Aceclofenac pharmaceutical composition

A technology of aceclofenac and composition, applied in the field of aceclofenac pharmaceutical composition, can solve the problems of inconvenience in production and clinical use, hindering calcium and iron absorption, affecting calcium metabolism and hormone secretion, etc. The effect of financial burden

Inactive Publication Date: 2009-07-15
王文菊
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In 2005, the injection of aceclofenac was launched in Spain. It is a combination of freeze-dried powder and special solvent. Potassium dihydrogen phosphate and sodium hydroxide are used as co-solvents to adjust the pH, and the aqueous solution of aceclofenac is obtained by vacuum freeze-drying. Injectable aceclofenac, but the marketed prescription contains phosphate, which is easy to form insoluble calcium salt in the body, which may affect calcium metabolism and hormone secretion, reduce and hinder the absorption of calcium and iron in the body, and bring some Negative impact, and special solvent is needed for dissolution, which brings inconvenience to production and clinical use

Method used

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  • Aceclofenac pharmaceutical composition
  • Aceclofenac pharmaceutical composition
  • Aceclofenac pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0050] Example 1 Injection prescription 1

[0051]

[0052] Take by weighing aceclofenac, arginine of prescription quantity, stir and be dissolved in 2000ml of water for injection, pH is about 7.0, add needle and use active carbon 0.05% (W / V) to adsorb 30 minutes, carbon removal, sterilization filtration (0.22 μm) are subpackaged under sterile conditions, freeze-dried (moisture content ≤ 2%), sealed and capped.

[0053] When this product is used clinically, it can be directly dissolved in physiological saline and then injected without additional special solvent.

example 2

[0054] Example 2 injection prescription 2

[0055]

[0056]

[0057] Take by weighing aceclofenac, arginine, sodium chloride of prescription quantity, stir and be dissolved in 2000ml of water for injection, pH is about 7.0, add needle and use active carbon 0.05% (W / V) to adsorb for 30 minutes, remove charcoal, remove Bacterial filtration (0.22 μm) is subpackaged under sterile conditions, freeze-dried (moisture content ≤ 2%), sealed and capped.

[0058] When this product is used clinically, it can be directly dissolved in water for injection and then injected without additional special solvent.

example 3

[0059] Example 3 Injection prescription 3

[0060]

[0061] Aceclofenac and Potassium Citrate Monohydrate of prescription quantity are taken by weighing, mix in water for injection 3000ml, add 1M sodium hydroxide solution and adjust pH to be 6.9, add needle and use gac 0.05% (W / V) to adsorb 30 minutes, remove Charcoal, sterilizing filter (0.22μm), subpackage under aseptic conditions, freeze-dry (moisture content ≤ 3%), seal and crimp the cap.

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PUM

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Abstract

The invention discloses an aceclofenac pharmaceutical composition which contains the following raw materials: 10-150 portions of aceclofenac and 2.5-140 portions of organic base solvent. The composition also contains the following raw materials: 0-50 portions of pH modifying agent, 0-500 portions of osmotic pressure regulator, 0-600 portions of stabilizing agent, 0-100 portions of local acetanilide and 2000-10000 portions of water. The invention does also not contain phosphate, does not influence the calcium metabolism and the hormone secretory and increases the absorption of internal calcium and iron; and injection is dissolved by using common injection water or physiological saline without special menstruum.

Description

technical field [0001] The present invention relates to aceclofenac pharmaceutical composition and its preparation method and use. Background technique [0002] Aceclofenac is a phenylacetic acid non-steroidal anti-inflammatory analgesic drug, which is a derivative of diclofenac. The English name is Aceclofenac (CAS RN: 89796-99-6), the chemical name is 2-2,6-dichlorophenyl-amino-phenylacetoxyacetic acid, and the molecular formula is C 16 h 13 Cl 2 NO 4 , the molecular weight is 354.19. [0003] [0004] Structurally, aceclofenac is related to diclofenac, aclofenac, and fenclofenac. In clinical practice, the pharmacological effects of aceclofenac are compared with other non-steroidal drugs (NSAIDs), in acute and chronic inflammation experimental models, aceclofenac shows a significant range of anti-inflammatory effects, strong analgesic and reconciliation Thermal action and low gastric toxicity and other characteristics. It is clinically suitable for the treatment ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/216A61K47/18A61K47/16A61K47/12A61P19/02A61P19/04A61P29/00A61P19/00
Inventor 王文菊
Owner 王文菊
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