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Coenzyme Q10 emulsion and its freeze dried prepn and their prepn process

A technology of freeze-dried emulsions and auxiliary emulsifiers, which can be used in pharmaceutical formulations, emulsion delivery, and medical preparations of non-active ingredients. and other issues to achieve good stability

Inactive Publication Date: 2007-11-07
姚瑶 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007]Coenzyme Q10 has low solubility in water, so it is difficult to make injections directly. Currently, the clinically used coenzyme Q10Injections are generally solubilized by non-aqueous solvents and a large amount of surfactants, which may cause adverse reactions such as allergies and hemolysis after administration. Dilution and excessive injection speed may cause drug precipitation and affect the safety of medication
In addition, coenzyme Q10 is sensitive to light, the quality of the preparation is not stable enough during processing and storage, and the clinical application of the product is limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Coenzyme Q 10 The composition of the emulsion is: Coenzyme Q 10 0.25g, soybean oil 10g, purified egg yolk lecithin 1.2g, glycerol 2.5g, and the rest water for injection, 100ml in total.

[0057] Coenzyme Q 10 The emulsion preparation process is as follows:

[0058] Coenzyme Q 10 Add soybean oil until completely dissolved, then add purified egg yolk lecithin and shear and stir evenly to obtain an oil phase; dissolve glycerin in water for injection at 40°C to obtain a water phase; add the water phase to the oil phase and stir for 30 minutes To obtain colostrum, adjust the pH value to 5.5-7.0, 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 to 15000psi, and repeat the homogenization for 3 to 5 times , Measure the particle size of the emulsion to obtain a uniformly dispersed emulsion with a particle size of 10 Emulsion...

Embodiment 2

[0060] Coenzyme Q 10 The composition of the emulsion is: Coenzyme Q 10 0.25g, medium chain oil 10g, purified egg yolk lecithin 1.2g, glycerin 2.5g, and the rest water for injection, 100ml in total.

[0061] Coenzyme Q 10 The emulsion preparation process is as follows:

[0062] Coenzyme Q 10 Add medium chain oil until completely dissolved, then add purified egg yolk lecithin and shear and stir evenly to obtain an oil phase; dissolve glycerin in water for injection at 40°C to obtain a water phase; add the water phase to the oil phase Stir for 30 minutes to obtain colostrum, adjust the pH value to 5.5-7.0, 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 to 15000psi, and repeat the homogenization for 3-3 times Measure the particle size of the emulsion 5 times to obtain a uniformly dispersed emulsion with a particle size of 10...

Embodiment 3

[0064] Coenzyme Q 10 The composition of the emulsion is: Coenzyme Q 10 0.25g, medium chain oil 5g, purified egg yolk lecithin 1.2g, poloxamer188 0.015g, glycerin 2.5g, the rest is water for injection, 100ml in total.

[0065] Coenzyme Q 10 The emulsion preparation process is as follows:

[0066] Coenzyme Q 10 Add medium chain oil until completely dissolved, then add purified egg yolk lecithin and shear and stir evenly to obtain an oil phase; dissolve poloxamer188 and glycerin in water for injection at 60°C to obtain a water phase; add the water phase to the oil Stir in the phase for 30 minutes to obtain colostrum, adjust the pH value to 5.5-7.0, 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 to 15000psi, and repeat the homogenization 3 to 5 times, measure the particle size of the emulsion, obtain a uniformly dispersed em...

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Abstract

The present invention discloses one new kind of medicine composition, coenzyme Q10 emulsion, and its preparation process. The emulsion contains coenzyme Q10 as the medicinal component in 0.25 %, and medicinal supplementary material including oil phase 1-20 %, emulsifier 0.01-10 %, auxiliary emulsifier 0.001-5 %, other stabilizer 0-2 % and isoosmotic regulator 1-10 %. Its freeze dried preparation contains also freeze drying protector except water for injection. The present invention also provides freeze dried coenzyme Q10 emulsion and its recipe and preparation process. The coenzyme Q10 emulsion and its freeze dried preparation have high stability even in high temperature up to 40 deg.c and high illumination up to 4500LX+ / -500 conditions.

Description

Technical field: [0001] The present invention relates to a kind of coenzyme Q 10 Emulsion and its lyophilized emulsion and preparation method. technical background: [0002] coenzyme Q 10 (Co Q 10 ) has a chemical structure of 2,3-dimethoxy-5-methyl-6-decoprenyl benzoguinone (2,3-dimethoxy-5-methyl-6-decoprenyl benzoguinone), which is a class of Fat-soluble quinones that share characteristics with vitamins. [0003] As early as the 1970s, foreign countries had a great deal of attention to coenzyme Q 10 A large number of clinical application studies have been started, and it has been found that it has excellent curative effects on diseases such as heart disease, malignant tumors, hypertension, cerebrovascular disorders, scurvy, acute hepatitis, etc., and can be used as a non-specific immune enhancer for the body, cell metabolism and Cellular respiration activator. Coenzyme Q 10 The marketed preparations include injections and oral dosage forms such as tablets, capsules...

Claims

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Application Information

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IPC IPC(8): A61K31/122A61K9/107A61K47/44A61P37/04A61P9/00A61P9/12A61P1/16A61P35/00A61K47/24
Inventor 姚瑶陶昱斐
Owner 姚瑶
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