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
出处
《中国药房》
CAS
CSCD
2004年第11期670-671,共2页
China Pharmacy
关键词
洛伐他汀
缓释片
质量控制
Lovastatin
sustained-release tablet
quality control
