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Esomeprazole sodium for injection and preparation method thereof

A technology for esomeprazole sodium and injection, which is applied in the field of medicine, can solve the problems that the clarity and stability of esomeprazole sodium cannot be guaranteed, and achieves reduction of preparation cost, improvement of pre-freezing temperature, and simplification of preparation method. Effect

Inactive Publication Date: 2015-12-16
SHANGHAI CHENPON PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In fact, in the actual application process, medical personnel often find that the clarity and stability of esomeprazole sodium for injection cannot be guaranteed, which is mainly related to its preparation method and preparation method. Therefore, a more excellent preparation Method, to guarantee that the product finally obtained, i.e. esomeprazole sodium for injection has more stable and more optimized performance, is an urgent need in this area

Method used

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  • Esomeprazole sodium for injection and preparation method thereof
  • Esomeprazole sodium for injection and preparation method thereof
  • Esomeprazole sodium for injection and preparation method thereof

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preparation example Construction

[0026] Technical scheme of the present invention, promptly a kind of preparation method of esomeprazole sodium for injection is characterized in that, with esomeprazole sodium as main agent, edetate disodium, sodium hydroxide are auxiliary materials, its The dosage form is freeze-dried powder injection, wherein the mass ratio of esomeprazole sodium to edetate disodium is 1:0.005-0.5, and the specific steps include:

[0027] Step 1: Add edetate disodium to 80-90% of the total amount of the preparation in water for injection below 30°C, and stir until completely dissolved;

[0028] Step 2: Add esomeprazole sodium and 1-5mol / L sodium hydroxide solution, stir until esomeprazole sodium is completely dissolved, and make the system pH 10.5-12.0;

[0029] Step 3: Dilute to volume with water for injection, stir to make the liquid medicine mix evenly;

[0030] Step 4: filter sterilization, filling;

[0031] Step 5: Freeze drying: Prefreeze at -50 to -30°C for 2-4 hours, then perform p...

Embodiment 1

[0038] A preparation method of esomeprazole sodium for injection is characterized in that the raw and auxiliary materials used in the preparation method all carry out the control of microorganisms and endotoxins, with esomeprazole sodium as the main agent, and Disodium diacetate and sodium hydroxide are auxiliary materials, and its dosage form is freeze-dried powder injection, wherein, the mass ratio of esomeprazole sodium and disodium edetate is 4.25:0.05, and the specific steps include:

[0039] Step 1: Add disodium edetate to 90% of the total amount of water for injection below 30°C, and stir until completely dissolved;

[0040] Step 2: Add esomeprazole sodium and an appropriate amount of 5mol / L sodium hydroxide solution, stir until esomeprazole sodium is completely dissolved, and make the system pH 11.5;

[0041] Step 3: Dilute to volume with water for injection, stir to make the liquid medicine mix evenly;

[0042] Step 4: Sterilize by filtration and fill into 5ml vials;...

Embodiment 2

[0045] A preparation method of esomeprazole sodium for injection is characterized in that the raw and auxiliary materials used in the preparation method all carry out the control of microorganisms and endotoxins, with esomeprazole sodium as the main agent, and Disodium chlorate and sodium hydroxide are auxiliary materials, and its dosage form is freeze-dried powder injection, wherein, the mass ratio of esomeprazole sodium and disodium edetate is 4.25:0.15, and the specific steps include:

[0046]Step 1: Add disodium edetate to 80% of the total amount of water for injection below 30°C, and stir until completely dissolved;

[0047] Step 2: Add esomeprazole sodium and an appropriate amount of 1mol / L sodium hydroxide solution, stir until esomeprazole sodium is completely dissolved, and make the system pH 11.5;

[0048] Step 3: Dilute to volume with water for injection, stir to make the liquid medicine mix evenly;

[0049] Step 4: Sterilize by filtration and fill into 5ml vials; ...

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Abstract

The invention provides a preparation method of esomeprazole sodium for injection. The preparation method comprises the following steps: step 1, adding edetate disodium into water for injection, and stirring for complete dissolution; step 2, adding esomeprazole sodium and a 1-5 mol / L sodium hydroxide solution, and stirring for complete dissolution to enable the system pH value to be 10.5-12.0; step 3, confirming a constant volume by use of water for injection, and stirring to enable the medical liquid to be uniformly mixed; step 4, filtering, sterilizing and filling; step 5, performing freeze drying in the way of pre-freezing for 2-4 h at 50 DEG C below zero to 30 DEG C below zero, then subliming for the first time for 2-12 h at 15 DEG C below zero to 0 DEG C, subliming for the second time for 2-12 h at 20-40 DEG C and controlling the vacuum degree to be 0.50 mbar or below to finally obtain esomeprazole sodium for injection. The esomeprazole sodium for injection is higher in stability, causes less mistakes during preparation and is more optimized during practical application.

Description

technical field [0001] The invention relates to the field of medicine, in particular to esomeprazole sodium for injection and a preparation method thereof. Background technique [0002] Esomeprazole, the S-optical isomer of omeprazole, is the world's first isomer proton pump inhibitor (PPI), which reduces gastric acid secretion by specifically inhibiting the proton pump of gastric parietal cells. A large number of clinical experiments and drug studies have confirmed that it can maintain gastric pH>4 for a longer time, have higher acid suppression efficiency, and have better curative effect than the previous two generations of PPI, with little individual difference. As a new generation of PPI, it has been widely used in clinical treatment of many acid-related diseases. [0003] The earliest application of esomeprazole was through oral administration. Although oral administration of esomeprazole can achieve good clinical effects, in some patients, such as dysphagia, vomiti...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/18
Inventor 陈霓祥沈莹宋晓丽杜狄峥
Owner SHANGHAI CHENPON PHARM TECH CO LTD
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