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Omeprazole sodium composition for injection

A technology of omeprazole sodium and its composition, which is applied in the field of pharmaceutical preparation, can solve problems such as unresolved technical defects, and achieve the effects of improving quality, avoiding scrapping, and good curative effect

Active Publication Date: 2011-08-17
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN 99811908.3 discloses an improved method for the synthesis, separation and purification of an anti-ulcer agent omeprazole, which does not solve the above-mentioned technical defects
Chinese patent CN 200610042004.1 discloses a stable new formulation of omeprazole sodium freeze-dried preparation for injection and its preparation process, which does not solve the above-mentioned technical defects
Chinese patent CN 200910244378.5 discloses a freeze-dried powder injection of omeprazole sodium and its preparation method and quality control method, but does not solve the above-mentioned technical defects

Method used

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  • Omeprazole sodium composition for injection
  • Omeprazole sodium composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Example 1 Omeprazole sodium composition for injection

[0069] prescription:

[0070] Omertazole sodium 426g

[0071] Ethyleine tetraysidine 8.52g

[0072] Add water for injection to 20kg

[0073] 1) Pharmaceutical liquid preparation: It is called olpuszole sodium and ethyleine tetrazide sodium diacerite preparation tank, add injection water, stir to dissolve and mix well, and use sodium hydroxide to adjust the pH value of 12.0;

[0074] 2) Plug -in processing:

[0075] A. Take sodium ethylehoettetate, and add the injection water by the weight ratio of 1: 1000 according to sodium sodium and injection water for ethyleine.

[0076] B. Take the plug, add the weight ratio of the plug and A solution 1:10, add the A solution, heat it to 47 ° C and heat for 30 minutes;

[0077] C. Take the rubber plug processed by the scripture B process, rinse for 15 minutes with injection filtering with 0.22 μm filters, and dry it in 121 ° C inside the rubber plug cleaning machine.

[0078] 3) S...

Embodiment 2

[0080] Example 2 Omeprazole sodium composition for injection

[0081] prescription:

[0082] Omertazole sodium 426g

[0083] Tetharine tethane 21.3g

[0084] Add water for injection to 20kg

[0085] 1) Pharmaceutical liquid preparation: It is called oloprazole sodium and ethyleine tetrazide sodium diacerite preparation tank, add injection water, stir to dissolve and mix well, and use sodium hydroxide to adjust the pH value of 11.0;

[0086] 2) Plug -in processing:

[0087] A. Take sodium ethylehoettetate, and add the injection of water by the weight ratio of 1: 1000 according to sodium sodium and injection water for ethyleine.

[0088] B. Take the plug, add the weight ratio of the plug and A solution 1:10, add the A solution, heat it to 41 ° C and heat for 30 minutes;

[0089] C. Take the rubber plug processed by the scripture B process, rinse for 15 minutes with injection filtering with 0.22 μm filters, and dry it in 121 ° C inside the rubber plug cleaning machine.

[0090] 3) St...

Embodiment 3

[0092] Example 3 Omepazole sodium composition for injection

[0093] prescription:

[0094] Omertazole sodium 426g

[0095] Ethyleine tetraitine 42.6g

[0096] Add water for injection to 20kg

[0097] 1) Pharmaceutical liquid preparation: It is called olpuszole sodium and ethyleine tetrazide sodium diacerite preparation tank, add injection water, stir to dissolve and mix well, and use sodium hydroxide to adjust the pH value of 11.5;

[0098] 2) Plug -in processing:

[0099] A. Take sodium ethyleine tethalcetate, add the weight ratio of 1: 1000 by sodium tetrazharotide and injection water, and add injection water for 1: 1000.

[0100] B. Take the plug, add the weight ratio of the plug and A solution 1:10, add the A solution, heat it to 44 ° C and heat for 30 minutes;

[0101] C. Take the rubber plug processed by the scripture B process, rinse for 15 minutes with injection filtering with 0.22 μm filters, and dry it in 121 ° C inside the rubber plug cleaning machine.

[0102] 3) Ster...

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Abstract

The invention provides an omeprazole sodium composition for injection. The omeprazole sodium composition for injection contains omeprazole sodium and ethylene diamine tetraacetic acid; and the weight ratio of the omeprazole sodium to the ethylene diamine tetraacetic acid is 1: (0.02-0.1). The composition is prepared by the following method: 1) preparing a liquid medicine: placing the omeprazole sodium and the ethylene diamine tetraacetic acid into a mixing pot, adding water for injection, stirring to dissolve the omeprazole sodium and the ethylene diamine tetraacetic acid and mixing uniformly, and adjusting the pH value to 11.0 to 12.0 by using sodium hydroxide; 2) processing by a rubber stopper; 3) performing aseptic filtering and packing; and 4) freezing and drying in vacuum so as to obtain the omeprazole sodium composition for injection. For medicaments, such as the omeprazole sodium which is easily reacted with an effusion from a capsule, the omeprazole sodium composition for injection can effectively guarantee that visible foreign matters and insoluble particles of the product meet the requirement of injection at the same time. By the omeprazole sodium composition for injection, the quality level is enhanced obviously, and potential hazards in clinical safe medication use of patients due to unqualified visible foreign matters and insoluble particles can be avoided; and the omeprazole sodium composition for injection has better curative effect and lower clinical side reaction.

Description

Technical field [0001] The present invention involves a antpartraoprazole sodium composition for injection, which belongs to the field of pharmaceutical preparation technology. Background technique [0002] Omeprazole sodium chemical name is 5-methoxy-2- ([(4-methoxy-4, 5-two-base-2-pyrimimyl) -Mores sulfaL) -LH-Phenylene Pymazole Sodium Piece, the structure is [0003] [0004] Omepazole sodium is H + K + ——TP enzyme inhibitors have a significant inhibitory effect on gastric acid secretion.After the intravenous dripping, this product will take effect quickly, and it can be reversed to inhibit gastric acid secretion once a day.Clinically, it is mainly used for acute gastrointestinal bleeding such as duodenal ulcers, gastric ulcers, and acute gastric mucosal lesions. [0005] Omeprazole sodium is unstable in an acidic environment. During the formulation process, a higher pH value (usually above 10.5) is used to improve the physical and chemical stability of the antpolitzole sodi...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/18A61K9/19A61P1/04A61J1/14
Inventor 陈庆财叶东陈祥峰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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