注射用氨苄西林钠中二甲硅油迁移量对澄清度的影响

目的:建立傅立叶变换衰减全反射红外光谱(FTIR-ATR)定量法测定氨苄西林钠中二甲硅油含量,探索二甲硅油量与药物澄清度的相关性。 方法:二氯甲烷溶解并制成每1 mL中含0.1 g氨苄西林钠的溶液,避免与胶塞接触的情况下小心摇匀,静置1 h,加样至FTIR-ATR的ZnSe晶体槽,扫描红外光谱图。利用二甲基硅油在(1260 ± 5)cm^-1处的特征吸收峰峰面积定量计算。 结果:二甲硅油在0~32.0 mg·mL^-1范围内线性良好,r=0.999。样品平均加样回收率为98.7%(n=9)。注射用氨苄西林钠中二甲硅油迁移量与浊度值呈一定的正相关,相关系数为r=0.672(P<0.05)。 结论:二甲硅油迁移量与浊度值有一定的相关性,可能是药物浊度值高的原因之一。

Objective: To establish a fourier transform infrared spectroscopy-attenuated total reflection spectra(FTIR- ATR)method for determination of polydimethylsiloxane in ampicillin sodium for injection,and to study the correlation between the migration of polydimethylsiloxane and the clarity of the drug. Methods: The sample of ampicillin sodium(0.1 g·mL^-1)was made with dichloromethane solution which was carefully shaked,avoiding contact with stopper.After standing for 1 h,the sample was put into the ZnSe crystal tank for FTIR-ATR to achieve the infra-red spectrogram.The dimethicone peak area at(υ=1260 ±5)cm^-1 was used to do quantitative calculation. Results: The linear range of polydimethylsiloxane was 0-32.0 mg·mL^-1 with correlation coefficient of 0.999.The average recovery(n= 9)of the method was 98.7%.Positive correlation was found between the migration of polydimethylsiloxane in ampicillin sodium for injection and the turbidimetric value(r= 0.672,P< 0.05). Conclusion: Migration of polydimethylsiloxane is related to the turbidimetric value,which may be one of the factors for hight turbidimetric values.

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