市售复方甘草含片与复方甘草片组分稳定性比较研究

Market Sales Compound Liquorice Buccal Tablets and Compound Liquorice Tablets Comparative Study on the Stability of the Components

目的:考察比较市售复方甘草含片与复方甘草片处方组分的稳定性。方法:按照2020版《中国药典》9001技术要求,观察影响因素及加速条件对复方甘草含片和复方甘草片处方组分稳定性的影响。结果:复方甘草含片和复方甘草片在高温、高湿条件下组分甘草酸和吗啡稳定,八角茴香油和樟脑有损失,在强光照射条件下组分甘草酸、吗啡、八角茴香油和樟脑均有损失,而八角茴香油和樟脑的损失率更高。结论:在高温、高湿及强光照射条件下复方甘草含片处方组分的损失率明显低于复方甘草片,将复方甘草片改进工艺制成复方甘草含片,其组分的稳定性明显提高,对复方甘草含片与复方甘草片的制备方法和药品储藏有一定的指导意义。

Objective:Comparison of market sales compound liquorice buccal tablets and compound liquorice tablets stability of the prescription composition.Methods:Based on"Chinese pharmacopoeia"2020 Edition 9001 technical requirements,to observe the severe test and accelerated conditions for the components stability influence of the compound liquoricebuccal tablets and compound liquorice tablets.Results:The contents of glycyrrhizic acid and morphine in compound liquorice buccal tablets and compound liquorice tablets were stable underhigh temperature,and high humidity conditions,and the contents of star anise oil and camphor content were lost,while the contents of glycyrrhizic acid,morphine,star anise oil and camphorwere lost under strong light irradiation,especially the lost rate was higherunder light irradiation conditions.Conclusion:The loss rate of each composition of compound liquorice buccal tablets was significantly lower than the compound liquoricetablets under the condition of high temperature,high humidity and strong light irradiation.The stability of compound liquoricebuccal tablets can be improved obviously by changing the preparation process of compound liquorice tablets.It has a certain guiding significance for the preparation and storage of compound liquorice buccal tablets and compound liquorice tablets.