摘要
目的测定盐酸吉西他滨在不同pH缓冲液中的平衡溶解度以及在正辛醇-水和正辛醇-缓冲液体系中的表观油水分配系数,并对其水溶液的稳定性进行研究。方法采用HPLC法测定盐酸吉西他滨的含量,摇床法测定该药物的表观溶解度和油水分配系数。结果 25℃条件下,盐酸吉西他滨在水中的平衡溶解度为58.82 g·L^-1,在酸性介质中的平衡溶解度相对增加;盐酸吉西他滨的表观油水分配系数LgP为-1.22;60℃条件下,盐酸吉西他滨水溶液在pH3.84-10.37内较稳定,pH小于2或pH大于11时,降解反应加快,药物含量明显下降。结论盐酸吉西他滨的水溶性较强,其水溶液在强酸和强碱环境下不稳定。
Objective To determine the equilibrium solubility of gemcitabine hydrochloride in various media and its partition coefficients in the n-octanol-water/buffer solution system and research the stability of gemcitabine hydrochloride in buffers with different pH.Methods A high performance liquid chromatography was established and used to detect concentration of gemcitabine hydrochloride;the equilibrium solubility and partition coefficients for the n-octanol-water/buffer solution systems of gemcitabine hydrochloride were determined by shaking flask method.Results The equilibrium solubility of gemcitabine hydrochloride in water at 25 ℃ was 58.82 g·L-1 and it was higher in acid medium.Then the partition coefficient LgP was-1.22.Between pH 3.84-10.37,the stability of gemcitabine hydrochloride was good without the decrease of content.However,a significant content decrease occured when the pH was below 2 or above 11.Conclusions The water-solubility of gemcitabine hydrochloride is very good.And gemcitabine hydrochloride is unstable under the environment of strong acid and strong alkali.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2010年第8期595-598,共4页
Journal of Shenyang Pharmaceutical University
基金
国家自然科学基金资助项目(30672555)
