清开灵注射液配伍注射用头孢西丁钠的稳定性研究

Stability on Qingkailing Injection used in combination with Cefoxintin Sodium for injection

目的研究清开灵注射液与注射用头孢西丁钠配伍的稳定性。方法在模拟临床用药浓度条件下,考察清开灵注射液与注射用头孢西丁钠配伍后4 h内溶液的外观、pH值、不溶性微粒的变化,并采用高效液相色谱法测定配伍液中黄芩苷和头孢西丁。结果 4 h内配伍液的外观、pH值无明显改变。随着时间的延长,配伍液中10μm、10μm以上的不溶性微粒数增多,1 h后超过《中国药典》2010年版标准。黄芩苷和头孢西丁的质量浓度均逐渐降低。结论清开灵注射液与注射用头孢西丁钠配伍后4 h内不稳定,不建议配伍使用。

Objective To investigate the stability of Qingkailing Injection used in the combination with Cefoxintin Sodium for injection. Methods The changes of solution color, pH values, and insoluble particles were observed in the simulation conditions of clinical concentration within 4 h. The contents of baicalin and cefoxintin were determined in Qingkailing Injection used in the combination with Cefoxintin Sodium for injection within 4 h by HPLC. Results The solution color and pH values showed no obvious changes. With the extending of compatible time, the numbers of insoluble particles of 10 Ixrn and above were increased and exceeded the China Pharmacopoeia （2010 Edition） requirements after 1 h. Meanwhile, the contents of baicalin and cefoxintin gradually decreased. Conclusion The solution is unstable after Qingkailing Injection used in the combination with Cefoxintin Sodium for injection within 4 h, therefore, it suggests not using Qingkailing Injection in the combination with Cefoxintin Sodium for injection.