CN107157925A - Aramine parenteral solution and preparation method thereof - Google Patents
Aramine parenteral solution and preparation method thereof Download PDFInfo
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- CN107157925A CN107157925A CN201710384596.3A CN201710384596A CN107157925A CN 107157925 A CN107157925 A CN 107157925A CN 201710384596 A CN201710384596 A CN 201710384596A CN 107157925 A CN107157925 A CN 107157925A
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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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
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Abstract
The invention discloses a kind of aramine parenteral solution, included in every 10000mL parenteral solutions：Aramine 190g, 90~110g of sodium chloride, 10~20g of sodium hydrogensulfite, 0.05~0.2g of mosatil, 0.01~0.1g of lipoic acid, surplus is water.The invention also discloses a kind of preparation method of aramine parenteral solution, including：Step 1: concentrated compounding：Water for injection is taken, leads to nitrogen, sodium hydrogensulfite and sodium chloride are dissolved afterwards, lipoic acid, mosatil and aramine is sequentially added, leads to nitrogen to saturation, filtering；Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, amount of preparation is injected water to, circulating filtration obtains semi-finished product to clear and bright；Step 3: nitrogen charging embedding after semi-finished product are filtered, 100 DEG C of flowing steam sterilizes 15 minutes, hunt leak, cooling obtains aramine parenteral solution.The inventive method and material is easy and effective, cost is relatively low, and indices meet the relevant regulations of State Food and Drug Administration.
Description
Technical field
The invention belongs to pharmaceutical field, it is related to a kind of aramine parenteral solution and preparation method thereof.
Background technology
Aramine is chemical name：(-)-α (1- aminoethyls) -3- salicylic alcohol bitartrates, weight wine
The acute hypotension occurred when stone acid aramine parenteral solution indication is 1. preventing and treating block inside vertebral canal anesthesia；2. due to bleeding, medicine
Thing allergy, postoperative complication and brain trauma or brain tumor Merger shock and the low blood pressure occurred, available for complementary symptomatic treatment；
3. it can also be used for the low blood pressure caused by cardiogenic shock or septicemia.Aramine parenteral solution is in preparation, storage, transport
During use, Oxidative demage is highly prone to, causes some or all of forfeiture of its effective component, influence patient's treatment.Cause
How this, avoided aramine not oxidized in each process, is the thorny problem that this area faces.
The content of the invention
It is an object of the invention to solve at least the above and/or defect, and provide at least will be described later excellent
Point.
It is a still further object of the present invention to provide a kind of aramine parenteral solution.
A further object of the present invention is to provide a kind of preparation method of aramine parenteral solution.
Therefore, the technical scheme that the present invention is provided is：
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, 90~110g of sodium chloride, 10~20g of sodium hydrogensulfite, mosatil 0.05~
0.2g, 0.01~0.1g of lipoic acid, surplus is water.
A kind of preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to room temperature, and logical nitrogen takes partial syringe water first afterwards to saturation,
The sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, lipoic acid, the edetic acid(EDTA) of recipe quantity is sequentially added
Calcium sodium and aramine, then lead to nitrogen to saturation, using 3 μm of titanium rod filter coarse filtration, are filled into dilute preparing tank again,
Subsequently added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection, and inject dilute preparing tank, until dense preparing tank
Rinsed well with the dead space capacity in titanium rod filter；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, amount of preparation is injected water to, is stirred, is passed through
The plate and frame filter press circulating filtration of 0.22 μm of filter membrane obtains semi-finished product to clear and bright；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
Preferably, in the preparation method of described aramine parenteral solution, in step one, water for injection cooling
To less than 30 DEG C.
Preferably, in the preparation method of described aramine parenteral solution, in the step 2, if necessary also
Solution ph is adjusted to 3.2~3.5 with liquor epinephrinae bitartratis ophthalmicus.
Preferably, in the preparation method of described aramine parenteral solution, the preparation side of the water for injection
Method includes：
(1) purified water is prepared；
(2) purified water is obtained into primary injection water after repeatedly distillation, sequentially passes through 0.45 μm and 0.22 μm
Millipore filter is filtered, and sterilize 15~20min at 121 DEG C of temperature afterwards, is then passed through nitrogen thereto again to saturation, obtains
To water for injection.
Preferably, in the preparation method of described aramine parenteral solution, also include in the step one
Take water for injection to be first heated to after 120 DEG C, be evacuated 15~20min using air extractor afterwards, be then passed through thereto again
15% (v/v) carbon dioxide, it is finally cold again to go to room temperature.
Preferably, in the preparation method of described aramine parenteral solution, in the step one, will be molten
Before liquid injection dilute preparing tank, first with water for injection filtration and washing filter, pipeline and dilute preparing tank, solution is injected described again afterwards
In dilute preparing tank.
The present invention at least includes following beneficial effect：
Contain mosatil in the parenteral solution of the present invention, can preferably suppress the oxidation of parenteral solution, while of the invention
Parenteral solution in be additionally added middle lipoic acid, lipoic acid and mosatil synergy, it is to avoid parenteral solution is preparing, storage and
The generation of the other impurities caused during use due to oxidation, aramine parenteral solution of the invention is substantially without miscellaneous
Matter, holding time are long, produce a desired effect when in use.
The present invention keeps nitrogen saturation state in solution, it is to avoid the oxidation of aramine in preparation process,
Before water for injection use, it is sterilized first, is evacuated again afterwards, and is passed through carbon dioxide thereto, it is ensured that
Water for injection no oxygen exist, it is ensured that later stage preparation process it is smooth, efficiently and quickly carry out.
Preparation technology Application way and material of the invention is easy and effective, cost is relatively low, and effective reduction production cost 10~
15%, and indices meet the relevant regulations of State Food and Drug Administration.
Further advantage, target and the feature of the present invention embodies part by following explanation, and part will also be by this
The research and practice of invention and be understood by the person skilled in the art.
Embodiment
With reference to embodiment, the present invention is described in further detail, to make those skilled in the art with reference to specification
Word can be implemented according to this.
It should be appreciated that such as " having ", "comprising" and " comprising " term used herein do not allot one or many
The presence or addition of individual other elements or its combination.
The present invention provides a kind of aramine parenteral solution, including：
Aramine 190g, 90~110g of sodium chloride, 10~20g of sodium hydrogensulfite, mosatil 0.05~
0.2g, 0.01~0.1g of lipoic acid, surplus is water.
The present invention also provides a kind of preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to room temperature, and logical nitrogen takes partial syringe water first afterwards to saturation,
The sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, lipoic acid, the edetic acid(EDTA) of recipe quantity is sequentially added
Calcium sodium and aramine, then lead to nitrogen to saturation, using 3 μm of titanium rod filter coarse filtration, are filled into dilute preparing tank again,
Subsequently added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection, and inject dilute preparing tank, until dense preparing tank
Rinsed well with the dead space capacity in titanium rod filter；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, amount of preparation is injected water to, is stirred, is passed through
The plate and frame filter press circulating filtration of 0.22 μm of filter membrane obtains semi-finished product to clear and bright；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
In one of embodiment of the present invention, preferably, in step one, water for injection is cooled to less than 30 DEG C.
In one of embodiment of the present invention, preferably, in the step 2, also being adjusted if necessary with liquor epinephrinae bitartratis ophthalmicus
Solution ph is saved to 3.2~3.5..
In one of embodiment of the present invention, preferably, the preparation method of the water for injection includes：
(1) purified water is prepared；
(2) purified water is obtained into primary injection water after repeatedly distillation, sequentially passes through 0.45 μm and 0.22 μm
Millipore filter is filtered, and sterilize 15~20min at 121 DEG C of temperature afterwards, is then passed through nitrogen thereto again to saturation, obtains
To water for injection.
In one of embodiment of the present invention, preferably, also including taking water for injection first in the step one
First it is heated to after 120 DEG C, is evacuated 15~20min using air extractor afterwards, is then passed through the two of 15% (v/v) thereto again
Carbonoxide, it is finally cold again to go to room temperature.
In one of embodiment of the present invention, preferably, in the step one, solution is being injected into dilute preparing tank
Before, first with water for injection filtration and washing filter, pipeline and dilute preparing tank, solution is injected in the dilute preparing tank again afterwards.
To make those skilled in the art more fully understand the present invention, following examples are now provided.
Embodiment 1
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, sodium chloride 90g, sodium hydrogensulfite 10g, mosatil 0.05g, lipoic acid
0.01g, surplus is water.
As above the preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to room temperature, and logical nitrogen takes partial syringe water first afterwards to saturation,
The sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, lipoic acid, the edetic acid(EDTA) of recipe quantity is sequentially added
Calcium sodium and aramine, then lead to nitrogen to saturation, using 3 μm of titanium rod filter coarse filtration, are filled into dilute preparing tank again,
Subsequently added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection, and inject dilute preparing tank, until dense preparing tank
Rinsed well with the dead space capacity in titanium rod filter；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, amount of preparation is injected water to, is stirred, is passed through
The plate and frame filter press circulating filtration of 0.22 μm of filter membrane obtains semi-finished product to clear and bright；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
Embodiment 2
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, sodium chloride 110g, sodium hydrogensulfite 20g, mosatil 0.2g, lipoic acid
0.1g, surplus is water.
As above the preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to less than 30 DEG C, and logical nitrogen takes partial syringe first afterwards to saturation
With water, the sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, sequentially add recipe quantity lipoic acid, according to
Ground acid calcium sodium and aramine, then lead to nitrogen to saturation, using 3 μm of titanium rod filter coarse filtration, are filled into dilute match somebody with somebody again
In tank, subsequently added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection, and inject dilute preparing tank, until
Dead space capacity in dense preparing tank and titanium rod filter is rinsed well；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, if necessary also with liquor epinephrinae bitartratis ophthalmicus adjust solution ph to
3.2, amount of preparation is injected water to, is stirred, the plate and frame filter press circulating filtration through 0.22 μm of filter membrane obtains half to clear and bright
Finished product；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
Embodiment 3
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, sodium chloride 100g, sodium hydrogensulfite 15g, mosatil 0.125g, lipoic acid
0.055g, surplus is water.
As above the preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be first heated to after 120 DEG C, utilization air extractor pumping 15 afterwards~
20min, is then passed through 15% (v/v) carbon dioxide thereto again, finally cold again to go to less than 30 DEG C, and logical nitrogen is to saturation,
Take partial syringe water first afterwards, the sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, then add successively
Enter the lipoic acid, mosatil and aramine of recipe quantity, nitrogen is then led to again to saturation, 3 μm of titanium rod mistakes are utilized
Filter coarse filtration, is filled into dilute preparing tank, is subsequently added by several times in dense preparing tank using water for injection, also through titanium rod filter mistake
Filter, and dilute preparing tank is injected, until the dead space capacity in dense preparing tank and titanium rod filter is rinsed well；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, if necessary also with liquor epinephrinae bitartratis ophthalmicus adjust solution ph to
3.5, amount of preparation is injected water to, is stirred, the plate and frame filter press circulating filtration through 0.22 μm of filter membrane obtains half to clear and bright
Finished product；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
Embodiment 4
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, sodium chloride 95g, sodium hydrogensulfite 12g, mosatil 0.07g, lipoic acid
0.07g, surplus is water.
As above the preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to less than 30 DEG C, and logical nitrogen takes partial syringe first afterwards to saturation
With water, the sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, sequentially add recipe quantity lipoic acid, according to
Ground acid calcium sodium and aramine, then lead to nitrogen to saturation, using 3 μm of titanium rod filter coarse filtration, are filled into dilute match somebody with somebody again
In tank, subsequently added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection, and inject dilute preparing tank, until
Dead space capacity in dense preparing tank and titanium rod filter is rinsed well, before solution is injected into dilute preparing tank, first with water for injection
Filtration and washing filter, pipeline and dilute preparing tank, afterwards again inject solution in the dilute preparing tank；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, if necessary also with liquor epinephrinae bitartratis ophthalmicus adjust solution ph to
3.3, amount of preparation is injected water to, is stirred, the plate and frame filter press circulating filtration through 0.22 μm of filter membrane obtains half to clear and bright
Finished product；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
The preparation method of the water for injection includes：
(1) purified water is prepared；
(2) purified water is obtained into primary injection water after repeatedly distillation, sequentially passes through 0.45 μm and 0.22 μm
Millipore filter is filtered, and sterilize 15min at 121 DEG C of temperature afterwards, is then passed through nitrogen thereto again to saturation, is noted
Penetrate and use water.
Embodiment 5
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, sodium chloride 105g, sodium hydrogensulfite 18g, mosatil 0.15g, lipoic acid
0.08g, surplus is water.
As above the preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to less than 30 DEG C, and logical nitrogen takes partial syringe first afterwards to saturation
With water, the sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, sequentially add recipe quantity lipoic acid, according to
Ground acid calcium sodium and aramine, then lead to nitrogen to saturation, using 3 μm of titanium rod filter coarse filtration, are filled into dilute match somebody with somebody again
In tank, subsequently added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection, and inject dilute preparing tank, until
Dead space capacity in dense preparing tank and titanium rod filter is rinsed well, before solution is injected into dilute preparing tank, first with water for injection
Filtration and washing filter, pipeline and dilute preparing tank, afterwards again inject solution in the dilute preparing tank；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, if necessary also with liquor epinephrinae bitartratis ophthalmicus adjust solution ph to
3.4, amount of preparation is injected water to, is stirred, the plate and frame filter press circulating filtration through 0.22 μm of filter membrane obtains half to clear and bright
Finished product；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
The preparation method of the water for injection includes：
(1) purified water is prepared；
(2) purified water is obtained into primary injection water after repeatedly distillation, sequentially passes through 0.45 μm and 0.22 μm
Millipore filter is filtered, and sterilize 20min at 121 DEG C of temperature afterwards, is then passed through nitrogen thereto again to saturation, is noted
Penetrate and use water.
Embodiment 6
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, sodium chloride 108g, sodium hydrogensulfite 16g, mosatil 0.12g, lipoic acid
0.09g, surplus is water.
As above the preparation method of aramine parenteral solution, comprises the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to less than 30 DEG C, and logical nitrogen takes partial syringe first afterwards to saturation
With water, the sodium hydrogensulfite and sodium chloride of recipe quantity are placed in dense preparing tank and dissolved, sequentially add recipe quantity lipoic acid, according to
Ground acid calcium sodium and aramine, then lead to nitrogen to saturation, using 3 μm of titanium rod filter coarse filtration, are filled into dilute match somebody with somebody again
In tank, subsequently added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection, and inject dilute preparing tank, until
Dead space capacity in dense preparing tank and titanium rod filter is rinsed well, before solution is injected into dilute preparing tank, first with water for injection
Filtration and washing filter, pipeline and dilute preparing tank, afterwards again inject solution in the dilute preparing tank；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, if necessary also with liquor epinephrinae bitartratis ophthalmicus adjust solution ph to
3.4, amount of preparation is injected water to, is stirred, the plate and frame filter press circulating filtration through 0.22 μm of filter membrane obtains half to clear and bright
Finished product；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 points
Clock, in the leak detection of vacuum -80kPa conditions above, is cooled to after room temperature, obtains aramine parenteral solution.
The preparation method of the water for injection includes：
(1) purified water is prepared；
(2) purified water is obtained into primary injection water after repeatedly distillation, sequentially passes through 0.45 μm and 0.22 μm
Millipore filter is filtered, and sterilize 18min at 121 DEG C of temperature afterwards, is then passed through nitrogen thereto again to saturation, is noted
Penetrate and use water.
Embodiment 7
Included in a kind of aramine parenteral solution, every 10000mL parenteral solutions：
Aramine 190g, sodium chloride 98g, sodium hydrogensulfite 14g, mosatil 0.14g, lipoic acid
0.07g, surplus is water.
1. concentrated compounding：Water for injection is cooled to room temperature (being less than 30 DEG C) in advance.With preceding logical nitrification.Take 60000ml~80000ml's
Preparation water, will be weighed and being checked sodium hydrogensulfite and sodium chloride are put in dense preparing tank and dissolved.Add weighing and being checked
Aramine, stirring, make fully dissolved.Liquid level leads to nitrogen.By 3 μm of titanium rod filter coarse filtration, it is filled into dilute preparing tank.
Water for injection is added into dense preparing tank by several times, dilute preparing tank (rinse well and be defined by dead space capacity) is injected through titanium rod filter.
2. dilute match somebody with somebody：Liquid level leads to nitrogen.It is dilute first to use water for injection filtration and washing filter, pipeline, Agitation Tank with preceding, bleed off cleaning
Water, then will receive dense preparing tank medical filtration to dilute preparing tank, plus preparation water is until about 95% or so of amount of preparation, stirring 5
Minute.PH value is surveyed, pH value is adjusted 3.2~3.5 with liquor epinephrinae bitartratis ophthalmicus if necessary.In the case of nitrogen is passed through incessantly, filling
Penetrate with water to amount of preparation, stir.Plate and frame filter press circulating filtration through 0.22 μm of filter membrane carries out visible foreign matters inspection to clear and bright
Look into.After qualified, fill in and ask verification certificate to notify on-site supervision person to be sampled semi-finished product, QC personnel are responsible for inspection.
3. the nitrogen charging embedding after 0.22 μm of end-filtration again after the assay was approved, 100 DEG C of flowing steam sterilizes 15 minutes, true
Reciprocal of duty cycle -80kPa conditions above is hunted leak.Semi-finished product are cooled to room temperature (10~30 DEG C), after offer for sale, lamp inspection, it is qualified after print bag.
Module number and treatment scale described herein are the explanations for simplifying the present invention.To the heavy winestone of the present invention
The application of sour aramine and preparation method thereof, modifications and variations will be readily apparent to persons skilled in the art.
Although embodiment of the present invention is disclosed as above, it is not restricted in specification and embodiment listed
With it can be applied to various suitable the field of the invention completely, can be easily for those skilled in the art
Other modification is realized, therefore under the universal limited without departing substantially from claim and equivalency range, the present invention is not limited
In specific details and shown here as the embodiment with description.
Claims (7)
1. a kind of aramine parenteral solution, it is characterised in that included in per 10000mL parenteral solutions：
Aramine 190g, 90~110g of sodium chloride, 10~20g of sodium hydrogensulfite, 0.05~0.2g of mosatil,
0.01~0.1g of lipoic acid, surplus is water.
2. the preparation method of the aramine parenteral solution described in claim 1, it is characterised in that comprise the following steps：
Step 1: concentrated compounding：Water for injection is taken to be cooled to room temperature, and logical nitrogen takes partial syringe water, will located first afterwards to saturation
The sodium hydrogensulfite and sodium chloride of side's amount, which are placed in dense preparing tank, to be dissolved, and sequentially adds lipoic acid, the mosatil of recipe quantity
And aramine, nitrogen is then led to again to saturation, using 3 μm of titanium rod filter coarse filtration, is filled into dilute preparing tank, then so
Added in dense preparing tank, also filtered through titanium rod filter by several times using water for injection afterwards, and inject dilute preparing tank, until dense preparing tank and titanium
Dead space capacity in rod filter is rinsed well；
Step 2: dilute match somebody with somebody：In the case of nitrogen is passed through incessantly, amount of preparation is injected water to, is stirred, through 0.22 μm
The plate and frame filter press circulating filtration of filter membrane obtains semi-finished product to clear and bright；
Step 3: again by nitrogen charging embedding after described 0.22 μm of end-filtration of semi-finished product, 100 DEG C of flowing steam sterilizes 15 minutes,
Vacuum -80kPa conditions above is hunted leak, and is cooled to after room temperature, is obtained aramine parenteral solution.
3. the preparation method of aramine parenteral solution as claimed in claim 2, it is characterised in that in step one, note
Penetrate and be water-cooled to less than 30 DEG C.
4. the preparation method of aramine parenteral solution as claimed in claim 2, it is characterised in that the step 2
In, solution ph also is adjusted to 3.2~3.5 with liquor epinephrinae bitartratis ophthalmicus if necessary.
5. the preparation method of aramine parenteral solution as claimed in claim 2, it is characterised in that the water for injection
Preparation method include：
(1) purified water is prepared；
(2) purified water is obtained into primary injection water after repeatedly distillation, sequentially passes through 0.45 μm and 0.22 μm of micropore
Filter is filtered, and sterilize 15~20min at 121 DEG C of temperature afterwards, is then passed through nitrogen thereto again to saturation, is noted
Penetrate and use water.
6. the preparation method of aramine parenteral solution as claimed in claim 2, it is characterised in that in the step one
In also include take water for injection to be first heated to after 120 DEG C, afterwards using air extractor be evacuated 15~20min, then again to
15% (v/v) carbon dioxide is wherein passed through, it is finally cold again to go to room temperature.
7. the preparation method of aramine parenteral solution as claimed in claim 2, it is characterised in that in the step one
In,, afterwards again will be molten first with water for injection filtration and washing filter, pipeline and dilute preparing tank before solution is injected into dilute preparing tank
Liquid is injected in the dilute preparing tank.
Priority Applications (1)
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110090580A (en) * | 2019-05-21 | 2019-08-06 | 北京市永康药业有限公司 | Aramine injection device for formulating |
| CN110988185A (en) * | 2019-12-20 | 2020-04-10 | 上海禾丰制药有限公司 | Impurity detection method and preparation method of m-hydroxylamine bitartrate injection |
| CN113197848A (en) * | 2021-05-24 | 2021-08-03 | 成都欣捷高新技术开发股份有限公司 | Metalhydroxylamine bitartrate pharmaceutical composition and preparation method thereof |
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| CN103371969A (en) * | 2012-04-17 | 2013-10-30 | 上海禾丰制药有限公司 | Metaraminol bitartrate injection and preparation technology thereof |
| CN106389312A (en) * | 2016-09-18 | 2017-02-15 | 天津金耀药业有限公司 | Pharmaceutical composition of metaraminol bitartrate injection |
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| CN103371969A (en) * | 2012-04-17 | 2013-10-30 | 上海禾丰制药有限公司 | Metaraminol bitartrate injection and preparation technology thereof |
| CN106389312A (en) * | 2016-09-18 | 2017-02-15 | 天津金耀药业有限公司 | Pharmaceutical composition of metaraminol bitartrate injection |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110090580A (en) * | 2019-05-21 | 2019-08-06 | 北京市永康药业有限公司 | Aramine injection device for formulating |
| CN110090580B (en) * | 2019-05-21 | 2020-06-23 | 北京市永康药业有限公司 | Preparation device of m-hydroxylamine bitartrate injection |
| CN110988185A (en) * | 2019-12-20 | 2020-04-10 | 上海禾丰制药有限公司 | Impurity detection method and preparation method of m-hydroxylamine bitartrate injection |
| CN110988185B (en) * | 2019-12-20 | 2022-03-18 | 上海禾丰制药有限公司 | Impurity detection method and preparation method of m-hydroxylamine bitartrate injection |
| CN113197848A (en) * | 2021-05-24 | 2021-08-03 | 成都欣捷高新技术开发股份有限公司 | Metalhydroxylamine bitartrate pharmaceutical composition and preparation method thereof |
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Application publication date: 20170915 |