Ilaprazole enteric capsule and preparation method thereof

A technology of enteric-coated capsules and ilaprazole, which is applied in the field of salt-coated enteric-coated capsules and its preparation, can solve problems such as large fluctuations in enteric-coated properties of blank capsule shells, affecting product quality stability of enteric-coated products, etc., and achieve effective It is beneficial to human health and safety, improves the bioavailability of drugs, and has the effect of good acid resistance

Inactive Publication Date: 2012-07-11
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The enteric properties of ordinary enteric-coated capsule preparations depend on the blank enteric-coated capsule shell, and the enteric properties of the blank capsule shell fluctuate greatly, which directly affects the enteric-coated properties of the product and the stability of product quality.

Method used

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  • Ilaprazole enteric capsule and preparation method thereof
  • Ilaprazole enteric capsule and preparation method thereof
  • Ilaprazole enteric capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: Preparation of pellets coated with ilaprazole sodium drug-loaded layer by centrifugal granulation

[0037] Table 1 Prescription of micropills containing ilaprazole sodium

[0038] material

amount (g)

Blank pellet core (0.2-0.3mm)

400

Ilaprazole Sodium

29

sodium hydroxide

29

Polyvinylpyrrolidone (PVP K30)

50

water

[0039] Preparation of 5% (m / m) polyvinylpyrrolidone aqueous solution: weigh 50 g of PVP and dissolve in 25% (v / v) ethanol aqueous solution. Weigh 400 g of 5% (m / m) PVP solution, add the prescribed amount of sodium hydroxide, adjust the pH to about 12, then weigh ilaprazole sodium and dissolve it therein. Weigh 500 g of blank pellet cores (sucrose pellet cores) and pour them into the feed pot, turn on the host, adjust the host speed, air volume, jet pressure, and spray rate, and spray the prepared drug-containing solution. After spraying the liquid medicine, continue...

Embodiment 2

[0042] Example 2: Preparation of pellets coated with ilaprazole magnesium drug-loaded layer by centrifugal granulation

[0043] Table 3 Prescription of pellets containing ilaprazole magnesium

[0044] material

[0045]Processing of raw materials and auxiliary materials: sieve magnesia and mannitol through 100 meshes, weigh the prescribed amount of micropowder silica gel and mix them evenly with magnesia, mannitol and CMS-Na for later use. Preparation of adhesive: preparation of 5% PVP solution: weigh 50 g of PVP and dissolve in 95% (v / v) ethanol aqueous solution. Weigh the prescribed amount of ilaprazole sodium and sodium hydroxide into a certain amount of 5% PVP solution and stir to dissolve. Weigh the prescribed amount of blank pellet cores (microcrystalline cellulose pellet cores) and pour them into the pot, turn on the host, adjust the host speed, air volume, jet pressure, and liquid spray rate, and spray the prepared drug-containing solution. Pour the mixed ex...

Embodiment 3

[0046] Example 3: Preparation of pellets coated with ilaprazole lithium drug-loaded layer by centrifugal granulation

[0047] Table 4 Prescription of micropellets containing ilaprazole lithium

[0048] material

[0049] Processing of raw materials and auxiliary materials: Magnesium hydroxide and pregelatinized starch are sieved through 100 meshes, and the prescribed amount of talcum powder is weighed and mixed with magnesium hydroxide, pregelatinized starch and low-substituted cellulose sodium for later use. Preparation of adhesive: preparation of 5% HPMC solution: weigh 50 g of HPMC and dissolve in 95% (v / v) ethanol aqueous solution. Weigh the prescribed amount of ilaprazole lithium and magnesium hydroxide and add to a certain amount of 5% HPMC solution and stir to dissolve. Weigh the prescribed amount of blank pellet cores (microcrystalline cellulose pellet cores) and pour them into the pot, turn on the host, adjust the host speed, air volume, jet pressure, and li...

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Abstract

The invention provides an ilaprazole enteric capsule and a preparation method thereof. The ilaprazole enteric capsule comprises enteric pellets and capsule auxiliary materials accepted in pharmacy, wherein the enteric pellets include pellet cores, medicine carrying layers, isolation layers and enteric coating layers, and the medicine carrying layers comprise ilaprazole or salt and stabilizing agents accepted in pharmacy. The ilaprazole enteric capsule has good acid resistance, is favorable for human health and safety due to the fact that prescription doesn't contain obstacle materials of anti-acid agents, surface active agents, organic solvents, hydrophobic materials or the like. After the capsule is taken, the pellets can be widely and evenly distributed in intestinal tracts. Dosage is dumped in scatter mode, so that distribution area of medicine on the surface of the intestinal tracts is enlarged, irritation of the medicine on the intestinal tracts is reduced or eliminated, and biological utilization rate of the medicine is improved. When the capsule is taken, content in the capsule can be poured out to be directly taken. Thus, the capsule is also suitable for patients with difficulties in swallowing and infants.

Description

technical field [0001] The invention relates to an enteric-coated capsule containing a proton pump inhibitor and a preparation method thereof, in particular to an enteric-coated capsule containing ilaprazole or a pharmaceutically acceptable salt thereof and a preparation method thereof. Background technique [0002] Ilaprazole is the latest generation of proton pump inhibitor developed by Ilyang Pharmaceutical Co., Ltd. and Livzon Pharmaceutical Co., Ltd. in Korea. It is widely used in various acid-related gastrointestinal diseases, such as duodenal Ulcers, gastric ulcers, reflux esophagitis, etc. Compared with other PPIs, ilaprazole is the proton pump inhibitor with the smallest dose in clinical use at present, and has the strongest activity of suppressing acid and healing ulcers; with a long half-life, it has the strongest effect of inhibiting gastric acid secretion at night, and can reduce acid breakthrough at night ( NAB) incidence rate, enhance curative effect; After c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/48A61K47/32A61K47/36A61K47/38A61P1/04
Inventor 侯雪梅金鑫陈乔柏张丽
Owner LIVZON PHARM GRP INC
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