Pharmaceutical composition of omeprazole sodium, and preparation method of pharmaceutical composition

A technology of omeprazole sodium and omeprazole meter, which is applied in the field of medicine, can solve the problems of increased safety hazards, turbid precipitation, non-compliance with regulations, etc., and achieve good patient tolerance, good clarity, and stable quality Effect

Active Publication Date: 2013-04-24
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] However, in long-term application, it is found that the above-mentioned omeprazole sodium for injection is easy to change color after being placed for a period of time, resulting in turbid precipitation. stipulations, increased safety hazards for patients

Method used

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  • Pharmaceutical composition of omeprazole sodium, and preparation method of pharmaceutical composition
  • Pharmaceutical composition of omeprazole sodium, and preparation method of pharmaceutical composition
  • Pharmaceutical composition of omeprazole sodium, and preparation method of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] [Example 1] Preparation of freeze-dried powder injection

[0059] Prescription 1 (Specification 40mg)

[0060]

[0061] Prescription 2 (Specification 60mg)

[0062]

[0063] Preparation Process:

[0064] 1) Add 80% of the total amount of water for injection at 10°C to 20°C in the liquid preparation tank, add the prescribed amount of sodium chloride and disodium edetate, and stir to dissolve completely;

[0065] 2) Use 2% sodium hydroxide solution to adjust the pH value of the solution to 11.0; then add the prescribed amount of omeprazole sodium into the above solution, and continue to stir until it is completely dissolved. The pH value of the test solution should be in the range of 10.6 to 11.0 Inside; add water for injection at 10°C to 20°C to the total amount, and mix well;

[0066] 3) Add 0.10% (g / ml) activated carbon to the clear solution, stir and adsorb for 30 minutes, and filter through decarbonization and the first 0.2 μm sterile filter. After the inte...

Embodiment 2

[0071] [Example 2] Preparation of freeze-dried powder injection

[0072] Prescription 1 (Specification 40mg)

[0073]

[0074] Prescription 2 (Specification 60mg)

[0075]

[0076] Preparation Process:

[0077] 1) Add 80% of the total amount of water for injection at 10°C to 20°C in the liquid preparation tank, add the prescribed amount of sodium chloride and disodium edetate, and stir to dissolve completely;

[0078] 2) Use 2% sodium hydroxide solution to adjust the pH value of the solution to 11.2; then add the prescribed amount of omeprazole sodium into the above solution, and continue to stir until it is completely dissolved. The pH value of the test solution should be in the range of 10.6 to 11.0 Inside; add water for injection at 10°C to 20°C to the total amount, and mix well;

[0079] 3) Add 0.10% (g / ml) activated carbon to the clear solution, stir and adsorb for 30 minutes, and filter through decarbonization and the first 0.2 μm sterile filter. After the inte...

Embodiment 3

[0086] Prescription 1 (Specification 40mg)

[0087]

[0088]

[0089] Prescription 2 (specification 60mg)

[0090]

[0091] Preparation Process:

[0092] 1) Add 80% of the total amount of water for injection at 10°C to 20°C in the liquid preparation tank, add the prescribed amount of sodium chloride and edetate disodium, and stir to dissolve completely;

[0093] 2) Use 2% sodium hydroxide solution to adjust the pH value of the solution to 10.7; then add the prescribed amount of omeprazole sodium into the above solution, and continue to stir until it is completely dissolved. The pH value of the test solution should be in the range of 10.6 to 11.0 Inside; add water for injection at 10°C to 20°C to the total amount, and mix well;

[0094] 3) Add 0.10% (g / ml) activated carbon to the clear solution, stir and adsorb for 30 minutes, and filter through decarbonization and the first 0.2 μm sterile filter. After the intermediate is qualified, the liquid medicine is subjected...

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PUM

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Abstract

The invention relates to a pharmaceutical composition of omeprazole sodium, and a preparation method of the pharmaceutical composition. The pharmaceutical composition of omeprazole sodium comprises the following raw materials by weight: 40-60 parts of omeprazole sodium, 5-10 parts of sodium chloride, 0.4-0.6 part of disodium edetate, a proper amount of pH regulating agent and 2-3 parts of water for injection; and the amount of omeprazole sodium is calculated in omeprazole. The pharmaceutical composition of omeprazole sodium does not change color, does not generate a cloudy precipitate, and has good stability, and the insoluble particles from the pharmaceutical composition combined with the injection are not obviously increased along with the extension of storage time; and the pharmaceutical composition is of great help to the improvement of output rate of the product, reduction of market risk of the product and better application in clinical treatment.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition of omeprazole sodium and a preparation method thereof. Background technique [0002] Digestive system disease is a common and frequently-occurring disease, and it is also a chronic disease that easily recurs. So far, there is no effective method for a complete cure. This has become one of the key topics in the field of pharmaceutical research. Statistical analysis shows that the incidence rate of digestive system diseases in the world accounts for 10-12% of human beings, and the incidence rate of digestive system diseases in cities and towns in my country is 11.43%, which is basically similar to many developed countries in Europe and America. Due to the characteristics of diet structure, the prevalence rate of residents in southern cities and southwestern regions is relatively high, and the incidence rate of peptic ulcer is relatively high in middle-ag...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/04A61K9/19A61P1/04A61P1/00
Inventor 钟正明王恒南黎李吴清刚
Owner HAINAN JINRUI PHARMA
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