CN103191431A - Coenzyme Q10 sodium chloride injection uneasy to crystallize and preparation method thereof - Google Patents
Coenzyme Q10 sodium chloride injection uneasy to crystallize and preparation method thereof Download PDFInfo
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- CN103191431A CN103191431A CN2013101159010A CN201310115901A CN103191431A CN 103191431 A CN103191431 A CN 103191431A CN 2013101159010 A CN2013101159010 A CN 2013101159010A CN 201310115901 A CN201310115901 A CN 201310115901A CN 103191431 A CN103191431 A CN 103191431A
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- coenzyme
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Abstract
The invention provides a coenzyme Q10 sodium chloride injection uneasy to crystallize and a preparation method thereof. The coenzyme Q10 sodium chloride injection mainly comprises the following raw materials: coenzyme Q10, tween 80, polyoxyl (40) stearate, injection water and sodium chloride. The preparation method comprises the following main steps: step A, uniformly mixing the tween 80 and the coenzyme Q10, heating the mixture in water bath to dissolve the mixture to form yellow transparent liquid, and adequately stirring and processing the yellow transparent liquid with ultrasound; step B, adding the injection water which is preheated to 60 to 80 DEG C into the solution obtained in the step A to obtain an aqueous solution, and adequately stirring and processing the aqueous solution with ultrasound; step C, adding the polyoxyl (40) stearate into the aqueous solution obtained in the step B and adequately stirring and processing with ultrasound; and step D, adding the injection water and sodium chloride, and sterilizing the mixture at high temperature and high pressure after canning the mixture. Through the formulation technology and the use of two cosolvents, the coenzyme Q10 solution can be clear for a long time, so that the product can be normally sold nationwide all the year round, and the sales cost can be greatly reduced.
Description
Technical field
The present invention relates to a kind of coenzyme Q10 sodium chloride injection and preparation method thereof, relate in particular to a kind of coenzyme Q10 sodium chloride injection that is difficult for crystallization and preparation method thereof.
Background technology
The prescription of existing coenzyme Q10 sodium chloride injection: coenzyme Q10, Tween 80, normal saline.Contain coenzyme Q10 (principal agent)-5mg in every 250ml normal saline, Tween 80 (cosolvent) 75mg, cosolvent and dissolution process defectiveness that existing coenzyme Q10 sodium chloride injection adopts, product transports at low temperatures to place after 2-3 month and crystallization namely occurs, it is muddy that liquid becomes, need to be used for injection through heat treated, especially in the winter time (storage and transportation conditions be (5)-(+10) degree centigrade), transportation through a few days, store again about 2-3 month, solution namely begins to occur muddy, and Q10 separates out from solution.
This phenomenon also can occur in spring and summer comparatively warm season, but time ratio winter long (4-6 month) that can store.Muddy injection occurs in intravenous drip, can block the syringe pipeline, can't finish injection.After muddiness appears in solution, must in hot water, carry out the heating in water bath clarification that could become again more than 10 minutes.A lot of hospitals are not free heats with condition, therefore only abandons using this product.Though coenzyme Q 10 injection has good effect for nutrition and protection heart, this defective has seriously restricted the use of product.
Summary of the invention
The invention provides a kind of coenzyme Q10 chloride injection liquid and preparation method thereof that is difficult for crystallization, originally be difficult for the coenzyme Q10 sodium chloride injection of crystallization, primary raw material comprises: coenzyme Q10, Tween 80 and stearic acid gather hydroxyl oxygen (40) fat, water for injection and sodium chloride.
Preferably, the mass ratio of coenzyme Q10 and Tween 80 is: 1:7 to 1:20.
Preferably, the mass ratio of poly-hydroxyl oxygen (40) fat of coenzyme Q10 and stearic acid is: 1:5 to 1:20.
Preferably, the mass ratio of poly-hydroxyl oxygen (40) fat of Tween 80 and stearic acid is: 7:5 to 1:1.5.
The present invention also provides the preparation method of the coenzyme Q10 sodium chloride injection that is difficult for crystallization, comprises following step:
Steps A: press Tween 80 and coenzyme Q10 mix homogeneously, the heating in water bath dissolving becomes yellow transparent liquid, fully stirs again, and is ultrasonic;
Step B: add the water for injection of 60-80 ℃ of preheating in the solution that steps A obtains, it is fully dissolved, make aqueous solution, keeping bath temperature is 70-80 ℃, fully stirs also ultrasonic.
Step C: in the aqueous solution of step B, add poly-hydroxyl oxygen (40) fat of stearic acid, fully stir also ultrasonic.
Step D: add water for injection and sodium chloride again, make the content of sodium chloride reach the concentration of normal saline, coenzyme Q10 content reaches the concentration of Recipe requirement, fully stirs high-temperature sterilization after the fill.That is: injection normal saline concentration is 0.9%.
The present invention also provides a kind of preparation method that is difficult for the coenzyme Q10 sodium chloride injection of crystallization, comprises following step:
Steps A ': after poly-hydroxyl oxygen (40) fat of Tween 80 and stearic acid mixed, under the heating in water bath state, dissolve coenzyme Q10;
Step B': add small amount of preheated again after fully stirring and arrive 60-80 ℃ water for injection, make aqueous solution, fully stirring and ultrasonic;
Step D': add water for injection and sodium chloride again, the content of sodium chloride reaches the concentration of normal saline, and coenzyme Q10 content reaches the concentration of Recipe requirement, fully stirs high-temperature sterilization after the fill.
Preferably, need preheating before the water for injection, preheat temperature is 60-80 ℃.
Preferably, steps A and steps A ' in bath temperature be 70-80 ℃.
Preferably, the bath temperature among the step B is 70-80 ℃.
Preferably, among described step B and the step C, the ultrasonic time is 10 to 15 minutes.
Coenzyme Q10 sodium chloride injection before the present invention on the market because crystallisation problems makes the province that this product is can only be in south warm, and uses in summer, and can not avoid occurring crystallization fully, has limited the sale of product greatly.The present invention is used two kinds of cosolvents by Recipe, makes coenzyme Q10 solution can keep clarification for a long time, makes can reduce selling cost greatly by product equal normal sale in China throughout the year, and the 5-10 that increases sales doubly.
The specific embodiment
Below more excellent embodiment of the present invention is described in further detail:
Embodiment 1
Prescription dosage:
Coenzyme Q10: 50mg
Tween 80: 500mg, a kind of surfactant in the state-promulgated pharmacopoeia.
Stearic acid gathers hydroxyl oxygen (40) fat (being called for short S40): be the another kind of surfactant in the state-promulgated pharmacopoeia, and ProductName: S40, prescription dosage 500mg is used with Tween 80.
Preparation method: with Tween 80 and coenzyme Q10 mix homogeneously, 70-80 ℃ of following heating in water bath dissolving becomes yellow transparent liquid according to prescription dosage.Fully stir, ultrasonic 10 minutes, in solution, add the water for injection 50ml of 60-80 ℃ of preheating again, make aqueous solution, fully stir also ultrasonic, add S40 again, fully stirring and ultrasonic adds sodium chloride and water for injection, reach the concentration that needs, total amount is 2500ml, is filled to the vial of 10 250ml, high pressure-temperature sterilization (120 degrees centigrade following 40 minutes).(concentration: contain coenzyme Q10 5mg in every 250ml normal saline, Tween 80-50mg, S40-50mg).
Embodiment 2
Prescription dosage:
Coenzyme Q10: 50mg
Tween 80: 500mg
Stearic acid gathers hydroxyl oxygen (40) fat (being called for short S40): prescription dosage 350mg.
Preparation method: with Tween 80 and coenzyme Q10 mix homogeneously, 70-80 ℃ of following heating in water bath dissolving becomes yellow transparent liquid according to prescription dosage.Fully stir, ultrasonic 10 minutes, in solution, add the water for injection of 60-80 ℃ of 50ml preheating again, make aqueous solution, fully stir and ultrasonic, add S40 again, fully stir and ultrasonic.Add sodium chloride and water for injection, reach normal saline concentration, cumulative volume reaches 2500ml, is filled in the vial of 10 250ml high pressure-temperature sterilization (120 ℃ following 40 minutes).(concentration: contain Q105mg in every 250ml normal saline, Tween 80-50mg, S40-35mg)).
Embodiment 3
Coenzyme Q10: 50mg
Tween 80: 500mg
Stearic acid gathers hydroxyl oxygen (40) fat (being called for short S40): prescription dosage 500mg.
Preparation method: with Tween 80 coenzyme Q10 mix homogeneously, 70-80 ℃ of following heating in water bath dissolving becomes yellow transparent liquid, fully stirred the back ultrasonic 15 minutes, the water for injection that in solution, adds 60-80 ℃ of preheating again, make aqueous solution, fully stirring and ultrasonic adds S40 again, fully stirring and ultrasonic.Add sodium chloride and water for injection (satisfying normal saline concentration), cumulative volume reaches 1250ml, divides 5 bottles of fills, the high pressure-temperature sterilization.(concentration: contain Q10:10mg in every 250ml normal saline, Tween 80-100mg, S40-100mg is the twice of embodiment 1).
Embodiment 4
Coenzyme Q10: 50mg
Tween 80: 500mg
Stearic acid gathers hydroxyl oxygen (40) fat (being called for short S40): prescription dosage 500mg.
Preparation method: according to prescription dosage Tween 80 is mixed with S40, add coenzyme Q10,70-80 ℃ of following heating in water bath dissolving becomes yellow transparent liquid.Fully stir, ultrasonic 12 minutes, in solution, add the water for injection of 60-80 ℃ of preheating again, make aqueous solution, fully stir also ultrasonic. add sodium chloride and water for injection (satisfying normal saline concentration), cumulative volume reaches 2500ml, divide 10 bottles of fills, autoclave sterilization.(concentration: contain Q10-5mg in every 250ml normal saline, Tween 80-50mg, S40-50mg).
Embodiment 5
Coenzyme Q10: 50mg
Tween 80: 500mg
Stearic acid gathers hydroxyl oxygen (40) fat (being called for short S40): prescription dosage 350mg.
The dosage Tween 80 of will filling a prescription mixes with Q10, and 70-80 ℃ of following heating in water bath dissolving becomes yellow transparent liquid, fully stirs the back ultrasonic 15 minutes, in solution, add the water for injection of 60-80 ℃ of preheating again, make aqueous solution, fully stir also ultrasonic, add S40 again, fully stir also ultrasonic.Add sodium chloride and water for injection (satisfying normal saline concentration), cumulative volume reaches 1250ml, again high-temperature sterilization after 5 bottles of the fills.(concentration: every bottle contains coenzyme Q10-10mg, Tween 80-100mg, S40-70mg).
Embodiment 6
The sample that will be obtained by embodiment 1 to 5, and the coenzyme Q10 sodium chloride injection of buying on the market is positioned over respectively on the simulate workbench, 100-300 rev/min of simulation bumper frequency, adjustable continuously, during experiment bumper is placed in the freezer and shakes, experimental temperature is-5-(+5) degree centigrade, and transportation and the condition of storage in imitation winter.Do not stop to carry out jolting, simulated automotive transportation in one day 24 hours.After the jolting 14 days, stop jolting, continue medicine is positioned in the freezer.2012/7/30 beginning is simulate on the simulation bumper, and experimental result is as shown in table 1.
Table 1
Embodiment | Experimental result |
Embodiment 1 | This sample up in by the end of February, 2013 till, solution remains clarification |
Embodiment 2 | This sample up in by the end of February, 2013 till, solution remains clarification |
Embodiment 3 | This sample up in by the end of February, 2013 till, solution remains clarification |
Embodiment 4 | This sample up in by the end of February, 2013 till, solution remains clarification |
Embodiment 5 | This sample up in by the end of February, 2013 till, solution remains clarification |
Comparative Examples | Crystallization appears at the beginning of 2012 10 months |
Embodiment 7
The sample that will be obtained by embodiment 1 to 5, and the coenzyme Q10 chloride injection of buying on the market are at the beginning of 2012 11 months, through logistics product is transported to Harbin, northeast from Shenzhen, place after two months, the mid-January is transported Shenzhen again back, and experimental result is as shown in table 2.
Table 2
Embodiment | Experimental result |
Embodiment 1 | Solution remains clarification |
Embodiment 2 | Solution remains clarification |
Embodiment 3 | Solution remains clarification |
Embodiment 4 | Solution remains clarification |
Embodiment 5 | Solution remains clarification |
Comparative Examples | Crystallization all appears |
Embodiment 8
The sample that will be obtained by embodiment 1 to 5, and the coenzyme Q10 sodium chloride injection of buying on the market, at the beginning of 2012 11 months, through automotive with Product transport to Urumchi, Xinjiang, place and transport Shenzhen after two months again back, experimental result is as shown in table 3.
Table 3
Embodiment | Experimental result |
Embodiment 1 | Solution remains clarification |
Embodiment 2 | Solution remains clarification |
Embodiment 3 | Solution remains clarification |
Embodiment 4 | Solution remains clarification |
Embodiment 5 | Solution remains clarification |
Comparative Examples | Crystallization all appears |
Illustrate: coenzyme Q10 is a kind of fat-soluble antioxidant, and the nutrition of energy human activin cell and cellular energy has the body immunity of raising, strengthens functions such as antioxidation, slow down aging and enhancing human activity, medically is widely used in cardiovascular system diseases.Because coenzyme Q10 is not dissolved in water, makes injection and need use cosolvent.The shortcoming of this formula for a product is that the product placement crystallization namely occurred in 2 months under low temperature environment on the current market, can stop up liquid-transport pipe-line.
Embodiment 8
Zoopery: 15 five jin rabbits whenever are five groups, the rabbit of each group is injected the injection that the sample that obtained by embodiment 1 to 5 obtains every day respectively, injection measurement is: 30ml/ days (dosage is 3 times of human body recommended dose), connecting and made a call to five days, every rabbit is not all found any untoward reaction.
Current production formulation content: contain coenzyme Q10: 5mg, Tween 80-75mg. in every 250ml sodium chloride solution
New formulation content: contain coenzyme Q10: 5mg in every 250ml sodium chloride solution, Tween 80-50mg, S40:35-50mg.
This shows that behind the compositional refinements, the coenzyme Q10 consumption in every bottle of injection does not change.The S40 cosolvent that increases is the pharmaceutic adjuvant that a kind of hypotoxicity has no side effect, and also is a kind of safe and widely used food additive, and is harmless.The content of Tween 80 has reduced 33% than original prescription, and side effect reduces.S40 does not all have pharmacology with Tween 80 and coenzyme Q10 and conflicts, and the main curative effect of this product is before identical with process modification, by the zoopery of strictness, through comprising efficacy analysis and oxicity analysis, the product curative effect is identical with former prescription, and has no side effect safely, and life-time service is harmless.
In the injection that the present invention obtains, use cosolvent for the not influence of curative effect of coenzyme Q10, this product can strengthen the heart vigor, strengthen body immunity, alternative common sodium chloride injection and multiple curative compatibility of drugs (for example various antibiotics) do not influence the medicine curative effect, simultaneously can the nutrition heart, strengthen the heart vigor, strengthen the manpower resistance, help human body to recover as early as possible.
Above content be in conjunction with concrete preferred implementation to further describing that the present invention does, can not assert that concrete enforcement of the present invention is confined to these explanations.For the general technical staff of the technical field of the invention, without departing from the inventive concept of the premise, can also make some simple deduction or replace, all should be considered as belonging to protection scope of the present invention.
Claims (10)
1. coenzyme Q10 sodium chloride injection that is difficult for crystallization, it is characterized in that primary raw material comprises: coenzyme Q10, Tween 80 and stearic acid gather hydroxyl oxygen (40) fat, water for injection and sodium chloride.
2. the coenzyme Q10 sodium chloride injection that is difficult for crystallization as claimed in claim 1 is characterized in that the mass ratio of coenzyme Q10 and Tween 80 is: 1:7 to 1:20.
3. the coenzyme Q10 sodium chloride injection that is difficult for crystallization as claimed in claim 1 is characterized in that, the mass ratio of poly-hydroxyl oxygen (40) fat of coenzyme Q10 and stearic acid is: 1:5 to 1:20..
4. the coenzyme Q10 sodium chloride injection that is difficult for crystallization as claimed in claim 1 is characterized in that, the mass ratio of poly-hydroxyl oxygen (40) fat of Tween 80 and stearic acid is: 7:5 to 1:1.5.
5. one kind prepares as each described method that is difficult for the coenzyme Q10 sodium chloride injection of crystallization of claim 1 to 4, it is characterized in that, comprises following step:
Steps A: press Tween 80 and coenzyme Q10 mix homogeneously, the heating in water bath dissolving becomes yellow transparent liquid, fully stirs again, and is ultrasonic;
Step B: in the solution that steps A obtains, add the water for injection of 60-80 ℃ of small amount of preheated, make aqueous solution, fully stir also ultrasonic;
Step C: in the aqueous solution of step B, add poly-hydroxyl oxygen (40) fat of stearic acid, fully stir also ultrasonic;
Step D: add water for injection and sodium chloride again, the content of sodium chloride reaches the concentration of normal saline, and coenzyme Q10 content reaches the concentration of Recipe requirement, fully stirs high-temperature sterilization after the fill.
6. one kind prepares as each described method that is difficult for the coenzyme Q10 sodium chloride injection of crystallization of claim 1 to 4, it is characterized in that, comprises following step:
Steps A ': after poly-hydroxyl oxygen (40) fat of Tween 80 and stearic acid mixed, under the heating in water bath state, dissolve coenzyme Q10, fully stirring;
Step B': add the water for injection of small amount of preheated again, make aqueous solution, fully stir also ultrasonic;
Step C': add water for injection and sodium chloride again, make the content of sodium chloride reach the concentration of normal saline, coenzyme Q10 content reaches the concentration of Recipe requirement, fully stirs high-temperature sterilization after the fill.
7. as claim 5 or 6 described methods, it is characterized in that the temperature of preheating was 60-80 ℃ before water for injection used.
8. as claim 5 or 6 described methods, it is characterized in that, steps A and steps A ' in bath temperature be 70-80 ℃.
9. method as claimed in claim 5 is characterized in that, the bath temperature among the step B is 70-80 ℃.
10. as claim 5 or 6 described methods, it is characterized in that among described step B and the step C, the ultrasonic time is 10 to 15 minutes.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN106491520A (en) * | 2015-09-08 | 2017-03-15 | 黄慧健 | A kind of coenzyme Q 10 injection liquid formulation and preparation method thereof |
CN111982763A (en) * | 2020-08-17 | 2020-11-24 | 上海普康药业有限公司 | Method for determining particle size and particle size distribution of coenzyme Q10 |
WO2020253710A1 (en) * | 2019-06-17 | 2020-12-24 | 宁波海奇合昇环能科技有限公司 | Method for preparing coenzyme q10 transparent aqueous dispersion |
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CN1593392A (en) * | 2004-01-15 | 2005-03-16 | 范敏华 | Freeze dried powder injection of coenzyme Q10 and its preparation process |
CN1861045A (en) * | 2006-06-20 | 2006-11-15 | 姚定全 | Coenzyme Q10 venoclysis injection |
CN101278907A (en) * | 2008-05-28 | 2008-10-08 | 喻文涛 | Coenzyme Q10 injection |
CN101480375A (en) * | 2008-08-20 | 2009-07-15 | 浙江医药股份有限公司新昌制药厂 | Coenzyme Q10 intravenous transfusion and preparation method thereof |
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- 2013-04-03 CN CN201310115901.0A patent/CN103191431B/en not_active Expired - Fee Related
Patent Citations (5)
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CN86100582A (en) * | 1986-05-21 | 1987-12-02 | 泰州生物化学制药厂 | A kind of coenzyme Q 10 injection that makes keeps clear and bright method |
CN1593392A (en) * | 2004-01-15 | 2005-03-16 | 范敏华 | Freeze dried powder injection of coenzyme Q10 and its preparation process |
CN1861045A (en) * | 2006-06-20 | 2006-11-15 | 姚定全 | Coenzyme Q10 venoclysis injection |
CN101278907A (en) * | 2008-05-28 | 2008-10-08 | 喻文涛 | Coenzyme Q10 injection |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN106491520A (en) * | 2015-09-08 | 2017-03-15 | 黄慧健 | A kind of coenzyme Q 10 injection liquid formulation and preparation method thereof |
WO2020253710A1 (en) * | 2019-06-17 | 2020-12-24 | 宁波海奇合昇环能科技有限公司 | Method for preparing coenzyme q10 transparent aqueous dispersion |
CN111982763A (en) * | 2020-08-17 | 2020-11-24 | 上海普康药业有限公司 | Method for determining particle size and particle size distribution of coenzyme Q10 |
CN111982763B (en) * | 2020-08-17 | 2021-05-14 | 上海普康药业有限公司 | Method for determining particle size and particle size distribution of coenzyme Q10 |
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