(R)-Lansoprazole time-selection pulse controlled-release pellet preparation and preparation method thereof

Abstract

The invention discloses an (R)-Lansoprazole time-selection pulse controlled-release pellet preparation and a preparation method thereof.The basic structure of the preparation comprises a blank pellet core, a medicine layer, a swelling layer and an enteric controlled release layer from inside to outside.The swelling layer contains swelling materials and a binding agent, and the enteric controlled release layer contains enteric materials and sustained-release materials.Compared with routine technologies, the release rate of the pellets, prepared through the preparation method, in a 0.1 mol/L hydrochloric acid solution is smaller than 10% of labeled amount within two hours of tolerance, certain time lag is presented at the upper end of the small intestine, and then quick pulse controlled-release is conducted.Adopted adjuvant is easy to get, the production technology is simple and controllable, and the preparation is suitable for industrial production.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to the composition of a dexlansoprazole timing pulse controlled release pellet preparation and a preparation method of the preparation. Background technique [0002] Proton pump inhibitors (PPIs) work by blocking the H+ and K+-ATPases of gastric parietal cells to inhibit the secretion of gastric acid. They are currently the most effective gastric acid secretion inhibitors and anti-ulcer drugs. They are widely used in peptic ulcer and eradication of Helicobacter pylori. The treatment of acid-related diseases such as bacterium (HP), Zollinger-Ehrlich syndrome, gastroesophageal reflux disease and upper gastrointestinal bleeding. Proton pump inhibitors are benzimidazole derivatives that can quickly pass through the cell membrane of the gastric parietal, accumulate in strong acid secretory tubules, and are converted into sulfenamide compounds, which are covalently bound to the sulfh...

AI Technical Summary

Problems solved by technology

[0005] CN104721151A discloses a preparation method of colon-targeted multi-layer coated pellets with multi-component synchronous release function, which includes drug-loaded pellet core, inner layer coating, middle layer coating, outer layer coating, which can After a delay, the drug is released in the colon, but the formulation has a slower onset of action

However, solubilizers and surfactants are added to the drug layer to adjust drug release, the prescription is more complicated, and no alkaline stabilizer is added to the drug layer, which will cause stability problems for this type of drug

In addition, the multi-layer coating preparation is relatively complicated in technology, and there is a certain degree of difficulty in industrial production.

Images