Study On The Method Of Quality Assessment Of Compound Kushen Injection

The Compound Kushen injection was the preparation of modern pharmacy techniques after baking Radix Sophorae flavescentis and Rhizoma Heterosmilacis japonicae. The quality assessments of the HPLC-FPS of Radix Sophorae flavescentis, Rhizoma Heterosmilacis japonicae and the Compound Kushen injection were developed.(1) The separation was carried out on a Hypersil ODS₂ column (200 mmx4.6 mm i. d, 5μm) with a mobile phase of methanol-acetonitrile-water-phosphoric acid (10: 30: 65: 0.05, v/v/v, including ODS with the concentration of 33 mmol·L^-1) at a flow rate of 1.0 mL·min^-1 and UV detection was performed under 210 nm with 25°C as the column temperature. Quantitative assays were performed on the oxysophocarpine and oxymatrine from the 23 samples of collected Radix Sophorae flavescentis. The linear ranges for oxysophocarpine and oxymatrine were 2.52—50.4μg·mL^-1 (r=0.9999) and 17.44—174.4μg·mL^-1 (r=0.9996), respectively. The average recoveries were 96.8% (RSD=1.7%) and 97.8% (RSD=2.0%), respectively.(2) Column chromatography was performed on a Kromasil C₁₈ column (250 mm×4.6 mm i. d, 5μm). The determination used methanol-water-triethylamine (53: 47: 0.02, v/v/v) as mobile phase. The flow rate was kept constant at 0.8 mL·min^-1 with a UV detector setting at 225 nm with column temperature at 25°C. Quantitative assays were performed on the matrine which was chosen as the quality control criterion from 24 samples of Radix Sophorae flavescentis from different origins. The linear range for the determination was 3.92-78.4μg·mL^-1 with the coefficient of determination r=0.9998. The average recovery was 97.2%. Precision gave a relative standard deviation (RSD) of 2.1%.(3) Quantitative assays were performed on the oxysophocarpine, oxymatrine and matrine chosen as the quality control criteria from 13 samples of the Compound Kushen injection under the same chromatography conditions with (1). The linear ranges were 2.52—50.4μg·mL^-1 (r=0.9999), 17.44-174.4μg·mL^-1 (r=0.9996), 1.96-39.20 mg·L^-1 (r=0.9997). The average recoveries were 98.2% (RSD=1.8%), 99.5% (RSD=2.2%), 102.3% (RSD=2.0%).(4) The analyses were achieved with a Luna C₁₈ column (250 mm×4.6 mm i. d, 5μm) with a gradient elution program with 0.03% phosphoric acid and acetonitrile with a flow rate of 1.0...