablets. Methods: The content of Pulsatilla saponin B4 was determined by HPLC. The appearance, friability, release and quality of Pulsatilla colon targeting tablets were investigated according to the 2010 edition of “Chinese Pharmacopoeia”. The expiration date of the preparation was calculated by classical thermostatic test. Results: After the samples were exposed to high temperature, high humidity, bright light and accelerated test, there was no significant change in each index. Conclusion: The compound Pulsatilla colon targeting tablets at room temperature (25 ℃) conditions, valid for 2.69 years.