CN102755348A - Carbohydrate and electrolyte injection and preparation method thereof - Google Patents
Carbohydrate and electrolyte injection and preparation method thereof Download PDFInfo
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- CN102755348A CN102755348A CN2012102646353A CN201210264635A CN102755348A CN 102755348 A CN102755348 A CN 102755348A CN 2012102646353 A CN2012102646353 A CN 2012102646353A CN 201210264635 A CN201210264635 A CN 201210264635A CN 102755348 A CN102755348 A CN 102755348A
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Abstract
The invention provides a carbohydrate and electrolyte injection which comprises the following components by weight part: 30 parts of glucose, 15 parts of fructose, 7.5 parts of xylitol, 0.73 part of sodium chloride, 0.41 part of sodium acetate, 0.185 part of calcium chloride, 0.255 part of magnesium chloride, 0.87 part of dipotassium phosphate, 0.0007 part of zinc sulfate, 0.21 part of sodium bisulfite and 250 parts of water for injection; and the PH value is 5.1-5.5. The injection is low in cost and wide in applicable range. The invention also provides a preparation method of the carbohydrate and electrolyte injection. The preparation method comprises the steps of dissolving carbohydrate and electrolyte (as raw and auxiliary materials), absorbing, decarbonizing, adjusting the pH, and sterilizing to obtain the carbohydrate and electrolyte injection. According to the preparation method, the process is simple, the method is suitable for industrial production, the problems that samples turn yellow after the sterilization, and white substances are separated out can be avoided by increasing the dissolving temperature to be 75 DEG C-85 DEG C and adjusting the pH of the solution, so that the carbohydrate and electrolyte injection is stable.
Description
Technical field
The invention belongs to medical technical field, particularly a kind of mixed sugar electrolyte injection and preparation method thereof.
Background technology
Under various pathogenic bacteria invasion and attack, reach average of operation periods, human body not only need keep the skin wet and electrolyte, and needs be main nutrition thermal source with the saccharic, therefore develop numerous nutrition infusion preparations additional.Owing to glucose wide material sources, cheap, therefore the sugared electrolyte injection of domestic clinical use at present is mainly Dextrose and Sodium Chloride Inj., yet it replenishes all very dullness in energy supplement and electrolyte, can't satisfy clinical demand.Simultaneously, for the diabetes patient, because diabetes patient's impaired glucose tolerance, the metabolism load is big behind the injectable dextrose monohydrate, can't effectively utilize glucose.In addition, only use glucose as substrate, the injection back possibly produce diabetes appearance and change aspect liver enzyme activity, even use insulin, the also remaining inhibition that glucose-6-phosphate dehydrogenase (G6PD) is arranged.
Can be used for clinical transfusion has at present had bigger development with saccharide, like glucose, the fructose of monosaccharide, and the maltose of disaccharides, the glycerol of triose alcohols, and the xylitol of pentose alcohols, the sorbitol of hexose alcohols.Mixed sugar has characteristics such as metabolism is complete, energy supply is high, blood glucose fluctuation is little, insulin dependency is less as energy matter; The mixed sugar electrolyte injection of exploitation is applicable to the patient's that anti-sugar such as diabetes, postoperative, burn and bacteremia are low energy, moisture and electrolytical replenishing based on this, more and more comes into one's own.
CN101947240 discloses a kind of method for preparing of mixed sugar electrolyte composition injection, and this method for preparing behind the accent pH to 4.5-7.0, uses pin to adsorb, take off charcoal with charcoal through mixed sugar and electrolyte are dissolved in the water for injection under 50 ℃, promptly gets.This method is because solution temperature is low, and especially when pH is higher, sample can flavescence after sterilization, and has a small amount of whiteness and separate out, and the mixed sugar electrolyte injection for preparing is unstable.
Summary of the invention
Goal of the invention: first purpose of the present invention provides a kind of mixed sugar electrolyte injection.
Second purpose of the present invention provides the method for preparing of above-mentioned mixed sugar electrolyte injection.
Technical scheme: the invention provides a kind of mixed sugar electrolyte injection, comprise the component of following weight portion: 30 parts of glucoses, 15 parts in fructose; 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate; 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate; 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.1-5.5.
Among the present invention, preferred sodium sulfite is as antioxidant, and its quality and said mixed sugar electrolyte injection volume ratio are (0.08-0.20): 100; Preferably, be 0.084:100.
Among the present invention, optimization citric acid is as the pH regulator agent, and its consumption is to make the pH value of whole solution system reach 5.1-5.5.
The present invention also provides the method for preparing of above-mentioned mixed sugar electrolyte injection, comprises the steps:
(1) with glucose, fructose, xylitol and electrolyte supplementary material, add in 75-85 ℃ the water for injection of amount of preparation 90%, stirring is dissolved it fully, gets mixed solution;
(2) in above-mentioned mixed solution, add needle-use activated carbon, the quality of said active carbon and the volume ratio of mixed solution are 0.05g:100ml, 55-65 ℃ insulated and stirred 10-20 minute, the decarburization of solution filtered while hot;
(3) add water for injection to full dose, use the pH regulator agent to transfer pH to 5.1-5.5;
(4) with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m;
(5) packing, sterilization promptly gets.
A kind of preferred as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention, in the step (1), said electrolyte supplementary material comprises sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite.
Further preferred as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention, the said components weight portion is respectively: 30 parts of glucoses, 15 parts in fructose; 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate; 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate; 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection.
Another kind as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention is preferred, and in the step (1), the temperature of said water for injection is 80 ℃.
Another kind as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention is preferred, and in the step (3), said pH regulator agent is a citric acid.
Another kind as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention is preferred, and in the step (5), sterilising temp is 115 ℃, and sterilization time is 30 minutes.
Beneficial effect: electrolyte injection provided by the invention is with low cost, applied widely; Mixed sugar has characteristics such as metabolism is complete, energy supply is high, blood glucose fluctuation is little, insulin dependency is less as energy matter in this injection, all can use for the low patient's of anti-sugar such as diabetes, postoperative, burn and bacteremia energy, moisture and electrolytical replenishing.Wherein, glucose can provide energy, and fructose and xylitol have and can not receive advantages such as glucokinase and the kinase whose adjusting of hexose through cell membrane, metabolism in non-insulin-dependent ground, can provide human body existence required energy simultaneously; Adopt xylitol and glucose to share the inhibition that can effectively prevent glucose-6-phosphate dehydrogenase (G6PD), so this mixed sugar electrolyte injection is specially adapted to the patient of metabolism obstacles of blood glucose.
Simple, the suitable suitability for industrialized production of the method for preparing technology of the mixed sugar injection that provides of the present invention; Through improving solution temperature to 75-85 degree centigrade; And the pH of regulator solution has effectively avoided the problem that sample flavescence, adularescent material are separated out after the sterilization; Thereby make that the mixed sugar electrolyte injection is more stable, the injection of this method preparation pH no change after different condition is handled, hydroxymethyl furfural content changes less.
The specific embodiment
Embodiment 1
The mixed sugar electrolyte injection, write out a prescription as follows:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.1.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 85 ℃ of waters for injection, be stirred to dissolving fully by 90% of amount of preparation.In above-mentioned solution, add needle-use activated carbon, the quality of said active carbon and the volume ratio of mixed solution are 0.05g:100ml, constantly stir 15 minutes down in 55-65 ℃ of heating condition; The decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10% is regulated pH to 5.1; With the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, plug bottle; Roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 2
The mixed sugar electrolyte injection, write out a prescription as follows:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.5.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 75 ℃ of waters for injection, be stirred to dissolving fully by 90% of amount of preparation.In above-mentioned solution, add needle-use activated carbon, the quality of said active carbon and the volume ratio of mixed solution are 0.05g:100ml, constantly stir 20 minutes down in 55-65 ℃ of heating condition; The decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10% is regulated pH to 5.5; With the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, plug bottle; Roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 3
The mixed sugar electrolyte injection, write out a prescription as follows:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.3.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 80 ℃ of waters for injection, be stirred to dissolving fully by 90% of amount of preparation.In above-mentioned solution, add needle-use activated carbon, the quality of said active carbon and the volume ratio of mixed solution are 0.05g:100ml, constantly stir 10 minutes down in 55-65 ℃ of heating condition; The decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10% is regulated pH to 5.3; With the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, plug bottle; Roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 4
Adopt existing method to prepare the mixed sugar electrolyte injection.
The mixed sugar electrolyte injection, write out a prescription as follows:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 6.5.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 50 ℃ of waters for injection, be stirred to dissolving fully by 90% of amount of preparation.In above-mentioned solution, add needle-use activated carbon, the quality of said active carbon and the volume ratio of mixed solution are 0.05g:100ml, constantly stir 10 minutes down in 55-65 ℃ of heating condition; The decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10% is regulated pH to 6.5; With the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, plug bottle; Roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 5
With the above 4 batches of mixed sugar electrolyte injections that prepare respectively at preparation back, 60 ℃ place after 5 days, 60 ℃ place after 10 days, illumination after 5 days, illumination after 10 days etc. different condition handle and detect, the result sees table 1.The result shows that the mixed sugar electrolyte injection presentation quality that this method prepares is good, and color and luster is clear and bright; Hydroxymethyl furfural content changes little; And the injection that the method that adopts comparative example 4 prepares is yellow green after the sterilization, after different condition is handled; Yellow green has the trend that increases the weight of, and hydroxymethyl furfural content changes greatly.
Table 1 is the testing result that mixed sugar electrolyte injection different condition is handled
Claims (8)
1. a mixed sugar electrolyte injection is characterized in that: the component that comprises following weight portion: 30 parts of glucoses, 15 parts in fructose; 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate; 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate; 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.1-5.5.
2. a kind of mixed sugar electrolyte injection according to claim 1 is characterized in that: also comprise the pH regulator agent, said pH regulator agent is a citric acid.
3. the method for preparing of the described a kind of mixed sugar electrolyte injection of claim 1 is characterized in that: comprise the steps:
(1) with glucose, fructose, xylitol and electrolyte supplementary material, add in 75-85 ℃ the water for injection of amount of preparation 90%, stirring is dissolved it fully, gets mixed solution;
(2) in above-mentioned mixed solution, add needle-use activated carbon, the quality of said active carbon and the volume ratio of mixed solution are 0.05g:100ml, 55-65 ℃ insulated and stirred 10-20 minute, the decarburization of solution filtered while hot;
(3) add water for injection to full dose, use the pH regulator agent to transfer pH to 5.1-5.5;
(4) with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m;
(5) packing, sterilization promptly gets.
4. the method for preparing of a kind of mixed sugar electrolyte injection according to claim 3; It is characterized in that: in the step (1), said electrolyte supplementary material comprises sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite.
5. the method for preparing of a kind of mixed sugar electrolyte injection according to claim 4 is characterized in that: the component by following weight portion is processed: 30 parts of glucoses, 15 parts in fructose; 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate; 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate; 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection.
6. the method for preparing of a kind of mixed sugar electrolyte injection according to claim 3 is characterized in that: in the step (1), the temperature of said water for injection is 80 ℃.
7. the method for preparing of a kind of mixed sugar electrolyte injection according to claim 3 is characterized in that: in the step (3), said pH regulator agent is a citric acid.
8. the method for preparing of a kind of mixed sugar electrolyte injection according to claim 3 is characterized in that: in the step (5), sterilising temp is 115 ℃, and sterilization time is 30 minutes.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103989705A (en) * | 2014-05-05 | 2014-08-20 | 肖义军 | Sugar electrolyte injection liquid 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 |
| CN108113998A (en) * | 2016-11-28 | 2018-06-05 | 华仁药业股份有限公司 | A kind of preparation method of parenteral solution |
| CN108969475A (en) * | 2018-08-13 | 2018-12-11 | 岳景春 | Application and low deuterium subset injection of the low deuterium subset in injection |
| CN109833330A (en) * | 2019-04-15 | 2019-06-04 | 河南利欣制药股份有限公司 | A kind of Dextrose and Sodium Chloride Inj. production technology |
| 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 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101947240A (en) * | 2010-09-13 | 2011-01-19 | 海南本创医药科技有限公司 | Mixed sugar electrolyte drug composite injection |
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2012
- 2012-07-27 CN CN 201210264635 patent/CN102755348B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101947240A (en) * | 2010-09-13 | 2011-01-19 | 海南本创医药科技有限公司 | Mixed sugar electrolyte drug composite injection |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103989705A (en) * | 2014-05-05 | 2014-08-20 | 肖义军 | Sugar electrolyte injection liquid and preparation method thereof |
| CN103989705B (en) * | 2014-05-05 | 2017-01-18 | 肖义军 | Sugar electrolyte injection liquid 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 |
| CN105497061B (en) * | 2015-12-24 | 2019-01-08 | 长沙利星医药科技开发有限公司 | A kind of electrolyte injection and preparation method thereof without glucose |
| CN108113998A (en) * | 2016-11-28 | 2018-06-05 | 华仁药业股份有限公司 | A kind of preparation method of parenteral solution |
| CN108969475A (en) * | 2018-08-13 | 2018-12-11 | 岳景春 | Application and low deuterium subset injection of the low deuterium subset in injection |
| CN109833330A (en) * | 2019-04-15 | 2019-06-04 | 河南利欣制药股份有限公司 | A kind of Dextrose and Sodium Chloride Inj. production technology |
| CN109833330B (en) * | 2019-04-15 | 2021-04-30 | 河南利欣制药股份有限公司 | Production process of glucose sodium chloride injection |
| 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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