激光显微共聚焦拉曼光谱研究硫酸氢氯吡格雷片晶型及其判别模型的建立

目的：采用激光显微共聚焦拉曼光谱仪研究硫酸氢氯吡格雷片晶型并建立定性判别模型。方法：建立硫酸氢氯吡格雷2种晶型的拉曼对照图谱，用OPUS软件聚类分析法判别出国内外不同厂家硫酸氢氯吡格雷片的晶型，再通过建立定性鉴别模型鉴别未知样品。结果：聚类分析结果表明8批硫酸氢氯吡格雷片均属于Ⅰ晶型，3批硫酸氢氯吡格雷片均属于Ⅱ晶型，采用一阶导数法和矢量归一化法处理图谱，用因子分析法计算，选择500~743、900~1000、1400~1650 cm^-1谱段建立定性模型，经验证，该模型的灵敏度、专属性、阴性预报性和检出效率均良好。结论：激光显微共聚焦拉曼光谱仪可用于固体口服制剂的晶型判别及实现快速、准确的定性鉴别。

Objective: To analyze the polymorphs of clopidogrel hydrogen sulphate tablets by laser confocal micro-Raman spectrometer and to establish the identification test model. Methods: Reference Raman spectra of the two crystal forms of clopidogrel hydrogen sulphate were established;then the polymorphs of the clopidogrel hydrogen sulphate tablets from different manufacturers were analyzed,and an identification test model was established to distinguish the unknown samples. Results: According to the results of the cluster analysis,the 8 batches of clopidogrel hydrogen sulphate tablets from domestic manufacturers belonged to form Ⅰ while the 3 batches of tablets from foreign manufacturers belonged to form Ⅱ.A qualitative model was created by choosing the first derivative and vector normalization method to process the spectra,using the factorization method to calculate,and selecting the 500-743 cm^-1,900-1000 cm^-1,1400-1650 cm^-1 regions to compare.This model was verified to have high sensitivity,good specificity,precise negative prediction and high detection efficiency. Conclusion: The laser confocal micro-Raman spectrometer can be used to analyze the polymorphs of solid oral preparations and the qualitative identification is rapid and accurate.

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