曲克芦丁注射液与2种注射液配伍的稳定性考察

Study on the Stability of the Compatibility of Troxerutin Injection and Other 2 Injections

目的:考察曲克芦丁注射液与0.9 %氯化钠注射液及葡萄糖氯化钠注射液配伍的稳定性。方法:分别观察及测定配伍液于25℃条件下、24h内的外观、pH值及不溶性微粒的变化,并采用紫外分光光度法测定其含量变化,另用薄层色谱法鉴别其配伍后有无新斑点产生。结果:曲克芦丁注射液与2种注射液配伍后24h内,其外观、pH值、含量均无明显变化,不溶性微粒的增加数也符合《中国药典》规定,薄层色谱鉴别中也无新斑点产生。结论:曲克芦丁注射液可与0.9 %氯化钠及葡萄糖氯化钠注射液于25℃下、在24h内配伍使用。

OBJECTIVE:To study the stability of troxerutin injection when mi xed with0.9%NaCl injection and glucose saline.METHODS:The appearance,the pH value and the insoluble particles of the mixture solution at a temperature of25℃within24hours were observed,the contents change of which were determined by UV and whether there occurred new spots or not in the mixture was identified by TLC.RESULTS:No significant changes were found in the appearance,the pH value and the contents in the mixture of troxerutin injection and0.9%NaCl injection and glucose saline,the increase of the insoluble particles was in line with the specification stated in Chinese Pharmacopoeia;no new spots was found in the TLC identification.CONCLUSION:Troxerutin injection can be mixed with the0.9%NaCl injection and glucose saline for use at a temperature of25℃within24hours.