注射用盐酸吉西他滨与4种临床常用输液的配伍稳定性

目的建立盐酸吉西他滨含量测定的H-PLC法,并研究盐酸吉西他滨与4种临床常用输液的配伍稳定性。方法用HPLC法测定盐酸吉西他滨与0.9%氯化钠注射剂、5%葡萄糖注射剂、葡萄糖氯化钠注射剂和乳酸钠林格注射剂配伍后在室温(25℃)、30℃、40℃及光照条件下,不同时间点的盐酸吉西他滨的含量,同时考察其外观及pH值变化。结果注射用盐酸吉西他滨与4种临床常用输液配伍后,室温和30℃下放置24 h,其外观、pH值无明显变化,含量无明显降低。40C下放置12 h,其外观、pH值、含量无明显变化;放置24 h后外观无变化,pH值略有升高,含量平均降低5%;(4 500±500)Lx照度下放置5 d,其外观、pH值无明显变化,含量元明显降低;放置10 d后,外观无变化,pH略有升高,含量平均降低4%。结论单从稳定性角度考虑,盐酸吉西他滨与4种临床常用输液可以配伍使用,但在40℃或(4 500±500)Lx照度条件下,存放时间不宜过长。

Compatible stability of gemcitabine hydrochloride for injection with four common clinical infusion fluids

AIM To establish a method for the determination of gemcitabine hydrochloride and to assess the sta- bility of gemcitabine hydrochloride for injection with the four common clinical infusion fluids. METHODS The contents of gemcitabine hydrochloride in the different fluids （0.9% sodium chloride injection, 5% dextrose injection, glucose and sodium chloride injection and sodium lactate ringer＇ s injection） were determined at different temperature and light condition of （4 500 ＋ 500） Lx by HPLC at different time points. The outward appearance, color variety and pH value were investigated as well. RESULTS Within 24 h, the contents, the outward appearance or the pH value of gemcitabine hydrochloride had no apparent changes at 25 and 30℃ ; after 24 h, the contents decreased by 5 % at average, the pH value increased slightly at 40~C ; after 10 days, the contents decreased by 4% at average, the pH value increased slightly at （4 500 ＋ 500）Lx. Otherwise, in the same condition the contents of gemcitabine hydrochloride in Gemzar fluids was lit- tle higher than in Yujie fluids. CONCLUSION Gemcitabine hydrochloride for injection are chemically stable in the four fluids, but in the condition of 40℃ and light it must be used carefully after a long time delay.