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目的:研究光照、高温条件下对新伤去瘀口服冻干颗粒中丹酚酸B稳定性的影响并预测其保质期,为制剂临床应用和贮存提供依据。方法:采用HPLC法对丹酚酸B进行含量测定,考察光照、温度对新伤去瘀口服冻干颗粒中丹酚酸B稳定性的影响。结果:新伤去瘀口服冻干颗粒在光照(4000Lx)下30 d内,丹酚酸B含量无变化;采用高温加速实验法预测制剂有效期为1.67 y。结论:新伤去瘀口服冻干颗粒对光照稳定,加速实验预测有效期为1.67 y。
Objective: To study the effects of light and high temperature conditions on the stability of salvianolic acid B in new wound-removal oral freeze-dried granules and to predict its shelf life, so as to provide basis for clinical application and storage of preparations. Methods: HPLC method was used to determine the content of salvianolic acid B. The effects of light and temperature on the stability of salvianolic acid B in freshly wounded oral lyophilized granules were investigated. RESULTS: The content of salvianolic acid B did not change within 30 days under light (4000 Lx) in freshly wounded oral lyophilized pellets. The accelerated period of experiment was 1.67 years. Conclusion: The new injury to the oral administration of freeze-dried particles is stable to light, and the accelerated experimental prediction is 1.67 years.