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Preparation process of freeze-dry powder injection containing esomeprazole sodium

A technology of esomeprazole sodium and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve problems such as lack of preparation samples, large pH value changes, and poor solution clarity, and achieve good resolubility, low water content, and low cost. low effect

Inactive Publication Date: 2012-09-12
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The sample of this patent is protected by nitrogen gas during the preparation process, the production cost is high, and the safety risk is high. The preparation sample has discoloration 2 to 4 hours after reconstitution, the clarity of the solution after reconstitution is poor, and the pH value changes greatly. There is a lack of long-term test data for stability tests of formulation samples in

Method used

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  • Preparation process of freeze-dry powder injection containing esomeprazole sodium
  • Preparation process of freeze-dry powder injection containing esomeprazole sodium
  • Preparation process of freeze-dry powder injection containing esomeprazole sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Prescription: (Specification: 40mg)

[0026] Esomeprazole sodium 100g (calculated as esomeprazole)

[0027] Mannitol 400g

[0028] Anhydrous sodium sulfite 10g

[0029] Sodium Calcium EDTA 5g

[0030] Add water for injection to 5000ml

[0031] Prepare 2500 sticks

[0032] Preparation:

[0033] Weigh the prescribed amount of mannitol, anhydrous sodium sulfite, calcium sodium edetate and dissolve them in fresh water for injection with a total volume of 80%, add the prescribed amount of esomeprazole sodium and stir until completely dissolved, add 10g of medicine Use charcoal, heat to 60°C, stir and adsorb at constant temperature for 20 minutes, and decarbonize and filter with a 0.8μm titanium rod. Use 1mol / L sodium hydroxide solution to adjust the pH of the filtrate to 10.6, and add water for injection to the full amount. After 0.45μm and 0.22μm two-stage precision filter for sterilization and filtration, the filtrate is checked for intermediates. After passing th...

Embodiment 2

[0035] Prescription: (Specification: 40mg)

[0036] Esomeprazole sodium 100g (calculated as esomeprazole)

[0037] Mannitol 400g

[0038] Sodium bisulfite 15g

[0039] Sodium Calcium EDTA 5g

[0040] Add water for injection to 5000ml

[0041] Prepare 2500 sticks

[0042] Preparation:

[0043] Weigh the prescribed amount of mannitol, sodium bisulfite, calcium sodium edetate and dissolve them in fresh water for injection with a total volume of 80%, add the prescribed amount of esomeprazole sodium and stir until completely dissolved, add 12g Medicinal charcoal, stirred and adsorbed for 30 minutes, decarbonized and filtered with a 0.8μm titanium rod. Use 1mol / L sodium hydroxide solution to adjust the pH of the filtrate to 10.6, and add water for injection to the full amount. After 0.45μm and 0.22μm two-stage precision filter for sterilization and filtration, the filtrate is checked for intermediates. After passing the aseptic filling, the filling volume is controlled at 2...

Embodiment 3

[0045] Prescription: (Specification: 40mg)

[0046] Esomeprazole sodium 100g (calculated as esomeprazole)

[0047] Mannitol 300g

[0048] Sodium pyrosulfite 15g

[0049] Sodium Calcium EDTA 5g

[0050] Add water for injection to 5000ml

[0051] Prepare 2500 sticks

[0052] Preparation:

[0053]Weigh the prescribed amount of mannitol, sodium pyrosulfite, and calcium sodium edetate and dissolve them in fresh water for injection with a total volume of 80%, add the prescribed amount of esomeprazole sodium and stir until completely dissolved, add 8g of medicinal Charcoal, stirred and adsorbed for 40 minutes, decarbonized and filtered with a 0.8 μm titanium rod. Adjust the pH of the filtrate to 10.8 with 0.5mol / L sodium hydroxide solution, and add water for injection to the full amount. After 0.45μm and 0.22μm two-stage precision filter for sterilization and filtration, the filtrate is checked for intermediates. After passing the aseptic filling, the filling volume is contr...

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Abstract

The invention relates to a preparation process of a freeze-dry powder injection containing esomeprazole sodium, and also provides the esomeprazole sodium for injection, which has the advantages of safe quality and high stability. The preparation process comprises the following steps of: dissolving the esomeprazole sodium, an excipient, a metal ion complexing agent, an antioxidant and the like in injection water; adding a pH value adjusting agent to adjust the pH of mixed solution; adding medicinal carbon to decolorize; filtering; canning the filtrate; partially plugging; performing freeze-drying; pressing a plug under vacuum; rolling a cover; performing lamp inspection; and packaging to obtain a finished product. The preparation process is rational in prescription design; the defects of instability of the esomeprazole sodium upon heating and poor clarity of solution after redissolution are effectively overcome; and a prepared product has the advantages of high stability, high redissolution and the like and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a preparation process of a freeze-dried powder injection containing esomeprazole sodium, and simultaneously provides a kind of esomeprazole sodium for injection with safe quality and good stability. Background technique [0002] Esomeprazole (Esomeprazole) is the S-optical isomer of omeprazole, the world's first isomer proton pump inhibitor (PPI), which reduces gastric acid secretion by specifically inhibiting the proton pump of gastric parietal cells. It has been confirmed by a large number of clinical experiments and drug research: it maintains gastric pH>4 for a longer time, has higher acid suppression efficiency, and has better curative effect than the previous two generations of PPI, with little individual difference. Due to its metabolic advantages, esomeprazole has higher bioavailability and more consistent pharmacokinetics than omeprazole, which incre...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 陈敏张静贺莲吴健民吴锋朱敏刘娟
Owner KAMP PHARMA
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