CN107468705A - A kind of compound electrolyte glucose injection and preparation method thereof - Google Patents
A kind of compound electrolyte glucose injection and preparation method thereof Download PDFInfo
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- 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
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of compound electrolyte glucose injection and preparation method thereof.The parenteral solution includes following components by weight percent：The 5.5g of sodium chloride 2.5, the 0.4g of magnesium chloride 0.1, the 0.3g of calcium chloride 0.1, the 0.75g of 1 3g, L malic acid of sodium acetate 0.25, the 30g of glucose 20, pH adjusting agent 4.5 6.5, the 100mg of antioxidant 10 and water for injection add to 1000ml；Present invention also offers the preparation technology of the sterile solution for injection, the parenteral solution achromaticity and clarification prepared using this method, side reaction is few, the medication compliance of patient and safe, parenteral solution suitable for supplementing water, electrolyte and carbohydrate after Post operation or wound, hypoimmunity is especially more suitable for, with hyperammonemia, angiocardiopathy, anaemia, the patient of the diseases such as uremia, hypertension, burn.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of compound electrolyte glucose injection and preparation method thereof.
Background technology
Body normal body fluid capacity, osmotic pressure and electrolyte content are that metabolism and each organ dysfunction are normally carried out
Basic guarantee.Wound, operation and many surgical diseases can cause internal water and rock-soil coupling, and the patient of peri-operation period is almost
There is different degrees of water and rock-soil coupling, cause the physiological function of body abnormal, the hypovolemic shock as caused by dehydration,
Arrhythmia cordis etc. caused by low potassium, if cannot correct for a long time, operation may be directly affected, cause operation delay, be postoperative
Prognosis is bad, possibly even threat to life.The main purpose of fluid infusion is to maintain effective perfusion of tissue, organ in art, maintains oxygen
Transport, body fluid, electrolyte concentration and blood sugar level are in normal range (NR).Clinical practice proves, largely inputs the replacements of extracellular fluids
Liquid has obvious benefit to operation, the stable circulation of trauma patient and improvement renal function.
Compound electrolyte glucose injection is a classification of big transfusion kind, because it has rapid, efficient, controlled release
The characteristics of, it is the daily medicine that must be used of medical institutions, while be also that clinical rescue medicine and vein treatment medicine are indispensable
Few carrier, highly important status is occupied on modern clinic.
In terms of compound electrolyte glucose injection, China's also larger gap compared with external.It is mainly shown as product
Kind is relatively simple, and Time To Market is short, and compound electrolyte transfusion at present does not form series；Hospital can not still be met with current kind
Demand.In Clinical practice, because folk prescription parenteral solution is frequently necessary to manually be mixed in Clinical practice, to reach a variety of electricity
The rational proportion of matter is solved, adds the labor intensity of medical personnel.Hold very much simultaneously as kind of electrolytes is various, during with liquid
Easily go wrong, also increase pollution risk in addition, for patient with severe symptoms, it is meant that add the risk of infection, and this
Often cause lethal factor.It is therefore clinical that there is an urgent need to be formulated rational compound electrolyte transfusion.
At present, subject matter existing for existing Multiple electrolytes injection is：1. selecting sodium lactate, sodium lactate is mainly in liver
Dirty metabolism, therefore, when applying the equilibrium liquid containing sodium lactate, because lactate is easily metabolized not by liver and kidney dysfunction entirely, except difficulty
To be fully converted to CO2And H2Outside O, lactic acid is easily set to accumulate and cause lactic acidosis.2. for kind of infusing, preferably to ensure it
Sterile level, at present by the way of terminal sterilization, as high-temperature heat sterilization.But under the high temperature conditions, glucose is easy
Pyrolysis produces furfural, and studies and show that furfural has excitant, and has anesthetic effect.Animal, which absorbs, can cause acute poisoning,
Respiratory tract, pulmonary edema, hepatic lesion, central nervous system damage, respiratory center paralysis are presented with, so that dead.More grind
Study carefully discovery, furfural has mutagenicity, and microsome in cell can be caused to be mutated, have potential genetoxic.3. due to potassium
Excretion feature, eats few row less, eats multiple rows of more, does not eat and also arranges, few for food-intake, hypopotassaemia easily occurs in the patient of fasting.
Clinically for long-term few food, fasting, diuresis or a large amount of vomitings, diarrhea patient, sylvite should be supplemented in time.In addition, in metabolic acid
During poisoning, serum potassium may not be low, after acid poisoning is corrected, also may occur in which hypopotassaemia.On the contrary, when kidney row's potassium reduction, it is such as anxious
Property kidney failure, cortex hormone of aadrenaline deficiency, the prolonged application of Potassium-sparing diuretic；Intracellular potassium removes, in haemolysis, acid
Poison, hyperkalemic periodic paralysis.The input of medicine containing potassium is excessive, such as heavy dose of to input excessive, too urgent, the above using or containing potassium solution
Reason can cause potassemia (hyperkalemia can lower the suppressed cardiac muscular tension of cardiac muscle, therefore can have bradycardia and Heart enlargement,
The generation of the dimnition of cardiac sound, easily occurs arrhythmia cordis；Often there are four limbs and mouth week stolidity, extremely tired, aching pain of muscles early stage, most
After have influence on respiratory muscle, can suffocate；Central nervous system shows as having the fidgets or obnubilation.).So clinically
Hypopotassaemia and potassemia incidence are higher.According to the characteristics of above potassium, when patient has hypopotassaemia or potassium ion just
Chang Shi, the compound electrolyte glucose injection containing potassium can be selected.But when patient has potassemia in itself, forbid using containing
The compound electrolyte glucose injection of potassium.At present with kind compound electrolyte glucose injection it is few distinguish containing potassium with
Preparation without potassium.
The content of the invention
In view of the shortcomings of the prior art, the invention provides a kind of compound electrolyte glucose injection and its preparation side
Method.The parenteral solution achromaticity and clarification, side reaction is few, the medication compliance of patient and safe, after Post operation or wound
The parenteral solution of water, electrolyte and carbohydrate is supplemented, hypoimmunity is especially more suitable for, is declined with dyshepatia, liver
Exhaust, hyperammonemia caused by liver cancer especially hepatosis, angiocardiopathy, anaemia, uremia, hypertension, the disease such as burn
The patient of disease.Meanwhile release containing potassium and two kinds of preparations without potassium, according to patient's serum potassium medication, more meet clinical application
Demand and principle.
The technical solution adopted in the present invention is：
A kind of compound electrolyte glucose injection be with sodium chloride, magnesium chloride, calcium chloride, sodium acetate, L MALIC ACID and
Chlorination
Potassium is active component, using glucose as osmotic pressure regulator, with pharmaceutically acceptable pH adjusting agent and specific anti-
Oxygen agent
With the sterile solution for injection of water for injection composition, it specifically includes following component：Sodium chloride 2.5-5.5g
The potassium chloride that content is 0.4-1.0g/1000ml can also wherein be included；
Above-mentioned antioxidant includes one in sodium hydrogensulfite, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, vitamin C
Kind,
Antioxidant is preferably vitamin C.
Above-mentioned pH value regulator is selected from pharmaceutically acceptable component.
Preferably, the parenteral solution is made up of the material of following weight proportion：
It is furthermore preferred that the parenteral solution is made up of the material of following weight proportion：
L MALIC ACID is a kind of organic acid needed by human, is the intercycle body of organism tricarboxylic acids, its essence is ginseng
Converted with metabolism and energy.Played an important role in the metabolic process that mitochondria produces energy matter ATP.Protein,
Lipid, carbohydrate etc. will finally pass through tricarboxylic cyclic oxidation and energize, and this is the final step of conversion process, and mostly important
One step, whether normal it is related to human physiological functions.Malic acid is the important component of malate aspartate shuttle simultaneously,
Reducing equivalent transfer between cytosol and mitochondria is played an important role.Due to malic acid in metabolism approach it is residing
Specific position, body metabolism can be directly participated in, is directly absorbed by the body, realized in the short time and provide energy to human body, eliminated tired
Labor, play a part of it is antifatigue, regain one's strength rapidly.L MALIC ACID can be used for treating hepatopathy, anaemia, hypoimmunity, urine
A variety of diseases such as toxication, hypertension, hepatic failure, and toxic action of the cancer therapy drug to normal cell can be mitigated.
The preparation method of above-mentioned compound electrolyte glucose injection comprises the following steps：
(1) sodium chloride of recipe quantity, magnesium chloride, calcium chloride, sodium acetate are weighed in water for injection, stirring and dissolving；
(2) recipe quantity antioxidant is put into above-mentioned solution, stirring and dissolving；
(3) L MALIC ACID and glucose are put into the above-mentioned solution containing antioxidant, stirring and dissolving；
(4) pH value of regulating liquid medicine, constant volume, charcoal absorption, charcoal, refined filtration are taken off；
(5) gained decoction is dispensed, jumped a queue, roll lid, 121 DEG C of moist heat sterilization 12-20min are got product.
The preparation method of the above-mentioned compound electrolyte glucose injection containing potassium chloride comprises the following steps：
(1) sodium chloride, magnesium chloride, calcium chloride, sodium acetate and the potassium chloride of recipe quantity are weighed in water for injection, stirring is molten
Solution；
(2) recipe quantity antioxidant is put into above-mentioned solution, stirring and dissolving；
(3) L MALIC ACID and glucose are put into the above-mentioned solution containing antioxidant, stirring and dissolving；
(4) pH value of regulating liquid medicine, constant volume, charcoal absorption, charcoal, refined filtration are taken off；
(5) gained decoction is dispensed, jumped a queue, roll lid, 121 DEG C of moist heat sterilization 12-20min are got product.
The present invention has the advantages that：
(1) sodium lactate is replaced from L MALIC ACID, because L MALIC ACID is not in liver metabolism and in muscle and its hetero-organization generation
Thank, oxygen demand is few compared with sodium lactate in metabolic process, and is directly entered tricarboxylic acid cycle after being metabolized, available for treatment because of blood circulation
Tissue fluid caused by amount reduces the factors such as caused shock and operation, wound, scald, massive haemorrhage is reduced, thin to supplement, adjust
Extracellular fluid, metabolic acidosis etc. is corrected, therefore be applicable to hepatosis, severe shock and child patient.
(2) the L MALIC ACID contained in this product has following beneficial effect：
1. L MALIC ACID has a variety of diseases such as treatment hepatopathy, anaemia, hypoimmunity, uremia, hypertension, hepatic failure
Disease, and toxic action of the cancer therapy drug to normal cell can be mitigated；
2. L MALIC ACID can improve utilization rate of the human body to amino acid, available for treatment uremia, hypertension etc. and reduce
Infringement of the cancer therapy drug to normal cell, for the ancillary drug after cancer Radiotherapy chemotherapy, wound can be promoted for burn treating
Healing；
3. L MALIC ACID can promote ammonia metabolism, ammonia concentration is reduced, has protective effect to liver, be to treat liver function not
Entirely, the good medicine of hyperammonemia caused by hepatic failure, liver cancer especially hepatosis.
4. L MALIC ACID is as one for the treatment of heart disease basal liquid composition, for K+、Mg2+Supplement, keep cardiac muscle energy
Amount metabolism, plays a protective role to the ischemic myocardium of miocardial infarction.
5. L MALIC ACID has protective effect to human vas endothelial cell, there is resistance to make endothelial cell injury effect
With.
In summary, the present invention uses the compound electrolyte glucose injection containing L MALIC ACID, suitable for Post operation
Or need to supplement the patient of water, electrolyte and carbohydrate after wound, hypoimmunity is especially more suitable for, with liver function not
Entirely, hyperammonemia caused by hepatic failure, liver cancer especially hepatosis, angiocardiopathy, anaemia, uremia, hypertension, burn
The patient of the diseases such as wound.
(3) antioxidant is added in product of the present invention, can effectively prevent glucose because oxidation point occurs in autoclaving process
Solution, causes the generation of the objectionable impurities such as furfural, patient medication compliance and safe.
(4) the present invention is released containing potassium and two kinds of preparations without potassium, is administered according to patient body situation and demand, more met
Clinical application demand and principle.
Embodiment
The present invention is described in detail with reference to embodiment and comparative example.Following examples are to the present invention
One kind describes in detail rather than is limitation of the present invention.
1. embodiment
1.1 prescription
| Supplementary material | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| Sodium chloride | 2.5g | 4.0g | 5.5g | 4.0g |
| Magnesium chloride | 0.1g | 0.25g | 0.4g | 0.25g |
| Calcium chloride | 0.1g | 0.2g | 0.3g | 0.2g |
| Sodium acetate | 1g | 2g | 3g | 2g |
| L MALIC ACID | 0.25g | 0.5g | 0.75g | 0.5g |
| Potassium chloride | 0.4g | 0.7g | 1.0g | / |
| Sodium hydrogensulfite | 10mg | / | / | / |
| Vitamin C | / | 100mg | / | 100mg |
| Sodium thiosulfate | / | / | 55mg | / |
| Glucose | 20g | 25g | 30g | 25g |
| PH value | 4.5 | 5.5 | 6.5 | 5.5 |
| Water for injection adds to | 1000ml | 1000ml | 1000ml | 1000ml |
1.2 preparation technology
(1) sodium chloride, magnesium chloride, calcium chloride, sodium acetate and the potassium chloride of recipe quantity are weighed in water for injection, stirring is molten
Solution；
(2) recipe quantity antioxidant is put into above-mentioned solution, stirring and dissolving；
(3) L MALIC ACID and glucose are put into the above-mentioned solution containing antioxidant, stirring and dissolving；
(4) pH value of regulating liquid medicine, constant volume, charcoal absorption, charcoal, refined filtration are taken off；
(5) gained decoction is dispensed, jumped a queue, roll lid, 121 DEG C of moist heat sterilizations are got product.
2. comparative example
2.1 prescription
| Supplementary material | Comparative example |
| Sodium chloride | 4.0g |
| Magnesium chloride | 0.25g |
| Calcium chloride | 0.2g |
| Sodium acetate | 2g |
| L MALIC ACID | 0.5g |
| Potassium chloride | 0.7g |
| Glucose | 25g |
| PH value | 5.5 |
| Water for injection adds to | 1000ml |
2.2 preparation technology
(1) sodium chloride, magnesium chloride, calcium chloride, sodium acetate and the potassium chloride of recipe quantity are weighed in water for injection, stirring is molten
Solution；
(2) L MALIC ACID and glucose are put into above-mentioned solution, stirring and dissolving；
(3) pH value of regulating liquid medicine, constant volume, charcoal absorption, charcoal, refined filtration are taken off；
(4) gained decoction is dispensed, jumped a queue, roll lid, 121 DEG C of moist heat sterilizations are got product.
3. result of the test
| Inspection project | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Comparative example |
| Furfural (%) | 0.21 | 0.19 | 0.21 | 0.20 | 3.95 |
| L MALIC ACID content (%) | 100.14 | 99.85 | 99.91 | 100.05 | 91.42 |
Prescription provided by the invention and the finished product obtained by preparation technology, anti-due to adding it can be seen from result of the test
Oxygen agent, objectionable impurities furfural content is significantly lower than the product without antioxidant in finished product, and patient medication compliance and security carry
It is high；Antioxidant is not used in comparative example, causes the content of L MALIC ACID to reduce, and curative effect reduces.
In summary, the parenteral solution achromaticity and clarification that prepared by the present invention, objectionable impurities furfural content is extremely low, and side reaction is few, suffers from
The medication compliance of person and safe, the injection suitable for supplementing water, electrolyte and carbohydrate after Post operation or wound
Liquid, due to the effect of L MALIC ACID, this product is especially more suitable for hypoimmunity, with dyshepatia, hepatic failure, liver cancer
The trouble of the diseases such as especially hyperammonemia caused by hepatosis, angiocardiopathy, anaemia, uremia, hypertension, burn
Person.Meanwhile release containing potassium and two kinds of preparations without potassium, according to patient's serum potassium medication, more meet clinical application demand with
Principle.
Claims (9)
- A kind of 1. compound electrolyte glucose injection, it is characterised in that：The parenteral solution is by the component system of following weight proportion Into：
- A kind of 2. compound electrolyte glucose injection according to claim 1, it is characterised in that：Described component may be used also Including potassium chloride, content 0.4-1.0g/1000ml.
- A kind of 3. compound electrolyte glucose injection according to claim 1, it is characterised in that：Described antioxidant packages Include one kind in sodium hydrogensulfite, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, vitamin C.
- A kind of 4. compound electrolyte glucose injection according to claim 1, it is characterised in that：Described pH value regulation Agent is selected from pharmaceutically acceptable component.
- A kind of 5. compound electrolyte glucose injection according to claim 1, it is characterised in that：Described antioxidant is excellent Elect vitamin C as.
- A kind of 6. compound electrolyte glucose injection according to claim 1, it is characterised in that：Preferably, the injection Liquid is made up of the component of following weight proportion：
- A kind of 7. compound electrolyte glucose injection according to claim 1, it is characterised in that：It is furthermore preferred that the note Liquid is penetrated to be made up of the material of following weight proportion：
- A kind of 8. method for preparing a kind of compound electrolyte glucose injection described in claim 1, it is characterised in that：Including Following steps：(1) sodium chloride of recipe quantity, magnesium chloride, calcium chloride, sodium acetate are weighed in water for injection, stirring and dissolving；(2) recipe quantity antioxidant is put into above-mentioned solution, stirring and dissolving；(3) L MALIC ACID and glucose are put into the above-mentioned solution containing antioxidant, stirring and dissolving；(4) pH value of regulating liquid medicine, constant volume, charcoal absorption, charcoal, refined filtration are taken off；(5) gained decoction is dispensed, jumped a queue, roll lid, 121 DEG C of moist heat sterilization 12-20min are got product.
- A kind of 9. method for preparing a kind of compound electrolyte glucose injection described in claim 2, it is characterised in that：Including Following steps：(1) sodium chloride, magnesium chloride, calcium chloride, sodium acetate and the potassium chloride of recipe quantity are weighed in water for injection, stirring and dissolving；(2) recipe quantity antioxidant is put into above-mentioned solution, stirring and dissolving；(3) L MALIC ACID and glucose are put into the above-mentioned solution containing antioxidant, stirring and dissolving；(4) pH value of regulating liquid medicine, constant volume, charcoal absorption, charcoal, refined filtration are taken off；(5) gained decoction is dispensed, jumped a queue, roll lid, 121 DEG C of moist heat sterilization 12-20min are got product.
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Cited By (5)
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| CN108904526A (en) * | 2018-08-17 | 2018-11-30 | 华仁药业股份有限公司 | A kind of children's electrolyte injection |
| CN109091500A (en) * | 2018-10-09 | 2018-12-28 | 济南康和医药科技有限公司 | A kind of children's compound electrolyte glucose injection and preparation method thereof |
| CN109432123A (en) * | 2018-11-23 | 2019-03-08 | 济南康和医药科技有限公司 | A kind of compound electrolyte glucose injection and preparation method thereof |
| CN109481459A (en) * | 2018-11-23 | 2019-03-19 | 济南康和医药科技有限公司 | A kind of compound electrolyte glucose injection and preparation method thereof |
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| CN108578426A (en) * | 2018-03-16 | 2018-09-28 | 辽宁药联制药有限公司 | A kind of aspartic acid Multiple electrolytes injection and preparation method thereof |
| CN108904526A (en) * | 2018-08-17 | 2018-11-30 | 华仁药业股份有限公司 | A kind of children's electrolyte injection |
| CN109091500A (en) * | 2018-10-09 | 2018-12-28 | 济南康和医药科技有限公司 | A kind of children's compound electrolyte glucose injection and preparation method thereof |
| CN109432123A (en) * | 2018-11-23 | 2019-03-08 | 济南康和医药科技有限公司 | A kind of compound electrolyte glucose injection and preparation method thereof |
| CN109481459A (en) * | 2018-11-23 | 2019-03-19 | 济南康和医药科技有限公司 | A kind of compound electrolyte glucose injection and preparation method thereof |
| CN109481459B (en) * | 2018-11-23 | 2021-07-20 | 济南康和医药科技有限公司 | Compound electrolyte glucose injection and preparation method thereof |
| CN109432123B (en) * | 2018-11-23 | 2021-07-20 | 济南康和医药科技有限公司 | Compound electrolyte glucose injection and preparation method thereof |
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