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A kind of production technology of glucose sodium chloride injection

A glucose sodium chloride, production process technology, applied in the production process field of glucose sodium chloride injection, can solve the problems of long production cycle, slow dissolution rate, high content of glucose degradation product 5-HMF, etc., to achieve stable product quality, The effect of reducing the increase of content, ensuring biological safety and quality stability

Active Publication Date: 2019-09-13
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a production process of glucose sodium chloride injection, which solves the problems of slow raw material dissolution rate, long production cycle and glucose degradation product 5-HMF in the sterilization process in the preparation method of glucose sodium chloride injection in the prior art high content problem

Method used

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  • A kind of production technology of glucose sodium chloride injection
  • A kind of production technology of glucose sodium chloride injection
  • A kind of production technology of glucose sodium chloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A kind of production technology of glucose sodium chloride injection of the present invention comprises the following steps:

[0034] 1) Weigh raw materials: Weigh the following raw materials in turn, glucose 60.00Kg, fructose 30.00Kg, xylitol 15.00Kg, magnesium chloride 0.510Kg, calcium chloride 0.370Kg, sodium chloride 1.460Kg, sodium acetate 0.820Kg, dihydrogen phosphate Potassium 1.740Kg, zinc sulfate 1.400g, sodium bisulfite 0.420Kg, citric acid 1.0Kg, water for injection 1000L;

[0035] 2) Raw material dissolution:

[0036] a) Add injection water at 30°C to a preparation tank with a volume of 300L, the amount of injection water is 10% of the total amount, start stirring, and add the above-mentioned sodium bisulfite, magnesium chloride, calcium chloride, sodium chloride and sulfuric acid in sequence Zinc, stirring and dissolving for 1min to make it all dissolve;

[0037] b) Add injection water at 50°C to the concentrated preparation tank with a volume of 600L, th...

Embodiment 2

[0044] A kind of production technology of glucose sodium chloride injection of the present invention comprises the following steps:

[0045] 1) Weigh raw materials: Weigh the following raw materials in turn, glucose 60.00Kg, fructose 30.00Kg, xylitol 15.00Kg, magnesium chloride 0.510Kg, calcium chloride 0.370Kg, sodium chloride 1.460Kg, sodium acetate 0.820Kg, dihydrogen phosphate Potassium 1.740Kg, zinc sulfate 1.400g, sodium bisulfite 0.420Kg, citric acid 1.1Kg, water for injection 1000L;

[0046] 2) Raw material dissolution:

[0047] a) Add injection water at 35°C to a preparation tank with a volume of 400L, the amount of injection water is 15% of the total amount, start stirring, and add sodium bisulfite, magnesium chloride, calcium chloride, sodium chloride and zinc sulfate in sequence , stir and dissolve for 3 minutes to make it all dissolve;

[0048] b) Add water for injection at 55°C to the concentrated preparation tank with a volume of 800L, the amount of water for ...

Embodiment 3

[0055] 1) Weigh raw materials: Weigh the following raw materials in turn, glucose 60.00Kg, fructose 30.00Kg, xylitol 15.00Kg, magnesium chloride 0.510Kg, calcium chloride 0.370Kg, sodium chloride 1.460Kg, sodium acetate 0.820Kg, dihydrogen phosphate Potassium 1.740Kg, zinc sulfate 1.400g, sodium bisulfite 0.420Kg, citric acid 1.2Kg, water for injection 1000L;

[0056] 2) Raw material dissolution:

[0057] a) Add injection water at 40°C to a preparation tank with a volume of 500L, the amount of injection water is 20% of the total amount, start stirring, and add sodium bisulfite, magnesium chloride, calcium chloride, sodium chloride and zinc sulfate in sequence , stir and dissolve for 5 minutes to make it all dissolve;

[0058] b) Add injection water at 60°C to the concentrated preparation tank with a volume of 1000L, the amount of injection water is 50% of the total amount, start stirring, add dipotassium hydrogen phosphate, after it dissolves, add glucose, fructose, wood Sug...

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Abstract

The invention discloses a process for pretreating glucose and sodium chloride injection, and belongs to the technical field of injection. The method comprises the following steps: (1) weighing raw materials; (2) dissolving the raw materials, namely a) adding sodium hydrogen sulfite, magnesium chloride, calcium chloride, sodium chloride and zinc sulfate into injecting water at 30-40 DEG C; (b) adding dipotassium phosphate, glucose, fructose, xylitol and sodium acetate into the injecting water at 50-60 DEG C; and (c) mixing the solution, adding citric acid and activated carbon, insulating and adsorbing; (3) decarburizing, delivering to a diluting tank; (4) complementing injecting water, and regulating the pH value to 6.5-7.5; (5) filling bags after rough filtration and fine filtration; and (6) sterilizing at 122 DEG C for 3-5 minutes. According to the process, raw materials are dissolved in batches with different dissolving temperatures, the dissolving speed is increased, the temperature is reasonably controlled, energy consumption and cost are reduced, the solution is uniformly mixed, and generation of glucose degraded products can be effectively reduced.

Description

technical field [0001] The invention belongs to the technical field of injections, in particular to a production process of glucose sodium chloride injection. Background technique [0002] Critically ill patients often need fluid replacement therapy due to various reasons, while trauma or stress and other factors in critically ill patients put the body in a state of high decomposition, resulting in malnutrition, low immune function, and weakened resistance; glucose is one of the main sources of heat for the human body 1. Sodium and chlorine are important electrolytes in the body. They mainly exist in the extracellular fluid and play a very important role in maintaining the volume and osmotic pressure of normal blood and extracellular fluid in the human body. [0003] Although glucose itself has no direct biological toxicity, glucose will produce a large amount of toxic glucose degradation products (glucose degradation products. GDPs) during high temperature sterilization and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K33/14A61K9/08A61K47/02A61K47/04A61P3/02A61P37/04A61P3/12A61K31/7004
Inventor 冯新光李继仁叶芳
Owner HUAREN PHARMACEUTICAL CO LTD
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