冠心宁注射液与两种输液的配伍稳定性研究

Stability of guanxinning injection in two injections

目的考察冠心宁注射液与5%葡萄糖注射液、氯化钠注射液配伍后的稳定性。方法将冠心宁注射液与5%葡萄糖注射液(20∶500、40∶500)、氯化钠注射液(10∶100、20∶100)分别按临床常用比例配伍后,依照2005版药典的方法考察不同时间点混合液的外观、pH值、不溶性微粒、紫外吸收光谱、细菌内毒素限量及冠心宁注射剂的含量变化。结果混合液外观、紫外吸收光谱无明显变化,细菌内毒素符合药典标准,pH值和不溶性微粒发生显著增加,且变化趋势与混合液放置时间延长(4 h内)及冠心宁注射液浓度具有一定的相关性。结论冠心宁注射液和5%葡萄糖注射液、氯化钠注射液配伍后微粒增加、葡萄糖含量下降应引起重视。

Aim To study the stability of guanxinning injection in 5% glucose solution and sodium chloride solution.Methods Guanxinning injection was mixed with 5% glucose injection and sodium chloride injections respectively according to the ratio of 20∶ 500,40∶ 500（5%GS）,10∶ 100,20∶ 100（NS）（v/v）.The appearance,pH,insoluble particles,UV and bacterial toxins limited of the mixture were determined within 4h by the methods described in Chinese Pharmacopoeia（2005）.Results The appearance and UV of mixed solutions had no significant change and bacterial toxin accord with Pharmacopoeia standards,but pH value and particulate matter showed change significantly.Conclusion The phenomena must be noticed on the increase of insoluble particles and the decrease of glucose after guanxinning injection and 5% glucose injection,sodium chloride injection were mixed in different ratios.