川射干口服液含量测定及稳定性研究

Determination of the content and stability of Chuanshegan oral liquid

为了考察川射干口服液稳定性,采用高效液相色谱法(HPLC)测定川射干口服液活性成分射干苷含量并进行方法学考察,通过影响因素试验和加速试验对川射干口服液的稳定性进行研究。结果:该法专属性强,在选定色谱条件下射干苷与其他杂质峰能够达到基线分离,在10~160μg/mL范围内浓度与峰面积呈线性相关,具有良好的精密度、重复性和准确度,平均回收率可达100.16%,表明本研究所采用的射干苷含量检测方法适用于川射干口服液含量测定。强光和高温对射干苷含量有一定影响,在加速条件下放置6个月,川射干口服液含量有所降低,为确保川射干口服液质量,储存过程需要控制温度和光照。

In order to explore the stability of Chuanshegan oral liquid, the HPLC method was employed to investigate the content of Tectoridin, the major bioactive component of Chuanshegan oral liquid, and a methodlogical observation was performed at the same time. Then theinfluencing factor test and the accelerated stability test were conducted to study the stability of Chuanshegan oral liquid. The results showed that, under chosen chromatography, the peak values of Tectoridin and other materials in Chuanshegan reached the baseline for separation, and, within the concentration range of 10~160 μg/mL, the concentration of Tectoridin had a good linear relationship with its peak area. The determination method proposed here was useful in detecting the content of Chuanshegan oral liquid with high specificity, precision and accuracy and an average recovery rate of 100.16%. However, the accelerated test showed that the content of Chuanshegan oral liquid was decreased under the strong light and high temperatureTherefore, the temperature and light should be strictly controlled during storage of the oral liquid.