S-pantoprazole sodium composite for injection and preparation method thereof

A technology of pantoprazole sodium and composition, applied in the field of pharmaceutical preparation, can solve problems such as unsolved technical defects, and achieve the effects of avoiding hidden dangers, reducing production costs, and eliminating the influence of decarbonized product quality

Active Publication Date: 2011-04-06
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN200810001189.0 discloses a pantoprazole sodium freeze-dried powder injection, including pantoprazole sodium and mannitol, adopts advanced freeze-drying process, does not solve the above-mentioned technical defects

Method used

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  • S-pantoprazole sodium composite for injection and preparation method thereof
  • S-pantoprazole sodium composite for injection and preparation method thereof
  • S-pantoprazole sodium composite for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Embodiment 1 prepares the S-pantoprazole sodium composition for injection

[0084] prescription:

[0085] S-pantoprazole sodium 846g

[0086] EDTA 8.46g

[0087] Mannitol 1Kg

[0088] Add water for injection to 20Kg

[0089] 1) Preparation of medicinal solution: Weigh S-pantoprazole sodium, mannitol and ethylenediaminetetraacetic acid according to the prescription and put them in the preparation tank, add water for injection to 20Kg, stir to dissolve and mix evenly, and adjust the pH value of the solution to 12.0 ;

[0090] 2) Activated carbon finishing:

[0091] a. Weigh 10g of activated carbon, add 500g of water for injection, stir to disperse evenly, adjust the pH value of the solution to 12.0, heat to 65°C and keep it warm for 30 minutes, and transfer the activated carbon suspension to a titanium rod filter for decarbonization while it is hot;

[0092] B, then rinse the gac collected by the titanium rod filter with water for injection until the pH value is les...

Embodiment 2

[0098] Embodiment 2 prepares the S-pantoprazole sodium composition for injection

[0099] prescription:

[0100] S-pantoprazole sodium 846g

[0101] Calcium Disodium EDTA 42.3g

[0102] Add water for injection to 60Kg

[0103] 1) Preparation of medicinal solution: Weigh S-pantoprazole sodium and calcium disodium edetate according to the prescription and put them in the preparation tank, add water for injection to 60Kg, stir to dissolve and mix evenly, and adjust the pH value of the solution to 11.0 ;

[0104] 2) Activated carbon finishing:

[0105] a. Weigh 300g of activated carbon, add 15Kg of water for injection, stir to disperse evenly, adjust the pH value of the solution to 11.0, heat to 66°C and keep it warm for 30 minutes, and transfer the activated carbon suspension to a titanium rod filter for decarbonization while it is hot;

[0106] B, then rinse the gac collected by the titanium rod filter with water for injection until the pH value is less than 8;

[0107] c....

Embodiment 3

[0112] Embodiment 3 prepares the S-pantoprazole sodium composition for injection

[0113] prescription:

[0114] S-pantoprazole sodium 1.268Kg

[0115] Calcium Disodium EDTA 25.36g

[0116] Add water for injection to 100Kg

[0117] 1) Preparation of medicinal solution: Weigh S-pantoprazole sodium and edetate calcium disodium according to the prescription and put them in the preparation tank, add water for injection to 100Kg, stir to dissolve and mix evenly, and adjust the pH value of the solution to 10.5 ;

[0118] 2) Activated carbon finishing:

[0119] a. Weigh 300g of activated carbon, add 15Kg of water for injection, stir to disperse evenly, adjust the pH value of the solution to 10.5, heat to 63°C and keep it warm for 30 minutes, and transfer the activated carbon suspension to a titanium rod filter for decarbonization while it is hot;

[0120] B, then rinse the gac collected by the titanium rod filter with water for injection until the pH value is less than 8;

[01...

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Abstract

The invention provides an S-pantoprazole sodium composite for injection, which is prepared through a method comprising the following steps of: (1) preparing liquid medicine: selecting S-pantoprazole sodium and edetic acid or edetate as raw materials, wherein the weight ratio of the S-pantoprazole sodium and the edetic acid or the edetate is 1:0.01-0.1; weighing a right amount of the raw materials, placing into a preparation tank, adding water for the injection till the weight of a solution is 11.82-118.2 times more than that of the S-pantoprazole sodium, stirring for dissolution, uniformly mixing, and regulating the pH value of the solution at 10.0-12.5; (2) finishing active carbon; (3) absorbing; (4) carrying out aseptic filtration and split charging; and (5) carrying out vacuum freeze drying so as to obtain the S-pantoprazole sodium composite for the injection. The S-pantoprazole sodium composite for the injection and the preparation method thereof can both ensure that product heat sources, visible foreign matters and insoluble particles meet the requirements of injections for the injections, i.e. S-pantoprazole sodium preparing liquid medicine which has higher pH.

Description

technical field [0001] The invention relates to an S-pantoprazole sodium composition for injection and a preparation method thereof, belonging to the technical field of medicine preparation. Background technique [0002] The chemical name of pantoprazole sodium is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzoimidazole Sodium, the structural formula is [0003] [0004] Pantoprazole is a sulfoxide and a chiral compound in which the sulfur atom is the stereogenic center. Thus, pantoprazole is a racemic mixture of two single enantiomers, R and S, and its salts also have corresponding configurations. Described in U.S. Patent No. 5,888,535, S-pantoprazole sodium has a stronger effect of inhibiting gastric acid secretion than racemic pantoprazole sodium and the R-type isomer. S-pantoprazole sodium can be studied as a proton pump inhibitor like esomeprazole (esomeprazole) for the treatment of diseases related to gastric acid secretion disorders, such ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 戴建国叶东陈卫东
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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