A kind of compound electrolyte injection and preparation method thereof

A technology for compound electrolytes and injections, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and devices for making medicines into special physical or taking forms, etc. and other problems, to achieve the effects of high storage stability, reduced impurity content, and high promotion value

Active Publication Date: 2022-05-06
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the problems that the existing compound electrolyte injection (II) has high impurity content and many types, the impurities increase significantly during long-term storage, and the production process is complicated, the present invention provides a compound electrolyte injection and a preparation method thereof

Method used

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  • A kind of compound electrolyte injection and preparation method thereof
  • A kind of compound electrolyte injection and preparation method thereof
  • A kind of compound electrolyte injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] This embodiment provides a kind of compound electrolyte injection (II), and the prescription dosage is shown in the following table:

[0030]

[0031] Water for injection to 1L.

[0032] The preparation method of above-mentioned compound electrolyte injection (II) is as follows:

[0033] Step a, add 700mL of fresh water for injection into the preparation tank, add the prescribed amount of L-malic acid, magnesium chloride, sodium chloride, potassium chloride, calcium chloride, sodium acetate and sodium hydroxide aqueous solution in sequence, and stir to dissolve , heated to boiling, and kept for 15 minutes to obtain a compound electrolyte solution;

[0034] Step b, adding water for injection to the compound electrolyte drug solution to the total amount of preparation, filtering through polyethersulfone folded filter elements with pore diameters of 0.45 μm and 0.2 μm in turn, filling the drug solution into a multi-layer co-extrusion infusion bag, and sealing , steril...

Embodiment 2

[0036] This embodiment provides a kind of compound electrolyte injection (II), and the prescription dosage is shown in the following table:

[0037]

[0038] Water for injection to 1L.

[0039] The preparation method of above-mentioned compound electrolyte injection (II) is as follows:

[0040] Step a, add 750mL of fresh water for injection into the preparation tank, add the prescribed amount of L-malic acid, magnesium chloride, sodium chloride, potassium chloride, calcium chloride, sodium acetate and sodium hydroxide aqueous solution in sequence, and stir to dissolve , heated to boiling, and kept for 10 minutes to obtain a compound electrolyte solution;

[0041] Step b, adding water for injection to the compound electrolyte drug solution to the total amount of preparation, filtering through polyethersulfone folded filter elements with pore diameters of 0.45 μm and 0.2 μm in turn, filling the drug solution into a multi-layer co-extrusion infusion bag, and sealing , steril...

Embodiment 3

[0043] This embodiment provides a kind of compound electrolyte injection (II), and the prescription dosage is shown in the following table:

[0044]

[0045] Water for injection to 1L.

[0046] The preparation method of above-mentioned compound electrolyte injection (II) is as follows:

[0047] Step a, add 800mL of fresh water for injection into the preparation tank, add the prescribed amount of L-malic acid, magnesium chloride, sodium chloride, potassium chloride, calcium chloride, sodium acetate and sodium hydroxide aqueous solution in sequence, and stir to dissolve , heated to boiling, and kept for 20 minutes to obtain a compound electrolyte solution;

[0048]Step b, adding water for injection to the compound electrolyte drug solution to the total amount of preparation, filtering through polyethersulfone folded filter elements with pore diameters of 0.45 μm and 0.2 μm in turn, filling the drug solution into a multi-layer co-extrusion infusion bag, and sealing , sterili...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and specifically discloses a compound electrolyte injection and a preparation method thereof. The preparation method is as follows: adding L-malic acid, magnesium chloride, sodium chloride, potassium chloride, calcium chloride, sodium acetate and sodium hydroxide in the prescribed quantity into the water for injection prepared with a total volume of 70-80% in sequence , stir and dissolve, heat to boil, keep for 10min-20min, add water for injection to the total amount of preparation, filter through multi-stage polyethersulfone filter elements with successively smaller pore diameters, fill, and sterilize to obtain compound electrolyte injection. The present invention prepares the compound electrolyte injection (II) with significantly reduced impurity types and contents through a one-step preparation method, which significantly improves the storage stability of the injection, and the impurity content does not increase significantly in the stability investigation test, and at the same time, The production process is greatly simplified, the production efficiency is improved, the production cost is reduced, the industrialized production is facilitated, and the invention has broad application prospects.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound electrolyte injection and a preparation method thereof. Background technique [0002] Compound Electrolyte Injection (II) is a compound preparation, an isotonic electrolyte solution, the electrolyte concentration is suitable for plasma electrolyte concentration, used to treat isotonic dehydration accompanied by or expected to occur acidosis, and supplement the loss of extracellular fluid , to maintain normal osmotic pressure in the extracellular and intracellular space. Compound Electrolyte Injection (II) contains potassium, calcium, magnesium, chloride and other ionic components in proportions similar to those in human plasma, and will not cause electrolyte imbalance, edema, or increased intracranial pressure when used for replacement therapy of extracellular fluid loss. It contains Acetate and malate can effectively avoid the occurrence of diluti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K33/14A61P3/12A61J3/00A61K31/19A61K31/194A61K33/00A61K33/06
CPCA61K31/194A61K33/06A61K33/14A61K31/19A61K33/00A61K9/08A61K9/0019A61P3/12A61J3/00A61K2300/00
Inventor 刘晓娟张泽慧王博金佳鑫张金葆杨学杰王素珍苏燕
Owner SHIJIAZHUANG NO 4 PHARMA
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