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目的:考察难溶性药物长春西汀单层控释片的稳定性,为其处方进一步优化、包装选择、贮藏及运输条件提供理论依据。方法:将自制的控释片分别进行影响因素、加速和长期放置后对关键质量指标进行考察分析。结果:高温和强光对控释片质量基本没有影响,湿度对其影响较大,在加速和长期稳定性试验过程中同样发现高湿环境对控释片的影响。结论:湿度对控释片质量影响较为明显,提示包装、贮藏及运输时要保持密闭干燥的环境。
OBJECTIVE: To investigate the stability of single-layer controlled-release tablets of vinpocetine, which is a poorly soluble drug, to provide a theoretical basis for the further optimization of its formulation, packaging selection, storage and transportation conditions. Methods: The self-made controlled release tablets were the influencing factors, accelerated and long-term placement after the key quality indicators were investigated. Results: High temperature and bright light had no effect on the quality of controlled release tablets. Humidity had a great effect on them. During the accelerated and long-term stability test, the effect of high humidity on controlled release tablets was also found. Conclusion: The effect of humidity on the quality of controlled release tablets is more obvious, which indicates that the closed and dry environment should be maintained during packaging, storage and transportation.