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目的考察山楂叶总黄酮磷脂复合物的稳定性,为其剂型选择、工艺设计与贮存条件的确定提供实验依据。方法对山楂叶总黄酮磷脂复合物进行强光照射、高温、高湿试验,考察其对复合物的质量、总黄酮和牡荆素鼠李糖苷质量分数的影响;以10 h后的复合物中总黄酮质量分数变化率为指标考察介质、温度、pH值对其稳定性的影响。结果山楂叶总黄酮磷脂复合物具有一定的抗光照、热稳定性,但高湿条件下复合物吸湿明显;介质种类对其影响较小,其水溶液在高温与高pH值条件下稳定性较差。结论山楂叶总黄酮磷脂复合物以固体形式保存,稳定性较好,因具有吸湿性,应在干燥条件下保存。
Objective To investigate the stability of total flavonoids in hawthorn leaf phospholipid complex and provide experimental basis for the selection of dosage forms, process design and storage conditions. Methods The total flavonoids of hawthorn leaves phospholipid complex were exposed to high light and high temperature, high humidity test to investigate the quality of the complex, total flavonoids and vitexin rhamnoside mass fraction; 10 h after the complex The change rate of total flavonoids mass index as an indicator to examine the medium, temperature, pH value of its stability. Results Hawthorn leaves total flavonoids phospholipid complex has certain anti-light, thermal stability, but the hygroscopic complex under high humidity conditions obvious; medium species less affected, the aqueous solution at high temperature and high pH value under the conditions of poor stability . Conclusion The hawthorn leaf flavonoid phospholipid complex is stored in solid form with good stability. Due to its hygroscopicity, it should be stored under dry conditions.