多烯酸乙酯软胶囊近红外光谱法一致性评价模型研究

目的: 利用近红外光谱(NIR)建立通用型多烯酸乙酯软胶囊的一致性检验模型,并对不同厂家的样品进行一致性检验。方法: 使用3台同一型号的近红外光谱仪在12 000~4 000 cm^-1范围内采集了8个厂家73批次样品的近红外光谱。通过聚类分析和二阶导数化和矢量归一化进行预处理,一致性指数限度设置为6,平滑点数13个,建立一致性检验模型。结果: 通用模型选定的特征谱段为9 000~7 895、6 500~5 950、5 262~4 752 cm^-1;在通用模型谱段和处理方法基础上,得到的细化特征谱段5 930~5 620、4 750~4 520 cm^-1使得不同厂家模型的专属性更强。结论: 所建立的一致性检验模型方法能够对多烯酸乙酯软胶囊进行快速鉴别。

Objective: To establish a universal conformity test model and a particular conformity test method of ethyl polyenoate soft capsules from different pharmaceutical manufacturers by the use of near infrared reflection (NIR). Methods: Based on the wavelength range of 12 000-4 000 cm^-1,three NIR spectrometers from the same manufacture were used to collect spectra of 73 batches of samples from eight pharmaceutical manufacturers.The conformity test mode was established after pre-treatment by the cluster analysis and the second derivative combining vector normalization method,in which the conformity index limit was set as 6 and the smooth points were 13. Results: Characteristic spectra of the universal conformity test model were 9 000-7 895 cm^-1,6 500-5 950 cm^-1 and 5 262-4 752 cm^-1.On the basis of characteristic spectra and pre-treatment of the universal model,the refined characteristic spectra of 5 930-5 620 cm^-1 and 4 750-4 520 cm^-1 enhanced the specificity of the particular conformity test model. Conclusion: The model established is able and suitable to rapidly identify ethyl polyenoate soft capsules.