Rabeprazole sodium enteric-coated pellet and preparation method thereof

Abstract

A rabeprazole sodium enteric-coated pellet is composed of a pellet core, an insulation layer and an enteric-coated layer from the inside to the outside, wherein by the total weight of the enteric-coated pellet, the content of the pellet core is 50 to 70 wt%, the content of the insulation layer is 10 to 20 wt%, and the content of the enteric-coated layer is 20 to 40 wt%; the pellet core comprises rabeprazole, a filling agent, an adhesive, a disintegrating agent, and an alkalizer, by the total weight of the pellet core, the content of the rabeprazole is 7 to 9 wt%, the content of the filling agent is 60 to 75 wt%, the content of the adhesive is 5 to 10 wt%, the disintegrating agent is 4 to 8 wt%, and the content of the alkalizer is 5 to 12 wt%. The rabeprazole sodium enteric-coated pellet has the advantages of low cost, stable quality, and good safety.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a rabeprazole sodium enteric-coated pellet and a preparation method thereof. Background technique [0002] Digestive system diseases are one of the common clinical diseases and frequently-occurring diseases. The incidence of gastrointestinal diseases in my country is 11.43%, among which the incidence of peptic ulcer is 4.54%. The pathogenesis of peptic ulcer is related to many factors, among which Helicobacter pylori plays an important role in the occurrence and recurrence of ulcer. Drugs for the treatment of peptic ulcer include antacids, drugs that inhibit gastric acid secretion, drugs that enhance gastric mucosal barrier function, and drugs against Helicobacter pylori. Among them, proton pump inhibitors have a relatively long acid-suppressing effect, so they are currently the most advanced class of drugs for the treatment of peptic ulcer. According to the...

AI Technical Summary

Problems solved by technology

② Ordinary capsules and tablets have limited diffusion area, slow drug absorption, fluctuating blood drug concentration, low bioavailability, and large local mucosal irritation; enteric-coated micropills have large diffusion area in the gastrointestinal tract and good absorption , high bioavailability, stable blood concentration, less irritation to mucous membranes

The auxiliary materials used in the blank core are sucrose or microcrystalline cellulose, but from the compatibility test of raw materials and auxiliary materials, it can be seen that rabeprazole sodium, sucrose and microcrystalline cellulose turn black and dark green under high humidity conditions, and when the The color of the main drug is easy to change when the drug is loaded onto the blank core under high humidity conditions. Sodium and appropriate auxiliary materials are mixed uniformly first to make a drug-containing pellet core with better stability, which will greatly improve production efficiency and reduce production costs

In addition, the plasticizer diethyl phthalate is used in the plasticizer of the enteric layer. Because diethyl phthalate is toxic to the human body, its use is now prohibited.

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