Omeprazole sodium freeze-dried powder injection and preparing method thereof

A technology of freeze-dried powder injection and omeprazole sodium, which is applied in the field of preparation of omeprazole sodium freeze-dried powder injection, can solve the problems of cumbersome preparation process, poor stability, and poor clarity, and achieve packaging Small size, good stability and excellent appearance

Active Publication Date: 2008-07-30
SHANDONG YUXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Prior art shows, omeprazole sodium lyophilized powder injection has poor clarity, poor stability, main drug content is low, and the defective of related substance content height, because in the omeprazole sodium lyophilized powder injection , in order to prevent metal ions from catalyzing the oxidation of the drug itself, a certain amount of metal ion chelating agent is added to reduce the concentration of metal ions. At the same time, a pH regulator must be added to make the pH value in the range suitable for the human body. Due to the preparation process

Method used

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  • Omeprazole sodium freeze-dried powder injection and preparing method thereof
  • Omeprazole sodium freeze-dried powder injection and preparing method thereof

Examples

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Effect test

Embodiment 1

[0075] 1. Prescription composition

[0076] 20mg

[0077] Omeprazole sodium 20g (calculated as omeprazole)

[0078] Add water for injection to 2000ml

[0079]

[0080] Freeze-dried to make 1000 vials

[0081] 2. Preparation method

[0082] Add the prescribed amount of omeprazole sodium into the liquid mixing tank, add 1500ml of water for injection and stir until completely dissolved, then adjust the pH to 11.0 with a sodium citrate solution with a concentration of 0.05mol / L, and add water for injection to 2000mL to obtain a mixed solution . Then add a total amount of 0.05% activated carbon for needles, stir for 15 minutes, and decarbonize by filtration. The obtained filtrate was fine-filtered with a 0.22 μm sterile microporous membrane, and the pH value, content and semi-plugging were measured. Then carry out freeze-drying: first lower the drug from normal temperature to -22.5°C, keep it warm for 60 minu...

Embodiment 2

[0084] 1. Prescription composition

[0085] 40mg

[0086] Omeprazole sodium 40g (calculated as omeprazole)

[0087] Add water for injection to 2000ml

[0088]

[0089] Freeze-dried to make 1000 vials

[0090] 2. Preparation method (specification: 20mg; 40mg)

[0091] Add the prescribed amount of omeprazole sodium raw material into the liquid mixing tank, add 1500mL of water for injection and stir until completely dissolved, then adjust the pH to 10.5 with 0.05mol / L sodium citrate solution, and add water for injection to the prescribed amount. Add a total amount of 0.05% activated carbon for needles, stir for 15 minutes, and decarbonize by filtration. Finely filter the medicinal solution with a 0.22 μm sterile microporous membrane, and measure the pH value, content, and half stoppering. Finally, freeze-drying: first lower the drug from normal temperature to -22.5°C, keep it warm for 30 minutes, the...

Embodiment 3

[0093] 1. Prescription composition

[0094] 20mg:

[0095] Omeprazole Sodium 22.31g

[0096] Mannitol 100g

[0097] Add water for injection to 1500ml

[0098]

[0099] Makes 1000 bottles

[0100] 2. Preparation method

[0101] Add the prescribed amount of omeprazole sodium and mannitol raw materials into the liquid mixing tank, add 1000mL water for injection and stir until completely dissolved, then adjust the pH value to 10.0 with 0.15mol / L sodium citrate solution, and then add water for injection to 1500mL to obtain a diluted solution, then add 0.05% activated carbon for needles with a weight of 0.05% of the diluted solution weight, stir for 20 minutes, filter and decarbonize to obtain a filtrate. Fine filter the filtrate with a 0.22 μm sterile microporous membrane, and measure the pH value, content, and half stoppering. Finally, freeze-drying: first lower the drug from normal temperature to -22.5°C, ...

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Abstract

The invention provides an omeprazole sodium freeze-dried injection and a preparation method which is simple and feasible and the prepared freeze-dried injection is high in drug contents and low in related substances content. The method comprises the following steps: (1) the raw materials of the recipe quantity are stirred with injection water until the omeprazole sodium is completely dissolved to get omeprazole sodium solutions; sodium citrate solutions are put into the solutions got from step (1) and the pH value of the solutions is adjusted to 10.0 to 11.0; the injection water is put into the prepared products got from step (2) to the recipe quantity and then pin activated carbon is put into the prepared products, and filter decarburization is carried out after stirring to get filtrates; the filtrates got from step (3) are fine filling filtered by 0.22Mum removal bacteria microporous membrane, and the filtrates after fine filling filtering are put into a bottle which is partially stoppered, and then the filtrates are freeze-dried to get the freeze-dried injection.

Description

technical field [0001] The invention belongs to the field of biomedicine, and what relates to is a kind of preparation method of lyophilized powder injection, more specifically, what the present invention relates to is a kind of preparation method of omeprazole sodium lyophilized powder injection. Background technique [0002] Omeprazole Sodium for Injection (Omeprazole Sodium for Injection, molecular formula: C 17 h 18 N 3 NaO 3 S·H 2 O, molecular weight: 385.41), its chemical name is: 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridyl) monomethyl]-sulfinyl] - 1H-benzimidazole sodium monohydrate. Chemical Structure: [0003] [0004] In the prior art, the auxiliary materials of this product are: mannitol and water for injection. This product is white or off-white loose lump or powder. As an alternative therapy for the following conditions when oral therapy is not appropriate: duodenal ulcer, gastric ulcer, reflux esophagitis, and Zollinger-Ellison syndrome. [0005]...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/10A61P1/04
Inventor 刘保起李明华李明杰
Owner SHANDONG YUXIN PHARMA CO LTD
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