CN1270702C - Intravenous injection liquid of coenzyme Q10, and its prepn. method - Google Patents
Intravenous injection liquid of coenzyme Q10, and its prepn. method Download PDFInfo
- Publication number
- CN1270702C CN1270702C CN 200410022007 CN200410022007A CN1270702C CN 1270702 C CN1270702 C CN 1270702C CN 200410022007 CN200410022007 CN 200410022007 CN 200410022007 A CN200410022007 A CN 200410022007A CN 1270702 C CN1270702 C CN 1270702C
- Authority
- CN
- China
- Prior art keywords
- injection
- ubiquinone
- osmotic pressure
- pressure regulator
- coenzyme
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- ACTIUHUUMQJHFO-UPTCCGCDSA-N coenzyme Q10 Chemical compound COC1=C(OC)C(=O)C(C\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CCC=C(C)C)=C(C)C1=O ACTIUHUUMQJHFO-UPTCCGCDSA-N 0.000 title claims abstract description 63
- ACTIUHUUMQJHFO-UHFFFAOYSA-N Coenzym Q10 Natural products COC1=C(OC)C(=O)C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)=C(C)C1=O ACTIUHUUMQJHFO-UHFFFAOYSA-N 0.000 title claims abstract description 56
- 235000017471 coenzyme Q10 Nutrition 0.000 title claims abstract description 56
- 239000007788 liquid Substances 0.000 title abstract description 16
- 238000000034 method Methods 0.000 title abstract description 10
- 238000010253 intravenous injection Methods 0.000 title abstract description 7
- 229940110767 coenzyme Q10 Drugs 0.000 title abstract 7
- 238000002347 injection Methods 0.000 claims abstract description 40
- 239000007924 injection Substances 0.000 claims abstract description 40
- 239000002904 solvent Substances 0.000 claims abstract description 20
- 230000003204 osmotic effect Effects 0.000 claims abstract description 17
- 239000000243 solution Substances 0.000 claims abstract description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- 238000002360 preparation method Methods 0.000 claims abstract description 13
- NPCOQXAVBJJZBQ-UHFFFAOYSA-N reduced coenzyme Q9 Natural products COC1=C(O)C(C)=C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)C(O)=C1OC NPCOQXAVBJJZBQ-UHFFFAOYSA-N 0.000 claims description 49
- 229940035936 ubiquinone Drugs 0.000 claims description 49
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 14
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 10
- 239000008215 water for injection Substances 0.000 claims description 10
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 9
- 239000003814 drug Substances 0.000 claims description 9
- 239000011780 sodium chloride Substances 0.000 claims description 7
- 229940079593 drug Drugs 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 4
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 4
- 238000012856 packing Methods 0.000 claims description 4
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 3
- 229910052799 carbon Inorganic materials 0.000 claims description 3
- 239000003610 charcoal Substances 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 239000008103 glucose Substances 0.000 claims description 3
- 238000009413 insulation Methods 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000004659 sterilization and disinfection Methods 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 239000000306 component Substances 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 abstract description 5
- 206010011409 Cross infection Diseases 0.000 abstract description 3
- 206010029803 Nosocomial infection Diseases 0.000 abstract description 3
- 238000010579 first pass effect Methods 0.000 abstract description 3
- 230000008901 benefit Effects 0.000 abstract description 2
- 230000008569 process Effects 0.000 abstract description 2
- 239000012155 injection solvent Substances 0.000 abstract 2
- 230000001105 regulatory effect Effects 0.000 abstract 2
- 241000894006 Bacteria Species 0.000 abstract 1
- 238000005538 encapsulation Methods 0.000 abstract 1
- 229940090044 injection Drugs 0.000 description 22
- 238000012360 testing method Methods 0.000 description 12
- 238000005286 illumination Methods 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- 239000002552 dosage form Substances 0.000 description 4
- UHOVQNZJYSORNB-UHFFFAOYSA-N Benzene Chemical compound C1=CC=CC=C1 UHOVQNZJYSORNB-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 208000006454 hepatitis Diseases 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 208000032467 Aplastic anaemia Diseases 0.000 description 1
- 208000006770 Ascorbic Acid Deficiency Diseases 0.000 description 1
- 206010007559 Cardiac failure congestive Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010008909 Chronic Hepatitis Diseases 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- 206010014561 Emphysema Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 description 1
- 229920001219 Polysorbate 40 Polymers 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 206010047623 Vitamin C deficiency Diseases 0.000 description 1
- 229930003448 Vitamin K Natural products 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000003064 anti-oxidating effect Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000008827 biological function Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000019522 cellular metabolic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229940121657 clinical drug Drugs 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 229940093181 glucose injection Drugs 0.000 description 1
- 230000010247 heart contraction Effects 0.000 description 1
- 231100000283 hepatitis Toxicity 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 239000004531 microgranule Substances 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 description 1
- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 description 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 description 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 description 1
- 229940101027 polysorbate 40 Drugs 0.000 description 1
- 150000004053 quinones Chemical class 0.000 description 1
- 125000004151 quinonyl group Chemical group 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 208000010233 scurvy Diseases 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- 229940046010 vitamin k Drugs 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention discloses an intravenous injection liquid containing a coenzyme Q10 and a preparing method thereof. The injection liquid is prepared from a coenzyme Q10, a solubilizing agent, injection solvent and an osmotic pressure regulating agent, wherein the coenzyme Q10 is used as an active component. The preparing method comprises the steps: the water-insoluble coenzyme Q10 is prepared into clear and transparent solution by the solubilizing agent, the injection solvent and the osmotic pressure regulating agent, and the clear and transparent solution is prepared into a preparation which meets the requirement of injections and is suitable for intravenous injection by volume determination, bacteria removal and encapsulation. The method of the present invention solves the technical problems of water insolubility and light instability of the coenzyme Q10. The injection liquid which is prepared with the method of the present invention and is used for intravenous injection has the advantages that no first pass effect is generated when the injection liquid is absorbed by a human body, the bioavailability is improved, the injection liquid is not prepared in the process of intravenous injection, the cross infection is avoided, the clinical application level and the safety of the coenzyme Q10 are improved. The injection liquid is convenient in use.
Description
Technical field
The present invention relates to ubiquinone
10Dosage form and preparation method thereof, particularly ubiquinone
10Venous transfusion and preparation method thereof belongs to the biochemical drug field.
Background technology
Ubiquinone
10Be a kind of fat-soluble quinones, have the common feature of vitamin, the similar vitamin K of chemical constitution, it has the various biological function, especially use it to have that dosage is little, toxicity is low, advantage that can the multiple disease of auxiliary treatment is used widely clinically.Ubiquinone
10It is a kind of good biochemical drug, has the activated effect of natural anti-oxidation and cellular metabolism, can significantly improve body immunity, this clinical drug is mainly used in sick treatment such as cardiovascular disease, vitamin C deficiency, aplastic anemia, duodenal ulcer, acute and chronic hepatitis, subacute severe hepatitis, congestive heart disease, emphysema and cancer patient's auxiliary treatment.
Ubiquinone
10Have and very easily be dissolved in chloroform, benzene, be soluble in acetone, ether, be insoluble in ethanol, the physicochemical property of water insoluble and methanol, and because ubiquinone
10Molecular structure in have quinonyl, see light, meet oxygen and very easily decompose, make it be difficult to be processed into the injection that is directly used in venoclysis.In the prior art, ubiquinone
10Dosage form be generally tablet, capsule and be used for the injection etc. of intramuscular injection owing to after tablet and the capsule oral administration first pass effect will be arranged all, so its bioavailability is not high, for solving this technical problem, Chinese patent CN1226823 is disclosed " to contain ubiquinone
10Pharmaceutical compositions " a kind of ubiquinone that contains is provided
10As the pharmaceutical compositions of active component, promote oral back ubiquinone
10Absorption; Disclosed " the ubiquinone of Japan Patent JP59148718
10Composition " for obtaining good oral absorption and effect, adopt lyophilization to make microgranule and be used for muscle or intravenous injection, but existing muscle or the intravenous ubiquinone of being used for
10Injection, need during intravenous injection to use with glucose injection or other solvent for injection dilution back, because needing to get liquid by prescription before the intravenous drip mixes, in the process for preparation of medicinal liquid, be subjected to the pollution of environment, apparatus easily, cause user to produce infusion reaction, the lighter can occur feeling sick, has a fever, feels cold, slow or too fast phenomenon are crossed in heart beating, therefore the serious entail dangers to life of going back, can be directly used in the ubiquinone of venoclysis
10It is very important that injection just seems in clinical practice, but prior art does not also break through problems such as solving its bioavailability and stability from dosage form, does not see ubiquinone
10Make the ubiquinone that can be directly used in venoclysis
10Injection and relevant report.
Summary of the invention
Deficiency at above-mentioned existing dosage form exists the object of the present invention is to provide a kind of ubiquinone that is directly used in venoclysis
10Injection need not preparation during venoclysis, avoided cross infection, has improved ubiquinone
10Clinical practice level and safety, the convenient use.
Another object of the present invention is to provide a kind of preparation above-mentioned ubiquinone
10The method of venoclysis injection adopts the inventive method to prepare ubiquinone
10Injection has solved ubiquinone
10Water-insoluble and the technical barrier of photo-labile, promoted ubiquinone
10Clinical practice.
For achieving the above object, a kind of ubiquinone
10Venous transfusion, this medicine is by ubiquinone
10Be active component and solubilizing agent, solvent for injection and osmotic pressure regulator composition, can contain following compositions by per 1000 bottles of venous transfusions:
Ubiquinone
105-60g
Polyoxyethylene sorbitan monoleate 1-200g
Solvent for injection 50-500L
Osmotic pressure regulator 0.45%-50%
The percentage ratio of wherein said osmotic pressure regulator is osmotic pressure regulator shared percentage by weight in the solution of being made up of above-mentioned component.
Described ubiquinone
10Venous transfusion, solvent for injection are selected from one or more in water, propylene glycol and the Polyethylene Glycol.
Described ubiquinone
10Venous transfusion, described osmotic pressure regulator is selected from one or both in sodium chloride and the sodium bicarbonate.
Described ubiquinone
10Venous transfusion, the preferred ingredient of per 1000 bottles of described transfusions is:
Ubiquinone
105-60g
Polyoxyethylene sorbitan monoleate 10-80g
Sodium chloride w/v 0.45%-0.9%
Water for injection 80-500L
Ubiquinone
10The venous transfusion preparation method is characterized in that comprising the steps:
1) takes by weighing each component by above-mentioned prescription, with ubiquinone
10, polyoxyethylene sorbitan monoleate mixes molten moltenly, add osmotic pressure regulator and 50% solvent for injection mixing then and get little yellow clear solution;
2) the injection active carbon of adding 0.01-0.5% in gained solution, stir, insulation is 10-30 minute in water-bath, filtered while hot, take off charcoal with the filter just of aseptic apyrogenic filter earlier, content, the aseptic no thermal source water for injection standardize solution of reuse are surveyed in sampling, making its drug content is the 5-60mg/ bottle, uses 0.22 μ m filter membrane aseptic filtration then;
3) fill is sealed, sterilization, quality examination, packing.
The ubiquinone that adopts the present invention to make
10Injection does not have first pass effect during absorption of human body, improved bioavailability, need not preparation during venoclysis, has avoided cross infection, and light, heat stability all significantly improves, and has widened the scope of application of said preparation, has very strong practicality.
The specific embodiment
Following specific embodiment is to further specify of the present invention, and therefore the present invention is not limited among the described scope of embodiments.
In the following embodiments, the preparation specification of formula for a product is every bottle of 5-60mg/, wherein ubiquinone
10Be principal agent, require by prescription dispensing respectively that the pH value of solution is in the scope of 4.0-7.0 according to different size; Solvent for injection according to the concentration of principal agent and the charging quantity of every medicine, adds an amount of as the solvent of dissolving raw material.
1, formula for a product
| Numbering | Principal agent | Solubilizing agent | Solvent for injection | Osmotic pressure regulator | Total amount (bottle) |
| 1 | Ubiquinone 10 5-60g | Polyoxyethylene sorbitan monoleate: 30g | Water for injection adds to 100L | Sodium chloride 0.6kg | 1000 bottles |
| 2 | Ubiquinone 10 5-60g | Polyoxyethylene sorbitan monoleate: 25g | Water for injection adds to 250L | Sodium chloride 2kg | 1000 bottles |
| 3 | Ubiquinone 10 5-60g | PEG400:40g polyoxyethylene sorbitan monoleate: 15g | Propylene glycol: 60g water for injection adds to 100L | Glucose 5kg | 1000 bottles |
| 4 | Ubiquinone 10 5-60g | General youth Buddhist nun restrains F-6: 80g | Water for injection adds to 200L | Glucose 20kg | 1000 bottles |
| 5 | Ubiquinone 10 5-60g | Polysorbate 40: 20g | Water for injection adds to 500L | Sorbitol: 50g sodium chloride: 4.5kg | 1000 bottles |
2, preparation technology:
1) under tight aseptic technique, in aseptic apyrogenic container, takes by weighing each component, with ubiquinone by above-mentioned prescription
10, polyoxyethylene sorbitan monoleate mixes molten moltenly, add osmotic pressure regulator and 50% solvent for injection mixing then and get little yellow clear solution;
2) the injection active carbon of adding 0.1% in gained solution, stir, insulation is 30 minutes in the water-bath, filtered while hot, take off charcoal with the filter just of aseptic apyrogenic filter earlier, content is surveyed in sampling, with aseptic no thermal source water for injection standardize solution, making its drug content is the 5-60mg/ bottle, reuse 0.22 μ m filter membrane aseptic filtration;
3) fill is sealed, sterilization, quality examination, packing.
Because ubiquinone
10Water insoluble, need earlier with polyoxyethylene sorbitan monoleate and ubiquinone
10Molten molten together, add solvent for injection again, stir, make into clear and bright solution, add osmotic pressure regulator then, stir the solution that makes into clear and bright homogeneous.Packing gets the injection finished product.
Stability experiment
Ubiquinone of the present invention
10The injection Detection of Stability is reported as follows:
Touchstone: National Drug Administration's standard (trying).
Test name: ubiquinone
10The injection stability experiment
Pilot project: strong illumination test, hot test
Test sample: ubiquinone
10Injection,
Experimental technique and result:
1, strong illumination test
The strong illumination proof box that sample of the present invention is placed tunable optical intensity is to handle 10 days under the condition of 45001x ± 5001x in light intensity, detects respectively 0 day, 5 days and the emphasis quality index of 10 days samples, can draw as drawing a conclusion from this result of the test:
Under strong illumination, no outer package sample is all with the prolongation of irradiation time, and outward appearance changes a lot, and pH value and content reduce significantly, and related substance increases significantly; Have the main quality index of sample of outer package to have no significant change, product is qualified, illustrates that this product sees that auroral poles easily decomposes, but as long as lucifuge is good, can make the product storage-stable fully.
Table 1. strong illumination result of the test
| Modes of emplacement | Test item | 0 day | 5 days | 10 days |
| Outer package is arranged | Outward appearance | The clear and bright liquid of little yellow | The clear and bright liquid of little yellow | The clear and bright liquid of little yellow |
| PH value | 5.96 | 5.90 | 5.82 | |
| Content (%) | 95.50 | 95.40 | 95.43 | |
| Clarity | Qualified | Qualified | Qualified | |
| Related substance (%) | 0.31 | 0.32 | 0.31 | |
| No outer package | Outward appearance | Little yellow clear liquid | Colourless clear liquid | Colourless clear liquid |
| PH value | 5.94 | 5.80 | 5.58 | |
| Content (%) | 95.50 | 58.45 | 30.50 | |
| Clarity | Qualified | Qualified | Qualified | |
| Related substance (%) | 0.31 | 12.86 | 41.73 |
2. hot test result
Under 40 ℃ of conditions, carry out hot test, respectively to handling 0 day, 5 days and the emphasis quality index of 10 days samples of the present invention detects, and with existing ubiquinone
10Little liquid drugs injection injection contrast, its result is shown in table 2 and table 3.According to the situation of change of content and related substance as can be known, the high-temperature stability of this product is greatly improved than the high-temperature stability of commercially available injection, so this product is longer in the effect duration at shading, airtight shady and cool place.
Table 2. hot test result (ubiquinone
10Venoclysis injection)
Table 3. hot test result (commercially available ubiquinone
10Injection)
Claims (5)
1, a kind of ubiquinone
10Venous transfusion is characterized in that this medicine is by ubiquinone
10Be active component and solubilizing agent, solvent for injection and osmotic pressure regulator composition, can contain following compositions by per 1000 bottles of venous transfusions:
Ubiquinone
105-60g
Polyoxyethylene sorbitan monoleate 1-200g
Solvent for injection 50-500L
Osmotic pressure regulator 0.45%-50%
The percentage ratio of wherein said osmotic pressure regulator is osmotic pressure regulator shared percentage by weight in the solution of being made up of above-mentioned component.
2, ubiquinone according to claim 1
10Venous transfusion is characterized in that solvent for injection is selected from one or more in water, propylene glycol and the Polyethylene Glycol.
3, ubiquinone according to claim 1
10Venous transfusion is characterized in that described osmotic pressure regulator is selected from one or more in sodium chloride, glucose and the sodium bicarbonate.
4, ubiquinone according to claim 1 and 2
10Venous transfusion is characterized in that the preferred ingredient of per 1000 bottles of described transfusions is:
Ubiquinone
105-60g
Polyoxyethylene sorbitan monoleate 10-80g
Sodium chloride 0.45%-0.9%
Water for injection 80-500L
5, a kind of ubiquinone
10The preparation method of venous transfusion is characterized in that comprising the steps:
1) takes by weighing each component by claim 1 or 2 described prescriptions, with ubiquinone
10, solubilizing agent mixes molten moltenly, add osmotic pressure regulator and 50% solvent for injection mixing then and get little yellow clear solution;
2) the injection active carbon of adding 0.01-0.5% in gained solution, stir, insulation is 10-30 minute in water-bath, filtered while hot, take off charcoal with the filter just of aseptic apyrogeneity filter earlier, content, the aseptic apyrogeneity water for injection of reuse standardize solution are surveyed in sampling, making its drug content is the 5-60mg/ bottle, uses 0.22 μ m filter membrane aseptic filtration then;
3) fill is sealed, sterilization, quality examination, packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410022007 CN1270702C (en) | 2004-03-10 | 2004-03-10 | Intravenous injection liquid of coenzyme Q10, and its prepn. method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410022007 CN1270702C (en) | 2004-03-10 | 2004-03-10 | Intravenous injection liquid of coenzyme Q10, and its prepn. method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1559387A CN1559387A (en) | 2005-01-05 |
| CN1270702C true CN1270702C (en) | 2006-08-23 |
Family
ID=34440973
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410022007 Expired - Lifetime CN1270702C (en) | 2004-03-10 | 2004-03-10 | Intravenous injection liquid of coenzyme Q10, and its prepn. method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1270702C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100525753C (en) * | 2005-11-15 | 2009-08-12 | 董英杰 | Coenzyme Q10Submicron emulsion injection and preparation method thereof |
| CN101066260B (en) * | 2006-11-17 | 2012-11-07 | 姚瑶 | Coenzyme Q10 emulsion and its freeze dried emulsion and their preparation process |
| CN101897684B (en) * | 2010-07-30 | 2014-04-30 | 西南大学 | Coenzyme Q10 injection medicinal composition packaged with plastic container |
-
2004
- 2004-03-10 CN CN 200410022007 patent/CN1270702C/en not_active Expired - Lifetime
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| Publication number | Publication date |
|---|---|
| CN1559387A (en) | 2005-01-05 |
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