Stable parecoxib sodium pharmaceutical composition for injection

A kind of technology of parecoxib sodium and composition, applied in the field of parecoxib sodium pharmaceutical composition

Inactive Publication Date: 2015-03-25
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And it is proved by pharmacological experiments that the prepared injection according to the formula has no hemolysis, blood vessel irritation and allergic reaction, and the parecoxib sodium pharmaceutical composition produced by the prior art has very strict requirements on storage and light protection. Requirements, the pH changes significantly when exposed to sunlight, which is inconvenient in the production process

Method used

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  • Stable parecoxib sodium pharmaceutical composition for injection
  • Stable parecoxib sodium pharmaceutical composition for injection
  • Stable parecoxib sodium pharmaceutical composition for injection

Examples

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Embodiment 1

[0071] The formula of every 1000 described parecoxib sodium pharmaceutical compositions consists of:

[0072] Parecoxib sodium as parecoxib 40g

[0073] Disodium hydrogen phosphate 8g

[0074] Edetate Calcium Sodium 0.4g

[0075] Appropriate amount of sodium hydroxide

[0076] Add water for injection to 2L.

[0077] The preparation process includes:

[0078] 1) Take 80% of the prescribed amount of water for injection, first add the prescribed amount of disodium hydrogen phosphate and calcium sodium edetate and stir until dissolved, set aside;

[0079] 2) Take the solution in 1), add 0.1mol / L sodium hydroxide aqueous solution, adjust the pH to 7.5;

[0080] 3) Add the prescribed amount of parecoxib sodium to the solution in 2), and stir until it is completely dissolved;

[0081] 4) Take the solution of 3), add 0.1% charcoal for needles in the amount of the solution, after stirring completely, let it stand for 20 minutes, filter, add water for injection to the full amount,...

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Abstract

The invention relates to a stable parecoxib sodium pharmaceutical composition for injection. The pharmaceutical composition specifically includes parecoxib sodium and injection additives. Disodium hydrogen phosphate and sodium calcium edentate are adopted as the buffering agent, and sodium hydroxide is taken as the pH regulator. The production process is feasible, the quality is stable and controllable, the skin irritation is small, and at the same time the composition is convenient for transportation and storage. The invention provides the reasonable preparation prescription and preparation technology for clinical medication, and industrialization is easy to realize.

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. technical background [0002] Parecoxib is a prodrug of valdecoxib, which is a highly selective COX-2 inhibitor in the clinical dose range. Parecoxib sodium has a quick onset and long-lasting analgesic effect. After a single intravenous or intramuscular injection of 40 mg of parecoxib sodium, the analgesic effect can be perceived at 7-13 minutes, and it has clinical significance at 23-39 minutes The analgesic effect, and reach the maximum effect within 2 hours. The analgesic effect of parecoxib 40mg is similar to that of intramuscular injection of ketorolac 60mg or intravenous injection of 30mg. After a single administration, the duration of parecoxib pain relief is related to the dosage and pain model, ranging from 6 to 12 hours or even longer. Parecoxib has high selectivity to COX-2 and only weak sele...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/18A61K47/04A61K31/42A61P29/00
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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