注射用卡络磺钠和二乙酰氨乙酸乙二胺与木糖醇注射液配伍稳定性研究

Compatibility of Carbazochrome Sodium Sulfonate and Ethylenediamine Diaceturate with Xylitol lnjection

目的考察注射用卡络磺钠和注射用二乙酰氨乙酸乙二胺分别与木糖醇注射液的配伍稳定性。方法采用HPLC,测定25℃和35℃条件下静置10h内注射用卡络磺钠和注射用二乙酰氨乙酸乙二胺与5%木糖醇注射液配伍后的含量变化,比较配伍前后外观、pH的变化。结果在25℃和35℃下配伍10h内卡络磺钠含量>97.8%、二乙酰氨乙酸乙二胺含量>98.1%,外观和配伍液pH值无明显变化。结论注射用卡络磺钠、注射用二乙酰氨乙酸乙二胺与5%木糖醇注射液10h内配伍稳定。

OBJECTIVE To study the compatibility of carbazochrome sodium sulfonate and ethylenediamine diaceturate with 5 % xylitol injection. METHODS Carbazochrome sodium sulfonate and ethylenediamine diacetu- rate were mixed in 5 % xylitol injection. The content of carbazochrome sodium sulfonate and ethylenediamine di- aceturate was determined by HPLC method, and pH values of the solution was measured, and appearance of the solution was observed within 10h at 25℃ and 35℃. RESULTS Compared with initial level, the content of car- bazochrome sodium sulfonate in 5 % xylitol injection is more than 97.8 %, and the content of ethylenediamine di- aceturate solution is more than 98.1%. The appearance and pH values have no apparent changes. CONCLUSION Carbazochrome sodium sulfonate and ethylenediamine diaceturate are stable in 5 % xylitol injection within 10h at 25℃ and 35℃ .