银花清咽片的稳定性研究

目的:考察银花清咽片的稳定性,为制定银花清咽片的有效期提供参考。方法:按2010年版《中国药典》(二部)附录中对薄膜衣片稳定性试验的有关要求,对银花清咽片进行影响因素试验、加速试验和长期试验,考察其在不同条件下的性状、崩解时间和主要成分含量的变化;采用高效液相色谱法测定制剂中绿原酸、木犀草苷、连翘苷和连翘酯苷A的含量。结果:样品分别在60△、相对湿度(90±5)%、照度为(4 500±500)lx的条件下放置10 d,在温度(40±2)△、相对湿度(75±5)%的条件下放置6个月,在温度(25±2)△、相对湿度(60±10)%的条件下放置12个月后,各项考察指标均未见明显变化,符合2010年版《中国药典》(二部)的质量标准规定。结论:银花清咽片稳定性较好,建议有效期暂定为1年。

Stability Study ofYinhua Qingyan Tablet

OBJECTIVE：To investigate the stability of Yinhua Qingyan tablet, and to provide reference for the formulation of validity period of it. METHODS： According to the requirements of stability test for film-coated tablet stated in part Ⅱ of Chinese Pharmacopeia, influential factor test, accelerated test and long-term test were carried out to investigate the property, disintegration time Of and the content of the active ingredients. The content of chlorogenic acid, galuteolin, forsythin and forsythoside were determined by HPLC. RESULTS： Yirthua qingyan tablet did not show obvious change in above index after setting at 60 ℃, relative humidity of （90 ± 5）% and illumination of （4500 ± 500）lx for 10 d; at（40 ± 2）℃, relative humidity of （75 ± 5）% for 6 months or at （25 ± 2）℃ ,relative humidity of （60 ± 10）% for 12 months. The indicators varied in the range of quality standards stated in part Ⅱ of Chinese Pharmacopeia. CONCLUSIONS： Yinhua qingyan tablet is relatively stable and its shelf-life is tentatively set up as 1 year.