Propofol composition

A composition, propofol technology, applied in the field of propofol composition, can solve the problems of increasing product cost, great pain, easy to encourage microorganisms, etc., and achieve the effect of reducing production cost, reducing pain of injection, and good stability

Inactive Publication Date: 2009-12-02
常州安孚立德药业技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages of propofol emulsion injection are: poor physical and chemical stability of the product, greater pain during injection, large particles may block blood vessels, and more complicated emulsion preparation process, and because the product formula does not contain antibacterial agents, the product A large amount of fat in the formula is easy to promote the production of microorganisms
The disadvantage of this formulation is the use of high concentrations (30-60% w / v) of HPβCD which has a significant impact on the safety of the product
It also increases product cost
The formula must be stored at 2-8°C, which brings inconvenience to transportation and storage

Method used

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Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0038] Preparation composition (10mL):

[0039] Propofol 50mg

[0040] Mannosyl-beta-cyclodextrin 1500mg

[0041] Bovine Serum Albumin 100mg

[0042] Acetylcysteine ​​0.5mg

[0043] Glycerin 1.8mg

[0044] Disodium hydrogen phosphate 85mg

[0045] Appropriate amount of NaOH or HCl

[0046] Appropriate amount of water

[0047] Preparation method: Dissolve disodium hydrogen phosphate in water for injection, adjust the pH to 8.5 (using HCl or NaOH) to prepare a buffer solution, add mannosyl-β-cyclodextrin, bovine serum albumin, glycerol, acetylcysteine Amino acid was added to the buffer solution, after it was completely dissolved, add propofol and stirred until the propofol was completely dissolved, then adjust the pH value to 8.5, then use the prepared disodium hydrogen phosphate buffer solution to make up the volume, filter and sterilize the solution and fill it with Packed in type I controlled vials to become the final product.

preparation Embodiment 2

[0049] Preparation composition (10mL):

[0050] Propofol 100mg

[0051] Hydroxypropyl-β-cyclodextrin 1500mg

[0052] Human Serum Albumin 300mg

[0053] ETDA 3.0mg

[0054] Sodium dihydrogen phosphate 60mg

[0055] Appropriate amount of NaOH or HCl

[0056] Appropriate amount of water

[0057] Preparation method: Dissolve sodium dihydrogen phosphate in water for injection, adjust the pH to 7.7 (using HCl or NaOH) to prepare a buffer solution, add hydroxypropyl-β-cyclodextrin, human serum albumin, and EDTA to the buffer solution, After complete dissolution, add propofol and stir until propofol is completely dissolved, adjust the pH value to 7.7, then use the prepared sodium dihydrogen phosphate buffer solution to make up the volume, filter and sterilize the solution and fill it into type I control vials Into the final product.

preparation Embodiment 3

[0059] Preparation composition (10mL):

[0060] Propofol 200mg

[0061] Hydroxypropyl-β-cyclodextrin 3000mg

[0062] Recombinant Albumin 1000mg

[0063] Sodium chloride 18mg

[0064] EDTA 5mg

[0065] Sodium citrate 192mg

[0066] Appropriate amount of NaOH or HCl

[0067] Appropriate amount of water

[0068] Preparation method: Dissolve sodium citrate in water for injection, adjust the pH to 7.5 (using HCl or NaOH) to prepare a buffer solution, add hydroxypropyl-β-cyclodextrin, recombinant albumin, sodium chloride, and EDTA to the buffer Solution, after completely dissolving, add propofol and stir until propofol is completely dissolved, adjust the pH value to 7.5, then use the prepared sodium citrate buffer solution to make up the volume, filter and sterilize the solution and fill it into type I control penicillin Bottled into the final product.

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PUM

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Abstract

The invention belongs to the pharmaceutical field, and relates to a propofol composition. The composition contains the following components in ratio by weight that propofol: cyclodextrin: albumin is 0.1-3:0.1-50:0.01-30. The composition has the advantages of good stability, significantly reduced injection pain, simple production process and low cost.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a propofol composition with good stability and simple production process. Background technique [0002] Propofol (2,6-diisopropylphenol) is a widely used intravenous anesthetic. Due to the poor water solubility of propofol, it is difficult to prepare propofol in aqueous solution. The current commercially available product is emulsion injection, which is composed of soybean oil, egg phospholipids, glycerin and the like. The disadvantages of propofol emulsion injection are: poor physical and chemical stability of the product, greater pain during injection, large particles may block blood vessels, and more complicated emulsion preparation process, and because the product formula does not contain antibacterial agents, the product A large amount of fat in the formula is easy to encourage the production of microorganisms. Therefore, during the use of propofol emulsion, attention must be paid to ...

Claims

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Application Information

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IPC IPC(8): A61K31/05A61K47/42A61K47/40A61P23/00
Inventor 贺欣贺明
Owner 常州安孚立德药业技术有限公司
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