对美国药典溶出度装置适用性试验的考察  

Suitability test for apparatus of USP dissolution test

作　　者：赵明[1] 张伟[1] 

机构地区：[1]北京市药品检验所

出　　处：《中国药学杂志》1994年第9期548-550,共3页Chinese Pharmaceutical Journal

摘　　要：为保证溶出度操作完全符合标准，并且没有显著的外部振动存在，美国药典提供了一个装置适用性试验。重点考察了使用未脱气递质和移动中心位置对美国药典装置适用性试验的影响。The USP provided an apparatus suitability test to ensure that a dissolutionapparatus operates satisfactorily and is free from significant extraneous vibration,Two officialcalibrators, both compressed tablets, were available for use in the test.The nondisintegratingcalibrator was labelled to contain 300mg of salicylic acid,the disintegrating calibrator was labelledto contain 50mg of prednisone. We studied the effects on using non-deaeration of media andmoving the center of vessels for both USP apparatus Ⅰ and Ⅱ.

关 键 词：美国药典 溶出度 装置适用性 

分 类 号：R921.712[医药卫生—药学]