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Pantoprazole sodium freeze dried injection and preparation method thereof

A technology of pantoprazole sodium and freeze-dried powder injection, which is applied in the field of pantoprazole sodium freeze-dried powder injection and its preparation, can solve problems such as bone calcium loss, and achieve the effects of alleviating pain, avoiding side effects, and reducing impact

Inactive Publication Date: 2007-08-08
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But this is suspected of conflicting with the patent (patent No. 01819379.X) authorized by my country; and, after infusion of edetic acid and / or its salt into the human body, it will complex with calcium ions in the blood and lead to bone calcium Potential side effects of churn

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  • Pantoprazole sodium freeze dried injection and preparation method thereof

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Embodiment 1

[0043] Embodiment 1, preparation and detection of pantoprazole sodium freeze-dried powder injection

[0044] One, prepare pantoprazole sodium freeze-dried powder injection

[0045] With reference to the process flow diagram shown in Fig. 1, prepare 1000 bottles (marked amount: containing 40g pantoprazole sodium) pantoprazole sodium freeze-dried powder injection with method of the present invention, concrete process comprises the following steps:

[0046] 1) Take materials by the following weight: mannitol 40.00g, sodium citrate 2.00g, pantoprazole sodium 44.72g;

[0047] 2) Dissolve mannitol and sodium citrate with 1800g water for injection, adjust the pH value to 10.5 with 2mol / L sodium hydroxide solution, add pantoprazole sodium, fully dissolve and then adjust the pH value with 2mol / L sodium hydroxide solution value to 10.5, and finally add water for injection at 4°C to 2000g;

[0048] 3) Sterilize by filtering twice with a filter membrane with a pore size of 0.22 μm;

[...

Embodiment 2

[0065] Embodiment 2, preparation and detection of pantoprazole sodium freeze-dried powder injection

[0066] Prepare 1000 bottles of pantoprazole sodium freeze-dried powder injection with the method of the present invention, concrete process comprises the following steps:

[0067] 1) Take materials by the following weight: dextran 24.00g, pantoprazole sodium 44.72g;

[0068] 2) Dissolve dextran with 1800g water for injection, adjust the pH value to 9.5 with 2mol / L disodium hydrogen phosphate solution, add pantoprazole sodium, fully dissolve and then adjust the pH value to 9.5 with 2mol / L disodium hydrogen phosphate solution , and finally add water for injection at 10°C to 2000g;

[0069] 3) Sterilize by filtering 3 times with a filter membrane with a pore size of 0.3 μm;

[0070] 4) Use an automatic filling machine (Nanjing Bojian Technology Co., Ltd. KFG-300 linear semi-dropper aseptic filling machine) to dispense the filtrate into 1000 bottles (specification: 10mL) of Xili...

Embodiment 3

[0073] Embodiment 3, preparation and detection of pantoprazole sodium freeze-dried powder injection

[0074] Prepare 1000 bottles of pantoprazole sodium freeze-dried powder injection with the method of the present invention, concrete process comprises the following steps:

[0075] 1) Take materials by the following weight: glucose 44.72g, potassium citrate 2.68g, pantoprazole sodium 44.72g;

[0076] 2) Dissolve glucose and potassium citrate with 1800g water for injection, adjust the pH value to 11.5 with 1mol / L potassium hydroxide solution, add pantoprazole sodium, fully dissolve and then adjust the pH value with 1mol / L potassium hydroxide solution value to 11.5, and finally add water for injection at 6°C to 2000g;

[0077] 3) Sterilize by filtering twice with a filter membrane with a pore size of 0.1 μm;

[0078] 4) Use an automatic filling machine (Nanjing Bojian Technology Co., Ltd. KFG-300 linear semi-dropper aseptic filling machine) to dispense the filtrate into 1000 bo...

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Abstract

The invention relates to a method for preparing batoracosodium freeze dried, whose pH value is 9.5-11.5. And the invention comprises 1 deal of batoracosodium, 0.5-1 deals of supporting agent, 0-0.06 deals of weak-acid strong-alkali salt, and some inorganic alkali. And the preparation comprises that 1, preparing materials; 2, dissolving the supporting agent and weak-acid strong-alkali salt via injection water, using inorganic salt to adjust the pH value to 9.5-11.5, adding batoracosodium, dissolving and using inorganic salt to adjust the pH value to 9.5-11.5; 3, filtering; 4, freezing and drying to obtain the final product. The invention can be used treat peptic ulcer, ulcer bleed, or the like.

Description

technical field [0001] The invention relates to a drug in the form of freeze-dried powder injection and a preparation method thereof, in particular to a freeze-dried powder injection of pantoprazole sodium and a preparation method thereof. Background technique [0002] Pantoprazole Sodium (Pantoprazole Sodium), chemical name: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]-sulfinyl-1H- Benzimidazole Sodium Salt. Pantoprazole sodium is a proton pump inhibitor antiulcer drug. Pantoprazole sodium injection is mainly used for peptic ulcer bleeding, acute gastric mucosal injury caused by non-steroidal anti-inflammatory drugs and ulcer bleeding under stress, general anesthesia or major surgery, and debilitated coma patients to prevent gastric acid reflux Treatment of diseases such as aspiration pneumonia. Pantoprazole sodium has poor stability and is very sensitive to light, heat, oxygen, water, etc., especially in acidic conditions, its chemical structure can undergo des...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/19A61K47/02A61K47/10A61K47/12A61K47/26A61K47/36A61P7/04A61P1/04
Inventor 杨春胡振湘王燕清周瑾毛小荣王瑾彭旺
Owner LIVZON PHARM GRP INC
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