Shah V P, Elkins J, Hanus J, Noorizadeh C, Skelly J P
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857.
Pharm Res. 1991 Jan;8(1):55-9. doi: 10.1023/a:1015826205930.
The in vitro drug release profile of hydrocortisone (HC) from creams, ointments, and lotions has been determined using an automated procedure. A diffusion cell system and commercially available synthetic membranes were utilized for the studies. The use of a synthetic membrane obviates the problems associated with using skin membranes. Uniform creams and ointment samples for determining release rate profile were prepared by using the teflon mask. Automated sampling avoids operator artifacts. The automated technique developed for determining the in vitro release rate profile of the drug from creams, ointments, and lotions using a diffusion-cell system appears to be a reasonable and practical procedure for assuring batch-to-batch uniformity of topical drug products.
已使用自动化程序测定了氢化可的松（HC）从乳膏、软膏和洗剂中的体外药物释放曲线。研究采用了扩散池系统和市售合成膜。使用合成膜避免了使用皮肤膜相关的问题。通过使用聚四氟乙烯面罩制备用于测定释放速率曲线的均匀乳膏和软膏样品。自动采样避免了操作人员的人为误差。所开发的使用扩散池系统测定药物从乳膏、软膏和洗剂中的体外释放速率曲线的自动化技术，似乎是确保局部用药物产品批次间一致性的合理且实用的方法。
