[关键词]
[摘要]
目的应用近红外光谱分析技术结合化学计量学方法建立制药过程中复方丹参滴丸包衣厚度的快速、无损检测的新方法。方法用近红外光谱仪扫描复方丹参滴丸包衣生产过程中的样品,对所得近红外漫反射光谱的预处理方法、有效谱段范围选择进行了讨论,并用偏最小二乘回归法(PLSR)建立测定滴丸包衣厚度的近红外光谱定量分析校正模型。结果对待测样本包衣厚度预测结果表明,所建校正模型预测相关系数R为0.974,校正误差均方根(RM SEC)为0.228,预测误差均方根(RM SEP)为0.338,效果比较理想。结论本实验所建方法快速、无损且准确可靠,可推广应用于中药生产药品包衣过程的在线检测。
[Key word]
[Abstract]
Objective Near-infrared spectroscopy(NIRS)and chemometrics were used to develop a nondestructive method for fast detection of Compound Danshen Dropping Pills’film coating thickness in pharmaceutical process.Methods Film coating thickness of Compound Danshen Dropping Pills was scanned bv NIRS instrument,the pretreatment methods and wavenumber selection of NIRS were discussed in detail.Partial least squares regress(PLSR)was utilized to build the quantitive calibration model.Results The film coating average thickness of samples for detecting was predicted through this model.Correlation coefficients(R),root mean square error of calibration(RMSEC),and root mean square error of prediction(RMSEP)obtained by PLSR model were 0.974,0.228,and 0.338,respectively.Conclusion The proposed method has the advantages of quickness,nondestructiveness and precision,which could be applied to the on-line monitor of Chinese materia medica pills 7 film coating process.
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[基金项目]
国家“十五”重大科技攻关计划资助项目(2001BA701A45);浙江省科技厅重大科技计划项目(021103549)