外用液体药用聚氯乙烯瓶中添加剂的含量和迁移量研究

Study on Content and Migration of Additives in Polyvinyl Chloride Bottles for External Use

摘要: 目的研究外用液体药用聚氯乙烯瓶中添加剂在复方黄松洗液中的迁移量，及对药品质量的影响。方法分别采用HPLC、GF-AAS、HS-GC/MS测定外用液体药用聚氯乙烯瓶中增塑剂邻苯二甲酸二辛酯(DOP)、热稳定剂硫醇甲基锡、增强剂甲基丙烯酸甲酯-丁二烯-苯乙烯共聚物(MBS)中苯乙烯单体的含量和在复方黄松洗液中的迁移量。结果建立外用液体药用聚氯乙烯瓶中多种添加剂在复方黄松洗液中迁移量的测定方法。结论所检测的添加剂在复方黄松洗液中的迁移量均远低于相关标准的限度。

Abstract: OBJECTIVE To study the migration of additives in polyvinyl chloride bottles for external use and the effects on drug quality. METHODS Appling the methods of HPLC, GF-AAS, HS-GC/MS respectively to determine the content of the plasticizer phthalate plasticizer dioctyl(DOP), the heat stabilizer methyltin mercaptide and the styrene monomer in enhancer methyl methacrylate butadiene styrene copolymer(MBS) in PVC bottles for external use, and the amount of migration in compound huangsong lotion. RESULTS Established methods for determination of the migration of additives of PVC bottles for external use in compound huangsong lotion. CONCLUSION The additives’ migration in compound huangsong lotion are far below the limits of related standards.