Stoughton R B
Division of Dermatology, University of California, School of Medicine, San Diego.
Int J Dermatol. 1992 Oct;31 Suppl 1:26-8. doi: 10.1111/j.1365-4362.1992.tb04009.x.
The vasoconstrictor assay, when properly performed, is a highly reliable method to determine bioequivalence of generic formulations. Recent research has resolved some of the remaining questions concerning the practical application of the assay. Significant vehicle-related differences have been observed between the potency of different, supposedly equivalent formulations now on the market. Large differences in concentrations of the active agent in similar vehicles usually have not resulted in corresponding differences in vasoconstrictor assay results. Finally, the time course of drug effects may differ among highly potent and less potent corticosteroids. In general, the higher the potency of the topical corticosteroid, the earlier the maximal effect is observed. This finding suggests that short application of highly potent agents might minimize systemic absorption without sacrificing efficacy.
血管收缩试验若操作得当，是测定仿制药生物等效性的一种高度可靠的方法。近期研究解决了该试验实际应用中尚存的一些问题。现已观察到，市面上一些所谓等效的不同制剂在效力方面存在显著的赋形剂相关差异。相似赋形剂中活性剂浓度的巨大差异通常并未导致血管收缩试验结果出现相应差异。最后，高效和低效皮质类固醇的药物效应时间进程可能有所不同。一般而言，局部皮质类固醇的效力越高，观察到最大效应的时间越早。这一发现表明，短期应用高效制剂可能在不影响疗效的情况下将全身吸收降至最低。
