The Study On Preparation Process And Quality Control Of Naodesheng Injection

In this paper, the study on preparation process and quality control of naodesheng injection was reported. Ginsenoside Rg₁, ginsenoside Rb₁, puerarin and safflor yellow A were referred to indices of quality control in the preparation. And TLC and RP-HPLC methods were established for identifying and determining them. The quality standard of naodesheng injection, its safety test and stability test were also studied.TLC methods were used for identifying ginsenoside Rg₁, ginsenoside Rb₁ and puerarin in naodesheng injection. Ginsenoside Rg₁, ginsenoside Rb₁, puerarin and safflor yellow A in the preparation were determined by RP-HPLC. A 200mm ×4.6mm Diamonsil column with a mobile phase consisting of Acetonitrile-Tetrahydrofunan-H₂O (18:5:77) was used to determine ginsenoside Rg₁. It was detected at 203nm. And the flow rate was 1.0 mL · min^-1. The chromatographic condition of ginsenoside Rb₁ was the same as that of ginsenoside Rgi except a mobile phase consisting of Acetonitrile-Tetrahydrofunan-H₂O ( 22:10:68 ) . A 250mm X 4.6mm Spherisorb ODSl column with a mobile phase consisting of methanol-0.1 % Citric acid solution (28:72) was used to determine puerarin. The UV detection wavelength was 250nm. The flow rate was 0.8 mL · min^-1. And a 250mm×4.6mm ZORBAX SB-C₁₈ column with a mobile phase consisting...