Esomeprazole sodium freeze-dried powder injection and preparation method thereof

A technology of esomeprazole sodium and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection of esomeprazole sodium and its preparation, can solve the problems of large medication risks, damage, poor effect, etc., and achieve quality improvement And safety, comfortable feeling, good moldability effect

Active Publication Date: 2012-02-22
NANJING YOKO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the one hand, the main drug active ingredient of this preparation is omeprazole, and its effect is worse than esomepraz

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 The preparation component and preparation method without adding mannitol

[0030] Prescription 1:

[0031] Esomeprazole Sodium 20mg

[0032] Edetate Calcium Sodium 1.5mg

[0033] Appropriate amount of sodium hydroxide

[0034] Water for injection 1ml

[0035] Process 1:

[0036] (1) Under the protection of nitrogen, add calcium sodium edetate to water for injection at 5°C, stir and mix evenly and control the temperature of the solution at 0-10°C, then add the main drug esomeprazole sodium, stir to make After dissolving and mixing evenly, adjust the pH value to 11.5 with 0.5 mol / l sodium hydroxide solution, add 0.05% (g / ml) activated carbon for adsorption for 15 minutes, and filter to remove carbon.

[0037] (2) Immediately carry out intermediate inspection after filtration, fill immediately after passing the inspection (each 1ml), send it to a freeze dryer for freeze drying, pre-freeze at -40°C for about 4 hours, and dry at a low temperature of -40~-2...

Embodiment 2

[0038] Example 2 Addition of mannitol formulation components and preparation method

[0039] Prescription 2:

[0040] Esomeprazole Sodium 20mg

[0041] Mannitol 20mg

[0042] Edetate Calcium Sodium 1.5mg

[0043] Appropriate amount of sodium hydroxide

[0044] Water for injection 1ml

[0045] Process 2:

[0046] (1) Under nitrogen protection, add mannitol and calcium sodium edetate to water for injection at 5°C, stir and mix evenly and control the temperature of the solution at 0-10°C, then add the main drug esomeprazole sodium, Stir to dissolve and mix evenly, adjust the pH value to 11.5 with 0.5mol / l sodium hydroxide solution, add 0.05% (g / ml) activated carbon for adsorption for 15min, and filter to remove carbon.

[0047] (2) Immediately carry out intermediate inspection after filtration, fill immediately after passing the inspection (each 1ml), send it to a freeze dryer for freeze drying, pre-freeze at -40°C for about 4 hours, and dry at a low temperature of -40~-2...

Embodiment 3

[0048] Example 3 Preparation Components and Preparation Method Adding Mannitol (No Nitrogen Protection During Preparation)

[0049] Prescription 3:

[0050] Esomeprazole Sodium 20mg

[0051] Mannitol 20mg

[0052] Edetate Calcium Sodium 1.5mg

[0053] Appropriate amount of sodium carbonate

[0054] Water for injection 1ml

[0055] Process 2:

[0056] (1) Add mannitol and calcium sodium edetate to water for injection, stir and mix evenly, then add the main drug esomeprazole sodium and cover, stir to dissolve and mix evenly, then use 1.0mol / l sodium carbonate solution Adjust the pH value to 10.8, add 0.1% (g / ml) activated carbon for adsorption for 30 minutes, and filter to remove carbon.

[0057] (2) After filtering, carry out intermediate inspection, and fill it after passing the inspection (1ml per tube), send it to a freeze dryer for freeze drying, pre-freeze at -40°C for about 5 hours, and dry at -40~0°C for about 20 hours in a low-temperature vacuum. Dry at 20°C fo...

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PUM

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Abstract

The invention belongs to the field of medicinal preparations, and mainly provides freeze-dried powder injection consisting of esomeprazole sodium, a propping agent, a metal ion chelant and a proper amount of pH regulator, and a preparation method for the injection. The freeze-dried powder injection has the advantages of compact form, high stability and small toxic and side effects, and is suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a freeze-dried powder injection of esomeprazole sodium and a preparation method thereof. Background technique [0002] Esomeprazole (Esomeprazole, Nexiumò, Cas No.: 119141-88-7) is the world's first isomer proton pump inhibitor (I-PPI) isolated and synthesized by AstraZeneca (AstraZeneca). Esomeprazole is the S-configuration isomer of Omeprazole; and the existing research results show that the efficacy and performance of the S-isomer of Omeprazole (ie esomeprazole) better than its R-configured isomer. Clinically, esomeprazole is usually used in the form of its metal salt, such as esomeprazole sodium, with a structural formula as shown in a. In March 2005, esomeprazole sodium for injection was approved by the FDA for the treatment of short-term gastroenteritis. The preparation composition and preparation technology are specific. [0003] a [0004] In vi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/16A61K47/26A61P1/04
Inventor 晁阳包玉胜叶海李正海顾传虎曹卫
Owner NANJING YOKO PHARMA
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