CN101912371A - Coenzyme Q10-containing injection composition and preparation method thereof - Google Patents
Coenzyme Q10-containing injection composition and preparation method thereof Download PDFInfo
- Publication number
- CN101912371A CN101912371A CN 201010266665 CN201010266665A CN101912371A CN 101912371 A CN101912371 A CN 101912371A CN 201010266665 CN201010266665 CN 201010266665 CN 201010266665 A CN201010266665 A CN 201010266665A CN 101912371 A CN101912371 A CN 101912371A
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- coenzyme
- injection
- reduced coenzyme
- solvent
- injection composition
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Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to a coenzyme Q10-containing injection composition which is characterized by comprising a main functional raw material of reduced type coenzyme Q10, and besides the reduced type coenzyme Q10 as the main functional raw material , the composition also comprises an emulsifier, an assistant, a surfactant and a solvent; wherein the emulsifier is polyethylene glycol or glycerol or the mixture of the polyethylene glycol and the glycerol; the assistant is a plurality of vitamins and amino acid which are required by the human body, or the mixture of the vitamins and a plurality of amino acids; the surfactant is Twain-20 or hydroxypropyl methyl cellulose; the solvent is normal saline or deionized water; and the injection composition is prepared according to the following content in percentage: 3.0-30 percent of the reduce type coenzyme Q10, 0-20 percent of the emulsifier, 0-15 percent of the assistant, 0-10 percent of the surfactant and the balance of the solvent.
Description
Technical field
The present invention relates to a kind of injection composition and preparation method thereof, especially a kind of injection composition that contains coenzyme Q10 and preparation method thereof.
Background technology
Coenzyme Q10 has another name called Ubidecarenone, is a kind of fat-soluble quinone, at room temperature is orange-yellow crystal, 48 ℃ of fusing points, odorless, tasteless, its similar is in vitamin K, because of the side chain on six of its parent nucleus (degree of polymerization of polyisopreneyl be 10 gain the name), it is a kind of quinones.Its another kind of form is a reduced coenzyme Q 10, and physiological function is mainly derived from the physical characteristic of the redox characteristic and the isoprenoid side chain of quinonyl, plays two effects in human body physiological function: the one, have tangible lipoid peroxidization resistant; The 2nd, in mitochondrion, be converted into its important function in the process of energy at nutrient substance.Quinone ring in the coenzyme Q10 works to transmit electronics and proton in oxidation-respiration chain.Coenzyme Q10 is since being found by scientist the sixties in last century, and it is requisite that it is not only all life forms in the effect that embodies aspect flight against senium of human body and the enhancing immune function of human body, but also be the key that forms ATP.It is that the Natural antioxidant of cell self and the activator of cellular metabolism have protection and recover biofilm structure integrity, the effect of stabilising membrane current potential, is again the nonspecific immunity strengthening agent of human body simultaneously.Present clinical practice is in the auxiliary treatment of diseases such as heart disease and hepatitis.Show through scientific research: in the coenzyme Q10 that people's human body contains, the 93%th, reduced coenzyme Q 10, the 7%th, oxidized coenzyme Q10, the main positive role of participant's human body be reduced coenzyme Q 10.
Be used for the coenzyme Q10 that body-care and auxiliary treatment are used at present, that a large amount of is the oxidized coenzyme Q10 that adopts chemical synthesis to produce.Main cause is: reduced coenzyme Q 10 is oxidized easily, so prepare the original position fabrication stage that natural ecosystem reduced coenzyme Q 10 only is in organism, does not reach the industrial-scale production stage as yet.In addition, though the inventor according to for many years to researching and proposing of coenzyme Q10 application number be 200910201918.1 " a kind of manufacture method of reduced coenzyme Q 10 method ", but also only be used for the utilization of capsule preparations at present, Shang Weijian has the report that reduced coenzyme Q 10 is made into the injection injection, its reason is: because coenzyme Q10 is a liposoluble substance, can't be dissolved in the injection solvent equably, thereby cause and in clinical application, to use this shortcoming by direct injection.
Summary of the invention
Purpose of the present invention: be intended to propose a kind of injection composition that contains coenzyme Q10 and preparation method thereof, solve coenzyme Q10 and can't be applied to clinical shortcoming with the injection form.
This injection composition that contains coenzyme Q10 is characterized in that: the primary raw material of described compositions is a reduced coenzyme Q 10.
This is the injection composition of major ingredient with the reduced coenzyme Q 10, also comprises emulsifying agent, auxiliary agent, surfactant and solvent, and its emulsifying agent that adopts is Polyethylene Glycol or glycerol, or the mixture of Polyethylene Glycol and glycerol; Described auxiliary agent is multivitamin, the aminoacid that needed by human body is wanted, or the mixture of vitamin and several amino acids; Described surfactant is tween 20 or hydroxypropyl emthylcellulose; Described solvent is normal saline or deionized water; And this injection composition is prepared according to following weight percent content, and wherein reduced coenzyme Q 10 is 3.0 ~ 30%; Emulsifying agent is 0 ~ 20%; Auxiliary agent is 0 ~ 15%; Surfactant 0 ~ 10%; Surplus is a solvent.
Described auxiliary agent is a kind of in water-soluble vitamin c, the watermiscible vitamin E, or the mixture of above-mentioned two kinds of water soluble vitamins.
Described auxiliary agent is the several amino acids that contains glycine, leucine, methionine, network propylhomoserin, histidine, threonine, alanine, isoleucine, tryptophan, cystine, lysine, Tianmen propylhomoserin, valine, phenylalanine, proline, serine, arginine glutamate.
The composition injection that contains reduced coenzyme Q 10, its preparation method is:
A, at first according to the requirement of actual disposition injection, determine that the prescription of injection is formed;
B, the emulsifying agent with selecting for use, auxiliary agent, surfactant dissolves are in normal saline or deionized water, the aqueous solution that then will be mixed with emulsifying agent, auxiliary agent, surfactant places high pressure homogenizer, and makes it fully to stir under 56 ~ 275MPa pressure environment;
C, in the process that stirs, the part material of the reduced coenzyme Q 10 of adapted is joined in the high pressure homogenizer among the step B lentamente, obtain to contain the primary water/oil type emulsified body of reduced coenzyme Q 10 thus;
D, then remaining reduced coenzyme Q 10 raw material and solvent are joined continue in the high pressure homogenizer to stir, finally obtain solvent endoparticle thing mean diameter at 60 ~ 100nm reduced coenzyme Q 10 injection.
What propose according to above technical scheme is injection composition of major ingredient and preparation method thereof with the coenzyme Q10, and having solved coenzyme Q10 is the preparation method of the injection of major ingredient, directly selects for use reduced coenzyme Q 10 as the main raw material(s) constituent especially first.This has not only expanded a new technological approaches for the exploitation of coenzyme Q10 novel form, simultaneously, also for coenzyme Q10 is more, more directly drop into clinical use technical support be provided.
The specific embodiment
This injection composition that contains coenzyme Q10 is characterized in that: the primary raw material of described compositions is a reduced coenzyme Q 10.
This is the injection composition of major ingredient with the reduced coenzyme Q 10, also comprises emulsifying agent, auxiliary agent, surfactant and solvent; Its emulsifying agent that adopts is Polyethylene Glycol or glycerol, or the mixture of Polyethylene Glycol and glycerol; Described auxiliary agent is multivitamin, the aminoacid that needed by human body is wanted, or the mixture of vitamin and several amino acids; Described surfactant is tween 20 or hydroxypropyl emthylcellulose; Described solvent is normal saline or deionized water.
And this injection composition is prepared according to following weight percent content, and wherein reduced coenzyme Q 10 is 3.0 ~ 30%; Emulsifying agent is 0 ~ 20%; Auxiliary agent is 0 ~ 15%; Surfactant 0 ~ 10%; Surplus is a solvent.
Below provide embodiments of the invention, and further set forth the present invention in conjunction with the embodiments.
Embodiment 1
Reduced coenzyme Q 10 30%
Macrogol 4000 10%
Glycerol 20%
Surfactant tween 20 0.5%
The deionized water surplus
Embodiment 2
Reduced coenzyme Q 10 10%
Macrogol 4000 5%
Surfactant tween 20 1%
The deionized water surplus
Embodiment 3
Reduced coenzyme Q 10 30%
Macrogol 4000 15%
Glycerol 10%
Surfactant tween 20 4%
The deionized water surplus
Preparation method: according to the weight percentage weighing of the foregoing description 1-3 component, and each component material joined in the high pressure homogenization machine, and make it under 56 ~ 275MPa pressure environment, fully to stir; After the homogeneity 2 hours, can obtain containing reduced coenzyme Q 10 injection waterborne compositions, then evenly divide to pack into 30000 and pacify in the bottle, make every peace bottle contain 30mg reduced coenzyme Q 10 injection waterborne compositions, after lyophilization is handled, the freeze dried powder that formation can clinical use.Add the 2ml normal saline at freeze dried powder when using and become intramuscular injection with the injection of prototype coenzyme Q10 as major ingredient.
Thisly contain the injection composition that reduced coenzyme Q 10 is a major ingredient, be applicable to the auxiliary treatment of diseases such as hepatitis, chronic obstructive pneumonia disease, pulmonary heart disease, senile diabetes, pulmonary tuberculosis, epidemic encephalitis type B, acute brain are blocked, lopsided nephritis, chronic bead inflammation, ASP, twelve earthly branches intestinal ulcer.
Embodiment 4
Reduced coenzyme Q 10 5%
Glycerol 10%
Water-soluble vitamin c 0.3%
Watermiscible vitamin E 0.5%
The normal saline surplus
Preparation method: according to the weight percentage weighing of the foregoing description 4 components, and each component material joined in the high pressure homogenization machine, and make it under 56 ~ 275MPa pressure environment, fully to stir; After the homogeneity 2 hours, after lyophilization is handled, the freeze dried powder that formation can clinical use.During use, the 5mg/200ml intravenous drip agent that normal saline can obtain containing reduced coenzyme Q 10 is injected in freeze dried powder dissolving back.This instillation is applicable to congestive heart failure, coronary heart disease, viral myocarditis, myocardial ischemia disease, angina pectoris, hypertension, arrhythmia, ventricular premature beat, formerly sends out secondary aldosteronism new, the treatment and the recovery of cervical region wound sequela, cerebrovascular disorders, hemorrhagic shock.
Embodiment 5
Reduced coenzyme Q 10 3%
Glycerol 6.2%
Hydroxypropyl emthylcellulose 10%
Aminoacids complex 20%
The deionized water surplus
Preparation method: according to the weight percentage weighing of the foregoing description 5 components, and each component material joined 45 ~ 50 ℃ of dissolvings of heating in the high pressure homogenization machine, and make it under 56 ~ 275MPa pressure environment, fully to stir; After the homogeneity 2 hours, make it at room temperature static, its upper strata transparent aqueous phase thing is the subcutaneous injection agent that contains reduced coenzyme Q 10.This injection can directly inject regenerated energy for skin, antioxidation, owing in constituent, added several amino acids, therefore esophageal tubes such as muscular dystrophy, dysacousis, nervous bladder inflammation, carbon monoxide, cardiac valve replacement, coronary artery bypass, heart transplant operation perfusion drug treatment had positive mating reaction.
18 seed amino acids and the function thereof that are adopted among the embodiment 5 are as follows:
One. glycine (GLY)
1, the cholesterol concentration in the reduction blood is prevented and treated hypertension;
2, the blood glucose value in the reduction blood is prevented and treated diabetes;
3, can prevent and treat blood clotting, thrombosis;
4, improve muscle vitality, prevent hyperchlorhydria;
5, sweet taste is 0.8 times of Saccharum Sinensis Roxb., human body is had Nutritions such as tonification.
Two. leucine (LEU)
1, the blood glucose value in the reduction blood has effect to treating dizziness;
2, promote skin, wound and bone that the healing effect is arranged;
If during 3 shortages, can stop growing, lose weight.
Three. methionine (MET)
1, participates in the synthetic of choline, have degreasant function, prevent and treat the arteriosclerosis hyperlipidemia;
2, the function that improves muscle vitality is arranged;
3, promote the synthetic of skin protein and insulin.
Four. tyrosine (TYR)
1, makes adrenal hormone, thyroxin and melanic essential amino acids;
But 2 senile dementia prevention and cure;
3, enhance metabolism appetite stimulator;
4, to effects such as chronic disease, nerve inflammation and dysplasia such as treatment gastric ulcers;
5, with chromogenesis relation is arranged, can sharp albinism during shortage.
Five. histidine (HIS)
1, participates in hyperglobulinemia and synthesize, promote blood to generate;
2, generation group ammonia, promotion vasodilation, the permeability of increase blood vessel wall;
3, cure gastropathy, duodenum etc. specially good effect is arranged;
4, promote glandular secretion, the anaphylaxis eqpidemic disease is produced effect;
5, can treat symptoms such as peptic ulcer, dysplasia;
6, to treatment cardiac insufficiency, angina pectoris, bring high blood pressure down, asthma and rheumatoid arthritis produce effect.
Six. threonine (THR)
Needed by human can make the people become thin during shortage, even dead.
Seven. alanine (ALA)
1, can promote metabolism (decomposition) effect of ethanol in the blood to strengthen liver function, the usefulness of hepatoprotective work is arranged.
2, sweet taste is 1.2 times of Saccharum Sinensis Roxb..
Eight. isoleucine (ILE)
1, can keep organism balance, the treatment mental disorder;
2, appetitive increase and anti-anemia effect are arranged;
If during 3 shortages, symptoms such as in the flue, stupor can occur.
Nine. tryptophan (TRY)
1, promotes the synthetic of hemoglobin;
2, prevent and treat pellagra;
3, promote growth, stimulating appetite;
4, sweet taste is 35 times of Saccharum Sinensis Roxb., and the low pool food that preparation is produced etc. are to diabetes, adiposis patient food
With better.
Ten. cystine (CYS)
1, treatment fatty liver and detoxifying effect are arranged;
2, the damage of treatment skin is to after being ill, puerperal alopecia is effective in cure.
11. lysine (LYB)
1, participates in the formation of matter between connective tissue, blood capillary epithelial cell, and keep normal permeability;
But 2 stimulating appetite promote pepsic secretion, and the enhance immunity ability is improved and grown late
Slow, prevent decayed tooth, promote children growth;
3, improve the absorption of calcium, promote bone growth;
If 4 lack, can reduce people's sensitivity, anemia, dizziness, head appear in women's federation's menolipsis
Dusk and condition of illness such as feel sick;
12. aspartic acid (ASP)
1, falls for blood ammonia, liver is had protective effect;
2, muscle there is protective effect, can treats angina pectoris, myocardial infarction etc. is had prevention effect;
3, increase delicate flavour, promote appetite.
13. valine (VAL)
1, impel nervous function normal;
If during 2 shortages, can cause the tactile sensing degree to improve especially, the coordinate movement imbalance of muscle;
3, can be used as the medicine of hepatic coma.
14. phenylalanine (PHE)
In body, change tyrosine into, promote thyroxine and kidney and adrenergic synthetic.
15. proline (PRO)
To the effective in cure effect of hypertension.
16. serine (SER)
1, the cholesterol concentration in the reduction blood is prevented and treated hypertension;
2, be the ingredient of the serinephosphatide in the tissue such as brain;
3, the tuberculosis bacteria disease produces effect, and can treat pneumonopathy.
17. glutamic acid (GLU)
1, reduces blood ammonia, the effect of separating the ammonia poison is arranged;
2, participate in the albumen and the pool metabolism of brain, accelerating oxidation improves the nervus centralis activity, keeping is arranged and promote the effect of function of brain cell, promotes the increase of intelligence;
3, to serious hepatic insufficiency, hepatic coma, acidosis, epilepsy schizophrenia, neurasthenia etc. have therapeutic effect;
4, treatment gastric ulcer, achyli, dyspepsia, inappetence are produced effect;
5, protection skin wet prevent and treat dry and crackedly, and as detergent, the cosmetics of preparation, unit stimulates to skin, mucosa, is suitable for the use of child and dermatosis patient.
18. arginine (ARG)
1, reduces blood ammonia, promote that carbamide generates in the body, treatment hepatic coma etc.;
2, increase muscle vitality, the retentivity function has effect to the treatment oligospermia.
According to this injection composition that contains coenzyme Q10 that proposes in the technique scheme and preparation method thereof, owing to adopt reduced coenzyme Q 10 as major ingredient, therefore overcome existing make the injection use and enter human body with oxidized coenzyme Q10 after, need in human body, convert this process of reduced coenzyme again to by reductase.There are some researches show now: Q10 compares with oxidized coenzyme, and reduced coenzyme Q 10 has the absorbed power that exceeds more than 8 times than oxidized coenzyme Q10, under same dosage, just can reach higher blood level with back 3 hours, so produce effects is faster.
Confirm that through zoopery it has following pharmacological action in interior animal entity:
1) myocardial contraction weakens and phosphagen and adenosine triphosphate content in the time of can alleviating acute ischemia
Minimizing, keep the mitochondrial morphosis of ischemic myocardial cells, ischemic myocardium is had the certain protection effect.
2) increase cardiac output, reduce Peripheral resistance, help anti-heart failure treatment, can suppress aldosterone
Synthetic and secretion, and block the effect of seven pairs of renal tubules.
When 3) perfusion exsomatizes the animal ventricle under anoxia condition, its action potential duration is shortened,
Generating chamber's arrhythmia threshold values has antiarrhythmic effect than the control animal height.
4) this product also has the cardiac toxicity effect and the hepatoprotective effect of anti-amycin.
This injection composition and the preparation side thereof of containing coenzyme Q10 according to above technical scheme proposition
Method, by reduced coenzyme Q 10 being made into the injection of clinical use, because reduced coenzyme Q 10 can be named soon and be absorbed by human body cell, therefore greatly improved the scope of application of reduced coenzyme Q 10 in clinical medicine, this not only improves the modern humans positive role of coenzyme Q10 in people's human body is had positive effect, also provides a kind of biological novel formulation with widely-used prospect for clinical medicine simultaneously.
Claims (6)
1.
A kind of injection composition that contains coenzyme Q10 is characterized in that: the major function raw material of described compositions is a reduced coenzyme Q 10.
2. the injection composition that contains coenzyme Q10 as claimed in claim 1 is characterized in that: being the injection composition of major function raw material with the reduced coenzyme Q 10, also contain emulsifying agent, auxiliary agent, surfactant and solvent; Its emulsifying agent that adopts is Polyethylene Glycol or glycerol, or the mixture of Polyethylene Glycol and glycerol; Described auxiliary agent is multivitamin, the aminoacid that needed by human body is wanted, or the mixture of vitamin and several amino acids; Described surfactant is tween 20, perhaps hydroxypropyl emthylcellulose; Described solvent is normal saline or deionized water; And this injection composition is prepared according to following weight percent content, and wherein reduced coenzyme Q 10 is 3.0 ~ 30%; Emulsifying agent is 0 ~ 20%; Auxiliary agent is 0 ~ 15%; Surfactant 0 ~ 10%; Surplus is a solvent.
3. a kind of injection composition that contains coenzyme Q10 as claimed in claim 1 is characterized in that: described auxiliary agent is a kind of in water-soluble vitamin c, the watermiscible vitamin E, or the mixture of above-mentioned two kinds of vitamin.
4. the injection composition that contains coenzyme Q10 as claimed in claim 1 is characterized in that: described auxiliary agent is the several amino acids that contains glycine, leucine, methionine, network propylhomoserin, histidine, threonine, alanine, isoleucine, tryptophan, cystine, lysine, Tianmen propylhomoserin, valine, phenylalanine, proline, serine, arginine glutamate.
5. as claim 1 or 2 or 3 described a kind of injection compositions that contain coenzyme Q10, its preparation method is:
A, at first according to the requirement of actual disposition injection, determine that the prescription of injection is formed;
B, the emulsifying agent with selecting for use, auxiliary agent, surfactant dissolves are in normal saline or deionized water, and the aqueous solution that then will be mixed with emulsifying agent places high pressure homogenizer, and make under 56 ~ 275MPa pressure environment and fully stir;
C, in the process that stirs, the part material of the reduced coenzyme Q 10 of adapted is joined in the high pressure homogenizer among the step B lentamente, obtain to contain the primary water/oil type emulsified body of reduced coenzyme Q 10 thus;
D, then remaining reduced coenzyme Q 10 raw material and solvent are joined continue in the high pressure homogenizer to stir, finally obtain solvent endoparticle thing mean diameter at 60 ~ 100nm reduced coenzyme Q 10 injection.
6. the injection composition that contains coenzyme Q10 as claimed in claim 5 is characterized in that: described reduced coenzyme Q 10 injection is at pack into peace bottle of branch, after freezing processing, promptly become can make that bed uses contain the reduced coenzyme Q 10 freeze dried powder.
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| CN106214645A (en) * | 2016-09-05 | 2016-12-14 | 雄九（上海）医药技术股份有限公司 | Lyophilized powder containing coenzyme Q10 and preparation method thereof |
| CN106377497A (en) * | 2016-09-05 | 2017-02-08 | 雄九（上海）医药技术股份有限公司 | Injection composition containing coenzyme Q10 and preparation method of injection composition |
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| CN1899272A (en) * | 2001-10-10 | 2007-01-24 | 钟渊化学工业株式会社 | Stabilized compositions of aqueous reduced coenzyme q solution |
| CN101066260A (en) * | 2006-11-17 | 2007-11-07 | 姚瑶 | Coenzyme Q10 emulsion and its freeze dried prepn and their prepn process |
| CN101307338A (en) * | 2008-07-17 | 2008-11-19 | 任雷 | Method for preparing reducing coenzyme Q10 |
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|---|---|---|---|---|
| CN1899272A (en) * | 2001-10-10 | 2007-01-24 | 钟渊化学工业株式会社 | Stabilized compositions of aqueous reduced coenzyme q solution |
| CN101066260A (en) * | 2006-11-17 | 2007-11-07 | 姚瑶 | Coenzyme Q10 emulsion and its freeze dried prepn and their prepn process |
| CN101307338A (en) * | 2008-07-17 | 2008-11-19 | 任雷 | Method for preparing reducing coenzyme Q10 |
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| CN106214645A (en) * | 2016-09-05 | 2016-12-14 | 雄九（上海）医药技术股份有限公司 | Lyophilized powder containing coenzyme Q10 and preparation method thereof |
| CN106377497A (en) * | 2016-09-05 | 2017-02-08 | 雄九（上海）医药技术股份有限公司 | Injection composition containing coenzyme Q10 and preparation method of injection composition |
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