Rabeprazole sodium enteric-coated pellet capsule and preparation method thereof

Abstract

The invention discloses a rabeprazole sodium enteric-coated pellet capsule and a preparation method thereof. The capsule is internally provided with a rabeprazole sodium enteric-coated pellet. The rabeprazole sodium enteric-coated pellet successively comprises a blank pellet core, a drug-containing layer, an insulation layer and an enteric-coated layer from the inside to the outside. The drug-containing layer comprises Rabeprazole sodium, an adhesive and a pH conditioning agent. The pH conditioning agent is composed of one or two components selected from sodium hydroxide, magnesium oxide, sodium carbonate and sodium bicarbonate. According to the technical scheme of the invention, the drug-containing layer is provided with the pH conditioning agent, and the isolation layer is arranged between the drug-containing layer and the enteric-coated layer. Therefore, the alkaline drug-containing layer is prevented from getting in contact with the acidulous enteric-coated layer. The enteric-coated layer is provided with a non-water-soluble plasticizer, thus being excellent in stability and acid tolerance. The enteric-coated layer can be quickly released in a pH 6.8 medium. The drug quality attributes of the above Rabeprazole sodium enteric-coated pellet capsule are kept consistent with those of original enteric-coated pellet capsules, so that the quality stability of drugs is ensured. the preparation method is simple to operate, low in production cost and high in efficiency, thus being suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically, the invention relates to an enteric-coated pellet capsule with rabeprazole sodium as an active ingredient and a preparation method thereof. Background technique [0002] With the development of the economy, the change of people's lifestyle and the increasing pressure of life, the incidence of peptic ulcer is getting higher and higher, which has become a common and frequently-occurring disease. The incidence of gastrointestinal diseases in my country is 11.43%, among which the incidence of peptic ulcer is 4.54%. Rabeprazole sodium is a new generation of benzimidazole compounds following omeprazole and lansoprazole. It is a strong proton pump inhibitor and is mostly used to treat gastrointestinal diseases caused by excessive gastric acid secretion. [0003] Rabeprazole sodium is easily degraded under conditions such as light, heat, acid, and oxidation, resulting in...

AI Technical Summary

Problems solved by technology

The coating uses more enteric-coated materials, and the production cost is high

The quality evaluation standard release involved in this patent is unreasonable to use a pH8.0 medium. The pH value of the human small intestine environment is basically 4-7, and the evaluation system using a pH8.0 medium does not have the ability to judge the rapid release of enteric-coated preparations after reaching the small intestine. At present, the dissolution medium of this preparation US FDA is a phosphate buffer solution with a pH of 6.8

[0007] Chinese patent CN102552159 relates to the drug layer without adding a stabilizer. In the embodiment, 80% ethanol is used as a solvent during the drug coating process, which can easily lead to the degradation of rabeprazole sodium, and the related substances are higher than the standard requirements

The micropills prepared by this method can only release more than 80% in 45min under such conditions, obviously in vitro pH6.8 phosphate buffer medium (without a large amount of organic solvent) can not release quickly

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