ABSTRACT
Objective To study the local irritation of repeated intrathecal injection of Ziconotide Acetate,and to provide reference for irritancy evaluation ofintrathecal injection.Methods Sixteen New Zealand rabbits were assigned into two groupsat random:Control group and Ziconotide Acetate group,eight animals each group.Totally 50 μL saline or Ziconotide Acetate (100 μg/mL) were administrated by repeated lumbar intrathecal injection once daily for 7 d.Animal behavior was observed every day,and four animals in each group were sacrificed 2 d later after the last injection,the lumbar spinal cord was removed for histopathological examination and irritancy evaluation.The remaining animals were sacrificed for initancy evaluation 14 d later after the last injection.Results Only one animal died after anesthesia on day three in saline group,while no obvious adverse reactions were observed in other rabbits during the entire study,and no intrathecal irritant reactions of histopathological examination were found in both groups.The reversible minor mechanical damage was observed at the injection point,2 d after the last administration.Conclusion For 7 d repeated lumbar intrathecal injection in rabbits,no intrathecal irritant reactions observed in Ziconotide group,and the New Zealand rabbit could be used as a local irritation evaluation model.
ABSTRACT
The adverse reactions caused by traditional Chinese medicine have occurred frequently, but there is a lack of scientific,objective and standardized methods for safety evaluation of traditional Chinese medicine.In the process of preclinical evaluation of traditional Chinese medicine, it is imperative to form a set of scientific, standardized and feasible evaluation system of modem Chinese herbal drug.We established the preclinical safety evaluation system of modem Chinese herbal drug including the quality control system of samples for the preclinical safety evaluation, the toxicity evaluation system of modem Chinese herbal drug and its preparation and the evaluation management system, and standardized each research link of preclinical evaluation of traditional Chinese medicine.Whether from protecting patients' health and increasing the safety of clinical medication, or from enriching and improving traditional Chinese medicine science, developing traditional Chinese medicine and promoting mutual connection of traditional Chinese medicine and international medicine, it has important instructional significance and application value.