A kind of pantoprazole enteric-coated pellets, pantoprazole enteric-coated sustained-release tablet and preparation method thereof

Abstract

The invention relates to the field of medicine, in particular to pantoprazole enteric-coated pellets, pantoprazole enteric-coated controlled-release tablets and a preparing method thereof.According to the method, at first, Eudragit NE30D is adopted for preparing a pantoprazole sodium applying layer, the defects that due to good water solubility of pantoprazole sodium, the applying layer is poor in pressure resistance and fragile are overcome, and the flexibility of the applying layer is improved; Eudragit NE30D is adopted again for preparing an isolating layer, and while the physical isolation effect between the applying layer and an enteric-coated layer is achieved, the flexibility and strain force of the isolating layer can further protect the applying layer against damage in the tablet pressing process.The prepared enteric-coated pellets and external adjuvant are mixed and directly pressed through a drying method to prepare the multi-unit type pantoprazole sodium enteric-coated controlled-release tablets.The phenomenon that tablet mixture materials are layered and mixed unevenly can be effectively improved.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a pantoprazole enteric-coated pellet, a pantoprazole enteric-coated slow-controlled release tablet and a preparation method thereof. Background technique [0002] Proton pump inhibitors (proton pump inhibitors, PPIs) are used to treat gastric acid abnormality-related diseases. The first-generation PPI omeprazole was launched in the United States in 1989. Pantoprazole is the third-generation proton pump inhibitor after omeprazole and lansoprazole. Launched in Germany in 1994. Pantoprazole is the first water-soluble proton pump inhibitor, clinically used to treat various gastric acid-related diseases, such as peptic ulcer, gastroesophageal reflux disease, etc. It is also very effective against diseases caused by Helicobacter pylori infection. [0003] In the listed pantoprazole preparation, mainly use its sodium salt as raw material. Pantoprazole sodium is a benzimidazole sulfonyl deri...

AI Technical Summary

Problems solved by technology

The existence of solid bridges affects the strength of the coating film of the drug layer, resulting in a greatly reduced elasticity, making the drug layer more brittle

Therefore, the conventional PPI enteric-coated pellet preparation method is adopted to prepare pantoprazole sodium enteric-coated pellets. When tableting, due to the poor strain force of the drug layer, it cannot withstand the deformation pressure of the tablet, and it is prone to rupture.

The rupture of the drug layer will affect other functional layers, so that the acid resistance of the micropills is greatly reduced, and the acid resistance of the prepared micropills cannot reach the standard. This is a major technical difficulty in the preparation of pantoprazole sodium micropills, which may It is also one of the reasons why there is no pantoprazole sodium micropellet tablet at present

Images