A kind of preparation method of 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

But in fact, due to the addition of adhesives and the large batches during mass production, it is difficult to control the impact of moisture and high temperature on omeprazole during the production process, so that omeprazole will degrade and produce impurities, which will affect the efficacy and quality of omeprazole. medication safety

The impurity test found that the total amount of impurities in wet granulated products is significantly higher than that of raw materials. If the workshop control is not good, the impurities will easily exceed the specified limit

Moreover, the stickiness of omeprazole itself is easily induced after the wet granulation process. High-specification products such as 40mg / tablet products are prone to sticking and punching when compressed, and the hardness of the plain tablet is not high enough to reach the coating. requirements

Therefore, wet granulation is not suitable for the preparation of omeprazole enteric-coated tablets, especially high-specification omeprazole enteric-coated tablets such as 40mg / tablet cannot be industrialized through wet granulation

[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.

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