Application Of NIR Spectroscopy In The Quality Control Of Compound Kushen Injection

Compound Kushen injection is a pure herbal preparation produced from Radix sophorae flavescentis and Heterosmilax japonica Kunth. It has many efficacies like clearing heat and promoting diuresis, removing heat and toxic substances from the blood, eliminating stagnation and pain, etc. It is widely used in the treatment of psoriasis, arrhythmia and cancer in clinic. Present quality control system of compound Kushen injection is incomplete. Most studies focused on the quality of finish products using conventional methods. This research mainly focuses on the application of NIR (Near-infrared) spectroscopy in the quality control of Chinese herb, producing processs and the intermediates of compound Kushen injection. The main contents including:1. An Ion-pair RP-HPLC method for the simultaneous determination of matrine, sophocarpine, oxysophocarpine and oxymatrine in compound Kushen injection was established. Compared with existing methods, the presented method is simple, accurate, without complex sample-preparation, and obviously improved the shape of chromatographic peaks, which can be used for the quality control of compound Kushen injection and its intermediates.2. Rapid quality evaluation of Radix sophorae flavescentis by NIR spectroscopy. Firstly, qualitative analysis method was developed by calculating similarities between validation samples and standard samples. Secondly, two different similarity evaluation methods were compared. Thirdly, the NIR quantitative model for the summation of matrine and oxymatrine in Radix sophorae flavescentis was established. The correlation between similarty and contents of active principle was also studied. Combing the qualitative analysis with the quantitative one, the rapid quality evaluation of Radix sophorae flavescentis could be realized.3. Rapid analysis of Heterosmilax japonica Kunth (HJK). Diffuse reflection spectra of HJK, Smilax glabra Roxb(SGR) and Smilax china L(SCL) were collected. Qualitative analysis, such as Cluster Analysis, Similarity Match and Discriminant Analysis were used to process the spectra. Fast discrimination methods based on NIR were developed, which can successfully distinguish the 3 similar medicinal materials. The established methods were sensitive, quick, and can be used for the quality control of HJK.4. On-line analysis of the extracting process of compound Kushen injection. Samples and correlative spectra were collected with online equipment in percolation process and decoction process. The contents of total alkaloids and soluble solids measured with standard methods were used as reference values. Multivariate calibration models based on partial least squares (PLS) algorithm were established to correlate the spectra and the reference values, and then the models were applied in the industrial processes. The established method is fast, accurate and reliable, which can be used as a process analysis method for monitoring the percolation process and decoction process of compound Kushen injection.5. Rapid simultaneous determination of 4 alkloids in the intermediates of compound Kushen injection. After the optimization of calibration parameters and the comparison of different spectra collective modes(transmission and transflective), transmission spectra were chosen to develop multivariate calibration models based on PLS algorithm by correlating the spectra and the reference values measured with standard method. Models updating was executed after a period of application in industry. The presented method is fast, accurate and reliable, which can be used as a fast analysis method for the Compound Kushen injection intermediates.