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Propofol freeze-dried emulsion and its preparing method

A technology of propofol freeze-dried emulsion and propofol, which is applied in the field of pharmaceutical compositions containing propofol, can solve the problems of inconvenient production, transportation and use, inability to withstand violent shaking and high and low temperature storage, and achieve good stability effect

Inactive Publication Date: 2007-08-01
姚瑶 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the product cannot withstand violent shaking and high and low temperature storage (commercially available product instructions require storage at 2-25°C and must not be frozen), all of which make the product inconvenient during production, transportation and use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The ingredients of propofol freeze-dried emulsion are: propofol 1g, soybean oil 20g, purified egg yolk lecithin 1.2g, cholesterol 0.2g, Tween-80 0.5g, EDTA-2Na 0.01g, sucrose 8g, hydrogenated Appropriate amount of sodium, the rest is water for injection, a total of 100ml.

[0048] The preparation process of propofol freeze-dried emulsion is as follows:

[0049] Dissolve the purified egg yolk lecithin and cholesterol in soybean oil with shearing and stirring at 40°C, then add propofol and mix evenly to obtain an oil phase; dissolve Tween-80 and EDTA-2Na in water for injection to obtain an aqueous phase; Add the water phase to the oil phase and stir for 10 minutes to obtain colostrum, adjust the pH value to 7.0-8.0, pass the colostrum through a high-pressure homogenizer, first adjust the pressure of the homogenizer to 5000psi and repeat the homogenization for 3 times, then adjust the pressure of the homogenizer 15,000 psi, repeated homogenization 3 to 5 times to obtain...

Embodiment 2

[0052] The ingredients of propofol freeze-dried emulsion are: propofol 2g, soybean oil 8g, egg yolk lecithin for injection 2.0g, Poloxamer 1.0g, oleic acid 0.05g, EDTA-2Na 0.005g, sucrose 10g, mannitol 5g , an appropriate amount of sodium hydroxide, and the rest is water for injection, a total of 100ml.

[0053] The preparation process of propofol freeze-dried emulsion is as follows:

[0054] Mix soybean oil and oleic acid at 60°C, then add propofol and mix evenly to obtain an oil phase; disperse egg yolk lecithin for injection in water for injection containing EDTA-2Na and Poloxamer to obtain a water phase; Add the water phase to the oil phase and shear for 10 minutes to obtain colostrum, adjust the pH value to 6.5-8.0, pass the colostrum through a high-pressure homogenizer, first adjust the pressure of the homogenizer to 5000psi and repeat the homogenization for 3 times, then adjust the homogenizer The pressure is 15,000 psi, and the homogenization is repeated 3 to 5 time...

Embodiment 3

[0057] The ingredients of propofol freeze-dried emulsion are: propofol 1g, soybean oil 15g, purified soybean lecithin 2.4g, oleylamine 0.05g, EDTA-2Na 0.005g, lactose 10g, glycerin 2.25g, sodium hydroxide Appropriate amount, the rest is water for injection, a total of 100ml.

[0058] The preparation process of propofol freeze-dried emulsion is as follows:

[0059] Disperse the purified soybean lecithin in soybean oil at 40°C, then add oleylamine and propofol and mix evenly to obtain an oil phase; dissolve glycerin and EDTA-2Na in water for injection to obtain a water phase; add the water phase to Cut the colostrum into the oil phase for 10 minutes, adjust the pH value to 7.0-8.0, pass the colostrum through the high-pressure homogenizer, first adjust the pressure of the homogenizer to 5000psi and repeat the homogenization twice, and then adjust the pressure of the homogenizer to 10000- 15000psi, repeated homogenization 3 to 5 times to obtain a uniform emulsion. Add the free...

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Abstract

The invention relates to a medicinal composition containing propofol and process for preparation, wherein each 1kg of the freeze-dried product comprises propofol 1g, oil for injection 0-20g, emulsifying agent 0.1-10g, auxiliary emulsifying agent 0.001-5g, other stabilizing agent 0-2g, freeze-drying protective agent 1-40g, and right amount of pH modifier. The invention can achieve better constancy.

Description

field of invention [0001] The invention relates to a pharmaceutical composition containing propofol and a preparation method of the composition. Background of the invention [0002] Propofol, chemically known as 2,6-diisopropylphenol, is an injectable anesthetic used to induce and maintain general anesthesia and is used for sedation in intensive care units. The use of propofol as an anesthetic has been applied for patents in many countries and regions, such as British Patent No. 1472793, U.S. Patents USP4056635, USP4452817, USP4798846, etc. [0003] Although propofol is a preferred anesthetic, it is a water-insoluble drug that is difficult to formulate directly into solution for intravenous administration. To solve the problem of propofol dosing, pharmacists have conducted a lot of research. Cremophor EL, an injectable non-ionic surfactant, was initially used to solubilize it to prepare a 1% aqueous solution of propofol. However, it has been shown that Cremophor EL has som...

Claims

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Application Information

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IPC IPC(8): A61K31/05A61K9/107A61K47/44A61P23/00
Inventor 姚瑶陶昱斐丁燕飞姜素芳胡高云丁劲松
Owner 姚瑶
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