Preparation method of omeprazole enteric capsule

Abstract

The invention discloses a preparation method of an omeprazole enteric capsule. The preparation method has the advantages of high stability and good in vitro dissolution curve, and can realize the consistency with original drug through human body bioequivalence tests.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of omeprazole enteric-coated capsules. Background technique [0002] The compound omeprazole was patented in 1978 and approved for medical use in 1988. It is listed on the World Health Organization's list of essential medicines as the most effective and safest medicine needed in the health system. It can be used not only for adults, but also for infants and young children. Although it is now a generic drug, as of 2014, the wholesale price in developing countries is US$0.01 to US$0.07 per dose. In the United States, the average price per pill is $0.50. In 2016, it was the seventh most prescribed drug in the United States, with prescriptions totaling more than $70 million. [0003] Omeprazole (Omeprazole) belongs to a kind of proton pump inhibitor (proton pumpinhibitor; PPI) in pharmacological action, and is used to treat gastroesophage...

AI Technical Summary

Problems solved by technology

If pellets with a wider particle size are used, problems of capsule filling weight and uneven release will occur

If the roundness of the pellets is poor, it will easily lead to deviations in the subsequent enteric coating process. If the enteric coating is incomplete or uneven, the product may not be able to effectively control the enteric coating mechanism or cause the pellets to be resistant to gastric acid. Insufficient sex will directly affect the curative effect of the drug in the human body

[0010] The micropills in the prior art belong to the matrix type micropills, and blank pellet cores with narrow particle size distribution and good roundness can be selected to solve the problem of roundness, but there are higher requirements for the hardness of the micropills, and the flow rate in the process The chemical damage will stick to the isolation layer when the isolation layer is coated, which will affect the stability. In addition, in order to maintain stability, some layers of packaging are added for isolation, resulting in the release rate being affected by the surface area of ​​the pellets. If the roundness reproducibility between product batches is poor, it may cause large differences in in vitro dissolution rate and in vivo efficacy between batches, making it difficult for generic products to have good consistency evaluation results

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