醒脑静注射液静脉药物配制中心集中配置后的有效时间研究

Investigation of the effect time of Xingnaojing injection after drug allocation in PIVAS

目的:研究确定醒脑静注射液与10%葡萄糖注射液、5%葡萄糖注射液、0.9%氯化钠注射液3种溶媒在PIVAS集中配置后的有效时间。方法:将醒脑静注射液分别与10%葡萄糖注射液、5%葡萄糖注射液、0.9%氯化钠注射液在PIVAS配置后,观测其在0～8 h内的性状、pH、不溶性微粒和渗透压摩尔浓度的变化;采用气相色谱法测定0～6 h内其有效成分麝香酮和冰片的含量。结果:醒脑静注射液与3种溶媒配置后8 h内药液性状、pH、不溶性微粒、渗透压均符合《中国药典》(2015年版)标准要求;有效成分麝香酮在0.9%氯化钠注射液中6 h内稳定,在5%葡萄糖注射液中4 h时降解11.92%,在10%葡萄糖注射液中4 h时降解8.83%;有效成分冰片在0.9%氯化钠注射液和5%葡萄糖注射液中6 h内稳定,在10%葡萄糖注射液中5 h时降解9.11%。结论:醒脑静注射液与0.9%氯化钠注射液PIVAS配置后的有效时间为6 h。醒脑静注射液与5%葡萄糖注射液、10%葡萄糖注射液PIVAS配置后的有效时间为3 h。

OBJECTIVE To investigate the effect time of Xingnaojing injection with 10%glucose injection,5%glucose injection and 0.9%sodium chloride injection after drug allocation in PIVAS.METHOD Xingnaojing injection was allocated with different solvents such as 10%glucose injection,5%glucose injection and 0.9%sodium chloride injection in PIVAS,and the changes were evaluated in appearance,pH,insoluble particle and osmotic moor concentration in 8 hours.The concentrations of muscone and borneol were determined using gas chromatography in 6 hours.RESULTS There were no significant changes in appearance,pH,insoluble particle,or osmotic moor concentration of Xingnaojing injection allocated with three different solvents in 8 hours,and met the requirement of Chinese Pharmacopoeia(2015).The concentration of muscone was stable for 6 hours in the 0.9%sodium chloride injection,but was degraded by 11.92%and 8.83%for 4 hours in 5%glucose injection and 10%glucose injection,separately.The concentration of borneol was stable in 0.9%sodium chloride injection and 5%glucose injection for 6 hours,but was degraded by 9.11%for 5 hours in 10%glucose injection.CONCLUSION The effect times of Xingnaojing injection allocated with 0.9%sodium chloride injection,5%glucose injection and 10%glucose injection are 6 hours,3 hours and 3 hours,respectively.