摘要
目的:建立应用声光可调滤光器(AOTF)-近红外(NIR)光谱技术对双黄连口服液进行现场快速定量分析的方法。方法:收集7个厂家58个不同批号双黄连口服液为样本,利用HPLC法测定校正集样品中3个成分的含量,并进行方法学考察,继而选用便携式AOTF近红外光谱仪采集光谱,通过The Unscrambler分析软件,利用偏最小二乘法(PLS1)对双黄连口服液中黄芩苷、绿原酸和连翘苷3个指标成分分别建立了定量分析模型,并对模型的微分处理方法、波长范围进行了研究。结果:建立的定量分析模型具有较好的预测能力,验证集样品3个成分黄芩苷、绿原酸和连翘苷的NIR预测值与HPLC参考值间的相关系数(r)分别为0.9909,0.9913,0.9640;平均相对误差分别为0.96%,5.62%,2.75%。方法精密度RSD值(n=20)分别为0.86%,0.82%,0.73%;方法稳定性RSD值(n=9)分别为0.98%,1.2%,1.1%。结论:本研究使用便携式AOTF近红外光谱仪,利用化学计量学软件,所建立的对双黄连口服液中3个指标成分的分析方法快速、准确,为双黄连口服液的现场、即时快速定量分析提供了一种新方法,同时也为生产过程中的在线质量监控奠定了基础。
Objective:To establish a new method for on-site rapidly analyzing the Chinese formulated product Shuanghuanglian oral liquid by portable acousto-optic tunable filter (AOTF)-near infrared(NIR) spectroscopy.Methods:58 different batches of Shuanghuanglian oral liquid collected fromseven pharmaceutical factories were usedto test.Three components in calibration set samples were examined by HPLC.Then,a portable fifth generation AOTF-NIR spectrometer was used to analyze the samples by the unscrambler program. Quantitative analysis models of three index constituents,which are baicalin,chlorogenic acid,and forsythin in Shuanghuanglian oral liquid,are estab-lished respectively take advantage of partial least squares(PLS1).Conditions for optimal model construction,such as different spectral pretreatments and wavelength regression,were studied within the framework of the unscrambler program.Results:The quantitative analysis models performed well for prediction,with the correlation coefficients for the three analyzed ingredients equal to0.9909,0.9913,and 0.9640,respectively.The average relative errors for the test sets were 0.96%,5.62%,and 2.75%,respectively.The precision RSDs(n=20)were 0.86%,0.82%,0.73%,and the stability RSDs(n=9)were 0.98%,1.2%,1.1%,respectively.Conclusion:The analysis method based on AOTF-NIR spectroscopy provides a foundation for rapid quantitative analyses of Shuanghuanglian oral liquid,which sets up the foundation of product-line control of Shuanghuanglian oral liquid and can be used for on-site rapid screening of drugs.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第9期1689-1694,共6页
Chinese Journal of Pharmaceutical Analysis
基金
山东省教育厅科研项目(J07YD12)
关键词
声光可调滤光器
近红外光谱技术
双黄连口服液
黄芩苷
绿原酸
连翘苷
现场快速定量分析
acousto-optic tunable filter
near-infrared spectroscopy
Shuanghuanglian oral liquid
baicalin
chlo-rogenic acid
forsythin
on-site rapid quantitative analysis