Blanco M, Gozález Bañó R, Bertran E
Departament de Quimica, Unitat de Quimica Analitica, Facultat de Ciencies, Universitat Autònoma de Barcelona, E-08193 Bellaterra, Spain.
Talanta. 2002 Jan 4;56(1):203-12. doi: 10.1016/s0039-9140(01)00559-8.
Obtaining completely uniform distribution of the active principle and excipients in a pharmaceutical preparation is essential with a view to ensuring correct dosage. Uniformity in pharmaceutical formulations has usually been controlled by collecting samples at different stages of the process in order to determine the active principle using a chromatographic or UV-Visible spectroscopic method. In this work, near infrared reflectance spectroscopy (NIRS) was used to monitor blending in order to ensure uniformity in a mixture consisting of three typical pharmaceutical excipients and one active principle. To this end, a method for calculating the Mean Square of Differences between two consecutive spectra was developed with a view to expeditiously identifying the time mixture homogeneity was attained. The performance of the proposed method was compared with that of two others routinely employed to monitor blending by use of the NIRS technique and the results were found to be quite consistent.
为确保正确的剂量，使活性成分和辅料在药物制剂中获得完全均匀的分布至关重要。药物制剂的均匀性通常通过在工艺的不同阶段采集样品来控制，以便使用色谱法或紫外-可见光谱法测定活性成分。在这项工作中，近红外反射光谱法（NIRS）被用于监测混合过程，以确保由三种典型药物辅料和一种活性成分组成的混合物的均匀性。为此，开发了一种计算两个连续光谱之间差异均方的方法，以便快速确定达到混合物均匀性的时间。将所提出方法的性能与另外两种常规用于通过近红外光谱技术监测混合的方法进行了比较，结果发现相当一致。
