论文部分内容阅读
目的:建立3个厂家的非洛地平缓释片近红外光谱法一致性检验模型,考察制剂工艺的差别,通过稳健、准确、代表性强的近红外一致性模型实现非洛地平缓释片的快速检验和筛查。方法:对评价性抽验抽取的6个厂家中的3个建立非洛地平缓释片近红外一致性检验模型,选取4 000~9 000 cm-1区段为建模区段、一阶导数+矢量归一化法作为预处理方法。结果:建立了3个厂家非洛地平缓释片的近红外一致性模型,对抽样的6个企业样品进行了预测,对本厂产品和其他厂家产品的预测成功率均为100%。结论:近红外光谱法能够用于快速鉴别不同厂家的非洛地平缓释片,对制剂工艺进行考察。
OBJECTIVE: To establish a consistency test model of three formulations of felodipine sustained-release tablets by near-infrared spectroscopy and to investigate the difference of preparation technology. Through the steady, accurate and representative near-infrared consistency model, Quick test and screening. Methods: Three models of felodipine sustained-release tablets near infrared (IR) were established in 3 out of 6 manufacturers selected by evaluation sampling. The model segment of 4 000-9 000 cm -1 was chosen as the modeling section, the first derivative + Vector normalization method as a pretreatment method. Results: A near-infrared consistency model of three manufacturers of felodipine sustained-release tablets was established. Six sampling samples were predicted. The predicted success rates of the two products were 100%. Conclusion: Near infrared spectroscopy can be used to quickly identify different manufacturers of felodipine sustained release tablets, the preparation process to investigate.