Compound Codonopsis Astragalus Injection Preliminary Study

The prescription of Radix codonopsitis and Radix astragali has the efficacy of supporting healthy energy, reinforcing deficiency and promoting blood flow. The injection of Radix codonopsi-tis and Radix astragali was successfuly prepared on the foundation of Shenqifuzheng injection which is the market available preparation based. on the same prescription. The present work solves the problem of high cost of storage and transportion, stability of aqueous solution and remarkable difference among batches of the infusion solutions of the traditional Chinese medicine.Polysaccharides, saponin and astragaloside IV were assayed by HPLC and chromatometry. The analysis methods had good accuracy, reliability and repeatability.The quality criteria of Radix codonopsitis and Radix astragali were studied by qualitative and quantitative analysis. The intermediates was extracted by water-alcohol method. The total content of the active components was above 25 % in the intermediates. Quality control of the intermediates and the initial stability of the intermediates was studied.The satisfactory injection was prepared. The injection was stable in at least 12 months at room temperature away from light. The compatibility of injection with glucose and sodium chloride injection was good. The freeze-drying preparation met the quality requirements of the Chinese herbal injection.The safety of the injection was assessed by the experiments of hypersensitiveness, haemolyticus and stimulation. The results showed that the hypersensitiveness of guinea-pigs, haemolyticus, muscle and blood vessel stimulation of rabbits were all negative.Fingerprint chromatograms of Radix codonopsitis, Radix astragali and injection were established. Methods of the fingerprint chromatograms were up to standard. Total area ratio to all the uncommon peaks, relative retention time and relative area ratio to the common peaks of 10 batches of Radix codonopsitis, Radix astragali and injection all met the related requirements of fingerprint chromatograms.