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Parecoxib sodium pharmaceutical composition for injection

A technology of parecoxib sodium and parecoxib, which is applied in the direction of drug combinations, active ingredients of heterocyclic compounds, antipyretics, etc., can solve problems such as inconvenience in the production process, achieve stable quality, simple and easy method, and reduce The effect of market risk

Inactive Publication Date: 2012-06-27
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Phosphate buffer solution (pH=7.8~8.0) was used, and the pH stability of the drug was improved, and the storage stability period can reach 36 months. During the development process, it was accidentally found in a wider pH range ( pH7.5~8.5), the pharmaceutical composition of parecoxib sodium for injection with phosphate buffer, mannitol and sodium hydroxide as auxiliary materials has better stability than that of foreign commercially available parecoxib sodium preparations, and passed Pharmacological experiments have shown that the prepared injection according to the formula has no hemolysis, vascular irritation and allergic reaction, and the parecoxib sodium pharmaceutical composition produced by the prior art has very strict requirements on storage and light protection. The pH changes significantly after being exposed to sunlight, which is inconvenient in the production process

Method used

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  • Parecoxib sodium pharmaceutical composition for injection
  • Parecoxib sodium pharmaceutical composition for injection
  • Parecoxib sodium pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] The formula of every 1000 described parecoxib sodium pharmaceutical compositions consists of:

[0082] Parecoxib sodium as parecoxib 40g

[0083] Dipotassium hydrogen phosphate 11.18g

[0084] Potassium dihydrogen phosphate 0.82g

[0085] Mannitol 20g

[0086] Appropriate amount of sodium hydroxide

[0087] Add water for injection to 2ml.

[0088] The preparation process includes:

[0089] 1) Weigh dipotassium hydrogen phosphate and potassium dihydrogen phosphate, add appropriate amount of water for injection to dissolve until completely, and set aside;

[0090] 2) Take 90% of the phosphate buffer solution in 1), and the temperature is 40±5°C, add the prescribed amount of parecoxib sodium, and stir until it is completely dissolved by visual inspection;

[0091] 3) Add 0.1% medical activated carbon to the solution in 2) and stir for 15 minutes to decolorize. After decolorization, filter and remove the carbon, add an appropriate amount of water ...

Embodiment 2

[0099] The formula of every 1000 described parecoxib sodium pharmaceutical compositions consists of:

[0100] Parecoxib sodium as parecoxib 20g

[0101] Dipotassium hydrogen phosphate 11.18g

[0102] Potassium dihydrogen phosphate 0.82g

[0103] Mannitol 40g

[0104] Appropriate amount of sodium hydroxide

[0105] Add water for injection to 2ml.

[0106]Preparation process: with embodiment 1.

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Abstract

The invention relates to a stable parecoxib sodium pharmaceutical composition for injection. The pharmaceutical composition specifically comprises parecoxib sodium and additive for injection, wherein the additive at least contains a phosphatic buffer with a pH of 7.8-8.0, and other additive is selected from mannitol and sodium hydroxide. The parecoxib sodium pharmaceutical composition for injection provided by the invention is filled in a colorless neutral borosilicate glass tube injection bottle, has good stability, stable pH and little stimulation on skin, and is convenient for transportation and storage. The parecoxib sodium pharmaceutical composition for injection provides reasonable preparation prescription and preparation technology for clinical medicament usage and is easy for realization of industrialization.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a stable pharmaceutical composition of parecoxib sodium for injection. Background technique [0002] Inflammatory reactions after noxious stimuli such as surgery and trauma can lead to the release of inflammatory mediators and pain-causing substances. In addition to directly causing pain, they can also cause blood vessels to dilate, tissue edema, increase the sensitivity of effector receptors, and reduce the pain threshold. This results in peripheral hyperalgesia. Selective COX-2 inhibitors can effectively inhibit the expression of peripheral COX-2 and reduce the synthesis of peripheral prostaglandins, thereby exerting analgesic and anti-inflammatory effects; at the same time, they can inhibit the expression of central COX-2, inhibit the synthesis of central prostaglandins and inhibit pain hypersensitivity, Give full play to the dual advantages of peripheral and central anal...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/42A61K47/04A61P29/02
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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