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The preparation method of omeprazole sodium for injection

A technology of omeprazole sodium and omeprazole sodium meter, which is applied in the field of medical preparations, can solve problems such as not being given, and achieve the effect of a reasonable production process

Active Publication Date: 2020-09-15
SHANDONG HEXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In the prior art, there is no technical inspiration for the prevention of aspiration pneumonia caused by acid reflux in the treatment of debilitated comatose patients after general anesthesia or major surgery with omeprazole sodium for injection

Method used

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  • The preparation method of omeprazole sodium for injection
  • The preparation method of omeprazole sodium for injection
  • The preparation method of omeprazole sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Example 1 The medicinal activated carbon used in Chinese medicine is coconut shell medicinal activated carbon, purchased from Zhengzhou Linhai Activated Carbon Co., Ltd., with a mesh size of 8-12 mesh.

[0056] The chitosan used in the examples is of analytically pure grade, with a degree of substitution ≥ 80%, and was purchased from Shanghai Macklin Biochemical Technology Co., Ltd.

[0057] The polyvinylpyrrolidone used in the examples is K30 analytically pure, purchased from Shanghai Abby Chemical Reagent Co., Ltd.

[0058] The polysulfone powder used in the examples is injection molding grade, the place of origin is Solvay, USA, purchased from Shanghai Zhengyong Plastic Chemical Co., Ltd., and the brand name is P-3703.

Embodiment 10

[0059] The hollow fiber ultrafiltration membrane used in Example 10 was purchased from Shenzhen Baideshui Technology Co., Ltd., with a pore size of 5-50 nm.

[0060] Carry out long-term stability test to the omeprazole sodium that embodiment 1-9 makes, at temperature 25 ℃ ± 2 ℃, place 6 months under moderate 60% ± 10% condition, every 3 months sampling is successively, respectively at 0 month, 3 months, and 6 months will be tested according to the key items of stability. The inspection basis is the second part of the 2015 edition of the "Chinese Pharmacopoeia" and the State Food and Drug Administration's drug supplement application approval document (approval number: 2012B00303).

[0061] The relevant items for detection of omeprazole sodium for injection are shown in Table 1:

[0062] Table 1 Test table for omeprazole sodium for injection

[0063]

[0064]

[0065] Example 1

[0066] Omeprazole sodium for injection is prepared by adding 21.3 g of omeprazole sodium, 0....

Embodiment 2

[0083] Omeprazole sodium for injection is prepared by adding 21.3 g of omeprazole sodium, 0.75 g of disodium edetate, and adding water for injection to 1000 mL per 1000 dosage unit prescription.

[0084] The preparation method of above-mentioned omeprazole sodium for injection is as follows:

[0085] S1. Add disodium edetate to water for injection with a volume of 80%, stir to dissolve, add omeprazole sodium, continue stirring for 20 minutes, and adjust the pH to 11 with 1.0mol / L sodium hydroxide aqueous solution , adding 0.1% of the mass of the liquid to be adsorbed with medicinal activated carbon for adsorption for 20 minutes, adding the remaining water for injection, and filtering to remove the activated carbon to obtain a semi-finished product;

[0086] S2. Take a sample to detect the content and pH value of the semi-finished product. After passing the inspection, use a 0.22 μm cartridge filter to sterilize and filter, quantitatively fill, and freeze-dry to obtain a freeze...

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Abstract

The invention provides omeprazole sodium for injection, a preparation method and application of the omeprazole sodium for prevention of aspiration pneumonitis caused by regurgitation of gastric juicein the adaptation disease and belongs to the field of medical preparations. The raw materials of the omeprazole sodium for injection comprise omeprazole sodium, ethylenediamine tetraacetic acid disodium salt and water for injection. The preparation method comprises the steps that the ethylenediamine tetraacetic acid disodium salt and the omeprazole sodium are added to the water for injection in sequence, the pH value of an aqueous solution of sodium hydroxide is adjusted, activated carbon is added for adsorption and heat source removal, remaining water for injection is added, the activated carbon is filtered out and removed or a super membrane is adopted for filtering and removing a heat source, and a semi-finished product is obtained; the content and pH value of the semi-finished productare detected, after the standard is achieved through inspection, sterilization and filtering, quantitative filling and freezing and drying are conducted, and a freeze-dried product is obtained; the freeze-dried product is compressed and subjected to capping, finished product inspection, label attachment and packaging are conducted, and the finished product is obtained. The invention further discloses application of the omeprazole sodium for injection for prevention of aspiration pneumonitis caused by regurgitation of gastric juice for a patient with general anesthesia or a patient with asthenia and coma after surgery in the adaptation disease.

Description

technical field [0001] The invention belongs to the field of medical preparations, in particular to omeprazole sodium for injection, a preparation method and its application in preventing aspiration pneumonia caused by gastric acid reflux. Background technique [0002] Omeprazole sodium for injection, chemical name: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl} - 1H-benzimidazole sodium monohydrate. The shape is white or off-white loose block or powder, and the special solvent is colorless transparent liquid. In the prior art, it is mainly used for: [0003] 1. Peptic ulcer bleeding, anastomotic ulcer bleeding; [0004] 2. Acute gastric mucosal damage complicated by stress and acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs; [0005] 3. Preventing the stress state of severe diseases (such as cerebral hemorrhage, severe trauma, etc.) and upper gastrointestinal bleeding caused by gastric surgery; [0006] 4. As an alternat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4439A61K47/18A61P1/04A61P11/00
CPCA61K9/0019A61K9/08A61K31/4439A61K47/183A61P1/04A61P11/00
Inventor 王素琴
Owner SHANDONG HEXING PHARMA
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