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Propofol medium/long-chain injection and preparation method thereof

A technology for injection and propofol, applied in the field of medicine, can solve problems such as undisclosed stabilizers, and achieve the effects of avoiding serious side effects, good stability and good biocompatibility

Active Publication Date: 2013-05-01
GUANGDONG JIABO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN1843338A discloses a kind of propofol injection, and it comprises propofol, refined soybean oil, stabilizer and sodium hydroxide, but this document does not disclose specific effective stabilizer

Method used

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  • Propofol medium/long-chain injection and preparation method thereof
  • Propofol medium/long-chain injection and preparation method thereof
  • Propofol medium/long-chain injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027]

[0028] The specific preparation method is as follows: pour the prescribed amount of propofol, oleic acid, soybean oil and lecithin into a crude milk tank, keep warm at 45°C, stir for 10 minutes at a speed of 2000rpm, mix and dissolve to obtain an oil phase; Dissolve glycerin in the prescribed amount of water for injection to obtain a water phase at a temperature of 45°C; add the above-mentioned oil phase to the water phase and stir for 10 minutes to make colostrum, and pass the colostrum through a homogenizer to maintain 8000psi high pressure, and high-pressure homogenization 7 times; sodium hydroxide was added to the liquid medicine to adjust the pH to 7, and the liquid medicine was filtered through a filter membrane with a pore size of 0.45 μm, then filled into ampoules and capped, 115 Sterilize at ℃ for 30 minutes, check for leaks, light inspection, labeling, packaging, ready to serve.

Embodiment 2

[0030] prescription:

[0031]

[0032]

[0033] The specific preparation method is as follows: pour the prescription amount of propofol, oleic acid, soybean oil and lecithin into the crude milk tank, keep warm at 80°C, stir for 20 minutes at a speed of 3000rpm, mix and dissolve to obtain the oil phase; Dissolve glycerin in the prescribed amount of water for injection to obtain the water phase, and make the temperature 60°C; add the above-mentioned oil phase to the water phase, stir for 20 minutes to make colostrum, and pass the colostrum through the homogenizer to maintain 5000psi high pressure, and high-pressure homogenization 6 times; add sodium hydroxide to the liquid medicine to adjust the pH value to 10, filter the liquid medicine through a filter membrane with a pore size of 5 μm under pressure, fill it into an ampoule bottle and cap it, and heat it at 121°C Sterilize for 8 minutes, check for leaks, light, label, pack, and you’re ready.

Embodiment 3

[0035] prescription:

[0036]

[0037] The preparation process is the same as in Example 1.

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PUM

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Abstract

The invention relates to a propofol medium / long-chain injection and a preparation method thereof. The formula of the propofol medium / long-chain injection is as follows: 10 g to 20 g of propofol, 50 g to 100 g of soybean oil, 50 g to 100 g of medium-chain triglycerides, 10 g to 15 g of lecithin, 0.1 g to 2 g of oleinic acid, 18 g to 25 g of glycerol, an appropriate amount of sodium hydroxide, and water for injection added up to 1000 ml. The propofol medium / long-chain injection is advantageous in reasonable compatibility, less irritation and good stability.

Description

technical field [0001] The invention relates to the technical field of medicine. In particular, it relates to a medium / long chain injection of propofol and a preparation method thereof. Background technique [0002] Propofol is a new type of alkylbenzene short-acting intravenous anesthetic, which has the characteristics of fast anesthesia induction, rapid recovery, complete functional recovery, and low incidence of postoperative nausea and vomiting. It is currently widely used clinically. For anesthesia induction, maintenance of anesthesia and sedation of critically ill patients. [0003] Because propofol is insoluble in water, it is often formulated into oil-in-water emulsions for clinical use. For example, propofol injection with the trade name Prima developed by the British Zeneca company has been sold in many countries. However, edetate disodium is used in existing marketed products, which is used to enhance the stability of propofol. Studies have shown that edetate d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K31/05A61K47/44A61K47/14A61P23/00
Inventor 岳峰梁成标刘红旗蔡文坚曾少群童伟国
Owner GUANGDONG JIABO PHARM CO LTD
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