近红外光谱法测定缓释制剂中冰片释放量

利用近红外光谱技术与化学计量学方法建立了冰片缓释样品近红外光谱与冰片浓度之间的定量模型，以实现冰片释放量的快速测定。配制与缓释制剂具有相同物质体系的的冰片醇水溶液，获取其近红外光谱，采用偏最小二乘法(PLS)建立冰片含量预测模型并考察了图谱类型、建模样品浓度及建模区间对校正模型和预测结果的影响。结果表明采用原始近红外光谱，在5 314～7 032 cm-1区间，将样品按照中高浓度、低浓度范围建模可以获得最佳校正结果与预测结果。最后采用所建的中高浓度区模型测定了冰片包合物在醇水体系中冰片含量，实现了对缓释制剂冰片累加释放量的快速测定，可为冰片缓释制剂的研发快速提供评价数据。

Near Infrared Spectrometry (NIRS) Method for the Determination of Borneol in Sustained-Release Drugs

In order to detect the release profile of borneol in sustained-release preparations, a series of NIRS calibration models were established on the basis of chemometrics and internal relationships between NIRS and analytical concentrations of samples, which contained the same substances as the preparations. Partial least square (PLS) algorithm was used to establish the model for predicting the content of borneol. The effect of spectra types, concentration range of samples, and calibration range on the models and predicting results were investigated. It was found that uhe best calibration models and prediction results can be obtained by using original spectra in the 5 314-7 032 cm -1 region. The models established according to standards' concentration levels are better than those established without considering concentration levels. Using the model 2 in which calibration standards had medium or high concentration levels, rapid and accurate measurement of borneol released from sustained-release preparation was realized. The results indicated that the method and models provide valuable criteria for developing sustained-release borneol preparations.