CN108066360A - A kind of compound sodium acetate ringer's injection and preparation method thereof - Google Patents
A kind of compound sodium acetate ringer's injection and preparation method thereof Download PDFInfo
- Publication number
- CN108066360A CN108066360A CN201610999197.3A CN201610999197A CN108066360A CN 108066360 A CN108066360 A CN 108066360A CN 201610999197 A CN201610999197 A CN 201610999197A CN 108066360 A CN108066360 A CN 108066360A
- Authority
- CN
- China
- Prior art keywords
- sodium acetate
- injection
- solution
- preparation
- compound sodium
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
- A61K33/42—Phosphorus; Compounds thereof
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
-
- 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
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- 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
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- 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
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
-
- 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
Abstract
The invention discloses a kind of compound sodium acetate ringer's injection and preparation method thereof, belong to the technical field of parenteral solution.The 1L parenteral solutions are prepared by the raw material of following parts by weight：0.800 0.900g of sodium chloride, 0.700 0.800g of potassium chloride, 0.280 0.350g of Magnesium dichloride hexahydrate, 1.000 1.200g of a glucose monohydrate acid calcium, 1.300 1.400g of potassium dihydrogen phosphate, 1.500 1.700g of sodium acetate trihydrate, 90 110g of DEXTROSE ANHYDROUS, the present invention also provides the preparation methods of above-mentioned parenteral solution.The present invention is a kind of hypotonic electrolyte glucose injection, belong to intracellular fluid replenisher, moisture and electrolyte in supplementing intracellular fluid, extracellular fluid and intercellular fluid simultaneously after entering in vivo, when being mainly used for being unable to oral uptake or intake energy deficiency, to maintain moisture and electrolyte balance and provide energy to body.
Description
Technical field
The invention belongs to the technical fields of parenteral solution, particularly relate to a kind of compound sodium acetate ringer's injection and its preparation side
Method.
Background technology
Peri-operation period glucose, electrolyte infusion are often divided into maintenance infusion and supplement two classes of infusion according to its purpose is different.It mends
It is for the maintenance for meeting physiological requirements amount is infused, including to body in the loss of body fluid caused by surgical disease, art to fill infusion
The continual cure that liquid is lost, effect is to supplement Water-Electrolyte lost before the treatment and because of vomiting, gastrointestinal decompression, intestinal fistula etc.
Caused additional loss.Moisture shortage amount can by weight loss amount or must the difference of amount of moisture and intake water amount calculate
It arrives；Electrolyte shortage amount can speculate according to the excretion or plasma electrolyte concentration of one day.Maintain infusion with supplement infusion in institute
The electrolyte concentration contained is different.It is to give the necessary amounts of one day to maintain infusion, including nutrients such as water, electrolyte and energy, i.e.,
It can sustain life.It is postoperative that the requirement of infusion is maintained to subtract increment in art for full-time requirement.
Clinically representational replenisher includes physiological saline, Ringer's solution, Ringer's solution and sodium acetate Ringer's solution
Deng.But the clinical practice of these replenishers has some limitations, for example ringer's solution main purpose is supplement water electrolysis
Matter is adjusted not notable enough for acid-base balance；Lactated Ringer'S Solution can correct acid poisoning, raised simultaneously serum lactic and contained
Amount creates a false impression to the state of an illness judgement of critical patient.
The content of the invention
The present invention provides a kind of compound sodium acetate ringer's injection and preparation method thereof, solve supplement in the prior art it is defeated
Formula of liquid is unreasonable, be unfavorable for patient to nutrient supplement simultaneously can also to the state of an illness of critical patient judgement create a false impression ask
Topic.
A kind of compound sodium acetate ringer's injection of the present invention, is mainly realized by the following technical programs：
Parenteral solution described in per 1000mL is prepared by the raw material of following parts by weight：Sodium chloride 0.800-0.900g, potassium chloride 0.700-
0.800g, Magnesium dichloride hexahydrate 0.280-0.350g, a glucose monohydrate acid calcium 1.000-1.200g, potassium dihydrogen phosphate 1.300-
1.400g, sodium acetate trihydrate 1.500-1.700g, DEXTROSE ANHYDROUS 90-110g.
The present invention provides a kind of hypotonic electrolysis according to the composition of human plasma, extracellular fluid and intracellular fluid electrolyte
Matter glucose intracellular fluid replenisher supplements intracellular fluid, extracellular fluid and intercellular fluid simultaneously after patient's body is entered
In moisture and electrolyte, during for being orally ingested deficiency or energy cannot be supplemented, supplement internal water and energy, maintain electrolysis
Matter balances；Sodium, potassium, magnesium, calcium, acetate, glucose acid group, phosphoric acid hydrogen radical ion in the present invention, the ion with human body fluid
Composition is close, and the hyponatremia and hypomagnesemia that magnesium ion is likely to occur when can avoid largely being administered, calcium ion can prevent low calcium
The appearance of mass formed by blood stasis, phosphate anion can prevent the appearance of hypophosphatemia, and glucose content height can provide sufficient energy for patient.
As a kind of preferred embodiment, parenteral solution described in per 1000mL is prepared by the raw material of following parts by weight：
Sodium chloride 0.876g, potassium chloride 0.748g, Magnesium dichloride hexahydrate 0.304g, a glucose monohydrate acid calcium 1.120g, biphosphate
Potassium 1.360g, sodium acetate trihydrate 1.640g, DEXTROSE ANHYDROUS 100g.Sugared electrolyte currently used for peri-operation period is infused, more
Number be with keep the skin wet with electrolyte based on, although portioned product contains glucose, but its concentration is relatively low, it is impossible to be provided for patient
Sufficient energy；The electrolyte injection of the present invention is formed based on cylinder electrolyte ion, each active ingredient Proper Match, fully
It ensure that demand of the patient to nutrient, meanwhile, the phenomenon that serum lactic content raises is avoided, the disease of critical patient will not be given
Feelings judgement creates a false impression.
As a kind of preferred embodiment, the pH value of the parenteral solution is 4.7-5.5.The present invention rationally has adjusted injection
The phenomenon that pH value of liquid, the pH value of this and human body fluid approaches, avoids acid poisoning.
As a kind of preferred embodiment, the pH value of the parenteral solution is 5.0-5.3.Further adjustment injection of the invention
The pH value of liquid makes its pH value milder, is more nearly with the pH value of human body fluid, patient is more suitable when in use.
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, is mainly subject to by the following technical programs
It realizes：Comprise the following steps：1）The injection water of recipe quantity 50-70% is added in dense preparing tank, the temperature of injection water is 60-70
DEG C, then, the Magnesium dichloride hexahydrate, a hydration calcium gluconate and DEXTROSE ANHYDROUS of recipe quantity are added in, stirring obtains just molten to dissolving
Liquid；2）Regulating step 1）The pH of the first solution of gained, makes its pH value then, add in the potassium dihydrogen phosphate of recipe quantity for 4.7-5.5,
After its dissolving completely, the sodium chloride, potassium chloride and sodium acetate trihydrate of recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
3）To step 2）In gained concentrated solution, activated carbon of the weight for the 0.1-0.2% of concentrated solution volume, stirring are added in, heat preservation is adsorbed,
De- charcoal, is delivered to dilute preparing tank；4）In dilute preparing tank, injection water is added to full dose, filling, moist heat sterilization obtains product.
The dissolving order of the invention for rationally having adjusted raw material, has been nursed one's health the pH value of liquid, and has been carried out using activated carbon in real time
Absorption, is finally prepared by high-temperature sterilization；The preparation method technological process of the present invention is short, and production efficiency is high, mild condition,
Convenient for control, the biological safety of product has been fully ensured that, it is easy to accomplish industrialization；The dosage of activated carbon is with every in the present invention
The quality g of the activated carbon that 100mL concentrated solutions are added is calculated, i.e. W/V, the method represented with %.
As a kind of preferred embodiment, the step 2）In, using the pH value of the first solution of citric acid adjusting.Citric acid
Very easily the pH value of first solution can be adjusted, meanwhile, citric acid radical is also the ion composition of human body fluid, makes note
Penetrate the ion composition that liquid is closer to human body fluid.
As a kind of preferred embodiment, the step 3）In, the temperature for keeping the temperature absorption is 55 DEG C, and adsorption time is
15-20min.The temperature and adsorption time of further control heat preservation absorption of the invention, so that activated carbon is preferably completed to medicine
The absorption of liquid, absorption are abundant.
As a kind of preferred embodiment, the step 3）In, de- charcoal is using 5 μm of stud filter core circulating filtration 15-
20min after taking off charcoal, is delivered to dilute preparing tank after 5 μm, 0.45 μm of filter element filtering successively.Stud filter core source is wide, user
Just, charcoal, filtering and good decolorizing effect are taken off；The de- charcoal of the present invention, filtering and decoloration are complete, further improve the bio-safety of liquid
Performance.
As a kind of preferred embodiment, the step 4）In, when filling, first using 0.2 μm of filter element filtering, then,
It is filling in the non-PVC-soft-bag of 250mL or 500mL, the temperature of moist heat sterilization is 121 DEG C, sterilization time 8-12min.
Carried out in the non-PVC-soft-bag of 250mL or 500mL it is filling, it is easy to use, avoid the plasticizer such as DEHP to patient it is carcinogenic, cause
Abnormal and immunotoxicity, drug safety.
As a kind of preferred embodiment, the step 4）In, before filling, intermediate is detected, if,
PH meets 4.7-5.5, and chloride content meets 0.320-0.380% g/mL, then detects qualification, carries out filling；If detection does not conform to
Lattice are, it is necessary to be adjusted, until detection is qualified.The present invention further controls the quality index of filling intermediate before, passes through
The control of pH value and chloride content fully ensures that the quality of finished product parenteral solution；If detection is unqualified, need to be adjusted,
Until detection is qualified.Chloride content detection is substantially qualified in the present invention, if detecting that its pH value is unqualified, using glacial acetic acid
Or sodium hydroxide is adjusted；Here chloride content be quality and volume by volume concentration, unit g/mL.
Beneficial effects of the present invention：The present invention is carried according to the composition of human plasma, extracellular fluid and intracellular fluid electrolyte
A kind of hypotonic electrolyte glucose intracellular fluid replenisher has been supplied, intracellular fluid, extracellular fluid are being supplemented simultaneously into rear in vivo
With the moisture and electrolyte in intercellular fluid, during for being orally ingested deficiency or energy cannot be supplemented, internal water and energy are supplemented
Amount maintains electrolyte balance.Sodium, potassium, magnesium, calcium, acetate, glucose acid group, phosphoric acid hydrogen radical ion in the present invention, with human body
The ion composition of body fluid is close, the hyponatremia and hypomagnesemia that magnesium ion is likely to occur when can avoid largely being administered, calcium ion
It can prevent the appearance of hypocalcemia, phosphate anion can prevent the appearance of hypophosphatemia, and glucose content height can provide for patient
Sufficient energy.Each active ingredient Proper Match of the present invention, has fully ensured that the nutrient that supplement is provided for patient, has avoided acid
The phenomenon that poisoning and the rise of serum lactic content, will not judge to create a false impression to the state of an illness of critical patient；Its preparation method technique
Simply, mild condition, biological safety is good, drug safety.
Specific embodiment
Technical scheme is clearly and completely described below in conjunction with specific embodiments of the present invention, is shown
So, described embodiment is only the part of the embodiment of the present invention, instead of all the embodiments.Based in the present invention
Embodiment, those of ordinary skill in the art's all other embodiments obtained without creative efforts, all
Belong to the scope of protection of the invention.
A kind of compound sodium acetate ringer's injection of the present invention, per parenteral solution described in 1000mL by the raw material of following parts by weight
It is prepared：Sodium chloride 0.800-0.900g, potassium chloride 0.700-0.800g, Magnesium dichloride hexahydrate 0.280-0.350g, a water
Close calcium gluconate 1.000-1.200g, potassium dihydrogen phosphate 1.300-1.400g, sodium acetate trihydrate 1.500-1.700g, anhydrous
Glucose 90-110g.
Preferably, parenteral solution described in every 1000mL is prepared by the raw material of following parts by weight：Sodium chloride 0.876g, chlorination
Potassium 0.748g, Magnesium dichloride hexahydrate 0.304g, a glucose monohydrate acid calcium 1.120g, potassium dihydrogen phosphate 1.360g, three hydration vinegar
Sour sodium 1.640g, DEXTROSE ANHYDROUS 100g.
Further, the pH value of the parenteral solution is 4.7-5.5.
Further, the pH value of the parenteral solution is 5.0-5.3.
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, comprises the following steps：1）Add in dense preparing tank
Enter the injection water of recipe quantity 50-70%, the temperature of injection water is 60-70 DEG C, then, add in recipe quantity Magnesium dichloride hexahydrate, one
Calcium gluconate and DEXTROSE ANHYDROUS are hydrated, stirring obtains just solution to dissolving；2）Regulating step 1）The pH of the first solution of gained, makes it
PH value is 4.7-5.5, then, adds in the potassium dihydrogen phosphate of recipe quantity, after its dissolving completely, sequentially adds the chlorination of recipe quantity
Sodium, potassium chloride and sodium acetate trihydrate, stirring and dissolving obtain concentrated solution；3）To step 2）In gained concentrated solution, it is dense to add in weight
The activated carbon of the 0.1-0.2% of liquor capacity, stirring, heat preservation absorption take off charcoal, are delivered to dilute preparing tank；4）In dilute preparing tank, add
Injection water is to full dose, and filling, moist heat sterilization obtains product.
Preferably, the step 2）In, using the pH value of the first solution of citric acid adjusting.
Specifically, the step 3）In, the temperature for keeping the temperature absorption is 55 DEG C, adsorption time 15-20min.
Further, the step 3）In, de- charcoal is to use 5 μm of stud filter core circulating filtration 15-20min, after taking off charcoal,
Successively dilute preparing tank is delivered to after 5 μm, 0.45 μm of filter element filtering.
Further, the step 4）In, when filling, first using 0.2 μm of filter element filtering, then, it is filling in 250mL or
In the non-PVC-soft-bag of 500mL, the temperature of moist heat sterilization is 121 DEG C, sterilization time 8-12min.
It is highly preferred that the step 4）In, before filling, intermediate is detected, if pH meets 4.7-5.5,
Chloride content meets 0.320-0.380% g/mL, then detects qualification, carries out filling；If detection is unqualified, it is necessary to be adjusted
It is whole, until detection is qualified.
Embodiment one
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, comprises the following steps：
1）Weigh following raw material：Sodium chloride 0.800g, potassium chloride 0.700g, Magnesium dichloride hexahydrate 0.280g, a glucose monohydrate
Sour calcium 1.000g, potassium dihydrogen phosphate 1.300g, sodium acetate trihydrate 1.500g, DEXTROSE ANHYDROUS 90g, injection appropriate amount of water；
2）The injection water of recipe quantity 50% is added in dense preparing tank, the temperature of injection water is 60 DEG C, then, adds in above-mentioned recipe quantity
Magnesium dichloride hexahydrate, a hydration calcium gluconate and DEXTROSE ANHYDROUS, stirring obtains just solution to dissolving；
3）The pH of above-mentioned just solution is adjusted, it is 4.7 to make its pH value, then, adds in the potassium dihydrogen phosphate of above-mentioned recipe quantity, treats that its is molten
After solution is complete, the sodium chloride, potassium chloride and sodium acetate trihydrate of above-mentioned recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
4）Into above-mentioned concentrated solution, 0.1% activated carbon that weight is concentrated solution volume, stirring are added in, heat preservation absorption takes off charcoal, defeated
It send to dilute preparing tank；
5）In dilute preparing tank, injection water is added to full dose, i.e. 1000mL, filling, moist heat sterilization obtains product.
Embodiment two
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, comprises the following steps：
1）Weigh following raw material：Sodium chloride 0.900g, potassium chloride 0.800g, Magnesium dichloride hexahydrate 0.350g, a glucose monohydrate
Sour calcium 1.200g, potassium dihydrogen phosphate 1.400g, sodium acetate trihydrate 1.700g, DEXTROSE ANHYDROUS 110g, injection appropriate amount of water；
2）The injection water of recipe quantity 70% is added in dense preparing tank, the temperature of injection water is 65 DEG C, then, adds in above-mentioned recipe quantity
Magnesium dichloride hexahydrate, a hydration calcium gluconate and DEXTROSE ANHYDROUS, stirring obtains just solution to dissolving；
3）The pH of above-mentioned just solution is adjusted, it is 5.5 to make its pH value, then, adds in the potassium dihydrogen phosphate of above-mentioned recipe quantity, treats that its is molten
After solution is complete, the sodium chloride, potassium chloride and sodium acetate trihydrate of above-mentioned recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
4）Into above-mentioned concentrated solution, 0.15% activated carbon that weight is concentrated solution volume, stirring are added in, heat preservation absorption takes off charcoal,
It is delivered to dilute preparing tank；
5）In dilute preparing tank, injection water is added to full dose, i.e. 1000mL, filling, moist heat sterilization obtains product.
Embodiment three
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, comprises the following steps：
1）Weigh following raw material：Sodium chloride 0.876g, potassium chloride 0.748g, Magnesium dichloride hexahydrate 0.304g, a glucose monohydrate
Sour calcium 1.120g, potassium dihydrogen phosphate 1.360g, sodium acetate trihydrate 1.640g, DEXTROSE ANHYDROUS 100g, injection appropriate amount of water；
2）The injection water of recipe quantity 60% is added in dense preparing tank, the temperature of injection water is 70 DEG C, then, adds in above-mentioned recipe quantity
Magnesium dichloride hexahydrate, a hydration calcium gluconate and DEXTROSE ANHYDROUS, stirring obtains just solution to dissolving；
3）The pH of above-mentioned just solution is adjusted, it is 5.0 to make its pH value, then, adds in the potassium dihydrogen phosphate of above-mentioned recipe quantity, treats that its is molten
After solution is complete, the sodium chloride, potassium chloride and sodium acetate trihydrate of above-mentioned recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
4）Into above-mentioned concentrated solution, the activated carbon of 0.2% weight of concentrated solution volume, stirring are added in, 15min are adsorbed in 55 DEG C of heat preservations,
15min is cycled using 5 μm of stud filter cores and carries out decarbonisation, then, successively after 5 μm, 0.45 μm of filter element filtering, is delivered to
Dilute preparing tank；
5）In dilute preparing tank, injection water is added to full dose, i.e. 1000mL, it is filling in the non-PVC of 250mL after 0.2 μm of filter element filtering
Soft bag, at 121 DEG C, moist heat sterilization 12min obtains product.
Example IV
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, comprises the following steps：
1）Weigh following raw material：Sodium chloride 0.876g, potassium chloride 0.748g, Magnesium dichloride hexahydrate 0.304g, a glucose monohydrate
Sour calcium 1.120g, potassium dihydrogen phosphate 1.360g, sodium acetate trihydrate 1.640g, DEXTROSE ANHYDROUS 100g, injection appropriate amount of water；
2）The injection water of recipe quantity 55% is added in dense preparing tank, the temperature of injection water is 60 DEG C, then, adds in above-mentioned recipe quantity
Magnesium dichloride hexahydrate, a hydration calcium gluconate and DEXTROSE ANHYDROUS, stirring obtains just solution to dissolving；
3）The pH of above-mentioned just solution is adjusted, it is 4.9 to make its pH value, then, adds in the potassium dihydrogen phosphate of above-mentioned recipe quantity, treats that its is molten
After solution is complete, the sodium chloride, potassium chloride and sodium acetate trihydrate of above-mentioned recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
4）Into above-mentioned concentrated solution, 0.1% activated carbon that weight is concentrated solution volume, stirring, 55 DEG C of heat preservation absorption are added in
20min cycles 20min using 5 μm of stud filter cores and carries out decarbonisation, then, successively after 5 μm, 0.45 μm of filter element filtering,
It is delivered to dilute preparing tank；
5）In dilute preparing tank, injection water is added to full dose, i.e. 1000mL, it is filling in the non-PVC of 500mL after 0.2 μm of filter element filtering
Soft bag, at 121 DEG C, moist heat sterilization 10min obtains product.
Embodiment five
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, comprises the following steps：
1）Weigh following raw material：Sodium chloride 0.876g, potassium chloride 0.748g, Magnesium dichloride hexahydrate 0.304g, a glucose monohydrate
Sour calcium 1.120g, potassium dihydrogen phosphate 1.360g, sodium acetate trihydrate 1.640g, DEXTROSE ANHYDROUS 100g, injection appropriate amount of water；
2）The injection water of recipe quantity 65% is added in dense preparing tank, the temperature of injection water is 65 DEG C, then, adds in above-mentioned recipe quantity
Magnesium dichloride hexahydrate, a hydration calcium gluconate and DEXTROSE ANHYDROUS, stirring obtains just solution to dissolving；
3）The pH of above-mentioned just solution is adjusted, it is 5.1 to make its pH value, then, adds in the potassium dihydrogen phosphate of above-mentioned recipe quantity, treats that its is molten
After solution is complete, the sodium chloride, potassium chloride and sodium acetate trihydrate of above-mentioned recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
4）Into above-mentioned concentrated solution, 0.15% activated carbon that weight is concentrated solution volume, stirring, 55 DEG C of heat preservation absorption are added in
18min cycles 18min using 5 μm of stud filter cores and carries out decarbonisation, then, successively after 5 μm, 0.45 μm of filter element filtering,
It is delivered to dilute preparing tank；
5）In dilute preparing tank, injection water is added to full dose, i.e. 1000mL, which is detected, if its pH meets
4.7-5.5, chloride content meet 0.320-0.380% g/mL, then detect qualification；If it is unqualified to detect pH value, using ice vinegar
Acid or sodium hydroxide are adjusted, until detection is qualified；Chloride content detection is substantially qualified in the present invention；After detection is qualified, warp
0.2 μm of filter element filtering, and it is filling in 500mL non-PVC-soft-bags, and at 121 DEG C, moist heat sterilization 12min obtains product.
Embodiment six
A kind of preparation method of compound sodium acetate ringer's injection of the present invention, comprises the following steps：
1）Weigh following raw material：Sodium chloride 0.876g, potassium chloride 0.748g, Magnesium dichloride hexahydrate 0.304g, a glucose monohydrate
Sour calcium 1.120g, potassium dihydrogen phosphate 1.360g, sodium acetate trihydrate 1.640g, DEXTROSE ANHYDROUS 100g, injection appropriate amount of water；
2）The injection water of recipe quantity 60% is added in dense preparing tank, the temperature of injection water is 70 DEG C, then, adds in above-mentioned recipe quantity
Magnesium dichloride hexahydrate, a hydration calcium gluconate and DEXTROSE ANHYDROUS, stirring obtains just solution to dissolving；
3）The pH of above-mentioned just solution is adjusted, it is 5.3 to make its pH value, then, adds in the potassium dihydrogen phosphate of above-mentioned recipe quantity, treats that its is molten
After solution is complete, the sodium chloride, potassium chloride and sodium acetate trihydrate of above-mentioned recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
4）Into above-mentioned concentrated solution, 0.2% activated carbon that weight is concentrated solution volume, stirring, 55 DEG C of heat preservation absorption are added in
15min cycles 20min using 5 μm of stud filter cores and carries out decarbonisation, then, successively after 5 μm, 0.45 μm of filter element filtering,
It is delivered to dilute preparing tank；
5）In dilute preparing tank, injection water is added to full dose, i.e. 1000mL, it is filling in the non-PVC of 500mL after 0.2 μm of filter element filtering
Soft bag, at 121 DEG C, moist heat sterilization 8min obtains product.
Experiment 1
By the embodiment of the present invention one to parenteral solution prepared by embodiment six according to《Chinese Pharmacopoeia》The four annex methods of version in 2015
PH value, chloride content, glucose content, 5 hydroxymethyl furfural content are detected, laboratory test results are as shown in table 1.
1 injectable liquefied composition testing result of table
As can be seen from Table 1, the pH value of parenteral solution of the present invention is between 4.7-5.5, the note of the method preparation by the present invention
Liquid is penetrated, chloride content maintains 99.8-100.2%, and glucose content maintains 98.0-99.2%, this throwing with composition of raw materials
Doses is basically identical, this illustrates parenteral solution basic free of losses of raw material in preparation process of the present invention；Meanwhile injection of the invention
Its 5 methyl furfural content of liquid is low, only 0.062-0.070, and it is less to illustrate that parenteral solution of the invention generates in preparation process
Glucose degradation products, particularly 5 hydroxymethyl furfural, greatly reduce damage of the glucose degradation products to patient's body.
Experiment 2
The parenteral solution of the present invention is taken to carry out zoopery, manufacture surgical injury Rabbit Model 12 is equally divided into two groups.Operation side
Method is to open abdomen small intestine and caecum is made to be exposed to outside abdominal cavity, and two group model rabbit are transfused the injection of the present invention immediately respectively after surgery
Liquid（Experimental group）With commercially available sodium lactate ringer's injection add 10% glucose group into control parenteral solution（Control group）；Infusion one day,
Observe the recovery situation of two group model rabbit；Detect body temperature, blood sodium, the blood of rabbit in the preoperative, in postoperative 1h, 4h, 8h and 12h
Potassium, blood magnesium, blood chlorine, the level of blood glucose and blood lactase acid, experimental result is as shown in table 2 and table 3.
Influence result of 2 parenteral solution of table to Rabbits Models body temperature, sodium, potassium, magnesium and chlorine
3 parenteral solution of table is to the influence result of Rabbits Models blood glucose and blood lactase acid
As can be seen from Table 2, the rabbit body temperature of postoperative control group is fluctuated, unstable, and the body temperature of experimental group rabbit is always
About 36.0 DEG C are maintained, is consistent with preoperative；Postoperative control group rabbit is in the blood sodium of different time points, blood potassium, blood chlorine, blood magnesium
Concentration is more preoperative to be raised, and experimental group rabbit the blood sodium of different time points, blood potassium, blood chlorine, blood magnesium levels with it is preoperative
It is basically identical, and change over time less；Postoperative two groups of rabbit are in the blood sodium at each time point, blood potassium, blood chlorine, blood magnesium levels phase
Than being transfused rabbit, that is, experimental group of parenteral solution of the present invention, electrolyte concentration is closer to preoperative in each time point blood
Concentration illustrates that the electrolyte balance of perioperative can be maintained by being transfused compound sodium acetate ringer's injection of the present invention.
As can be seen from Table 3, the blood glucose rise of postoperative experimental group rabbit is slow, and the blood glucose rise amplitude of control group rabbit
It is larger, since the compound sodium acetate ringer's injection in the present invention is free of lactate, it is therefore prevented that lactic acid is converted into glucose, therefore long
Time infusion will not cause blood glucose rise；Meanwhile the Serum lactic acid content of postoperative experimental group rabbit does not change substantially, maintains always
Level in the preoperative, and the Serum lactic acid content of control group rabbit shows continuous raised trend, this sodium lactate woods of control group
After lattice parenteral solution inputs for a long time, lactic acid content increases in blood, can increase liver kidney burden；And compound sodium acetate woods lattice of the present invention
Parenteral solution largely inputs for the patients of replenishers advantageously hepatic and renal function exception, acid poisoning, need long-time.
Therefore, the compound sodium acetate ringer's injection of the perioperative infusion present invention both can maintain electrolyte and blood glucose level just
Often, and lactate level is not caused to raise, is conducive to maintain homoiostasis, is worth clinical promotion and application.
Beneficial effects of the present invention：The present invention is carried according to the composition of human plasma, extracellular fluid and intracellular fluid electrolyte
A kind of hypotonic electrolyte glucose intracellular fluid replenisher has been supplied, intracellular fluid, extracellular fluid are being supplemented simultaneously into rear in vivo
With the moisture and electrolyte in intercellular fluid, during for being orally ingested deficiency or energy cannot be supplemented, internal water and energy are supplemented
Amount maintains electrolyte balance.Sodium, potassium, magnesium, calcium, acetate, glucose acid group, phosphoric acid hydrogen radical ion in the present invention, with human body
The ion composition of body fluid is close, the hyponatremia and hypomagnesemia that magnesium ion is likely to occur when can avoid largely being administered, calcium ion
It can prevent the appearance of hypocalcemia, phosphate anion can prevent the appearance of hypophosphatemia, and glucose content height can provide for patient
Sufficient energy.Each active ingredient Proper Match of the present invention, has fully ensured that the nutrient that supplement is provided for patient, has avoided acid
The phenomenon that poisoning and the rise of serum lactic content, will not judge to create a false impression to the state of an illness of critical patient；Its preparation method technique
Simply, mild condition, biological safety is good, drug safety.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
With within principle, any modifications, equivalent replacements and improvements are made should all be included in the protection scope of the present invention god.
Claims (10)
1. a kind of compound sodium acetate ringer's injection, which is characterized in that per parenteral solution described in 1000mL by the original of following parts by weight
Material is prepared：
Sodium chloride 0.800-0.900g, potassium chloride 0.700-0.800g, Magnesium dichloride hexahydrate 0.280-0.350g, a hydration grape
Calciofon 1.000-1.200g, potassium dihydrogen phosphate 1.300-1.400g, sodium acetate trihydrate 1.500-1.700g, DEXTROSE ANHYDROUS
90-110g。
2. compound sodium acetate ringer's injection according to claim 1, which is characterized in that per parenteral solution described in 1000mL by
The raw material of following parts by weight is prepared：
Sodium chloride 0.876g, potassium chloride 0.748g, Magnesium dichloride hexahydrate 0.304g, a glucose monohydrate acid calcium 1.120g, phosphoric acid
Potassium dihydrogen 1.360g, sodium acetate trihydrate 1.640g, DEXTROSE ANHYDROUS 100g.
3. compound sodium acetate ringer's injection according to claim 1 or 2, it is characterised in that：
The pH value of the parenteral solution is 4.7-5.5.
4. compound sodium acetate ringer's injection according to claim 3, it is characterised in that：
The pH value of the parenteral solution is 5.0-5.3.
5. the preparation method of compound sodium acetate ringer's injection according to claim 1 or 2, which is characterized in that including with
Lower step：
1）The injection water of recipe quantity 50-70% is added in dense preparing tank, the temperature of injection water is 60-70 DEG C, then, adds in prescription
The Magnesium dichloride hexahydrate of amount, a hydration calcium gluconate and DEXTROSE ANHYDROUS, stirring obtain just solution to dissolving；
2）Regulating step 1）The pH of the first solution of gained, makes its pH value then, add in the potassium dihydrogen phosphate of recipe quantity for 4.7-5.5,
After its dissolving completely, the sodium chloride, potassium chloride and sodium acetate trihydrate of recipe quantity are sequentially added, stirring and dissolving obtains concentrated solution；
3）To step 2）In gained concentrated solution, activated carbon of the weight for the 0.1-0.2% of concentrated solution volume, stirring are added in, heat preservation is inhaled
It is attached, charcoal is taken off, is delivered to dilute preparing tank；
4）In dilute preparing tank, injection water is added to full dose, filling, moist heat sterilization obtains product.
6. the preparation method of compound sodium acetate ringer's injection according to claim 5, it is characterised in that：
The step 2）In, using the pH value of the first solution of citric acid adjusting.
7. the preparation method of compound sodium acetate ringer's injection according to claim 5, it is characterised in that：
The step 3）In, the temperature for keeping the temperature absorption is 55 DEG C, adsorption time 15-20min.
8. the preparation method of compound sodium acetate ringer's injection according to claim 5, it is characterised in that：
The step 3）In, de- charcoal be using 5 μm of stud filter core circulating filtration 15-20min, after taking off charcoal, successively by 5 μm,
Dilute preparing tank is delivered to after 0.45 μm of filter element filtering.
9. the preparation method of compound sodium acetate ringer's injection according to claim 5, it is characterised in that：
The step 4）In, when filling, first using 0.2 μm of filter element filtering, then, the filling non-PVC-soft in 250mL or 500mL
In bag, the temperature of moist heat sterilization is 121 DEG C, sterilization time 8-12min.
10. the preparation method of compound sodium acetate ringer's injection according to claim 9, it is characterised in that：
The step 4）In, before filling, intermediate is detected, if pH meets 4.7-5.5, chloride content meets
0.320-0.380% g/mL then detect qualification, carry out filling；If detection is unqualified, it is necessary to be adjusted, until detection is closed
Lattice.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610999197.3A CN108066360A (en) | 2016-11-14 | 2016-11-14 | A kind of compound sodium acetate ringer's injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610999197.3A CN108066360A (en) | 2016-11-14 | 2016-11-14 | A kind of compound sodium acetate ringer's injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108066360A true CN108066360A (en) | 2018-05-25 |
Family
ID=62161770
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610999197.3A Pending CN108066360A (en) | 2016-11-14 | 2016-11-14 | A kind of compound sodium acetate ringer's injection and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108066360A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553468A (en) * | 2018-06-25 | 2018-09-21 | 南京正大天晴制药有限公司 | A kind of antibacterial compound sodium acetate ringer's injection and preparation method thereof |
| CN108969474A (en) * | 2018-07-11 | 2018-12-11 | 安徽双鹤药业有限责任公司 | Sodium acetate woods lattice glucose injection and preparation method thereof |
| CN109498649A (en) * | 2018-12-10 | 2019-03-22 | 南京恩泰医药科技有限公司 | A kind of sodium potassium magnesium calcium glucose injection and preparation method |
| CN113041218A (en) * | 2021-03-23 | 2021-06-29 | 回音必集团江西东亚制药有限公司 | Calcium gluconate and sodium chloride injection and preparation method thereof |
| CN114452252A (en) * | 2022-01-20 | 2022-05-10 | 湖北华仁同济药业有限责任公司 | Compound calcium gluconate injection and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06172191A (en) * | 1992-12-07 | 1994-06-21 | Green Cross Corp:The | Glucose-containing electrolyte infusion solution |
| US6277557B1 (en) * | 1997-10-21 | 2001-08-21 | Regents Of The University Of Minnesota | Infusible grade short-term cell storage medium |
| CN103393715A (en) * | 2013-07-22 | 2013-11-20 | 珠海经济特区生物化学制药厂 | Sodium potassium magnesium calcium and glucose injection and preparation method thereof |
| CN103610693A (en) * | 2013-12-03 | 2014-03-05 | 辽宁海思科制药有限公司 | Parenteral nutrition injection composition |
-
2016
- 2016-11-14 CN CN201610999197.3A patent/CN108066360A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06172191A (en) * | 1992-12-07 | 1994-06-21 | Green Cross Corp:The | Glucose-containing electrolyte infusion solution |
| US6277557B1 (en) * | 1997-10-21 | 2001-08-21 | Regents Of The University Of Minnesota | Infusible grade short-term cell storage medium |
| CN103393715A (en) * | 2013-07-22 | 2013-11-20 | 珠海经济特区生物化学制药厂 | Sodium potassium magnesium calcium and glucose injection and preparation method thereof |
| CN103610693A (en) * | 2013-12-03 | 2014-03-05 | 辽宁海思科制药有限公司 | Parenteral nutrition injection composition |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553468A (en) * | 2018-06-25 | 2018-09-21 | 南京正大天晴制药有限公司 | A kind of antibacterial compound sodium acetate ringer's injection and preparation method thereof |
| CN108969474A (en) * | 2018-07-11 | 2018-12-11 | 安徽双鹤药业有限责任公司 | Sodium acetate woods lattice glucose injection and preparation method thereof |
| CN109498649A (en) * | 2018-12-10 | 2019-03-22 | 南京恩泰医药科技有限公司 | A kind of sodium potassium magnesium calcium glucose injection and preparation method |
| CN113041218A (en) * | 2021-03-23 | 2021-06-29 | 回音必集团江西东亚制药有限公司 | Calcium gluconate and sodium chloride injection and preparation method thereof |
| CN114452252A (en) * | 2022-01-20 | 2022-05-10 | 湖北华仁同济药业有限责任公司 | Compound calcium gluconate injection and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN108066360A (en) | A kind of compound sodium acetate ringer's injection and preparation method thereof | |
| AP1185A (en) | Novel pharmaceutical composition for the use in emergency treatment and preparation method thereof. | |
| CN101167740B (en) | Compound sodium acetate electrolyte injection and preparation method thereof | |
| CN101991589B (en) | Glycerol fructose injection and preparation method thereof | |
| CN102670497A (en) | Stable S-oxiracetam preparation for injection and preparation method of same | |
| CN101721423B (en) | Bicarbonate physiological balanced solution and preparation method thereof | |
| CN103432164B (en) | peritoneal dialysis solution and preparation method thereof | |
| CN104224829A (en) | Injection containing sodium, potassium, magnesium, calcium and glucose injection and preparation method of injection | |
| CN104586885A (en) | Compound sodium bicarbonate electrolyte injection composition and preparation method thereof | |
| CN103393715B (en) | Sodium potassium magnesium calcium and glucose injection and preparation method thereof | |
| KR20100017183A (en) | Body-temperature lowering depressant | |
| CN103385889B (en) | Carbohydrate and electrolyte mixed injection and preparation method thereof | |
| CN103860592B (en) | A kind of preparation method of inverted sugar electrolytes injection | |
| CN106309481A (en) | Compound potassium aspartate-glucose injection and preparation method thereof | |
| KR20110131204A (en) | Plasma-adapted full electrolyte solution | |
| CN100571714C (en) | The blood replacing base liquid that is used for blood purification treatment | |
| CN103800285B (en) | A kind of sodium bicarbonate injection and preparation method thereof | |
| CN109481459A (en) | A kind of compound electrolyte glucose injection and preparation method thereof | |
| CN109091500A (en) | A kind of children's compound electrolyte glucose injection and preparation method thereof | |
| CN101926807A (en) | Fructose combination medicament | |
| CN107898808B (en) | Intravenous nutritional preparation for children | |
| CN105497061B (en) | A kind of electrolyte injection and preparation method thereof without glucose | |
| CN108272819A (en) | A kind of aspartic acid Multiple electrolytes injection and preparation method thereof | |
| JPH0469341A (en) | Sugar electrolytic solution for tpn | |
| CN103845358B (en) | Comprise the pharmaceutical composition of hetastarch and the electrolyte solution containing bicarbonate ion |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20180525 |