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Sodium esomeprazole for injection

A technology for esomeprazole sodium and injection, which is applied to medical preparations without active ingredients, medical preparations containing active ingredients, and the digestive system, etc. Calcium drop and other problems, to avoid contact between rubber stopper particles and drugs, avoid abnormal phenomena, and reduce total impurities

Active Publication Date: 2018-09-21
HUBEI RENMIN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to being able to complex with calcium at the same time, it may cause calcium loss after being imported into the human body, and a decrease in blood calcium in the body may cause a series of clinical problems; , an effective solution
[0008] By retrieving the prior art, it is found that for the problem that esomeprazole sodium is unstable to metal ions, light, heat, oxygen and water, the common solution is to combine esomeprazole sodium with metal ion chelating agent and antioxidant and other additives are prepared into freeze-dried powder injections. However, metal ion chelating agents can cause calcium loss in the human body. Antioxidant sodium bisulfite is irritating to the skin, eyes, and respiratory tract, and can cause allergic reactions, corneal damage, blindness, and asthma. Hazards to patient safety

Method used

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  • Sodium esomeprazole for injection
  • Sodium esomeprazole for injection
  • Sodium esomeprazole for injection

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Embodiment Construction

[0046] The implementation of the present invention will be described in detail below in conjunction with the examples, but they do not constitute a limitation of the present invention, and are only examples. At the same time, the advantages of the present invention are clearer and easier to understand through the description.

[0047] Esomeprazole sodium for injection is characterized in that: it is esomeprazole sodium for injection with 40 mg specification, and the formula components are:

[0048]

[0049] Sodium hydroxide is a pH regulator; medicinal charcoal and water for injection are substances used in the preparation and finally removed;

[0050] The method for preparing described esomeprazole sodium for injection is characterized in that, comprises the steps:

[0051] Step 1: Pretreatment of bottles, stoppers and aluminum caps

[0052] ① Freeze-dried vials: medium borosilicate vials are cleaned, dried and sterilized, and insoluble particles and visible foreign matt...

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Abstract

The invention discloses sodium esomeprazole for injection. The sodium esomeprazole for injection is the sodium esomeprazole for injection with the specification of 40 mg, and is prepared from 42.5 mgof esomeprazole, 2.5 mg of sodium calcium edentate and a proper amount of sodium hydroxide, pH is adjusted to 11.5+ / -0.3, 1 mg of medicinal carbon is used, and the weight of injection water is set as1,000 mg. The sodium esomeprazole for injection has the advantages of being capable of avoiding adverse reactions, stable and few in single impurity and total impurity.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to esomeprazole sodium for injection. Background technique [0002] Esomeprazole is the S-optical isomer of omeprazole, the world's first isomer proton pump preparation, developed by AstraZeneca Pharmaceuticals Co., Ltd., and approved by FDA in March 2005. Esomeprazole reduces gastric acid secretion through a specific targeting mechanism, and inhibits the proton pump of gastric parietal cells to reduce gastric acid secretion. The site and mechanism of action are that esomeprazole is concentrated and converted into an active form in the high-acid environment of the acid-secreting microtubules of the parietal cells, thereby inhibiting the H+ / K+-ATP (proton pump) at this site, and affecting the basic gastric acid secretion and stimulation. Gastric acid secretion is inhibited. [0003] The chemical name of esomeprazole sodium is: S-5-methoxy-2-[(4-methoxy-3,5-dimet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4439A61K47/12A61P1/04
CPCA61K9/0019A61K9/08A61K31/4439A61K47/12A61P1/04
Inventor 李爱菊伍雄辉朱胜节赵砥余记川
Owner HUBEI RENMIN PHARMACEUTICAL CO LTD
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