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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。
OBJECTIVE To study the migration of additives in liquid polyvinyl alcohol (PVC) bottles for compound Huangsong lotion and its influence on the quality of medicines. Methods HPLC, GF-AAS and HS-GC / MS were used to determine the contents of dioctyl phthalate (DOP), thiol methyltin, heat stabilizer and enhancer A The content of styrene monomer in the methyl methacrylate-butadiene-styrene copolymer (MBS) and the migration amount in the compound Huangsong lotion. Results The method for determination of the migration of various additives in liquid Huangyong lotion was established. Conclusion The migration of the tested additives in the compound Huangsong lotion is far below the limits of the relevant standards.