双波数ATR-FTIR法快速测定铝镁二甲硅油咀嚼片中二甲硅油含量  

Rapid Determination of Dimethicone Content in Aluminum Magnesium Dimethicone Chewable Tablets by ATR-FTIR Using Double Wavenumber Calculation

作　　者：易思敏 赵希睿 居一宜 李舸远 YI Simin;ZHAO Xirui;JU Yiyi;LI Geyuan(School of Science,China Pharmaceutical University,Nanjing 211198,China;School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China)

机构地区：[1]中国药科大学理学院,南京211198 [2]南京中医药大学药学院,南京210023

出　　处：《中国现代应用药学》2025年第4期623-631,共9页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立一种能快速测定铝镁二甲硅油咀嚼片中二甲硅油含量的方法,为铝镁二甲硅油咀嚼片质量控制提供快速有效的手段,同时为其他固体制剂中二甲硅油的快速测定提供参考。方法运用衰减全反射傅里叶变换红外光度(attenuated total reflection Fourier transform infrared spectroscopy,ATR-FTIR),在1260 cm^(−1)测定二甲硅油的特征吸收峰,以二甲硅油含量-校正吸光度作标准曲线对未知含量的铝镁二甲硅油咀嚼片中二甲硅油含量进行测定,并以F检验和t检验法检验差异性。结果铝镁二甲硅油咀嚼片中二甲硅油含量在2.0%~100.0%线性良好,相关系数r为0.9996(n=7),供试品与对照品在2 h内稳定性良好;建立的ATR-FTIR法与以往方法检测结果比较差异无统计学意义。结论建立的双波数ATR-FTIR法专属性佳、重现性好、仪器精密度高、准确度高,且安全、环保、快速,可作为铝镁二甲硅油咀嚼片中二甲硅油的含量测定方法,也可作为其他固体制剂中二甲硅油含量的潜在快速测定方法。OBJECTIVE To establish a method for the rapid determination of dimethylsilicone oil content in aluminum magnesium dimethylsilicone oil chewable tablets,provide a rapid and effective means for the quality control of aluminum magnesium dimethylsilicone oil chewable tablets,and provide a reference for the rapid determination of dimethylsilicone oil in other solid preparations.METHODS Attenuated total reflection Fourier transform infrared spectroscopy(ATR-FTIR)was used to determine the characteristic absorption peak of dimethylsilicone oil at 1260 cm^(−1),and the content of dimethylsilicone oil in aluminum magnesium dimethylsilicone oil chewable tablets with unknown content was determined with the standard curve of dimethylsilicone oil content-corrected absorbance,and the difference was tested by F test and t test.RESULTS The content of dimethylsilicone oil in aluminum magnesium dimethylsilicone oil chewable tablets was linear in the range of 2.0%−100.0%,and the correlation coefficient r was 0.9996(n=7).The stability of test product and control product was good within 2 h.There was no significant difference between the established ATR-FTIR method and the previous method.CONCLUSION The established twowave number ATR-FTIR method has exhibits excellent specificity,good reproducibility,high instrumental precision,and high accuracy.Additionally,it is safe,environmentally friendly,and rapid,and can be used as a method for the determination of dimethylsilicone oil content in aluminum magnesium dimethylsilicone oil chewable tablets,and also as a potential rapid determination method for dimethylsilicone oil content in other solid preparations.

关 键 词：单次衰减全反射 傅里叶变换红外光谱 铝镁二甲硅油咀嚼片 二甲硅油 快速测定 

分 类 号：R917.101[医药卫生—药物分析学]