ABSTRACT
In this paper, the principle of NIRS (near infrared spectroscopy)-based process trajectory technology was introduced.The main steps of the technique include:â in-line collection of the processes spectra of different technics; â¡ unfolding of the 3-D process spectra;⢠determination of the process trajectories and their normal limits;⣠monitoring of the new batches with the established MSPC (multivariate statistical process control) models.Applications of the technology in the chemical and biological medicines were reviewed briefly. By a comprehensive introduction of our feasibility research on the monitoring of traditional Chinese medicine technical process using NIRS-based multivariate process trajectories, several important problems of the practical applications which need urgent solutions are proposed, and also the application prospect of the NIRS-based process trajectory technology is fully discussed and put forward in the end.
Subject(s)
Drugs, Chinese Herbal/standards , Spectroscopy, Near-Infrared , Chemistry, Pharmaceutical/standards , Medicine, Chinese Traditional , Quality ControlABSTRACT
In this paper, the principle of NIRS (near infrared spectroscopy)-based process trajectory technology was introduced.The main steps of the technique include:① in-line collection of the processes spectra of different technics; ② unfolding of the 3-D process spectra;③ determination of the process trajectories and their normal limits;④ monitoring of the new batches with the established MSPC (multivariate statistical process control) models.Applications of the technology in the chemical and biological medicines were reviewed briefly. By a comprehensive introduction of our feasibility research on the monitoring of traditional Chinese medicine technical process using NIRS-based multivariate process trajectories, several important problems of the practical applications which need urgent solutions are proposed, and also the application prospect of the NIRS-based process trajectory technology is fully discussed and put forward in the end.