CN101744834A - Compound fructose electrolyte injection and preparation method and application thereof - Google Patents
Compound fructose electrolyte injection and preparation method and application thereof Download PDFInfo
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- CN101744834A CN101744834A CN200910260055A CN200910260055A CN101744834A CN 101744834 A CN101744834 A CN 101744834A CN 200910260055 A CN200910260055 A CN 200910260055A CN 200910260055 A CN200910260055 A CN 200910260055A CN 101744834 A CN101744834 A CN 101744834A
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Abstract
The invention provides a compound fructose electrolyte injection, which consists of the following raw materials in proportion by weight: 0.85 to 4.5 grams of anhydrous fructose, 0.35 to 0.65 gram of sodium chloride, 0.022 to 0.035 gram of potassium chloride, 0.02 to 0.025 gram of magnesium chloride, 0.42 to 0.7 gram of sodium gluconate, 0.25 to 0.5 gram of sodium acetate, and the balance of water for injection based on the total amount of 100 mL. The invention also provides a preparation method for the compound fructose electrolyte injection and application thereof. The compound fructose electrolyte injection is independent of insulin metabolism, and is very suitable to be used by diabetics and hepatopaths; the sodium acetate is used for replacing sodium lactate to avoid a large amount of lacticemia symptoms caused in the process of transfusion; the metabolism is stable so that the compound fructose electrolyte injection is suitable for wound and operation patients; besides, the compound fructose electrolyte injection has high energy and good safety.
Description
Technical field
The present invention relates to medical technical field, specifically, the present invention relates to a kind of compound fructose electrolyte injection, and its production and application.
Background technology
Clinically, the patient Chang Buneng behind the surgical operation is feed in a large number immediately, need keep the skin wet from vein, electrolyte and heat.In addition, when causing hemorrhagic shock, also need electrolyte supplement solution in operation or wound.Particularly for the patient who accepts kidney transfer operation, the overwhelming majority will experience the postoperative diuresis stage, 24 hours urine amount of patient can reach thousands of even up to ten thousand milliliters, and be attended by a large amount of electrolyte and from urine, run off, thereby must keep the intravital water of patient, electrolyte and acid-base balance by fluid-supplement therapy during this period.
In recent years, electrolyte injection progressively carries out the transition to compound electrolyte from single electrolyte, is further development of containing of various concentration of sugared compound electrolyte injection, for clinical practice is provided convenience.At present, by the different phase of the state of an illness and object the electrolyte transfusion is divided into 4 kinds, promptly initial liquid, dehydration replenish liquid, keep liquid and recover liquid, make medication more reasonable and conveniently.The electrolyte injection that also has several specific uses in addition, the gastric juice when losing as gastric juice replenish liquid, the duodenum when intestinal juice is lost replenishes promotion diuresis and the transfusion of electrolyte supplement and energy and the TPN basal liquid of cooperation total parenteral nutrition therapy (TPN) etc. behind liquid, the urethrectomy.
In containing sugared compound electrolyte injection, most widely used is glucose, essential by brain because it meets the physiological requirement of human body most, 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: because operation or post-traumatic body are in stress state, the ability of utilizing to glucose reduces, therefore quick a large amount of glucoses of importing, not only can not be made full use of by body, also can cause blood glucose obviously to raise, cause the instability of organismic internal environment; Glucose metabolism in vivo is slow, makes easily by blood glucose instability in the injection patient body, increases the weight of the diabetic symptom; Hyperglycemia is suppressed steatolysis, causes body the nitrogenize phenomenon to occur; The kind composition is single, can not replenish liquid etc. as other nutritional labelings of operation back.More than these cause traditional nutrition transfusion can not adapt to more and more higher clinical requirement, particularly to diabetes and wound emergent due to the patient of insufficient insulin must the supplemented with exogenous insulin or with fructose, xylitol, sorbitol replacement.What most possibly replace glucose infusion liquid at present 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 also by the collection of state-promulgated pharmacopoeia such as American and Britain, moral, day, has become the second largest transfusion 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 again.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 object of the present invention is to provide a kind of compound fructose electrolyte injection that effectively prevents blood sugar increasing, is suitable for the postoperative fluid-supplement therapy.
Another object of the present invention is to provide the preparation method of described compound electrolyte injection.
The present invention also aims to provide the application of described compound electrolyte injection.
In order to realize purpose of the present invention, a kind of compound fructose electrolyte injection of the present invention, it is made up of following materials of weight proportions:
No Fruit candy 0.85～4.5g, sodium chloride 0.35～0.65g, potassium chloride 0.022～0.035g,
Magnesium chloride (MgCl
26H
2O) 0.02～0.025g, gluconic acid sodium salt 0.42～0.7g,
Sodium acetate 0.25～0.5g, add the injection water to 100mL.
Wherein, preferred proportioning is: no Fruit candy 2.015g, sodium chloride 0.535g, potassium chloride 0.0298g, magnesium chloride (MgCl
26H
2O) 0.0206g, gluconic acid sodium salt 0.598g, sodium acetate 0.362g, add the injection water to 100mL.
Compound fructose electrolyte injection of the present invention, be according to the basis of postoperative fluid infusion, replace glucose, and each component has been carried out on the basis of the experiment of component analysis and research with fructose, select suitable concentration range, be mixed with the compound injection of specific proportioning.
Wherein, fructose is a kind of left-handed hexose, is the isomer of glucose.The pharmacological action of fructose is identical with glucose basically, the effect of have direct heat supply, replenishing body fluid and nutrition whole body.But metabolism is faster than glucose in vivo behind the fructose intravenously administrable, easily absorbed by body, and the fructose metabolism is not mainly by relying on the fructokinase of insulin regulation and control, therefore it can walk around glucolytic rate-limiting enzyme---and phosphofructokinase carries out autonomous metabolism, therefore is particularly suitable for the emergent patient's postoperative fluid-supplement therapy that causes insufficient insulin of diabetics and wound.
In addition, this product has also adopted sodium acetate because sodium acetate metabolism is fast than sodium lactate in vivo, can be comprised general metabolisms such as kidney, muscle by other organs beyond the liver, so can not occur circulation time in vivo accumulating, and not contain lactate, the lacticemia that has caused when having avoided a large amount of transfusion.And may have the enhance immunity effect after the acetic acid injection, also have the effect that keeps maincenter body temperature under the generalized anesthetic state simultaneously.
The preparation method of compound fructose electrolyte injection of the present invention comprises the steps:
1) taking by weighing each raw material by weight ratio, join in the water for injection of cumulative volume 80%, is below 70 ℃ in temperature, stirs to make its dissolving;
2) press cumulative volume and add 0.2～0.5g/L medicinal carbon, boil and stir 5～20min, filter carbon removal;
3) supply surplus with water for injection, stir;
4) regulate pH to 5.5～6.5;
5) fine straining, fill, sterilization.
Wherein, the condition of described sterilization is 121 ℃ of moist heat sterilization 10～20min.
The application of compound fructose electrolyte injection of the present invention in the injection of the additional body fluid in preparation operation back.
The invention has the advantages that compound fructose electrolyte injection of the present invention does not rely on insulin metabolism, be fit to very much diabetics and hepatopath and use; Replace sodium lactate with sodium acetate, the lacticemia that has caused when having avoided a large amount of transfusion; Metabolic stability is fit to wound and surgical patient and uses; And the energy height, safety is good.
Description of drawings
Fig. 1 is preparation technology's flow chart of compound fructose electrolyte injection of the present invention.
The specific embodiment
Below further specify the present invention by specific embodiment, but be not used for limiting the scope of the invention.
Embodiment 1 (annotate: following examples are all made according to processing step shown in Figure 1)
1, product component:
No Fruit candy 2.015kg
Sodium chloride (NaCl) 0.535kg
Potassium chloride (KCl) 0.0298kg
Magnesium chloride (MgCl
26H
2O) 0.0206kg
Gluconic acid sodium salt 0.598kg
Sodium acetate 0.362kg
Add the injection water to 100L.
2, the preparation method of the compound fructose electrolyte injection of said ratio:
1) takes by weighing each raw material by said ratio, join in the water for injection of cumulative volume 80%, under 65 ℃ temperature, fully stir and make its dissolving;
2) press cumulative volume and add the 0.3g/L medicinal carbon, boil and stir 5min, filter carbon removal;
3) add water for injection to 100L, stir;
4) regulate pH to 6.0 with 1mol/L hydrochloric acid, sample thief is surveyed intermediate pH value, content;
5) after fine straining, fill, the sealing in 121 ℃ of warm sterilization 14min;
6) after sterilization finishes, visual examination outward appearance and content, qualified back packing.
Embodiment 2
1, product component:
No Fruit candy 0.85kg
Sodium chloride (NaCl) 0.35kg
Potassium chloride (KCl) 0.022kg
Magnesium chloride (MgCl
26H
2O) 0.02kg
Gluconic acid sodium salt 0.42kg
Sodium acetate 0.25kg
Add the injection water to 100L.
2, the preparation method of the compound fructose electrolyte injection of said ratio:
1) takes by weighing each raw material by said ratio, join in the water for injection of cumulative volume 80%, under 60 ℃ temperature, fully stir and make its dissolving;
2) press cumulative volume and add the 0.2g/L medicinal carbon, boil and stir 15min, filter carbon removal;
3) add water for injection to 100L, stir;
4) regulate pH to 6.5 with 1mol/L hydrochloric acid, sample thief is surveyed intermediate pH value, content;
5) after fine straining, fill, the sealing in 121 ℃ of warm sterilization 20min;
6) after sterilization finishes, visual examination outward appearance and content, qualified back packing.
Embodiment 3
1, product component:
No Fruit candy 4.5kg
Sodium chloride (NaCl) 0.65kg
Potassium chloride (KCl) 0.035kg
Magnesium chloride (MgCl
26H
2O) 0.025kg
Gluconic acid sodium salt 0.7kg
Sodium acetate 0.5kg
Add the injection water to 100L.
2, the preparation method of the compound fructose electrolyte injection of said ratio:
1) takes by weighing no Fruit candy, sodium chloride, potassium chloride, magnesium chloride, gluconic acid sodium salt, sodium acetate by said ratio, join in the water for injection of full dose volume 80%, under 68 ℃ temperature, fully stir and make its dissolving;
2) press cumulative volume and add the 0.5g/L medicinal carbon, boil and stir 20min, filter carbon removal;
3) add water for injection to 100L, stir;
4) regulate pH to 5.5 with 1mol/L hydrochloric acid, sample thief is surveyed intermediate pH value, content;
5) after fine straining, fill, the sealing in 121 ℃ of warm sterilization 10min;
6) after sterilization finishes, visual examination outward appearance and content, qualified back packing.
Below, further specify the present invention by pharmacological effect experiment and stability test to compound fructose electrolyte injection of the present invention.
Experimental example 1
According to medicine registration requirement, we have carried out blood vessel irritation, anaphylaxis and hemolytic test to the compound fructose electrolyte injection of real examination example 1 preparation.
One, blood vessel irritation experiment
Getting body weight is 12 of the healthy rabbits of 2.0～2.5kg, is divided into 2 groups at random, 6 every group.Adopt rabbit ear edge vein slowly to inject, injection volume 5mL/kg, one group of compound fructose electrolyte injection with embodiment 1, another group is used glucose injection, once a day, and successive administration 7 days, cut off the rabbit ear in last administration after 24 hours, place 10% formalin fixed preparation, send pathology to carry out histological examination (5 places at rabbit ear edge venous different parts draw materials, and promptly begin entad to hold every 1cm from first position of injection beginning and do a section) then.
Through rabbit ear edge vein pathological examination, compound fructose electrolyte injection group rabbit ear edge vein tube wall is complete, and the endotheliocyte structure is clear, does not have obvious pathological changes, the slight dilatation and congestion of blood vessel, no cell infiltration.The histology of sodium chloride matched group auricular vein changes similar to the medication group.The result shows that medication group vein blood vessel is normal, do not see degeneration is arranged, the reaction of obvious stimulation such as necrosis.
Two, the hypersensitive test of compound fructose electrolyte injection
Get 18 of the healthy guinea pigs that body weight is about 240g, be divided into 3 groups, 6 every group, i.e. compound fructose electrolyte injection group, normal saline matched group, Radix Trichosanthis group.Compound fructose electrolyte injection 1mL, equivalent normal saline and the Radix Trichosanthis 2.5mg of every other day injection embodiment 1 inject 3 times altogether respectively; And then be divided into two groups, 3 every group.Injecting in the first time respectively had lumbar injection compound fructose electrolyte injection 0.2mL in back 14 days and 21 days, and equivalent normal saline and Radix Trichosanthis 0.25mg observe the anaphylaxis situation then.The results are shown in Table 1, shown in the table 2.Table 3 is the anaphylaxis grade scale.
Reaction after the 14th day Cavia porcellus of table 1 excites
Reaction after the 21st day Cavia porcellus of table 2 excites
Table 3 Cavia porcellus anaphylaxis hierarchical table
By table 1, table 2 as can be seen: compound fructose electrolyte injection of the present invention does not cause the Cavia porcellus anaphylaxis.
Three, hemolytic experiment
The preparation of (1) 2% Sanguis Leporis seu oryctolagi suspension
Get one of rabbit, the small beaker from heart extracting blood 10mL to clean dried, stir except that defibrinating with Glass rod, add normal saline 3mL, centrifugal abandoning supernatant adds the 10mL normal saline again, shakes up gently, recentrifuge and abandoning supernatant are till so repeating not take on a red color to supernatant several times; Measure the 2mL blood cell, add normal saline, be diluted to 2% suspension confession test usefulness to 100mL.
(2) test
Get 7 in test tube, according to the form below adds each solution, shakes up, and compound fructose electrolyte injection concentration is 10%, and respectively at being incubated 0.5,1,2,3 hour in 37 ℃ of waters bath with thermostatic control, the result is as shown in table 4.
Table 4 compound fructose electrolyte injection hemolytic test result
Annotate: +++complete hemolysis; ++ part haemolysis; + cohesion;-do not condense, there is not cohesion
As can be seen from Table 4, compound fructose electrolyte injection did not cause haemolysis and cell condensation in 3 hours.
Experimental example 2
One, the clinical pharmacology effect of fructose
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 the clinical mode that must and often adopt.Glucose is clinical the most frequently used energy supplement agent, but the venous transfusion 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, and in vivo without phosphoglucomutase, directly the hexokinase metabolism is a fructose-1, 6-diphosphate, 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.
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.Fructose also can be used as intestinal cleaning agents, carries out TC, satisfactory effect.
Two, the pharmacological effect of compound fructose electrolyte of the present invention:
The fructose of compatibility mainly is present in the fructokinase metabolism in the liver in the compound fructose electrolyte injection of the present invention, is not subjected to the influence of insulin, is fit to very much diabetics and hepatopath and uses; Metabolic stability is particularly suitable for wound and surgical patient and uses.
The present invention is the hypotonicity electrolyte of potassium, sodium, chlorine and the compound preparation of fructose, be used for can not oral administration picked-up or absorb when insufficient, moisture and electrolyte are kept in supply.
Three, the compound fructose electrolyte injection of embodiment 1 (test group) and glucose injection (matched group) are to the influence research of hypertensive diabetes patient blood glucose and blood insulin levels.
Experimental technique is gone into to organize the patient and was risen at the 1st day, and every morning 8 is lighted intravenous drip 100mL test drug, continues intravenous drip 3h.Write down body temperature, blood Fg, heart rate, observation after the medication respectively and have or not phlebitis and anaphylaxis.Detect electrocardiogram, blood, routine urinalysis after the medication, liver, renal function (ALT, AST, BUN, Cr), electrolyte concentration (Na, K, Cl).Postoperative was got blood at medication 0,1,4h respectively on the 2nd day, detected blood glucose and blood insulin; After the postoperative medication in the 2nd, 3 days and experiment postoperative morning on the 4th of finishing, detect blood glucose, blood insulin 1 time respectively; Glucose in urine detects 1 time after respectively at postoperative medication in the 1st, 2,3 days with semiquantitative method, and postoperative detects 1 time the 4th day morning.The result is shown in table 5 and table 6.
The situation of change of blood glucose and blood insulin parameter sees Table 5 in two groups of patient treatment processes of experimental result, before and after the treatment.Blood sugar level increases behind the 1st day matched group infusion glucose injection of the postoperative 1h, and blood sugar level reaches the highest in the 4h after administration; Test group blood sugar level behind the infusion compound fructose electrolyte injection does not have obvious change, and is lower than the blood sugar level of glucose group all the time, and relatively, difference has statistical significance (P＜0.05) between two groups; After the postoperative transfusion in the 2nd, 3 days, the test group blood sugar level significantly is lower than matched group, and comparing difference has statistical significance between two groups; Blood sugar level comparing difference not statistically significant (P＞0.05) between two groups of postoperatives the 4th day.
The 1st day test group of postoperative behind infusion in the 4h, the visible fuctuation within a narrow range of blood insulin levels, 4h and the 2nd, 3,4 day behind the infusion, with ratio before the medication, insulin level changes not statistically significant; Matched group blood insulin levels behind infusion significantly increases, 4h and the 2nd, 3,4 day behind the infusion, with before the medication relatively, difference all has statistical significance; Relatively, difference has statistical significance between test group and matched group group; After the postoperative transfusion in the 2nd, 3 days, the matched group blood insulin levels all is significantly higher than test group; The 4th day morning of postoperative after the off-test, before two groups of blood insulin levels and the medication relatively, difference not statistically significant, comparing difference not statistically significant between group.
The variation of glucose in urine is as shown in table 6 in two groups of patient treatment processes, before and after the treatment, obviously increases before the medication of matched group glucose in urine delivery ratio, and test group glucose in urine after postoperative medication in the 1st day was discharged and increased, glucose in urine was discharged not have and changed after the medication in the 2nd, 3 day; The increase of matched group glucose in urine delivery ratio test group is more obvious, and comparing difference has statistical significance between two groups.
The situation of change of table 5 matched group and test group blood glucose and blood insulin
The situation of change of table 6 matched group and test group glucose in urine
Annotate: ++ than normal person's glucose in urine height; + slightly higher than normal person glucose in urine;-normal person glucose in urine
Experimental example 3 stability tests
One, accelerated test
Respectively prepare a collection of three reply side's fructose electrolyte injection samples that prepare altogether by embodiment 1,2 and 3 preparation methoies, place the calorstat of 40 ± 2 ℃ of temperature to store six months, the 1st, 2,3,6 month pick test the results are shown in Table 7.
Assay full inspection in 6th month is qualified.Character, visible foreign matters all do not have significant change, and pH slightly descends, and content does not almost change, and the 5 hydroxymethyl furfural (5-HMF) that the fructose degraded produces slightly increases, but is starkly lower than standard.The preparation method that product of the present invention is described is better.
Two, long term test
Respectively prepare a collection of three reply side's fructose electrolyte injection samples that prepare altogether by embodiment 1,2 and 3 preparation methoies, place under 25 ± 2 ℃ of conditions, pick test in the time of the 3rd, 6,9 month the results are shown in Table 7
Test agent in three batches of assay 9th month, pH slightly descends, and content does not have significant change, and the 5 hydroxymethyl furfural (5-HMF) that the fructose degraded produces increases to some extent, but in acceptability limit.Constant product quality of the present invention is described, effect duration is long.
The table 7 compound fructose electrolyte injection accelerated test and the investigation result that keeps sample for a long time
Three, influence factor's test
Press the compound fructose electrolyte injection sample of embodiment 1 preparation method preparation, under illumination condition (2 * 20W daylight lamp, sample is apart from light source 15cm, illumination 4500Lux), respectively in test initial (0 day) and the 5th, 10 day sampling and measuring; Other gets the compound fructose electrolyte injection sample of embodiment 1 preparation method preparation, places 60 ℃ of calorstats, respectively in test initial (0 day) and the 5th, 10 day sampling and measuring; Other gets the compound fructose electrolyte injection sample of embodiment 1 preparation method preparation, places refrigerator and cooled to freeze (10～-20 ℃) 2 days, investigates 2 days then under 40 ℃ of acceleration environments, and sampling detects, and so circulates three times, the results are shown in Table 8.
Table 8 compound fructose electrolyte injection influence factor tests the investigation result
The result shows: compound fructose electrolyte injection of the present invention is more stable.
Though, above the present invention is described in detail with general explanation, specific embodiments and experiment, but on basis of the present invention, those of ordinary skill in the field can make some modifications or improvements it, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (5)
1. a compound fructose electrolyte injection is characterized in that, it is made up of following materials of weight proportions:
No Fruit candy 0.85～4.5g, sodium chloride 0.35～0.65g, potassium chloride 0.022～0.035g,
Magnesium chloride 0.02～0.025g, gluconic acid sodium salt 0.42～0.7g, sodium acetate 0.25～0.5g,
Add the injection water to 100mL.
2. compound electrolyte injection according to claim 1 is characterized in that, it is made up of following materials of weight proportions:
No Fruit candy 2.015g, sodium chloride 0.535g, potassium chloride 0.0298g, magnesium chloride 0.0206g,
Gluconic acid sodium salt 0.598g, sodium acetate 0.362g, add the injection water to 100mL.
3. prepare the method for claim 1 or 2 described compound electrolyte injection, it is characterized in that, comprise the steps:
1) taking by weighing each raw material by weight ratio, join in the water for injection of cumulative volume 80%, is below 70 ℃ in temperature, stirs to make its dissolving;
2) press cumulative volume and add 0.2～0.5g/L medicinal carbon, boil and stir 5～20min, filter carbon removal;
3) supply surplus with water for injection, stir;
4) regulate pH to 5.5～6.5;
5) fine straining, fill, sterilization.
4. preparation method according to claim 3 is characterized in that, the condition of described sterilization is 121 ℃ of moist heat sterilization 10～20min.
5. claim 1 or the 2 described compound fructose electrolyte injections application in the injection of the additional body fluid in preparation operation back.
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Application publication date: 20100623 |