Compound electrolyte injection and preparation method thereof

A compound electrolyte and injection technology, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, and devices that make drugs into special physical or ingestible forms, and can solve complex production processes, high impurity content, and increased impurities problems such as high storage stability, reduced impurity content, and high promotional value

Active Publication Date: 2021-08-20
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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  • Compound electrolyte injection and preparation method thereof
  • Compound electrolyte injection and preparation method thereof
  • 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 medicinal preparations, and specifically discloses a compound electrolyte injection and a preparation method thereof. The preparation method includes: successively adding L-malic acid, magnesium chloride, sodium chloride, potassium chloride, calcium chloride, sodium acetate and sodium hydroxide with a prescription dosage in order into 70-80% of the total preparation volume of water for injection, performing stirring and dissolving, performing heating to a boil, maintaining for 10-20 min; and replenishing the water for injection to the total preparation volume, performing filtering by using multistage polyethersulfone filter with successively reduced pore diameters, performing filling, and then performing sterilization to obtain the compound electrolyte injection. Through the one-step preparation method, the compound electrolyte injection (II) having significantly reduced impurity types and content can be obtained; the storage stability of the injection can be significantly enhanced; in a stability investigation test, the increasing of impurity content is not obvious; in addition, production technologies are greatly simplified, production efficiency is enhanced, and costs of production are reduced; and therefore, commercial production can be realized. The compound electrolyte injection and the preparation method thereof have wide 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 spaces. 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 dilut...

Claims

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Application Information

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Patent Type & Authority Applications(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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