Pharmaceutical composition containing esomeprazole sodium and preparation method thereof

A technology of esomeprazole sodium and its composition, which is applied in the field of freeze-dried powder injection containing esomeprazole sodium and its preparation, and can solve the problem of color change of liquid medicine, inability to control impurities, increase of colored impurities, etc. problem, to achieve the effect of inhibiting growth

Inactive Publication Date: 2018-11-13
CHENGDU GUOHONG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] CN102440965A Example 1 discloses a freeze-dried preparation composed of esomeprazole sodium and ethylenediaminetetraacetic acid, the activated carbon used to adsorb impurities in the preparation process has undergone specific finishing steps to release the activated carbon in advance Easy-to-release impurities in the product, so as to control the visible foreign matter and insoluble particles in the product to a lower level, but this method cannot further control the impurities in the product, especially the colored impurities
[0005] The prior art also improves the stability of the preparation by adding stabilizers such as amino acids, antioxidants such as sodium sulfite, or preparing phospholipid complexes in the prescription, in order to reduce the generation of im

Method used

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  • Pharmaceutical composition containing esomeprazole sodium and preparation method thereof
  • Pharmaceutical composition containing esomeprazole sodium and preparation method thereof
  • Pharmaceutical composition containing esomeprazole sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131]

[0132] Prepare freeze-dried powder injection according to the following steps:

[0133] (1) Prepare 80% of the prescription amount of water for injection at room temperature (10-30°C) in the liquid preparation tank, add the prescribed amount of edetate disodium, stir and dissolve completely at room temperature (10-30°C), use 1mol / L of sodium hydroxide solution, the pH of the liquid is adjusted to 10.7;

[0134] (2) Add the prescribed amount of esomeprazole sodium, stir until it is completely dissolved, add water for injection at room temperature (10-30°C) to make up the volume until the full volume is prepared, stir for 10 minutes after constant volume, and use 1mol / L of hydroxide Sodium solution adjusts the pH of the medicinal solution to 11.5;

[0135] (3) Filter the solution obtained in step (2) through a 0.22 μm sterile filter, fill the filtrate into a neutral borosilicate glass control injection bottle, stopper halfway, and send it to a lyophilizer for lyoph...

Embodiment 2

[0144]

[0145] Prepare freeze-dried powder injection according to the following steps:

[0146] (1) Prepare 60% of the prescription amount of water for injection at room temperature (10-30°C) in the liquid preparation tank, add the prescribed amount of edetate disodium, stir and dissolve completely at room temperature (10-30°C), use 0.5mol / L of sodium hydroxide solution to adjust the pH of the liquid to 11.2;

[0147] (2) Add the prescribed amount of esomeprazole sodium, stir until it is completely dissolved, add water for injection at room temperature (10-30°C) to make up the volume until the full volume is prepared, stir for 10 minutes after constant volume, and use 0.5mol / L hydrogen The sodium oxide solution adjusts the pH of the medicinal solution to 11.0;

[0148] (3) Filter the solution obtained in step (2) through a 0.22 μm sterile filter, fill the filtrate into a neutral borosilicate glass control injection bottle, stopper halfway, and send it to a lyophilizer fo...

Embodiment 3

[0157] Samples are prepared according to the prescription described in Example 1, and the liquid preparation method is as follows:

[0158] (1) Prepare 90% of the prescription amount of water for injection at room temperature (10~30°C) in the liquid preparation tank, add the prescribed amount of edetate disodium, stir and dissolve completely at room temperature (10~30°C), use 1.2mol / L of sodium hydroxide solution to adjust the pH of the liquid to 10.7;

[0159] (2) Add the prescribed amount of esomeprazole sodium, stir until completely dissolved, add water for injection at room temperature (10~30°C) to make up the volume until the full volume is prepared, stir for 10 minutes after constant volume, and use 1.2mol / L hydrogen The sodium oxide solution adjusts the pH of the medicinal solution to 11.5;

[0160] (3) Filter the solution obtained in step (2) through a 0.22 μm sterile filter, fill the filtrate into a neutral borosilicate glass control injection bottle, stopper halfwa...

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Abstract

The invention relates to a pharmaceutical composition containing esomeprazole sodium and a preparation method thereof. The pharmaceutical composition is freeze-dried powder for injection, and for every 1000 bottles, the pharmaceutical composition is composed of the following pharmaceutical ingredients of 20-40 grams of the esomeprazole sodium, 1.5 grams of disodium edetate, and 1 liter of water for injection. The preparation method of the pharmaceutical composition containing the esomeprazole sodium includes the steps of liquid preparation and freeze drying, wherein in the process of liquid preparation, the esmeprazole sodium, the disodium edetate, and the water for injection are mixed to prepare a liquid of a pH of 11.0 to 11.5; the step of freeze drying includes freeze control 1, freezecontrol 2, sublimation drying 1, sublimation drying 2 and desorption drying. The pharmaceutical composition containing the esomeprazole sodium has various advantages, such as having low moisture content, few metal ions and colored impurities and good stability, and having no significant increase in impurities accompanied by changes in solution color after long-term placement.

Description

technical field [0001] The invention relates to the field of pharmaceutical technology, more specifically, to a freeze-dried powder injection containing esomeprazole sodium and a preparation method thereof. Background technique [0002] The chemical name of Esomeprazole sodium is (S)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl ] Sodium sulfinyl-1H-benzimidazole) has become the first choice drug for the treatment of acid-related diseases such as peptic ulcer and gastroesophageal reflux disease because of its strong gastric acid inhibitory effect, long-lasting effect and small side effects. In 2007, the China Food and Drug Administration approved the import preparation of AstraZeneca's esomeprazole sodium freeze-dried powder injection, the trade name is Nexium, and the specifications are 40mg and 20mg azole meter), the prescription is composed of esomeprazole sodium and edetate disodium, which is compatible with 0.9% sodium chloride solution for intravenous injecti...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
CPCA61K9/19A61K9/0019A61K31/4439A61K47/183
Inventor 蒋代财陈洋汪飞郭礼新郭晖
Owner CHENGDU GUOHONG PHARMA
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