摘要
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（ FFIR - 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 diehloromethane solution which was carefully shaked ,avoiding contact with stopper. After standing for 1 h,the sample was put into the ZnSe crystal tank for FFIR -ATR to achieve the infra -red spec- trogram. The dimethicone peak area at （v = 1260 ± 5 ）cm- 1 was used to do quantitative calculation. Results： The line- ar 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 ampi- cillin sodium for injection and the turbidimetric value （r = 0. 672,P 〈 0.05 ）. Conclusion： Migration of polydime- thylsiloxane is related to the turbidimetric value, which may be one of the factors for hight turbidimetric values.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第3期508-510,516,共4页
Chinese Journal of Pharmaceutical Analysis
