配置后的8种中药注射液在不同温度及放置时间下的微粒变化

目的通过研究温度与放置时间对8种常用中药注射液微粒数的影响,为护理人员临床安全用药提供参考依据。方法应用微粒分析仪测定8种中药注射剂与溶媒配伍后,在三种不同温度环境和五个不同放置时间下测定不同粒径的微粒数并观察其变化。结果通过对实验所记录数据的重复测量分析统计显示:除了血栓通注射液与5%葡萄糖混合液,其余7种中药注射液与0.9%氯化钠注射液配伍后溶液中≥10μm和≥25μm微粒数均不符合药典的规定,且小于10μm的微粒占到90%以上。8种中药注射液与溶媒配伍后,血栓通、苦碟子在常温下不同粒径的微粒数目较少,其中血栓通在t=120 min、苦碟子在t=180 min时与即刻相比较溶液中≥2μm微粒数目较少且有统计学意义(P0.05),其他6种中药注射液与溶媒配伍后在高温下微粒数目较少,其中刺五加、艾迪、康艾、参麦注射液在t=180 min、银杏达莫在t=30 min时与即刻相比较,溶液中≥2μm微粒数目较少且有统计学意义(P0.05),香菇多糖在t=120 min微粒较少,但与即刻相比较差异无意义(P0.05)。结论建议不同药物在各自相对较佳的温度、放置时间下进行配置与静脉给药,或者使用更好的终端过滤器,以提高临床用药的安全性。

Study for the particles change of 8 kinds of traditional Chinese medicine injection under different ambient temperature and storage time

Objective To study the impact of temperature and storage time to eight commonly used traditional Chinese medicine＇s stability of clinical pharmacy,and to provide the reference for clinical drug safety.Method The number changes of particles of these traditional Chinese medicine injection was detected by particle analyzer at three different temperatures and five.Result The records of experimental data by repeated measures analysis of statistics, except for the Xuesaitong with 5%glucose injection,particles of≥10μm and≥25μm of the others seven mixture of injection with 0.9%sodium chloride injection drug≥10μm and≥25μm＇s particles does not conform to the provisions of both pharmacopoeia,and less than10μm particles is more than 90%.8 kinds of medicine injection and solvent is compatibility,Xuesaitong,Kudiezi at room temperature,the number of particles less T=120 min and T = 180 min,the number of particles≥2μm less compared with immediate solution.There is significant difference （P〈0.05）,and other 6 kinds of medicine injection and compatibility of tylosin in high temperature,Aidi,Kangai, Shenmai at T=180 min,Yinxindamo at T=30min,the number of particles≥2μm less compared with immediate, there is significant difference（P〈0.05）,Xiangguduotang in T=120 min particles less,but compared with immediate was not statistically significant（P〉0.05）.Conclusion Different drugs should be in their relative suggested temperature,time and place under intravenous drug use,or better terminal filter in order to improve the safety of clinical medication.