基于近红外光谱法检测注射用绒促性素的一致性研究

Uniformity study of chorionic gonadotropin for injection using near⁃infrared spectroscopy

目的:建立一种快速、稳健的近红外光谱模型,考察不同厂家生产的注射用绒促性素的差别,以实现对不同生产工艺注射用绒促性素的快速检验和筛查的目的。方法:采取无损检测积分球漫反射模式,建立厂家A生产的注射用绒促性素近红外光谱法的一致性模型,通过该模型对不同处方工艺注射用绒促性素研究采用主成分分析法,将光谱数据重构,在主成分空间中研究各厂家样品的距离,以评价制剂工艺的相似程度。结果:选取光谱6960~5550和5100~3990 cm^(-1)段建立一致性检验模型,该模型能够区分厂家A与其他厂生产的注射用绒促性素,预测正确率均为100%,对原厂样品也实现了正确判别;主成分分析结果与一致性模型相对应。结论:近红外光谱法能够用于快速筛查工艺稳定的注射用绒促性素产品,所建立的一致性模型可用于建模厂家的注射用绒促性素快速筛查,并可以正确地区分其他厂家的产品,进一步实现质量可控,保证用药安全的。

Objective:To establish fast and robust uniformity models for chorionic gonadotropin injection(HCG injection)using near⁃infrared spectroscopy(NIRS),and to rapidly detect and screen HCG injection in different prescription processes.Methods:NIRS qualitative modes for HCG injection produced by manufacturer A were established using the integrating sphere diffuse reflection mode of nondestructive testing.Principal component analysis was used to reconstruct the spectral data for the studies of HCG injection and discriminate different processes.The distance of samples from different manufacturers was studied in the principal component space to evaluate the uniformity of processes.Results:The NIR consistency model of HCG injection produced by manufacturer A was established.The model could distinguish HCG injection produced by manufacturer A from those produced by other manufacturers with the prediction accuracy of 100%.The original samples were also identified correctly,in accordance with the results of principal component analysis model.Conclusion:NIR spectroscopy can be used for rapid screening of HCG injections in stable process,and the established uniformity model can be used for rapid identification of HCG injections from modeling manufacturers and products from other manufacturers,so as to achieve quality control and ensure drug safety.