Method for refining lansoprazole bulk drug

Abstract

The invention relates to a refining method for a lansoprazole crude drug, which is characterized in that the lansoprazole sample is dissolved in anhydrous alcohol and stirred to complete dissolution, and activated carbon is added to be stirred, pumped and filtered; then the solution which is placed in a freezing chamber to freeze and crystallize is pumped and filtered to be dry, the filter cake is washed to be dry by the anhydrous alcohol, and white solid can be obtained; finally, the obtained white solid is dried in an oven, and the solid is turned over discontinuously during the drying until reaching constant weight. The preparation method for the lansoprazole crude drug is simple and convenient, high in refining yield, low in the total impurities of the refined lansoprazole and good in clarity after being prepared into injections.

Description

A kind of refining method of lansoprazole crude drug technical field The invention relates to a method for refining a bulk drug of lansoprazole, in particular to a method for refining a bulk drug of lansoprazole, a medicine for treating peptic ulcer, and belongs to the technical field of drug synthesis. Background technique Lansoprazole (Lansoprazole) is an upgraded product of omeprazole, which was successfully developed by Takeda Corporation of Japan in 1991. After being approved by the FDA in May 1995, it was launched in the United States under the product name "Prevacid". In 2005, the sales of Takeda Corporation, Tap Pharmaceuticals, Wyeth and Abbott in the seven largest pharmaceutical markets in the world reached 4.526 billion US dollars. In 2006, it was rated as one of the top ten best-selling drugs in the world by the American "Forbes" magazine. one. Lansoprazole is a new type of drug that inhibits gastric acid secretion. Its structural feature is a substituted be...

AI Technical Summary

Problems solved by technology

1. The total impurities meet the standard of oral medicine, but not necessarily meet the standard of injection;

2. After making injections, the clarity does not meet the standard

The lansoprazole raw material can be refined by recrystallization from common solvents such as ethanol, methanol, n-hexane, etc. Considering the requirements of injection medicine, the first choice is to refine with less toxic ethanol, but the lansoprazole obtained by refining lansoprazole with ethanol as a solvent Refined products often have high impurities and low yields, and there is no feasible solution in actual production