世界中医药

目的：建立药品包材中残留溶剂的含量测定方法。方法：色谱柱为DM-WA（30 mm×0.25 mm×0.25 μm）；程序升温，30 ℃保持10 min，以10 ℃/min上升至90 ℃，保持2 min，以90 ℃/min上升至160 ℃，保持5 min；进样口温度160 ℃；氢焰离子化检测器，温度220 ℃；以正己烷为内标定量。结果：丙酮、乙酸乙酯、丁酮、异丙醇、苯、甲苯的回归方程分别为Y=3.5638X+0.0120，Y=3.6619X+0.0099，Y=4.9390X+0.0104，Y=3.7315X+0.0042，Y=10.112X+0.0291，Y=10.258X+0.0370。蒙脱石散包材残留溶剂为甲苯，平均回收为97.2%，RSD=1.41%。结论：该方法准确、重现性好、灵敏度高，可用于药品包材残留溶剂的含量测定。

English Summary:

To establish a standard method for the determination of residual solvents in pharmaceutical packaging materials.Methods: Gas chromatography was performed with chromatographic column of DM – WAX (30 mm×0.25 mm×0.25 μm) and the temperatures of injection port and hydrogen flame ionization detector were set at 160 ℃ and 220 ℃ respectively.Temperature programme: the column temperature rose to 30 ℃ and hold for 10 mins; rose by 10 ℃ per minute from 30 ℃ to 90 ℃,and hold for 2 minutes,then by 90 ℃ per minute to 160 ℃ and hold for 5 minutes.n-hexane was the internal standard when determinating the content of residual solvents in different pharmaceutical packaging materials.Results: Acetone,ethyl acetate,butanone,isopropyl alcohol,benzene,toluene regression equations were Y=3.5638X+0.0120，Y=3.6619X+0.0099，Y=4.9390X+0.0104，Y=3.7315X+0.0042，Y=10.112X+0.0291，Y=10.258X+0.0370 respectively.The residual solvents in Montmorillonite powder packaging material is toluene,the average recovery is 97.2%，RSD=1.41%.Conclusion: The method is accurate,reproducible,high sensitivity,and can be used for the determination of residual solvents in pharmaceutical packaging materials.

查看全文查看/发表评论下载PDF阅读器