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目的对渗透泵型缓控释药品制剂建立合理的近红外光谱测样方法,并探讨其模型建立的基本思路。方法通过研究单室单层和单室双层渗透泵制剂的结构特点,以几个典型品种的渗透泵制剂为例,考察其结构对光谱测定的影响,确定其光谱采集方法,并建立合理的模型,以及验证模型的专属性。结果渗透泵型缓控释制剂的薄膜包衣不会掩盖片芯药物的光谱信息,且所建立的模型具有良好的专属性。结论对渗透泵型缓控释制剂可不去除包衣直接测定近红外光谱,再建立合适的模型单独或联合使用。
OBJECTIVE To establish a reasonable near-infrared spectrometric method for osmotic pump controlled release pharmaceutical preparations and to explore the basic idea of its model establishment. Methods By studying the structural characteristics of single-chamber and single-chamber double-layer osmotic pump formulations, taking several typical osmotic pump formulations as an example, the effect of their structure on spectrometry was investigated, and their spectral acquisition methods were determined, and a reasonable Model, and verify the model’s specificity. Results The film-coated osmotic pump controlled release formulation did not mask the spectral information of the core drug and the established model was well-defined. CONCLUSION: The controlled-release formulations for osmotic pumps can be used to determine the near-infrared spectroscopy without removing the coating, and then establish the appropriate model for use alone or in combination.