CN107898807A - A kind of iron sucrose injection and preparation method thereof - Google Patents
A kind of iron sucrose injection and preparation method thereof Download PDFInfo
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- CN107898807A CN107898807A CN201711367005.8A CN201711367005A CN107898807A CN 107898807 A CN107898807 A CN 107898807A CN 201711367005 A CN201711367005 A CN 201711367005A CN 107898807 A CN107898807 A CN 107898807A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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Abstract
The present invention relates to field of medicine preparing technology, discloses a kind of iron sucrose injection and preparation method thereof.The preparation method of the iron sucrose injection of the present invention, it includes：The disperse system for including sucrose iron material is subjected to dilute match somebody with somebody；The pH value for the disperse system for including sucrose iron material is adjusted to alkalescence, obtains the first disperse system；First disperse system is filtered；The first disperse system after filtering is subjected to filling, sealing；The first disperse system after filling, sealing operation is sterilized；Wherein, it is dilute to be carried out with operation at 80 90 DEG C.The iron sucrose injection content of preparation meets that regulation, impurity content are small, stability is good, and technical process is environmentally friendly, energy saving, and product yield is high.The iron sucrose injection of the present invention is made using the preparation method, has the features such as impurity content is few, and quality stability is good.
Description
Technical field
The present invention relates to field of medicine preparing technology, in particular to a kind of iron sucrose injection and preparation method thereof.
Background technology
Iron deficiency is the second reason of anemia status in patients with maintenance hemodialysis, and the iron related with haemodialysis, which is lost, causes iron deficiency
Hematopoietin synthesis deficiency in one of reason uremic patient body, giving recombinant human erythropoietin can effectively control
Treat Uremic anemia.The effect of hematopoietin, depend on patient's body iron promoter, usually have and more than half use promoting erythrocyte
The patient of generation extract for treating can cause curative effect not good enough because of iron deficiency.Also having some patients to be drained because of renal function reduces, and iron promoter is normal
Or rise, but iron utilization rate reduces, and iron is unable to quick release to meet the hematopoiesis demand of marrow, produces feature asiderosis, leads
Curative effect is caused to reduce, in addition it is invalid, recapture good effect after supplementing chalybeate at this time.
Iron sucrose injection is a kind of new iron supplementary, and safety applications have been for many years abroad.Iron sucrose injection is in clinic
In be used for Oral Iron Preparations effect it is bad and need Intravenous Iron in Maintenance treat patient, such as：The intolerable patient of Oral Iron Preparations, take orally
Chalybeate absorbs bad patient etc..
Iron sucrose is that multinuclear iron hydroxide core is surrounded by the sucrose molecule of a large amount of Non-covalent bindings, and under physiological status
Ferritin structure it is similar, form the compound that average molecular weight is 43KDa.This macromolecular complex stable structure can
It is eliminated to avoid from kidney, iron ion will not be discharged in physiological conditions.The iron of intestinal mucosa is absorbed into according to body need
Or to be directly entered marrow to use for hematopoiesis, or combined with intestinal mucosa apoferritin and stored wherein in the form of ferritin.
The energy consumption in production process of existing iron sucrose injection, exhaust emission are larger, and product yield is low, and impurity is more, production
Quality is not sufficiently stable.
The content of the invention
It is an object of the invention to provide a kind of preparation method of iron sucrose injection, its preparation process energy conservation and environmental protection, production
Quality is stable, impurity is less, and product yield is high.
Another object of the present invention is to provide a kind of iron sucrose injection, its iron sucrose injection provided by the present invention
Preparation method be made, stable quality, impurity are less.
What the embodiment of the present invention was realized in：
A kind of preparation method of iron sucrose injection, it includes：
The disperse system for including sucrose iron material is subjected to dilute match somebody with somebody；
Include the pH value of the disperse system of sucrose iron material described in adjusting to alkalescence, obtain the first disperse system；
First disperse system is filtered；
First disperse system after filtering is subjected to filling, sealing；
First disperse system after filling, the described sealing operation is sterilized；
Wherein, it is described it is dilute with operation carried out at 80-90 DEG C.
In an embodiment of the present invention：
First disperse system includes：0.3~0.4g/mL sucrose iron material, pH adjusting agent and water.
In an embodiment of the present invention：
The pH value of first disperse system is 11~11.5.
In an embodiment of the present invention：
The pH adjusting agent uses sodium hydroxide.
In an embodiment of the present invention：
When sterilizing to first disperse system, sterilized using 120-125 DEG C of temperature.
In an embodiment of the present invention：
When sterilizing to first disperse system, sterilized using 121 DEG C of temperature.
In an embodiment of the present invention：
The disinfecting action is completed in sterilizing chamber, and the disinfecting action continues 8-15min.
In an embodiment of the present invention：
The disinfecting action is completed in sterilizing chamber, and the disinfecting action continues 12min.
In an embodiment of the present invention：
The container of filling first disperse system is glass ampoule bottles.
A kind of iron sucrose injection provided by the invention, is made using the preparation method of above-mentioned iron sucrose injection.
The beneficial effect of the embodiment of the present invention is：
The preparation method of the iron sucrose injection of the present invention, it includes：The disperse system for including sucrose iron material is carried out
It is dilute to match somebody with somebody；The pH value for the disperse system for including sucrose iron material is adjusted to alkalescence, obtains the first disperse system；First disperse system is carried out
Filtering；The first disperse system after filtering is subjected to filling, sealing；The first disperse system after filling, sealing operation is carried out
Sterilizing；Wherein, it is dilute to be carried out with operation at 80-90 DEG C.The iron sucrose injection content of preparation meet regulation, impurity content it is small,
Stability is good, and technical process is environmentally friendly, energy saving, and product yield is high.The iron sucrose injection of the present invention is made using the preparation method,
It is few with impurity content, the features such as quality stability is good.
Brief description of the drawings
In order to illustrate the technical solution of the embodiments of the present invention more clearly, below will be to needed in the embodiment attached
Figure is briefly described, it will be appreciated that the following drawings illustrate only certain embodiments of the present invention, therefore be not construed as pair
The restriction of scope, for those of ordinary skill in the art, without creative efforts, can also be according to this
A little attached drawings obtain other relevant attached drawings.
Fig. 1 is the preparation flow figure of iron sucrose injection in an embodiment of the present invention.
Embodiment
, below will be in the embodiment of the present invention to make the purpose, technical scheme and advantage of the embodiment of the present invention clearer
Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, builds according to normal condition or manufacturer
The condition of view carries out.Reagents or instruments used without specified manufacturer, is the conventional production that can be obtained by commercially available purchase
Product.
A kind of preparation method of iron sucrose injection of the present invention includes：
Fig. 1 is the preparation flow figure of iron sucrose injection in an embodiment of the present invention, refer to Fig. 1.
Iron sucrose injection is injection with small volume, is had no special requirements to the osmotic pressure of preparation.But in order to greatest extent
Ground reduce due to osmotic pressure it is improper caused by drug risk, should make its with normal human blood osmotic pressure (285~
It is 310mOsmol/kg) as far as possible close.Therefore the usage and dosage of the isotonic regulator of preparation is screened here.
Before studying the prescription system of preparation, the first interaction to main ingredient and auxiliary material is investigated.For parenteral solution,
The pH of system can not only influence the dissolubility of main ingredient, and can influence the stability of main ingredient.The final security for influencing medication.Cause
This, influence of the different pH value to the stability of main ingredient is most important.The preparation prescription pH value of embodiment of the present invention is set as 11-
11.5。
Comprehensive each side factor, it is as follows to draft preparation prescription：
0.3~0.4g/mL sucrose iron material and appropriate pH adjusting agent, solvent are water so that whole disperse system
PH value is adjusted to 11-11.5, obtains the first disperse system.In an embodiment of the present invention, pH adjusting agent uses the hydroxide of 0.1M
Sodium solution.
Activated carbon has the function that decoloration and absorption pyrogen.But if usage is improper to introduce pyrogen on the contrary.And use
Amount must be suitable, otherwise may influence the content of preparation due to absorption main ingredient.In an embodiment of the present invention, it is added without work
Property charcoal.
Batch temperature is screened：
Water for injection is under normal conditions, it is necessary to more than 80 DEG C insulations or more than 65 DEG C soak cycles or less than 4 DEG C storages.Root
Understand that it is slightly soluble in water according to iron sucrose raw material standard.Find that its dissolution velocity is very big by Water Temperature from experiment, therefore in work
Skill screens " batch temperature " when screening, investigate preparation at this temperature index of correlation (such as dissolving situation, dissolving it is time-consuming,
In relation to material etc.) situation.In an embodiment of the present invention, dilute timing is being carried out, is keeping 80-90 DEG C of temperature.
It is dilute match somebody with somebody after the completion of, using 0.22 μm of plate-frame filtering to filling post, measure content, it is spare.
Sterilizing parameter (temperature and time) screens：
Injection with small volume uses terminal sterilization method more.Sterilising temp is excessive or overlong time may result in main ingredient drop
Solution, influences drug content and related material.But if sterilising temp is too low or the time may not enough not reach wanting for " sterile " again
Ask.Because this product is to thermostabilization, sterilization process first choice overkill method.Common three sterilizing parameters are mainly investigated in this experiment：121
℃×8min、121℃×12min、121℃×15min。
The selection gist of packaging material：
This product inner packaging material is glass ampule.Examination according to influence factor result of the test, accelerated test and long term test
Test result and carry out thoroughly evaluating, it is final to determine that used inner packaging material is reasonable, it disclosure satisfy that transport, storage, using process
In requirement to stability.
After the completion of sterilizing, cooled down, hunted leak.
Preparation method of the iron sucrose injection provided in the embodiment of the present invention more than is made.
Embodiment 1
The present embodiment provides a kind of preparation method of iron sucrose injection.In the present embodiment, it is as follows to draft preparation prescription：
1.5g sucrose iron material, the sodium hydroxide of suitable 1M, solvent are water so that the pH value of whole disperse system is adjusted to
11, obtain the first disperse systems of 5ml.
Activated carbon is added without in first disperse system.
Mixed to sucrose iron material, sodium hydroxide by solvent of water, carry out dilute timing in dilute preparing tank, keep temperature
80 DEG C of degree.
For parenteral solution, the pH of system can not only influence the dissolubility of main ingredient, and can influence the stability of main ingredient.Finally
Influence the security of medication.Therefore, influences of the pH to the stability of main ingredient is most important.In the present embodiment, preparation order is：
Dilute preparing tank maintains the temperature at 80 DEG C, weighs the iron sucrose bulk drug of recipe quantity, adds into dilute preparing tank.Stir molten
Solution.The sodium hydroxide solution of 0.1mol/L is added, adjusts pH to 11.0；Add suitable water for injection.
It is spare to filling post, measure content to reuse 0.22 μm of plate-frame filtering.
Between semi-finished product filling, that sealing is qualified are passed to sterilizing, through damp and hot 120 DEG C, sterilize 8min.
The preparation of filling completion is cooled down, is hunted leak.
Embodiment 2
The present embodiment provides a kind of preparation method of iron sucrose injection.In the present embodiment, it is as follows to draft preparation prescription：
1.8g sucrose iron material, the sodium hydroxide of suitable 1M, solvent are water so that the pH value of whole disperse system is adjusted to
11.2, obtain the first disperse systems of 5ml.
Activated carbon is added without in first disperse system.
Mixed to sucrose iron material, sodium hydroxide by solvent of water, carry out dilute timing in dilute preparing tank, keep temperature
85 DEG C of degree.
For parenteral solution, the pH of system can not only influence the dissolubility of main ingredient, and can influence the stability of main ingredient.Finally
Influence the security of medication.Therefore, influences of the pH to the stability of main ingredient is most important.In the present embodiment, preparation order is：
Dilute preparing tank maintains the temperature at 85 DEG C, weighs the iron sucrose bulk drug of recipe quantity, adds into dilute preparing tank.Stir molten
Solution.The sodium hydroxide solution of 0.1mol/L is added, adjusts pH to 11.2；Add suitable water for injection.
It is spare to filling post, measure content to reuse 0.22 μm of plate-frame filtering.
Between semi-finished product filling, that sealing is qualified are passed to sterilizing, through damp and hot 121 DEG C, sterilize 8min.
The preparation of filling completion is cooled down, is hunted leak.
Embodiment 3
The present embodiment provides a kind of preparation method of iron sucrose injection.In the present embodiment, it is as follows to draft preparation prescription：
2g sucrose iron material, the sodium hydroxide of suitable 1M, solvent are water so that the pH value of whole disperse system is adjusted to
11.5, obtain the first disperse systems of 5ml.
Activated carbon is added without in first disperse system.
Mixed to sucrose iron material, sodium hydroxide by solvent of water, carry out dilute timing in dilute preparing tank, keep temperature
90 DEG C of degree.
For parenteral solution, the pH of system can not only influence the dissolubility of main ingredient, and can influence the stability of main ingredient.Finally
Influence the security of medication.Therefore, influences of the pH to the stability of main ingredient is most important.In the present embodiment, preparation order is：
Dilute preparing tank maintains the temperature at 90 DEG C, weighs the iron sucrose bulk drug of recipe quantity, adds into dilute preparing tank.Stir molten
Solution.The sodium hydroxide solution of 0.1mol/L is added, adjusts pH to 11.5；Add suitable water for injection.
It is spare to filling post, measure content to reuse 0.22 μm of plate-frame filtering.
Between semi-finished product filling, that sealing is qualified are passed to sterilizing, through damp and hot 125 DEG C, sterilize 12min.
The preparation of filling completion is cooled down, is hunted leak.
Embodiment 4
The present embodiment provides a kind of preparation method of iron sucrose injection.In the present embodiment, it is as follows to draft preparation prescription：
1.8g sucrose iron material, the sodium hydroxide of suitable 1M, solvent are water so that the pH value of whole disperse system is adjusted to
11.5, obtain the first disperse systems of 5ml.
Activated carbon is added without in first disperse system.
Mixed to sucrose iron material, sodium hydroxide by solvent of water, carry out dilute timing in dilute preparing tank, keep temperature
80 DEG C of degree.
For parenteral solution, the pH of system can not only influence the dissolubility of main ingredient, and can influence the stability of main ingredient.Finally
Influence the security of medication.Therefore, influences of the pH to the stability of main ingredient is most important.In the present embodiment, preparation order is：
Dilute preparing tank maintains the temperature at 80 DEG C, weighs the iron sucrose bulk drug of recipe quantity, adds into dilute preparing tank.Stir molten
Solution.The sodium hydroxide solution of 0.1mol/L is added, adjusts pH to 11.5；Add suitable water for injection.
It is spare to filling post, measure content to reuse 0.22 μm of plate-frame filtering.
Between semi-finished product filling, that sealing is qualified are passed to sterilizing, through damp and hot 121 DEG C, sterilize 8min.
The preparation of filling completion is cooled down, is hunted leak.
Embodiment 5
The present embodiment provides a kind of preparation method of iron sucrose injection.In the present embodiment, it is as follows to draft preparation prescription：
2g sucrose iron material, the sodium hydroxide of suitable 1M, solvent are water so that the pH value of whole disperse system is adjusted to 11,
Obtain the first disperse systems of 5ml.
Activated carbon is added without in first disperse system.
Mixed to sucrose iron material, sodium hydroxide by solvent of water, carry out dilute timing in dilute preparing tank, keep temperature
85 DEG C of degree.
For parenteral solution, the pH of system can not only influence the dissolubility of main ingredient, and can influence the stability of main ingredient.Finally
Influence the security of medication.Therefore, influences of the pH to the stability of main ingredient is most important.In the present embodiment, preparation order is：
Dilute preparing tank maintains the temperature at 85 DEG C, weighs the iron sucrose bulk drug of recipe quantity, adds into dilute preparing tank.Stir molten
Solution.The sodium hydroxide solution of 0.1mol/L is added, adjusts pH to 11.0；Add suitable water for injection.
It is spare to filling post, measure content to reuse 0.22 μm of plate-frame filtering.
Between semi-finished product filling, that sealing is qualified are passed to sterilizing, through damp and hot 120 DEG C, sterilize 15min.
The preparation of filling completion is cooled down, is hunted leak.
In conclusion the preparation method of the iron sucrose injection of the present invention, it includes：Point of sucrose iron material will be included
Dissipate system and carry out dilute match somebody with somebody；The pH value for the disperse system for including sucrose iron material is adjusted to alkalescence, obtains the first disperse system；By first point
Scattered system is filtered；The first disperse system after filtering is subjected to filling, sealing；By first point after filling, sealing operation
Scattered system sterilizes；Wherein, it is dilute to be carried out with operation at 80-90 DEG C.The iron sucrose injection content of preparation meets regulation, impurity
Content is small, stability is good, and technical process is environmentally friendly, energy saving, and product yield is high.The iron sucrose injection of the present invention uses the preparation side
Method is made, and has the features such as impurity content is few, and quality stability is good.
The foregoing is only a preferred embodiment of the present invention, is not intended to limit the invention, for the skill of this area
For art personnel, the invention may be variously modified and varied.Within the spirit and principles of the invention, that is made any repaiies
Change, equivalent substitution, improvement etc., should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of preparation method of iron sucrose injection, it is characterised in that it includes：
The disperse system for including sucrose iron material is subjected to dilute match somebody with somebody；
Include the pH value of the disperse system of sucrose iron material described in adjusting to alkalescence, obtain the first disperse system；
First disperse system is filtered；
First disperse system after filtering is subjected to filling, sealing；
First disperse system after filling, the described sealing operation is sterilized；
Wherein, it is described it is dilute with operation carried out at 80-90 DEG C.
2. the preparation method of iron sucrose injection according to claim 1, it is characterised in that：
First disperse system includes：0.3~0.4g/mL sucrose iron material, pH adjusting agent and water.
3. the preparation method of iron sucrose injection according to claim 2, it is characterised in that：
The pH value of first disperse system is 11~11.5.
4. the preparation method of iron sucrose injection according to claim 2, it is characterised in that：
The pH adjusting agent uses sodium hydroxide.
5. the preparation method of iron sucrose injection according to claim 1, it is characterised in that：
When sterilizing to first disperse system, sterilized using 120-125 DEG C of temperature.
6. the preparation method of iron sucrose injection according to claim 5, it is characterised in that：
When sterilizing to first disperse system, sterilized using 121 DEG C of temperature.
7. the preparation method of iron sucrose injection according to claim 5, it is characterised in that：
The disinfecting action is completed in sterilizing chamber, and the disinfecting action continues 8-15min.
8. the preparation method of iron sucrose injection according to claim 7, it is characterised in that：
The disinfecting action is completed in sterilizing chamber, and the disinfecting action continues 12min.
9. the preparation method of iron sucrose injection according to claim 1, it is characterised in that：
The container of filling first disperse system is glass ampoule bottles.
10. a kind of iron sucrose injection, it is characterised in that the iron sucrose injection is using any one of claim 1-9 institute
The preparation method for the iron sucrose injection stated is made.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711367005.8A CN107898807A (en) | 2017-12-18 | 2017-12-18 | A kind of iron sucrose injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711367005.8A CN107898807A (en) | 2017-12-18 | 2017-12-18 | A kind of iron sucrose injection and preparation method thereof |
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| CN107898807A true CN107898807A (en) | 2018-04-13 |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1739531A (en) * | 2005-09-12 | 2006-03-01 | 南京生命能科技开发有限公司 | Ferric saccharate injection for treating iron-deficiency anemia and its prepn process |
| CN101671373A (en) * | 2009-10-10 | 2010-03-17 | 天津中敖生物科技有限公司 | Preparation method for iron sucrose bulk drug and injection thereof |
| CN103040730A (en) * | 2011-10-13 | 2013-04-17 | 天津中敖生物科技有限公司 | Iron sucrose injection and preparation method thereof |
| CN103622979A (en) * | 2012-08-21 | 2014-03-12 | 天津中敖生物科技有限公司 | Preparation method of iron sucrose bulk drug and injection |
| CN106137953A (en) * | 2016-08-01 | 2016-11-23 | 嘉实（湖南）医药科技有限公司 | Iron sucrose injection and preparation method thereof |
| CN106474150A (en) * | 2016-11-25 | 2017-03-08 | 威海恒基伟业信息科技发展有限公司 | A kind of treat Iron Sucrose Injection of iron deficiency anemia and preparation method thereof |
-
2017
- 2017-12-18 CN CN201711367005.8A patent/CN107898807A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1739531A (en) * | 2005-09-12 | 2006-03-01 | 南京生命能科技开发有限公司 | Ferric saccharate injection for treating iron-deficiency anemia and its prepn process |
| CN101671373A (en) * | 2009-10-10 | 2010-03-17 | 天津中敖生物科技有限公司 | Preparation method for iron sucrose bulk drug and injection thereof |
| CN103040730A (en) * | 2011-10-13 | 2013-04-17 | 天津中敖生物科技有限公司 | Iron sucrose injection and preparation method thereof |
| CN103622979A (en) * | 2012-08-21 | 2014-03-12 | 天津中敖生物科技有限公司 | Preparation method of iron sucrose bulk drug and injection |
| CN106137953A (en) * | 2016-08-01 | 2016-11-23 | 嘉实（湖南）医药科技有限公司 | Iron sucrose injection and preparation method thereof |
| CN106474150A (en) * | 2016-11-25 | 2017-03-08 | 威海恒基伟业信息科技发展有限公司 | A kind of treat Iron Sucrose Injection of iron deficiency anemia and preparation method thereof |
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