CN101167739A - Compound fructose electrolyte injection and preparation method thereof - Google Patents
Compound fructose electrolyte injection and preparation method thereof Download PDFInfo
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- CN101167739A CN101167739A CNA2007100599107A CN200710059910A CN101167739A CN 101167739 A CN101167739 A CN 101167739A CN A2007100599107 A CNA2007100599107 A CN A2007100599107A CN 200710059910 A CN200710059910 A CN 200710059910A CN 101167739 A CN101167739 A CN 101167739A
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Abstract
The invention relates to the technical field of chemical medicament, in particular to a compound electrolyte injection of diabetin and process for preparation, wherein the compound electrolyte injection of diabetin takes natrium chloride, potassium chloride, diabetin, sodium lactate solution and glacial acetic acid as raw materials. The compound electrolyte injection of diabetin of the invention has the advantages that the invention does not depend on insulin metabolism and fits for diabetic and hepatopath, the metabolism is stable and fits to patients with wound and operation specially, energy is high and safety is good, the patients with operation and other patients with inaccessibility food-intake diseases are infused and supplied through vein which is a necessary and frequently-used process to hold water and electrolyte.
Description
Technical field
The present invention relates to the technical field of chemicals, particularly relating to a kind of is compound fructose electrolyte injection of making of raw material and preparation method thereof with sodium chloride, potassium chloride, fructose sodium lactate solution, glacial acetic acid.
Background technology
The electrolyte transfusion is mainly used in clinically corrects water and metabolic disturbance of electrolyte in the patient body, keeps the body fluid osmotic pressure and recovers the body normal physiological function.Electrolyte transfusion in recent years progressively carries out the transition to compound electrolyte from single electrolyte, is further development of containing of lactated Ringer's injection or various concentration of sugared compound electrolyte transfusion, for clinical practice is provided convenience.Make 4 kinds of compound electrolyte transfusions (initial liquid, dehydration replenish liquid, keep liquid, recover liquid) in Japan by state of an illness different phase and the transfusion of object electrolyte, make medication more reasonable and convenient.Also have electrolyte transfusion, the gastric juice when gastric juice is lost of several special usefulness to replenish the TPN basal liquid etc. that liquid, the duodenum when intestinal juice is lost replenish the transfusion of promotion diuresis behind liquid, the urethrectomy and electrolyte supplement and energy and cooperates total parenteral nutrition therapy (TPN) in addition.The transfusion of nutrition class is very extensive in China's clinical practice, its main uses be by vein to can not normally taking food or the metabolic patient of superelevation provides the nutrients such as sugar, fat, aminoacid, vitamin and trace element of needed by human, have huge market scale and market capacity at home.
Most widely used in the saccharide is glucose, essential by brain because it meets requirement on the Human Physiology most in saccharide, also can be utilized by all organs of human body, and be the main heat energy source of intravenous nutrition always.But glucose infusion liquid has certain limitation clinically, as: glucose must rely on just energy metabolism of insulin; Metabolism is slow in vivo, makes easily by blood glucose instability in the injection patient body, increases the weight of the diabetic symptom; Hyperglycemia makes steatolysis be subjected to press down, and causes body the nitrogenize phenomenon to occur; The kind composition is single, can not replenish as other nutritional labelings of operation back etc.More than these cause traditional nutrition transfusion can not adapt to more and more higher clinical requirement, its market share begins progressively atrophy, price also drops day by day, thus to diabetes and wound emergent due to the patient of insufficient insulin must the supplemented with exogenous insulin or replace with fructose, xylitol, sorbitol.At present, what most possibly replace glucose infusion liquid is fructose, and this is a kind of high-energy nutrition transfusion that does not rely on insulin metabolism.The injection that contains the fructose class is very active in the performance of international medical market, its high curative effect, safety are extensively approved, China's pharmacopeia is existing to be recorded, and is also recorded by state-promulgated pharmacopoeia such as American and Britain, moral, days, has become the second largest injection that is only second to glucose in some countries.Also there is very high requirement in China hospital to this type of new product, and its market prospect is held a optimistic attitude.
Fructose is natural to be present in the feverfews such as Mel and Jerusalem artichoke, Herba Cichorii, and it is the isomers of glucose, and the tool levorotation claims levulose.Oral slower than glucose absorption, afterwards or behind the intravenously administrable metabolism is faster than glucose in vivo but absorb, and is easily absorbed by body, and does not rely on insulin, and is little to blood sugar influence, is applicable to patient's makeup energy of diabetics and hepatic insufficiency.
Summary of the invention
The purpose of this invention is to provide a kind of is compound fructose electrolyte injection of making of raw material and preparation method thereof with sodium chloride, potassium chloride, fructose sodium lactate solution, glacial acetic acid.
Screen suitable prescription to achieve the object of the present invention, again each component in the prescription has been carried out providing a kind of compound fructose electrolyte injection on the basis of the experiment of component analysis and research, it is characterized in that making injection is that raw material is made with the following materials by weight:
Sodium chloride 166.25g～193.5g potassium chloride 142.5g～165g
Fructose 2565g～2970g
Sodium lactate solution (72%) (being equivalent to sodium lactate) 295.45g～342.1g
Glacial acetic acid (the superfine acetic acid of JIS) 7.5055g～8.69g adds the injection water to 100L.
Described compound fructose electrolyte injection, it is characterized in that making injection is that raw material is made with the following materials by weight:
Sodium chloride 175g potassium chloride 150g fructose 2700g
Sodium lactate solution (72%) (being equivalent to sodium lactate) 311g
Glacial acetic acid (the superfine acetic acid of JIS) 7.9g adds the injection water to 100L.
Described compound fructose electrolyte injection is characterized in that its preparation method is: meet the distilled water manufacturing of Chinese Pharmacopoeia standard with purified water according to conventional method, leaving water temperature is more than 80 ℃; In blend tank, drop into the allotment water of regulation allotment liquid measure about 90%; Require the required supplementary material of weighing according to prescription; Stir the allotment water on one side, Yi Bian the raw material-sodium chloride, potassium chloride, fructose, sodium lactate solution, the glacial acetic acid that drop into successively through confirming make its dissolving; Examine the allotment of liquid measure input and use water for injection, make liquid measure accurately to the allotment liquid measure of stipulating; Regulate the seasoning liquid temperature, just carrying out the liquid temperature compensation, making liquid measure is 20 ℃ regulation allotment liquid measure to being equivalent to the liquid temperature accurately; Stirred 15 minutes; Get a certain amount of seasoning liquid, in the container of the regulation of packing into, confirm content and pH value; After middle control index is up to specification, carry out the heat treatment of seasoning liquid: add a certain amount of medicinal carbon, blend tank is all sealed, stir on one side, heat to 80 ℃ on one side, kept 30 minutes; Make the liquid temperature remain on 80 ℃～85 ℃; After heat treatment finished, cooling was also carried out nitrogen replacement to a whole set of pipeline, carries out preceding filtration then, and making seasoning liquid is 6 to 12 sections 40B filter by the assembling hop count, carries out coarse filtration, with the active carbon elimination; About about 20 minutes, after the visible foreign matters passed examination, make seasoning liquid again by assembling, through the filtering 293 φ accurate filters of 0.45m filter membrane, carry out secondary filter after, after about 15 minutes, after the visible foreign matters passed examination, can carry out the liquor charging operation to the filling engineering;
Seasoning liquid is delivered to the filling engineering after filtering, carries out quantitative filling through filling machine by different size, and heats the molten capping of closing, and all finished product is all delivered to the sterilization engineering by the weight detecting machine; The sterilization engineering is according to the production technology operation of sterilizing, and sterilization is delivered to the inspection engineering after finishing; Check that engineering carries out outward appearance and content visual examination by technological requirement, and all finished products all carry out the leakage inspection by high pressure micropore leak tester, deliver to Packaging Engineering after qualified; Packaging Engineering carries out labeling, peplos and the vanning of finished product by the related process requirement, and vanning is after behind the weight check, get product.
Effect of the present invention: the advantage of compound fructose electrolyte injection mainly shows in the following areas: do not rely on insulin metabolism, be fit to very much diabetics and hepatopath and use; Metabolic stability is particularly suitable for wound and surgical patient and uses; The energy height, safety is good; Patient with operation and other are difficult for the directly all kinds of disease patients of feed, by the venoclysis supply, keep the essential and mode that often adopt of moisture and electrolyte.
The specific embodiment
Embodiment 1 preparation compound fructose electrolyte injection 100L:
Preparation prescription:
Sodium chloride 175g potassium chloride 175g fructose 2700g
Sodium lactate solution (72%) (being equivalent to sodium lactate) 311g
Glacial acetic acid (the superfine acetic acid of JIS) 7.9g adds the injection water to 100L
Preparation method:
Preparation method is: meet the distilled water manufacturing of Chinese Pharmacopoeia standard with purified water according to conventional method, leaving water temperature is more than 80 ℃; In blend tank, drop into the allotment water of regulation allotment liquid measure about 90%; Require the required supplementary material of weighing according to prescription; Stir the allotment water on one side, Yi Bian the raw material-sodium chloride, potassium chloride, fructose, sodium lactate solution, the glacial acetic acid that drop into successively through confirming make its dissolving; Examine the allotment of liquid measure input and use water for injection, make liquid measure accurately to the allotment liquid measure of stipulating; Regulate the seasoning liquid temperature, just carrying out the liquid temperature compensation, making liquid measure is 20 ℃ regulation allotment liquid measure to being equivalent to the liquid temperature accurately; Stirred 15 minutes; Get a certain amount of seasoning liquid, in the container of the regulation of packing into, confirm content and pH value; After middle control index is up to specification, carry out the heat treatment of seasoning liquid: add a certain amount of medicinal carbon, blend tank is all sealed, stir on one side, heat to 80 ℃ on one side, kept 30 minutes; Make the liquid temperature remain on 80 ℃; After heat treatment finished, cooling was also carried out nitrogen replacement to a whole set of pipeline, carries out preceding filtration then, and making seasoning liquid is 6 to 12 sections 40B filter by the assembling hop count, carries out coarse filtration, with the active carbon elimination; About about 20 minutes, after the visible foreign matters passed examination, make seasoning liquid again by assembling, through the filtering 293 φ accurate filters of 0.45m filter membrane, carry out secondary filter after, after about 15 minutes, after the visible foreign matters passed examination, can carry out the liquor charging operation to the filling engineering;
Seasoning liquid is delivered to the filling engineering after filtering, carries out quantitative filling through filling machine by different size, and heats the molten capping of closing, and all finished product is all delivered to the sterilization engineering by the weight detecting machine; The sterilization engineering is according to the production technology operation of sterilizing, and sterilization is delivered to the inspection engineering after finishing; Check that engineering carries out outward appearance and content visual examination by technological requirement, and all finished products all carry out the leakage inspection by high pressure micropore leak tester, deliver to Packaging Engineering after qualified; Packaging Engineering carries out labeling, peplos and the vanning of finished product by the related process requirement, and vanning is after behind the weight check, compound xylitol electrolyte injection gets product.
Embodiment 2: the clinical practice summary of compound fructose electrolyte injection:
1. the physiological disposition of fructose: healthy people continues input fructose can reach steady plasma-drug concentration 6～8mmolL
-1, ATP and Phos all drop to steady-state level in the body, are respectively preceding (74.0 ± 5.9) % of administration and (54.6 ± 3.3) %, and hepatic clearance is 0.53mlg
-1(liver is heavy) min
-1, endocellular metabolism meets the first order kinetics process.
2. the mechanism of action of fructose: healthy people of calorigenic action and the oral fructose (1gkg of liver cirrhosis person
-1Body weight) its cumlative energy consumption figures is respectively (1.76 ± 0.24) kJkg after 3 hours
-1(1.59 ± 0.55) kJkg
-1, then much lower behind the oral glucose, be (0.98 ± 0.13) kJkg
-1, with healthy people than there were significant differences (P＜0.05), the still normal exothermic reaction of tool of fructose is described when liver cirrhosis, and energize.
To the effect of insulin have report to healthy people and liver cirrhosis patient respectively with 200,500mgkg
-1H
-1Venoclysis fructose, the fructosemia concentration that the result is two groups is identical, the author thinks that fructose can stimulate insulin secretion, other chemical compounds of fructose plurality cause that blood sugar increasing and insulin response are lower, because the effect of fructose rising insulin active than glucose a little less than, blood glucose only slightly rises behind operation or the critical patient's infusion fructose of wound.
Cytoprotective fructose adds the infringement in the time of can reducing the perfusion of Hepar Mus temperature anoxia in the UW liquid, reduces release (66 ± 15) Uml of aspartic acid transferring enzyme
-1With hepatic parenchymal cells death (39 ± 7) %, also can reduce at 4 ℃ and deposit the primary cellular defect that caused because of anoxia in 20 hours, improve its recover normal temperature (37 ℃) and again during the oxygenation hepatocyte survive, and make the metabolic capacity of cell, the glyconeogenesis of, lactic acid synthetic as albumen, recover sooner, and the primary cellular defect that ATP, glucose, galactose, antioxygen mannitol etc. can not cause anti-hypoxia.10～20mmolL
-1Fructose can be protected the infringement of Hepar Mus cells in vitro antagonism acetaminophen, hydrazine, cholate etc., and the also reliable glycolysis of fructose suppresses the reactive oxygen species that ferrum catalysis forms, thus the primary cellular defect that oxidant causes before protecting effectively
3. the clinical practice of fructose
3.1 energy supplement agent
Patient with operation and other are difficult for the directly all kinds of disease patients of feed, and coming makeup energy by the venoclysis nutritional solution is clinical essential and mode that often adopt.Glucose is clinical the most frequently used energy supplement agent, but the venoclysis glucose often causes fluctuating widely of human blood glucose concentration, especially for the energy supplement of diabetics, adopts glucose can cause blood glucose fluctuation excessive, and is unfavorable to disease controlling.And blood sugar content maintains certain level, and particularly the normal functional activity of cerebral tissue is very important to guaranteeing each histoorgan of human body.Fructose is a kind of left-handed hexose, in vivo without phosphoglucomutase, is fructose-1, 6-diphosphate by the hexokinase metabolism directly, has accelerated accretion rate, rapidly supplying energy.In addition, the activity of fructokinase does not rely on the insulin regulation and control, and fructose can metabolism be glycogen under the situation of no insulin, and fructose injection does not have obvious influence to hepatic and renal function, blood uric acid and blood, routine urinalysis.Therefore fructose injection has bigger clinical value.People's such as Meng Desheng experimental result shows, fructose injection and glucose injection are renderd a service aspect the body energy supply quite, and fructose has the advantage that the blood glucose fluctuation amplitude is little, adverse reaction rate is low (0%), and fructose injection is used to perform the operation and the energy supplement safety of non-patient with operation, effectively.
3.2 other effects
Fructose can be used for treating habitual constipation, also can be used as the auxiliary treatment of Meniere, unstable angina pectoris, infantile viral myocarditis etc.Also there is report that fructose is used as intestinal cleaning agents, carries out TC, satisfactory effect.
Pharmacological effect:
1. this product is the needed K of electrolyte of extracellular fluid and intracellular fluid, the hypotonicity electrolyte of Na, Cl and the preparation of fructose, being used for can not oral uptake or absorb when insufficient, supply is kept the sodium lactate of compatibility in moisture and 2. compound preparations of electrolyte at the body intracellular metabolite, produces HCO
3 -Anion is kept the HCO in the extracellular fluid
3 -Concentration is improved acidosis.
3. the fructose of compatibility mainly is present in fructokinase (ketohexokinase fructokinase) metabolism in the liver in this compound preparation, is not subjected to the influence of insulin, converts the energy rapidly to, also obtains utilizing when diabetic disease states or during hepatic insufficiency.
Indication: can not oral uptake or absorb when insufficient, moisture and electrolyte are kept in supply
Claims (3)
1. compound fructose electrolyte injection, it is characterized in that making injection is that raw material is made with the following materials by weight:
Sodium chloride 166.25g～193.5g potassium chloride 142.5g～165g
Fructose 2565g～2970g
Sodium lactate solution (72%) (being equivalent to sodium lactate) 295.45g～342.1g
Glacial acetic acid (the superfine acetic acid of JIS) 7.5055g～8.69g adds the injection water to 100L.
2. compound fructose electrolyte injection according to claim 1 comprises an amount of water for injection, and it is characterized in that making injection is that raw material is made with the following materials by weight:
Sodium chloride 175g potassium chloride 150g fructose 2700g
Sodium lactate solution (72%) (being equivalent to sodium lactate) 311g
Glacial acetic acid (the superfine acetic acid of JIS) 7.9g adds the injection water to 100L.
3. compound fructose electrolyte injection according to claim 1 and 2 is characterized in that its preparation method is:
Meet the distilled water manufacturing of Chinese Pharmacopoeia standard with purified water according to conventional method, leaving water temperature is more than 80 ℃; In blend tank, drop into the allotment water of regulation allotment liquid measure about 90%; Require the required supplementary material of weighing according to prescription; Stir the allotment water on one side, Yi Bian the raw material-sodium chloride, potassium chloride, fructose, sodium lactate solution, the glacial acetic acid that drop into successively through confirming make its dissolving; Examine the allotment of liquid measure input and use water for injection, make liquid measure accurately to the allotment liquid measure of stipulating; Regulate the seasoning liquid temperature, just carrying out the liquid temperature compensation, making liquid measure is 20 ℃ regulation allotment liquid measure to being equivalent to the liquid temperature accurately; Stirred 15 minutes; Get a certain amount of seasoning liquid, in the container of the regulation of packing into, confirm content and pH value; After middle control index is up to specification, carry out the heat treatment of seasoning liquid: add a certain amount of medicinal carbon, blend tank is all sealed, stir on one side, heat to 80 ℃ on one side, kept 30 minutes; Make the liquid temperature remain on 80 ℃～85 ℃; After heat treatment finished, cooling was also carried out nitrogen replacement to a whole set of pipeline, carries out preceding filtration then, and making seasoning liquid is 6 to 12 sections 40B filter by the assembling hop count, carries out coarse filtration, with the active carbon elimination; About about 20 minutes, after the visible foreign matters passed examination, make seasoning liquid again by assembling, through the filtering 293 φ accurate filters of 0.45m filter membrane, carry out secondary filter after, after about 15 minutes, after the visible foreign matters passed examination, can carry out the liquor charging operation to the filling engineering;
Seasoning liquid is delivered to the filling engineering after filtering, carries out quantitative filling through filling machine by different size, and heats the molten capping of closing, and all finished product is all delivered to the sterilization engineering by the weight detecting machine; The sterilization engineering is according to the production technology operation of sterilizing, and sterilization is delivered to the inspection engineering after finishing; Check that engineering carries out outward appearance and content visual examination by technological requirement, and all finished products all carry out the leakage inspection by high pressure micropore leak tester, deliver to Packaging Engineering after qualified; Packaging Engineering carries out labeling, peplos and the vanning of finished product by the related process requirement, and vanning is after behind the weight check, promptly.
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|---|---|---|---|
| CNB2007100599107A CN100544734C (en) | 2007-10-16 | 2007-10-16 | Compound fructose electrolyte injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2007100599107A CN100544734C (en) | 2007-10-16 | 2007-10-16 | Compound fructose electrolyte injection and preparation method thereof |
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| CN100544734C CN100544734C (en) | 2009-09-30 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011153470A3 (en) * | 2010-06-03 | 2012-01-26 | Stokely-Van Camp, Inc. | Electrolyte blends providing reduced salty taste |
| CN112603888A (en) * | 2020-12-30 | 2021-04-06 | 中国大冢制药有限公司 | Preparation method of mixed sugar electrolyte injection and prepared mixed sugar electrolyte injection |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1068778C (en) * | 1998-05-15 | 2001-07-25 | 赵超英 | Novel drug composition for treating and curing and its preparing method |
| CN1319398A (en) * | 2001-02-23 | 2001-10-31 | 暨南大学 | Fructose-1,6-magnesium diphosphate injection and productive method thereof |
| CN100333728C (en) * | 2005-05-11 | 2007-08-29 | 中国人民解放军第二军医大学 | Compound electrolytic fructose injection |
-
2007
- 2007-10-16 CN CNB2007100599107A patent/CN100544734C/en not_active Ceased
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011153470A3 (en) * | 2010-06-03 | 2012-01-26 | Stokely-Van Camp, Inc. | Electrolyte blends providing reduced salty taste |
| CN102917606A (en) * | 2010-06-03 | 2013-02-06 | 斯托克里-丰康普公司 | Electrolyte blends providing reduced salty taste |
| EP3510874A3 (en) * | 2010-06-03 | 2019-08-21 | Stokely-Van Camp, Inc. | Electrolyte blends providing reduced salty taste |
| CN112603888A (en) * | 2020-12-30 | 2021-04-06 | 中国大冢制药有限公司 | Preparation method of mixed sugar electrolyte injection and prepared mixed sugar electrolyte injection |
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| Publication number | Publication date |
|---|---|
| CN100544734C (en) | 2009-09-30 |
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