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Trimebutine maleate suppository and preparation method thereof

A technology of trimebutine acid suppository and trimebutine maleate, which is applied in the field of trimebutine maleate suppository and preparation thereof, can solve the problem of unsuitability for oral medication, unfavorable frequent administration, poor patient compliance, etc. problem, to achieve the effect of improving bioavailability and avoiding the first pass effect

Inactive Publication Date: 2012-05-23
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Due to the short half-life of trimebutine maleate, common solid preparations need frequent administration, and most of the patients treated with this medicine have symptoms of nausea or vomiting, which is not conducive to frequent administration, and the patient's compliance is poor; in addition, for some Oral medication is not suitable for children, the elderly and people who have difficulty swallowing
Oral solid preparations have obvious first-pass effect and low bioavailability

Method used

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  • Trimebutine maleate suppository and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0019] Embodiment: prepare 1000 trimebutine maleate suppositories, adopt following prescription:

[0020] Trimebutine Maleate 100g

[0021] Macrogol 1000 1000g

[0022] Macrogol 6000 500g

[0023] Glycerin 150g

[0024] water 250g

[0025]

[0026] Makes 1000 capsules

[0027] Preparation method: Put the prescribed amount of polyethylene glycol 1000, polyethylene glycol 6000, glycerin and water in a 5000ml beaker, heat in a water bath at 80°C until completely melted, stir evenly and keep warm for 30 minutes, add the prescribed amount of Trimebutine maleate is stirred until it is completely dissolved, and the molten solution of the medicine is filled into the suppository shell to obtain.

[0028] The trimebutine maleate suppository of the present invention adopts an anal administration method, and the active ingredient of the drug passes through the inferior rectal vein and anal vein, bypasses the liver through the internal iliac vein, enters th...

Embodiment 2

[0029] Embodiment 2: prepare 1000 trimebutine maleate suppositories, adopt following prescription:

[0030] Trimebutine Maleate 150g

[0031] Macrogol 1500 1250g

[0032] Macrogol 6000 300g

[0033] Glycerin 100g

[0034] water 200g

[0035]

[0036] Makes 1000 capsules

[0037] Preparation method: put the prescribed amount of polyethylene glycol 1500, polyethylene glycol 6000, glycerin and water in a 5000ml beaker, heat in a water bath at 80°C until melted, stir evenly and keep warm for 30 minutes, add the prescribed amount of horse Trimebutine leicate is stirred until it is completely dissolved, and the molten solution of the drug is filled into the suppository shell to obtain it.

Embodiment 3

[0038] Embodiment 3: prepare 1000 trimebutine maleate suppositories, adopt following prescription:

[0039] Trimebutine Maleate 180g

[0040] Macrogol 400 1220g

[0041] Poloxamer 300g

[0042] Propylene glycol 100g

[0043] water 200g

[0044]

[0045] Makes 1000 capsules

[0046] Preparation method: Put the prescribed amount of polyethylene glycol 400, poloxamer, propylene glycol and water in a 5000ml beaker, heat in a water bath at 80°C until melted, stir evenly and keep warm for 30 minutes, add the prescribed amount of Malay Trimebutine acid is stirred until it is completely dissolved, and the molten solution of the medicine is filled into the suppository shell to obtain the product.

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Abstract

The invention relates to a trimebutine maleate suppository and a preparation method thereof. The trimebutine maleate suppository comprises a suppository shell and a content, wherein the content comprises 2 percent to 10 percent of trimebutine maleate, 40 percent to 90 percent of water-soluble base materials and 5 percent to 15 percent of humectants according to the percentage by weight. The trimebutine maleate suppository disclosed by the invention has the advantages that through an anus drug administration manner, active pharmaceutical ingredients enter into an inferior vena cava through an inferior rectal vein and an anal vein via an internal iliac vein after bypassing a liver and enter into systemic circulation, so a liver first pass effect is effectively avoided, the pharmaceutical bioavailability is improved, oral administration is not used, adverse reactions of a patient, which is produced during the oral administration, is avoided, and the compliance of the patient is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a trimebutine maleate suppository and a preparation method thereof. Background technique [0002] Trimebutine maleate is a gastrointestinal rhythm regulator that is different from cholinergic drugs and antidopamine drugs. It is clinically used to treat gastrointestinal symptoms caused by chronic gastritis (abdominal fullness, abdominal pain, nausea, belching) and irritable bowel syndrome. [0003] The relevant characteristics of trimebutine maleate are as follows: [0004] 1. Different from other digestive system drugs, for the movement of the digestive tract, due to the difference in the physiological state of the digestive tract, it can produce a bidirectional effect of promotion or inhibition, so as to normalize the abnormal movement of the digestive tract; [0005] 2. Promote gastric emptying; [0006] 3. It has a relieving effect on gastrointestinal symptoms suc...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K31/24A61K47/34A61P1/04A61P1/00
Inventor 范敏华刘海刘华
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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