Propofol compounds

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: 2008-07-23
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 a high concentration (30-60% w / v) of HPBCD 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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Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0036] prescription:

[0037] Propofol 10g

[0038] Hydroxypropyl-B-cyclodextrin 100g

[0039] Human Serum Albumin 100g

[0040] Glycerin 1.8g

[0041] Disodium EDTA 0.05g

[0042] Disodium hydrogen phosphate 12g

[0043] Appropriate amount of NaOH / HCL

[0044] Appropriate amount of water

[0045] Preparation method: Dissolve disodium hydrogen phosphate in water for injection, adjust pH to 7.5 (using HCL or NaOH) to prepare 1000ml buffer solution, add hydroxypropyl-B-cyclodextrin, human serum albumin, glycerol, ethylene di Add disodium amine tetraacetate to 500ml buffer solution, after completely dissolving, add propofol and stir until completely dissolved, adjust the pH value to 7.5, then use the prepared buffer solution to set the volume to 1000ml, filter and sterilize, and fill the solution in Type I glass bottles into the final product.

preparation Embodiment 2

[0047] prescription:

[0048] Propofol 10g

[0049] Hydroxypropyl-B-cyclodextrin 100g

[0050] Bovine Serum Albumin 100g

[0051] Mannitol 5g

[0052] Acetylcysteine ​​0.01g

[0053] Glycine 1.5g

[0054] Appropriate amount of NaOH / HCL

[0055] Appropriate amount of water

[0056]Preparation method: Dissolve glycine in water for injection, adjust pH to 7.0 (using HCL or NaOH) to prepare 1000ml buffer solution, add hydroxypropyl-B-cyclodextrin, bovine serum albumin, mannitol, acetylcysteine Add 500ml of buffer solution to the acid, after it is completely dissolved, add propofol and stir until it is completely dissolved, then adjust the pH to 7.0, then use the prepared buffer solution to set the volume to 1000ml, filter and sterilize the solution and fill it into a type I glass bottle Into the final product.

preparation Embodiment 3

[0058] prescription:

[0059] Propofol 10g

[0060] Hydroxypropyl-B-cyclodextrin 100g

[0061] Human Serum Albumin 100g

[0062] Sodium chloride 7g

[0063] Disodium EDTA 0.05g

[0064] Sodium citrate 5g

[0065] Appropriate amount of NaOH / HCL

[0066] Appropriate amount of water

[0067] Preparation method: Dissolve sodium citrate in water for injection, adjust pH to 7.0 (using HCL or NaOH) to prepare 1000ml buffer solution, mix hydroxypropyl-B-cyclodextrin, human serum albumin, sodium chloride, ethyl alcohol Add 500ml of diaminetetraacetic acid buffer solution into 500ml buffer solution, add propofol and stir until completely dissolved, adjust the pH value to 7.0, then use the prepared buffer solution to set the volume to 1000ml, filter and sterilize and fill the solution Into the final product in type I glass bottles.

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PUM

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Abstract

The invention belongs to the pharmaceutical field, which relates to a propofol combination. The weight proportion of the materials contained in the combination is: propofol: hydroxypropyl-B-cyclodextrin: albumin is equal to 0.1-2 : 1-35 : 1-35. The combination has good stability, simple production technique and low cost, and the injection pain is alleviated obviously. .

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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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/38A61K47/40A61K9/08A61P23/00A61K31/05
Inventor 贺欣
Owner 常州安孚立德药业技术有限公司
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