洛伐他汀缓释片的质量控制研究  

Study on Quality Control of Lovastatin Sustained-release Tablets

作　　者：易涛[1] 易以木[2] 

机构地区：[1]广州军区武汉总医院药剂科,武汉市430070 [2]华中科技大学同济医学院药学院,武汉市430030

出　　处：《中国药房》2004年第11期670-671,共2页China Pharmacy

摘　　要：目的研究洛伐他汀缓释片的质量控制方法。方法采用紫外分光光度法测定含量;根据《中国药典》缓释、控释制剂指导原则选择适宜的体外释放条件。结果洛伐他汀在177～1062μg/ml浓度范围内线性关系良好;洛伐他汀缓释片含量在95%～105%范围内;其在pH=70的十二烷基硫酸钠溶液中可持续释药24h,释放规律符合零级动力学和Higuchi方程。结论本方法方便、准确、重现性好,可用于洛伐他汀缓释片的质量控制。OBJECTIVE:To evaluate the quality control of Lovastatin sustained-release tablets METHODS:The various factors affecting in vitro dissolution were investigated The content of Lovastatin in sustained-release tablets was detected with UV-spectrophotomery RESULTS:The calibration curves of lovastatin was linear from 1 77～10 62μg/ml;The contents of tablets were between 95%～105% It kept releasing for 24h in sodium lauryl sulfate solution at pH=7 0 The releasing rule fitted zero degree dynamic equation and Higuchi equation CONCLUSION:The determination method is simple,accurate and repeatable The method can be used for quality control of Lovastatin Sustained-release tablets

关 键 词：洛伐他汀 缓释片 质量控制 

分 类 号：R927.1[医药卫生—药学] R972.4