CN103385889A - Carbohydrate and electrolyte mixed injection and preparation method thereof - Google Patents
Carbohydrate and electrolyte mixed injection and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a carbohydrate and electrolyte mixed injection. The injection comprises following components in per bottle: 30 g of glucose (regarded as an anhydrous substance), 15 g of fructose, 7.5 g of xylitol, 0.730 g of sodium chloride, 0.410 g of sodium acetate, 0.185 g of calcium chloride, 0.255 g of magnesium chloride, 0.870 g of dipotassium phosphate, 0.700 mg of zinc sulfate, 0.18 g of L-valine, an appropriate amount of citric acid and 500 mL of water for injection. The invention also provides a preparation method of the carbohydrate and electrolyte mixed injection. The preparation method comprises a step of adding the calcium chloride and the dipotassium phosphate into 400 mL of the water for injection, wherein the temperature of the water for injection is 70 DEG C, and adjusting pH to 5.0 by using the citric acid after the mixture is stirred into an opacifying form; a step of adding the magnesium chloride, the sodium chloride, the sodium acetate and the zinc sulfate, and stirring until the solution is colorless and clear; a step of adding the glucose, the fructose and the xylitol, and stirring until the solution is colorless and clear; a step of adding the L-valine, and stirring until the solution is colorless and clear; a step of adding active carbon used for injections, stirring uniformly, allowing the mixture to stand, filtering by using microfiltration membranes to remove the carbon and to degerm; and a step of adding the remaining water for injection to obtain the carbohydrate and electrolyte mixed injection.
Description
Technical field
The present invention relates to carbohydrate-electrolyte solution and preparation method thereof.
Background technology
Wound, patient with operation and critical patient,, because its body is in high decomposing state, cause malnutrition, and immunologic hypofunction usually needs fluid-supplement therapy to sustain life.An importance of fluid-supplement therapy is to supplement heat energy, and the supply of heat energy is the most commonly used with glucose.Stress state because critical patient exists, change the body carbohydrate metabolism, has insulin resistant, and operation wound also can cause insulin resistant and cause hyperglycemia; But mainly, still because of the too much glucose of infusion (comprising parenteral nutrient solution), cause the generation of glucose far away more than utilization, produce hyperglycemia, hyperglycemia causes a large amount of glucoses to lose from urine, causes osmotic diuresis, can cause water, electrolyte disturbance.Simultaneously hyperglycemia can enlarge body inflammatory reaction and oxidative stress status after wound, then increases SIRS and infects the probability of complication, and severe patient can cause multiple organ dysfunction syndrome.Solve the measure of hyperglycemia: the hyperglycemia that causes except disease itself needs symptomatic treatment, the more important thing is to change traditionally in glucose or the Dextrose and Sodium Chloride Inj. mode to the body energy supply, application fructose or xylitol Substitute For Partial glucose are the body energy supply.Fructose mainly generates fructose 1-phosphate through fructokinase catalysis in liver, kidney and small intestinal, because it can walk around rate-limiting enzyme (phosphofructokinase) in glycolysis, therefore the decomposition rate in liver is faster than glucose, metabolic process does not rely on insulin, do not raise and reduce blood glucose, can be in the situation that, without the insulin participation, be converted into glycogen, impact on blood glucose is less, the absorbing of easier body; But use separately the fructose energy supply can cause the acidosis of metabolic.Xylitol additional heat and glucose are suitable, can improve carbohydrate metabolism, metabolism does not rely on the participation of insulin in vivo, directly permeate through cell membranes involved in sugar metabolism and do not increase blood sugar concentration, and there are the insulin secretion of promotion and hepatic glycogen synthetic, the ketoplastic effect of inhibition is still arranged, blood plasma fatty acid is generated reduce, help the metabolism of protein, fat and steroid, but use separately the xylitol energy supply easily to cause renal dysfunction.The expert of Japan and European countries draws glucose through a large amount of zoopery and clinical verifications: the standard proportioning of fructose: xylitol=4:2:1, mixed sugar by this standard proportional is the most abundant at body metabolism, can make the side effect of these three kinds of monosaccharide be down to minimum, can supplement body fluid and energy for the patient, can reduce the fluctuation of blood sugar for human body and insulin again, reduce the damage to organs such as human kidneys.
Another main purpose of fluid-supplement therapy is to correct water, electrolyte and acid-base balance simultaneously, supplements main trace element.The normal human, by regulating actions such as nerve, endocrine, keeps body fluid capacity, osmotic pressure, various electrolyte concentration and acid-base value and is in normal range.Except this above-mentioned balance of normal appearance in generation, evolution of a lot of diseases was not normal, body fluid is lost in a large number or simple a large amount of infusion saccharide is infused can cause that also above-mentioned balance is not normal.Corresponding clinical symptoms appears in water, electrolyte and acid base imbalance, and some is threat to life even.
For a long time, the domestic glucose injection that uses clinically, Dextrose and Sodium Chloride Inj., chloride injection liquid measure remain on more than 90% always in the transfusion kind, and annual consumption reaches billions of bottles (bag).Above-mentioned transfusion is except part as pharmaceutical carrier, and major part is used for fluid-supplement therapy.Along with the progress of science and technology and going deep into of clinical application research, the hyperglycemia hazardness due to the heat energy that glucose injection or Dextrose and Sodium Chloride Inj. are made fluid-supplement therapy is supplied with manifests day by day.The clinical medicine that needs in a large number place of glucose injection or Dextrose and Sodium Chloride Inj..
Summary of the invention
Problem to be solved by this invention is to provide a kind of carbohydrate-electrolyte solution and preparation method thereof, gained carbohydrate-electrolyte solution energy place of glucose injection or Dextrose and Sodium Chloride Inj. and good stability.
Technical scheme provided by the invention is: carbohydrate-electrolyte solution, every bottle contains: glucose (by anhydride): 30g, and fructose: 15g, (sugar part adds up to xylitol: 7.5g: 52.5g), sodium chloride: 0.730g, sodium acetate: 0.410g, calcium chloride: 0.185g, magnesium chloride: 0.255g, citric acid: appropriate (transferring pH to 5.0), dipotassium hydrogen phosphate: 0.870g, zinc sulfate: 0.700mg, Valine 0.18g and water for injection: 500ml.
Every bottle of injection also contains the 0.210g sodium sulfite.
The present invention also provides the preparation method of above-mentioned carbohydrate-electrolyte solution, comprises the following steps:
(1) calcium chloride, dipotassium hydrogen phosphate are joined in the water for injection of 70 ℃ of 400 ml, after stirring into the milkiness shape, with citric acid, transfer pH5.0, obtain clear solution
(2) magnesium chloride, sodium chloride, sodium acetate, sodium sulfite (when needed) and zinc sulfate are joined solution
, be stirred to the solution achromaticity and clarification and obtain solution
(3) at solution
In add glucose, fructose and xylitol, be stirred to the solution achromaticity and clarification and obtain the solution III;
(4) add Valine in the solution III, be stirred to the solution achromaticity and clarification and obtain the solution IV;
(5) get after needle-use activated carbon adds a small amount of water for injection accent charcoal paste and join in the solution IV, stir evenly, standing 20 minutes, adopt 0.45 μ m filtering with microporous membrane to take off charcoal, adopt 0.22 μ m microporous filter membrane fine straining degerming, add water for injection and namely obtain carbohydrate-electrolyte solution to full dose.
Main applicable disease is: can not oral administration or oral administration can not fully absorb the time, and supplement and keep moisture and electrolyte, and the supply energy.
Usage and dosage: slowly intravenous drip.Usually, each 500ml～1000ml that is grown up.Injection speed (pressing glucose meter), the adult per hour must not surpass the 0.5g/kg body weight usually.Can consider increase and decrease according to different situations such as age, symptom and body weight.
Preparation of the present invention is the compound recipe bulk capacity injection; Glucose wherein, fructose, xylitol, sodium chloride, calcium chloride, sodium acetate, potassium dihydrogen phosphate, zinc sulfate raw material all record by two ones of Chinese Pharmacopoeia versions in 2010, magnesium chloride records in the 5th of national drug standards chemical drugs provincial standard rising national standard.
Glucose in carbohydrate-electrolyte solution of the present invention, fructose, xylitol form in the 4:2:1 ratio, study and experimental results show that, mixed sugar by this standard proportioning is the most abundant at body metabolism, can make the side effect of glucose, fructose, xylitol be down to minimum, can supplement body fluid and heat for the patient, can reduce the fluctuation of blood sugar for human body and insulin again, reduce the damage to organs such as human kidneys.
The present invention contains sodium chloride, magnesium chloride, calcium chloride, dipotassium hydrogen phosphate, sodium acetate, can supplement the main electrolyte that needed by human body is wanted, not only can supplement intracellular fluid but also can supplement the required cation of extracellular fluid, take into full account the required electrolytical supply of Human Physiology.Being the main cation of extracellular fluid as sodium, is to keep constant body fluid osmotic pressure concentration and the main matter of extracellular fluid volume; Potassium is main cation in cell, to keeping normal neural muscle excitability, plays an important role; Calcium phosphorus is except participating in bone metabolism, calcium ion is closely related as second message,second messenger and the many functions of body in cell, as assist to regulate neurotransmitter and endocrine release and storage, keep nervimuscular NE, promote nerve ending secretion acetylcholine, blood calcium reduction can cause neural muscle excitability to raise, and twitches.Phosphorus is that energy i (in vivo) metabolism institute is essential; Magnesium is the important cation that is only second to potassium in cell,, as the cofactor of a lot of enzymes, can keep myocardium ionic equilibrium, regulates potassium channel, and low magnesium can cause multiple arrhythmia.Sodium acetate in vivo with generate new salt and acetic acid in strong acid August, simultaneously muscle and peripheral organization's metabolism are bicarbonate radical (finally being decomposed into carbon dioxide and water) to acetic acid in vivo, therefore sodium acetate has the cushioning effect to acid, can correct metabolic acidosis, contained buffer salt dipotassium hydrogen phosphate can be kept the acid-base balance of human body.
Preparation of the present invention also contains trace zinc, zinc participates in the synthetic of plurality of enzymes (as carbonic anhydrase, DNA and RNA polymerase, lactic acid dehydrogenase, thymidine kinase, alkali phosphatase, pancreas peptidase etc.) and activates, important physiological function, enhancing development are brought into play in protein, nucleic acid absorption and digestion synthetic, intestinal albumen; By to the synthetic of gustin in taste bud and prevent buccal mucosa epithelial cell parakeratosis, keep normal appetite and the sense of taste, strengthen the phagocyte phagocytic activity, chemotactic vigor and sterilizing function; And keep Free Radical Level in phagocyte by sudismase, the cell membrane of free radical energy destroy microorganisms, performance bactericidal action, the healing of acceleration of wound, burn, ulcer; Metabolism and vision to vitamin A play an important role; Promote and the maintenance function; Stabilizing cell membrane, improve tissue energy metabolism and Tissue respiration.
Glucose can dewater under certain condition and generate harmful 5 hydroxymethyl furfural (as human body band thigh and internal organs are had detrimental effect).The applicant is unexpected to be found, adds a certain amount of Valine can suppress the increase of its content in the generation of 5 hydroxymethyl furfural and storing process in carbohydrate-electrolyte solution, improves the stability of carbohydrate-electrolyte solution.
Preparation of the present invention is high-capacity injection, and clinical use need not allocated, and can directly carry out intravenous drip, and clinical practice is convenient.
Carbohydrate-electrolyte solution of the present invention has insulin-dependent little, and blood glucose fluctuation is little, is applicable to the patient's of metabolism obstacles of blood glucose state energy supply; Can provide energy fast, fully, the heat that uses more separately three kinds of components to provide is high, and every 100ml can provide the heat of 42 kilocalories of human bodies; Promotion to protein, lipogenesis significantly strengthens; Multiple electrolyte (potassium, sodium, calcium, magnesium, zinc, chlorine, phosphorus) can be provided, in time supplement physiology required, the characteristics of regulating acid-base balance.Be applicable to the fluid-supplement therapy of critical patient, wound and hands postoperative patient, can reduce glucose or Dextrose and Sodium Chloride Inj., be used for the untoward reaction that the hyperglycemia due to fluid-supplement therapy causes; Can place of glucose injection or Dextrose and Sodium Chloride Inj. and good stability.Progressively will replace glucose or Dextrose and Sodium Chloride Inj. carries out fluid-supplement therapy with mixed sugar or Nulomoline electrolytes injection clinically, so the present invention have wide potential applicability in clinical practice and huge market capacity.
The specific embodiment
Embodiment 1:
Carbohydrate-electrolyte solution, every bottle contains: glucose (by anhydride): 30g, fructose: 15g, (sugar part adds up to xylitol: 7.5g: 52.5g), sodium chloride: 0.730g, sodium acetate: 0.410g, calcium chloride: 0.185g, magnesium chloride: 0.255g, sodium sulfite: 0.210g, citric acid: appropriate, dipotassium hydrogen phosphate: 0.870g, zinc sulfate: 0.700mg, Valine 0.18g and water for injection: 500ml.
The present invention also provides the preparation method of above-mentioned carbohydrate-electrolyte solution to comprise the following steps:
(1) calcium chloride, dipotassium hydrogen phosphate are joined in the water for injection of 70 ℃ of 400 ml, after stirring into the milkiness shape, with citric acid, transfer pH5.0, obtain clear solution
(2) magnesium chloride, sodium chloride, sodium acetate, sodium sulfite and zinc sulfate are joined solution
, be stirred to the solution achromaticity and clarification and obtain solution
(3) at solution
In add glucose, fructose and xylitol, be stirred to the solution achromaticity and clarification and obtain the solution III;
(4) add Valine in the solution III, be stirred to the solution achromaticity and clarification and obtain the solution IV;
(5) get after needle-use activated carbon adds a small amount of water for injection accent charcoal paste and join in the solution IV, stir evenly, standing 20 minutes, adopt 0.45 μ m filtering with microporous membrane to take off charcoal, adopt 0.22 μ m microporous filter membrane fine straining degerming, add water for injection to full dose.
(6) embedding: medicine liquid irrigation is encapsulated in infusion bottle.
(7) sterilizing: after leak detection, 115 ℃ sterilizing 30 minutes.
Comparative example 1:
Carbohydrate-electrolyte solution, every bottle contains: glucose (by anhydride): 30g, fructose: 15g, (sugar part adds up to xylitol: 7.5g: 52.5g), sodium chloride: 0.730g, sodium acetate: 0.410g, calcium chloride: 0.185g, magnesium chloride: 0.255g, 0.21 part of sodium sulfite, citric acid: appropriate, dipotassium hydrogen phosphate: 0.870g, zinc sulfate: 0.700mg, water for injection: 500ml.
Preparation method is with embodiment 1.
Comparative example 2:
Carbohydrate-electrolyte solution, every bottle contains: glucose (by anhydride): 30g, and fructose: 15g, (sugar part adds up to xylitol: 7.5g: 52.5g), sodium chloride: 0.730g, sodium acetate: 0.410g, calcium chloride: 0.185g, magnesium chloride: 0.255g, 0.21 part of sodium sulfite, dipotassium hydrogen phosphate: 0.870g, zinc sulfate: 0.700mg, water for injection: 500ml.
Preparation method:
Add glucose by recipe quantity, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, sodium sulfite, dipotassium hydrogen phosphate, zinc sulfate, add 80 ℃ of waters for injection by 90% of amount of preparation, is stirred to fully and dissolves.Add needle-use activated carbon, stirred 20 minutes under 55-65 ℃ of heating condition, the decarburization of solution filtered while hot, add surplus water for injection, adjust pH 5.0, and with 0.45 μ m microporous filter membrane fine straining, fill, the plug bottle, roll lid, and 115 ℃ are sterilizing 30 minutes.
The carbohydrate-electrolyte solution of embodiment 1 and comparative example 1 and comparative example 2 preparations is carried out accelerated stability investigate (40 ℃ ± 2 ℃, RH 75% ± 5%) and long-time stability investigation, the results are shown in Table 1.Particulate determination wherein: according to two appendix IX C of Chinese Pharmacopoeia version in 2010, first method inspection.
Table 1 carbohydrate-electrolyte solution accelerated test result
Table 2 carbohydrate-electrolyte solution long-term test results
Experimental data shows: the content of the carbohydrate-electrolyte solution 5 hydroxymethyl furfural that the embodiment of the present invention 1 makes is low and substantially unchanged, and particulate matter is low and change little; Content and the particulate matter of the carbohydrate-electrolyte solution 5 hydroxymethyl furfural that comparative example 1, comparative example 2 make are higher, and along with the variation of time large (in Table 1,2).The embodiment of the present invention 1 is because added Valine than comparative example 1, compare its preparation method from comparative example 2 and adopt the technology controlling and process such as different charging sequence, pH value, control the content of particulate matter and 5 hydroxymethyl furfural, improved stability and the safety of product.
Compare carbohydrate-electrolyte solution of the present invention and the traditional glucose injection clinical effectiveness to the complication patient.
Method: adopt the randomized controlled method, select 100 customary surgery patients, be divided into each 50 examples for the treatment of group and matched group.Aftertreatment group patient venoclysis mixed sugar electrolyte, matched group patient infusion 10% glucose injection, 4d continuously.Record blood glucose and insulin dosage, measure the variation of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), detect urine ketoboidies, glucose in urine and urinary nitrogen discharge capacity, record the untoward reaction in therapeutic process.Result: compare with matched group, after the treatment group operation in patients, 2～4d treatment group blood sugar increasing amplitude obviously reduces (P0.05); Postoperative 1～4d insulin dosage obviously reduces (P0.01); The IL-6 of postoperative 3d and 4d and TNF-α all obviously reduce (P0.05 or 0.01); The urine ketoboidies is close with the glucose in urine positive rate; The urinary nitrogen discharge capacity obviously reduces (P0.05); Occur without obvious adverse reaction in therapeutic process.Conclusion: the mixed sugar electrolyte is less to blood sugar influence, and insulin dosage is few, and the body inflammatory response light is fit to the postoperative use of surgery patients.
Claims (4)
1. carbohydrate-electrolyte solution, every bottle of injection contains: glucose: 30g, fructose: 15g, xylitol: 7.5g, sodium chloride: 0.730g, sodium acetate: 0.410g, calcium chloride: 0.185g, magnesium chloride: 0.255g, citric acid: appropriate, dipotassium hydrogen phosphate: 0.870g, zinc sulfate: 0.700mg, Valine 0.18g and water for injection: 500ml.
2. carbohydrate-electrolyte solution according to claim 1, it is characterized in that: every bottle of injection also contains the 0.210g sodium sulfite.
3. the preparation method of carbohydrate-electrolyte solution claimed in claim 1 comprises the following steps:
(1) calcium chloride, dipotassium hydrogen phosphate are joined in the water for injection of 70 ℃ of 400 ml, after stirring into the milkiness shape, with citric acid, transfer pH5.0, obtain clear solution
(2) magnesium chloride, sodium chloride, sodium acetate, sodium sulfite and zinc sulfate are joined solution
, be stirred to the solution achromaticity and clarification and obtain solution
(3) at solution
In add glucose, fructose and xylitol, be stirred to the solution achromaticity and clarification and obtain the solution III;
(4) add Valine in the solution III, be stirred to the solution achromaticity and clarification and obtain the solution IV;
(5) get after needle-use activated carbon adds a small amount of water for injection accent charcoal paste and join in the solution IV, stir evenly, standing 20 minutes, adopt 0.45 μ m filtering with microporous membrane to take off charcoal, adopt 0.22 μ m microporous filter membrane fine straining degerming, add water for injection and namely obtain carbohydrate-electrolyte solution to full dose.
4. preparation method according to claim 3 is characterized in that: add sodium sulfite when adding magnesium chloride, sodium chloride, sodium acetate and zinc sulfate in step (2), the addition of sodium sulfite is counted 0.210g by every bottle of injection.
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Cited By (3)
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| CN105497061A (en) * | 2015-12-24 | 2016-04-20 | 长沙利星医药科技开发有限公司 | Glucose-free novel electrolyte injection and preparation method thereof |
| CN105560281A (en) * | 2014-10-08 | 2016-05-11 | 华仁药业股份有限公司 | Mixed saccharide electrolyte injection and preparation method thereof |
| 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 |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109010362A (en) * | 2018-10-09 | 2018-12-18 | 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 |
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| CN102973556A (en) * | 2012-12-13 | 2013-03-20 | 天津金耀集团有限公司 | Compound amino acid injection (18AA-IV) composition |
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| CN101732243A (en) * | 2008-11-26 | 2010-06-16 | 重庆医药工业研究院有限责任公司 | Stable methyl naltrexone injection and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105560281A (en) * | 2014-10-08 | 2016-05-11 | 华仁药业股份有限公司 | Mixed saccharide electrolyte injection and preparation method thereof |
| CN105497061A (en) * | 2015-12-24 | 2016-04-20 | 长沙利星医药科技开发有限公司 | Glucose-free novel electrolyte injection and preparation method thereof |
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| 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 |
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