Safflower Injection For Quality Control Of Research

In this paper, 22 samples of Carthamus tinctorius were collected from different areas. It was identified that all of them were Carthamus tinctorius. First, the standard substance of hydroxysafflor yellow A was isolated from Carthamus tinctorius and the structure was elucidated by UV, IR, MS, 1H-NMR and 13C-NMR. The content of hydroxysafflor yellow A was 98.4% by HPLC. HPLC with UV detector was used to analyze the flavone in the samples of Carthamus tinctorius and hydroxysafflor yellow A was used as internal standard compound: Chromatography was performed on a Kromasil KR100-5 C18 column (250 mm×4.6 mm, 5 μm) using acetonitrile-0.01 mol .L-1 NH4H2PO4 solution as the mobile phase (gradient elution) and detected at 332 nm. The flow rate was 1.0 mL . min-1. Based on this study, HPLC fingerprint analysis method for Carthamus tinctorius was developed. Analyzing by Computer Aided Similarity Evaluation system, the similarity of Carthamus tinctorius from different areas was more than 0.80.Extraction and isolation methods of safflor yellow in Carthamus tinctorius were studied in this paper. Safflor yellow was extracted from Carthamus tinctorius by using water and isolated by using macroporous resin. By using the content of hydroxysafflor yellow A as quality control criteria, extraction and isolation process of safflor yellow in Carthamus tinctorius was optimized with the aid of orthogonal design and mono-factor trial. It was demonstrated that this method was convenient, economical and suitable for manufacture in industry.Quality control of extraction and isolation technics was studied in this paper. A RP-HPLC method was developed to determinate the content ofhydroxysafflor yellow A in safflor yellow. As a result, a good linearity was obtained from 10.1-505.0μg . mL-1 with r = 0.9999 for hydroxysafflor yellow A. The average recovery was 98.2%, RSD = 1.3% (n = 9). The method was proved to be simple, precise, sensitive.Based on the study of fingerprints of Carthamus tinctorius. HPLC method was used to analyze 10 batchs safflor yellow and safflower injection respectively. The fingerprints of safflor yellow and safflower injection were set up. Analyzing by Computer Aided Similarity Evaluation system, the similarity of safflor yellow and safflower injection was more than 0.90 respectively. The studies are useful for the quality control of safflor yellow and safflower injection.