目的 研究清開(kāi)靈注射液與注射用頭孢西丁鈉配伍的穩(wěn)定性。方法 在模擬臨床用藥濃度條件下，考察清開(kāi)靈注射液與注射用頭孢西丁鈉配伍后4 h內(nèi)溶液的外觀、pH值、不溶性微粒的變化，并采用高效液相色譜法測(cè)定配伍液中黃芩苷和頭孢西丁。結(jié)果 4 h內(nèi)配伍液的外觀、pH值無(wú)明顯改變。隨著時(shí)間的延長(zhǎng)，配伍液中10 μm、10 μm以上的不溶性微粒數(shù)增多，1 h后超過(guò)《中國(guó)藥典》2010年版標(biāo)準(zhǔn)。黃芩苷和頭孢西丁的質(zhì)量濃度均逐漸降低。結(jié)論 清開(kāi)靈注射液與注射用頭孢西丁鈉配伍后4 h內(nèi)不穩(wěn)定，不建議配伍使用。

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 μm 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.