NIRDRS法对微球制剂的粒径及跨度的研究

Studies on of the Particle Diameter and Microsphere Span by NIRDRS Method

目的:采用近红外漫反射光谱技术,建立一种快速测定微球的粒径及其跨度的方法。方法:建立校正样品集与测试样品集,采集近红外光谱,运用偏最小二乘法建立数学模型,对测试集进行预测。结果:校正样品集的最佳主成分数分别为(Rank_1)=2,(Rank_2)=1;内部交叉验证均方差(RMSECV_1)=0.78,(RMSECV_2)=0.22;决定系数(R^(21))=98.58,(R^(22))=93.35。测试样品集的预测结果,粒径:预测均方差(RMSEP)=0.99,决定系数(R^2)=97.84,评估均方差(RMSEE)=1.12;跨度:预测均方差(RMSEP)=0.28,决定系数(R^2)=93.03,评估均方差(RMSEE)=0.23。结论:近红外漫反射光谱测定微球的粒径及其跨度结果可靠,可用于微球制剂的质量控制。

Objective: To establish a method to determination the diameter of particle and span of the microsphere by near-infrared diffuse reflectance spectrometry (NIRDRS) ,and compared the result with FAM. Methods: Collect the NIR spectra and treat them with partial least squares(PLS). A math model was established and tested. Results:Rank_1=2,Rank_2=1; RMSECV_1=0.78, RMSECV_2=0.22; R^(21)= 98.58, R^(22)= 93.35. RMSEP_1= 0.99, R^(21)=97.84,RMSEE_1=1.12;RMSEP_2=0.28,R^(22)-93. 03, RMSEE_2=0.23. Conclusion:The method can determine multi correlative target at same time. The technology provided sufficient theoretical basis for process monitoring and appraising the quality standard of the preparation of microsphere.