Of Lansoprazole Oral Administration And Injection Administration

Lansoprazole is a new type of proton pump inhibitor (PPI) after omeprazole, it has the curative effect to the peptic ulcer, it can be widely used in the digestive function disorder diseases relevant to acid secretory.A HPLC method was used to study the basic physicalchemical properties of Lansoprazole, to build the quality control of Lansoprazole for injection, to study the content and related substance of Lansoprazole enteric-coated tablets. At the same time, a spectrophotometric method was built to determine the drug release from the tablets. Both of them was proved to be a high-sensitivity, strong-specificity method and can satisfy any analytical requirement in this study correctly and conveniently.To prepare the Lansoprazole for injection and Lansoprazole enteric-coated tablets, several characters of Lansoprazole were examined before prescription. The solubilities and stabilities of Lansoprazole in solutions of different pH were investigated. And the stability of Lansoprazole was also investigated. It was shown that the solubility and stability were better with high pH and the drug was insensitive to high temperature and light.After performulation study, salification method was selected to prepare drug solution, and the injectable powder were obtained finally by freezing-dried. The freezing-dried process was as followed: pre-freeze for 4 hours under -45℃, the drug was dried for 20 hours in vacuum under -15℃. After that, the temperature was raised to 35℃and went on drying for 7 hours in vacuum. The prescription and technological process were optimized by the criterion of appearance, moisture and resolubility. And then, the quality standard of Lansoprazole for injection was set up. Three batches Lansoprazole for injection were appraised by this standard, consequently, all samples were qualified.On the basis of investigating the characters of Lansoprazole and various ingredients, the effect of particle size, kinds and quantities of solubilizing agent,stabilizing agent,disintegrant and the weight addition of tablets owing to the isolation gown and enteric coating layer on drug release were researched. Three batches Lansoprazole enteric-coated tablets were appraised by the quality standard, consequently, all samples were qualified. The stability of preparations were investigated to determine the expiration date and the condition of storage.Irritative, anaphylaxis, haemolyticus and acute toxicity tests were preformed to evaluate the injectable safety of the preparation. The safety test proved the production was safe to inject.