摘要
比较2种他克莫司软膏在离体乳猪皮肤及裸鼠皮肤的渗透吸收规律,评价质量一致性。采用改良Franz扩散池进行体外透皮试验,以LC-MS/MS法测定接收液及皮肤中的他克莫司浓度。结果表明,以猪皮为屏障时,3批受试软膏及原研制剂的24 h累积渗透量分别为（243.50±72.07）、（247.22±66.42）、（237.76±92.81）和（226.00±38.88）ng/cm2,24 h皮肤滞留量分别为（1 866.21±164.91）、（1 686.11±176.54）、（1 817.08±221.52）和（1 769.77±254.50）ng/cm2。以裸鼠皮肤为屏障时,2种制剂的24 h累积渗透量均约是猪皮的3~4倍。本研究结果提示受试软膏与原研制剂的体外经皮渗透性能基本一致。
To provide a reference for the quality consistency evaluation of two brands of tacrolimus ointment, the transdermal permeation behaviors with piglet skin and nude mouse skin as barriers were investigated. The modifi ed Franz diffusion cell was employed for the in vitro transdermal permeation test. The tacrolimus concentration in receiving liquids and skins was measured by LC-MS/MS. The results showed that when using piglet skin as the barrier, the cumulative penetration amounts at 24 h of three batches of test ointment and the original preparation were（243.50±72.07）,（247.22±66.42）,（237.76±92.81） and（226.00±38.88）ng/cm2, and the cumulative retention amounts in skin at 24 h were（1 866.21±164.91）,（1 686.11±176.54）,（1 817.08±221.52） and（1 769.77±254.50）ng/cm2, respectively. When using nude mouse skin as the barrier, the cumulative penetration amounts at 24 h of both two brands of tacrolimus ointment were three to four times higher than those in piglet skin groups. It indicated that the in vitro transdermal behavior of the test ointment and original preparation were consistent.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2015年第4期354-358,共5页
Chinese Journal of Pharmaceuticals
