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Freeze dry preparation containing diclofenac salt and lidocaine and its preparation method

A technology of diclofenac salt and lidocaine, which is applied to the freeze-dried preparation containing diclofenac salt and lidocaine and the field of preparation thereof, can solve problems such as cost increase, and achieve reduced production energy consumption, good solubility and stability, and convenient transportation. Effect

Inactive Publication Date: 2006-10-18
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commercially available injections use light-proof packaging materials, which increases the cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Take 100g of Tween-80, add it to about 1200ml of water for injection at about 40°C, stir to dissolve, add 75g of diclofenac sodium and stir to dissolve. Dissolve 23.1 g of lidocaine hydrochloride with a small amount of water for injection and add it into the above solution under constant stirring, and adjust the pH value to about 8.0 with 5 mol / L sodium hydroxide solution. Then add 240g mannitol, 2g sodium bisulfite, 0.2g disodium edetate and stir to dissolve completely; add water for injection to 2000ml. Add 0.05% (g / ml) activated charcoal for needles to the liquid medicine, stir at room temperature for 30 minutes, decarbonize and filter. Measure the pH value and main drug content. Sterilize by fine filtration with a 0.22 μm microporous membrane filter. Under aseptic conditions, the resulting solution was placed in sterile vials (2ml each), freeze-dried according to conventional methods, and sealed. The freeze-dried powder preparation A containing diclofenac and lid...

Embodiment 2

[0030]Take 100g of Tween-80, add about 2000ml of water for injection, stir to dissolve, add 75g of diclofenac sodium and stir to dissolve. Dissolve 23.1 g of lidocaine hydrochloride with a small amount of water for injection and add it into the above solution under constant stirring, and adjust the pH value to about 8.5 with 5 mol / L sodium trisodium phosphate solution. Then add 240g mannitol and 2g sodium bisulfite and stir to dissolve completely; add water for injection to 5000ml. Add 0.05% (g / ml) activated charcoal for needles to the liquid medicine, stir for 30 minutes, decarbonize and filter. Measure the pH value and main drug content. Sterilize by fine filtration with a 0.22 μm microporous membrane filter. Under aseptic conditions, the resulting solution was placed in sterile vials (5ml each), freeze-dried according to conventional methods, and sealed. The freeze-dried powder preparation B containing diclofenac and lidocaine of the present invention is obtained.

Embodiment 3

[0032] Take 200g of Tween-80, 240g of mannitol, and 2g of sodium bisulfite, add them to about 1500ml of water for injection, stir to dissolve, add 75g of diclofenac sodium and stir to dissolve. Dissolve 23.1g of lidocaine hydrochloride with a small amount of water for injection and add to the above solution under constant stirring, adjust the pH value to about 7.5 with phosphate buffer solution; add water for injection to 2000ml. Add 0.05% (g / ml) activated charcoal for needles to the liquid medicine, stir for 30 minutes, decarbonize and filter. Measure the pH value and main drug content. Sterilize by fine filtration with a 0.22 μm microporous membrane filter. Under aseptic conditions, the resulting solution was placed in sterile vials (2ml each), freeze-dried according to conventional methods, and sealed. The lyophilized powder preparation C containing diclofenac and lidocaine of the present invention is obtained.

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PUM

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Abstract

The invention relates to a freeze-dried powder preparation containing diclofenac and lidocaine, which consists of Tween 80 containing solubilization, a pharmaceutically acceptable pH regulator for adjusting the pH value of the solution, a therapeutically effective amount of diclofenac and The solution of lidocaine, the pH value of the solution is greater than 7.0, is obtained after freeze-drying. The solution may also contain other pharmaceutically acceptable auxiliary materials. The preparation of the invention has stable performance, convenient transportation, long storage period, and no adverse reactions caused by organic solvents such as ethanol during use.

Description

[0001] The technical field [0002] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a freeze-dried preparation containing diclofenac and lidocaine for pain caused by osteoarthritis, rheumatoid arthritis and other various non-rheumatic inflammations and a preparation method thereof. technical background [0003] Diclofenac is a representative anti-inflammatory and analgesic drug among phenylacetic acids. It mainly inhibits cyclooxygenase and prevents arachidonic acid from being converted into prostaglandins. It has two isomers COX-1 and COX of cyclooxygenase. -2 has a similar effect. Compared with many traditional non-steroidal anti-inflammatory drugs (the effect of inhibiting COX-1 is significantly higher than that of COX-2), it has relatively mild gastrointestinal reactions at equivalent anti-inflammatory doses. Diclofenac sodium or diclofenac potassium is one of the most commonly used non-steroidal anti-inflammatory drugs with s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/196A61K9/19A61P19/02A61K31/167
Inventor 孟凡清
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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