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Gabexate mesylate composition for injection and preparation method thereof

A technology of gabexate mesylate and its composition, which is applied in the field of medicine, can solve the problems of affecting the efficacy of the product and the decrease of the main drug content, and achieve the effect of eliminating safety risks, simple prescription and good safety

Active Publication Date: 2013-07-24
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the adsorption of medicinal charcoal, the one-step liquid preparation process will easily lead to a decrease in the content of the main drug in the preparation, thereby affecting the efficacy of the product

Method used

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  • Gabexate mesylate composition for injection and preparation method thereof
  • Gabexate mesylate composition for injection and preparation method thereof
  • Gabexate mesylate composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: the preparation of gabexate mesylate for injection

[0021] Prescription: (based on 1000 bottles)

[0022]

[0023] Preparation process: (1) Take 200g of mannitol and add it to 2000ml of water for injection. After stirring and dissolving, add 0.1% (w / v) medicinal charcoal, stir well and keep the temperature at about 60°C for 15 minutes. Use 0.45μm Coarse filtration with a microporous membrane to obtain a filtrate. (2) Add 100g of Gabexate mesylate into the mannitol filtrate, dissolve and stir, fine filter with a 0.22μm microporous membrane, replenish water to 2000ml, fill in 7ml vials, 2.0ml per bottle, and place in the freezer In a drying oven, freeze-dry (-40°C, pre-freeze for 4 hours and start vacuuming, control the vacuum between 10 and 30 Pa, raise the temperature to -20°C, keep it for 12 hours, raise the temperature to 0°C, keep it for 2 hours, and raise the temperature to 20 ℃, kept for 4h, and the cold trap temperature was kept at -60℃ during ...

Embodiment 2

[0024] Embodiment 2: the preparation of gabexate mesylate for injection

[0025] Prescription: (based on 1000 bottles)

[0026]

[0027] Preparation process: (1) Take 200g of mannitol and add it to 2000ml of water for injection. After stirring and dissolving, add 0.1% (w / v) medicinal charcoal, stir well and keep the temperature at about 70°C for 20 minutes. Use 0.45μm Coarse filtration with a microporous membrane to obtain a filtrate. (2) Add 100g of Gabexate mesylate into the mannitol filtrate, dissolve and stir, fine filter with a 0.22μm microporous membrane, replenish water to 2000ml, fill in 7ml vials, 2.0ml per bottle, and place in the freezer In a drying oven, freeze-dry (-40°C, pre-freeze for 4 hours and start vacuuming, control the vacuum between 10 and 30 Pa, raise the temperature to -20°C, keep it for 12 hours, raise the temperature to 0°C, keep it for 2 hours, and raise the temperature to 20 ℃, kept for 4h, and the cold trap temperature was kept at -60℃ during ...

Embodiment 3

[0028] Embodiment 3: the preparation of gabexate mesylate for injection

[0029] Prescription: (based on 1000 bottles)

[0030]

[0031] Preparation process: (1) Take 200g of mannitol and add it to 2000ml of water for injection, stir to dissolve, add 0.1% (w / v) medicinal charcoal, stir well and keep the temperature at about 80°C for 10 minutes, then use 0.45μm Coarse filtration with a microporous membrane to obtain a filtrate. (2) Add 100g of Gabexate mesylate into the mannitol filtrate, dissolve and stir, fine filter with a 0.22μm microporous membrane, replenish water to 2000ml, fill in 7ml vials, 2.0ml per bottle, and place in the freezer In a drying oven, freeze-dry (-40°C, pre-freeze for 4 hours and start vacuuming, control the vacuum between 10 and 30 Pa, raise the temperature to -20°C, keep it for 12 hours, raise the temperature to 0°C, keep it for 2 hours, and raise the temperature to 20 ℃, kept for 4h, and the cold trap temperature was kept at -60℃ during the free...

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Abstract

The invention provides a gabexate mesylate composition for injection. The formula is simple. Two-step liquid preparation method is adopted in the preparation process, and the preparation method specifically comprises the following steps: firstly dissolving auxiliary materials, adding medicinal carbon, fully stirring, keeping the temperature at 60 DEG C-80 DEG C to perform adsorption, filtering, then adding a main medicine into filtrate, performing fine filtration, and freeze-drying to prepare a freeze-dried preparation. By adopting the two-step liquid preparation method, the adsorption against the main medicine of the medicinal carbon is reduced, and the stirring is simultaneously performed at higher temperature to fully play the adsorption action of the medicinal carbon and ensure that the content and the pyrogen of a sample are in line with the requirements. The prepared product according to the invention is better than the prior art in the quality evaluation indexes of traits, content, clarity, related substances and the like, and is more suitable for large industrialized production.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a gabexate mesylate composition for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Gabexate mesylate, the chemical name is the mesylate salt of ethyl p-(6-guanidineacetoxy)benzoate, and the molecular formula is C 16 h 23 N 3 o 4 ·CH 4 o 3 S, the molecular weight is 417.48, and the structural formula is: [0003] [0004] Gabexate mesylate is a non-peptide proteolytic enzyme inhibitor developed in Japan in the 1970s. In 1977, it was certified by the Special Ministry of Pharmaceuticals in Japan. It was produced and sold by Japan Ono Pharmaceutical Company in 1978. The trade name is FOY. . Gabexate mesylate has the characteristics of small molecular weight and no immunoprototype. It can inhibit the activity of proteases such as trypsin, kallikrein, plasmi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/235A61K47/10A61P1/18A61P7/02
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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