Mixed carbohydrate-electrolyte injection and preparation method thereof

A technology of electrolyte injection and mixed sugar, which is applied in the direction of drug combination, pharmaceutical formula, and active ingredients of phosphorus compounds, etc., which can solve problems such as inability to ensure long-term stability, low 5-hydroxymethylfurfural, and increased production costs, so as to avoid Precipitation of crystals, simplification of process, and reduction of production time and cost

Active Publication Date: 2013-11-27
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, this preparation process does not control the nitrogen filling process of the preparation process and filling process, and cannot ensure that 5-hydroxymethylfurfural remains at a low level during the long-term stability process
Moreover, the steps of the above preparation method are cumbersome, feeding three times, adding activated carbon twice for adsorption, the amount of activated carbon is too high (0.05-0.07%), and adjusting the pH value twice, which increases the production cost

Method used

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  • Mixed carbohydrate-electrolyte injection and preparation method thereof
  • Mixed carbohydrate-electrolyte injection and preparation method thereof
  • Mixed carbohydrate-electrolyte injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Mixed sugar electrolyte injection, the prescription is as follows:

[0031]

[0032]

[0033] The preparation steps are as follows:

[0034] (1) Add the prescribed amount of anhydrous glucose, fructose, xylitol, sodium chloride, sodium acetate, and dipotassium hydrogen phosphate to water for injection (80°C) in turn under nitrogen-filled conditions. After completely dissolving, use Citric acid to adjust the pH value, add activated carbon, stir, and filter to obtain the filtrate; the whole process controls the dissolved oxygen at 2-3ppm;

[0035] (2) Add the prescribed amount of zinc sulfate, calcium chloride, magnesium chloride and sodium bisulfite to the filtrate obtained in step (1) under the condition of nitrogen filling, stir, dissolve, and constant volume, and control the dissolved oxygen in the whole process at 2 -3ppm. Then filter with a 0.45 μm filter element and a 0.2 μm filter element in sequence, fill with nitrogen (residual oxygen content is less tha...

Embodiment 2

[0037] Mixed sugar electrolyte injection, the prescription is as follows:

[0038]

[0039]

[0040] The preparation steps are as follows:

[0041] (1) Add the prescribed amount of anhydrous glucose, fructose, xylitol, sodium chloride, sodium acetate, and dipotassium hydrogen phosphate to water for injection (80°C) in turn under nitrogen-filled conditions. After completely dissolving, use Citric acid to adjust the pH value, add activated carbon, stir, and filter to obtain the filtrate; the whole process controls the dissolved oxygen at 1-2ppm;

[0042] (2) Add the prescription amount of zinc sulfate, calcium chloride, magnesium chloride and sodium bisulfite to the filtrate obtained in step (1) under the condition of nitrogen filling, stir, dissolve, and constant volume, and control the dissolved oxygen in the whole process at 1 -2ppm. Then filter with a 0.45 μm filter element and a 0.2 μm filter element in sequence, fill with nitrogen (residual oxygen content is less t...

Embodiment 3

[0044] Mixed sugar electrolyte injection, the prescription is as follows:

[0045]

[0046] The preparation steps are as follows:

[0047](1) Add the prescribed amount of anhydrous glucose, fructose, xylitol, sodium chloride, sodium acetate, and dipotassium hydrogen phosphate to water for injection (75°C) in turn under nitrogen-filled conditions. After completely dissolving, use Citric acid to adjust the pH value, add activated carbon, stir, and filter to obtain the filtrate; the whole process controls the dissolved oxygen to be lower than 1ppm;

[0048] (2) Add the prescription amount of zinc sulfate, calcium chloride, magnesium chloride and sodium bisulfite to the filtrate obtained in step (1) under the condition of nitrogen filling, stir, dissolve, and constant volume, and control the dissolved oxygen in the whole process to be lower than 1ppm. Then filter with a 0.45 μm filter element and a 0.2 μm filter element in sequence, fill with nitrogen (residual oxygen content...

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Abstract

The invention belongs to the field of a pharmaceutical preparation, and particularly relates to a mixed carbohydrate-electrolyte injection and a preparation method thereof. A pH modifier of the injection is citric acid, and pH is 4.0-4.4. By controlling the dosage range of the pH modifier, the pH range of the finished product can meet the specification only by regulating the pH value for one time in the preparation process. In addition, according to the method, activated carbon is added only in the step, and the activated carbon is not added in the preparation process, so that the risk of introducing metal ions and other impurities through the activated carbon can be effectively avoided, and toxins in bacteria of the finished product are qualified. According to the method, the technology is further simplified, the production time and cost can be shortened and lowered, and the sterilized product has no crystallization or precipitation phenomenon. After being stored for 24 months, the 5-hydroxymethyl-furfural range of the injection is within 0.03-0.05, and the impurities are controlled at the extremely low level; after being stored for 24 months, the injection almost has no character change and is still colorless clear liquid compared with the injection which is stored for zero day.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a mixed sugar-electrolyte injection and a preparation method thereof. Background technique [0002] In recent years, with the development of parenteral nutrition (PN), the development of high-concentration carbohydrate nutrition maintenance solution has also been deepened. Domestic sugar electrolyte infusions mainly include the first-generation glucose sodium chloride injection; the second-generation compound glucose electrolyte and compound glucose-lactated Ringer injection; the third-generation invert sugar-electrolyte injection; the fourth-generation Mix sugar electrolyte injection. [0003] In the mixed sugar electrolyte injection, glucose, fructose and xylitol are combined in a ratio of 4:2:1 to efficiently provide energy for the human body. Fructose and xylitol have no effect on blood sugar levels. In addition, this product can supplement the main el...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/42A61K9/08A61P3/02A61P3/12A61K31/7004
Inventor 李长军李洁苏询王兆强邵义红
Owner SHANDONG QIDU PHARMA
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