pH值依赖的帕瑞昔布钠溶液化学稳定性、溶解度和油水分配系数研究  

pH-dependent solution chemical stability,solubility and oil-water partition coefficient of parecoxib sodium

作　　者：黄晶 李爽 吴春芝[2] 谷福根[2] HUANG Jing;LI Shuang;WU Chun-zhi;GU Fu-gen(School of Pharmacy,Inner Mongolia Medical University,Hohhot 010110;Affiliated Hospital,Inner Mongolia Medical University,Hohhot 010050)

机构地区：[1]内蒙古医科大学药学院,呼和浩特010110 [2]内蒙古医科大学附属医院,呼和浩特010050

出　　处：《中南药学》2022年第1期99-103,共5页Central South Pharmacy

摘　　要：目的研究介质pH值对帕瑞昔布钠(PCX)溶液化学稳定性、溶解度及油水分配系数的影响,为PCX鼻腔给药新剂型的研究提供理论依据。方法建立PCX的HPLC分析方法,研究不同pH条件下药物溶液化学稳定性、溶解度及油水分配系数。结果pH<6.0时,PCX溶液的化学稳定性较差,当pH≥6.0时,PCX溶液的化学稳定性良好;PCX的溶解度随着介质pH值的增大而增大,在碱性pH下其溶解度较好;PCX的油水分配系数随着pH值的增大而逐渐减小,在酸性pH下,油水分配系数较大,而在碱性pH下,油水分配系数很小。结论PCX溶液化学稳定性、溶解度及油水分配系数具有明显的pH值依赖性。Objective To determine the effect of media pH on the solution chemical stability,solubility and oil-water partition coefficient of parecoxib sodium(PCX)to provide a theoretical foundation for the development of a new PCX nasal preparation.Methods A HPLC analytical method for the determination of PCX was established.The solution chemical stability,solubility and oil-water partition coefficient of PCX at different pH values were measured.Results The stability of PCX solution was poor when pH<6.0,while chemical stability was good at pH≥6.0.The solubility of PCX increased with the increase of media pHs,with better drug solubility in alkline pH condition.The oil-water partition coefficient decreased with the increase of media pHs.Conclusion The chemical stability,solubility and oil-water partition coefficient of PCX are obviously dependent on the media pHs.

关 键 词：帕瑞昔布钠 理化性质 化学稳定性 溶解度 油水分配系数 pH依赖性 

分 类 号：R284.1[医药卫生—中药学]