摘要
目的:研究红花输液在加热制备前后成分的整体变化,给药品的安全性评价提供参考依据。方法:以羟基红花黄色素A为参照物,应用HPLC指纹图谱检测方法,对红花输液从药材、中间体到成品的全制备过程进行跟踪检测,其检测点温度分别设置为室温、100℃、115℃,观察不同温度下各样品指纹图谱中特征峰的出现和消失;峰面积减少和增大的变化。结果:温度升至100℃时,保留时间在7、26～27、44min时新的峰出现,8、36min原有的峰消失,当温度继续升至115℃时,7、10min的峰又消失;保留时间在31～32、44min时的峰随着温度的升高峰面积加大,37min时的峰(HSYA)随着温度升高峰面积减少。结论:随着温度的升高,红花输液中有新的化合物产生,但随着温度的继续升高,新的化合物又遭到破坏。
AIM ： To study incorporate changes of compound in safflower infusion solution before and after heating by HPLC fingerprint, in order to provide reference of drug＇ s safety evaluation. METHODS： Hydroxysafflor yellow A was used as reference substance, safflower infusion solution was detected by HPLC fingerprint in the whole manufacturing process from original raw material ,intermediate to finished product. The detector temperature was set at room temperature, 100 ℃, 115 ℃, and then the change in the peak＇ disappearance and appearance was observed and the peak area＇ decrease and increase showed by characteristic absorption peak of every sample product at dif- ferent temperature. RESULTS： As the temperature rose to 105 ℃, new peaks appeared at the retention time of 7, 26 - 27,44 minutes, original peaks would disappear at the time 8,36minutes. As the temperature continued to rise to 115 ℃ ,the peak at the time of 7,10 minutes disappeared again, the peak area increased during the temperature ris- ing at retention the time of 31 -32,44 minutes and decreased at the retention time of 37 minutes. CONCLUSION： It indicates that, heating safflower infusion solution would produce a new compound. As the temperature continues to rise, the new compound would be destroyed.
出处
《中成药》
CAS
CSCD
北大核心
2009年第2期165-168,共4页
Chinese Traditional Patent Medicine
关键词
指纹图谱
红花输液
羟基红花黄色素A
fingerprint
safflower infusion solution
hydroxy safflower yellow A
