梦宁片中栀子苷的稳定性研究

Study on the Stability of Geniposide in Mengning Tablets

目的 建立梦宁片中栀子苷含量的HPLC测定方法,并以此考察栀子苷的热稳定性,为确定梦宁片的有效期提供动力学数据。方法 超声提取样品,流动相:0.2％三乙胺水溶液(含0.1％磷酸)-乙腈(85:15):检测波长240 nm;流速:1.0 mL·min^(-1)。采用高温加速试验法对栀子苷的热稳定性进行研究。结果 栀子苷在0.10μg～0.52μg的范围内线性关系良好,相关系数r=0.9997;平均回收率为98.92％,RSD=2.81％(n:5);该复方中栀子苷的变化为一级反应,常温下梦宁片以栀子苷为指标的有效期为2.83年。结论 该方法的建立对快速确定药品的有效期,缩短新药的开发周期具有实际意义。

Objective To establish a HPLC method for the determination of geniposide in Mengning Tablets and to investigate the thermal stability of geniposide. Methods The content of geniposide in Mengning Tablets was determined on a E- clipse XDB-C_(18) column with a mobile phase consisting of 0.2% triethylamine (containing 0.1% phosphate) and acetonitrile (85: 15) at a flow rate of 1.0 mL·min^(-1) and detected at a wavelength of 240 nm. The thermal stability of geniposide was investigated by hyperthermal accelerated test. Results A linearity was obtained from 0. 10 μg to 0.52 μg of geniposide (r=0.9997, n=5) and the recovery was 98.92%(n=5). The variation of geniposide in Mengning Tablets was in first-order reaction and the expiry date of the medicine at normal temperature was 2.83 years when geniposide content was used as criteria. Conclusion This is a fast method for the determination of the expiry date of a Chinese patent medicine and this method is useful infor the development of a new medicine.