药用铝箔中可挥发性残留物的测定及来源研究  

Determination and Source Research of Volatile Residues in Medicinal Aluminum Foil

作　　者：李颖 尹光 赵霞[1] 肖新月[1] Li Ying;Yin Guang;Zhao Xia;Xiao Xinyue(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2022年第8期921-933,共13页Chinese Pharmaceutical Affairs

摘　　要：目的:分析研究市售药用铝箔中可挥发性残留物的含量及其来源,探索相应改进策略。方法:建立顶空气相色谱分析外标法,并对33批药用铝箔样品中可挥发性残留物含量进行测定。结果:药用铝箔中直接添加类可挥发性残留物包含异丙醇和乙二醇乙醚,其对应的检出含量分别为0.03~1.49 mg/m~2和0.02~0.36 mg/m~2,均<0.50 mg/m~2。反应生成的可挥发性残留物包含丙酮、甲醇、乙醇、异丁醇和正丁醇,其中丙酮的检出含量为0.01~0.04 mg/m~2,推测可能来源于油墨中稀释剂异丙醇的高温氧化;其他醇类物质的检出含量范围0.01~9.78 mg/m~2,由生产工艺推测,其来源是保护层形成过程中氨基树脂的交联反应产物。结论:市售药用铝箔整体质量参差不齐。控制保护层原料的选择和生产工艺是改善甲醇、异丁醇和正丁醇残留偏高的较优方法。Objective: To analyze and study the content and source of volatile residues in commercially available medicinal aluminum foil and explore corresponding improvement strategies. Methods: An external standard method for headspace gas chromatography was established and the content of volatile residues in 33batches of medicinal aluminum foil samples was determined. Results: The direct-added volatile residues in medicinal aluminum foil include isopropanol and ethyl glycol ether, and their corresponding contents detected are 0.03-1.49 mg/m2 and 0.02-0.36 mg/m2, both of which are less than 0.50 mg/m2. The volatile residues produced by the reaction include acetone, methanol, ethanol, isobutanol and n-butanol. The content detected from acetone is 0.01-0.04 mg/m2, which may derive from the high temperature oxidation of isopropanol, the diluent in the ink. The content detected from the other alcohols ranges from 0.01 to 9.78 mg/m2. It is inferred from the production process that the residues come from the cross-linking reaction of the amino resin during the formation of the protective layer. Conclusion: The quality of commercially available medicinal aluminum foil remains dif ferent. Controlling the raw material selection and production process of the protective layer are good ways to decrease the residual high levels of methanol, isobutanol and n-butanol.

关 键 词：药用铝箔 可挥发性残留物 顶空气相色谱法 挥发物测定 药品包装材料 

分 类 号：R917[医药卫生—药物分析学]