CN101721424B - Bicarbonate physiological balanced solution and preparation method thereof - Google Patents
Bicarbonate physiological balanced solution and preparation method thereof Download PDFInfo
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- CN101721424B CN101721424B CN2009102075618A CN200910207561A CN101721424B CN 101721424 B CN101721424 B CN 101721424B CN 2009102075618 A CN2009102075618 A CN 2009102075618A CN 200910207561 A CN200910207561 A CN 200910207561A CN 101721424 B CN101721424 B CN 101721424B
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Abstract
The invention discloses a bicarbonate physiological balanced solution which belongs to the field of infusion preparations and is prepared form the following raw materials: sodium chloride, potassium chloride, calcium chloride, magnesium sulfate, sodium bicarbonate, citric acid, trisodium citrate and optional glucose. All the raw materials are accurately weighed according to corresponding portions, and dissolved in water for injection; the volume is determined; CO2 gas is introduced; the pH value is adjusted; and the solution is filtered, filled, packed, sterilized, labeled and then stored at room temperature. The solution has the advantages that ion components and a penetration concentration are similar to those of extracellular fluid and have physiological performance. The balanced solution is suitable for supplementing the extracellular fluid by injection, intravenous drip or oral administration, has an adjustment function for acid-base balance, and is also used as a surgical washing fluid or buffering solution.
Description
Technical field
The present invention relates to great transfusion preparation, specifically is a kind of bicarbonate physiological balanced solution.Be that a kind of ion component and osmotic pressure are followed the more close balance liquid of extracellular fluid, be applicable to that through injection or intravenous drip approach or the additional extracellular fluid of oral route acid-base balance is had regulating action, also can be used as surgical flush fluid or buffer solution and use.
Background technology
The balance liquid of medical profession use at present mainly contains three kinds: and ringer's solution (Ringer ' s solution; RS), Lactated Ringer'S Solution (Lactated Ringer ' s solution; LRS) and the acetic acid ringer's solution (Acetated Ringer ' s solution, ARS).
1880-1883 Britain physiologist and clinician Sydney Ringer (1835-1910) are all of a sudden with tap water configuration frog heart muscle perfusion liquid; Find that its myocardial contractility is better than the normal saline of distilled water configuration; Its composition analysis drawn with micro-potassium/calcium ion contained in the tap water and bicarbonate can improve myocardial contractility; So at first propose the notion of compound electrolyte solution, ringer's solution hence obtains one's name, claim again " ringer's solution ".The advantage of ringer's solution is: ooze Na with blood plasma etc.
+, K
+Concentration and blood plasma are close.Not enough point: 1. Cl
-Be higher than plasma content, a large amount of infusions can produce detrimental effect to body, can cause iatrogenic hyperchloremia property metabolic acidosis (Hyperchloremic metabolic acidosis, HCMA).2. free calcium Ca
2+Content is up to more than the 2.0m mol/L, reduces the perioperative blood loss though help lend some impetus to blood coagulation, a large amount of infusions (＞3L) might shorten clotting time, cause the tangible hypercoagulability of body.3. there is not direct buffer base in its composition.
People expect in ringer's solution, adding the buffered with bicarbonate tissue acidosis at first, but hinder its application because of forming deposition with calcium/magnesium ion.The thirties in last century, early stage Alexis Hartmann added lactic acid acid-base balance being played cushioning effect in ringer's solution, and Lactated Ringer'S Solution thereby appearance are claimed again " HartmannShi liquid ".Compare with ringer's solution, Lactated Ringer'S Solution contains K
+, Ca
2+And Lactate
-, having cushioning effect, whole hemodynamic Effects can be improved the survival rate of sepsis and traumatic hemorrhagic shock.Drawback is: 1. Na
+Content (130m mol/L) and total osmotic concentration (274mOsm/L) are lower than ECF, and a large amount of inputs can cause hyponatremia and reduce the extracellular fluid osmotic pressure causing interstitial edema that it is unfavorable to use the patient that cerebral edema danger is arranged.2. free calcium Ca
2+Equally there is the probability of disturbing blood coagulation in content 2.0m mol/L with common ringer's solution.3. contained D-lactate has the potential apoptosis effect nature lactic acid that causes that D-lactic acid and two kinds of optical isomers of L-lactic acid are arranged in the Lactated Ringer'S Solution; D-lactic acid has direct toxic action by metabolism and to hepatocyte, pulmonary epithelial cells and neuron in vivo hardly, and a large amount of inputs can increase alveolar epithelial cells and hepatocellular apoptosis in the short time; Can be the L type by metabolic endogenous lactic acid, mainly generate equimolecular HCO at liver metabolism
3 -Its effect of performance buffering.Because of restrictions such as production technologies, the lactate majority in the commercially available Lactated Ringer'S Solution is the raceme of D-lactic acid and L-lactate mixed in equal amounts, and therefore the potential apoptosis effect that causes is arranged.4. a large amount of infusion Lactated Ringer'S Solutions can cause hyperlactacidemia in the hyperlactacidemia short time, and exogenous input L-lactate in vivo metabolism be that (1 molecule L-lactic acid metabolism generates equimolecular HCO to a power consumption process
3 -To consume 6 molecule ATP), generate HCO
3 -In and H
+Become CO
2Life period hysteresis quality when waving cushioning effect with waterishlogging (after 1.5 hours, just playing a role greatly), this is unfavorable to hepatotomy regulating liver-QI transplant operation, is used as priming fluid in the extracorporeal circulation and also is prone to take place hyperlactacidemia.
For avoiding lactic acid to accumulate untoward reaction, the acetic acid ringer's solution that the U.S. hundred special companies in 1979 release, trade name cry " suddenly arteries and veins power A " (PLASMA-LYTE, Baxter), promptly with acetate (Acetate
-) replace lactate to make the additional liquid of extracellular fluid crystal, it is a kind of not calcareous compound electrolyte solution.In view of existing the danger of concurrent hyperlactacidemia, hundred special companies, the infusion Lactated Ringer'S Solution thinks that vigorous arteries and veins power A is the compound electrolyte solution of physiology.Its advantage is that pH value is 7.4, and osmotic concentration is near blood plasma (308mOsm/L); Cl
-And Na
+Concentration is near blood plasma, K
+And Mg
2+Concentration is near extracellular fluid; The acetate and the glucose acid group (for the twice of normal plasma value) that contain the bicarbonate precursor substance can be brought into play bigger buffer capacity; Do not contain lactic acid, yet not extra rising blood glucose, do not increase the weight of burden of liver; The extracorporeal circulation preliminary filling is seldom accumulated; Under generalized anesthetic state, be beneficial to advantages such as keeping central body temperature in addition in addition.But have research to show, the acetic acid ringer's solution is not superior to Lactated Ringer'S Solution in correction metabolic acidosis and energy ATP supply.Its drawback is: 1. do not contain Ca
2+Be that a major defect calcium is the interior effect of cell signaling molecule the most widely, almost relate to the vital movement in all cells, be not only important secondary signal molecule, various especially vital movements self are regulated molecule from steady adjusting.Think at present and when selecting the supplementary functionality extracellular fluid, can not select not have this non-physiologic crystalloid fluid of calcium liquid.2. acetic Acid Metabolism diabetic ketoacidosis patient and hepatectomy patient body intracellular metabolite will reduce to 1/3 and metabolism incomplete.3. acetic acid has the expansion vascular effect, and fast a large amount of infusions have inhibitory action to cardiovascular system.4. aggressive aspergillosis enzyme linked immune assay testing result is disturbed in vigorous arteries and veins power A venoclysis meeting, therefore to hematopathy and tumor patient that aspergillosis infects septicemia hidden danger being arranged for avoiding false diagnosis, the taboo use.
The composition contrast (seeing table 1) of above-mentioned various balance liquid and blood plasma (Plasma)/tissue fluid (Interstitial)/intracellular fluid (Intracellular) all awaits improving.
Table 1: the contrast of various balance liquids and blood plasma/tissue fluid/intracellular fluid composition (adopt osmotic concentration Osmolarity, unit is mOsm/L).
Annotate:
*Wherein plasma ion calcium normal value is 1.0-1.2m mol/L (2.0-2.4mOsm/L), and ARS (Baxter) also contains gluconic acid 23m mol/L (Gluconate 23mOsm/L).
Sodium bicarbonate is not need the organism metabolism process just can bring into play the physiological buffering alkali of alkalization effect rapidly; Why be not added in the ringer's solution, be to make the production technology of bicarbonate ringer's solution three fail to reach pharmaceutics production requirement (HCO under the room temperature during the last ten years in the past because of sedimentation problem always always
3 -Be easy to generate CO
3 2-, CO
2And H
2O 2HCO
3 -→ CO
3 2-+ CO
2+ H
2O, CO
3 2-+ Ca
2+→ CaCO
3↓); But, HCO after simple sodium bicarbonate injection venoclysis
3 -The buffer base of not getting involved metabolic process and combining with the bivalent cation metabolism to become in the blood plasma with regard to instantaneous manages to stablize that calcium/magnesium ion just can reach stablizing of bicarbonate in the mixed solution as long as this is just indicating.Experiment proof (pH＜8.0) under suitable pH condition adds suitable normal citrate (Citrate in solution
3-) time, Citrate
3-Can with Ca
2+, Mg
2+The generation complex reaction forms stable complex and avoids deposition.
Summary of the invention
The object of the present invention is to provide a kind of bicarbonate physiological balanced solution and preparation method thereof; It compares its ion component and osmotic concentration with extracellular fluid (extracellular fluid with present clinical common dosage forms; ECF) more close; Be applicable to that through injection or intravenous drip approach or the additional extracellular fluid of oral route acid-base balance is had regulating action; Also can be used as surgical flush fluid or buffer solution uses.
The present invention realizes with following technical scheme: a kind of bicarbonate physiological balanced solution, this balance liquid are in the preparation process, to feed CO
2Gas regulation pH processes, and each ion molar concentration is respectively:
Sodium ion Na
+135-145m mol/L
Chloride ion Cl
-105-120m mol/L
Potassium ion K
+3-5.5m mol/L
Calcium ion Ca
2+0.5-1.5m mol/L
Magnesium ion Mg
2+0.7-1.1m mol/L
Sulfate ion SO
4 2-0.7-1.1m mol/L
Bicarbonate ion HCO
3 -23-27m mol/L
Citrate ion Citrate
3-1.5-3m mol/L,
The optional glucose that contains of said balance liquid.
What find based on the application is that citrate stablize on the basis of calcium ions and magnesium ions, and the concentration that need satisfy citrate ion just can realize the basic purpose of inventing within the specific limits.
Research worker has been carried out further research again.If use trisodium citrate to stablize calcium ions and magnesium ions separately, its pH value does not meet psychological need more than 8.0, must regulate its PH.But when using acid such as hydrochloric acid, sulphuric acid to regulate, at first can cause the decomposition of bicarbonate radical to take place, can't guarantee that particularly the bicarbonate concentration in the solution can't reach requirement in heat sterilization or the long preservation process; Anionic introducings such as secondly a large amount of chlorine, sulfate radical can make the various ion concentrations of solution exceed the optimum range of each ion concentration of physiological balance liquid.Therefore research worker is sought the introducing and the existing way of best citrate, when in system, quoting citric acid and arbon dioxide solution simultaneously, can reach an optimum efficiency through the wonderful discovery of screening.When controlling content and the pH value of citrate simultaneously like the combination of independent use citric acid and trisodium citrate, reach satisfactory PH, the amount ratio of citric acid is bigger, and this can cause the decomposition of bicarbonate radical to take place equally.Though also have indivedual methods to use carbon dioxide regulator solution PH, discover that simple use carbon dioxide regulator solution needs the carbon dioxide in the solution to reach very big dividing potential drop.CO
2Hypertonia is given in the explained hereafter and is brought many pH unstable factors.Therefore the simple carbon dioxide that uses neither optimum selection.
Chance on the concentration that satisfies overall citrate basis within the specific limits; When being utilized in the combination that charges into carbon dioxide, citric acid and trisodium citrate in the solution and controlling pH value; Surprisingly in the solution not only the concentration of citrate meet the demands; PH also can meet the demands, and the stability that the most important thing is the bicarbonate radical in the solution also is best.
In order to achieve the above object, this balance liquid prepares and uses sodium chloride, potassium chloride, calcium chloride, magnesium sulfate, sodium bicarbonate, citric acid and trisodium citrate in the process, processes after being dissolved in water for injection by proportioning.In order to achieve the above object, citric acid and trisodium citrate by weight, citric acid: the trisodium citrate amount ratio is 1: 2.5-3.5, preferred 1: 3.
The said goods obtains through following method:
1. take by weighing each raw material in proportion, subsequent use;
2. with sodium chloride, potassium chloride, calcium chloride, magnesium sulfate, citric acid and trisodium citrate, and the optional glucose that adds adds the water for injection stirring and dissolving and must dispose liquid I;
3. sodium bicarbonate is added in the water for injection, dissolving feeds CO in water before the sodium bicarbonate dissolving or after the dissolving
2To saturated or must dispose liquid II near saturated; Preferably, about 30 ℃ of water temperatures, using the purpose of carbon dioxide this moment is to reduce the pH of solution, makes dissolved bicarbonate radical more stable in the preparation process;
4. with step 2. and 3. gained configuration liquid I mix and add the injection water with configuration liquid II and be settled to full dose, in solution, feed CO
2Regulating pH value is 6.0～7.5, preferred pH between 6.7-7.3, preferably about 7.0; Discover that this step can obviously be reduced in the sedimentary generation of calcium ions and magnesium ions in the later stage sterilization heating process after feeding carbon dioxide.The technical staff can filter before or after regulating pH according to the needs of implementing;
5. with 4. gained solution embedding of step; Perhaps,
Adopt medical non-PVC multi-layer co-extruded film transfusion bag compartment promptly to join the embedding of formula transfusion package technology calcium chloride, magnesium sulfate, the optional glucose that adds: calcium chloride, magnesium sulfate not to be added dissolving among the configuration liquid I with the optional glucose that adds in 2. and, face with preceding extruding mixing with calcium chloride, magnesium sulfate and the glucose of choosing interpolation wantonly the preparation liquid one after with aforementioned standardize solution leave two Room or three Room compartment embeddings in abovementioned steps;
Preferably, this method also comprises 6. sterilization steps; For processing safety, need treat after the preferred sterilization that temperature reduces to the room temperature taking-up of boiling after 2 hours.
Essential calcium/the magnesium ion of histiocyte metabolism that contains in the composition of said balance liquid; Used raw material calcium chloride and magnesium sulfate adopt conventional transfusion package or adopt and promptly join the formula transfusion package, extruding mixing before promptly packing, use with medical non-PVC multi-layer co-extruded film transfusion bag compartment.
Institute's calcic or magnesium ion can not form deposition for fully taking place to form complexation calcium or magnesium after the complex reaction with citric acid in the composition of said balance liquid.
The composition of described balance liquid can provide the necessary energy metabolism substrate of cell base metabolism glucose in addition, and its value approaches euglycemia concentration, can not raise because of conventional infusion causes blood sugar concentration.Its addition is that every 1000ml bicarbonate physiological balanced solution contains glucose 0g-50g or molar concentration 0-278mmol/L.
After in said balance liquid solution, feeding medical standard carbon dioxide adjusting pH value, corresponding 2000ml, 1000ml, 500ml, 250ml, the 100ml of being distributed into; Adopt vial, medical PVC bottle or medical non-PVC multi-layer co-extruded film transfusion bag packing autoclaving.
Physicochemical property is stable under the room temperature of this bicarbonate physiological balanced solution sterilization encapsulation back, need not cryopreservation.
The present invention compared with prior art has the following advantages and purposes: 1. prescription more conforms with physiology, and bicarbonate does not need the metabolism power consumption just can just directly bring into play the effect of acid-base balance in input at once, can not cause hyperlactacidemia; Sodium ions content and osmotic concentration are more near biological value; Cl
-Content is near extracellular fluid, low than ringer's solution, and therefore a large amount of infusions can not cause iatrogenic hyperchloremia property metabolic acidosis; Contain with the close magnesium ion of extracellular fluid concentration, help keeping serum Mg
2+Stable, can activate involved in sugar, protein, lipometabolic plurality of enzymes, for stoping immunological stress and oxidative stress, alleviating that insulin resistant and lipid peroxidation have positive role under the stress state.2. to cardiovascular system unrestraint effect.3. littler to organismic internal environment interference, tissue fluid over loading and the influence of intercellular substance edema, will lose for perioperative supplementary functionality extracellular fluid provides better liquid selective.4. can be made into oral administration solution and be used for children's or adult's oral supplementation extracellular fluid, also can be used as surgical flush fluid or buffer solution and use.5. select an amount of citric acid, citrate and carbon dioxide combination to regulate pH and can not cause HCO
3 -Remarkable reduction (fall is in the normal physiological scope), but can significantly control the configuration solution pH; And select to use the unique advantage of this technological improvement to be that the carbon dioxide that can simplify technological process, needn't adopt excess pressure carries out pH regulator, can make the electrolyte and the HCO of the balance liquid that disposes in addition
3 -Content more approaches body physiological state; Can also play good metabolism opsonic action in an amount of citric acid input body, help the generation of energy because an amount of citric acid as mesostate very important in the tricarboxylic acid cycle, can bring into play the substrate for induction effect.Its not enough point is in theory, and a large amount of fast infusion may cause the relative minimizing of plasma free calcium, but this quick transfusion are impossible occur clinically in the practice during like >=5000ml/h, and it is rare therefore in fact this insufficient chance taking place; Nonetheless, hypocalcemia when heavy dose is used, in a single day occurs, suitably replenish calcium chloride or calcium gluconate and can correct.
Concrete implementation
Comparative Examples 1
1. take by weighing sodium chloride (NaCl) 6.2g, potassium chloride (KCl) 0.3g, calcium chloride (CaCl
22H
2O) 0.22g, magnesium sulfate (MgSO
47H
2O) 0.25g adds an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate (NaHCO
3) 2.3g adds an amount of water for injection (logical Medical C O
2About 30 ℃ of water temperatures), stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add the injection water and be settled to 1000ml, lead to medical standard C O
2Gas (about about 60 minutes), regulating pH value is 6.0～7.5;
4. filtration, 120 ℃ of conventional sterilizations of embedding 20 minutes;
5. treat after the sterilization that temperature reduces to the room temperature taking-up of boiling more than 2 hours.
Experiment proof: all defective (above microgranule number average＞3000 of diameter >=2 μ m/ml), naked eyes are seen all has deposition to produce to fine grain measurement before and after filtering.
Comparative Examples 2
1. take by weighing sodium chloride (NaCl) 6.2g, potassium chloride (KCl) 0.3g, calcium chloride (CaCl
22H
2O) 0.22g, magnesium sulfate (MgSO
47H
2O) 0.25g, trisodium citrate (Na
3C
6H
5O
72H
2O) 0.6g adds an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate (NaHCO
3) 2.3g adds an amount of water for injection, stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add the injection water and be settled to 1000ml, filtration, embedding;
4. 120 ℃ of routines were sterilized 20 minutes;
5. the taking-up of boiling, naked eyes are seen and fine grain measurement all reaches the pharmacopeia related preparations and learns requirement, do not have deposition; Measure [HCO
3 -] in the normal physiological scope, but the pH measured value is all greater than 8.0.
Reached a conclusion by above-mentioned experiment: citrate has Stabilization (not producing deposition) to calcium ions and magnesium ions.
Comparative Examples 3
1. take by weighing sodium chloride (NaCl) 6.2g, potassium chloride (KCl) 0.3g, calcium chloride (CaCl
22H
2O) 0.22g, magnesium sulfate (MgSO
47H
2O) 0.25g, citric acid (C
6H
8O
7) 0.6g, add an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate (NaHCO
3) 2.3g adds an amount of water for injection, stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add and inject water and be settled to 1000ml; It is thus clear that wherein there is bubble to overflow immediately; The pH that measures solution descends obviously (all less than 5.0) with the increase of citric acid adding amount, gives NaOH acid-base titration citric acid then and regulates pH value to 7.0, refilters, embedding;
4. 120 ℃ of routines were sterilized 20 minutes;
5. treat after the sterilization that temperature reduces to room temperature taking-ups of boiling, naked eyes are seen and fine grain measurement all reaches the pharmacopeia related preparations and learns requirement, do not have and precipitate; But practical measurement [HCO
3 -] be 10-23m mol/L (and [HCO
3 -] successively decrease with the increase of citric acid adding amount).
Reach a conclusion by above-mentioned experiment: adopt citric acid to combine the technology path of calcium ions and magnesium ions infeasible separately.Though can avoid the deposition when calcium ions and magnesium ions and bicarbonate ion dissolve altogether in the electrolyte solution to separate out problem, pH descends obviously (all less than 5.0, having exceeded the compensatory zone that psychological need can allow) with the increase of citric acid adding amount in the solution, [HCO
3 -] can because citric acid in sodium bicarbonate after with CO
2Gas form is overflowed from solution, [HCO
3 -] and pH decline; Its fluctuation range exceeds the physiology allowed band, and this stability to the bicarbonate ion in the joining electrolyte solution has totally unfavorable influence, do not meet psychological need.
Comparative Examples 4
1. take by weighing sodium chloride (NaCl) 6.2g, potassium chloride (KCl) 0.3g, calcium chloride (CaCl
22H
2O) 0.22g, magnesium sulfate (MgSO
47H
2O) 0.25g, trisodium citrate (Na
3C
6H
5O
72H
2O) 0.6g adds an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate (NaHCO
3) 2.3g adds an amount of water for injection, stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add the injection water and be settled to 1000ml, feeding Medical C O
2, reach the physiological pH scope until pH value, find that pH also can be with CO
2Increasing of partial pressure value and descending;
4. filter embedding, 120 ℃ of conventional sterilizations 20 minutes;
5. pressure carbon dioxide increase in the container of heating back in this experiment for preventing explosion and carbon dioxide and configuration solution fully being dissolved, is reduced to the square taking-up of boiling of room temperature (about more than 2 hours) so need treat temperature after the sterilization;
Reached a conclusion by above-mentioned experiment: naked eyes are seen and fine grain measurement all reaches pharmacopeia related preparations requirement, do not have deposition; Measure [HCO in the gained solution
3 -] fluctuation range be 20-35m mol/L, pH measured value fluctuation range is 6.0-8.0.Reach a conclusion by above-mentioned experiment: contain the solution of trisodium citrate separately and regulate pH with medical carbon dioxide merely, can be because CO
2Dissolving and pH is descended, but CO under the high pressure
2The ionization of dissolving back goes out the hydrionic while in aqueous solution has also increased bicarbonate ion; Observe [HCO in this test
3 -] and CO
2The increase of dividing potential drop and increasing; When CO2 dividing potential drop＞120mmHg, contained [HCO in the solution
3 -] (＞30mmHg) obviously can exceed psychological need scope (23-27mmHg).
Embodiment 1
1. take by weighing sodium chloride (NaCl) 6.2g, potassium chloride (KCl) 0.3g, calcium chloride (CaCl
22H
2O) 0.22g, magnesium sulfate (MgSO
47H
2O) 0.25g, citric acid (C
6H
8O
7) 0.2g, trisodium citrate (Na
3C
6H
5O
72H
2O) 0.6g adds an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate (NaHCO
3) 2.3g adds an amount of water for injection (logical Medical C O
2About 30 ℃ of water temperatures), stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add the injection water and be settled to 1000ml, lead to medical standard C O
2Gas makes that the pH value scope of gained solution is 7.0, records CO this moment
2The adjusting partial pressure value is 70mmHg, airtight filtration, embedding;
4. 120 ℃ of routines were sterilized 20 minutes;
5. pressure carbon dioxide increase in the container after these article heat is fully dissolved for preventing explosion and making carbon dioxide and dispose solution,
Reduce to room temperature taking-ups of can boiling more than 2 hours so need treat temperature after the sterilization, labeling or signature are packed;
Experimental result: each ion concentration of surveying its gained bicarbonate physiological balanced solution is Na
+139m mol/L, Cl
-113mmol/L, K
+4m mol/L, Ca
2+1.5m mol/L, Mg
2+1m mol/L, SO4
2-1m mol/L, HCO
3 -26mmol/L, Citrate
3-3m mol/L; Under 28 ℃ of conditions of room temperature, using pH appearance actual measurement pH is 7.00;
Study on the stability: room temperature, natural lighting condition held; After 60 days the stability data of surveying show that each composition in the solution of gained, pH, osmotic pressure are all stable under air-tight package technology fully, significant change do not occur; The color and luster no change of solution does not have deposition and produces.
Embodiment 2
1. take by weighing sodium chloride (NaCl) 6.2g, potassium chloride (KCl) 0.3g, calcium chloride (CaCl
22H
2O) 0.11g, magnesium sulfate (MgSO
47H
2O) 0.25g, citric acid (C
6H
8O
7) 0.1g, trisodium citrate (Na
3C
6H
5O
72H
2O) 0.3g adds an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate (NaHCO
3) 2.3g adds an amount of water for injection (logical Medical C O
2About 30 ℃ of water temperatures), stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add the injection water and be settled to 1000ml, lead to medical standard C O
2Gas makes that the pH value scope of gained solution is 7.0, records CO this moment
2Regulate partial pressure value and be about 70mmHg, airtight filtration, embedding;
4. 120 ℃ of routines were sterilized 20 minutes;
5. pressure carbon dioxide increase in the container after these article heat is fully dissolved for preventing explosion and making carbon dioxide and dispose solution,
Reduce to room temperature taking-ups of can boiling more than 2 hours so need treat temperature after the sterilization, labeling or signature are packed;
Experimental result: each ion concentration of surveying its gained bicarbonate physiological balanced solution is Na
+136m mol/L, Cl
-111.5mmol/L, K
+4m mol/L, Ca
2+0.75m mol/L, Mg
2+1m mol/L, SO
4 2-1m mol/L, HCO
3 -26mmol/L, Citrate
3-1.5m mol/L; Under 28 ℃ of conditions of room temperature, using pH appearance actual measurement pH is 7.00;
Study on the stability: room temperature, natural lighting condition held; After 60 days the stability data of surveying show that changing does not appear in each composition, pH in the solution of gained under air-tight package technology fully; There is not deposition.
Embodiment 3
1. take by weighing sodium chloride (NaCl) 6.2g, potassium chloride (KCl) 0.3g, calcium chloride (CaCl
22H
2O) 0.22g, magnesium sulfate (MgSO
47H
2O) 0.25g, glucose (C
6H
12O
6) 0.9g, citric acid (C
6H
8O
7) 0.2g, trisodium citrate (Na
3C
6H
5O
72H
2O) 0.6g adds an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate (NaHCO
3) 2.3g adds an amount of water for injection (logical Medical C O
2About 30 ℃ of water temperatures), stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add the injection water and be settled to 1000ml, lead to medical standard C O
2Gas makes the pH value scope of gained solution be 6.0～7.5, and (preferred pH7.0 records CO this moment
2The adjusting partial pressure value is 70mmHg), airtight filtration, embedding;
4. 120 ℃ of routines were sterilized 20 minutes;
5. pressure carbon dioxide increase in the container after these article heat is fully dissolved for preventing explosion and making carbon dioxide and dispose solution,
Reduce to room temperature taking-ups of can boiling more than 2 hours so need treat temperature after the sterilization, labeling or signature are packed;
Experimental result: each ion concentration of surveying its gained bicarbonate physiological balanced solution is Na
+139m mol/L, Cl
-113mmol/L, K
+4m mol/L, Ca
2+1.5m mol/L, Mg
2+1m mol/L, SO
4 2-1m mol/L, HCO
3 -26mmol/L, Citrate
3-3m mol/L, Glucose 5m mol/L; Under 28 ℃ of conditions of room temperature, using pH appearance actual measurement pH is 7.00;
Study on the stability: room temperature, natural lighting condition held; After 60 days the stability data of surveying show that each composition in the solution of gained, pH, osmotic pressure are all stable under air-tight package technology fully, significant change do not occur; The color and luster no change of solution does not have deposition and produces.
Claims (1)
1. bicarbonate physiological balanced solution, it is characterized in that: surveying each ion concentration of this physiological balance liquid is Na
+136m mol/L, Cl-111.5m mol/L, K
+4m mol/L, Ca
2+0.75m mol/L, Mg
2+1m mol/L, SO
4 2-1m mol/L, HCO
3 -26m mol/L, Citrate
3-1.5m mol/L; Under 28 ℃ of conditions of room temperature, using pH appearance actual measurement pH is 7.00;
Said physiological balance liquid obtains through following prepared:
1. take by weighing sodium chloride nacl 6.2g, potassium chloride (KCl) 0.3g, two hydration calcium chloride CaCl
22H
2O0.11g, bitter salt MgSO
47H
2O 0.25g, citric acid C
6H
8O
70.1g, two hydration trisodium citrate Na
3C
6H
5O
72H
2O 0.3g adds an amount of water for injection stirring and dissolving;
2. take by weighing sodium bicarbonate NaHCO
32.3g, add logical Medical C O
2, 30 ℃ of water temperatures an amount of water for injection, stirring and dissolving;
3. will be 1. with 2. dispose liquid and mix and add the injection water and be settled to 1000ml, lead to medical standard C O
2Gas makes that the pH value scope of gained solution is 7.0, records CO this moment
2The adjusting partial pressure value is 70mmHg, airtight filtration, embedding;
4. 120 ℃ of routines were sterilized 20 minutes;
5. pressure carbon dioxide increases in the container of these article heating back, for anti-explosion and carbon dioxide and configuration solution are fully dissolved, reduces to the room temperature taking-up of can boiling more than 2 hours so need treat temperature after the sterilization, and labeling or signature are packed.
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| CN2009102075618A CN101721424B (en) | 2008-10-21 | 2009-10-20 | Bicarbonate physiological balanced solution and preparation method thereof |
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| CN2009102075618A CN101721424B (en) | 2008-10-21 | 2009-10-20 | Bicarbonate physiological balanced solution and preparation method thereof |
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| CN101721424B true CN101721424B (en) | 2012-07-25 |
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| CN104586885A (en) * | 2015-02-06 | 2015-05-06 | 河北天成药业股份有限公司 | Compound sodium bicarbonate electrolyte injection composition and preparation method thereof |
| CN107279620A (en) * | 2017-07-25 | 2017-10-24 | 郭志福 | A kind of electrolyte beverage composition and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1135886A (en) * | 1995-05-15 | 1996-11-20 | 林涛 | Antidiarrheal, antiemetic and analgesic electrolyte oral liquid |
| CN1456171A (en) * | 2002-05-10 | 2003-11-19 | 刘继东 | Compound electrolyte intra-ocular flushing liquor |
| CN101194738A (en) * | 2006-12-07 | 2008-06-11 | 李志国 | Electrolyte beverage |
| CN101355953A (en) * | 2005-11-08 | 2009-01-28 | 味之素株式会社 | Promoter for recovery from anesthesia |
| CN101721423A (en) * | 2008-10-21 | 2010-06-09 | 曾因明 | Bicarbonate physiological balanced solution and preparation method thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1135886A (en) * | 1995-05-15 | 1996-11-20 | 林涛 | Antidiarrheal, antiemetic and analgesic electrolyte oral liquid |
| CN1456171A (en) * | 2002-05-10 | 2003-11-19 | 刘继东 | Compound electrolyte intra-ocular flushing liquor |
| CN101355953A (en) * | 2005-11-08 | 2009-01-28 | 味之素株式会社 | Promoter for recovery from anesthesia |
| CN101194738A (en) * | 2006-12-07 | 2008-06-11 | 李志国 | Electrolyte beverage |
| CN101721423A (en) * | 2008-10-21 | 2010-06-09 | 曾因明 | Bicarbonate physiological balanced solution and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| JP特开平10-203961A 1998.08.04 |
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