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目的:预测复方当归粉针剂的稳定性以保证临床用药安全有效。方法:采用经典恒温加速法,分别在65℃,75℃, 85 ℃,95℃恒温条件下,在不同间隔时间内用RP-HPLC法测定制剂中阿魏酸含量。结果:在有效期内,温度和时间不影响复方当归粉针剂的颜色、澄明度和pH值;复方当归粉针剂中阿魏酸含量随温度、时间而变化,属于1级降解反应。结论:复方当归粉针剂在室温下的有效期为2．19年,符合中药稳定性要求。
Objective: To predict the stability of compound Angelica injection in order to ensure the safety and effectiveness of clinical medication. Methods: The contents of ferulic acid in the preparation were determined by RP-HPLC at constant intervals of 65 ℃, 75 ℃, 85 ℃ and 95 ℃ by classical thermostatic accelerated method. Results: The temperature and time did not affect the color, clarity and pH value of the compound Angelica sinensis injection in the effective period. The content of ferulic acid in the compound Angelica sinensis powder injection changed with the temperature and time, which was the first grade degradation reaction. Conclusion: The compound Angelica powder injection at room temperature for a period of 2.19 years, in line with the stability requirements of traditional Chinese medicine.