基 于 重 量、残 留 量 及 含 量监 测技 术 的 PIVAS输液质量监测模式构建

OBJECTIVE To construction a reliable, simple and rapid quality monitoring model for infusion preparation in PIVAS, in order to ensure the safety and effectiveness during the patients′ infusion. METHODS We adopted testing measures (gravimetric, drug residue, and qualitative and quantitative analysis method) in the quality control of the whole transfusion process for infusion preparation in PIVAS. The ceftazidime for injection representing powder injection, betahistine hydrochloride and doxofylline injection representing aqueous solution was selected as research object to investigate the relationship between the weight of infusion, drug residue and relative percentage of drug content. RESULTS The qualified rates of relative percentage of ceftazidime infusion before and after gravimetric monitoring technology were 76.0% and 84.8%, respectively. There was no significant correlation between the increase of infusion weight and drug content (r2=0.002). The linear correlation coefficient r2 between the residual volume of liquid with the residual amount of drug were 0.378 and 0.693, respectively. The qualified rates of relative percentage of betahistine hydrochloride and doxofylline injection representing aqueous solution were 97.3%, and the correlation r2 between the increase of infusion weight and the content of betahisteine hydrochloride and doxofylline were 0.724 and 0.588, respectively. CONCLUSION The testing measures of drug residue and gravimetric technology can be used as daily indicators for PIVAS transfusion preparation quality monitoring, but the qualitative and quantitative analysis method were the gold standard for the quality control of infusion preparation. The combination of testing measures (weight monitoring, residual and quantitative analysis technology) can effectively improve the quality of infusion preparation and ensure the effectiveness and safety of clinical infusion medication.