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Rabeprazole enteric-coated micro pellet, and preparation method thereof

A technology of rabeprazole intestine and beprazole intestine, which is applied in the directions of pill delivery, microcapsules, pharmaceutical formulations, etc., can solve the problems of poor stabilization effect and the like, and achieve the effects of long validity period, short time and high efficiency

Active Publication Date: 2016-03-30
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug-containing layer uses an alkalizing agent to adjust the pH, and the isolation layer only contains a blocker, which has poor stabilizing effect

Method used

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  • Rabeprazole enteric-coated micro pellet, and preparation method thereof
  • Rabeprazole enteric-coated micro pellet, and preparation method thereof
  • Rabeprazole enteric-coated micro pellet, and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0075] A kind of rabeprazole enteric-coated pellets, including a blank pellet core, a drug-loaded layer, an isolation coat layer, and an enteric coat layer from the inside to the outside, wherein the weight gain of the drug-loaded layer is 25%, and the weight gain of the isolation coat layer is 25%. %, the weight gain of the enteric coating layer is 15%, wherein the drug-loaded layer consists of rabeprazole or rabeprazole sodium, hydroxypropyl methylcellulose (E-8), sodium bisulfite and dodecane Sodium sulfate; the isolation coat layer is composed of hydroxypropyl methylcellulose (E-8), polyethylene glycol-6000, titanium dioxide and disodium hydrogen phosphate; the enteric coating layer is composed of acrylic resin type C (L- 30D), macrogol-6000 and talc.

Embodiment 2

[0077] A kind of rabeprazole enteric-coated pellets, including a blank core, a drug-loaded layer, an isolation coat layer, and an enteric coat layer from the inside to the outside, wherein the weight gain of the drug-loaded layer is 27%, and the weight gain of the isolation coat layer is 23%. %, the weight gain of the enteric coating layer is 15%, wherein the drug-loaded layer consists of rabeprazole or rabeprazole sodium, hydroxypropyl methylcellulose (E-8), sodium bisulfite and dodecane Sodium sulfate; the isolation coat layer is composed of hydroxypropyl methylcellulose (E-8), polyethylene glycol-6000, titanium dioxide and disodium hydrogen phosphate; the enteric coating layer is composed of acrylic resin type C (L- 30D), macrogol-6000 and talc.

Embodiment 3

[0079] A kind of rabeprazole enteric-coated pellets, including a blank pellet core, a drug-loaded layer, an isolation coat layer, and an enteric coat layer from the inside to the outside, wherein the weight gain of the drug-loaded layer is 30%, and the weight gain of the isolation coat layer is 22%. %, the weight gain of the enteric coating layer is 13%, wherein the drug-loaded layer consists of rabeprazole or rabeprazole sodium, hydroxypropyl methylcellulose (E-8), sodium bisulfite and dodecane Sodium sulfate; the isolation coat layer is composed of hydroxypropyl methylcellulose (E-8), polyethylene glycol-6000, titanium dioxide and disodium hydrogen phosphate; the enteric coating layer is composed of acrylic resin type C (L- 30D), macrogol-6000 and talc.

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Abstract

The invention relates to a rabeprazole enteric-coated micro pellet, and a preparation method thereof. The rabeprazole enteric-coated micro pellet comprises a core pellet, a drug-carrying layer, an insulating coating layer, and an enteric coating layer from inside to outside; the weight of the drug-carrying layer accounts for 25 to 30%, the weight of the insolating coating layer accounts for 22 to 27%, and the weight of the enteric coating layer accounts for 13 to 17%; the drug-carrying layer is composed of rabeprazole or rabeprazole sodium, sucrose, hydroxypropyl methyl cellulose, sodium hydrogen sulfite, and lauryl sodium sulfate; the insulating coating layer is composed of hydroxypropyl methyl cellulose, polyethylene glycol 6000, titanium dioxide powder, and disodium hydrogen phosphate; and the enteric coating layer is composed of C-type acrylic resin, polyethylene glycol 6000, and talcum powder. A drug release curve and a drug intestinal absorption rate curve which are coincident with each other are obtained via appropriate controlling on enteric solubility and drug release rate of the rabeprazole enteric-coated micro pellet; existing time of drugs in intestinal tract in free states is shorter; less degradation is caused; bioavailability is high; and it is shown by clinical experiments that obvious effective rate is higher, stability is higher, and the rabeprazole enteric-coated micro pellet is convenient for patients to eat.

Description

technical field [0001] The invention relates to a rabeprazole enteric-coated pellet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The chemical name of rabeprazole sodium is 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole sodium . It is unstable when exposed to light, heat, and acid, and it is easy to decompose to make the drug inactive. Therefore, it should avoid contact with gastric acid when it is made into oral preparations. Rabeprazole sodium is mainly used for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma). Auxiliary for the eradication of Helicobacter pylori in patients with gastric ulcer or duodenal ulcer, which belongs to digestive system diseases. This product is converted into an active form (sulfinyl form) under acidic conditions in gastric parietal cells, by modifying the proton pum...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/02A61K31/4439A61K9/48A61K9/20A61P1/04
CPCA61K9/2081A61K9/501A61K31/4439A61K47/02
Inventor 曾培安吴健民姜勇吴成龙张静
Owner KAMP PHARMA
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