Preparation method of mixed sugar electrolyte injection and mixed sugar electrolyte injection prepared by preparation method

An electrolyte injection and sugar-mixed technology, which is applied in the field of medical injections, can solve the problems of introduction, high residual oxygen in the solution, and poor quality of mixed sugar-electrolyte injection, and achieve the effect of high clarity and less impurities

Inactive Publication Date: 2021-04-06
CHINA OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The prior art also discloses some preparation schemes for mixed sugar-electrolyte injections, but the residual oxygen in the solution in the existing preparation methods is relatively high, which will lead to the degradation of anhydrous glucose and fructose to produce 5-hydroxymethylfurfural; Type activated carbon is used as an adsorbent for adsorption, but activated carbon will introduce other impurities; therefore, the quality of the mixed sugar-electrolyte injection prepared by the existing scheme is poor

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  • Preparation method of mixed sugar electrolyte injection and mixed sugar electrolyte injection prepared by preparation method
  • Preparation method of mixed sugar electrolyte injection and mixed sugar electrolyte injection prepared by preparation method

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[0040] According to one aspect of the present invention, a preparation method of mixed sugar electrolyte injection, the preparation method comprises the following steps:

[0041] (a), providing mixed sugar, electrolyte components, water and pH regulator as raw materials;

[0042] (b), using the raw materials provided in step (a) to prepare the solution;

[0043] The preparation of the solution includes the following steps: first, the mixed sugar and electrolyte components are dissolved in part of the water to obtain a solution A; then the pH regulator is added to the solution A, and the remaining water is added to mix to obtain a solution B, and the solution preparation is completed ;

[0044] In the step (b) solution preparation process, feed high-purity nitrogen through sterilization and filtration, and control the residual oxygen content of the solution during the preparation process to be 0.01-0.2 mg / L;

[0045] (c) The solution B formulated in step (b) is subjected to f...

Embodiment 1

[0079] A preparation method of mixed sugar electrolyte injection, said preparation method comprising the following steps:

[0080] 1. Provide mixed sugar, electrolyte components, water and pH regulator as raw materials;

[0081] The composition of the raw materials is as follows: 730g of sodium chloride, 410g of acetic acid, 1140g of dipotassium hydrogen phosphate trihydrate, about 490g of citric acid, 185g of calcium chloride, 255g of magnesium chloride, 0.7g of zinc sulfate, 210g of sodium bisulfite, Anhydrous glucose 30000g, fructose 15000g, xylitol 7500g, water for injection about 440000 parts;

[0082] 2. Use a blending tank with a stirring paddle for liquid preparation, add 80% pre-prepared volume of water for injection, heat to boil, remove residual oxygen in the water for injection, and cool down at 40°C;

[0083] 3. Put sodium chloride, sodium acetate, dipotassium hydrogen phosphate trihydrate, citric acid, calcium chloride, magnesium chloride, zinc sulfate, sodium b...

Embodiment 2

[0087] A preparation method of mixed sugar electrolyte injection, said preparation method comprising the following steps:

[0088] 1, with embodiment 1;

[0089] 2. Use a blending tank with a stirring paddle for liquid preparation, add 80% pre-prepared volume of water for injection, heat to boil, remove residual oxygen in the water for injection, and cool down at 50°C;

[0090] 3. Put sodium chloride, sodium acetate, dipotassium hydrogen phosphate trihydrate, citric acid, calcium chloride, magnesium chloride, zinc sulfate, sodium bisulfite, anhydrous glucose, fructose, xylitol into the liquid mixing tank in sequence , stir for 30 minutes after putting in to dissolve all the raw materials, adjust the pH value of the solution to 5.06 with citric acid solution, add water for injection to the full amount, stir for 30 minutes and then take a sample to detect the intermediate. During the blending process, the sterilized Filtered high-purity nitrogen to control the residual oxygen o...

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Abstract

The invention provides a preparation method of a mixed sugar electrolyte injection and the mixed sugar electrolyte injection prepared by the preparation method, which relate to the technical field of medical injections. According to the preparation method, the mixed sugar, the electrolyte component, the water and the pH regulator are used as raw materials to blend the solution. The preparation method comprises the following steps of firstly, dissolving mixed sugar and electrolyte components in part of water to obtain a solution A, adding a pH regulator into the solution A, adding the balance of water, and uniformly mixing to obtain a solution B, and sequentially carrying out refined filtration, filling and sterilization on the solution B to obtain the mixed sugar electrolyte injection. According to the preparation method, high-purity nitrogen subjected to sterilization and filtration is introduced in the solution blending process, and the residual oxygen content of the solution in the blending process is controlled to be 0.01-0.2 mg/L, so that the residual oxygen content in the solution is effectively reduced, degradation of related substances in the blended solution is greatly reduced, the product is purer, and the product quality is improved.

Description

technical field [0001] The invention relates to the technical field of medical injections, in particular to a method for preparing a mixed sugar-electrolyte injection and the prepared mixed sugar-electrolyte injection. Background technique [0002] Under the invasion of various germs and during the operation period, the human body not only needs to replenish water and electrolytes, but also needs to supplement the nutritional heat source mainly sugar, so many nutritional infusion preparations have been developed. Due to the wide variety of sources of glucose and the low price, glucose-electrolyte injections currently used clinically in China are mainly glucose-sodium chloride injections. However, it is very monotonous in terms of energy supplementation and electrolyte supplementation, which cannot meet clinical needs. At the same time, for diabetics, due to the abnormal glucose tolerance of diabetics, the metabolic load after glucose injection is heavy, and glucose cannot be...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K33/42A61P3/02A61P3/12A61K31/7004A61K31/047A61K33/14A61K31/19A61K33/06A61K33/30A61K33/04
CPCA61K9/08A61K9/0019A61K31/7004A61K31/047A61K33/14A61K31/19A61K33/42A61K33/06A61K33/30A61K33/04A61P3/02A61P3/12A61K2300/00
Inventor 李正艳刘玉张轻轻王菲菲
Owner CHINA OTSUKA PHARM CO LTD
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