多层共挤输液用膜制袋中双酚A的测定方法

Determination of Bisphenol A in Multi-layer Co-extrusion Film for Infusion Bags

目的建立多层共挤输液用膜制袋中双酚A的含量测定方法。方法以四氢呋喃和甲醇为提取溶剂,利用HPLC法对包装材料的双酚A含量进行测定,并对测定方法进行初步方法学验证。结果建立了多层共挤输液用膜制袋中双酚A的测定方法,双酚A在0.1127~2.2540ng·ml^(-1)范围内线性关系良好(r=0.9997),方法检测限(S/N=3)为0.007 89ng,本方法平均回收率为85.77%~88.18%;提取试验结果表明,双酚A是潜在浸出物。结论本文建立的多层共挤输液用膜制袋中双酚A的检测方法简便,准确,可用于该包装系统中双酚A质量控制。

Objective To establish a method for determination of bisphenol A in multi-layer co-extrusion film for infusion bags.Methods With tetrahydrofuran and methylbenzene as extraction solvents,the high performance liquid chromatography was used for bisphenol A content determination in drug loading containers,and the measurement method was validated by methodology.Results A method was established for determination of bisphenol A in the multi-layer co-extrusion film for infusion bags.After testing,bisphenol A was detected in most batches of the multi-layer co-extrusion film for infusion bags.The results showed that bisphenol A in the concentration range of 0.1127-2.2540 ng·ml^-1 had a good linear relationship（r =0.9997）.The method detection limit（S/N=3）was 0.007 89 ng,and the average recovery was 85.77% -88.18% .Bisphenol A was identified as a potential extract for further migration tests.Conclusion The additive detection method established in this article for the multi-layer co-extrusion film for infusion bags is simple,accurate,and can be used in assay of extractable contents and quality control.