摘要
目的 :建立那格列奈片的体外溶出度的测定方法。方法 :桨法 ,高效液相色谱法检测 ,提取溶出参数T50 、Td、m进行统计分析 ,并采用相似因子法评价试验药品和进口对照品溶出度的相似程度。结果 :三批试验药品的溶出度批内、批间无显著性差异 ,三批试验品的相似因子分别为 84 .0 ,80 .0 ,79.5 ,三批样品的溶出度与国外制剂相似。结论 :本方法测定简便 ,结果准确可靠 ;试验药品与对照品的体外溶出度无明显差异 。
OBJECTIVE To establish the dissolution method for nateglinide tablets.METHODS According to Chinese pharmacopoeia (2000) dissolution method Ⅱ.The dissolution of nateglinide tablets was determined by HPLC.The parameters ( T 50 , T d, m ) obtained from the dissolution tests were analysed. Degree of similarity of the dissolution was assessed using trial drugs and controlled drug. RESULTS The dissolution of three batches of trial drugs was similar to controlled drug.The similar factor was 84.0 , 80.0 and 79.5 ,respectively.CONCLUSIONS The method is simple,sensitive and accurate.The dissolution rates between trial drugs and controlled drug had no difference. The results showed that the technology of producting trial drugs was stable.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第2期82-84,共3页
Chinese Journal of Hospital Pharmacy
