赛特铂胶囊的溶出度及稳定性研究  

Study on the dissolution and stability of Satraplatin capsules

作　　者：张望刚[1] 吕良忠[1] 方晴霞[1] 王俏[2] 王胜浩[2] 陈国神[2] 

机构地区：[1]浙江省人民医院药剂科,浙江杭州310014 [2]浙江省医学科学院药物研究所,浙江杭州310013

出　　处：《华西药学杂志》2014年第6期633-634,共2页West China Journal of Pharmaceutical Sciences

基　　金：浙江省科技厅项目(2011F10048)

摘　　要：目的测定赛特铂胶囊的溶出度并考察其稳定性。方法考察溶出介质和转速,确定溶出度的测定方法,并考察其均一性及重复性;进行赛特铂胶囊的影响因素和稳定性试验。结果赛特铂3-60μg·m L＾-1与峰面积的线性关系良好（r=0.9995）,加样回收率为100.4%±1.41%;3批样品在5 min时溶出均〉45%,30 min时溶出约90%;赛特铂胶囊经稳定性试验考察,含量未见明显变化。结论溶出度的测定方法可靠、重复性好;赛特铂胶囊的稳定性较好。OBJECTIVE To determine the dissolution of Satraplatin capsules and investigate its stability. METHODS The method of dissolution test were built by selecting the dissolution medium and rotation speed,and then the homogeneity and repeatability of dissolution test was observed. The stability of Satraplatin capsules was studied. RESULTS The linear range of 3- 60 μg·m L- 1（ r =0. 9995）. The average recovery was 100. 4% ± 1. 41%. The homogeneity and repeatability were good. The dissolution of three group samples were beyond 45% in 5 minutes and approximately 90% in 30 minutes. The content of Satraplatin capsules had no obvious change after influence factor test. CONCLUSION The method of dissolution is reliable,stable and good in reproducibility,and the stability of Satraplatin capsules is good.

关 键 词：赛特铂胶囊 溶出度 高效液相色谱 稳定性试验 

分 类 号：R94[医药卫生—药剂学] R917[医药卫生—药学]