利福喷丁的溶解性与稳定性考察  

Study on Solubility and Stability of Rifapentine

作　　者：折胜利[1] 罗兰[2] 吕顺忠[2] 古丽再努尔·吐尔逊[2] 蒋岳华[1] 宋兴华[1] 

机构地区：[1]新疆医科大学第一附属医院骨科,乌鲁木齐830054 [2]新疆医科大学第一附属医院药学部,乌鲁木齐830054

出　　处：《中国药房》2012年第17期1556-1558,共3页China Pharmacy

基　　金：新疆维吾尔自治区自然科学基金资助项目(2010211A46)

摘　　要：目的:考察利福喷丁的溶解性及其稳定性,为开发其新剂型奠定基础。方法:采用紫外分光光度法测定利福喷丁在11种溶剂中的溶解度及研究4种增溶剂对其的增溶作用;考察其在正己烷和正辛醇中的表观油水分配系数及在高湿、高温、光照条件下的稳定性。结果:利福喷丁在三氯甲烷中溶解性较好,溶解度为13.076 mg.L-1,在水中溶解性较差,为3.046 mg.L-1;吐温-80对其增溶作用较强,溶解度达到823 mg.L-1;在正己烷和正辛醇中的表观油水分配系数分别为4.778±0.41、17.441 2±2.79;稳定性指标中色泽和主药含量在考察期内均有变化。结论:利福喷丁的脂溶性强、水溶性差,合适的增溶剂对其有一定的增溶作用,其在高温、高湿、光照条件下不太稳定。OBJECTIVE： To study the solubility and stability of rifapentine,and to lay a good foundation for the further development of new dosage form of it.METHODS： The solubility of rifapentine in 11 solvents was determined by UV spectrophotometry,and solubilization effects of 4 kinds of solubilizers on it were investigated.The apparent oil/water partition coefficients of hexane and n-caprylic alcohol were investigated,and the stability of it was determined under high temperature,high humidity and light.RESULTS： Rifapentine showed good solubility in chloroform with solubility of 13.076 mg·L-1;it showed poor solubility in water with solubility of 3.046 mg·L-1.Tween-80 played strong solubilization roles and the solubility was up to 823 mg·L-1.The apparent oil/water partition coefficients in hexane and n-caprylic alcohol were 4.778±0.41 and 17.441 2±2.79.Color and the content of main components among stability index had changed.CONCLUSION： Rifapentine shows strong fat-solubility and poor water-solubility,and suitable solubilizer can improve the solubility of it.It is not stable under high temperature,high humidity and light.

关 键 词：利福喷丁 溶解度 紫外分光光度法 稳定性 

分 类 号：R978.3[医药卫生—药品]