The Preparation Process Improvement And Quality, Safety Evaluation Studies Of Maiguan Fukang Table

The preparation process, quality control and safety of the Maiguan Fukang table’s production stages were studied in this paperOrthogonal design optimized Maiguan Fukang table granulating and coating process. In the final, the production process parameters of boiling granulating have been identified. The relative density is1.25～1.35; the speed of the peristaltic pump is20～35rad/min; the material temperature is20to50℃; and the atomizing pressure is0.1～0.4MPa. The best parameters of coating production process is that the piece bed temperature is50～60℃, the coating solution concentration is6%, the coating liquid flow is110ml/min, and the pan speed is4～6rad/min. Finished the consecutive batches to enlarge production and stability test, the appearance, hardness, disintegration time, tablet weight variation, microbial limit of the end products have researched the evaluation requirements. The result shows that good quality evaluation criteria and process parameters stability suitable apply to mass production actually.The microscopic identification method of turmeric, the identification method of salvia and frankincense TLC and the assay method of high performance liquid content of salvianolic acid B were developed for Maiguan Fukang table. Content limit is2.0mg/tablets (sugar-coated tablets or0.3g film-coated tablets),4.0mg/tablet (0.6g film-coated tablets). The chromatographic conditions were C18column(250X4.6mm,5μm) under40℃. The mobile phase consisted of methanol-acetonitrile formic acid-water (30:10:1:59) The flow rate was1.0mL/min. The detection wavelength was286nm and the number of theoretical plates calculated by salvianolic acid B peak was8,000.Groping and durability tests showed that this method is a exclusive and feasible quality standard detection method for Maiguan Fukang table.Maiguan Fukang powder have continuously fed to rats for six month. Dose group divided into low, medium and high dose group in20,40,80times the clinical dose. The hematology, blood chemistry, reticulocyte count, organ coefficient, organ histopathological indicators were observed. Drug accumulation did not result in serious toxic effects on rat body and the hepatotoxicity which relatived to the dose has only existed. This toxicity was reversible when stopped taking the pills. The dose in the climical manual(8table*3times/day) is the non-toxic reaction dose. Therefore Maiguan is safe and effective clinical agents for the treatment of vasculitis, scleroderma, atherosclerosis of lower extremity vascular occlusive disease.