CN110123835A - A kind of preparation method of iron dextran injection - Google Patents
A kind of preparation method of iron dextran injection Download PDFInfo
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- CN110123835A CN110123835A CN201910507689.XA CN201910507689A CN110123835A CN 110123835 A CN110123835 A CN 110123835A CN 201910507689 A CN201910507689 A CN 201910507689A CN 110123835 A CN110123835 A CN 110123835A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/721—Dextrans
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P7/06—Antianaemics
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Abstract
The invention discloses a kind of preparation methods of iron dextran injection, it is related to pharmaceutical production technology field, solve the problems, such as that existing production technology complex reaction yield is low, a kind of preparation method of iron dextran injection has technical point that comprising the following specific steps S1 alkalizes；S2 acidification；S3 complex reaction；S4 purification；S5 is prepared and encapsulating；A kind of preparation method of iron dextran injection is by adjusting complex reaction process, the additional amount and addition sequence of Different Optimization sodium hydroxide and iron chloride, complex reaction is allowed constantly to carry out, iron ion is avoided to become ferric hydroxide precipitate in advance under alkaline environment, influence the whole yield of iron dextran injection, the waste for reducing raw material, improves the utilization rate of product.
Description
Technical field
The present invention relates to a kind of pharmaceutical production technique, the preparation methods of specifically a kind of iron dextran injection.
Background technique
Dextran (dextran), is a kind of high molecular polymer as made of several glucose polymerisations, and also referred to as Portugal is poly-
Sugar since the glucose molecule number of polymerization is different, and generates the product of different molecular weight, comprising: high molecular dextran (weight
Average molecular weight 100-200kDa), medium molecular dextran (weight average molecular weight 60-80kDa), D-40 (divide equally again
Son amount 20-40kDa) Dextran 10 (weight average molecular weight 10-20kDa), scintilla dextran (weight average molecular weight 7-
10kDa) and special scintilla dextran (weight average molecular weight 3-6kDa)；Iron-dextrin can be obtained in dextran and iron complexing.
And iron dextran injection indication is unsatisfied scarce suitable for being unable to Oral Iron Preparations or Oral Iron Preparations treatment
Iron patient, iron dextran injection cause the production process finished product of iron dextran injection to be received due to complex reaction complexity
Rate is low, and consumption of raw materials is larger.
Therefore, it is proposed that a kind of preparation method of iron dextran injection solves the above problems.
Summary of the invention
The purpose of the present invention is to provide a kind of preparation methods of iron dextran injection, to solve above-mentioned background technique
The problem of middle proposition.
To achieve the above object, the invention provides the following technical scheme:
A kind of preparation method of iron dextran injection, comprising the following steps:
S1 alkalization
In reaction pot plus the scintilla dextran of 45~50 DEG C of water for injection 15000ml warming-in-water addition 10kg stirs
It mixes, the sodium hydroxide solution 3000ml that mass fraction 20% is slowly added dropwise makes into clear solution；
S2 acidification
Bath temperature is controlled at 55~60 DEG C, the ferric trichloride that mass fraction is 40% is slowly added dropwise under vigorous stirring
Solution 3000ml, time for adding 1.5h；
S3 complex reaction
Bath temperature is continued to rise to 95~100 DEG C, at the same be added dropwise mass fraction be 40% liquor ferri trichloridi with
The sodium hydroxide solution that mass fraction is 20%, the total amount of liquor ferri trichloridi are 40000ml, the sodium hydroxide solution total amount
For 34000~35000ml, time for adding is not less than 5 hours, and after the completion of dropwise operation, the reaction was continued 1 hour, final tune
Saving pH value is 7.0~7.5；
S4 purification
It extracts reaction solution under moderate-speed mixer, slowly pours into ethyl alcohol, dextran iron precipitate will be precipitated and press dry, heat molten
Heating eliminates ethyl alcohol in appropriate water for injection, filters, and is measured by sampling, and after qualified, i.e., uses for preparing injection
S5 is prepared and encapsulating
Above-mentioned solution is taken, filling, which is penetrated, is diluted with water to normal concentration, after adding the benzyl alcohol that mass fraction is 1%, passes through again
Encapsulating after filtering packs refrigeration after carrying out high-temperature sterilization.
As a further solution of the present invention: at first the alkalinization can carry out at normal temperature, sodium hydroxide to be added dropwise
Amount is to be warming up to 55~85 DEG C of reactions not less than 2600ml；
As a further solution of the present invention: it is fast after first slow when the liquor ferri trichloridi is added dropwise, avoid the formation of hydroxide
Iron precipitating.
As a further solution of the present invention: 120~150 revs/min of the revolving speed of the moderate-speed mixer.
As a further solution of the present invention: the concentration of the ethyl alcohol is 90% or more.
As the present invention further scheme: the preparation be formulated into potting process encapsulating terminate it is small no more than 8
When.
As a further solution of the present invention: the high-temperature sterilization uses 116 DEG C of sterilizing 30min.
Compared with prior art, the beneficial effects of the present invention are: a kind of preparation method of iron dextran injection is effective
Optimize iron-dextrin complex reaction process, reduces the waste of raw material, improve the yield of product
Specific embodiment
Technical solution of the present invention is described in more detail With reference to embodiment.
Embodiment 1
A kind of preparation method of iron dextran injection, comprising the following steps:
S1 alkalization
In reaction pot plus the scintilla dextran of 45~50 DEG C of water for injection 15000ml warming-in-water addition 10kg stirs
It mixes, the sodium hydroxide solution 3000ml that mass fraction 20% is slowly added dropwise makes into clear solution；
S2 acidification
Bath temperature is controlled at 55~60 DEG C, the ferric trichloride that mass fraction is 40% is slowly added dropwise under vigorous stirring
Solution 3000ml, time for adding 1.5h；
S3 complex reaction
Bath temperature is continued to rise to 95~100 DEG C, at the same be added dropwise mass fraction be 40% liquor ferri trichloridi with
The sodium hydroxide solution that mass fraction is 20%, the total amount of liquor ferri trichloridi are 40000ml, the sodium hydroxide solution total amount
For 34000~35000ml, time for adding is 5 hours, and after the completion of dropwise operation, the reaction was continued 1 hour, final adjusting PH
Value is 7.0；
S4 purification
It extracts reaction solution under moderate-speed mixer, slowly pours into ethyl alcohol, dextran iron precipitate will be precipitated and press dry, heat molten
Heating eliminates ethyl alcohol in appropriate water for injection, filters, and is measured by sampling, and after qualified, i.e., uses for preparing injection；
S5 is prepared and encapsulating
Above-mentioned solution is taken, filling, which is penetrated, is diluted with water to normal concentration, after adding the benzyl alcohol that mass fraction is 1%, passes through again
Encapsulating after filtering packs refrigeration after carrying out high-temperature sterilization.
It is first slow rear fast when the liquor ferri trichloridi is added dropwise, avoid the formation of ferric hydroxide precipitate.
120~150 revs/min of the revolving speed of the moderate-speed mixer.
The concentration of the ethyl alcohol is 90% or more.
Encapsulating is formulated into the preparation and potting process to be terminated to be no more than 8 hours.
The high-temperature sterilization uses 116 DEG C of sterilizing 30min.
Embodiment 2
A kind of preparation method of iron dextran injection, comprising the following steps:
S1 alkalization
The water for injection 15000ml of room temperature is added in reaction pot, then adds the scintilla dextran stirring of 10kg,
The sodium hydroxide solution 3000ml that mass fraction 20% is slowly added dropwise makes into clear solution, sodium hydroxide solution additional amount to be added dropwise
When not less than 2600ml, it is warming up to 55~85 DEG C of reactions；
S2 acidification
Bath temperature is controlled at 55~60 DEG C, the ferric trichloride that mass fraction is 40% is slowly added dropwise under vigorous stirring
Solution 3000ml, time for adding 1.5h；
S3 complex reaction
Bath temperature is continued to rise to 95~100 DEG C, at the same be added dropwise mass fraction be 40% liquor ferri trichloridi with
The sodium hydroxide solution that mass fraction is 20%, the total amount of liquor ferri trichloridi are 40000ml, the sodium hydroxide solution total amount
For 34000~35000ml, time for adding is 5 hours, and after the completion of dropwise operation, the reaction was continued 1 hour, final adjusting PH
Value is 7.0；
S4 purification
It extracts reaction solution under moderate-speed mixer, slowly pours into ethyl alcohol, dextran iron precipitate will be precipitated and press dry, heat molten
Heating eliminates ethyl alcohol in appropriate water for injection, filters, and is measured by sampling, and after qualified, i.e., uses for preparing injection
S5 is prepared and encapsulating
Above-mentioned solution is taken, filling, which is penetrated, is diluted with water to normal concentration, after adding the benzyl alcohol that mass fraction is 1%, passes through again
Encapsulating after filtering packs refrigeration after carrying out high-temperature sterilization.
It is first slow rear fast when the liquor ferri trichloridi is added dropwise, avoid the formation of ferric hydroxide precipitate.
120~150 revs/min of the revolving speed of the moderate-speed mixer.
The concentration of the ethyl alcohol is 90% or more.
Encapsulating is formulated into the preparation and potting process to be terminated to be no more than 8 hours.
The high-temperature sterilization uses 116 DEG C of sterilizing 30min.
Embodiment 3
A kind of preparation method of iron dextran injection, comprising the following steps:
S1 alkalization
The water for injection 15000ml of room temperature is added in reaction pot, then adds the scintilla dextran stirring of 10kg,
The sodium hydroxide solution 3000ml that mass fraction 20% is slowly added dropwise makes into clear solution, sodium hydroxide solution additional amount to be added dropwise
When not less than 2600ml, it is warming up to 55~85 DEG C of reactions；
S2 acidification
Bath temperature is controlled at 55~60 DEG C, the ferric trichloride that mass fraction is 40% is slowly added dropwise under vigorous stirring
Solution 3000ml, time for adding 1.5h；
S3 complex reaction
Bath temperature is continued to rise to 95~100 DEG C, at the same be added dropwise mass fraction be 40% liquor ferri trichloridi with
The sodium hydroxide solution that mass fraction is 20%, the total amount of liquor ferri trichloridi are 40000ml, the sodium hydroxide solution total amount
For 34000~35000ml, time for adding is 5 hours, and after the completion of dropwise operation, the reaction was continued 1 hour, final adjusting PH
Value is 7.2；
S4 purification
It extracts reaction solution under moderate-speed mixer, slowly pours into ethyl alcohol, dextran iron precipitate will be precipitated and press dry, heat molten
Heating eliminates ethyl alcohol in appropriate water for injection, filters, and is measured by sampling, and after qualified, i.e., uses for preparing injection
S5 is prepared and encapsulating
Above-mentioned solution is taken, filling, which is penetrated, is diluted with water to normal concentration, after adding the benzyl alcohol that mass fraction is 1%, passes through again
Encapsulating after filtering packs refrigeration after carrying out high-temperature sterilization.
It is first slow rear fast when the liquor ferri trichloridi is added dropwise, avoid the formation of ferric hydroxide precipitate.
120~150 revs/min of the revolving speed of the moderate-speed mixer.
The concentration of the ethyl alcohol is 90% or more.
Encapsulating is formulated into the preparation and potting process to be terminated to be no more than 8 hours.
The high-temperature sterilization uses 116 DEG C of sterilizing 30min.
Embodiment 4
A kind of preparation method of iron dextran injection, comprising the following steps:
S1 alkalization
The water for injection 15000ml of room temperature is added in reaction pot, then adds the scintilla dextran stirring of 10kg,
The sodium hydroxide solution 3000ml that mass fraction 20% is slowly added dropwise makes into clear solution, sodium hydroxide solution additional amount to be added dropwise
When not less than 2600ml, it is warming up to 55~85 DEG C of reactions；
S2 acidification
Bath temperature is controlled at 55~60 DEG C, the ferric trichloride that mass fraction is 40% is slowly added dropwise under vigorous stirring
Solution 3000ml, time for adding 1.5h；
S3 complex reaction
Bath temperature is continued to rise to 95~100 DEG C, at the same be added dropwise mass fraction be 40% liquor ferri trichloridi with
The sodium hydroxide solution that mass fraction is 20%, the total amount of liquor ferri trichloridi are 40000ml, the sodium hydroxide solution total amount
For 34000~35000ml, time for adding is 5 hours, and after the completion of dropwise operation, the reaction was continued 1 hour, final adjusting PH
Value is 7.5；
S4 purification
It extracts reaction solution under moderate-speed mixer, slowly pours into ethyl alcohol, dextran iron precipitate will be precipitated and press dry, heat molten
Heating eliminates ethyl alcohol in appropriate water for injection, filters, and is measured by sampling, and after qualified, i.e., uses for preparing injection
S5 is prepared and encapsulating
Above-mentioned solution is taken, filling, which is penetrated, is diluted with water to normal concentration, after adding the benzyl alcohol that mass fraction is 1%, passes through again
Encapsulating after filtering packs refrigeration after carrying out high-temperature sterilization.
It is first slow rear fast when the liquor ferri trichloridi is added dropwise, avoid the formation of ferric hydroxide precipitate.
120~150 revs/min of the revolving speed of the moderate-speed mixer.
The concentration of the ethyl alcohol is 90% or more.
Encapsulating is formulated into the preparation and potting process to be terminated to be no more than 8 hours.
The high-temperature sterilization uses 116 DEG C of sterilizing 30min.
Embodiment 5
A kind of preparation method of iron dextran injection, comprising the following steps:
S1 alkalization
The water for injection 15000ml of room temperature is added in reaction pot, then adds the scintilla dextran stirring of 10kg,
The sodium hydroxide solution 3000ml that mass fraction 20% is slowly added dropwise makes into clear solution, sodium hydroxide solution additional amount to be added dropwise
When not less than 2600ml, it is warming up to 55~85 DEG C of reactions；
S2 acidification
Bath temperature is controlled at 55~60 DEG C, the ferric trichloride that mass fraction is 40% is slowly added dropwise under vigorous stirring
Solution 3000ml, time for adding 1.5h；
S3 complex reaction
Bath temperature is continued to rise to 95~100 DEG C, at the same be added dropwise mass fraction be 40% liquor ferri trichloridi with
The sodium hydroxide solution that mass fraction is 20%, the total amount of liquor ferri trichloridi are 40000ml, the sodium hydroxide solution total amount
For 34000~35000ml, time for adding is 6 hours, and after the completion of dropwise operation, the reaction was continued 1 hour, final adjusting PH
Value is 7.5；
S4 purification
It extracts reaction solution under moderate-speed mixer, slowly pours into ethyl alcohol, dextran iron precipitate will be precipitated and press dry, heat molten
Heating eliminates ethyl alcohol in appropriate water for injection, filters, and is measured by sampling, and after qualified, i.e., uses for preparing injection
S5 is prepared and encapsulating
Above-mentioned solution is taken, filling, which is penetrated, is diluted with water to normal concentration, after adding the benzyl alcohol that mass fraction is 1%, passes through again
Encapsulating after filtering packs refrigeration after carrying out high-temperature sterilization.
It is first slow rear fast when the liquor ferri trichloridi is added dropwise, avoid the formation of ferric hydroxide precipitate.
120~150 revs/min of the revolving speed of the moderate-speed mixer.
The concentration of the ethyl alcohol is 90% or more.
Encapsulating is formulated into the preparation and potting process to be terminated to be no more than 8 hours.
The high-temperature sterilization uses 116 DEG C of sterilizing 30min.
The principle of the present invention is: it is anti-that a kind of preparation method of iron dextran injection effectively optimizes iron-dextrin complexing
Process is answered, the waste of raw material is reduced, improves the yield of product.
Better embodiment of the invention is explained in detail above, but the present invention is not limited to above-mentioned embodiment party
Formula within the knowledge of one of ordinary skill in the art can also be without departing from the purpose of the present invention
It makes a variety of changes.
Claims (7)
1. a kind of preparation method of iron dextran injection, which comprises the following steps:
S1 alkalization
In reaction pot plus the scintilla dextran of 45~50 DEG C of water for injection 15000ml warming-in-water addition 10kg stirs, and delays
The slow sodium hydroxide solution 3000ml that mass fraction 20% is added dropwise makes into clear solution；
S2 acidification
Bath temperature is controlled at 55~60 DEG C, the liquor ferri trichloridi that mass fraction is 40% is slowly added dropwise under vigorous stirring
3000ml, time for adding 1.5h；
S3 complex reaction
Bath temperature is continued to rise to 95~100 DEG C, while liquor ferri trichloridi and quality that mass fraction is 40% is added dropwise
The total amount of the sodium hydroxide solution that score is 20%, liquor ferri trichloridi is 40000ml, and the sodium hydroxide solution total amount is
34000~35000ml, time for adding are not less than 5 hours, and after the completion of dropwise operation, the reaction was continued 1 hour, final adjusting
PH value is 7.0~7.5；
S4 purification
It extracts reaction solution under moderate-speed mixer, slowly pours into ethyl alcohol, dextran iron precipitate will be precipitated and press dry, heating is dissolved in suitable
Heating eliminates ethyl alcohol in amount water for injection, filters, and is measured by sampling, and after qualified, i.e., uses for preparing injection
S5 is prepared and encapsulating
Above-mentioned solution is taken, filling, which is penetrated, is diluted with water to normal concentration, after adding the benzyl alcohol that mass fraction is 1%, again passes by filter
Encapsulating afterwards packs refrigeration after carrying out high-temperature sterilization.
2. the preparation method of iron dextran injection according to claim 1, which is characterized in that the alkalinization rises
It can first carry out at normal temperature, amount of sodium hydroxide to be added dropwise is to be warming up to 55~85 DEG C of reactions not less than 2600ml.
3. the preparation method of iron dextran injection according to claim 1, which is characterized in that the ferric trichloride is molten
It is fast after the drop added-time is first slow, avoid the formation of ferric hydroxide precipitate.
4. the preparation method of iron dextran injection according to claim 1, which is characterized in that the moderate-speed mixer
120~150 revs/min of revolving speed.
5. the preparation method of iron dextran injection according to claim 1, which is characterized in that the concentration of the ethyl alcohol
90% or more.
6. the preparation method of iron dextran injection according to claim 1, which is characterized in that the preparation and encapsulating
Being formulated into encapsulating in the process terminates to be no more than 8 hours.
7. the preparation method of iron dextran injection according to claim 1, which is characterized in that the high-temperature sterilization is adopted
With 116 DEG C of sterilizing 30min.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1102981A (en) * | 1993-11-23 | 1995-05-31 | 广西南宁金星实业开发公司 | Ferric selenium injection for animal |
| WO2009063018A1 (en) * | 2007-11-13 | 2009-05-22 | Agilan Gmbh | Aqueous iron dextran preparation having one or more para-hydroxybenzoate compounds and/or salts thereof |
| CN102429865A (en) * | 2011-12-01 | 2012-05-02 | 广西壮族自治区化工研究院 | Preparation method of super-micro molecular iron dextran |
| CN106543294A (en) * | 2015-09-18 | 2017-03-29 | 瑞普（天津）生物药业有限公司 | A kind of preparation method of iron-dextrin |
| CN107049933A (en) * | 2017-02-28 | 2017-08-18 | 广西壮族自治区化工研究院 | A kind of weight average molecular weight is the preparation method of 3,000 24000 iron dextran injection |
-
2019
- 2019-06-12 CN CN201910507689.XA patent/CN110123835A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1102981A (en) * | 1993-11-23 | 1995-05-31 | 广西南宁金星实业开发公司 | Ferric selenium injection for animal |
| WO2009063018A1 (en) * | 2007-11-13 | 2009-05-22 | Agilan Gmbh | Aqueous iron dextran preparation having one or more para-hydroxybenzoate compounds and/or salts thereof |
| CN102429865A (en) * | 2011-12-01 | 2012-05-02 | 广西壮族自治区化工研究院 | Preparation method of super-micro molecular iron dextran |
| CN106543294A (en) * | 2015-09-18 | 2017-03-29 | 瑞普（天津）生物药业有限公司 | A kind of preparation method of iron-dextrin |
| CN107049933A (en) * | 2017-02-28 | 2017-08-18 | 广西壮族自治区化工研究院 | A kind of weight average molecular weight is the preparation method of 3,000 24000 iron dextran injection |
Non-Patent Citations (1)
| Title |
|---|
| 仲肇明等: "右旋糖酐铁注射液的制备", 《医药工业》 * |
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