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Enteric-coated preparation for treating digestive diseases and preparation method thereof

A technology for digestive diseases and enteric-coated preparations, which is applied in the field of drugs for the treatment of digestive diseases, and can solve problems such as the reports and patents of enteric-coated preparations of troxipide that have not yet been seen

Inactive Publication Date: 2010-11-10
广西方略药业集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] But so far, do not see any reports and patents of enteric-coated preparations of troxipide in the prior art

Method used

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  • Enteric-coated preparation for treating digestive diseases and preparation method thereof
  • Enteric-coated preparation for treating digestive diseases and preparation method thereof
  • Enteric-coated preparation for treating digestive diseases and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] The preparation of embodiment one Trexipide enteric-coated pellet capsule

[0073] Its formula is:

[0074]

[0075] Specific preparation method: add the transparent Opadry of prescription amount in the ball core to 800ml of water, stir for 10 minutes, add the prescription amount of trocipide, stir for 45 minutes, pass through an 80 mesh sieve, and prepare the trocipide coating liquid, spare.

[0076] Put the blank pellet core into the fluidized bed, control the air inlet temperature at 45-55°C, spray and coat with troxipiride coating solution, after coating, dry the enteric-coated pellets at 50°C for 1 hour , to prepare Traxipide pellets for subsequent use.

[0077] Add the transparent Opadry of the prescription amount of the isolation layer into 230ml of water, stir for 45 minutes, and pass through a 40-mesh sieve to obtain the coating solution of the isolation layer, which is set aside.

[0078] Put the troxipide pellets into the fluidized bed, control the air ...

Embodiment 2

[0082] The preparation of embodiment ditroxipide enteric-coated tablet

[0083] Its formula is:

[0084]

[0085] The specific preparation method: pass the raw materials and auxiliary materials of the prescription amount of the tablet core layer through an 80-mesh sieve respectively, and set aside.

[0086] Mix the sieved trociproxil with microcrystalline cellulose, lactose and crospovidone. Use appropriate amount of 5% starch slurry to make soft material, and granulate with 18 mesh sieve. Dry at 50°C for 3 hours. Sieve through a 20 mesh sieve. Add the sieved magnesium stearate, mix evenly, and compress into tablets to obtain tablet cores, which are set aside.

[0087] Add the HPMC-E6 of the prescription amount of the isolation layer into 150ml of water, stir for 45 minutes, and pass through a 40-mesh sieve to obtain a coating solution for the isolation layer, which is set aside.

[0088] Put the tablet cores into a high-efficiency coating pan with a rotation speed of ...

Embodiment 3

[0093]The preparation of embodiment tritrexipide enteric-coated granules

[0094] Its formula is:

[0095]

[0096] The specific preparation method: pass the raw materials and auxiliary materials of the above prescription amount of the granular layer through 80 mesh sieves respectively, and set aside.

[0097] Mix the sieved troxipiride with lactose, mannitol, sodium carboxymethylcellulose and aspartame evenly, make a soft material with an appropriate amount of 5% starch slurry, and granulate with an 8-mesh sieve. Dry at 50°C for 3 hours. Sieve with 8-60 mesh sieve, collect the particles of 8-60 mesh sieve, set aside.

[0098] Add the enteric-coated Opadry in the prescribed amount of the enteric-coating layer into 440ml of water, stir for 45 minutes, and pass through a 40-mesh sieve to obtain an enteric-coating solution, which is set aside.

[0099] Put the granules into a high-efficiency coating pan, the speed is 30 rpm, the temperature of the tablet bed is controlled a...

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Abstract

The invention provides an enteric-coated preparation for treating digestive diseases and a preparation method thereof. The enteric-coated preparation is a troxipide enteric-coated preparation, and active ingredients of the enteric-coated preparation are troxipide. The enteric-coated preparation comprises troxipide enteric-coated micropills, troxipide enteric-coated tablets, troxipide enteric-coated hard capsules, troxipide enteric-coated soft capsules, troxipide enteric-coated granules, troxipide enteric-coated solid dispersoids and the like. The troxipide cannot be absorbed in the stomach, so the troxipide is prepared into the enteric-coated preparation, so that the absorption programs and state of the ordinary oral administration preparation are changed, the aim of releasing and absorbing medicaments after the medicaments reach intestinal positions is fulfilled, the bioavailability of the preparation can be improved, and simultaneously, the medicaments also can be prevented from disintegrating in the stomach to stimulate lesion sites of gastric ulcer and acute and chronic gastritis and aggravate symptoms of nausea and vomit of patients. After the troxipide is prepared into the enteric-coated preparation, the compliance of the patients and the curative effect can be improved, and the side effect is reduced.

Description

technical field [0001] The invention belongs to medicines for treating digestive diseases, and relates to an enteric-coated preparation of troxipide and a preparation method thereof. Background technique [0002] Troxipide (also known as Troxipide) is a new type of defense factor and enhanced gastritis and gastric ulcer therapeutic agent. Its chemical name is (±) 3,4,5-trimethoxy-N-3-piperidinylbenzamide, and its molecular formula is C 15 h 22 N 2 o 4 , the molecular weight is 294.35, and the structural formula is as follows: [0003] [0004] Traxipide is used to treat gastric ulcer and improve gastric mucosal lesions (erosion, bleeding, redness, edema) in acute gastritis and acute exacerbation of chronic gastritis. Studies on its mechanism of action have shown that it interacts with proton pump inhibitors and H 2 - Different from receptor antagonists, it has no effect on gastric acid secretion, but enhances the defense factor of gastric mucosal anti-injury ability...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K9/32A61K9/36A61K9/38A61K9/48A61K47/32A61K47/34A61K47/38A61K31/4462A61P1/04A61K47/10
Inventor 杨进明王德武莫国飞
Owner 广西方略药业集团有限公司
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