苯妥英钠片溶出度试验方法的改进  

Method Improvement of Dissolution Evaluation of Phenytoin Sodium Tablets

作　　者：李杨[1] 闻京伟[1] 蒋登高[2] 郭毅[1] 

机构地区：[1]河南省食品药品检验所,郑州450003 [2]郑州大学化工与能源学院,郑州450001

出　　处：《中国药房》2014年第5期458-460,共3页China Pharmacy

摘　　要：目的：建立测定苯妥英钠片溶出度新的、稳定的方法，同时考察12个厂家247批苯妥英钠片的溶出度。方法：以pH10．0缓冲液（硼砂-氢氧化钠）500ml代替《中国药典》中的水为溶出介质，转速为50r／min，取样时间为30min，光纤溶出仪测定，采用0．5cm探头，检测波长为258nm同时比较苯妥英钠在水和缓冲液中24h的稳定性及采用《中国药典》方法与新方法测得的溶出度结果。结果：苯妥英钠检测质量浓度线性范围为0．032-0．320mg／ml（r=0．9999），回收率为101．5％（RSD=0．4％，n=3）。苯妥英钠在水和缓冲液中24h的吸光度的RSD分别为2．9％、0．3％（n=6）；新方法检测247批样品不合格率为8．1％，而《中国药典》方法检测样品全部合格。结论：新方法更能体现出不同厂家和批号之间样品的溶出差别，并且检测溶液的稳定性更好，能够更好地对全国样品进行监测。OBJECTIVE： To establish a new stable method for the dissolution determination of Phenytoin sodium tablets, and to investigate the dissolution of 247 batches of Phenytoin sodium tablets from 12 manufacturers. METHODS： The dissolution process of Phenytoin sodium tablets was monitored by fiber-optic dissolution test system in the medium of pH 10.0 buffer （borax-sodiurn hydrate） instead of water in Chinese Pharmacopoeia, at the rotation speed of 50 r/min and detection wavelength of 258 nm, using 0.5 cm probe. The sampling time was 30 min. 24 h stability of phenytoin sodium in water and buffer solution were compared, and results of the method stated in Chinese Pharmacopoeia were compared with those of new method. RESULTS： The linear range of phenytoin sodium were 0.032-0.320 mg/ml （r=0.999 9） with an average recovery of 101.5% （RSD=0.4%, n=3）. RSDs of 24 h absorbance of phenytoin sodium were 2.9% in water and 0.3% in buffer solution （n=6）. Among 247 batches of samples, 8.1% of samples were unqualified with new method, but all samples were qualified with the method of Chinese Pharmacopoeia. CONCLUSIONS： The method can identify the difference of different batches of samples from different manufacturers, and keep solution more stable. It can monitor the national sample investigation better.

关 键 词：苯妥英钠片 溶出度 方法改进 光纤溶出仪 PH 10 0缓冲液 

分 类 号：R927.2[医药卫生—药学]