近红外光谱分析技术对替加氟微乳进行含量测定

Quantity study in FT-207 micro emulsion by NIR

目的:采用近红外光谱建模方式对替加氟(FT-207)微乳制剂进行定量分析。方法:卵磷脂、乙醇、超纯水与异丙基豆蔻酸酯(IPM)制成空白微乳,卵磷脂、乙醇、超纯水与IPM,加入一定量的FT-207,得FT-207含药微乳。对不同浓度的空白微乳和含药微乳样品进行近红外光谱的测量,对所得近红外光谱用"建模"方法进行定量分析。结果:空白微乳的校正方程参数R2(%):水,99.59;卵磷脂,99.26;乙醇,98.83;IPM,99.91。RMSECV:水,0.424;卵磷脂,0.794;乙醇,0.820;IPM,0.490。FT-207含药微乳的校正方程参数R2(%):水,99.75;卵磷脂,98.37;乙醇,98.97;IPM,99.93;FT-207,75.74。RMSECV(P):水,0.359;卵磷脂,1.107;乙醇,0.767;IPM,0.426;FT-207,2.43×10-5。回收率均在95%～105%之内。结论:建模方式是近红外光谱应用的经典方式,替加氟微乳制剂的良好分析结果再一次验证了近红外光谱在药物制剂分析中应用的优势。

Objective：The feasibility of fast and correctly detecting the quantity in FT-207 micro emulsion by NIR was studied.Method：The blank micro emulsion contains water,lecithin,ethanol and isopropyl myristate （IPM）.The real micro emulsion contains FT-207 besides blank micro emulsion.Quantity study were by model-setting on the NIR spectra,which were from series blank micro emulsions and real micro emulsions.Results：R2（%）of correction equation on blank micro emulsion are 99.59 （water）,99.26 （lecithin）,98.83 （ethanol） and 99.91 （IPM）.RMSECV of that are 0.424 （water）,0.794 （lecithin）,0.820 （ethanol） and 0.490（IPM）.Correspondingly R2（%）of correction equation on real micro emulsion are 99.75 （water）,98.37 （lecithin）,98.97（ethanol）,99.93（IPM） and 75.74（FT-207）.RMSECV（P） of that are 0.359 （water）,1.107 （lecithin）,0.767 （ethanol）,0.426 （IPM） and 2.43×10-5（FT-207）.Accuracies in a day and between days are both between 95%-105%.Conclusion：Model-setting is the classic mode in using NIRS.The results proved again that NIR spectroscopy analysis technology has superiority in pharmaceutical analysis.