不同厂家洛伐他汀口服制剂溶出度比较  

The comparation of dissolution degree of different manufacturer Simvastatin oral liquid

作　　者：张海红 刘放[2] 

机构地区：[1]浙江嵊泗人民医院药剂科,嵊泗202450 [2]浙江省医学科学院药物研究所,杭州310013

出　　处：《海峡药学》2011年第7期22-25,共4页Strait Pharmaceutical Journal

摘　　要：目的考察洛伐他汀胶囊（片）的溶出度及其体释药性质。方法照溶出度测定法[中国药典2005版二部附录XC溶出度试验法第一法（转篮法）]。以磷酸盐缓冲液．正丙醇（2：1）900mL为溶出介质。采用高效液相法测定．检测波长为238nm。结果洛伐他汀线性范围1．988μg·mL^-1-29．820μg·mL^-1，r=0．9998（n=7），回收率99．5％100．0％，RsD=0．4％-0．8％（n=9）。结论该方法简便、准确、灵敏，该制剂具有良好的溶出度。符合规定。OBJECTIVE To study the dissolution rate and in vitro releasing characteristics of lovastatin capsules （tablets）. METHODS The experiment was conducted according to the first method （the rateting basket method） dissolution rate in China Pharmacopeia 2005, second section, appendix XC. Phosphate buffer solution-npropanol （2 ： 1 ） 900mL was used as the mediums for dissolution, and the determination method was HPLC. RESULTS The calibration curve of lovastatin was linear within a range of 1.998μg·mL^-1 29.820μg· mL^-1, r = 0. 9998, and the range of the recovery was 99.5 %- 100.0 %, RSD = 0.4 % --0.8 %. CONCLUSION The method is simple, accurate and sensitive. It shows a good dissolution rate.

关 键 词：洛伐他汀 洛伐他汀片 洛伐他汀胶囊 溶出度 高效液相色谱法 比较 

分 类 号：R942[医药卫生—药剂学]