Thermolability in the process of safflower infusion solution by HPLC fingerprint / 中成药

ABSTRACT

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 different 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 rising 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.