曲安奈德在聚丙烯酸酯压敏胶中稳定性研究

曲安奈德是一种用于治疗皮肤炎症的中长效糖皮质激素.采用高效液相色谱-二极管阵列检测器(HPLC-DAD),考察了曲安奈德在强酸、强碱、强氧化剂强制降解条件下的稳定性,以及与几种常用聚丙烯酸酯压敏胶的相容性.结果发现,曲安奈德在酸性和氧化性条件下,实验后测定含量分别为100.02%和92.47%,而在碱性条件下完全降解.曲安奈德与压敏胶DURO-TAK87-2510、87-4098、87-2051配伍时稳定,而与DURO-TAK87-2677、87-2852或87-2516配伍时含量显著降低(分别为70.96%、80.38%和6.53%),但各检测波长下未见有关物质生成.参照各国药典,进一步使用液相色谱-高分辨质谱联用(LC-HRMS)技术分析样品中的有关物质,未见已收载的各有关物质.比较实验中所用各种聚丙烯酸酯压敏胶的特性,推测这种现象可能与DURO-TAK87-2677、87-2852和87-2516中存在的交联剂有关.

Stability of triamcinolone acetonide in polyacrylates press sensitive adhesives

Triamcinoloneacetonideisamediumandlong-actingglucocorticoidusedintreatmentof variousdermatoses.AnHPLC-DADmethodisusedtodetectthestabilityoftriamcinoloneacetonide inforceddegradationexperimentunderstrongacid/alkali/oxidantcondition,anditscompatibility withseveralpolyacrylatespresssensitiveadhesives(PSA).Intheforceddegradationexperiment,the concentrationsoftriamcinoloneacetonideare100.02%and92.47%inacidicandoxidativeconditions respectively,butitcompletelydegradesinthebasiccondition.Triamcinoloneacetonideisstablewhen thepatchesuseDURO-TAK?? 87-2510,87-4098,87-2051asmatrix,buttheconcentrationdecreases incaseofDURO-TAK?? 87-2677,87-2852or87-2516(70.96%,80.38% and6.53%respectively), andnoimpuritypeakisobservedinthesampleateachexperimentwavelength.ThenaLC-HRMS methodisemployedtoscreentheimpuritiesoftriamcinoloneacetonideinthesamplesaccordingtoa variety of pharmacopeias, but none of the related substance has been detected. Thus the characteristicsofthepolyacrylatesPSAarecompared,anditisassumedthatthedegradationiscaused bythecrosslinkersexistinginPSADURO-TAK?? 87-2677,87-2852and87-2516.