Study On The Quality And Stability Of Sulfadoxine

Sulfadoxine, as new long-acting sulfonamides, foreign called Sulfadoxine commodity the named Fanasil or Fanazil. Our country began trial production in1967, used clinically in1969, in April1970in Shanghai identification. Sulfadoxine has the longest effective concentration time in the blood in currently sulfa drugs and its half-life is150hours. Take medicine weekly. Chinese enterprises seized the opportunities and expanded the scale of production. The production and export were tested rapid growth, making China become the main producer and exporter of sulfa drugs in the world. This paper developed the sulfadoxine pharmaceutical raw materials, confirmed its chemical structure, and did some quality control and stability studies on it.Structure authentication of sulfadoxine:We have authenticated its structure through element analysis, infrared absorption spectrum, ultraviolet absorption spectrum, NMR, DEPT, MS, differential thermal analysis, gravitational thermal analysis and X-ray diffraction. Compared with the spectra reported in the references, results show that the structure of synthetic chemicals is entirely correct.Quality reduction:According to Chinese Pharmacopoeia2010Edition, we have studied on its physical and chemical constants, characteristic spectrum identification, loss on drying, Residue on Ignition, heavy metals, arsenic salts, related substances and determination of the quality, etc. Make comparative studies about relevant materials of sulfadoxine by the methods of thin layer chromatography (TLC) in the European Pharmacopoeia and Pharmacopoeia of the People’s Republic of China, Main ingredients and degradation products of spots can be better separated. The European pharmacopoeia and China pharmacopoeia methods for determining relevant materials in the raw sulfadoxine can be used for detecting relevant materials in the raw sulfadoxine, and the two methods complement each other for quality control.To establish a method for the determination of residual Organic solvent, acetic acid and NN-Dimethylformamide, methanol and trichlorethylene in sulfadoxine.Method for the determination accuracy, precision, recovery rate, durability and solution stability of a series of method validation.Sulfadoxine stability study:According to the new drug (western medicine) pharmaceutical research guiding principle comments and the relevant requirements of the appendix in two parts of the2010edition Chinese Pharmacopeia. We did some stability research to this product. The results show that removing the outer packing, this product’s complete index test results had not significantly changed in the conditions of strong light, high temperature and high humidity. The product stimulated listed packaging sample placed by40℃±2℃, RH75%±5%for6months and25℃±2℃, RH60%±10%long-term tests for18months. The index of examination results had no change, neither. The product has basic stable physical and chemical properties. According to the stability study results and the national drug standards of sulfadoxine, recommend that this product should be shading and sealing preservation.