Submicron emulsion injection liquid of CoQ10 and preparation process thereof

A sub-microemulsion and injection technology, applied in the fields of health care products and medicines, can solve problems such as application difficulties, unstable injection, and increased side effects.

Active Publication Date: 2007-05-23
SHENYANG WANJIA INST OF BIOLOGICAL TECH RES +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But there are many problems, such as coenzyme Q published in Chinese Pharmacopoeia 10 The injection is dissolved with a large dose of Tween 80, which causes a lot of allergies and hemolysis clinically.
At the same time, since coenzyme Q 10 Unstable to light, heat and water, so Q 10 The injection solution is very unstable and easily decomposed
And it can only be injected intramuscularly. Although the microemulsion technology has improved the above-mentioned technology, it is still difficult to apply it because of the addition of some surfactants as creaming agents, and the safety of injection of many excipients has not been determined.
[0004] coenzyme Q 10 Due to its important physiological functions, it has become a research hotspot in the medical and pharmaceutical circles. There are a large number of published literature and patents, among which coenzyme Q 10 There are many utility patents, and the following patents are related to this patent after retrieval: ①World patent WO20041080208, which uses emulsification technology, but belongs to the field of food, and mainly discloses the formula and process of preparing an oral milk powder and organic co-composition , no coenzyme Q was involved 10 Submicroemulsion Injection Technology
② Chinese patent CN200410022007 describes a stable coenzyme Q 10 The injection preparation method mainly uses the surfactant Tween 80 to help dissolve, and at the same time adds Ve and other inhibitors, but the water cannot be completely isolated, and the stability will be affected: the surfactant will also increase the occurrence of side effects
③ Chinese patent CN02808179 describes a 10 The microemulsion preconcentrate and microemulsion are mainly prepared by surfactant Tween 80 and triglyceride, which are suitable for oral administration and not suitable for injection
In the literature Int.J.Pharm 2004 Apr 1:273(1-2):63-73 author PalamkuluA describes a coenzyme Q 10 The self-emulsifying drug delivery system mainly uses the oil phase mixed with various surfactants to make oral preparations. After oral administration, it is mixed with gastric juice to form a microemulsion to promote coenzyme Q 10 Absorption, which is quite different from this patent, the above patents and contents do not involve coenzyme Q 10 Submicroemulsion injection and preparation method thereof

Method used

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  • Submicron emulsion injection liquid of CoQ10 and preparation process thereof
  • Submicron emulsion injection liquid of CoQ10 and preparation process thereof
  • Submicron emulsion injection liquid of CoQ10 and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Coenzyme Q of the present invention 10 Submicroemulsion injection is composed of the following raw materials in weight ratio:

[0047] coenzyme Q 10 : soybean oil: lecithin: glycerin: water for injection = 0.1:7:0.5:2:89;

[0048] Weigh coenzyme Q according to the above weight ratio 10 1g, join in the 70g injection grade soybean oil (Tieling City Beiya Medicinal Oil Company), make dissolving; 5g refined egg yolk lecithin (German lipoid company) is dispersed in 100g water; Apparatus factory) with 10000rpm, mix and homogenize for 2-5 minutes, add 790g water for injection, 20g glycerol, with 10000rpm, homogenize for 3-5 minutes, form colostrum, colostrum is joined in high-pressure milk homogenizer (Italian ATS company ), pass N 2 Protection, the initial pressure is 20-30MPa, circulate for 2 minutes, then increase to 80-100Mpa, circulate 6 times, release homogeneous milk. In the 100-level purification workshop, microporous membrane equipment is used to pass through a 0...

Embodiment 2

[0050] Coenzyme Q of the present invention 10 Submicroemulsion injection is composed of the following raw materials in weight ratio:

[0051] coenzyme Q 10 : soybean oil: lecithin: glycerin: oleic acid: water for injection = 2:30:3:2.5:1:65;

[0052] Take coenzyme Q according to the above weight ratio 10 20g, join in 300g injection grade soybean oil, make dissolving, oleic acid 10g; 30g refined egg yolk lecithin (German lipoid company) is dispersed in 150g water; , mix and homogenize for 2-5 minutes, add 500g water for injection, 25g glycerin, and homogenize for 3-5 minutes at 15000rpm to form colostrum, then, use a high-pressure homogenizer, under a pressure of 20MPa, pass N 2 Protected, after 1 cycle, a uniform emulsion is formed. All the other are with embodiment 1. As determined by liquid chromatography, contains coenzyme Q 10 18mg / ml, the emulsion particle size below 1000nm is greater than 85%.

Embodiment 3

[0054] Coenzyme Q of the present invention 10 Submicroemulsion injection is composed of the following raw materials in weight ratio:

[0055] coenzyme Q 10 : soybean oil: lecithin: glycerin: oleic acid: water for injection = 1:17:2:2.2:0.5:75;

[0056] Weigh coenzyme Q according to the above weight ratio 10 10g, join in 170g injection grade soybean oil, make dissolving, oleic acid 5g; 20g refined egg yolk lecithin (German lipoid company) is dispersed in 200g water; , mix and homogenize for 2-5 minutes, add 550g water for injection, 22g glycerin, and homogenize for 3-5 minutes at 20000rpm to form colostrum, then, use a high-pressure homogenizer, under a pressure of 60MPa, pass N 2 Protected, after 5 cycles, a uniform emulsion was formed. All the other are with embodiment 1. As determined by liquid chromatography, contains coenzyme Q 10 11mg / ml, 1000nm emulsion is greater than 93%.

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Abstract

The invention relates to a method for preparing coenzyme Q10 sub micro-emulsion injection, wherein said agent can treat cardiovascular disease, hepatitis, etc, while it can be injected or orally taken. And it comprises coenzyme Q10, soya oil, lecithin, glycerin, and injection water at 0.1-2:7-30:0.5-3:2-2.5:0-1:65-89; it uses high-speed mixer or ultrasonic vibration to form initial emulsion, via high-pressure mixer to prepare coenzyme Q10 sub micro-emulsion. Said agent is water-packing-oil sub micro emulsion, which packs coenzyme in water-packing-oil micro oil to reduce excited reaction and side effect, with target function.

Description

technical field [0001] The present invention relates to a kind of coenzyme Q 10 Submicroemulsion injection and preparation method thereof, the preparation has good therapeutic effect on diseases such as cardiovascular diseases, hepatitis, low immunity, etc., can be injected or taken orally, and belongs to the technical field of medicines and health care products. Background technique [0002] coenzyme Q 10 Also known as ubiquinone, also known as decenoquinone, ubiquinone alcohol, vitamin Q, vitamin coenzyme Q, the English name is Coenzyme Q 10 , Ubiquinone, molecular formula C 59 h 90 o 4 . This substance is the body's own substance, and it also widely exists in the animal heart and other organs. It can be extracted from the animal heart, and can also be obtained through chemical synthesis and biosynthesis. coenzyme Q 10 It is an indispensable and important physiological substance in the human body. Its chemical structure characteristics determine that it has many imp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/122A61P3/02
Inventor 董英杰艾莉
Owner SHENYANG WANJIA INST OF BIOLOGICAL TECH RES
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