维A酸贴剂的体外透皮扩散研究

Study on Transdermal Diffusion of Tretinoin Patches in vitro

目的:研究自制的维A酸贴剂的体外透皮扩散率及在皮肤内的蓄积量。方法:按《中国药典》2005年版规定测定含量均匀度,以酸性异丙醇为溶剂,在波长352nm处测定维A酸,用透皮扩散仪测定透皮贴剂与市售维A酸乳膏对小鼠皮的扩散率及皮肤内的蓄积量。结果:贴剂的含量均匀度合格;测定的平均回收率为97.99%。测得含量为9.73mg/片,为标示量的97.3%;贴剂的扩散率虽低于乳膏,但皮肤内的蓄积量明显高于乳膏。结论:该贴剂能使药物蓄积于皮肤内,有利于提高对皮肤病的疗效和降低毒性,值得进一步开发。

Objective： To study the transdermal diffusion rate and the drug amount retained in skin of self-prepared tretinoin patches in vitro. Method： Uniformity of drug content was determined according to Pharmacopoeia of China （ 2005 ） ; tretinoin was determined by spectophotometrically at 352 nm using acidic isopropvl alcohol as the solvent： and transdermai diffusion through mouse skin and drug residue on the skin were measured with tretinoin cream as the control in vitro. Result： Uniformity of drug content of the patches was up to the standard. Mean recovery of the determination method was 97.99% and drug content was 9.73 mg per patch （ labeled amount 97.3% ）. Transdermal diffusion rate of the patches was lower than that of the cream In vitro, however, the patches showed significantly higher drug amount retained in the skin. Conclusion： The assay method is reliable, and the patches show good capacity to retain drug in the skin, which indicates the patches might enhance therapeutic efficiency against skin diseases and reduce adverse effects, thus are worthy of the study for further development.