Application Research On Near Infrared Spectroscopy In The Manufacturing Process Of "Xuebijing" Injection

The modernization of Traditional Chinese Medicine(TCM) is blocked by its poor consistence and instability.One of the main reasons is the absence of fast and efficient analytical methods for manufacture process of TCM.As one of the techniques for on-line monitoring,fast and non-destructive analyzing,near infrared spectroscopy(NIRS) has already been widely used in many areas,but scarily in TCM pharmacy process.As a result,establishing the technology of quality control for the whole process,which is solidly based the study of NIRS suitable for the manufacture process of TCM,will ensure the consistence and stability of TCM products.The study of different raw materials and process links in the production of "xuebijing" injection by NIRS is carried out in this dissertation.The main researches are as followed:1.The research set up a novel method for fast determination of active components in water extracting process of Paeonia lactiflora by near infrared spectroscopy(NIRS) targeted at the absence of on-line detection means in the process.HPLC was used as the reference method to determine the content of Paeoniflorin and a multivariate calibration model based on PLS algorithm was developed to correlate the spectra and the corresponding values determined by the reference method.The method mentioned above is proved to be convenient,rapid and nondestructive,accurate and reliable,and is applicable for fast determination and monitoring of active components in extraction process of traditional Chinese medicine.2.The content of HSYA in the process of countercurrent extracting of Carthamus tinctorius L.was determined by Near-infrared Spectroscopy(NIRS),which was used to predict the concentration variation of HSYA in the different stages of countercurrent extracting.The performance of calibration model established was good,the correlation coefficient of which achieved 0.98.Meanwhile,the model gave a good prediction which exactly reflected the trend of HSYA content.It was concluded that the proposed method provides a novel efficient and environmental friendly approach for the fast determination of the active components in traditional Chinese medicine for countercurrent extracting process analysis and the rapid on-line endpoint determination during the process.3.NIRS was adopted in the concentrating process of Carthamus tinctorius L.to realize the real-time monitoring on HSYA content,alcohol content and density value,which hadn't been reported in literature.At the same time,the fitting curve of the density and alcohol concentration were developed, avoiding effectively tedious operations by GC,shortening analytical time and eventually realizing fast determination of alcohol content.It is concluded that NIRS can be used as a rapid method to determinate three key quality control indexes(the density,concentration of HSYA and ethanol) at one time in the process of concentrating process of Carthamus tinctorius L.alcohol sedimentation solution, which provided a reliable vector for on-line detection and rapid endpoint determination on the process of concentration of Chinese herb,eventually ensured the quality of Chinese medicine preparations.4.To realize fast judgment on the leak point,NIRS was used for rapid determination on change curve of HSYA content based on the purification of Carthamus tinctorius L.by macroporous resin. Meanwhile,spectral variance in absorption and elution was calculated by moving block of standard deviation(MBSD) and worked as evaluation index of endpoint judgment to realize the rapid fast determination of endpoint.