Nimesulide sustained-release pellets and preparation method thereof

Abstract

The invention provides nimesulide sustained-release pellets composed of basic pellets and sustained-release coatings, wherein the basic pellets comprise 40-80% of nimesulide, 5-20% of starch, 5-30% of powdered sugar and 5-20% of hydroxypropyl methylcellulose; and the sustained-release coatings comprise 3-40% of ethylcellulose, 20-80% of HP-55 and 3-40% of talcum powder. The invention also provides the preparation method of the nimesulide sustained-release pellets. The nimesulide sustained-release pellets provided by the invention have good sustained-release effect, convenience in processing and suitability for industrial mass production.

Description

technical field [0001] The invention relates to a nimesulide sustained-release pellet and a preparation method thereof. Background technique [0002] Arthritis is recognized as one of the top five diseases (cardiovascular disease, arthritis, Alzheimer's disease, cancer, AIDS) that will affect human health and medical consumption in the next 25 years. my country has a large population and a vast territory. According to estimates by rheumatology experts, the incidence of rheumatism is as high as 3‰. As we enter the 21st century, the problem of population aging in our country will become increasingly prominent, and the aging of the population is directly proportional to the incidence of this type of disease, so the market will have greater demand for human medicines. [0003] Nimesulide is a new type of non-steroidal anti-inflammatory drug, as the first selective cyclooxygenase-2 (COX-2) inhibitor, it has good anti-inflammatory, analgesic and antipyretic properties It is suit...

AI Technical Summary

Problems solved by technology

[0005] In the Chinese invention patent application with publication number CN1399543A, a controlled-release composition containing nimesulide is disclosed, which contains nimesulide accounting for 5-95w / w of the composition as an active drug, accounting for 2 - 95% w / w of one or more slow-release materials and 0-90% w / w of pharmaceutical excipients, although the controlled-release composition can control the timing and quantification of active ingredients of the drug at a zero-order rate constant speed drug release, but due to the complex processing and high cost of the controlled release composition, it has not been authorized in China

[0006] In the Chinese invention patent with the publication number CN100346778C, a slow-release composition of nimesulide is disclosed, using two kinds of hydroxypropyl methylcellulose and ethyl cellulose with different methoxyl content as the slow-release matrix Although it has a certain slow-release effect, because the prescription contains a high proportion of polymer slow-release materials such as hydroxypropyl methylcellulose and ethyl cellulose, the viscosity of the soft material is very large after being made into a soft material, and it is not easy to Sieve granulation, and with the volatilization of ethanol during the preparation process, the viscosity of the soft material increases, so it is only suitable for laboratory-scale production, not suitable for industrial mass production