Study On Improving Quality Standards Of Xiyanping Injectiion

Xiyanping injection is one of the special species in Jiangxi Qingfeng Pharmaceutical Company Limted,which is andrographolid and sulfuric acid、ethanol heating reaction preparation of multi-component injection,It can invigorate the heat clearing and detoxicating,relieving cough and dysentery,clinical mainly used for bronchitis、tonsillitisbacterial、dysentery.It has existed in "Drug standards of Jiangxi province"(1982Edition) and "National medicine Standards Compilation"proprietary local standard part of medicine pulmonary system (two).This paper is on the foundation of original standard,increased volume、bacteriostatic、ability of Sodim17-hydro-9-dehydro-andrographolide-19-diyl disulfate TLC differential and adopted HPLC to determine the17-hydro-9-dehydro andrographolide-19-diyl disulfate,and the raw material medicine、injection were fingerprint examiniation,further ensuring drug quality.To find out the effective quality control method of Xiyanping injection, the group first on the contrast experiment, identified the fingerprints of conditions, and the fingerprint of4elements of the extraction, isolation and structure identification.Experimental results show, the group first on the contrast experiment, identified the The4component of the Staphylococcus aureus、bacillus、Escherichia coli and Shigella has different degrees of inhibition,so the group through the consult literature and experiments using HPLC on the volume, stability,bacteriostaticability of17-hydro-9-dehydro andrographolide-19-diyl disulfate sodium content.the methoed performed on a Diamonsil C18(250mm×4.6mm,5μm) column with a gradient of the following solvent mixtures:solvent A,potassium dihydrogen phosphate buffer salt (dissolve1.369g potassium dihydrogen phophat-e and1.0g heptane-1-sulfonic acid sodium salt in1000ml water); solvent B,acetonitrile.The flow rate was1.0mL·min-1, the detection wavelength was225nm,and the column tempe-rature was25℃.17-hydro-9-dehydro-andrographolide-19-diyl disulfate showed a good linear in the ranges of0.03190～0.6380mg·ml-1(r=0.99990), The average recoveries (n=3) were102.05%(RSD=0.42%), The method is simple, sensitive and accurate, which can be used for the quality control of Xiyanping injection.