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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: To quantitatively analyze tegafur (FT-207) microemulsion by near-infrared spectroscopy. METHODS: Blank microemulsion, lecithin, ethanol, ultrapure water and IPM were prepared from lecithin, ethanol, ultrapure water and isopropyl myristate (IPM), and a certain amount of FT-207 was added to obtain FT-207 Drug microemulsion. Near-infrared spectroscopy measurements of blank microemulsion and drug-containing microemulsion at different concentrations were carried out, and the resulting near-infrared spectra were quantitatively analyzed by “modeling ” method. Results: The calibration equation for blank microemulsion was R2 (%): water, 99.59; lecithin, 99.26; ethanol, 98.83; IPM, 99.91. RMSECV: water, 0.424; lecithin, 0.794; ethanol, 0.820; IPM, 0.490. Calibration equation for FT-207 drug-containing microemulsion PARAMETERS R2 (%): Water, 99.75; Lecithin, 98.37; Ethanol, 98.97; IPM, 99.93; FT-207, 75.74. RMSECV (P): Water, 0.359; Lecithin, 1.107; Ethanol, 0.767; IPM, 0.426; FT-207, 2.43 x 10-5. The recovery rates are within 95% ~ 105%. Conclusion: The modeling method is a classical way of near-infrared spectroscopy. The good analysis result of Tegafur microemulsion once again verifies the advantages of NIR spectroscopy in the analysis of pharmaceutical preparations.