Kirchhoefer R D, Hamilton J F
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Analysis, St. Louis, MO 63101, USA.
J AOAC Int. 1996 Jul-Aug;79(4):1005-8.
Forty-four niacin formulations were examined by the United States Pharmacopeia dissolution test, consisting of 0.1N HCl with apparatus 1 and 2. Each formulation was tested with apparatus 1 (basket) at 100 rpm and apparatus 2 (paddle) at 50 and 100 rpm. Dissolution results varied widely among manufacturers.
美国药典溶出度试验对44种烟酸制剂进行了检测,采用0.1N盐酸,使用装置1和装置2。每种制剂分别在装置1(吊篮)中以100转/分钟、在装置2(桨板)中以50转/分钟和100转/分钟进行测试。不同厂家的溶出度结果差异很大。