Application Of NIR And UV Spectroscopy In Quality Control Of Tanreqing Injection

Traditional Chinese medicine injection (TCMI) is a peculiar dosage form of Traditional Chinese medicine in China. The quality control and safety problems of TCMI have a great relationship with its developmental prospects. The formula of Tanreqing injection is composed of radix scutellariae, bear biliary drainage powder, cornu caprae hircus, flos lonicerae and forsythia suspense according to Chinese compatibility principles of "monarch, minister, adjuvant and dispatcher". It is used for the treatment of acute pneumonia, upper respiratory tract infection and viral pneumonic in clinic. Taking Tanreqing injection as the research object and PAT (process analytical technology) theory as guidance, this research mainly focuses on the application of NIR and UV spectroscopy in quality control of Tanreqing injection. The main contents include the following aspects:1. Rapid quality evaluation of bear biliary drainage powder by Near-infrared (NIR) spectroscopy. Firstly, qualitative analysis was used to the quality evaluation of bear biliary drainage powder with comparison of different spectra pretreatment methods and similarity match methods. Then, quantitative analysis was made to establish the NIR calibration model to simultaneous determination of tauroursodeoxycholic acid and taurochenodeoxycholic acid in bear biliary drainage powder. Combing the qualitative analytical methods with the quantitative one, the rapid quality evaluation of bear biliary drainage powder could be realized.2. Rapid analysis of Radix Scutellariae and decoction pieces by Ultraviolet (UV) spectroscopy. Principle component analysis (PCA) and cluster analysis were used for the qualitative analysis of UV spectroscopy. and the good discrimination of Radix Scutellariae and its prepared slice was obtained. HPLC-UV was used as the reference method to determine the content of baicalin and wogonoside in Radix Scutellariae and the multivariate calibration models based on PLS algorithm were developed to analyze the correlation between the UV spectra and the corresponding values determined by the reference method.3. Rapid determination of five organic acids in Flos Lonicerae extracts by UV Spectroscopy. The HPLC method was used as the reference method to determine the contents of chlorogenic acid, caffeic acid,3,4-dicaffeoylquinic acid,3, 5-dicaffeoylquinic acid and 4,5-dicaffeoylquinic acid in the Flos Lonicerae extracts. UV absorption spectrum was scanned. The PLS models were developed to correlate the UV spectra with the corresponding values determined by the reference method. Then the performance of calibration models was validated. The present method was fast, accurate and could be a method for the rapid determination of organic acids in Flos Lonicerae extracts.4. Rapid determination of total amino acids in cornu caprae hircus extract by Near-infrared spectroscopy. Spectrophotometry method with cation exchange resin separation-post column derivatization was used as the reference method for the determination of total amino acids. The calibration models were developed to correlate the NIR spectra with the corresponding values determined by the reference method. The models are simple, accurate and could be used for the quality control of cornu caprae hircus extract.