7种糖尿病常用药与木糖醇注射液的配伍稳定性研究

Stability of xylitol injection combined with the seven drugs commonly used in diabetic patients

目的：用HPLC法探索7种糖尿病病人常用药与木糖醇注射液的配伍稳定性,为临床用药提供参考。方法：建立HPLC法测定硫辛酸注射液、注射用埃索美拉唑钠、注射用血栓通、丹参酮ⅡA磺酸钠注射液、氨溴索注射液、氨茶碱注射液、地塞米松磷酸钠注射液7种药品在木糖醇注射液中的含量。观察配伍液在室内见光或避光条件下,放置不同时间后的外观,测定pH值及含量。结果：硫辛酸注射液在室内见光条件下,0~8h内配伍液由无色澄清变为黄色,pH值由7.84降为5.76,6h后含量〈90%;在避光条件下,pH值无明显变化,8h内含量为98.53%。注射用埃索美拉唑钠无论是避光还是室内见光条件,在6h时配伍液均由无色澄清变为微黄色,pH值均略有下降,8h后含量分别是97.33%、96.22%。其他5种药品与木糖醇注射液配伍后,在避光条件和室内见光条件下,8h内配伍液的pH值、颜色、澄清度均无明显变化,含量测定结果均〉98%。结论：硫辛酸注射液见光易分解,建议临床避光下使用。注射用埃索美拉唑钠与木糖醇注射液配伍6h内可安全使用。其他5种药品与木糖醇注射液配伍8h内稳定,可配伍使用。

Objective： To investigate the stability of xylitol injection combined with the seven drugs commonly used in dia-etic patients by using HPLC method,in order to provide reference for clinical drug use. Methods： The HPLC methods for content determination of 7 kinds of injections, such as thioctic acid（TA）,esomeprazole sodium（ES）,Xueshuantong,tanshinone Ⅱ A sodium sulfonate,ambroxol, aminophylline, dexamethasone sodium phosphate were established. The appearance of the 7 injections were closely observed, and pH value and the contents were determined under indoor light and dark conditions. Results： Under indoor light,the color of TA mixture in xylitol injection changed from colorless to yellow within 8 h. The pH value of the mixture decreased from 7.84 to 5.76. The content of TA decreased to less than 90 %0 after 6 h. However, under dark conditions, the pH value of the mixture showed no significant changes and the content of TA decreased to 98.53% after 8 h. No matter whether it was under indoor light or at dark conditions,the color of ES in xylitol injection changed from colorless to pale-yellow in 6 hours. The pH value of the mixture decreased slightly. The contents of ES decreased to 97.33% and 96.22% after 8 h under the above conditions. There were no significant changes in pH value, color and clarity in the other 5 mixtures within 8 h. The content of the other 5 mixtures detected were all above 98%. Conclusion： TA injection was liable to decomposition under light conditions, and it was recommended that it be used under dark conditions. When combined with xylitol injection, esomeprazole sodium injection could be safely used within 6 hours. The property of the other 5 drugs when combined with xylitol injection remained stable within 8 hours, so they could be used safely clinically.