The Synthesis Of Omeprazole's Intermediate And Research Of Omeprazole's Gastric Immediate Release Tablets

Omeprazole has good effectiveness in peptic ulcer, with high efficiency and low toxin, and it is characteristic of high cure rate by using less time with better endurance, it was created by Astra company in Sweden. With the largest medical sales volume in the world, Omeprazole is popular in medical market.This paper is the process for improving the synthesis of key intermediate of in the synthesis route: the aim relates to develop the synthesis route, reduce the cost, and increase the product recovery; to achieve the green production process, and to improve reaction conditions and protect environment by taking the new reaction reagent to solve the problems concerning methoxylation, reduction reaction; to take uniform design, optimal reaction condition level, for finding best product recovery. This design taking paracetamol tablets(paracetamol) as raw material, takes method of uniform design in every reaction so as to find best result. This design also taking non-polluting green production process is the essential treatment to eliminate pollution. As a valuable attempt, the academic value of this topic puts green production process into the research of medicine and medical production.Firstly,in preparation process,Omeprazole determines the best condition for synthesizing Omeprazole's intermediate 2-Nrlry-4-methyoxy-amino- benzene by orthogonal experiment in preparation forming technology aspect: under 20℃, HNO30.82ml,H2SO40.62ml'strring time and yield of time as follows: 160min and 71.46%,which improved the production rate in the course of synthesising intermediate of 2-Nrlry-4-methyoxy-amino-benzene. This design developing the reaction conditions, improving the production rate suits the industrial production. In preparation forming technology aspect, this design improved the Omepazole's gastric immediate release tablets that makes dissolution time hysteresis, gastric juice soluble, and fast release, by making microencapsulation of Omepazole and mixed squashes with antacid Sodium Bicarbonate and Magnesium Hydroxide. This medicine is also popular in the use of medical macroencapsulation in the spray dry technology.Secondly , in quality standard aspects , this design identifies Omeprazole's intermedia by infrared spectralcolorimetry, measures the content of Omeprazole's Gastric immediate release tablets by high performance liquid chromatography, controlling the quality of medicine very well.Finally, studying on stability aspects, this medicine has a good stability in the inner investigation stage. So, it can make a good guarantee for success of this product.