CN108451974A - A kind of aspartic acid Multiple electrolytes injection and preparation method thereof - Google Patents
A kind of aspartic acid Multiple electrolytes injection and preparation method thereof Download PDFInfo
- Publication number
- CN108451974A CN108451974A CN201810216538.4A CN201810216538A CN108451974A CN 108451974 A CN108451974 A CN 108451974A CN 201810216538 A CN201810216538 A CN 201810216538A CN 108451974 A CN108451974 A CN 108451974A
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- China
- Prior art keywords
- injection
- aspartic acid
- multiple electrolytes
- preparation
- acid multiple
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Classifications
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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
- A61K31/185—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
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- 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
- A61K33/14—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 present invention provides a kind of aspartic acid Multiple electrolytes injections and preparation method thereof, and the injection is in terms of 500mL, including following components, and the weight of each component indicates as follows：0.25~0.75g of sodium chloride；15~20g of glucose；40% 1~2g of solution of sodium lactate；0.6~1.0g of aspartic acid；Surplus is water.The product is total intravenous nutrition injection, can provide a variety of electrolyte and carbohydrate simultaneously for body, the purpose that can be reached supplement body body fluid, maintain fluid and electrolyte balance, provide energy.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of compound aspartic acid potassium sodium lactate electrolyte injection and
Preparation method.
Background technology
Water, electrolyte metabolism disorders are clinically very common.The disease of many tracts, some systemic pathology
After process, such as hepatic sclerosis, diabetes, pulmonary heart disease, burn and scald and operation, it can cause or disorderly with water and electrolyte metabolism
Disorderly；Certain variations of external environment, certain iatrogenic factors such as drug improper use, also often can cause water and electrolyte metabolism disorderly
Disorderly.If cannot timely correct, water, electrolyte metabolism disorders itself can make each tract of whole body especially cardiovascular again
Corresponding obstacle occurs for the metabolism of system, the physiological function of nervous system and body, can seriously lead to death often.Cause
This, the problem of water, electrolyte metabolism disorders, is one of problem particularly important in medical science, receives medical science work
The most attention of person.
The drug of clinically used supplement and adjusting water, electrolyte balance has physiological saline, Ringer's solution, sodium lactate woods at present
Lattice liquid, 5% G/NS solution and 5% glucose lactate Ringer's solution and acetic acid Ringer's solution etc., and these drugs
The medicine of middle supplement potassium is potassium chloride, and potassium chloride also makes chlorine ion concentration increase while supplementing potassium ion, largely can when supplement
Cause high chlorine metabolic acidosis, is subject to certain restrictions in clinical application.
Invention content
Present invention seek to address that problem as described above.The present invention provides a kind of aspartic acid compound electrolyte injection
Liquid, the product are total intravenous nutrition injection, can provide a variety of electrolyte and carbohydrate simultaneously for body, can reach supplement body body
Liquid, the purpose for maintaining fluid and electrolyte balance, energy being provided.
The present invention provides a kind of aspartic acid Multiple electrolytes injection, in terms of 500mL, including following components, each group
The weight divided indicates as follows：
Wherein, including following components, the weight of each component indicate as follows：
Wherein, the compound injection pH is 5.0~7.0.
According to another aspect of the present invention, a kind of preparation side of aspartic acid Multiple electrolytes injection is additionally provided
Method includes the following steps：
(1) sodium chloride, glucose, 40% solution of sodium lactate are placed in by predetermined ratio in beaker, addition 200-250mL,
65-75 DEG C of water for injection, stirring and dissolving；
(2) cooling, pH is detected, with salt acid for adjusting pH between 5-7；It is settled to 300mL, activated carbon is added, filtering must note
Penetrate liquid 1；
(3) aspartic acid of predetermined ratio is placed in beaker, is added in 200mL waters for injection, activated carbon, mistake is added
Filter, obtains injection 2.
Wherein, further comprising the steps of after the step (3)：
(4) injection 1 and injection 2 are filled into the Room and two Room of dual-chamber bag respectively；
(5) it sterilizes.
Wherein, the volume ratio of the injection 1 and injection 2 is 3：2.
Wherein, the filter sizes that the step (2) and the middle filtering of step (3) use are 0.22um.
Wherein, the sterilization method of the step (5) is moist heat sterilization；Sterilising conditions are 115 DEG C and sterilize 30min or 121 DEG C
Sterilize 15min.
The aspartic acid Multiple electrolytes injection of the present invention, in terms of 500mL, including sodium chloride 0.25~0.75g, it is excellent
Choosing, be 0.585g；The content of 40% solution of sodium lactate is 1~2g, it is preferred that is 1.4g.Sodium be intracellular important sun from
Son plays important role in a variety of enzyme reactions and muscle contraction, by single sodium chloride sodium chloride and sodium lactate
Instead of reducing the level of chlorion in prescription, can be made using the combination of the sodium chloride of the concentration, 40% solution of sodium lactate defeated
The molar concentration of sodium ion is consistent with human body cell external solution intermediate ion concentration in liquid, closer to the composition of each ion in blood,
It can effectively correct metabolic acidosis simultaneously.
The content of glucose is 15~20g, it is preferred that is 17.044；Glucose supplements energy.It is dense that this is added in prescription
The glucose of degree forms a kind of total intravenous nutrition injection, can provide a variety of electrolyte and carbohydrate simultaneously for body.
Aspartic acid is a kind of electrolyte complementary medical, there is many advantages compared with potassium chloride：(1) it is dense that chlorion is not increased
Degree；(2) L-aminobutanedioic acid is the precursor of internal oxaloacetic acid, is played an important role in tricarboxylic acid cycle.Meanwhile L-aminobutanedioic acid is also joined
Add ornithine to recycle, promote the metabolism of ammonia and carbon dioxide, is allowed to generate urea, reduces the content of ammonia and carbon dioxide in blood.
L-aminobutanedioic acid and cell have very strong affinity, can be used as potassium, magnesium ion enters the carrier of cell, and potassium ion is made to return to cell
It is interior, promote cell depolarization and cell metabolism, maintains its normal function.The content of aspartic acid is 0.6~1.0g, preferably
, it is 0.724g.The molar concentration of potassium ion is consistent with human body cell external solution intermediate ion concentration in infusion.Aspartic acid conduct
Emerging benefit potassium preparation, L-aminobutanedioic acid have very strong affinity with cell, can be used as the carrier that potassium ion enters cell, make potassium ion
It returns into the cell, promotes cell depolarization and cell metabolism, maintain its normal function, and have protective effect to Apoptosis.
The L-aminobutanedioic acid of the present invention add the sodium chloride that Multiple electrolytes injection includes, glucose, 40% solution of sodium lactate,
Aspartic acid, only with above four kinds of components, ingredient is simple；But show that each component has been combined with each other by many experiments
To the optimum proportioning of optimal effectiveness.
The preparation method of aspartic acid Multiple electrolytes injection of the present invention includes：
(1) sodium chloride, glucose, 40% solution of sodium lactate are placed in by predetermined ratio in beaker, addition 200-250mL,
65-75 DEG C of water for injection, stirring and dissolving；
(2) cooling, pH is detected, with salt acid for adjusting pH between 5-7, keeping consistent with pH value of human body, is settled to 300mL,
Activated carbon is added, filtering obtains injection 1；
(3) aspartic acid of predetermined ratio is dissolved in 200mL waters for injection, is filtered, activated carbon is added, is injected
Liquid 2.
(4) injection 1 and injection 2 are filled into the Room and two Room of dual-chamber bag respectively；Timesharing primarily to
Each component in infusion is set to stablize, with L-aminobutanedioic acid Maillard reaction can occur for glucose, generate impurity.
(5) it sterilizes, sterilization method generally uses moist heat sterilization；Sterilising conditions are 30min or 121 DEG C of sterilizing of 115 DEG C of sterilizings
15min。
Wherein, the volume ratio of injection 1 and injection 2 is 3：2；The filter hole that filtering uses in step (2) and step (3)
Diameter is 0.22um.
Specific implementation mode
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the implementation of the present invention
Example, is clearly and completely described technical scheme of the present invention, it is clear that described embodiment is that a part of the invention is real
Example is applied, instead of all the embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not making creation
Property labour under the premise of the every other embodiment that is obtained, shall fall within the protection scope of the present invention.It should be noted that not rushing
In the case of prominent, the features in the embodiments and the embodiments of the present application mutually can be combined arbitrarily.
The aspartic acid Multiple electrolytes injection of the present invention, in terms of 500mL, including 0.25~0.75g of sodium chloride；Portugal
15~20g of grape sugar；40% 1~2g of solution of sodium lactate；0.6~1.0g of aspartic acid；Surplus is water；
Preferably, sodium chloride 0.585g；Glucose 17.044g；40% solution 1.4g of sodium lactate；Aspartic acid
0.724g；Surplus is water.
Preparation method includes：Sodium chloride, glucose, 40% solution of sodium lactate are placed in by predetermined ratio in beaker, are added
200-250mL, 65-75 DEG C of waters for injection, stirring and dissolving；It is cooling, pH is detected, with salt acid for adjusting pH between 5-7；It is settled to
300mL, is added activated carbon, and filtering obtains injection 1；The aspartic acid of predetermined ratio is dissolved in 200mL waters for injection, is added
Enter activated carbon, filters, obtain injection 2；Injection 1 and injection 2 are filled into the Room and two Room of dual-chamber bag respectively；It goes out
Bacterium.
The specific embodiment of aspartic acid Multiple electrolytes injection of the present invention and preparation method thereof is listed below：
Embodiment
Preparation method：Sodium chloride, glucose, 40% solution of sodium lactate are placed in by predetermined ratio in beaker, are added
240mL, 70 DEG C of waters for injection, stirring and dissolving；It is cooling, pH is detected, with salt acid for adjusting pH between 5.6-6.0；It is settled to
300mL, is added activated carbon, and 0.22um membrane filtrations obtain injection 1；The aspartic acid of predetermined ratio is dissolved in 200mL injections
With in water, activated carbon is added, 0.22um membrane filtrations obtain injection 2；Injection 1 and injection 2 are filled into dual chamber respectively
A Room and two Room for bag；121 DEG C of sterilizing 15min.
The content of injection each component is as shown in table 1, in terms of 500mL.
Table 1
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | |
| Sodium chloride | 0.25 | 0.32 | 0.40 | 0.50 | 0.62 | 0.68 |
| Glucose | 18 | 15 | 17 | 20 | 16 | 17.5 |
| 40% solution of sodium lactate | 1.2 | 1 | 1.1 | 1.5 | 1.6 | 2 |
| Aspartic acid | 0.76 | 0.6 | 0.85 | 0.9 | 0.65 | 0.80 |
| Water | Surplus | Surplus | Surplus | Surplus | Surplus | Surplus |
Test case
As can be seen from Table 2, between 95%-105%, related substance is respectively less than every content of injection finished product
0.1%, and difference is little between prescription, is suitable for clinical transfusion requirement.
To sum up, aspartic acid Multiple electrolytes injection of the invention, the product are total intravenous nutrition injection, can be same
When for body provide a variety of electrolyte and carbohydrate, supplement body body fluid can be reached, fluid and electrolyte balance is maintained, energy is provided
Purpose.
Finally it should be noted that：Herein, the terms "include", "comprise" or its any other variant are intended to non-
It is exclusive to include, so that the process, method, article or equipment comprising a series of elements includes not only those elements,
But also include other elements that are not explicitly listed, or further include solid by this process, method, article or equipment
Some elements.In the absence of more restrictions, the element limited by sentence " including one ... ", it is not excluded that including institute
State in the process, method, article or equipment of element that there is also other identical elements.
The above embodiments are merely illustrative of the technical solutions of the present invention, rather than its limitations.Although with reference to the foregoing embodiments
Invention is explained in detail, it will be understood by those of ordinary skill in the art that：It still can be to aforementioned each implementation
Technical solution recorded in example is modified or equivalent replacement of some of the technical features；And these modification or
It replaces, the spirit and scope for various embodiments of the present invention technical solution that it does not separate the essence of the corresponding technical solution.
Claims (8)
1. a kind of aspartic acid Multiple electrolytes injection, which is characterized in that in terms of 500mL, including following components, each component
Weight indicate it is as follows：
2. aspartic acid Multiple electrolytes injection as described in claim 1, in terms of 500mL, which is characterized in that including with
The weight of lower component, each component indicates as follows：
3. aspartic acid Multiple electrolytes injection as claimed in claim 1 or 2, which is characterized in that the compound injection
Liquid pH is 5.0~7.0.
4. a kind of preparation method of aspartic acid Multiple electrolytes injection according to any one of claim 1-3,
It is characterized by comprising the following steps：
(1) sodium chloride, glucose, 40% solution of sodium lactate are placed in by predetermined ratio in beaker, 200-250mL, 65-75 is added
DEG C water for injection, stirring and dissolving；
(2) cooling, pH is detected, with salt acid for adjusting pH between 5-7；It is settled to 300mL, activated carbon is added, filtering obtains injection
1；
(3) aspartic acid of predetermined ratio is placed in beaker, is added in 200mL waters for injection, activated carbon is added, filtered,
Obtain injection 2.
5. the preparation method of aspartic acid Multiple electrolytes injection as claimed in claim 4, which is characterized in that described
It is further comprising the steps of after step (3)：
(4) injection 1 and injection 2 are filled into the Room and two Room of dual-chamber bag respectively；
(5) it sterilizes.
6. the preparation method of aspartic acid Multiple electrolytes injection as claimed in claim 4, which is characterized in that the note
The volume ratio for penetrating liquid 1 and injection 2 is 3：2.
7. the preparation method of aspartic acid Multiple electrolytes injection as claimed in claim 4, which is characterized in that the step
Suddenly the filter sizes that (2) and the middle filtering of step (3) use are 0.22um.
8. the preparation method of aspartic acid Multiple electrolytes injection as claimed in claim 5, which is characterized in that the step
Suddenly the sterilization method of (5) is moist heat sterilization；Sterilising conditions are 30min or 121 DEG C of sterilizing 15min of 115 DEG C of sterilizings.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810216538.4A CN108451974A (en) | 2018-03-16 | 2018-03-16 | A kind of aspartic acid Multiple electrolytes injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810216538.4A CN108451974A (en) | 2018-03-16 | 2018-03-16 | A kind of aspartic acid Multiple electrolytes injection and preparation method thereof |
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| Publication Number | Publication Date |
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| CN108451974A true CN108451974A (en) | 2018-08-28 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810216538.4A Pending CN108451974A (en) | 2018-03-16 | 2018-03-16 | A kind of aspartic acid Multiple electrolytes injection and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112426359A (en) * | 2020-11-30 | 2021-03-02 | 山东齐都药业有限公司 | Double-chamber bag sugar-containing ringer's solution and preparation method thereof |
-
2018
- 2018-03-16 CN CN201810216538.4A patent/CN108451974A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112426359A (en) * | 2020-11-30 | 2021-03-02 | 山东齐都药业有限公司 | Double-chamber bag sugar-containing ringer's solution and preparation method thereof |
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Application publication date: 20180828 |