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Sodium potassium magnesium calcium glucose injection composition and preparation method thereof

A technology of glucose injection and injection, which is applied in the field of medicine, can solve the problems of increasing the risk of use and the increase of impurities in glucose degradation, and achieve the effects of reducing allergic reactions, reducing irritation, and good stability

Pending Publication Date: 2022-05-27
JIANGSU HENGRUI MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that when the pH value of the product is 6.0, after 12 minutes of high-temperature sterilization at 121°C, which meets the sterilization requirements of injections in my country, the impurities of glucose degradation are greatly increased, which increases the risk of product use.

Method used

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  • Sodium potassium magnesium calcium glucose injection composition and preparation method thereof
  • Sodium potassium magnesium calcium glucose injection composition and preparation method thereof
  • Sodium potassium magnesium calcium glucose injection composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: Preparation of sodium potassium magnesium calcium glucose injection (250ml / bag, 21000 bags)

[0030] Table 1 Composition and dosage of sodium potassium magnesium calcium glucose injection (250ml / bag, 21000 bags)

[0031] The item name Each bag consists of 21,000 bags of batch prescription quantity sodium chloride 1.593g 33.453Kg potassium chloride 0.075g 1.575Kg magnesium chloride 0.051g 1.071Kg Calcium gluconate 0.168g 3.528Kg Sodium citrate 0.147g 3.087Kg Sodium acetate 0.851g 17.871Kg Glucose without anhydrous 2.500g 52.500Kg hydrochloric acid Amount Amount Water for injection Add to 250ml Added to 5250L

[0032] Preparation method:

[0033] 1) Using a stainless steel preparation tank with a stirring paddle, first add about 25% of the total weight of the water for injection, put in the prescribed amount of calcium gluconate, stir to dissolve;

[0034] 2) Add water for injection to the prepa...

Embodiment 2

[0038] Example 2: Preparation of sodium potassium magnesium calcium glucose injection (500ml / bag, 15000 bags)

[0039]Table 2 Composition and dosage of sodium potassium magnesium calcium glucose injection (500ml / bag, 15000 bags)

[0040]

[0041]

[0042] Using the same method as Example 1 to prepare sodium potassium magnesium calcium glucose injection, the difference is: the prescription amount of the two specifications there is a difference in the last digit due to rounding.

Embodiment 3

[0043] Example 3: sodium potassium magnesium calcium glucose injection pH value study

[0044] Table 3 pH filter results

[0045]

[0046] Note: "*" indicates absorbance detection value.

[0047] From the results of Table 3, it can be seen that the glucose content in the solution after sterilization is basically unchanged when the sterilization conditions are 121 °C for 15 min and 121 °C sterilization for 12 min, and the pH value is 5.0 and 5.5. When the pH value exceeds 5.5, with the increase of the pH value, the glucose content in the solution after sterilization gradually decreases, and the amount of degraded impurity fructose gradually increases.

[0048] The results of the sterilized solution under sterilization conditions of 121 °C for 8 min are as shown in Table 4.

[0049] Table 4 Results of further studies at pH

[0050]

[0051] Note: 1) "*" indicates the absorbance detection value; 2) This batch of liquid drugs is sterilized at 121 °C for 8 min.

[0052] From the re...

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PUM

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Abstract

The invention relates to a sodium potassium magnesium calcium glucose injection composition and a preparation method thereof. Specifically, the invention relates to a sodium-potassium-magnesium-calcium glucose injection prepared from sodium chloride, potassium chloride, magnesium chloride, calcium gluconate, sodium citrate, sodium acetate and anhydrous glucose as raw materials and a preparation method of the sodium-potassium-magnesium-calcium glucose injection. The sodium, potassium, magnesium, calcium and glucose injection provided by the invention is a terminal sterilized large-capacity injection, is safe and stable, and meets the requirements of medicinal preparations. The molar concentration, osmotic pressure and pH value of various ions contained in the injection are close to those of human extracellular fluid, and the injection can be used for supplementing extracellular fluid and correcting metabolic acidosis when circulating blood volume and interstitial fluid are reduced.

Description

Technical field [0001] The present invention belongs to the field of pharmaceutical technology, specifically relates to a sodium potassium magnesium calcium glucose injection pharmaceutical composition and preparation method thereof. Background [0002] In the composition of the human body, water accounts for about 60% of the body weight. Body fluid balance plays an important role in the human body, which can maintain the homeostasis of the human body environment. Clinically, various traumas, surgeries and a variety of diseases can cause imbalance in the body's fluid balance, and severe fluid balance disorders can lead to tissue and organ dysfunction, system dysfunction, and even shock death. Therefore, crystalline solutions came into being. [0003] At present, the clinical use of extracellular fluid supplementation solutions are: normal saline, ringer solution, lactate ringer solution (containing sugar and no sugar two), acetate ringer solution (sugary and sugar-free two), sodi...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K9/08A61P7/08A61K31/19A61K31/191A61K31/194A61K31/7004A61K33/06
CPCA61K33/14A61K31/191A61K33/06A61K31/19A61K31/194A61K31/7004A61K9/0019A61K9/08A61P7/08A61K2300/00
Inventor 柴夫娟孙琼周晓丹董凤史海贤刘凯
Owner JIANGSU HENGRUI MEDICINE CO LTD
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