Glucose polymer peritoneal dialysis solution and preparation process thereof

A technology of glucose polymer and peritoneal dialysis solution, which is applied in the field of glucose polymer peritoneal dialysis solution and its preparation process, can solve the problems of affecting the curative effect of peritoneal dialysis, fast degradation speed, and small size of glucose molecules, so as to improve the curative effect of clinical use, Reduced damage and easy operation

Inactive Publication Date: 2018-01-09
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides a glucose polymer peritoneal dialysis fluid and a preparation process thereof, which solves the problems in the prior art that the glucose molecular size is small and its degradation speed is fast, which affects the curative effect of peritoneal dialysis

Method used

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  • Glucose polymer peritoneal dialysis solution and preparation process thereof
  • Glucose polymer peritoneal dialysis solution and preparation process thereof

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Effect test

Embodiment 1

[0030] In this embodiment, the product scale of producing 300 bags of 2.0L specification is taken as an example, and the preparation volume is 600L.

[0031] (1) Weighing: glucose polymer 45kg, magnesium chloride 0.030kg, calcium chloride 0.154kg, sodium chloride 3.21kg, sodium lactate 2.688kg, where the glucose polymer is icodextrin.

[0032] (2) Add 80% of the full batch volume of fresh water for injection into the concentrated preparation container, and the temperature of the water for injection is 50°C; then, add 100% of the prescription amount of glucose polymer, calcium chloride, sodium chloride, magnesium chloride, and sodium lactate , stir to dissolve.

[0033] (3) After all the above components are dissolved, add 0.01% (W / V) activated carbon, stir well, keep warm and stir for adsorption at 50-60°C, and decarbonize and filter.

[0034] (4) Transfer the above liquid medicine to a dilute preparation tank, add the remaining water for injection after cooling, measure the ...

Embodiment 2

[0038] In this embodiment, the product scale of producing 600 bags of 1.0L specification is taken as an example, and the preparation volume is 600L.

[0039] (1) Weighing: 60kg of glucose polymer, 0.030kg of magnesium chloride, 0.154kg of calcium chloride, 3.21kg of sodium chloride, 2.688kg of sodium lactate, where the glucose polymer is maltodextrin.

[0040] (2) Add 70% of the full batch volume of fresh water for injection into the concentrated preparation container, and the temperature of the water for injection is 60°C; then, add 100% of the prescription amount of glucose polymer, calcium chloride, sodium chloride, magnesium chloride, and sodium lactate, Stir to dissolve.

[0041] (3) After all the above components are dissolved, add 0.1% (W / V) activated carbon, stir well, keep warm and stir for adsorption at 50°C, and decarbonize and filter.

[0042] (4) Transfer the above medicinal solution to the dilute preparation tank, add the remaining water for injection after cool...

Embodiment 3

[0046] In this embodiment, the product scale of producing 200 bags of 3.0 L is taken as an example, and the preparation volume is 600 L.

[0047] (1) Weighing: glucose polymer 90kg, magnesium chloride 0.030kg, calcium chloride 0.154kg, sodium chloride 3.21kg, sodium lactate 2.688kg, where the glucose polymer is icodextrin and maltodextrin according to the quality of 1:1 than the composition of the mixture.

[0048] (2) Add 60% of the full batch volume of fresh water for injection to the concentrated preparation container, and the temperature of the water for injection is 80°C; then, add 100% of the prescription amount of glucose polymer, calcium chloride, sodium chloride, magnesium chloride, and sodium lactate , stir to dissolve.

[0049] (3) Add 0.5% (W / V) activated carbon after it is completely dissolved, stir well, keep warm and stir for adsorption at 60°C, and decarbonize and filter.

[0050] (4) Transfer the above medicinal solution to a dilute preparation tank, add the...

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Abstract

The invention discloses a glucose polymer peritoneal dialysis solution and a preparation process of the glucose polymer peritoneal dialysis solution, belonging to the technical field of peritoneal dialysis. The glucose polymer peritoneal dialysis solution is prepared from the following components in parts by weight: 50-150 g/L of glucose polymer, 80-150 mEq/L of sodium ions, 80-110 mEq/L of chloride ions, 0-4.0 mEq/L of calcium ions, 0-4.0 mEq/L of magnesium ions, 10-45 mEq/L of lactate radical ions, and an appropriate amount of water for injection. The components are mixed and dissolved, active carbon is added, thermal insulation and adsorption are carried out, decarburization and filtering are carried out, the pH value is adjusted, filling is carried out, opening sealing is carried out,sterilization is carried out, and thus the product is obtained. Compared with the traditional peritoneal dialysis solution, the product provided by the invention has the advantage that little glucosedegradation products, especially 5- hydroxymethylfurfural, are generated, and injuries caused by the product to the peritoneum during clinical use of the product are reduced; meanwhile, the stabilityof the molecular weight of the glucose polymer is guaranteed, and the effective ultrafiltration during the long abdomen indwelling period is realized.

Description

technical field [0001] The invention belongs to the technical field of peritoneal dialysis, in particular to a glucose polymer peritoneal dialysis fluid and a preparation process thereof. Background technique [0002] Peritoneal dialysis (PD) uses the patient's peritoneum as a semipermeable membrane, injects peritoneal fluid into the peritoneal cavity, and uses the solute concentration gradient and osmotic gradient between the plasma and the peritoneal fluid to remove nitrogen metabolism and renal excretion under normal circumstances. Toxic substances in the body, and help to regulate body fluids, electrolytes and acid-base balance; as a method of treating end-stage renal disease (end stage renal disease, ESRD) patients, because of its home treatment, it is easy to operate and reduces The special advantages of blood-borne disease transmission and protection of residual renal function have been widely used in recent years. [0003] The existing peritoneal dialysis solution i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/06A61P7/08A61K33/00A61K31/716A61K31/715A61K31/19
Inventor 沈圣民李继仁
Owner HUAREN PHARMACEUTICAL CO LTD
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