Preparation method for omeprazole enteric coated tablet

Abstract

The invention relates to a preparation method for an omeprazole enteric coated tablet. The components comprise in percents by weight: 10-50% of omeprazole, 1.25-6.25% of superfine silica powder, 30-78% of lactose, 2-3% of copolyvinylpyrrolidone, 5-12% of crospovidone, 1.5-2.0% of sodium octadecyl fumarate and 0.5-1.0% of magnesium stearate. The preparation method comprises: uniformly mixing micronized omeprazole and superfine silica powder, sieving; sieving copolyvinylpyrrolidone, crospovidone, lactose and sodium octadecyl fumarate, uniformly mixing with omeprazole and superfine silica powder, adding into a drying-method granulator, granulating for 3-4 times, screening out integrated particles with a 60 mesh sieve and obtaining dry particles; blending uniformly the dry particles and magnesium stearate by a three-dimensional mixer, adding into a tablet press for pressing tablets; and then coating to obtain the omeprazole enteric coated tablet. The formula is simple; the preparation method helps to solve the industrialized production problem of omeprazole enteric coated tablet high-specification products such as a product with a specification of 40 mg/tablet; and the preparation is controllable in quality, the product is good in uniformity, and impurity content is low.

Description

Technical field: [0001] The invention relates to a preparation method of omeprazole enteric-coated tablets, belonging to the technical field of medicine preparation. Background technique: [0002] The localized defect of the endometrial tissue in the part of the digestive tract that contacts the gastric juice, including the lower part of the esophagus and the first segment of the gastroduodenum, is usually called gastric ulcer and duodenal ulcer, collectively called peptic ulcer, and erosive gastritis can be Evolve into ulcer disease, motherland's medicine claims epigastric pain. In terms of epidemiology, peptic ulcer is a common disease, and its incidence rate varies greatly in different periods and regions, and the total incidence rate accounts for about 10-20% of the population. About 10% of patients with peptic ulcer disease in the United States, 12.3% in Germany; According to a survey in a few areas in my country, the incidence of digestive tract diseases is 11.43%, of...

AI Technical Summary

Problems solved by technology

[0006] Due to the special nature of omeprazole, which is insoluble in water, it needs to be micronized to improve the dissolution of the drug. If the method of direct powder compression is adopted, the bulk density of the micronized drug and the excipients selected for direct compression of the powder The physical properties such as particle size and particle size distribution are very different. In the process of mixing raw materials and auxiliary materials, it is difficult to mix the main drug after micronization with other auxiliary materials, and its content uniformity is not easy to control. Therefore, the direct powder compression method cannot be used.

Images