5-单硝酸异山梨酯制剂溶出度的研究  

STUDY OF DISSOLUTION OF ISOSORBIDE 5 MONONITRATE PREPARATIONS

作　　者：王建卓[1,2] 李琳[1,2] 魏树礼[1,2] 

机构地区：[1]北京医科大学药剂教研室 [2]北京市天坛医院药剂科

出　　处：《中国医药工业杂志》1997年第6期259-260,共2页Chinese Journal of Pharmaceuticals

摘　　要：对５－单硝酸异山梨酯两种市售制剂的溶出度进行ＲＰ－ＨＰＬＣ外标法测定。流动相为甲醇－水（１∶３），检测波长２２０ｎｍ，线性范围２～８０μｇ／ｍｌ，最低检测浓度０．１μｇ／ｍｌ，ＲＳＤ小于１％。经非线性回归，证实缓释制剂的释药符合一级方程Ｄｔ＝Ｄｍａｘ［７０％（１－ｅ－ｋ（ｔ－ｔ０）＋３０％］。The determination of the dissolution of isosorbide 5 mononitrate preparations was carried out with RP HPLC external standard method. The mobile phase was CH 3OH H 2O(1∶3), and detected at 220nm. The sample size was 150 μl. The linear range was 2～80 μg/ml and the lowest detectable concentration was 0.1 μg/ml. The RSD of the determinations was less than 1%. Two marketed preparations were tested. After non linear regression, it was found that the drug release of the extended release preparation fitted with first order equation D t = D max [70%( 1-e -k(t-t 0) )+30%].

关 键 词：单硝酸异山梨酯 缓释制剂 溶出度 

分 类 号：R972.3[医药卫生—药品] R944.9[医药卫生—药学]