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Compound electrolyte invert sugar injection liquid

A technology of electrolyte injection and invert sugar, applied in the field of medicine, can solve the problems of sulfite allergic reaction, serious condition, rapid onset, etc., and achieve the effect of eliminating harm

Inactive Publication Date: 2014-09-03
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] To solve the problem of injection stability, the commonly used method in this field is to add an appropriate amount of stabilizer to the prescription. However, the application of stabilizer in injections has been questioned at present. Sulfite allergic reactions lead to rapid onset and serious illness.

Method used

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  • Compound electrolyte invert sugar injection liquid
  • Compound electrolyte invert sugar injection liquid
  • Compound electrolyte invert sugar injection liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] prescription

[0042] Raw materials / excipients Feeding amount (g)

[0043] Glucose monohydrate 22kg

[0044] Fructose 20kg

[0045] Sodium chloride 468g

[0046] Potassium chloride 744g

[0047] Magnesium Chloride Hexahydrate 244g

[0048] Sodium Lactate (40.7%) 2.752kg

[0049] Sodium dihydrogen phosphate 300g

[0050] Sodium bisulfite 208g

[0051] Hydrochloric acid (37%) 197g.

[0052] Steps: Weigh each component according to the feeding amount, add an appropriate amount of water for injection at 70°C to dissolve, pump it into the concentrated preparation tank, and add water to 160L (40% of the total amount). Add 240g of activated carbon for needles at 0.15% (W / V) of the liquid volume, circulate for 30 minutes, absorb pyrogens, and remove carbon by coarse filtration. Pump the concentrated dosing solution into the dosing tank, add water for injection to dilute to 400L, circulate for 30min, and fine filter at 0.22mm. After the fine filtrate is checked for cla...

Embodiment 2

[0054] Raw materials / excipients Feeding amount (g)

[0055] Glucose monohydrate 22kg

[0056] Fructose 20kg

[0057] Sodium chloride 468g

[0058] Potassium chloride 744g

[0059] Magnesium Chloride Hexahydrate 244g

[0060] Sodium Lactate (40.7%) 2.752kg

[0061] Sodium dihydrogen phosphate 300g

[0062] Sodium bisulfite 208g

[0063] Hydrochloric acid (37%) 180g.

[0064] Steps: Weigh each component according to the feeding amount, add an appropriate amount of water for injection at 40°C to dissolve, pump it into the concentrated preparation tank, and add water to 160L (40% of the total amount). Add 224g of activated carbon for needles at 0.14% (W / V) of the liquid volume, circulate for 30 minutes, absorb pyrogens, and remove carbon by coarse filtration. Pump the concentrated dosing solution into the dosing tank, add water for injection to dilute to 400L, circulate for 30min, and fine filter at 0.22mm. After the fine filtrate is checked for clarity, it is filled into a...

Embodiment 3

[0066] Feeding according to the following formula, based on the amount of 400L,

[0067] Glucose monohydrate 22kg

[0068] Fructose 20kg

[0069] Sodium chloride 468g

[0070] Potassium chloride 744g

[0071] Magnesium Chloride Hexahydrate 244g

[0072] Sodium Lactate (40.7%) 2.752kg

[0073] Sodium dihydrogen phosphate 300g

[0074] Sodium bisulfite 208g

[0075] Hydrochloric acid (37%) 200g

[0076] It is characterized in that the preparation method is as follows:

[0077] (1) Concentrated preparation, weigh sodium chloride, sodium bisulfite, and other ingredients according to the prescription: glucose monohydrate, fructose, potassium chloride, magnesium chloride hexahydrate, sodium dihydrogen phosphate, sodium lactate, add concentrated hydrochloric acid, add appropriate amount Dissolve in water for injection at 80°C, pump into the concentrated preparation tank, and add water to 160L;

[0078] (2) To remove pyrogens, add 256g of activated carbon for needles in an am...

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Abstract

The invention provides a preparation method of invert sugar electrolyte injection liquid. The prescription of the injection liquid is as follows: each 1000ml of injection liquid comprises 50g of glucose, 50g of fructose, 1.46g of sodium chloride, 1.86g of potassium chloride, 2.80g of sodium lactate, 0.75g of sodium dihydrogen phosphate and 0.286g of magnesium chloride; water for injection is added to reach 1000ml. By adopting the compound electrolyte invert sugar injection liquid provided by the invention, the contradiction between an added stabilizing agent and an adverse reaction can be solved, namely that the hazards caused by the stabilizing agent contained in an invert sugar electrolyte solution in clinical applications can be reduced to a highest extent or even can be avoided, and meanwhile, the effects of the stabilizing agent on the stability of an injection in transportation and storage processes can be maintained.

Description

[0001] technical field [0002] The invention belongs to the technical field of medicine, and in particular relates to a compound electrolyte invert sugar injection and a preparation method thereof. Background technique [0003] Invert sugar electrolyte injection is a sterilized aqueous solution of equal amounts of fructose and glucose (invert sugar), sodium chloride, potassium chloride, magnesium chloride, sodium dihydrogen phosphate and sodium lactate, which can provide patients with water, electrolytes and energy, and produce Diuretic effect and metabolic alkalinization effect, the lactate contained in it is metabolized in the liver to generate glycogen, which is in H + Participate in the final generation of CO 2 and water. Clinically, it is suitable for rehydration therapy for patients who need non-oral supplementation of water or energy and electrolytes. It is widely used at home and abroad, and it is included in the United States Pharmacopoeia because of its good eff...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/42A61K47/04A61P7/08
Inventor 郑璐吴斌高苇姚书扬李玲玲丛海建
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA