CN110478367A - A kind of inverted sugar electrolytes injection and preparation process - Google Patents
A kind of inverted sugar electrolytes injection and preparation process Download PDFInfo
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Abstract
This hair Gongming has opened a kind of inverted sugar electrolytes injection and preparation process, described to be with ratio, and in water for injection, fructose, DEXTROSE ANHYDROUS, sodium chloride, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, sodium lactate, sodium hydrogensulfite is added.Preparation process is completed by following steps: water for injection is squeezed into dense preparing tank, sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, DEXTROSE ANHYDROUS, fructose, sodium lactate stirring and dissolving are put by recipe quantity, put into active carbon, charcoal is taken off after stirring and adsorbing, medical fluid is squeezed into dilute preparing tank, pH value is adjusted after mending water for injection to full dose, last filling, sterilizing, packaging.The present invention provides the new proportion components of inverted sugar electrolytes injection.The present invention provides the new process for producing of inverted sugar electrolytes injection.Process for producing of the invention has sterilization sterilization effect well.
Description
Technical field
The present invention relates to a kind of injection and preparation processes.Belong to injection field of medicine production.
Background technique
Inverted sugar electrolytes injection belongs to parenteral nutrition class drug, and composition (is turned by the fructose and glucose of equivalent
Change sugar), sodium chloride, potassium chloride, magnesium chloride, sodium dihydrogen phosphate and sodium lactate sterile water solution, can be provided for patient water, be electrolysed
Matter and energy, and diuresis and metabolic alkalinization are generated, contained lactate generates glycogen in hepatic metabolism, participates in H+
Under, ultimately generate CO2 and water.Non-oral routes are clinically applicable to keep the skin wet or the benefit of the patient of the energy and electrolyte
Liquid treatment.Inverted sugar electrolytes injection people configuration proportion does not have always better proportion, infuses existing inverted sugar electrolyte
It is low to penetrate liquid drug effect, therapeutic effect needs to be further increased.
In the production process of injection, sterile production is always the key of injection production, be in the mistake of production injection
Cheng Zhong is repeatedly sterilized, to reach total number of bacteria control within qualified quantity.
It is also the same in inverted sugar electrolytes injection production process, it is necessary to control total number of bacteria.Present method of controlling
Predominantly, it in high-cleanness production environment area, completes with after pharmacy industry, activated carbon adsorption degerming of row removes when in dense preparing tank
Impurity.Then de- charcoal is refiltered, sterilizing is completed.When dependent on this kind of mode, to reach better sterilization effect, it is necessary to be addition
The active carbon and active carbon of sufficient amount must be stirred time enough in dense preparing tank, can be only achieved preferably to thin
Bacterium absorption.
But after the amount of activated carbon in dense preparing tank is excessive, and adsorption time is too long, it can adsorb in dense preparing tank
Medicine company effective ingredient, reduce the effective ingredient amount of end product, and if active carbon addition quantity up to more, can be to medicine
Liquid forms new pollution, and increases the process and cost of later period de- charcoal.Therefore, it was produced in existing inverted sugar electrolytes injection
Cheng Zhong, it is necessary to which the dosage for controlling active carbon is balanced choice on bactericidal effect and activated carbon dosage, and appropriate reduction sterilization is wanted
It asks, it is up to standard within regulation is controlled the size to meet bacterial number, does not control bacterial number further.
For infusing inverted sugar electrolytes injection, directly input in blood of human body, wherein the bacterial number contained
It is lower, it is theoretically then safer, and the speed of bacterial growth is and not know that the bacterium of type can be various multiple than faster
It is grown in miscellaneous environment, therefore, if the bacterial number being packaged in early period in medical fluid is lower, following period of time of the later period in inventory
The bacterial number grown in medical fluid is certainly fewer.It is extremely important to effectively being sterilized in liquid in medical fluid production period.
Therefore, in existing note inverted sugar electrolytes injection production method, that is, wish preferably to control bacterial number, again
Worry loss drug effect, and increase filtering cost, belongs to insoluble problem contradiction.
Summary of the invention
To solve the above-mentioned problems, the present invention provides a kind of inverted sugar electrolytes injection and preparation processes.Described
Under matching for example:
In water for injection, fructose, DEXTROSE ANHYDROUS, sodium chloride, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, lactic acid is added
Sodium, sodium hydrogensulfite.
A kind of inverted sugar electrolytes injection as described above, further explains and is, as follows by weight ratio: injection
With 500 parts of water, 12.5 parts of fructose, 12.5 parts of DEXTROSE ANHYDROUS, 0.7305 part of sodium chloride, 0.9319 part of potassium chloride, magnesium chloride
0.1428 part, 0.3750 part of sodium dihydrogen phosphate, 1.4008 parts of sodium lactate, 0.2602 part of sodium hydrogensulfite.
A kind of preparation process of inverted sugar electrolytes injection, is completed by following steps:
(1), water for injection is squeezed into dense preparing tank, puts into sodium chloride, sodium hydrogensulfite, potassium chloride, chlorination by recipe quantity
Magnesium, sodium dihydrogen phosphate, DEXTROSE ANHYDROUS, fructose, sodium lactate stirring and dissolving put into active carbon, stirring and adsorbing；
(2), charcoal is taken off；
(3), medical fluid is squeezed into dilute preparing tank, is squeezed into together dilute match with water for injection repeated flushing dense preparing tank and by flushing water
Tank；
(4), water for injection is mended in dilute preparing tank to full dose, adjusts pH value；
(4), circulation keeps medical fluid uniform, and intermediate is taken to monitor medical fluid pH；
(5), medical fluid is filtered to visible foreign matters qualification, then is sampled and surveyed PH；
(6), filling, sterilizing, packaging.
A kind of preparation process of inverted sugar electrolytes injection as described above, specifically:
Described squeezes into water for injection in dense preparing tank, specifically, the 60% of water for injection full dose is added in dense preparing tank
Water for injection；
The investment active carbon, specifically, investment it is dilute match volume 0.02% (W/V) active carbon, stir about 15 minutes.
The de- charcoal, specifically, through stud filtering decarbonization；
The adjusting pH value, specifically, with 10%HCL adjust pH value to: 4.7~5.3；
The medical fluid is filtered to visible foreign matters qualification, specifically, medical fluid is filtered through 0.22 μm of millipore filter to can
See foreign matter qualification.
The sterilizing, specifically, 121 DEG C of overheat constant temperature water baths sterilize 10 minutes.
A kind of preparation process of inverted sugar electrolytes injection as described above, specifically:
The described sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, anhydrous of successively being put by recipe quantity
Glucose, fructose, sodium lactate stirring and dissolving further include, first by sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, di(2-ethylhexyl)phosphate
Hydrogen sodium, DEXTROSE ANHYDROUS, fructose, sodium lactate are placed in ultrasonic tank and sterilize and dissolve, step specifically: (1), prepare ingredient
Object: sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, DEXTROSE ANHYDROUS, fructose, sodium lactate；(2), it carries out
Ultrasonic sterilization: being added in ultrasonic tank with water for injection more than 5 times of volumes of material, and will put into ultrasonic tank with material,
Sonic oscillation progress first time sterilization in 8-10 minutes, and dissolution simultaneously matches material in water for injection；(3), it will sterilize and dissolve
With material import dense preparing tank.
A kind of preparation process of inverted sugar electrolytes injection as described above, specifically:
The sonic oscillation parameter are as follows: sound intensity 1-5W/cm2, frequency 30-40KHz, ultrasonic pot bottom generates 10.5 μm
Amplitude；Ultrasonic output power is 45-55w, ultrasonic waveform is impulse wave, pulse width 8-12ms.
A kind of preparation process of inverted sugar electrolytes injection as described above, specifically:
The step further includes, and after mending water for injection to full dose in dilute preparing tank, recirculation water shearing is carried out in dilute preparing tank
Sterilization；Recirculation water shearing sterilization is specifically, liquid rotates 20-25 minutes repeatedly in agitation dilute preparing tank.
A kind of preparation process of inverted sugar electrolytes injection as described above, specifically:
Liquid rotates repeatedly in the agitation dilute preparing tank, revolves specifically, first stirring liquid in dilute preparing tank to a direction
Turn 1-3 minutes, then stirs liquid in dilute preparing tank again and rotated 1-3 minutes from another direction, rotated repeatedly, and every 1-
The direction of rotation of conversion in 3 minutes generates high shear force；
The agitating method that liquid rotates repeatedly in agitation dilute preparing tank are as follows: the water outlet of several first group of reflux pump is with clockwise
Direction is simultaneously arranged on dilute preparing tank outer wall from dilute preparing tank inner circle tangential direction, and the water inlet of first group of reflux pump is arranged in dilute preparing tank
First group of reflux pump of bottom, above-mentioned setting completes right handed agitation in dilute preparing tank；
The water outlet of several second group of reflux pump is matched in a counterclockwise direction and from the setting of dilute preparing tank inner circle tangential direction dilute
On tank wall, in dilute preparing tank bottom, second group of reflux pump of above-mentioned setting completes dilute match for the water inlet setting of second group of reflux pump
The agitation rotated counterclockwise in tank；
Above-mentioned first group of reflux pump is alternately and repeatedly opened with second group of reflux pump, rotates liquid in dilute preparing tank repeatedly, is produced
Raw high shear force.
A kind of preparation process of inverted sugar electrolytes injection as described above, specifically:
The water outlet parameter of the water outlet are as follows: flow is greater than 50L/min, flow velocity 2-3.5m/s.
A kind of preparation process of inverted sugar electrolytes injection as described above, specifically:
In pouring process, persistently to the rotational agitation repeatedly of liquid in dilute preparing tank；Specifically, liquid rotation in agitation dilute preparing tank
Turn 1-3 minutes, then from inversely stirring again in dilute preparing tank liquid in rotation 1-3 minutes, rotates repeatedly, and every 1-3 minutes
A direction of rotation is converted, high shear force is generated.
Until medicine liquid tank is installed into dilute preparing tank
The invention has the advantages that:
The present invention provides the new proportion component of inverted sugar electrolytes injection and ratios.Conversion of the invention
Sugared electrolyte injection has better therapeutic effect.
The present invention provides the new process for producing of inverted sugar electrolytes injection.
Process for producing of the invention has sterilization sterilization effect well.
In the case where not putting into more activated carbon adsorptions sterilization, conducive to boiled water shearing in ultrasonic sterilization, dense preparing tank
Power sterilizes, and the sterilizing of recirculation water shearing force, multiple sterilization steps preferably reduce the bacteria total amount in medical fluid in dilute preparing tank.Or
In the case that bacteria total amount of the person in the existing medical fluid of holding is constant and product is qualified, the present invention can put into the use of active carbon less
Amount, and the time of activated carbon adsorption is reduced, to keep the effective ingredient of medical fluid.
Specific embodiment
The present invention is first dissolved, then through concentrated compounding, is then diluted, and is finally carried out canned.
Present invention ultrasonic sterilization in dissolution, then boil and sterilize through concentrated compounding, water flow sterilization in dilute preparing tank is then carried out, finally
Carry out it is canned, and while canned water flow sterilize.
Embodiment one: this product unit dose composition
Embodiment two: the inverted sugar electrolytes injection of manufacturing specification 500ml, total 2625L.
Embodiment three:
1, concentrated compounding: 60% water for injection of full dose is put into concentrated compounding filling, sodium chloride, sulfurous acid are successively put by recipe quantity
Hydrogen sodium, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, DEXTROSE ANHYDROUS, fructose, sodium lactate, stirring and dissolving.
2, be added it is dilute match volume 0.02% (W/V) active carbon, stir about 15 minutes, through stud filtering decarbonization, flushing water one
And beat to dilute preparing tank, benefit adds to the full amount of water for injection, cycle balance.
3, dilute to match: benefit inject water to nearly full dose, with 10%HCL adjust pH value: 4.7~5.3, add water to full dose, follow
Ring is uniform.After detecting semi-finished product content, pH value qualification, medical fluid is filtered through 0.22 μm of millipore filter to visible foreign matters qualification.
4, filling, sealing.121 DEG C of overheat constant temperature water baths sterilize 10 minutes.Lamp inspection, packaging.
Example IV:
1, prepare to match material: sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, DEXTROSE ANHYDROUS, fruit
Sugar, sodium lactate.
2, it carries out ultrasonic sterilization: the water for injection of 100L being added in ultrasonic tank, and half is put into ultrasound with material
In tank, sonic oscillation progress first time sterilization in 8-10 minutes, the sonic oscillation parameter are as follows: sound intensity 1-5W/cm2, frequency
30-40KHz, ultrasonic pot bottom generate 10.5 μm of amplitudes；Ultrasonic output power is 45-55w, ultrasonic waveform is impulse wave, pulse
Width 8-12ms.
While sterilize for the first time and dissolve with material in water for injection；And will sterilize and dissolve with material
Import dense preparing tank.
The other half is sterilized and dissolved in ultrasonic tank with material using above step again, then equally imports concentrated compounding
Tank cleans ultrasonic tank, and ejected wash water is imported dense preparing tank.
3,60% water for injection of water for injection full dose is added in dense preparing tank.
Then low-pressure boiled shearing water sterilization is carried out；
Then the low-pressure boiled shearing water sterilization extracts negative pressure extremely specifically, by being heated to 75-80 DEG C in dense preparing tank
It is -62KPa to -53KPa negative pressure in dense preparing tank, then persistently dense preparing tank is heated, and continues to extract negative pressure in tank, and keep dense
It is -62KPa to -53KPa with pressure inside the tank, makes to generate boiling 23 minutes in dense preparing tank with this condition.It is generated using water boiling
Shearing force sterilized.
Put into it is dilute with volume 0.02% (W/V) active carbon, stir about 15 minutes；
4, through stud filtering decarbonization；
5, medical fluid is squeezed into dilute preparing tank, squeezes into dilute preparing tank with water for injection repeated flushing dense preparing tank and together,
6, water for injection is mended in dilute preparing tank to full dose, and recirculation water shearing sterilization is then carried out in dilute preparing tank；Recirculation water shearing
Sterilization is specifically, liquid rotates 20-25 minutes repeatedly in agitation dilute preparing tank.Specifically, liquid in rotation 1-3 points in agitation dilute preparing tank
Clock rotates repeatedly then from inversely stirring again in dilute preparing tank liquid in rotation 1-3 minutes, and primary every conversion in 1-3 minutes
Direction of rotation generates high shear force.
The agitating method that liquid rotates repeatedly in agitation dilute preparing tank are as follows: the water outlet of several first group of reflux pump is with clockwise
Direction is simultaneously arranged on dilute preparing tank outer wall from dilute preparing tank inner circle tangential direction, and the water inlet of first group of reflux pump is arranged in dilute preparing tank
First group of reflux pump of bottom, above-mentioned setting completes right handed agitation in dilute preparing tank；
The water outlet of several second group of reflux pump is matched in a counterclockwise direction and from the setting of dilute preparing tank inner circle tangential direction dilute
On tank wall, in dilute preparing tank bottom, second group of reflux pump of above-mentioned setting completes dilute match for the water inlet setting of second group of reflux pump
The agitation rotated counterclockwise in tank.
Above-mentioned first group of reflux pump is alternately and repeatedly opened with second group of reflux pump, rotates liquid in dilute preparing tank repeatedly, is produced
Raw high shear force, the water outlet parameter of water outlet are as follows: flow is greater than 50L/min, flow velocity 2-3.5m/s.
7, with 10%HCL adjust pH value to: 4.7~5.3；
8, circulation keeps medical fluid uniform, and intermediate is taken to monitor medical fluid pH；
9, medical fluid is filtered through 0.22 μm of millipore filter to visible foreign matters qualification.It samples again and surveys PH.
10, filling, and in pouring process, persistently to the rotational agitation repeatedly of liquid in dilute preparing tank；Match specifically, agitation is dilute
Pot liquid rotates 1-3 minutes, then from inversely stirring again in dilute preparing tank liquid in rotation 1-3 minutes, rotates repeatedly, and every
Every the direction of rotation of conversion in 1-3 minutes, high shear force is generated；The water outlet parameter of the water outlet are as follows: flow is greater than 50L/
Min, flow velocity 2-3.5m/s.
Until medicine liquid tank is installed into dilute preparing tank.
11,121 DEG C of overheat constant temperature water baths sterilize 10 minutes.Packaging.
The agitating device that liquid rotates repeatedly in above-mentioned agitation dilute preparing tank are as follows: two groups of reflux pumps are set on dilute preparing tank, the
One group of reflux pump is rotated clockwise for stirring liquid in dilute preparing tank, and second group of reflux pump is for stirring the liquid inverse time in dilute preparing tank
Needle rotation.
The water outlet of first group of reflux pump is arranged outside dilute preparing tank in a clockwise direction and from dilute preparing tank inner circle tangential direction
On wall, for example, 5 water outlets are arranged in first group of reflux pump, equably it is distributed on dilute preparing tank outer wall from top to bottom.When this 5
When water outlet high speed sprays into liquid into dilute preparing tank along a tangential direction, the medical fluid that will be stirred in dilute preparing tank is rotated clockwise.
The bottom in dilute preparing tank is arranged in the water inlet of first group of reflux pump, sucks medical fluid from the bottom in dilute preparing tank.Cause
This medical fluid is exactly to pass through first group of reflux pump to be recycled.
The water outlet of second group of reflux pump is arranged outside dilute preparing tank in a counterclockwise direction and from dilute preparing tank inner circle tangential direction
On wall, first group of reflux pump of remaining structural reference.Medical fluid in second group of reflux pump agitation dilute preparing tank rotates counterclockwise.
Above-mentioned first group of reflux pump is alternately and repeatedly opened with second group of reflux pump, rotates liquid in dilute preparing tank repeatedly, is produced
Raw high shear force.
In the above embodiment of the present invention, first various be put into ultrasonic tank with material is dissolved, then carries out ultrasonic sterilization.
Ultrasonic wave is to be made of a series of longitudinal wave of density interphases, and propagated around by liquid medium.When sound can be sufficiently high, In
In the loose half period, the attraction between liquid phase molecule is broken, formed cavitation nucleus, the service life of cavitation nucleus is about 0.1 μ S, it
The moment of explosion can produce localized hyperthermia and the hyperbaric environment of about 4000K and 100MPa, and generating speed is about 110m/s tool
There is the microjet of intense impact, microjet effect can form strong mechanical stirring effect between interface, and this effect can
To break through the limitation of wake boundary, thus chemical reaction process and transmittance process between strengthening interface.
Ultrasonic wave is the sound wave that frequency is greater than 20kHz, is a kind of mechanical oscillation propagated in medium.Due to its frequency
Height, wavelength are short, and other than having the characteristics that good directionality, power are big, penetration power is strong, ultrasonic energy causes cavitation and one
The special effects of series, such as mechanics effect, calorifics effect, chemical effect and biological effect.Sterilization effect possessed by ultrasonic wave
Power makes microbial cell content by strong concussion mainly due to cavitation caused by ultrasonic wave, to reach pair
The destruction of microorganism.So-called cavitation is when ultrasonic wave acts in the medium, and intensity is more than a certain air threshold values
When, cavitation phenomenon can be generated, i.e., small air complex is activated under ultrasonic wave effect in liquid, shows as the vibration of complex
A series of dynamic processes such as swing, grow, shrink and collapse.The moment that air bubble shrinks and collapses in insulation steeps interior present
5000 DEG C or more of high temperature and the rate of temperature change of 109K/s generate the strong impact wave for being up to 108N/m2.Utilize ultrasonic air
Change the local instantaneous high-temperature and temperature alternating variation, local instantaneous pressure and pressure change that effect generates in a liquid, makes liquid
In certain bacteriums it is lethal, it is virally inactivated, or even make the cell wall damage of some microorganisms of small volume.
In this example, ultrasonic sterilization effect is as follows:
| Sterilize duration | Output power | Ultrasonic frequency | Sterilization effect |
| 1 minute | 50w | 30KHz | 8% |
| 3 minutes | 50w | 30KHz | 14% |
| 5 minutes | 50w | 30KHz | 17% |
| 7 minutes | 50w | 30KHz | 21.5% |
| 9 minutes | 50w | 30KHz | 22.5% |
| 10 minutes | 50w | 30KHz | 23.3% |
| 13 minutes | 50w | 30KHz | 24.0% |
| 15 minutes | 50w | 30KHz | 24.4% |
In the test of ultrasonic sterilization, sterilization time can have an impact final sterilization effect, when longer sterilizing
Between can bring better sterilization effect, when sterilization time was at 5 minutes or more, sterilization effect can be with significantly increasing, but works as
More than after a certain period of time, 13 minutes or more, sterilization effect was not in that ratio increases, result, it is believed that the sterilizing in 5-10 minutes
Time is most significant.The present invention takes 5-10 minutes ultrasonic sterilization times in an implementation, ultrasonic sound use cost, the time with
It is balanced between sterilizing.
The mode that dilute preparing tank takes rotary injection water to sterilize.
And ultrasonic tank volume minimum, it is less than 1000L, therefore can use sonic oscillation, but dense preparing tank and dilute preparing tank volume
Excessive, using sonic oscillation, cost is excessively high.
Because the injection water flow of high-speed circulating allows bacterium that can not be attached to wall surface of the container, and recycles injection water flow tool
There is uncertain sinuous flow, between making water for injection molecule mutual extrusion, generates shearing force, this shearing force, which has cell to destroy, to be made
With.Therefore achieve the effect that certain.
But the shearing force sterilizing for being conducive to the injection water flow of high-speed circulating should not cross for a long time, because of medical fluid people of the invention
The canned time prepared is unsuitable too long, it is necessary to complete in 16 hours so canned.Therefore it must be strictly controlled each step process
Time, second is that water for injection shearing force bactericidal effect is limited, and after circulation time being more than 30 minutes, sterilization effect decline is prolonged
Become meaningless for a long time.Therefore the water for injection shearing force sterilization cycles time of the present invention takes 20-25 minutes.
In canning process, persistently to the rotational agitation repeatedly of liquid in dilute preparing tank, until medicine liquid tank is installed into dilute preparing tank.
Bacterium is further suppressed to grow during this period.
The inverted sugar electrolytes injection preparation process that the present invention obtains is feasible, produces result tables through three batches of sample amplifications
Bright, this product preparation process reproducibility is good.
Show through stability study: investigating within accelerated test 6 months its pH value as the result is shown and be slightly decreased, 5-HMF is in rising
Trend, each batch in quality standard limit, because packaging material have certain permeability slightly increase this product fractions content,
About 2~3% or so, the content of lactate is accelerated to test 6 months when 0 compared with content, and there are about 2% or so declines for content, divide
Analyse reason: sodium lactate forms carbon dioxide and water after decomposing, therefore content is on a declining curve, and every content's index is in regulation content
In limits, other indices meet this product standard regulation；This product was investigated through long term test 18 months shows this product
Without significant changes, 5-HMF compared with testing result, slightly rises when 0 for appearance, pH value, and absorbance is sub- between 0.05~0.06
Sodium bisulfate content between residue 2-13%, was far below standard limits, every content's index is in regulation content limit at 18 months
In range.It can thus be assumed that this quality is more stable, it is quality controllable.
Clinical research shows: the equivalent fructose and glucose that inverted sugar electrolytes injection of the invention includes, to blood glucose
It is smaller with the influence of fluctuations of insulin level, it is more suitable for the energy supplement of diabetic, hence it is evident that mitigate organism metabolism burden,
Lapsing to and treating conducive to disease；Contain and the comparable sodium of plasma concentration, potassium, magnesium, chloride ion and suitable lactic acid in this product
Salt, sodium dihydrogen phosphate are conducive to the electrolyte balance of patient.
In short, inverted sugar electrolytes injection of the invention has good validity and higher safety for clinical
Property.Clinically there is extensive use space, researching and developing the kind has great Social benefit and economic benefit.
Above-mentioned is exemplary illustration of the present invention, does not represent protection scope of the present invention.
Claims (10)
1. a kind of inverted sugar electrolytes injection, which is characterized in that the allocation ratio is as follows:
In water for injection, be added fructose, DEXTROSE ANHYDROUS, sodium chloride, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, sodium lactate,
Sodium hydrogensulfite.
2. a kind of inverted sugar electrolytes injection as described in claim 1, which is characterized in that as follows by weight ratio: note
It penetrates and uses 500 parts of water, 12.5 parts of fructose, 12.5 parts of DEXTROSE ANHYDROUS, 0.7305 part of sodium chloride, 0.9319 part of potassium chloride, magnesium chloride
0.1428 part, 0.3750 part of sodium dihydrogen phosphate, 1.4008 parts of sodium lactate, 0.2602 part of sodium hydrogensulfite.
3. a kind of preparation process of inverted sugar electrolytes injection, which is characterized in that it is completed by following steps,
(1), water for injection is squeezed into dense preparing tank, puts into sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, phosphorus by recipe quantity
Acid dihydride sodium, DEXTROSE ANHYDROUS, fructose, sodium lactate stirring and dissolving put into active carbon, stirring and adsorbing；
(2), charcoal is taken off；
(3), medical fluid is squeezed into dilute preparing tank, with water for injection repeated flushing dense preparing tank and flushing water is squeezed into dilute preparing tank together,
(4), water for injection is mended in dilute preparing tank to full dose, adjusts pH value；
(4), circulation keeps medical fluid uniform, and intermediate is taken to monitor medical fluid pH；
(5), medical fluid is filtered to visible foreign matters qualification, then is sampled and surveyed PH；
(6), filling, sterilizing, packaging.
4. a kind of preparation process of inverted sugar electrolytes injection as claimed in claim 3, which is characterized in that specifically: institute
That states squeezes into water for injection in dense preparing tank, specifically, 60% water for injection of water for injection full dose is added in dense preparing tank；
The investment active carbon, specifically, investment it is dilute match volume 0.02% (W/V) active carbon, stir about 15 minutes.
The de- charcoal, specifically, through stud filtering decarbonization；
The adjusting pH value, specifically, with 10%HCL adjust pH value to: 4.7~5.3；
The medical fluid is filtered to visible foreign matters qualification, specifically, medical fluid is filtered through 0.22 μm of millipore filter to visible different
Object is qualified.
The sterilizing, specifically, 121 DEG C of overheat constant temperature water baths sterilize 10 minutes.
5. a kind of preparation process of inverted sugar electrolytes injection as claimed in claim 3, which is characterized in that
Described is successively put into sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, anhydrous grape by recipe quantity
Sugar, fructose, sodium lactate stirring and dissolving further include, first by sodium chloride, sodium hydrogensulfite, potassium chloride, magnesium chloride, sodium dihydrogen phosphate,
DEXTROSE ANHYDROUS, fructose, sodium lactate are placed in ultrasonic tank and sterilize and dissolve, step specifically: (1), prepare to match material: chlorine
Change sodium, sodium hydrogensulfite, potassium chloride, magnesium chloride, sodium dihydrogen phosphate, DEXTROSE ANHYDROUS, fructose, sodium lactate；(2), ultrasound is carried out
Sterilization: being added in ultrasonic tank with water for injection more than 5 times of volumes of material, and will put into ultrasonic tank with material, ultrasound
Progress first time sterilization in 8-10 minutes is vibrated, and dissolution simultaneously matches material in water for injection；(3), it will sterilize and what is dissolved match
Material imports dense preparing tank.
6. a kind of preparation process of inverted sugar electrolytes injection as claimed in claim 5, which is characterized in that
The sonic oscillation parameter are as follows: sound intensity 1-5W/cm2, frequency 30-40KHz, ultrasonic pot bottom generates 10.5 μm of amplitudes；
Ultrasonic output power is 45-55w, ultrasonic waveform is impulse wave, pulse width 8-12ms.
7. a kind of preparation process of inverted sugar electrolytes injection as claimed in claim 3, which is characterized in that the step
It further include that recirculation water shearing sterilization is carried out after mending water for injection to full dose in dilute preparing tank, in dilute preparing tank；Recirculation water shearing sterilization
Specifically, liquid rotates 20-25 minutes repeatedly in agitation dilute preparing tank.
8. a kind of preparation process of inverted sugar electrolytes injection as claimed in claim 7, which is characterized in that the agitation
Liquid rotates repeatedly in dilute preparing tank, rotates 1-3 minutes specifically, first stirring liquid in dilute preparing tank to a direction, then stirs again
Liquid rotates 1-3 minutes from another direction in dynamic dilute preparing tank, rotates repeatedly, and every the primary rotation of conversion in 1-3 minutes
Direction generates high shear force；
The agitating method that liquid rotates repeatedly in agitation dilute preparing tank are as follows: the water outlet of several first group of reflux pump is in a clockwise direction
And be arranged on dilute preparing tank outer wall from dilute preparing tank inner circle tangential direction, the water inlet of first group of reflux pump is arranged at dilute preparing tank bottom
First group of reflux pump in portion, above-mentioned setting completes right handed agitation in dilute preparing tank；
The water outlet of several second group of reflux pump is arranged outside dilute preparing tank in a counterclockwise direction and from dilute preparing tank inner circle tangential direction
On wall, in dilute preparing tank bottom, second group of reflux pump of above-mentioned setting is completed in dilute preparing tank for the water inlet setting of second group of reflux pump
The agitation rotated counterclockwise；
Above-mentioned first group of reflux pump is alternately and repeatedly opened with second group of reflux pump, rotates liquid in dilute preparing tank repeatedly, is generated high
Shearing force.
9. a kind of preparation process of inverted sugar electrolytes injection as claimed in claim 8, which is characterized in that the water outlet
The water outlet parameter of mouth are as follows: flow is greater than 50L/min, flow velocity 2-3.5m/s.
10. a kind of preparation process of inverted sugar electrolytes injection as claimed in claim 3, which is characterized in that in filling mistake
Cheng Zhong, persistently to the rotational agitation repeatedly of liquid in dilute preparing tank；Specifically, agitation dilute preparing tank in liquid in rotation 3-5 minutes, then from
It inversely stirs in dilute preparing tank liquid in rotation 3-5 minutes, rotates repeatedly again, and every the direction of rotation of conversion in 3-5 minutes,
Generate high shear force；
Until medicine liquid tank is installed into dilute preparing tank.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910950086.7A CN110478367A (en) | 2019-10-08 | 2019-10-08 | A kind of inverted sugar electrolytes injection and preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910950086.7A CN110478367A (en) | 2019-10-08 | 2019-10-08 | A kind of inverted sugar electrolytes injection and preparation process |
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| CN110478367A true CN110478367A (en) | 2019-11-22 |
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| CN201910950086.7A Withdrawn CN110478367A (en) | 2019-10-08 | 2019-10-08 | A kind of inverted sugar electrolytes injection and preparation process |
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| Country | Link |
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2019
- 2019-10-08 CN CN201910950086.7A patent/CN110478367A/en not_active Withdrawn
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Application publication date: 20191122 |