Study On The Modern Preparation Of SFPA Injection And The Quality Control Of The HPLC Fingerprint Chromatography

The SFPA total alkaloids that were composed of SF alkaloids (total alkaloids of Radix Sophorae flavescentis) and PA alkaloids (total alkaloids of Cortex Phellodendri) were the effective parts of the SFPA injection. The chemical constituents effect of pharmacology and clinical application of the two Chinese traditional medicines were summarized.Nine alkaloid compounds were isolated from the radix of Sophora flavescens Ait. On the basis of physical and chemical properties and spectroscopic method, nine compounds were elucidated as sophoranol, oxymatrine, oxysophocarpine, N-methylcytisine, anagyrine, sophocarpine, isomatrine, matrine and sophoridine. Three alkaloid compounds were isolated from bark of Phellodendron amurense Rupr. On the basis of physical and chemical properties and spectroscopic method, three compounds were elucidated as jatrorrhizine, berberine and palmatine. These compounds provided the contrasts of HPLC fingerprint chromatographic peak.The extraction technology of SFPA alkaloids of the raw materials and the preparation of SFPA were studied by a series of orthogonal design using contents of SFPA alkaloids and purity as indices. The sterilization condition was studied and the preparation was stable under film filtration sterilization. The brown ampoule was better than the common ampoule through the comparing of stability. The stability of injection was also researched. The results showed that the preparation technology of SFPA injection was reasonable.The HPLC fingerprint chromatograms quality control standard of SF alkaloids of SFPA injection and intermediate were developed. A reverse-phase HPLC method has been developed for the determination. Separations were achieved with a reversed-phase C18 column and the solvent system employed was acetonitrile /ammonium sulfate /SDS 83:17:0.05 (v/v/v). The flow-rate was kept constant at 1.0 mL/min with column temperature at 40 # with a UV detector setting at 220 nm. The obtained HPLC fingerprint chromatogram is up to standard based on the results of methodology. This assay for SF alkaloids are simple, rapid and with good reproducibility and provides a quantitative basis for the quality assessment for SF alkaloids. Based on the results of HPLC fingerprint chromatogram, contents of SF alkaloids similarity and the contents of matrine and oxymatrine were chosen as the quality control indices to the quality assessment of SFPA injection and intermediate. Correlation research was studied through the HPLC fingerprint chromatogram of the raw material -, intermediate and injection. The results showed that the substance (SF alkaloids) that is controlled by the HPLCfingerprint chromatogram were recurred among the material intermediate and injection. The HPLG fingerprint chromatogram of the material intermediate and injection were inosculated. The contents of SF alkaloids in intermediate and injection were effectively controlled by the contents of SF alkaloids in materials.The quality of injection and intermediate were studied. The total solid weight and the contents of effective parts achieved standard of injection and intermediate beside the common standard of injection of Pharmacopoeia of China. Matrine, oxymatrine, berberine and palmatine in injection and intermediate were determined by RP-HPLC. Above methods were simple, rapid, and accurate and provided a qualitative and quantitative basis for the quality assessment of the SFPA injection and intermediate.The HPLC fingerprint chromatograms standard of PA alkaloids of SFPA injection and intermediate were developed. A reverse-phase HPLC method has been developed for the determination. Separations were achieved with a reversed-phase C18 column and the solvent system employed was acetonitrile/ sodium dihydrogen phosphate / SDS 68:32:0.05 (v/v/v). The flow-rate was kept constant at 1.0 mL/min with column temperature at 30 with a UV detector setting at 345 nm. The obtained HPLC fingerprint chromatogram is up to standard based on the results of methodology. This assay for PA alkaloids are simple, rap...