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Compound electrolyte glucose injection and preparation method thereof

A technology of glucose injection and compound electrolyte, which is applied in the direction of medical formula, medical preparations containing active ingredients, metabolic diseases, etc., can solve the problems of single ingredients and cannot fully meet the needs of water and electrolyte balance, and avoid the increase of content High, high drug compliance and safety, and the effect of improving storage stability

Active Publication Date: 2019-03-19
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Electrolyte injection mainly contains glucose and sodium chloride, which is relatively simple in composition and cannot fully meet the body’s needs for water and electrolyte balance. Moreover, the glucose content in the compound electrolyte glucose injection is relatively large, and related substances will increase during the preparation and storage process. , how to effectively control the content of related substances, prolong drug stability, and improve drug safety are key issues that need to be solved urgently

Method used

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  • Compound electrolyte glucose injection and preparation method thereof
  • Compound electrolyte glucose injection and preparation method thereof
  • Compound electrolyte glucose injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]

[0041]

[0042] Preparation:

[0043] (1) Weigh 50% of the prescribed amount of water for injection, keep it warm at 35°C, add the prescribed amount of sodium chloride, magnesium chloride, calcium chloride, sodium acetate, malic acid, and sodium hydroxide into the water for injection in turn, stir to dissolve, and continue to fill Nitrogen, avoid light;

[0044] (2) adding acetic acid and sodium hydroxide to adjust the pH of the above solution to 5.0;

[0045] (3) drop the prescribed amount of glucose into the solution of the above step (2), stir and dissolve;

[0046] (4) constant volume, fine filtration;

[0047] (5) Divide the obtained liquid medicine (500ml / bottle), stopper, cover, and sterilize with damp heat at 121°C for 20 minutes to obtain the finished product.

[0048] Steps (1), (2), and (3) During the liquid preparation process, continuously fill with nitrogen to discharge the oxygen in the solution; the whole preparation process of this product is...

Embodiment 2

[0050]

[0051]

[0052] Preparation:

[0053] (1) Weigh 50% of the prescribed amount of water for injection, keep it warm at 25°C, add the prescribed amount of sodium chloride, magnesium chloride, calcium chloride, sodium acetate, malic acid, and sodium hydroxide into the water for injection in turn, stir to dissolve, and continue to fill Nitrogen, avoid light;

[0054] (2) adding potassium hydroxide and formic acid, the pH of the above solution is adjusted to 4.5;

[0055] (3) drop the prescribed amount of glucose into the solution of the above step (2), stir and dissolve;

[0056] (4) constant volume, fine filtration;

[0057] (5) Divide the obtained liquid medicine (500ml / bottle), stopper, cover, and sterilize with damp heat at 121°C for 25 minutes to obtain the finished product.

[0058] Steps (1), (2), and (3) During the liquid preparation process, continuously fill with nitrogen to discharge the oxygen in the solution; the whole preparation process of this produc...

Embodiment 3

[0060]

[0061] Preparation:

[0062] (1) Weigh 50% of the prescribed amount of water for injection, keep it warm at 40°C, add the prescribed amount of sodium chloride, magnesium chloride, calcium chloride, sodium acetate, malic acid, and sodium hydroxide into the water for injection in turn, stir to dissolve, and continue to fill Nitrogen, avoid light;

[0063] (2) adding dilute hydrochloric acid and sodium hydroxide to adjust the pH of the above solution to 5.2;

[0064] (3) drop the prescribed amount of glucose into the solution of the above step (2), stir and dissolve;

[0065] (4) constant volume, fine filtration;

[0066] (5) Divide the obtained liquid medicine (500ml / bottle), stopper, cover, and sterilize with damp heat at 121°C for 15 minutes to obtain the finished product.

[0067] Steps (1), (2), and (3) During the liquid preparation process, continuously fill with nitrogen to discharge the oxygen in the solution; the whole preparation process of this product i...

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Abstract

The invention relates to a compound electrolyte glucose injection and a preparation method thereof. The injection is prepared from the following components in 500ml: 0.8-4.0g of sodium chloride, 0.1-0.4g of magnesium chloride, 0.07-0.34g of calcium chloride, 0.5-2.5g of sodium acetate, 0.2-1.0g of malic acid, 15-45g of glucose and 0.05-0.45g of sodium hydroxide and pH regulator which is used for regulating pH to 4.5-5.5. The preparation method comprises the following steps: liquid preparing, filtering, filling, capping, sterilizing and inspecting with a light, wherein the step of liquid preparing adopts a mode of combining concentrated preparation and diluted preparation, low temperature is adopted in the concentrated preparation process, nitrogen is introduced in the whole liquid preparation process for protecting from light. The electrolyte glucose injection prepared by adopting the method has good drug stability and small side effect, patients have high compliance and safety, the requirement of patients for fluid infusion and electrolyte disturbance in an operating process can be met, and the injection is applicable to liver dysfunction, severe shock and child patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a compound electrolyte glucose injection and a preparation method thereof. Background technique [0002] Compound Electrolyte Glucose Injection is suitable for patients who cannot eat, should not eat or eat seriously insufficient, and suffer from nutritional disorders and malnutrition after external gastrointestinal fistula, external pancreatic fistula or major pancreatectomy, total bowel or small bowel resection Preoperative preparation of patients; patients with poor general condition after receiving chemotherapy for malignant tumors; patients who cannot eat for a long time after major surgery are an important part of parenteral nutrition therapy. [0003] Glucose is a ubiquitous metabolic natural substrate in living cells. Glucose is the most important carbohydrate for energy supply under physiological conditions, and the energy supply of nerve tissue, erythrocytes an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K33/06A61K33/00A61K9/08A61P3/12A61P3/02A61K31/19A61K31/194A61K31/7004
CPCA61K9/0019A61K9/08A61K31/19A61K31/194A61K31/7004A61K33/00A61K33/06A61K33/14A61P3/02A61P3/12
Inventor 彭艳丽李鹏张颖张作平李娟娟朱文霞
Owner JINAN KANGHE MEDICAL TECH
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