近红外光谱法快速测定复方感冒灵颗粒中对乙酰氨基酚的含量  

Rapid Determination of Paracetamol in Compound Ganmaoling Granules by Near Infrared Spectroscopy

作　　者：符国成 李贱娥 陆美清 李柯[2] 梁雪娟[2] FU Guocheng;LI Jian'e;LU Meiqing;LI Ke;LIANG Xuejuan(Huarun 39(Chenzhou)Pharmaceutical Co.,Ltd.,Chenzhou 423000;Hunan Academy of Chinese Medicine,Changsha 410013)

机构地区：[1]华润三九(郴州)制药有限公司,湖南郴州423000 [2]湖南省中医药研究院,湖南长沙410013

出　　处：《中国医药工业杂志》2023年第12期1768-1773,共6页Chinese Journal of Pharmaceuticals

基　　金：湖南省自然科学基金项目(2020JJ9005)。

摘　　要：建立了近红外光谱(NIRS)法快速测定复方感冒灵待分装颗粒中对乙酰氨基酚(1)的含量。本研究共收集了232个复方感冒灵颗粒样品,采用高效液相色谱(HPLC)法测定其中1的含量,并通过积分球漫反射方式收集颗粒的NIRS,运用偏最小二乘法(PLS)建立了1含量的NIRS定量分析模型。随后,采用不同的光谱波段、主因子数及预处理方法对模型进行优化。结果显示,在建立的优化模型中,交叉验证均方根误差(RMSECV)及R2分别为0.259、0.9658;预测集的验证集均方根误差(RMSEP)及R分别为0.253、0.9992。上述试验证实了NIRS与PLS结合能够成功用于监测复方感冒灵待分装颗粒中1的含量。所建立的近红外光谱快速检测方法具有模型性能好、预测精度高、快速分析、无损的优点。该方法的应用能够大幅提高复方感冒灵颗粒的生产流转效率。A near infrared spectroscopy(NIRS)method was established to rapidly determine the content of paracetamol(1)in compound Ganmaoling granules to be packaged.Two hundred and thirty-two samples of compound Ganmaoling granules were collected and the content of 1 was determined by HPLC.The NIRS spectra of the granules were collected by integrating sphere diffuse reflection,and a quantitative analysis model of NIRS for 1 content was established using partial least squares(PLS).And different spectral bands,principal factor numbers,and preprocessing methods were investigated to optimize the model.The results showed that in the established optimal model,the root mean square error of cross validation(RMSECV)and R?were 0.259 and 0.9658,respectively.The root mean square error of prediction(RMSEP)and R value of the validation set were 0.253 and 0.9992,respectively.The above experiment confirmed that the combination of NIRS and PLS could be successfully applied to monitor 1 content in the the compound Ganmaoling granules to be packaged.The established near infrared rapid detection method has the advantages of good model performance,high prediction accuracy,quick analysis,and non-destructive testing.The application of this method can significantly improve the production and circulation efficiency of compound Ganmaoling granules.

关 键 词：近红外光谱 复方感冒灵颗粒 对乙酰氨基酚 含量 快速分析 

分 类 号：O657.33[理学—分析化学]