Pharmaceutical composition of diclofenac sodium for injection and preparation method thereof

A technology of diclofenac sodium and its composition, which is applied in the field of medicine, can solve the problems of poor long-term stability of diclofenac sodium preparations, high toxicity and side effects, and easy crystallization and degradation, etc., so as to improve the analgesic effect, reduce the damage to the human body, and reduce the dosage Effect

Active Publication Date: 2020-05-29
JIANGSU SIMIAO MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to overcome the problems of poor long-term stability, easy crystallization and degradation, and large toxic and side effects of the existing diclofenac sodium preparations for injection, the present invention adopts a specific diclofenac sodium pharmaceutical composition and preparation method, thereby obtaining stable, safe and reliable quality , the pharmaceutical composition of diclofenac sodium for injection with little toxic and side effects

Method used

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  • Pharmaceutical composition of diclofenac sodium for injection and preparation method thereof
  • Pharmaceutical composition of diclofenac sodium for injection and preparation method thereof
  • Pharmaceutical composition of diclofenac sodium for injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0057]

[0058] The preparation method is:

[0059] 1) Dissolve hydroxypropyl-β-cyclodextrin in part of the water for injection, then add diclofenac sodium, stir until completely dissolved, add tromethamine and sodium hydroxide, stir to dissolve, and add the remaining amount of water for injection;

[0060] 2) Add 0.1% activated carbon, stir for 15 minutes, decarbonize with a titanium rod filter, and then sterilize with a 0.22 μm filter membrane to obtain an intermediate solution;

[0061] 3) detecting the content of diclofenac sodium in the intermediate solution by HPLC;

[0062] 4) Fill the glass bottle with nitrogen, control the residual oxygen amount to 1.7%, and the dissolved oxygen amount to 0.7 mg / L. According to the measurement results of the diclofenac sodium content, the obtained medicinal solution is divided into each glass bottle according to the preparation unit, Half stopper;

[0063] 5) Put the filled glass bottles in a freeze-drying box, cool down to -40°C...

preparation Embodiment 2

[0065]

[0066] The preparation method is:

[0067] 1) Dissolve sulfobutyl-β-cyclodextrin in part of the water for injection, then add diclofenac sodium, stir until completely dissolved, add tromethamine, stir to dissolve, and add the remaining amount of water for injection;

[0068] 2) Add 0.05% activated carbon, stir for 20 minutes, decarbonize with a titanium rod filter, and then sterilize with a 0.22 μm filter membrane to obtain an intermediate solution;

[0069] 3) detecting the content of diclofenac sodium in the intermediate solution by HPLC;

[0070] 4) Fill the glass bottle with nitrogen, control the residual oxygen amount to 1.6%, and the dissolved oxygen amount to 0.6 mg / L. According to the measurement results of the diclofenac sodium content, the obtained medicinal solution is divided into each glass bottle according to the preparation unit, Half stopper;

[0071] 5) Put the filled glass bottles in a freeze-drying box, cool down to -40°C, pre-freeze at -40°C f...

preparation Embodiment 3

[0073]

[0074] The preparation method is:

[0075] 1) Dissolve glucosyl-β-cyclodextrin in part of the water for injection, then add diclofenac sodium, stir until completely dissolved, add disodium hydrogen phosphate, stir to dissolve, and add the remaining amount of water for injection;

[0076] 2) Add 0.05% activated carbon, stir for 30 minutes, decarbonize with a titanium rod filter, and then sterilize with a 0.22 μm filter membrane to obtain an intermediate solution;

[0077] 3) detecting the content of diclofenac sodium in the intermediate solution by HPLC;

[0078] 4) Fill the glass bottle with nitrogen, control the amount of residual oxygen to 1.5%, and the amount of dissolved oxygen to be 0.5 mg / L. According to the measurement results of the content of diclofenac sodium, the obtained medicinal solution is divided into each glass bottle according to the preparation unit, Half stopper;

[0079] 5) Put the filled glass bottle in a freeze-drying box, cool down to -40°C,...

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Abstract

Provided in the present invention is a pharmaceutical composition of diclofenac sodium for injection, used for the treatment of mild, moderate, and severe pain; a solution prepared from a formulation comprising the following components or preferably composed of the following components is prepared by freeze drying: diclofenac sodium, a water-soluble cyclodextrin derivative, a stabiliser, and water for injection, the stabiliser increasing the placement stability of the composition.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of diclofenac sodium for injection and a preparation method of the preparation. Background technique [0002] Diclofenac Sodium (Diclofenac Sodium) belongs to phenylacetic acid derivatives, is the third generation of powerful non-steroidal anti-inflammatory analgesics, also known as Diclofenac, Futaline, Amirel, white crystalline powder, odorless, It is easily soluble in acetone, soluble in methanol and ethanol, slightly soluble in water, has hygroscopicity, and its molecular formula is C 14 h 10 Cl 2 NNaO 2 , with a molecular weight of 318. The structural formula of diclofenac sodium is as follows: [0003] [0004] The main mechanism of action of diclofenac sodium is to inhibit the activity of cyclooxygenase, thereby blocking the conversion of arachidonic acid into prostaglandins. At the same time, it can also promote the combi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/196A61K47/61A61K47/18A61K47/02A61P29/00
CPCA61K9/0019A61K9/19A61K31/196A61K47/02A61K47/18
Inventor 吴夙慧张涛陈锡平
Owner JIANGSU SIMIAO MEDICAL TECH CO LTD
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