利用近红外光谱法及一致性检验模型鉴别肚痛健胃整肠丸  

Identification of Dutong Jianwei Zhengchang Pills By Near Infrared Spectroscopy and Conformity Test Model

作　　者：韩莹[1] 曾文珊[1] 刘红果 李刘炜 林东 袁震霆 HAN Ying;ZENG Wenshan;LIU Hongguo;LI Liuwei;LIN Dong;YUAN Zhengting(Guangzhou Institute for Drug Control,Guangzhou,Guangdong 510160,China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《今日药学》2024年第3期196-199,共4页Pharmacy Today

基　　金：广州市市场监督管理局科技项目(2023KJ31)。

摘　　要：目的利用近红外光谱法建立肚痛健胃整肠丸一致性检验模型,可快速准确鉴别药品真伪,加强流通使用环节药品的质量监管,保障公众用药安全。方法收集肚痛健胃整肠丸正品、伪品以及挑战品,扫描其近红外光谱图。通过计算机光谱软件对谱图进行预处理,试验选取适宜的建模参数及特征谱段,利用一致性检验最大CI值算法建立模型,保证模型的准确性和耐用性。结果所建肚痛健胃整肠丸近红外模型能够准确识别正品、伪品及挑战品,识别正确率达到100%。结论利用近红外光谱法及一致性检验模型能够快速鉴别肚痛健胃整肠丸真伪,筛查结果准确可靠,可实际应用于该品牌药品的质量快速筛查。OBJECTIVE To establish qualitative model of Dutong Jianwei Zhengchang pills by near-infrared spectroscopy and conformity test for identifying the authenticity of drugs quickly and accurately,as well as the quality supervision of drugs in circulation and usage in order to ensure the drug safety.METHODS Authentic products of Dutong Jianwei Zhengchang pills,counterfeit products found in drug administration,and similar properties varieties were collected.The near-infrared spectrogram were scanned,and preprocessed by opus software.The appropriate model parameters and characteristic spectral segments were selected in experiments,which was used to establish the conformity test model.The maximum CI value algorithm was used to establish the model to ensure the accuracy and durability.RESULTS The model of Dutong Jianwei Zhengchang pills distinguished the authenticity of samples accurately,with the accuracy of 100%.CONCLUSION Making use of near-infrared spectroscopy and conformity testing model can distinguish the authenticity of Dutong Jianwei Zhengchang pills quickly,accurately and reliably,which can be applied to the rapid quality screening of this brand of drug.

关 键 词：近红外光谱法 一致性检验 肚痛健胃整肠丸 

分 类 号：R975[医药卫生—药品]