双贯滴眼液稳定性研究

目的　研究双贯滴眼液的稳定性,并预测其室温条件下有效期。方法　以双贯滴眼液中绿原酸含量为指标,采用高效液相色谱法测定其含量变化,恒温加速方法、室温条件下强光照射方法和留样观察方法测定稳定性。结果　双贯滴眼液中绿原酸在酸性环境较碱性中稳定,在强光下稳定性差。结论　双贯滴眼液的pH应控制在 5 5 0～ 6 0 0之间,避光保存,有效期为 30 5天。

Study on stability of Shuangguan Eye Drops

Objective To study the stability of Shuangguan Eye Drops and predict its period of validity at room temperature. Methods By using the contents of Chlorogenic acid in Shuangguan Eye Drops as the index, the changes in the contents were determined by HPLC. The stability test was carried out by the methods of thermostatic accelerated and exposure to high light at room temperature and sample reserving observation. Results The experiment showed the Chloride acid in Shuangguan Eye Drops was more stable in acidic water than in basic water, and unstable to the high light. Conclusion The pH of Shuangguan Eye Drops should be controlled in the range of 5.50～6.00, and kept in lightproof place. The period of validity at 25℃ was 305 days.