CN104906055B - A kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent - Google Patents
A kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent Download PDFInfo
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Abstract
The invention provides a kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent, comprise the following steps：A) CTP, excipient and the first water for injection are mixed, carries out pH value regulation, obtain mixed solution A；B) mixed solution A is mixed with the second water for injection, is filtered, freezed and dried successively, obtain lyophilized cytidine disodium triphosphate powder needle agent；The mass ratio of first water for injection and the second water for injection is 6：(3~5).Compared with prior art, preparation method provided by the invention can effectively control the content of impurity in lyophilized cytidine disodium triphosphate powder needle agent, improve the quality stability and qualification rate of product.Test result indicates that the impurity content of the lyophilized cytidine disodium triphosphate powder needle agent obtained using preparation method provided by the invention is below 0.41%.
Description
Technical field
The present invention relates to technical field of medicine, is to be related to a kind of CTP freeze-dried powder more specifically
The preparation method of injection.
Background technology
CTP is nucleotide derivative, participates in phospholipid anabolism in vivo, it can pass through blood-brain
CSF barrier, it is intermediate product and energy source of the cephalin synthesis with nucleic acid metabolism, can also improves nerve cell membranous structure
Stability and rebuild ability, support that Neuronal Survival, delaying cell aging are dead, improve nerve cell antibody Monoclonal ability,
Promote Neurite Outgrowth.At present, after CTP clinically can effectively prevent neural cell injury or ischemic
Secondary death, can also stablize liver plasma membrane, be repaired after promoting hepatocellular injury, for cardiac muscle and brain caused by vascular sclerosis
Nutritious, promotion regeneration and repair are organized, is widely used in cerebral concussion and sequelae, cerebral hemorrhage sequelae, vegetative nerve
The auxiliary treatment of the disease such as disorderly, neurosis and cardiac insufficiency, progressive myocardial atrophy, hepatitis.
In recent years, CTP has been made various pharmaceutical dosage forms and is used for clinical treatment, wherein, with the phosphorus of injection three
Sour cytidine disodium is the most commonly used, the huge market demand.In pharmaceutical preparation production process, injection CTP is made
Into lyophilized cytidine disodium triphosphate powder needle agent.The preparation method of existing lyophilized cytidine disodium triphosphate powder needle agent includes：Using
CTP, auxiliary material and water for injection, it is freeze-dried that lyophilized cytidine disodium triphosphate powder needle agent is made.In freeze-drying process
In, moisture directly distils without liquid condition, and physics, chemical property and the shape of so dried material are substantially not
Become, loss of effective components is small, is sealed cycle length.
But existing preparation method can not control the uniformity of CTP in product, using product
During caking or dissolving it is not thorough, so as to make obtained product exist redissolve the time it is long the problem of, be unfavorable for facing for product
Bed application.
The content of the invention
In view of this, it is an object of the invention to provide a kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent,
Preparation method provided by the invention can effectively control the uniformity of CTP in product, when reducing the redissolution of product
Between.
The invention provides a kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent, comprise the following steps：
A) CTP, excipient and the first water for injection are mixed, carries out pH value regulation, obtain mixed solution
A；
B) mixed solution A is mixed with the second water for injection, is filtered, freezed and dried successively, obtain three phosphorus
Sour cytidine disodium freeze drying powder injection；
The mass ratio of first water for injection and the second water for injection is 8：(1~3).
Preferably, the mass ratio of CTP, excipient and the first water for injection described in step a) is 1：(1
~5)：(50~70).
Preferably, excipient described in step a) includes mannitol, dextran, lactose monohydrate, glucose, sweet ammonia
One or more in acid and polyvinylpyrrolidone.
Preferably, the process of the regulation of pH value described in step a) is specially：
The pH value of the mixed solution of CTP, excipient and the first water for injection is adjusted using pH adjusting agent
To 5.0~7.0, mixed solution A is obtained.
Preferably, the pH adjusting agent includes arginine, hydrochloric acid, sodium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, carbon
One or more in sour hydrogen sodium, sodium citrate, sodium lactate, sodium acetate, sodium tartrate and sodium maleate.
Preferably, the process filtered described in step b) is specially：
The mixed solution of mixed solution A and the second water for injection is subjected to refined filtration twice；
The micropore filter element aperture of the first time refined filtration is 0.4 μm~0.5 μm；The micropore filter element of second of refined filtration
Aperture is 0.2 μm~0.25 μm.
Preferably, the temperature freezed described in step b) is -45 DEG C~-35 DEG C, and the time is 1h~3h.
Preferably, the temperature dried described in step b) is 30 DEG C~40 DEG C, and the time is 2h~5h.
Preferably, process dry described in step b) is specially：
The mixed solution of mixed solution A after freezing and the second water for injection is warming up to drying temperature, place is dried
Reason, obtains lyophilized cytidine disodium triphosphate powder needle agent；
The speed of the heating is 7 DEG C/h~8 DEG C/h.
Preferably, the step b) also includes：
Before the mixed solution A is mixed with the second water for injection, the mixed solution A is pre-processed；It is described pre-
The process of processing is specially：
Decarbonisation is carried out after the mixed solution A is mixed with activated carbon.
The invention provides a kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent, comprise the following steps：A) will
CTP, excipient and the mixing of the first water for injection, carry out pH value regulation, obtain mixed solution A；B) will be described mixed
Close solution A to mix with the second water for injection, filtered, freezed and dried successively, obtain lyophilized cytidine disodium triphosphate powder needle
Agent；The mass ratio of first water for injection and the second water for injection is 8：(1~3).Compared with prior art, the present invention provides
Preparation method can effectively control the uniformity of CTP in lyophilized cytidine disodium triphosphate powder needle agent, reduce production
The redissolution time of product.Test result indicates that the CTP freeze-dried powder obtained using preparation method provided by the invention
The redissolution time of injection is within 13 seconds.
Embodiment
Below in conjunction with the embodiment of the present invention, technical scheme is clearly and completely described, it is clear that institute
The embodiment of description is only part of the embodiment of the present invention, rather than whole embodiments.Based on the embodiment in the present invention,
The every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made, belongs to this hair
The scope of bright protection.
The invention provides a kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent, comprise the following steps：
A) CTP, excipient and the first water for injection are mixed, carries out pH value regulation, obtain mixed solution
A；
B) mixed solution A is mixed with the second water for injection, is filtered, freezed and dried successively, obtain three phosphorus
Sour cytidine disodium freeze drying powder injection；
The mass ratio of first water for injection and the second water for injection is 8：(1~3).
In the present invention, CTP, excipient and the first water for injection are mixed, carries out pH value regulation, obtain
To mixed solution A.The present invention first mixes CTP, excipient and the first water for injection.In the present invention, institute
It is main ingredient to state CTP, and the present invention is not particularly limited to the source of the CTP, using ability
Commercial goods known to field technique personnel.In the present invention, the excipient preferably includes mannitol, dextran, breast
One or more in sugared monohydrate, glucose, glycine and polyvinylpyrrolidone, more preferably mannitol and dextrose
One or both of acid anhydride, most preferably mannitol.In the present invention, the CTP, excipient and the first note
It is preferably 1 to penetrate with the mass ratio of water：(1~5)：(50~70), more preferably 1：2：60.
In the present invention, the process that CTP, excipient and the first water for injection are mixed preferably has
Body is：
By CTP and excipient under conditions of stirring, it is added in the first water for injection and is mixed,
Obtain mixed solution.The present invention is not particularly limited to the method for the stirring, using well known to those skilled in the art artificial
Stirring or mechanical agitation.In the present invention, the temperature of the stirring is preferably 35 DEG C~45 DEG C, more preferably 40 DEG C.
After completing the mixing, the mixed solution of the invention by CTP, excipient and the first water for injection
Carry out pH value regulation.In the present invention, the process of the pH value regulation is preferably specially：
The pH value of the mixed solution of CTP, excipient and the first water for injection is adjusted using pH adjusting agent
To 5.0~7.0, mixed solution A is obtained.In the present invention, the pH adjusting agent preferably include arginine, hydrochloric acid, sodium hydroxide,
In disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium acid carbonate, sodium citrate, sodium lactate, sodium acetate, sodium tartrate and sodium maleate
One or more, more preferably arginine.In a preferred embodiment of the invention, the pH adjusting agent is that mass concentration is
10% arginine solution.In the present invention, using pH adjusting agent preferably by CTP, excipient and the first injection
Adjusted with the pH value of the mixed solution of water to 5.0~7.0, more preferably 5.5~6.5, most preferably 6.0.
After obtaining the mixed solution A, the present invention preferably also includes：
The mixed solution A is pre-processed.In the present invention, the purpose of the pretreatment is to improve mixed solution A
Clarity, absorption pyrogen and filtrating aid function.In the present invention, the process of the pretreatment is preferably specially：
Decarbonisation is carried out after the mixed solution A is mixed with activated carbon.In the present invention, the addition of the activated carbon
Amount is preferably 0.1 ‰~1.0 ‰, more preferably the 0.6 ‰ of mixed solution A quality.In the present invention, the time of the mixing is excellent
Elect 10min~20min, more preferably 15min as.The present invention is not particularly limited to the method for the carbonization treatment, using this
The technical scheme of activated carbon in solution is removed known to art personnel, preferably stud takes off charcoal.
After completing the pretreatment, the present invention mixes the mixed solution A with the second water for injection, carries out successively
Filter, freeze and dry, obtain lyophilized cytidine disodium triphosphate powder needle agent.In the present invention, by the mixed solution A and the second note
Penetrate and mixed with water.In the present invention, the mass ratio of first water for injection and the second water for injection is 8：(1~3), it is preferably
4：1.
In the present invention, after the mixed solution A is mixed with the second water for injection, filtered, freezed and done successively
It is dry, obtain lyophilized cytidine disodium triphosphate powder needle agent.In the present invention, the process of the filtering is preferably specially：
The mixed solution of mixed solution A and the second water for injection is subjected to refined filtration twice.Side of the present invention to the refined filtration
Method is not particularly limited, using the technical scheme of micropore filter element refined filtration well known to those skilled in the art.In the present invention,
The micropore filter element aperture of the first time refined filtration is preferably 0.4 μm~0.5 μm, more preferably 0.45 μm；Second of refined filtration
The aperture of micropore filter element be preferably 0.2 μm~0.25 μm, more preferably 0.22 μm.
After completing the filtering, the present invention is freezed the mixed solution after filtering.The present invention is set to the freezing
It is standby to be not particularly limited, using freeze dryer well known to those skilled in the art.In the present invention, the temperature of the freezing is preferred
For -45 DEG C~-35 DEG C, more preferably -40 DEG C,；The time of the freezing is preferably 1h~3h, more preferably 2h.
After completing the freezing, the mixed solution after freezing is dried the present invention, obtains CTP jelly
Dry powder injection.In the present invention, the temperature of the drying is preferably 30 DEG C~40 DEG C, more preferably 35 DEG C；The drying when
Between be preferably 2h~5h, more preferably 3.5h.In the present invention, the process of the drying is preferably specially：
The mixed solution of mixed solution A after freezing and the second water for injection is warming up to drying temperature, place is dried
Reason, obtains lyophilized cytidine disodium triphosphate powder needle agent.In the present invention, the speed of the heating is preferably 7 DEG C/h~8 DEG C/h,
More preferably 7 DEG C/h.
The invention provides a kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent, comprise the following steps：A) will
CTP, excipient and the mixing of the first water for injection, carry out pH value regulation, obtain mixed solution A；B) will be described mixed
Close solution A to mix with the second water for injection, filtered, freezed and dried successively, obtain lyophilized cytidine disodium triphosphate powder needle
Agent；The mass ratio of first water for injection and the second water for injection is 8：(1~3).Compared with prior art, the present invention provides
Preparation method can effectively control the uniformity of CTP in lyophilized cytidine disodium triphosphate powder needle agent, reduce production
The redissolution time of product.Test result indicates that the CTP freeze-dried powder obtained using preparation method provided by the invention
The redissolution time of injection is within 13 seconds.
It in addition, while preparation method provided by the invention improves product quality, can shorten the lyophilization cycle of product, it is raw
Production capacity consumption reduces, and drug safety is improved, suitable for industrial mass production.
In order to further illustrate the present invention, it is described in detail below by following examples.Following examples of the present invention
CTP used is provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Embodiment 1
Prepare the lyophilized cytidine disodium triphosphate powder needle agent 1000 that specification is 20mg/ branch：
(1) 20g CTPs and 40g mannitol are added to 1200g waters for injection first, under the conditions of 40 DEG C
Stirring, obtains the mixed solution of CTP and mannitol；Adjusted again with the arginine solution that mass concentration is 10%
PH to 6；Then 0.75g activated carbons stirring 15min is added, stud takes off charcoal afterwards, obtains mixed solution A.
(2) above-mentioned mixed solution A is mixed with 300g waters for injection, successively through 0.45 μm of micropore filter element refined filtration and 0.22 μm
Filling after micropore filter element refined filtration, half tamponade；Product is placed in freeze dryer again, 2h is freezed under the conditions of -40 DEG C, then control rises
Warm speed is after 7 DEG C/h is warming up to 35 DEG C, to dry 3.5h, obtains lyophilized cytidine disodium triphosphate powder needle agent, observes product characteristics
Loose bulk is freezed for white.
The redissolution time for the lyophilized cytidine disodium triphosphate powder needle agent that the preparation method provided the embodiment of the present invention 1 obtains
Detected, detection method is specially：5mL waters for injection are extracted with syringe, injection is equipped with the medicine bottle of 0.5mg products, note
The time that record product is completely dissolved is to redissolve the time.Test result shows that the preparation method that the embodiment of the present invention 1 provides obtains
Lyophilized cytidine disodium triphosphate powder needle agent the redissolution time be 12 seconds.
Embodiment 2
Prepare the lyophilized cytidine disodium triphosphate powder needle agent 500 that specification is 40mg/ branch：
(1) 20g CTPs and 20g mannitol are added to 1200g waters for injection first, under the conditions of 40 DEG C
Stirring, obtains the mixed solution of CTP and mannitol；Adjusted again with the arginine solution that mass concentration is 10%
PH to 6.5；Then 0.75g activated carbons stirring 15min is added, stud takes off charcoal afterwards, obtains mixed solution A.
(2) above-mentioned mixed solution A is mixed with 150g waters for injection, successively through 0.45 μm of micropore filter element refined filtration and 0.22 μm
Filling after micropore filter element refined filtration, half tamponade；Product is placed in freeze dryer again, 2h is freezed under the conditions of -45 DEG C, then control rises
Warm speed is after 8 DEG C/h is warming up to 40 DEG C, to dry 5h, obtains lyophilized cytidine disodium triphosphate powder needle agent, and observation product characteristics are
White freezes loose bulk.
The CTP that the preparation method that the method for testing provided according to embodiment 1 is provided embodiment 2 obtains
The redissolution time of freeze drying powder injection is detected, and obtains redissolving the time as 13 seconds.
Embodiment 3
Prepare the lyophilized cytidine disodium triphosphate powder needle agent 1000 that specification is 20mg/ branch：
(1) 20g CTPs and 100g mannitol are added to 1200g waters for injection first, in 40 DEG C of conditions
Lower stirring, obtains the mixed solution of CTP and mannitol；Again with the arginine solution pH that mass concentration is 10%
To 5；Then 0.75g activated carbons stirring 15min is added, stud takes off charcoal afterwards, obtains mixed solution A.
(2) above-mentioned mixed solution A is mixed with 450g waters for injection, successively through 0.45 μm of micropore filter element refined filtration and 0.22 μm
Filling after micropore filter element refined filtration, half tamponade；Product is placed in freeze dryer again, 3h is freezed under the conditions of -40 DEG C, then control rises
Warm speed is after 7 DEG C/h is warming up to 30 DEG C, to dry 2h, obtain lyophilized cytidine disodium triphosphate powder needle agent.
The CTP that the preparation method that the method for testing provided according to embodiment 1 is provided embodiment 3 obtains
The redissolution time of freeze drying powder injection is detected, and obtains redissolving the time as 13 seconds.
Comparative example
The preparation method for using prior art to provide prepares the lyophilized cytidine disodium triphosphate powder needle agent that specification is propped up for 20mg/
1000：
(1) 20g CTPs are added in 1500g waters for injection and dissolved, then with citron acid for adjusting pH to 4.5
Afterwards, activated carbon stirring and adsorbing 15min is added, filters carbon removal, then is filtered with 22 μm of filters, it is filling.
(2) product is placed in freeze dryer, 4h is freezed under the conditions of -48 DEG C, then control heating rate to be heated up for 4 DEG C/h
To after 40 DEG C, 6h is dried, obtains lyophilized cytidine disodium triphosphate powder needle agent.
The CTP that the preparation method that the method for testing provided according to embodiment 1 is provided comparative example obtains freezes
The redissolution time of dry powder injection is detected, and obtains redissolving the time as 29 seconds.
The described above of the disclosed embodiments, professional and technical personnel in the field are enable to realize or using the present invention.It is right
A variety of modifications of these embodiments will be apparent for those skilled in the art, and as defined herein one
As principle can realize in other embodiments without departing from the spirit or scope of the present invention.Therefore, the present invention will
It will not be intended to be limited to the embodiments shown herein, and be to fit to consistent with principles disclosed herein and features of novelty
Most wide scope.
Claims (3)
1. a kind of preparation method of lyophilized cytidine disodium triphosphate powder needle agent, it is characterised in that comprise the following steps：
A) CTP, excipient and the first water for injection are mixed, carries out pH value regulation, obtain mixed solution A；Institute
The mass ratio for stating CTP, excipient and the first water for injection is 1：(1~5)：(50~70)；
The process of pH value regulation is specially：
Using pH adjusting agent by the pH value of the mixed solution of CTP, excipient and the first water for injection adjust to
5.0~7.0, obtain mixed solution A；
B) after being pre-processed to the mixed solution A, the mixed solution A is mixed with the second water for injection, carried out successively
Filtering, freeze and dry, obtain lyophilized cytidine disodium triphosphate powder needle agent；
The process of the pretreatment is specially：
Decarbonisation is carried out after the mixed solution A is mixed with activated carbon；
The process of the filtering is specially：
The mixed solution of mixed solution A and the second water for injection is subjected to refined filtration twice；
The micropore filter element aperture of the first time refined filtration is 0.4 μm~0.5 μm；The aperture of the micropore filter element of second of refined filtration
For 0.2 μm~0.25 μm；
The temperature of the freezing is -45 DEG C~-35 DEG C, and the time is 1h~3h；The temperature of the drying is 30 DEG C~40 DEG C, the time
For 2h~5h；
The process of the drying is specially：
The mixed solution of mixed solution A after freezing and the second water for injection is warming up to drying temperature, processing is dried, obtains
To lyophilized cytidine disodium triphosphate powder needle agent；
The speed of the heating is 7 DEG C/h~8 DEG C/h；
The mass ratio of first water for injection and the second water for injection is 8：(1~3).
2. preparation method according to claim 1, it is characterised in that excipient described in step a) includes mannitol, the right side
Revolve the one or more in sugared acid anhydride, lactose monohydrate, glucose, glycine and polyvinylpyrrolidone.
3. preparation method according to claim 1, it is characterised in that the pH adjusting agent includes arginine, hydrochloric acid, hydrogen-oxygen
Change sodium, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium acid carbonate, sodium citrate, sodium lactate, sodium acetate, sodium tartrate and sodium maleate
In one or more.
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| CN106265538B (en) * | 2016-08-31 | 2019-05-07 | 湖南科伦制药有限公司 | A kind of preparation method of Ramosetron HCl freeze drying powder injection |
| CN107233321A (en) * | 2017-08-08 | 2017-10-10 | 湖南科伦制药有限公司 | A kind of preparation method of trinosin freeze drying powder injection |
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| CN101297796A (en) * | 2007-04-30 | 2008-11-05 | 山东京博控股发展有限公司 | Grifola frondosa beta-dextran freeze-dried powder for injection |
| CN101390873A (en) * | 2008-08-07 | 2009-03-25 | 宁辉 | Cytidine disodium triphosphate and arginine composition and preparation method thereof |
| CN101518515A (en) * | 2009-04-03 | 2009-09-02 | 四川科伦药物研究有限公司 | Cytidine disodium triphosphate freeze-dried powder-injection for injection |
| CN102757471A (en) * | 2012-07-24 | 2012-10-31 | 江西省康华医药科技有限公司 | Novel active cytidine disodium triphosphate compound and pharmaceutical composition thereof |
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| US9290530B2 (en) * | 2011-07-21 | 2016-03-22 | The Regents Of The University Of California | Chemoenzymatic synthesis of heparin and heparan sulfate analogs |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101297796A (en) * | 2007-04-30 | 2008-11-05 | 山东京博控股发展有限公司 | Grifola frondosa beta-dextran freeze-dried powder for injection |
| CN101390873A (en) * | 2008-08-07 | 2009-03-25 | 宁辉 | Cytidine disodium triphosphate and arginine composition and preparation method thereof |
| CN101518515A (en) * | 2009-04-03 | 2009-09-02 | 四川科伦药物研究有限公司 | Cytidine disodium triphosphate freeze-dried powder-injection for injection |
| CN102757471A (en) * | 2012-07-24 | 2012-10-31 | 江西省康华医药科技有限公司 | Novel active cytidine disodium triphosphate compound and pharmaceutical composition thereof |
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Address after: Yueyang economic and Technological Development Zone Industrial Park Road 414100 Hunan Kanwan chisi city in Yueyang Province Applicant after: Hunan Kelun Pharmaceutical Co., Ltd. Address before: Chengguan town of Yueyang County in Hunan province 414000 Yueyang Rong Road (county eco industrial park No. 3) Applicant before: Hunan Kelun Pharmaceutical Co., Ltd. |
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