基于指纹图谱技术评价银杏达莫注射液与7种药物的配伍稳定性

Compatible stability of ginkgo leaf extract and dipyridamole injection with seven injections based on HPLC fingerprint technology

目的:建立配伍稳定性评价方法考察银杏达莫注射液与7个药物的配伍稳定性,为临床用药安全提供科学依据。方法:建立评价指标:外观及可见异物、pH值、渗透压、含量、HPLC指纹图谱的余弦夹角相似度S、定量相似度P和含量相似度C,评价其配伍稳定性。结果:在本实验考察范围内银杏达莫注射液与吡拉西坦、维生素B6、硝酸甘油和多索茶碱4个药物配伍前后各评价指标均无显著差异,配伍过程中理化性质稳定;而三磷酸胞苷二钠、尼莫地平和奥扎格雷钠配伍药液的颜色、含量、P值和C值均有显著变化,不宜与银杏达莫配伍使用。结论:结合指纹图谱建立的配伍稳定性考察方法全面准确,适宜于中药注射剂稳定性评价。

OBJECTIVE To established a method for evaluating compatible stability of ginkgo leaf extract and dipyridarnole injection （GLEDI） with seven drugs, provide a scientific basis for clinical drug safety. METHODS Compatibility stability was evaluated by using the following indicators： appearance and visible foreign matter, pH value, osmolality, content and angle co- sine similarity S, quantitative similarity P and content similarity C of HPLC fingerprints. RESULTS GLEDI in combination with piracetam, vitamin B6, nitroglycerin or doxofylline produced no significant differences in the observed indicators. Physical and chemical properties of mixed liquids were stable, with no significant differences in indicators from the original injection. GLEDI was not compatible with cytidine triphosphate disodium, nimodipine and ozagrel. Color, content, P and C values of mixed liquid were significantly changed. CONCLUSION Based on HPLC fingerprint technology, the method is comprehensive and accurate for evaluating and investigating compatible stability, and it is suitable for stability evaluation of TCM injections.