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Omeprazole sodium freeze drying powder injection pharmaceutical composition for injection

A technology of omeprazole sodium and freeze-dried powder injection, which is applied in the field of medicine and can solve the problems of increasing the moisture content of freeze-dried powder injection and unstable freeze-dried powder.

Inactive Publication Date: 2015-06-03
山东北大高科华泰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mannitol itself has a certain degree of water absorption, adding it to the prescription increases the moisture of the freeze-dried powder, making the freeze-dried powder unstable

Method used

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  • Omeprazole sodium freeze drying powder injection pharmaceutical composition for injection
  • Omeprazole sodium freeze drying powder injection pharmaceutical composition for injection
  • Omeprazole sodium freeze drying powder injection pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0092] Preparation Example 1. Preparation of powder injection containing omeprazole sodium

[0093] formula:

[0094] Omeprazole Sodium

40mg,

Maltose

5mg,

EDTA-2Na

1.5mg,

pH adjuster (mainly using sodium hydroxide)

to pH10.5,

Water for Injection

Appropriate amount, add to 1ml.

[0095] Preparation:

[0096] (1) Weigh the main drug and auxiliary materials of the recipe, place them in a stainless steel bucket, add about 80% of the water for injection in the recipe, dissolve each component, and then add 0.1% (w / v) of activated carbon by solution volume, Stir for 30 minutes, filter and decarbonize, and add water for injection to the full amount of the prescription.

[0097] (2) Sampling the filtrate, measure the pH value, and adjust the pH value to a specified value with a pH regulator if necessary (the specified value is the pH value measured by diluting the dry powder obtained by freeze drying into a solution c...

Embodiment 1

[0108]

preparation example 2

[0121] Preparation example 2, powder injection of the present invention

[0122] The prescription and preparation method refer to Preparation Example 1, the only difference is that the dosage of EDTA-2Na is changed to 1 mg or 2 mg, and two batches of powder injections are obtained, and the numbers are respectively recorded as Ex21 and Ex22.

[0123] The recipe and preparation method refer to Preparation Example 1, the only difference is that the pH value is controlled to 10.0 or 11.0, and freeze-drying is performed using the freeze-drying curve B described in this article to obtain two batches of powder injections, the numbers are respectively recorded as Ex23 , Ex24.

[0124] The prescription and preparation method refer to Preparation Example 1, and the only difference is that the amount of water for injection is adjusted so that the solid content of the filtrate obtained in step (3) is 4%, 7%, and 10%, and three batches of powder injections are obtained, No. They are rec...

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Abstract

The invention relates to an omeprazole sodium freeze drying powder injection pharmaceutical composition for injection. In particular, on the one hand, the invention relates to a freeze drying powder injection pharmaceutical composition which comprises omeprazole sodium, ethylenediamine tetraacetic acid disodium salt and an optional acidifying or alkalizing agent; on the other hand, the invention further relates to a method for preparing the omeprazole sodium freeze drying powder injection pharmaceutical composition for injection. The method is a conventional preparation method of the omeprazole sodium freeze drying powder injection pharmaceutical composition for injection. The omeprazole sodium freeze drying powder injection pharmaceutical composition for injection provided by the invention can be used for treating gastropathy and has an anticipated good property. For example, the omeprazole sodium freeze drying powder injection pharmaceutical composition for injection not only has excellent physical and chemical stabilities, but also has an excellent biological property.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a freeze-dried powder injection pharmaceutical composition that can be used for treating gastric diseases, in particular to a freeze-dried powder injection pharmaceutical composition comprising omeprazole sodium. The freeze-dried powder injection pharmaceutical composition of the present invention has desirable good properties. Background technique [0002] Digestive system disease is a common and frequently-occurring disease, and it is also a chronic disease that is easy to relapse. So far, there is no effective means to completely cure it. This has become one of the key topics in the field of pharmacy. Statistical analysis shows that the incidence of digestive system diseases in the world accounts for 10-12% of human beings, and the incidence of digestive system diseases in urban areas in my country is 11.43%, which is basically similar to many developed countries in Europe and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/26A61K47/18A61P1/04
Inventor 张铂钧周洪娟周雨汐路艳君魏媛媛
Owner 山东北大高科华泰制药有限公司
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