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Trimebutine maleate injection and preparation method thereof

The technology of trimebutine maleate and injection is applied in the field of trimebutine maleate injection and preparation thereof, and can solve the problem of low bioavailability, large fluctuation of blood drug concentration, and half-life of trimebutine maleate. Shortage and other problems, to achieve the effects of high bioavailability, simple preparation method, and no first-pass effect

Inactive Publication Date: 2012-04-04
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 to be administered frequently, and the blood concentration fluctuates greatly, which brings a lot of inconvenience to patients, and the solid preparations have slow onset of action, obvious first-pass effect, and low bioavailability. Low

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: Prepare 1000ml trimebutine maleate injection, using the following prescription:

[0021] Trimebutine maleate 10g benzyl alcohol 10ml

[0022] Sodium chloride 9mg water for injection dilute to 1000ml

[0023] Preparation:

[0024] First add benzyl alcohol to 500ml water for injection, stir well, add sodium chloride, stir to dissolve, then add trimebutine maleate, stir to dissolve, then add water to make the volume to 1000ml, stir and mix evenly, and then pass through 0.45. μm and 0.22μm filters are sterilized and filtered, and then filled after filtration.

[0025] The trimebutine maleate injection of the present invention has good curative effect on gastrointestinal symptoms and irritable bowel syndrome caused by chronic gastritis, and has fast onset, avoids first-pass effect, high bioavailability, and preparation method simple.

Embodiment 2

[0026] Example 2: Preparation of 1000ml trimebutine maleate injection, using the following prescription:

[0027] Trimebutine maleate 10g benzyl alcohol 10ml

[0028] Sodium chloride 9mg water for injection dilute to 1000ml

[0029] Preparation:

[0030] First add benzyl alcohol to 500ml water for injection, stir well, add sodium chloride, stir to dissolve, then add trimebutine maleate, stir to dissolve, then add water to make the volume up to 1000ml, stir and mix well, fill, Sterilize at 121°C for 15 minutes.

Embodiment 3

[0031] Example 3: Preparation of 1000ml trimebutine maleate injection, using the following prescription:

[0032] Trimebutine maleate 10g benzyl alcohol 10ml

[0033] Sodium chloride 9mg water for injection dilute to 1000ml

[0034] Preparation:

[0035] First add benzyl alcohol to 500ml water for injection, stir well, add sodium chloride, stir to dissolve, then add trimebutine maleate, stir to dissolve, then add water to make the volume up to 1000ml, stir and mix well, fill, Sterilize at 116°C for 40 minutes.

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PUM

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Abstract

The present invention relates to a trimebutine maleate injection and a preparation method thereof. The trimebutine maleate injection comprises a pharmaceutical active component of trimebutine maleate, and an additional preparation adjuvant, wherein 1 ml of the trimebutine maleate injection contains 5-20 mg of the trimebutine maleate, the additional preparation adjuvant comprises 0.1-2% of an analgesics, 0.5-1.5% of an osmotic pressure regulator, and the balance of water. The trimebutine maleate injection of the present invention has characteristics of quick onset, first pass effect-free property, high bioavailability and simple preparation method.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to trimebutine maleate injection and a preparation method thereof. Background technique [0002] Trimebutine maleate is a gastrointestinal rhythm regulator different from cholinergic drugs and antidopamine drugs. It is clinically used to treat gastrointestinal symptoms caused by chronic gastritis (abdominal fullness, abdominal pain, Nausea, heating) and irritable bowel syndrome. [0003] The relevant characteristics of trimebutine maleate are as follows: [0004] 1. Unlike other digestive system drugs, for digestive tract movement, due to the difference in the physiological state of the digestive tract, it can promote or inhibit the two-way effect of normalizing the abnormal movement of the digestive tract; [0005] 2. It can promote gastric emptying; [0006] 3. It can relieve gastritis, peptic ulcer, irritable bowel syndrome and other gastrointestinal symptoms, especially abdomina...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/24A61K47/10A61P1/04
Inventor 范敏华司秉坤
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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