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Parecoxib sodium pharmaceutical composition for injection

A technology of parecoxib sodium and its composition, which is applied in the field of parecoxib sodium pharmaceutical composition, can solve problems such as inconvenient production process, achieve stable quality, simple and easy method, and improve product quality

Inactive Publication Date: 2015-03-18
TIANJIN HANRUI PHARMA
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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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  • 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

[0078] The formula of every 1000 described parecoxib sodium pharmaceutical compositions consists of:

[0079] Parecoxib sodium as parecoxib 40g

[0080] Disodium hydrogen phosphate 6.54g

[0081] Sodium dihydrogen phosphate 0.46g

[0082] Phosphoric acid / sodium hydroxide Appropriate amount

[0083] Add water for injection to 2L.

[0084] The preparation process includes:

[0085] 1) Take 90% of the prescribed amount of water for injection, first add the prescribed amount of disodium hydrogen phosphate and sodium dihydrogen phosphate and stir until dissolved, set aside;

[0086] 2) Take the solution in 1), add 0.1mol / L phosphoric acid or sodium hydroxide aqueous solution, adjust the pH to 8.1;

[0087] 3) Add the prescribed amount of parecoxib sodium into the solution of 2) at 25°C, and stir until completely dissolved;

[0088] 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 15 minutes, f...

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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 an additive for injection, wherein disodium hydrogen phosphate and sodium dihydrogen phosphate are used as buffer agents, and phosphoric acid / sodium hydroxide is used as a pH regulator. The medicine composition is feasible in production process, stable and controllable in quality, low in irritation on the skin, convenient to transport and store and capable of providing reasonable preparation prescription and preparation process for clinical medication, and easily realizes 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] Postoperative pain is acute pain that occurs immediately after surgery (usually lasting no more than 7 days). Postoperative pain, if not adequately controlled initially, may develop into chronic pain, which may also change in nature to neuropathic or mixed pain. 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 analgesia. [0003] Parecoxib is a prodrug of valdecoxib, which is a highly selective COX-2 inhibitor in the...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/42A61J3/00A61P29/00A61P25/04
Inventor 严洁李轩
Owner TIANJIN HANRUI PHARMA
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