Gao Zongming, Moore Terry W, Doub William H, Westenberger B J, Buhse Lucinda F
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri 63101, USA.
J Pharm Sci. 2006 Jul;95(7):1606-13. doi: 10.1002/jps.20622.
Dissolution testing is a critical method for the determination of pharmaceutical product quality and bioequivalence. For some products, dissolved gases in the dissolution medium affect dissolution results thus requiring degassing of the medium prior to use. In this study, we use a total dissolved gas and oxygen meter to measure both oxygen and total gases in dissolution media before and after application of a variety of deaeration methods. Dissolution testing results using a 10 mg Prednisone tablet (NCDA #2) are compared with the percent saturation of oxygen and total gases found in the medium. Reaeration of the medium during different stirring rates was also measured. This study confirms that measurement of total gases and not just oxygen in the medium is necessary to assess adequacy for dissolution testing. For those deaeration techniques that are performed at room temperature, the percent saturation of the total dissolved gases must be well below 100% to prevent outgassing once medium is brought to dissolution test method temperature, typically 37 degrees C.
溶出度测试是测定药品质量和生物等效性的关键方法。对于某些产品，溶出介质中的溶解气体会影响溶出结果，因此在使用前需要对介质进行脱气处理。在本研究中，我们使用总溶解气体和氧气测量仪来测量在应用各种脱气方法前后溶出介质中的氧气和总气体含量。将使用10毫克泼尼松片（NCDA #2）的溶出度测试结果与介质中氧气和总气体的饱和百分比进行比较。还测量了在不同搅拌速率下介质的再曝气情况。本研究证实，为评估溶出度测试的充分性，测量介质中的总气体而非仅氧气是必要的。对于那些在室温下进行的脱气技术，总溶解气体的饱和百分比必须远低于100%，以防止介质达到溶出度测试方法温度（通常为37摄氏度）后出现脱气现象。
